Podcast appearances and mentions of Janet Kennedy

We were out in Riverside Parks at the "You've Got Mail" Promenade bench of our choice talking with NYCSleepDoctor.com Dr, Janet Kennedy. The tourist helicopters were ubiquitous and our UWS neighbors had many questions for Dr. Kennedy about their sleep issues. If there is one thing I learned from this conversation is that a good night's sleep is basic to good health and an interesting life. Listening to Janet's expert advice will probably push you to a more wakeful existence. Alan Winsonbarcrawlradio@gmail.com Hosted on Acast. See acast.com/privacy for more information.

A 78-year-old man who transitioned to a woman, J-Serv, a new bill in MN would heavily restrict the transfer or sale of a firearm, Chris Dahlberg, and city councilor Janet Kennedy will seek a county board seat...See omnystudio.com/listener for privacy information.

This episode contains the full audio from a candidate forum hosted by the News Tribune and Duluth Area Chamber of Commerce. Guests are Ginka Tarnowski and incumbent Janet Kennedy, who are running for the Duluth City Council district 5 seat.  The Duluth News Tribune Minute is a product of Forum Communications Company and is brought to you by reporters at the Duluth News Tribune, Superior Telegram and Cloquet Pine Journal. Find more news throughout the day at duluthnewstribune.com. If you enjoy this podcast, please consider supporting our work with a subscription at duluthnewstribune.news/podcast. Your support allows us to continue providing the local news and content you want.

NYC Sleep Doctor, Dr. Janet Kennedy, is here to share all insights surrounding sleep. In this episode we get into the role sleep plays in our day to day function, performance anxiety and perfectionism when it comes to sleeping well, how we can support our bodies when it comes to getting the best nights rest we can while also TRUSTING OUR BODIES that they know what they are doing, what role our hormones play when it comes to sleep and of course i ask specific niche questions that I just had to know. Dr. Janet Kennedy is a clinical psychologist dedicated to treating sleep problems in adults and young children based in NY and has shared her learnings and insights from practicing for over 15 years in the New York Times, Good Morning America and Fast Company among several other reputable outlets. Link to NYC Sleep Doctor: https://nycsleepdoctor.com/Link to Sophie's Instagram: https://www.instagram.com/sophieiweill/?hl=enLink to Sophie's TikTok: https://www.tiktok.com/@sophieiweillLink to Sophie's YouTube: https://www.youtube.com/channel/UCZKo8SEpPpcGXCsf_F-Uo2Q Hosted on Acast. See acast.com/privacy for more information.

Welcome to an exciting episode all about weighted blankets! We've got two fabulous guests on board today, Dr. Janet Kennedy and Dr. Kathrin Hamm.Dr. Kathrin Hamm is the brilliant creator of a weighted blanket line, Bearaby. Her struggle with chronic insomnia drove her to seek a better solution. She created a revolutionary weighted blanket crafted from breathable cotton, ensuring ultimate comfort and temperature control (and it looks beautiful!). Dr. Janet Kennedy delves into the science behind the effectiveness of weighted blankets.Discover this game-changing blanket and how it can be your perfect sleep companion. Sweet dreams await!BIO:Dr. Kathrin Hamm, CEO and Founder of Bearaby, the leading home wellness and sustainable weighted blanket brand. Specifically, I'd love for you to consider interviewing her for an upcoming episode,  alongside Janet Kennedy, Ph.D., a Brooklyn-based clinical psychologist, sleep expert and author with two decades of specialized experience treating sleep disorders. Kathrin's is a compelling story: after leaving her role as an economist with the World Bank in 2018 following her own personal struggle with chronic insomnia, she found respite in the science of Deep Touch Pressure, and was able to improve her sleep issues naturally. Growing frustrated when she couldn't find a weighted blanket that checked all of her boxes (breathable, sustainable, stylish), she drained her 401K to create her own. Bearaby's award-winning, sustainable, and first-of-its-kind products include weighted “Napper” blankets, calming “Hugget” pillows, a cooling “Pupper Pod” dog bed, a “Cuddler” body pillow, and most recently, a weighted “Napigan” (cardigan).Alongside, Janet Kennedy, Ph.D. is a clinical psychologist and sleep expert with two decades of specialized experience treating sleep disorders. She is the founder of NYC Sleep Doctor and NYC Sleep Consulting LLC, where she provides psychotherapy, coaching and consulting services. Dr. Kennedy is the author of The Good Sleeper: The Essential Guide to Sleep for Your Baby (and You). She is also a sought-after speaker for corporate wellness events (Facebook, Barclays, Lazard, Chanel, Aesop), retail events, and in-house product development events. Dr. Kennedy has been featured on Good Morning America, NY1 News, ABC News, The Tamron Hall Show, Good Day New York, Business Insider, and CBS This Morning; and podcasts such as MomBrain, Secrets of the Most Productive People (Fast Company Magazine), The Upgrade, Reid This Reid That, Raw Beauty Talks, and Simple Families. She has been widely quoted in print and online publications such as The New York Times, The Washington Post, Elle, Parents Magazine, Marie Claire, Self, Shape, Parade, Redbook, and Real Simple. Dr. Kennedy lives with her family in Brooklyn, NY.SHOW NOTES:  

On this episode of People Always, Patients Sometimes we welcome Michelle Shogren back to the podcast. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We recently spoke to Michelle Shogren, a familiar face in the clinical trials industry, most recently at Bayer Pharmaceuticals. She recently left Bayer to form her own consulting firm called Innovate In What You Do! Michelle is parlaying her 25 years of experience fostering teams and developing an innovation mindset into her consultancy. Michelle and our host, Janet Kennedy, have a lively conversation about innovation, which I know you'll enjoy on this episode of People Always, Patients Sometimes.   Janet Kennedy: (00:47) Hi, I'm Janet Kennedy and I'm a member of the Spencer Health Solutions team. It's always a pleasure to talk to Michelle Shogren on People Always, Patients Sometimes. We spoke to Michelle recently on an episode about innovation in clinical trials and the pharmaceutical industry. Today, we're gonna be talking about Michelle's new company Innovate In What You Do! Welcome back to the podcast, Michelle.   Michelle Shogren: (01:11) Hi, Janet. Thanks for having me back again.   Janet Kennedy: (01:13) I am so excited about your new company, but for those folks who might have jumped into this episode and hadn't heard the previous one, do you mind setting the stage a little bit and telling us a little bit about your background?   Michelle Shogren: (01:25) Sure, happy to do that. So I've been in the clinical trial space now for about 25 years in different roles of patient caregiver study coordinator, site, director, marketing director on that side of the fence. Then I jumped over into the CRO world as a monitor and on to pharma to be a monitor, country lead monitor, study lead monitor, and eventually working in process excellence, and then starting an innovation function. The innovation function I created in 2015 with a team of six people who were working on something called fostering innovation. And we were trying to prove innovation made sense in R&D other than coming up with just the molecule. We were able to successfully launch that and grow it over the seven year period to a point where they said, "You know what, you're doing so much now, and it's so impactful for clinical development and operations; let's move you up to strategy portfolio and operations, and you can support all of pharma R&D," which included 11 functions now, instead of just one. So obviously we were doing something right along the way, and now I've had a chance to leave Bayer and focus on some family and some health needs. And I decided what a better time to start my own company to try to help even more people and stay close to the patients.   Janet Kennedy: (02:44) All right. So I guess we're gonna start with a challenge. It's very comfortable, sometimes working for a very big organization with a lot of structure and benefits and support, and you've gone 180 degrees and you are now a self-employed entrepreneur. I understand that through work in innovation, you have to think like an entrepreneur in a big company. Do you think that that's laid the groundwork for your decision to start your company?   Michelle Shogren: (03:12) I think it definitely made it easier for me. It's also something that I've been considering and thinking about for a few years and had planned as a later in life activity anyways. So when the catalyst of change came, I thought, "You know what? We can just go ahead and advance it and make it faster." But you're right. It's a little scary   Janet Kennedy: (03:31) Well, there are a lot of folks out there to support you. That's the one thing that I would share with you; I did come from an entrepreneurial background, was very involved in startup weekends and innovation programs. And it is the most collegial group I have ever run into. Everybody wants you to succeed and they're all there to support. So I think even though you are pretty fresh on the entrepreneurial track, you will find that the network is there to support you. So there's a little bit of encouragement for you going forward.   Michelle Shogren: (04:03) Thanks, Janet. I needed that today.   Janet Kennedy: (04:06) Well, tell me about the company itself, Innovate In What You Do! Why call it that and what is it all about?   Michelle Shogren: (04:13) Well, you know, it's actually, it was a phrase that our corporate innovation had thrown out one time in a presentation and had used it a couple different times. And I said, "You know what? I love this phrase because of the fact, it doesn't ask you to do innovation." It says, "You know what? You can innovate in the things that you do on a regular basis." And that is my philosophy going forward. Why innovate in some other space? You wanna innovate in what you do. And it was all around the fact that how can we be better at our day to day activities, and how can we make a difference for people out there? I have a near and dear passion of patients. So of course, if I can use these powers for good of helping patients in particular, that would be great, but I really just have a purpose within me to help others. And I think innovating what you do can do that.   Janet Kennedy: (05:04) Now. I sense that this is not a quick decision that you made and that this is something you actually have experience doing. So tell me how the actual services that you would consider providing in your new business relate to the work that you did at Bayer.   Michelle Shogren: (05:21) So I have been consulting in some form or fashion for years and years and years, usually just pro bono, trying to help people out and give them encouragement or some direction when they were misguided. Either startup companies, tech companies, different solution providers would come to us and I would say, "Hey, what do you think about this or that," in order to help them figure out, how do they fit into this world of pharma? How do they communicate better? And how do they think about their users at all the steps of the way? A lot of times when we think end users, we think patients, but there's study teams, there's sites. There's so many different pieces that all have to come together to make it work. So one portion of in innovating, what you do is around innovation consulting and trying to help those same people going forward.   Michelle Shogren: (06:06) So maybe it's a pharma company trying to create an innovation function like I did, or maybe it is somebody who has an innovation function and they're struggling with taking those ideas that they have, and actually getting them to incubate and moving them on to implementation. But it could also be other sectors in the same environment or ecosystem that we sit in. So other solution providers, tech companies, startup companies, things of that nature, but it can also be innovating in your leadership style because that's another big piece that people need help with. And that goes back into innovating what you do.   Janet Kennedy: (06:42) All right. So let's go break this down a little bit and I'm gonna get myself some free consulting here. So here's our scenario A - it is a company that really never had anybody with a title of innovation; they were just a traditional company doing the traditional things, but they recognized that maybe their process was a little stale or that they were doing business as usual so much that business was maybe even declining or productivity was declining. That's a pretty big task to come in as an outsider and try to shift that. So how would you go about it?   Michelle Shogren: (07:15) It depends on what their main problem or what they think their problem is. Sometimes they don't even know. And that's where we have the first stage of Innovate In What You Do! So I call it my 'two eyes wide' approach. Cause if you look at the abbreviation for Innovate In What You Do!, it's I.I. - two eyes - and then W Y D - which also sounds like wide. So with this approach, we always have to make sure we know the problem itself and there's different innovation techniques that we can do to ensure that we are thinking about this all the way around. And we really do understand what the problem is. If they have that figured out, then we look to see, okay, well, what are your ideas that you have to fix it? Sometimes they have ideas and they just don't know what to do with it. And I can help them with that other times, they're like, you know what?   Michelle Shogren: (08:00) We just know the problem. And we've been kind of trying to come up with ideas for a long time and not have a much success. So in those cases, I can help with innovation workshops, design sprints, things like that, using my knowledge of seven different innovation methods, as well as facilitation methods that allow them to focus on the content and not how to get to a solution or a resolution. If they have the ideas and they need to figure out how do I incubate them for success? A lot of people approach things like regular projects, just typical project management. This doesn't work for innovation. You actually need to know how to do innovation project management, which is an advanced form of project management. It allows you to do iterations and pivots where a standard project management doesn't even know what to do in those situations.   Michelle Shogren: (08:46) And it also has a huge focus on the user. And how do you bring their voice in early? And how are you testing along the way to make sure you're on the right path and set up for success and building champions within the people that you're gonna have to end up selling this to later on. And if they have an idea of how to do that, and they've gone through everything, but now they're struggling to actually implement it. They've proven in a proof of concept. It makes sense. It totally has the benefits that are there and it's doable, but they're just failing at how to get that implemented either at their company, or maybe they're trying to sell something to another company. That's another piece that we can help as well to try to figure out, okay, why is this a problem? What do you need for a good pitch? Do you have all the data that's necessary? Are you prepared for the questions they're gonna ask? And then what are the tips and tricks that I can share from all the years of experience of being able to be proactive instead of reactive in this environment.   Janet Kennedy: (09:43) So let's go back to the companies that maybe accept the idea that they need to be innovating or they're attempting innovation, but it really isn't getting off the launchpad. A lot of the problem is most employees feel like I'm already busy. Now I'm already overwhelmed. I can't get my regular work done. And now I need to go into a workshop and we're gonna brainstorm some stuff, but I'm gonna go back to my regular job after that. How do you get people on board and then how do you make them or encourage accountability once you've finished a workshop?   Michelle Shogren: (10:15) Great question Janet. Many times when we find the situation, I can simply ask them, "Oh, well, how long have you been working on this topic?" And most of the time, it's not a brand new topic. It's something they've been struggling with. And they say, "Oh, we've been working on this for months already." I'm like, "Oh, okay. Well, how many ideas did you come up with in those meetings over the last couple of months?" "Oh, well we had a few, but you know, um, nothing really seemed to land well," is usually what they say. And I said, "Oh, well, can you show me the list of ideas?" "Oh, well, we don't really document them. We just talk about them." And that's big problem. Number one is that they've obviously spent a lot of time on it. And if I could have a workshop with them for two to three hours, bring all the right people together, ensure that the process was followed.   Michelle Shogren: (11:03) I provide the time constraints that are necessary to keep from overthinking or chasing rabbits down holes we don't need to do. And I ensure there's documentation of all of the ideas and the concepts that come out of it. Now I've given to them what they've tried to do for the last three to six months, possibly in two to three hours. And if you add an extra hour onto that, I can give you your next step session, where we talk about jobs to be done. What are the first next steps? Because sometimes people think, "Oh gosh, there's so much to be done." And they look at the end, result, that's out there and they get overwhelmed, kind of like me in housework. So this way I can say, "Hey, what's just the first next step to get this moving in the right direction. Who's gonna be responsible for it? And when do you think it's realistic to get this step done?" And I'll help them map that through in order to be able to ensure life after the workshop actually yields results. And you can bolt on a consulting subscription to it afterwards to help make sure they're driving in that direction and see how they're going along the way and where do they need help. And sometimes you just need someone to push you. You just need that meeting on the calendar to make sure stuff's getting done.   Janet Kennedy: (12:09) Even if it is the day before the meeting.   Michelle Shogren: (12:12) Exactly. And many times it is, but Hey, at least it got done.   Janet Kennedy: (12:16) So innovation also sounds hugely expensive. When you talk to companies, are you telling them that there's no reason meeting if you haven't set aside some budget to support the ideas that will come out of this?   Michelle Shogren: (12:30) No, actually I don't because you know, back in my previous life, when I was right out of school and going into college, I sold Kirby vacuum cleaners, and these were vacuum cleaners that cost about $1,400 to purchase. And I was selling them in rural south Texas, where people made that in the entire month of work. And I found a way to be the top salesperson, even though budget constraints were definitely an issue because if there's enough value there, if there's enough shown benefits, if you do your job well enough in researching and testing things, to have data driven decisions, they'll find a way to find the money.   Janet Kennedy: (13:07) Oh, that's an excellent point. So I'm now picturing you going to door selling vacuums, and I love this idea in my head. And that brings me to my next question is: a great percentage of your experience has been in pharmaceutical industries, but everybody needs to innovate. So do you feel like the processes that you've set up, the programs that you're going to be offering, that they are applicable to any industry?   Michelle Shogren: (13:32) Absolutely. I think that the innovation piece of it provides the framework to be able to be applied to any place. And I've actually helped my friends in different industries innovate in what they do just as a friend. So I've helped a day spa figure out how do they retain their people that are working there, their employees, after they get trained, because they were all jumping ship. I've had a funeral home that was trying to figure out how do they have advertising in a situation like that that was quite difficult. So you can, you can apply it in any kind of area. One of the things though that I think sets me apart is the fact that I do have all the experience in all the different roles along the life cycle of a clinical trial. And that's one reason why I'm predominantly positioning myself within this area still, cause that's really where my passion lies. However, my daughter Ren, who is 26, she has come on as a creative director for my company and she has different backgrounds. She has actually worked for bayer as well for a year, as well as other medical companies. And she's also done some really interesting, crazy things with auto dealerships and marketing companies and emergency response companies. So she's seen a lot of other things and she's gonna be able and available to help in some other sectors as well, doing some of the similar things.   Janet Kennedy: (14:58) Well, that was going to be my next question, which is, there is no way you could do this on your own, so how are you building out your community? Do you see this aside from your very talented daughter, do you see this as something that is trainable and replicable so that you could have additional folks leading a workshop for instance?   Michelle Shogren: (15:18) Absolutely. And I already have some people that have reached out to me and were interested in helping and coming to work for me, which is really exciting. I need to have the amount of work first for me to bring them on, but I have several that have experience with innovation, possibly even with me in the past, so that I know their skill sets and their capabilities. Because whenever you do a workshop, especially you need to have two people it's so much better. And I also wanna bring in some diversity and mix because I really believe we need diversity and inclusion in order to have impactful innovation. So that's another big piece. So I'm looking for people that could support also in different places around the world going forward, but I can't get too far ahead of myself. Let's see if this even takes off the ground first.   Janet Kennedy: (16:04) All right. Then one last question, and it's obviously self-serving because I believe the more podcasts the better, but I see on your website, you're thinking about launching a podcast. So what's your plan for that?   Michelle Shogren: (16:17) My thought was I could interview different thought leaders about some of the things that they did as far as innovation, but we could also have some podcasts of talking about what you can do in these situations where it's more of an interview situation. And we talk through what different tools could you do, some easy things you can apply in your day to day work and you can just listen to it and have it to take away with you. Some simple understanding the problem exercises or possibly innovating in under an hour, what you could do with your teams in a regular meeting, some of these key pieces to help them learn and grow and take away some valuable educational information.   Janet Kennedy: (16:56) Oh, I think that's incredibly exciting. Well, I wish you so much luck and success with your new company. I know we'll be talking to you and working with you going forward, but I guess break a leg and I hope it goes very, very well for you.   Michelle Shogren: (17:11) Thank you so much, Janet. I really appreciate you having me here today.   Janet Kennedy: (17:14) You've been listening to the People Always, Patients Sometimes podcast, today with our guest Michelle Shogren of Innovate In What You Do!

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We are proud of the amazing work that pharmacies do to support patient health and wellbeing. The need for innovation in the clinical trial ecosystem has challenged traditional pharmacies to rethink their strategy since they are the ones with the greatest access to a diverse and underserved population. On this episode of People Always, Patients Sometimes, we hear from a member of the clinical trials team at Walgreens that recently announced a corporate launch into providing clinical trial services at neighborhood store locations. Adam Sampson, head of clinical delivery operations for Walgreens is one of the team members tasked with managing the plan at clinical trial services to brick and mortar locations by the end of the year. I hope you enjoy this conversation on People Always, Patients Sometimes.   Janet Kennedy: (00:53) Hi, I'm Janet Kennedy and a member of the Spencer Health Solutions team. I'm looking forward to speaking with today's podcast guest, Adam Samson on People Always, Patients Sometimes. Adam is the Head of Clinical Delivery Operations for Walgreens, and he has a really big project in front of him. Welcome to the podcast, Adam!   Adam Samson: (01:12) Thanks so much, Janet. I really appreciate you having me on the show.   Janet Kennedy: (01:15) Well, you know, we've heard a little bit about you from my CEO, Tom Rhoads, but I'd really like to figure out how you got where you are today, especially from your startup background. So do you mind giving us a little bit of a catch up with your career and how you ended up where you are today?   Adam Samson: (01:31) Yeah, I'd be glad to. So I started my career in clinical trials as many people do, you know the cliches - to say that we kind of fell into the industry. I was a registered dietician out of undergrad and very quickly found my way into interacting directly with patients as part of clinical trials and worked as a clinical research coordinator for a few years and transitioned from there about 10 years ago into the more business side of our industry. So I worked at a couple mid-size CROs, took a very standard path. I was a regional monitor, worked in project management in line management. And then about seven years ago, my wife and I moved out here to North Carolina and I worked at Duke Clinical Research Institute for a few years. While at Duke, I did a lot of work in government funded trials in the pediatric space and completed a master's degree through George Washington in clinical trials.   Adam Samson: (02:28) And then I moved to a large pharma company and was conducting global, late phase studies. And then the pandemic hit, like many of us, I was, scrambling to keep my study going. You know, it's a hundred sites in eight countries. And how do we, possibly kind of keep operations, running lots of challenges. It was an eye opening experience around how in this industry, we really are under utilizing technology. That's no surprise to anyone we've gotten a bit better, but especially at that time, the start of the pandemic, getting even things like e-consent and other things approved was very challenging. So I decided to kind of take a leap of faith and join a very small time startup that was in the decentralized clinical trial space and had a great software product, but wanted to really build out their services and operations.   Adam Samson: (03:22) I joined the team when there were about 15 people and was with the team until series B and about 130 people. It was a really exciting couple years and enjoyed working in that space of how do we bring trials into patients homes and give them additional options to participate in trials? The one thing that remains a pervasive challenge when we're trying to do decentralized trials is that technology of course, is not enough. Sometimes patients there's a lack of trust. If things come through via email or they see them on the internet, not everybody wants somebody in their home. Sometimes people want to, go to a trusted healthcare provider, that's local to them. So when I saw this opportunity open up at Walgreens recently, where Walgreens was getting into the clinical trials business kind of light bulb went off, I'd been watching what's happening just overall in the retail pharmacy space.   Adam Samson: (04:16) And, I saw this as just an incredible opportunity to be able to take what I had learned across my career and kind of running trials in the traditional site based model, as well as, more recently working in the decentralized trials model and saying, "What if, we can take the best of both?" And we've got the technology and Walgreens has 9,000 approximately stores in the US. So 78% of the, the us population is within five miles of the Walgreens. What if we can take and plug clinical trials into that, right? There's the existing trust within the Walgreens brand and with the pharmacists that these patients are seeing every day. And we can really build a model on a really strong foundation that Walgreens has started to build in the healthcare space. So I joined the team as Head of Clinical Delivery Operations, as you said. And my role here is really to operationalize our stores, our physical footprint. How do we make sure that we have the right people process and technologies to be able to start seeing clinical trial patients within some of Walgreen's locations?   Janet Kennedy: (05:26) All right. So let's go back a little bit to joining Walgreens in clinical trials. This is very new for them and you are in a very new group at Walgreens, are you not?   Adam Samson: (05:37) Absolutely. Yeah, you're correct. So about seven months ago, actually I might even take a step farther back than that and say spring of last year, we had our new - no longer new, I guess - CEO, Roz Brewer, joined. And Roz, very quickly - I believe it was by, by fall of last year - announced that we were moving into the healthcare space with the offering of Walgreen's Health. As part of that vision that she had, right? Overall moving to a more interoperable health type framework to ensure for our patients, our main constituents here at Walgreens, that we were not decoupling them from their healthcare providers, but really helping to bridge that care continuum. Part of that offering, they realized clinical trials could be part of this, right? So about seven months ago, my boss, Ramita Tandon, our Chief Clinical Trials Officer, joined the team, joined Walgreens Health, and she began to lay the framework for what this clinical trial business would look like. What services we might offer to begin with, what are the key roles that we needed leadership to get going?   Adam Samson: (06:50) And then Ramita, a couple months ago started bringing on other folks like myself. So I've been with Walgreens - I believe this is the end of week six for me - we've had some folks on a couple weeks longer, or a couple weeks less than me, but we're coming from different backgrounds. We have folks on the product side, we have folks who are really accustomed on digital optimization and how do we engage with patients in a meaningful way, making sure that we leverage our footprint to engage with folks in diverse communities. so really exciting to be part of this new and growing team.   Janet Kennedy: (07:29) I am both thrilled and awestruck for a huge company like that to make such a big move is amazing. And I keep thinking, you're trying to move a tank when the industry needs to be on motorcycles. That might be a horrible analogy, but it's a huge company you said over what, 7,000 locations within five miles of individuals. So how do you do that? Are you cherry picking certain markets or certain states where you already have some of those type of services in play or is this literally you're starting from a blackboard and you're just starting from the very beginning.   Adam Samson: (08:09) Yeah, it's a really good question. And honestly kind of going back to when I first saw the opportunity open up here for a position with Walgreens, my first thought similar to years I think was how could this possibly happen as a company so big, right? how could you possibly get something this big done, and after a call with Ramita, it was quite clear to me that Walgreens was very much invested in this, but also that they had the leadership team Ramita included to really make this happen. I've been blown away since I've joined at not just our small core group that is starting, but outside of that, in the Walgreens ecosystem, just a lot of excitement around Walgreen's health and clinical trials in particular. So obviously we're part of this larger company, but we are somewhat entrepreneurs, right?   Adam Samson: (08:54) We are being given the opportunity to start something new within a very large business and allowing some flexibility around how we might be able to make sure that we can do that in a way that is both effective and compliant, but also nimble. Now 9,000 stores - obviously we're not gonna try and open them all at once and, and activate them as clinical trial sites. The biggest thing on my mind right now is I'm traveling to a number of different locations. We have other folks on our team who are as well meeting with stores, understanding capabilities. We have identified already a number of stores that really are the ideal kind of first step, if you will, to be clinical trial sites. So we have a few investments, key investments that we've made, and some companies that I'll talk about that will really support that.   Adam Samson: (09:47) And also, I will say that Walgreens has, we've started building out what we call health corners. So this has already been happening for a year. Plus health corners are a place where there are a small physical footprint within a Walgreen store. That's staffed with a registered nurse or a registered pharmacist. They have private health rooms and they have places to interact with technology. And it's a place where our patients can go and they can have deep discussions that can help them with chronic care. They can have blood pressure drawn, maybe they could have, blood taken, these type of things to help with chronic disease management and others questions that might come up. Our idea first is to leverage these existing capabilities, as you can probably draw the connection there, right? We've already got nurses, we've got a private health space.   Adam Samson: (10:39) So we're gonna use that and make sure that we put trained clinical research professionals in place to support these activities within these spaces and support them with centralized staff as well. Now we don't wanna stop there. we don't wanna be limited. Now we are somewhere in the range of 200 health corners. I believe by the end of the year, we don't wanna only focus there. As I mentioned, we have some, some other key partners. One is village me medical or village MD. So village MD is actually a primary care offering in a community based setting. And these will be co-located with Walgreen. So this is actually 3,200 square feet of a Walgreen store that will be dedicated to primary care staffed with physicians and other clinicians. So this is another great opportunity for us to be able to leverage the existing Walgreens Health enterprise, to be able to plug clinical trials in make sure that we're doing it in compliant way, but utilizing the existing infrastructure.   Adam Samson: (11:38) There are some other exciting partnerships we have with Shields Health and specialty pharmacy, as well as CareCentrix in post-acute and, and home care. But as far as the physical space and building that out, that's where my focus is right now. How do we activate existing health corners and Village MD, but also looking at our our physical footprint that's out there that has private health rooms because of the immunizations. We administered approximately 63 million COVID vaccines. These spaces are already being used for healthcare purposes. How can we staff those stores and make sure that they are compliant to do certain clinical trial procedures, lots to think about long winded answer there, but really, really kind of cool work to start conceptualizing.   Janet Kennedy: (12:27) I've spent a little bit of time in the shopping center industry. So I feel like I've got a grasp of retail space issues and questions. And let me ask you this. A lot of the Walgreens, I would imagine in more rural or suburban areas have lots of space, but not necessarily in downtown Atlanta or downtown Raleigh or downtown New York city, are you gonna be able to find the space you need in those urban populations, which also are in areas that wouldn't be dealing with underserved populations?   Adam Samson: (12:58) Yeah. And I'm glad you mentioned that too, because this is as we've been very public about in our announcement, one of our biggest focuses right now is making sure that as we are opening up these type of health corners for healthcare purposes, but also our clinical trial purposes. So more than 50% of Walgreens stores are in socially vulnerable areas. And right now there is a huge push in industry and for very good reason to increase, diversity and inclusion within clinical trials, as we're looking at potential locations of where do we start doing this? We're not making it easy on ourselves. We're not, yeah. Let's, to your point, right, go to just the stores with the highest volume or anything. We're very much focused on going into places where there is not as much access to clinical trials or healthcare overall, and areas that are in communities that are overall just underserved. We have already started having these discussions with the the regional managers to identify those stores where, to your point there's only so much retail space or pharmacy space, and this is another thing that we're bringing into stores.   Janet Kennedy: (14:08) Well, you know, I'm wondering about how you're finding out what the needs are. Have you been in communication with some of the larger pharmaceutical companies in a, a, what if scenario, you know, if this were available, what kind of things could we bring to the table? What would you need to get from us? Obviously, patient records are a big part of what you have and also from the geographic location. I mean, so often now clinical trials are done where the principal investigators are. And a lot of the principal investigators are in larger city centers where there are medical centers and universities. How do you balance those needs with what do you actually have to have for the space to conduct a clinical trial?   Adam Samson: (14:51) Great question. And so, yeah, when it comes down to it and what I've spent a lot of the past two years prior to coming to Walgreens doing is trying to figure out how can we leverage some of these new models, right? So how can we leverage, not necessarily even fully decentralized hybrid type models. And we're looking at that with Walgreens too, right? How can we potentially have something at something like a Village MD where there's primary care and physicians and have kind of a hub and spoke model potentially right. Where we would have a PI within a certain region that might be conducting activities within a larger clinical type site, but then have within perhaps a 40 or 50 mile radius, we have X number of Walgreens locations and patients are able to go there for perhaps some of the follow up, right? They can meet with coordinators and have their blood drawn. They can have assessments done, and then if need be, they could come into the to the larger, location for certain procedures throughout the course of that trial. So looking at it in a very broad way and saying, we need to make sure that there's that PI oversight. How can we enable that though over a bit of a larger distance through centralized administrative support, as well as really best in class technology,   Janet Kennedy: (16:07) As I think about a Walgreen's on every street corner, what about the idea of the local Walgreen staff actually going to the patient to their home? Is that something you've discussed?   Adam Samson: (16:18) So we are absolutely looking at also as an option, not just in store, but also bringing this at home, in a doctor's office via mobile app. So we will be in addition to the existing Walgreen staff, which we very well are looking at opportunities for folks to be upskilled into clinical trials. We will be partnering with folks like, those that we have potentially over at CareCentrix and others that are accustomed to working within patients homes so that we can offer that as a service as well, where we could if it's permitted by the protocol, be able to, rather than have patients come all the way into a larger clinic or even to have to drive 10 minutes down the road to a Walgreens that we could potentially go out for certain things like blood draws and other things, and be able to see patients in their home, especially for those type of conditions patients might have where it makes access to clinical trials has decreased because of decreased mobility.   Janet Kennedy: (17:16) Now, the patient is obviously an important part of what we're talking about because that's one of the reasons that clinical trials do struggle that it isn't wrapped around what the patient needs, what the patient expects and how to support them best. Have patients been involved in these kinds of conversations, has Walgreen committed to any kind of patient advocacy committee group or focus group or anything of that sort?   Adam Samson: (17:41) Yeah, I mean, it's very early days, I will say, right. So we did launch just last month, but I am thrilled that we have on board, some folks like Kendal Whitlock who comes with just vast experience in this area, right? Working with patient groups and ensuring that we get that type of representative voice within our research program. we're also talking some other organizations right now that I can't share publicly just yet. but really positioning ourselves very early on. Like I said, we're only a month or so in since our launch to make sure that we are not assuming what our constituents and what our patients want, but making sure that we're hearing directly from people within the communities. Another thing just to kind of bridge off of that is we're looking at not just how do we inform Walgreen's patients and customers about clinical trials that, that might qualify for them, but also how do we kind of help the industry and our patients with this grassroots basic general clinical research, understanding and education, because as you well know, the barriers in a lot of these communities to clinical trials is either a lack of understanding or a lack of trust.   Adam Samson: (18:56) And if we just go in and, and start advertising clinical trials and every single Walgreens, I don't think that that's really gonna solve the problem. So we wanna be able to do some of that foundational clinical trial education through our pharmacist, through, through other staff to really start to build those connections with patients and hear from them so that that can help us inform our strategy.   Janet Kennedy: (19:21) Well, that's really exciting because aside from the two things you already mentioned, just awareness that a patient could be eligible for a clinical trial is a real challenge. So I think the opportunity that you have to make folks aware that it's happening on my street corner is a lot different than, you know, what a lot of patients experience. And certainly if there is at all, a silver lining to the pandemic is that I believe people became aware that clinical trials are an essential part of forwarding health and forwarding the learning about drugs and new ways to deal with illnesses and diseases. So hopefully people have also understood that it is a process that while doesn't happen overnight, we were able to escalate that during the pandemic, but that it's essential that we have patients a part of the process.   Adam Samson: (20:16) Absolutely. Yeah. And this idea of trying to assume what patients might want or to kind of do those checkbox activities of like, oh, well, we talked to a patient. I think, as an industry we're, we're moving past that. We're understanding that this is more than that, that we really need to engage in a meaningful way and that it's not a one and done kind thing. And I've been really glad to see that Walgreens very much is taking that approach to everything. And across the Walgreens health platform we have 160 million approximately lives that we service through Walgreens. And the trust that we have with those customers and those patients is something that is really first and foremost to Walgreen. So as we look at things like supporting, recruitment, as part of clinical trials, looking at insights gained through real world evidence, we have a really robust foundation around regulatory and privacy to make sure that we're not in any way violating that trust. And we're giving our patients, our customer the opportunity to opt in and opt out of these type of things. So that it's again seen as something that we can engage with them on, in a way that works for them, get their feedback. But if they're not interested also be able to not push the issue beyond the point where it should.   Janet Kennedy: (21:44) Absolutely. I think that should be the tenant of any healthcare organization patient first and what are they going to be comfortable with? Well, I'm really excited that I was able to capture you so early and fresh in your experience with Walgreens and at the very beginning of your more public announcements related to getting involved in clinical trials. And I'm not gonna put you on the spot per se, or hold you to this, but what does it really mean? What's it gonna take to get you up and running? And, and when will the first clinical trials be supported at a local Walgreens   Adam Samson: (22:19) We're shooting for this year, right. We, we want this to take months, not years to get off the ground. There's already, as I mentioned, been some groundwork done even before this initial team has started, there's been some really great work done by folks here at Walgreens to make sure that we're gonna be able to roll this thing out in a very compliant way. And now we got the folks on board that are needed to really start executing. And we're not starting from zero as well because we have as I mentioned, some physical locations that are very well staffed and set up to be able to support clinical trials. So we don't wanna rush, we do wanna walk before we run, but we anticipate that this year we will enroll patients within, a small number of clinical trials and start to get the wheels moving on this and then learn and, and build over time to be able to offer an increasing number of services and to be able to, service protocols of increasing complexity. So yeah, I would say, and expect by the end of the year to hear that we've had our first patient in store and certainly even before then, that we're, supporting recruitment in different ways as well.   Janet Kennedy: (23:27) Oh, that is very exciting. Well, I look forward to not only catching up with you in six months, or a year and finding out how things rolled out, but also speaking to other members of your team, hearing maybe a little bit more about how real world data and real world evidence will be incorporated into the programs; how patient engagement is going. So let's continue the conversation and thank you very much for being a part of People Always, Patients Sometimes.   Adam Samson: (23:54) Absolutely. Thanks so much, Janet for the opportunity. I look forward to reconnecting, and thanks so much everybody who listens.

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Today we have the first of two interviews with Michelle Shogren. Michelle is a familiar face on conference stages as a 25 year veteran of the clinical trials industry. Most recently as Senior Director of Business Excellence and Innovation for Pharma R&D at Bayer Pharmaceuticals. She recently left Bayer to form her own consulting firm, but more on that in a later episode. For now, I know you enjoy this discussion on innovation in the pharma industry with Michelle Shogren and Janet Kennedy, on this episode of People Always, Patients Sometimes.   Janet Kennedy: (00:40) Hi, I'm Janet Kennedy and I'm a member of the Spencer Health Solutions team. It is such a pleasure to have Michelle Shogren as our guest on People Always, Patients Sometimes. We've known Michelle for a few years and have followed her leadership posts on social media even longer. Welcome to the podcast, Michelle!   Michelle Shogren: (00:58) Thank you so much, Janet, for having me. I'm really excited to be here today.   Janet Kennedy: (01:02) You know, you've heard a little bit about Michelle from our CEO, Tom Rhoads, but I'd really like to dig in and learn a lot more about you and your background. So can you kinda gimme the short version of how you got where you are today?   Michelle Shogren: (01:16) I think like many of us, I kind of fell into clinical research. I started out as a nurse and someone upstairs was doing clinical trials and got to go to cool places for investigator meetings. And I said, I wanna do that too. And I convinced the doctor that maybe this was also a good way to show our patients. We were forward thinking and we were looking at additional options and have another revenue stream to come into the office. And we kicked it off from there fast forward, 25 years later. And here we sit today, having had a chance to be a patient in trials, a caregiver for my family, as well as be on the site side of things as a site director and marketing director, as well as a study coordinator. And then on the CRO and pharma side, as a monitor and someone leading the studies at different levels, as well as having an opportunity to start an innovation function at Bayer.   Janet Kennedy: (02:07) Well, that really was a short introduction and I have like 10 questions just from hearing that. You know, it's interesting - you really have walked the walk. So it isn't just an esoteric type of job description; you have participated in and are living the life that many of our patients and our colleagues just talk about.   Michelle Shogren: (02:31) Yeah. I actually have personally experienced the value that can come from clinical trials as someone, as an individual who needed help and have offered this kind of help to my friends and family by helping them search for trials and finding ones that might meet their needs because it's an often missed opportunity for patients out there.   Janet Kennedy: (02:53) So when you joined a pharmaceutical company, was it a big shock? Was it very different from what you were expecting or did it feel like a natural evolution?   Michelle Shogren: (03:03) I think one of the most surprising things for me was I had always heard that big pharma was only after your money and they couldn't trust them. And when I came to pharma and I started meeting all the people who are in research and development, I found that so many had stories like me, so many were connected to someone who had some condition and they were trying to find hope for them. And so many were dedicating their lives to really make people better or bring new opportunities there. And I was blown away by the size of the hearts from these people.   Janet Kennedy: (03:33) But from a size perspective, many pharmaceutical companies, and certainly say top 20, are huge organizations. So somehow I have a hard time getting the word 'innovation' and big, giant, slow moving tank of a company in the same place at the same time.   Michelle Shogren: (03:53) Absolutely. So when we started the innovation function at Bayer, it was funny because at the time back in, I guess it was 2015, we were doing an initiative called fostering innovation cause nobody thought we needed innovation in R&D other than finding the new molecules themselves, which is very innovative - I give it that, but there's so much more involved. And we had to do an eight month long research project to find out exactly, does this make sense or not? And then we had to pitch it and say, Hey, we really think this does make sense. And we can make a big difference for Bayer for our patients out there who need it and for the rest of the world, by having this. And it was a little bit of a tough sell. They're like, "Oh, I don't know. You know, we're really regulated here. I don't know how much we can do that's different." But we convinced them to do it. And it was a little struggle to get it going. And the culture change around. It was also hard. People were used to doing everything the same way for such a long time, but it was amazing to see the changes.   Janet Kennedy: (04:50) So when you joined the innovation group and I'm looking here for officially your role there, so you moved from business process manager, process excellence, to head of innovation. That seems a very dramatic switch.   Michelle Shogren: (05:06) Yeah. So I guess my whole career, I was always innovating in what I did anyways. I was always finding things that I said, there's gotta be a better way and then posing solutions and in process excellence, a lot of that is part of what they were doing. They were looking for. How do you bring the excellence into our ways of working? So once we did this initiative, which I was a team member with six people, we needed to have a head for this new function that we had created and I applied and was lucky enough to get that role. And so that's where I made the jump, but it felt very natural for me, especially having been part of innovation for so long in different ways.   Janet Kennedy: (05:45) So I'm interested in the definition of innovation from a pharmaceutical company's perspective. I'm feeling like early on innovation was all in the lab, but now it's really every department ought to be thinking about how they can innovate.   Michelle Shogren: (06:01) Yeah Janet, you're exactly right. It was always about bringing those new molecules to life or new products on a shelf. And people missed the opportunity to innovate in how they do things and their ways to gain efficiencies, to decrease time to market, to improve their business models of their own working groups, even. So this shift that we had, a mindset of, how do you apply innovation to your day to day activities was really monumental going forward. And we had a corporate innovation function that was starting at the same time as our innovation function, which formed an umbrella of services, which was absolutely wonderful. I don't think we would've been able to really get off the ground as easily as we did without having that group there. But it became very evident that we could do a lot here. And especially when we started really focusing more on our users and their involvement earlier on in our processes, that was a big change that came about with bringing in innovation.   Janet Kennedy: (07:02) Well, I definitely wanna talk about patients in a little bit, but let's stay focused for just a second on this idea of innovation. Now we know that telehealth has been around for over 20 years, and in some cases, people are thinking like digital health just grew up in the last two years or the last three years. But when you think about the kind of things you were recommending innovating way back when in the dark ages of 10 years ago, what kind of things were you actually focusing on?   Michelle Shogren: (07:31) I remember one of the first things that we were really bringing in at the time was eConsent and we had looked out into the industry and we saw this coming and there was a lot of pushback for it and not really a sure belief that it made sense or how could we even be sure that the actual patient was the one consenting and is this really adding value or just complexity? So that was one of the early on ones. And then now we have it as optional tool for all of our studies. So a lot has changed since then. And we were able to show that, just like children learn differently - some of them need to have something that is written, others wanna hear it, others have to interact with it to really understand things - especially our informed consents needed to have the same type of opportunity for our patients.   Janet Kennedy: (08:19) Oh, that's fascinating. So then things really start to take off in the startup health space, which doesn't necessarily mean that they were funded by or driven by pharma, but it's all happening outside. So how did you go about as a company evaluating some of these new, very green ideas?   Michelle Shogren: (08:40) That's a funny thing. So while technology involves so quickly in leaps and bounds, unfortunately, big pharma companies move much slower. We're used to having several years to get a drug to market. And these tech companies are launching new products left and right. So for us just to stay up on top of what's out there and what's being offered and being able to see how does this even fit into our regulated environment? What are the risks associated? Where are the real benefits at was a daunting task? And I think most pharma companies also felt that when you add in our archaic procurement type of process, which worked well for many, many years, for many different reasons, all of a sudden it didn't work well for this new style of work, this technology business situation, we would vet companies based on how long they've been around and you know, their financial ability to stay afloat. When you think about needing the data from these tech companies for many, many years later, you're sometimes just hoping and praying they stay afloat to the end of your study. How are you gonna be sure that they're gonna have the audit trails and the data that's necessary to go to the health authorities if we get an inspection many years later. So a lot of things had to change. A lot of mindsets had to change in order to be able to bring some of these things in   Janet Kennedy: (09:58) Well now, with those needs for oversight, the FDA plays a little bit of a role here. Have you felt like they have partnered well with digital health in order to enable pharmaceutical companies to actually use this digital tool?   Michelle Shogren: (10:13) They've done a lot of different things. They have offered some kind of measures that are trying to have a call to action, to have more things electronic. They have also enabled things like the 21st century cures act to be able to present data in different ways that we could capture in different ways, but they fall short of telling us how to do things and what exactly do they want and what is really acceptable, which is the part that makes it very difficult for the pharma companies. If you're spending millions and millions of dollars to run a study, the risk that you go to present it then to those health authorities and they throw it out simply because the way you captured data with one of these tech companies or you interacted on a medication adherence tool or something else like that, that could be very detrimental.   Michelle Shogren: (11:02) And it would mean that maybe we can't do more studies because we've wasted, now the money on this. So the pharma companies are asking for the regulators, "Hey, throw us a bone, let us know what do we need to have for you." So we make sure we're spending our money in the right ways and we are heading in the right direction. But then you have the health authorities and they say, Hey, we wanna see change here. We wanna support this, but this is not our area of expertise either, so you need to come with proposals. You need to show us things and make recommendations to us and talk through your ideas and we'll be happy to talk about them. And there's a bit of a mis match around well, whose job is it to really make these decisions at this point?   Janet Kennedy: (11:44) Well, I'm also curious about people within a large pharmaceutical organization - and I'm not necessarily speaking specifically about Bayer. You have been on, on the stage at multiple national conferences and trade shows and addressing with your colleagues, some of these issues. So I know you can also speak to the industry at large, but when I think about all the different players in a clinical trial from patient to the lab team, I can see that a lot of folks are traveling at different speeds. And that obviously a patient perspective is I want it now, I want it yesterday, to the general, just idea generation of what the new drug is going to be. My question really has to do with, do you feel like innovation and the idea of using new tools for clinical trials - is it reaching all personas that might be involved? Are principal investigators - for instance - are they forward thinking? Are the people writing protocols? Are they forward thinking? And if they're lagging or dragging their feet, does that make this whole thing hugely inefficient and not successful?   Michelle Shogren: (12:56) I think it's an interesting question because of the fact, I think in general, people want to be forward thinking and some of them really think they are forward thinking, but then we have this little glitch in the system, which is almost built into our DNA from caveman times, even I would say, which is our protector mode where, you know, back then it was, Hey, don't touch the fire, cause it's hot. Now we use the protector mode for our families, as well as our work environments where we're out there to say all the challenges that we see as soon as we see something new, like, Ooh, step back, watch out. You know, this could cause this problem or that problem. And these are the risks could be associated with it. And we have a hard time being willing to jump that hurdle. Then when we identify all these potential risks of maybe sometimes just the unknown and this holds us back in several different areas, there's a mix of people in every job and every role, some of them are groundbreakers and they're pushing the envelope every day and every night other people are working the opposite side saying, Hey, that sounds great, but it poses too much risk for us.   Michelle Shogren: (14:04) And that's where we have the little bit of the battle. But one of our biggest battles I think is having even awareness about our clinical trials and having enough patients to recruit, to be able to go into them. And that seems to be the biggest slowdown for getting drugs to market.   Janet Kennedy: (14:20) Now, does that mean you need more principal investigators across the country? Does that mean you need just a better way to communicate trials to patients?   Michelle Shogren: (14:30) I think it's definitely a better way to communicate trials to patients. One of the things that came out of COVID was the fact that everybody has heard of a clinical trial at this point. And many people feel like they're part of a really big one, right? So in one way, I think that's helped some for the awareness, but people don't always realize that there's clinical trials out there and available for a multitude of different reasons. And it's not necessarily a one stop shop. We know that amount of people that actually hear about a clinical trial as a care option for them is in the single digits of percentages, which is just crazy. We have to find a way to democratize access to clinical trials and share the awareness to patients as well as community doctors and having the right PIs and the right sites out there are really helpful. But having been on the site side of things, I can tell you, you know, sometimes it's just trying to find somebody who would reply to an and for a clinical trial can be challenging or having the right patients. Once you get through all the crazy inclusion, exclusion requirements for the trial is also a challenge. So we might have enough PIs out there, but we could always use more in different communities and add some diversity into our clinical trials as well.   Janet Kennedy: (15:46) You know, when I think about myself, for instance, and admittedly I've been in healthcare, so I'm a little more aware obviously of what a clinical trial is or about, but I'm like, "Eh, I take a little of this and I take a little of that, but gee, nobody would want me in a clinical trial. I'm healthy. I don't have a rare disease. I don't have a hugely debilitating condition." So of course it wouldn't even occur to me that somebody would be looking for someone like me.   Michelle Shogren: (16:12) Yeah. And I think that's one of the biggest problems. Like how do we increase the awareness? I remember my dad was lucky actually he had high blood pressure, pretty simple. Right. And why would you need a clinical trial for that? And my mom reached out to me and she was like, "Hey Chelle, I gotta tell you, they just offered Joe a clinical trial." And I'm like, "Wait, what? For what?" And she said, "For his blood pressure." I'm like, "He's a horrible patient. Why would they offer him a clinical trial?" And she said, "Oh, because of the fact he is a horrible patient. They really think he needs more monitoring. He needs somebody to help him get on a good path going forward and take the medication on a regular basis." Because he was great about taking it for about a week. Once he got a new one.   Michelle Shogren: (16:51) And then you didn't go back to the doctor for three to six months. So he'd take it for about a week before he saw the doctor again and who knows what happened in the middle. So they thought, you know what, he's really having a hard time with his heart. He needs to have more structure to it. So by going into a clinical trial, he was going in every four to six weeks and he was able to take a medication that didn't give him some of the swelling and other problems that the ones that he had tried before did. So he was actually more willing to take it. So it turned into a really nice thing for him and people just don't realize those kind of studies are out there.   Janet Kennedy: (17:24) Well, it's funny, you mentioned that cause I'm going through some interesting challenges with my own parents, but part of their problem is they're just beyond the digital divide. I mean I've noticed them not being able to interact with the television as easily as they used to just a few years ago and indeed traded televisions with them because I had a simple Roku remote that only had six buttons - and that's still a challenge. So we also have an issue of being digitally savvy. And as you looked at tools for your company or for the other panels and scenarios that you were a part of, how do you think digital intelligence digital experience comes into play with some of these tools?   Michelle Shogren: (18:08) Well, I definitely see a difference between our digital natives, which have grown up with technology their whole lives and the digital immigrants as we call them for the ones who had to come over to this way of working. But it's also an interesting thing that we found that through our mythbusting sessions, sometimes we would have people that were in that digital immigrant category, helping us to troubleshoot and problem solve when the technology went bad. So they were sometimes even more savvy than we were. So it's not a one size fits all approach, but there is definitely a difference for how much bandwidth somebody can handle at what time. And this is also where we run into a little bit of problems because a one size fits all approach, seldom does. So how do we ensure that when we bring technology into a trial, we can hit these different needs and capabilities of our patients while they're in the study and really make them feel supported while still achieving the goals that we have.   Janet Kennedy: (19:04) And does the patient have a role in this process, a physical role - a person who actually represents the patient at the table?   Michelle Shogren: (19:14) Yeah. So that's one of the big things that I pushed for. I call myself a 'patient passioneer,' which was a word that came up from somebody within our organization. And I absolutely loved it and I have kind of stolen it from him. Thanks Oliver, if you're out there! But I feel like we have to do better here. A lot of times when we were first starting, we were saying, "Okay, it makes sense. You know, I would see that a patient would need this or would like this." And we thought we understood them. And sometimes we even talked to doctors and doctors of course knew what the patient needed or wanted, because they saw them face to face. So we trusted them. Then as we move forward, we started seeing, we were rolling things out, and there were problems. And there were difficulties for the patients.   Michelle Shogren: (19:56) They were trying different things than what was intended. And it became a bit of an eye-opening experience that, hey, maybe we didn't think this through all the way. Or maybe the people that we thought knew didn't know as much as we had hoped because there's so many different variables out there. And that's where we started really trying to bring the patient voice in. And as an industry, this is something that we talked about for a few years. And now I think it's something that we're doing for the last couple of years as well, but we can still do better. And we also have to bring it in earlier in the process. A lot of times people are throwing this in right before they launch a trial. Like just to see, is there an oh crap moment ahead? And we need to come up with a quick help desk support plan for it before it rolls out. It's too late in the process to really make big changes. So we've gotta do it sooner. And we even need to think about it in the design process at the very, very beginning. And we're just now moving as an industry towards that, but I'm really excited that we're having those conversations.   Janet Kennedy: (20:58) Do you see more and more patient advocate committees or designators at pharmaceutical companies?   Michelle Shogren: (21:06) Yes, definitely. There are some companies which were faster moving than other companies and there's some still lagging. So it's a nice call to action for those laggards out there to bring more patients in. But I do see this changing and moving, especially if you look at now versus probably five years ago, it's dramatically different. And even with having COVID and that crisis out there, we've managed to bring patient voice in through different means. Maybe sometimes an interview that's on the phone. Sometimes it might be a survey with a couple of people they could do at home. Other times it might be with a focus group or a sounding board that is probably more digital lately, but it's happening more and more. And I'm really excited when I see things where brand teams have now added some type of a patient committee or at least a patient advisor into the overall conversations on a regular basis and then go to them on maybe a quarterly basis saying, "Okay, this is where we're at right now. What are your thoughts about X, Y, and Z?" That to me, shows progress   Janet Kennedy: (22:09) Putting on your industry, prognostication hat for a second; obviously the pandemic was a game changer on pretty much every level. What do you see from the past has been the most important changes that have come to clinical trial innovation as a result of the pandemic. And looking ahead at just a few years, because there's no point looking further ahead than that for right now -what do you see being the biggest game changers in the industry?   Michelle Shogren: (22:40) Well, I think with the pandemic, one of the big things that we realized is we were kind of getting in our own way when it came to technology sometimes because the sites embraced it and often offered it before we were ever ready or prepared to have the conversation. So where we were thinking that the sites wouldn't wanna do it, or they were worried about the burden, they were the ones saying, Hey, we're already doing telemedicine visits with our patients. And some of the sites were already FedExing medication to the patients. And we were like, oh no, we have to figure this out. Um, so one big learning was that there might be more of an appetite when there's a need than when it was a nice to have. And I think the study teams also were quicker to embrace it because they realized we always put our patients safety first and foremost in everything that we do.   Michelle Shogren: (23:26) So they needed to make sure how are we gonna keep our patients safe if we can't bring them in the office all the time. And if we're not able to do those blood draws in the clinic, because a fear of contaminating them with COVID. So hopefully all of these things that we learned will be able to continue. And I'm one of the people that signed up for the #NoGoingBack pledge. And I hope everybody listening to this did as well, but I'm already starting to see some seepage back into the old ways of working where we say, "Okay, we only did this because of the pandemic. We don't have to do this anymore." And you're right. We don't have to do it anymore; but we could do it. And it might decrease burden on patients. And we might be able to really make a big difference to someone who wasn't previously able to do a trial by leveraging things like telemedicine visits, for example.   Janet Kennedy: (24:13) Well, excellent. Michelle, this has been a fabulous conversation and one that I would like to pick up in the near future. I can't thank you enough for being a guest on People Always, Patients Sometimes.   Michelle Shogren: (24:25) Thank you so much, Janet, for having me.

Zebra Technologies is one of the largest suppliers of barcode printing and scanning devices globally. In 1991, Zebra introduced 2D barcode scanners followed by Radio Frequency Identification (RFID) tracking tags, rugged mobile computers, tablets, and wearable devices for increased inventory and asset visibility. Lately, it's been acquiring companies in software, robotics, AI, data capture, and real-time location systems, all to help it transform from a traditional hardware-centric company to a software solutions organization to realize a vision it calls enterprise asset intelligence (EAI) at the edge. Today, Zebra has customers in manufacturing, retail, healthcare, transportation, logistics, and the public sector, with over 10,000 partners across 100 countries. In today's episode, Chris Hood sits down with Janet Kennedy, Vice President, North America Regions at Google Cloud, and Tom Bianculli, SVP and CTO at Zebra Technologies, to go behind the scenes of this Transformation Debrief conversation to learn how Zebra Technologies has navigated these changes.

Zebra Technologies is one of the largest suppliers of barcode printing and scanning devices globally. In 1991, Zebra introduced 2D barcode scanners followed by Radio Frequency Identification (RFID) tracking tags, rugged mobile computers, tablets, and wearable devices for increased inventory and asset visibility. Lately, it's been acquiring companies in software, robotics, AI, data capture, and real-time location systems, all to help it transform from a traditional hardware-centric company to a software solutions organization to realize a vision it calls enterprise asset intelligence (EAI) at the edge. Today, Zebra has customers in manufacturing, retail, healthcare, transportation, logistics, and the public sector, with over 10,000 partners across 100 countries. In today's episode, Chris Hood sits down with Janet Kennedy, Vice President, North America Regions at Google Cloud, and Tom Bianculli, SVP and CTO at Zebra Technologies, to go behind the scenes of this Transformation Debrief conversation to learn how Zebra Technologies has navigated these changes.

The rare disease community has found strength in small numbers by banding together to share their stories. On this rare disease day, we would like to take a moment to recognize and celebrate the patient advocates and organizations that keep the focus on these underserved communities. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. I'm proud to announce that today's podcast will be the first in a series of conversations with leaders in the rare disease community. Our host, Janet Kennedy, welcomes Eden Lord to the People Always, Patients Sometimes podcast. Eden is the founder of the Dash Alliance and 24 Hours of Rare: a Global Celebration of Rare Disease. I hope you enjoy their conversation as much as I did.   Janet Kennedy: (00:49) As we celebrate Rare Disease Day, I have the honor of bringing somebody to the podcast that, in my mind, overwhelms me with her initiatives and dedication to helping create community and conversation in the rare disease community. Eden Lord is the founder of multiple rare disease initiatives, including the Dash Alliance, the Rare Fare, 24 Hours of Rare, and Rare 72! So much happening to make it easier for folks who are in the rare disease community to come together for conversation. So on this special day, Eden, welcome to People Always, Patient Sometimes.   Eden Lord: (01:34) Thank you so much for having me.   Janet Kennedy: (01:36) You know, I actually had a chance to meet Eden a few years ago when I was invited - and I'm very proud to say - to sit on a panel during one of her virtual events. And it was a real eye opener. And, you know, we talk about imposter syndrome; I'm very fortunate in that I am a generally very healthy person. And when you are surrounded by people who are feeling the struggle of their health, every second they breathe, it sure does put things in perspective. And I was honored to be part of that program, but also humbled, by what a challenge life can be in living with a rare disease.   Eden Lord: (02:18) It definitely is, but there are so many blessings that come with the path that you walk in the disease community and so many people - like yourself - that you get to meet who really have an understanding, or want to have a better understanding, of what it's like to be a patient or raising a patient and what that path looks like and how people can help. It's the attitude that we look for when we're building our communities. And it's definitely a hard road, but it is definitely a blessed road as well.   Janet Kennedy: (02:46) Tell me a little bit about your background and how you became such an advocate for rare disease.   Eden Lord: (02:54) Well, I, myself am a third generation rare disease patient. So it started with my grandfather, passed my dad, myself, and now we are raising four kiddos who all have a chromosome microdeletion, and it has manifested in multiple rare disease diagnoses for two out of our four kids, likely going to be three out of our four kids. So been hoeing this row for a while now.   Janet Kennedy: (03:18) So from a rare disease perspective, I think the first challenge might be even figuring out that you have a rare disease?   Eden Lord: (03:26) Definitely has been a struggle to walk that path towards diagnosis. And, you know, everyone's story is different. For us, the story that stands out is our daughter who was not caught on newborn screening panels with her condition. And it was four months before we reached a diagnosis and it was a significant medical crisis that precipitated her diagnosis. So that's definitely something that we're cognizant of is the path that it takes. I think, on average, it's seven years before you actually have that diagnosis in hand. And that's if you're one of the lucky ones; a lot of the times you won't have an answer and you will go undiagnosed. And then you're at a point where you're just treating symptoms.   Janet Kennedy: (04:02) Now to be qualified - and I'm doing air quotes here - as a rare disease patient, that means you're one in what? Is it one in a million, one in 10 million? How do you qualify as a rare disease patient?   Eden Lord: (04:16) Well, it's gonna depend on a couple of things. One, it's going to depend on what country you live in and what the prevalence is. And that changes frequently, because again, we don't have everybody diagnosed that needs to be diagnosed. But here in the US, we would say it's one in every 10 or about 10%. So if you put population somewhere around 300 million, we're looking at 30 million Americans who are living with a diagnosis right now.   Janet Kennedy: (04:41) Well, that's actually quite a significant number.   Eden Lord: (04:44) It's not small. Factor in who's still waiting for a diagnosis; you know, I suspect that number climbs significantly, and those are the people that we really want to also reach as a community and support, even though they don't have a name to put with what's going on in their lives.   Janet Kennedy: (05:02) Now I have to say that I think the rare disease community is very fortunate in that you and your husband have a unique set of skills that have enabled you to say, well, not only are we gonna manage and deal with our family's health issues, but we're gonna do something to help other people. So tell me a little bit about how what you're going through as a family ended up actually becoming the profession that you've committed to.   Eden Lord: (05:28) Well, for us, it was kind of a frustration post-diagnosis for our daughter because we literally left the hospital and didn't even have a sheet of paper with her diagnosis written on it. In this instance, she suffers from something called panhypopituitarism, and the only way I could remember what that diagnosis was, was Peter Pan, and thinking, I need to go home and research the heck out of this and figure out what's what, because this was prior to smartphones and I didn't have a laptop with me, so I was kind of on my own as far as research because the hospital didn't provide that information. So for us, it's really been an opportunity and a challenge to take our backgrounds in tech and education and try to build resources and tools that make things like, you know, diagnosis support, or different medical devices, medical treatments, more accessible to people and give them a place where they feel like they're connected and engaged, even if they can't travel to a conference. Even if they're struggling to figure out where to start, we just wanna try to be that touchstone and point people towards the best resources available for the diagnosis and the situation that they're living in.   Janet Kennedy: (06:37) And what does that mean from the standpoint, if I were to go to the web, how would I find that information? How would I interact with you and your husband, Jeff?   Eden Lord: (06:45) So we have a couple of different channels right now. We have the Dash Alliance, which is kind of our main umbrella organization. And under that, we work with several different organizations to help them become more patient-centric, to amplify the patient voice. We kind of worked across the spectrum with different stakeholders in the rare disease community there. It absolutely also means that patients and caregivers in other industries, stakeholders, representatives have access to our virtual events, which for us is a goal to try to bring as many people together in the same room and kind of do away with the hindrances of travel, the cost, the, just physical challenges of managing oxygen or a wheelchair or whatever that may be, and give people a space to gather that is safe, where they know that their voices are being heard, and that they can network with other experts in the field or other patients who are just living the same or a similar story that they are are.   Janet Kennedy: (07:39) You know, it's interesting you mentioned the travel; COVID aside, it is essential that patients participate in national conferences and be face to face with the pharmaceutical medical communities. However, even before COVID, that was not an easy trick. Aside from the financial impact, it's not easy for a lot of folks who need to be seen and heard to travel, get on a plane, go to these places, and actively participate. So it doesn't matter that COVID showed up; you really needed to have a virtual event in order to support these patients.   Eden Lord: (08:18) Absolutely. And that's kind of why we launched this in the first place with the virtual platform and virtual events is because I was doing quite a bit of travel and I was attending conferences. And it was fantastic because you build really solid, good relationships with people at the events. And then you see them a few months later, but the problem was you saw the same faces in every room, no matter what side of the country you were on. It's very frustrating when you go in and you say, okay, this person would benefit, this person in my network would benefit, but I know they couldn't be here because Delta's broken their wheelchair twice, or this has happened, or this has occurred with their oxygen, or they just can't travel because it's an expense, or who's going to watch their kids if they come to advocate for their loved ones in DC. There's so many barriers that should not necessarily be there, and the virtual event platform was our way of telling everyone you're welcome here. So our first year, our theme was "welcome to the table, we saved you a seat." Because there is a place for you, and there is a place for your voice, and we will do our very best to amplify it and connect you with the people who need to hear it the most.   Janet Kennedy: (09:26) So what's the virtual event that's tied around Rare Disease Day?   Eden Lord: (09:31) So that's something that we started last year that was so much fun. We had an absolute blast. What we do is for 24 hours solid, we skip around the globe and we get updates from people who are actually in the field doing the work. So nonprofit organizations, patient organizations, industry - everyone hops on board. They give us an update, and it hits noon at the local time, depending on which time zone we're in. So if we're in California, it'll be lunchtime. And that's the hour that that will pop up and air. And it's really fun to just get different updates and to kind of celebrate the advances that people are making across the globe. And it just shows us that we're all connected and we're all unified in our mission, which is to improve the lives of our disease patients and families.   Janet Kennedy: (10:13) Okay. That sounds really cool. Where does the day start then?   Eden Lord: (10:18) We are starting in the UK, so it will be 12 o'clock their time, 7:00 AM Eastern. And we've got a fantastic panel from Rare Revolution Magazine, and they're kicking everything off, talking about turning the tide on rare disease, and then it just skips across the globe from there. But it's pretty fun. Lots of caffeine is consumed during that 24 hours, but it's a blast.   Janet Kennedy: (10:38) Okay. So I'm trying to figure out how you can manage that by yourselves; you must be exhausted. So where does it end if it starts in Great Britain, it ends in...?   Eden Lord: (10:48) We are actually ending in Paris this year. We have a speaker - we're kind of jumping a little bit - we have a speaker who is currently hospitalized with COVID and has asked for that time slot and thinks that he will be up and raring to go. And we said, "You know what? We will do what we need to do. You tell us where you wanna be planted on the schedule and that's where we will put you." So he is a very distinguished physician. We're very, very lucky to have him and glad that he's recovering.   Janet Kennedy: (11:13) Is there a chance for folks to engage and interact during this? Or is it just a series of speakers?   Eden Lord: (11:18) No, there is definitely always interaction in our events. That's where the best stuff comes from, is from the interaction and, you know, the opportunity to connect with other people. We actually, this year, made the decision to incorporate working groups into our schedule. So by continent, with the exception of the very cold ones, we will be incorporating working groups where anyone is welcome to attend, discuss what they're currently working on, what their current challenges are on their continent, and how we can support those challenges and needs.   Janet Kennedy: (11:48) Oh, that's amazing. You must have a very busy weekend getting ready for Monday. Whew!   Eden Lord: (11:52) We do. But we're excited. I mean, this is, this is what we all live for. This is like our superbowl, right? You know, showcase and highlight and raise awareness.   Janet Kennedy: (12:00) That's amazing. Okay. Tell everybody what the website is.   Eden Lord: (12:03) The website for this is www.24hoursofrare.com.   Janet Kennedy: (12:08) Okay. And that is 24hoursofrare.com. Oh, no spelling, that was, that was a bad idea. Okay! But here's the thing; if you happen to be listening after the 28th of February or the 1st of March, be aware that this content is still going to be available to you. So where can they find this content: on the same web link?   Eden Lord: (12:34) Yes. Same web link, which will take you out to our YouTube channel, which is where we house all of our previous sessions and just really great content, really great speakers. We're so fortunate that we've had the participants we've had over the years.   Janet Kennedy: (12:47) Tell me a little bit about running a virtual event for this community. We obviously need to get more voices at the table. Are you getting, not just patients, but are you getting the people that need to be hearing from patients to attend?   Eden Lord: (13:03) I think we really are. We are definitely seeing a shift, not just with the events that we produce, but the events that we're hosting for other rare disease nonprofits, and organizations. They're really using this as kind of the platform to bring everybody together, regardless of where we go from here with physical, in-person events. So we actually have, I believe two hybrid conferences on the books for this spring; might be three, I'll have to check. But people know that "virtual's not going away." It's imperative that we continue to bring content and amplify the voices of those at home. So when you're able to do that in a hybrid situation, say, "Okay, I'm gonna have my people on the ground. I'm gonna have pharma on the ground." But one of the things that we're now able to do with a hybrid model is hand a tablet to that person in the booth and say, "Here, you can still connect with people who are attending from their living room." You can still have access to that booth rep for that pharma company or that medical device company. It is such a huge game changer. It really changes the landscape and how things look going forward. So I would be very surprised if people do not continue to implement the hybrid models going forward, just because of the need to continue the conversation that we've already started during COVID.   Janet Kennedy: (14:21) You know, I am curious since you are very savvy about how to connect with folks online, about your experience dealing with a grandfather and a father, and now yourself and now having a child; so four generations. What's the difference in how they managed - meaning your father and grandfather - how they managed information gathering and connecting and learning about their situation, versus say your daughter's generation, who you could consider a digital native. From the standpoint of empowerment, engagement, getting involved in their own care, what do you see generationally as the differences?   Eden Lord: (15:07) Such differences, Janet. And you make just excellent points about being digital native and what that means now. So, you know, when my grandfather was first diagnosed with multiple different things - multiple myeloma, Alzheimer's - that in itself was a struggle; dealing with an Alzheimer's diagnosis, in addition to cancer, and eventually pancreatic cancer. My grandpa was an attorney and he was a highlighter. So if you wanted to do you research, my grandpa would highlight things. He would underline things in books. So it was all medical books, and what could he read about his condition when he was able to do so. And my uncle was the same way. You know, my mother's the same way. We were all raised to be highlighters and underline the material that's important. So we would go in as caregivers and really oversee setting up his medication for the week. And it was very much, we're going to take care of you, kind of an attitude; patriarch of the family, we're here, whatever you need, clean the house, you know, keep up on your medical appointments with you, things like that.   Eden Lord: (16:06) It was we're here. We're rallying for you. With my father - my dad was highly educated, very, very intelligent, but did not really want to know all the specifics. He had been through so much medical minutia and things that, you know, no one typically goes through as a healthy person, starting from when he was very, very small with accidents - he spent a lot of time in the hospital as a child - so he just didn't want to know. So I kind of took it very seriously as my responsibility to know everything. He ended up with a five way bypass at one point. He ended up with a diagnosis that I had to ask for the blood test for. They diagnosed him with amyloidosis - which I always butcher that word - and I had to ask for the multiple myeloma test.   Eden Lord: (16:46) So that was really taking the research skills that I knew from taking care of my grandfather and seeing kind of that example given to me, and going out and doing the same for my dad, because he didn't wanna know the details of what was going on. He was showing up for procedures, but he just didn't wanna know the background. And then with Cambria it's been very much, "How do we keep her away from the stuff we don't want her to see on the internet?" if she wants to go out and do that research, because for her, she wants to know everything there is to know. She wants to be informed. She wants to know what the rest of her life is going to look like, and she wants to know where the tools and resources are to improve her life right now. So it's just been a huge spectrum kind of on down the line of how we approach and how we take care of things and what we entrust to people. And, you know, it's generational in part too.   Janet Kennedy: (17:35) So are you finding that basically anybody after the baby boom, is more empowered as a patient, more engaged as a patient, or are we still dealing with there's different personalities? There are folks that jump all in and say, "I'm gonna be really a part of my diagnosis and get a handle on this." And there are folks who just still, "I'll do what the doctor tells me."   Eden Lord: (17:57) I think there's always gonna be the personality of, "Hey, you know, I might not speak up just because I'm an introvert and I'm used to just accepting status quo, cause that makes me comfortable." And there's nothing wrong with that. But definitely post baby boomer generation, there is not the hesitancy to question a physician. And back in the day it was 'the neurologist says to do this, the oncologist says to do this, so this is what we're gonna do.' And there was no brooking an argument, there was nothing. It was just, that's the way things were. And now very much, we go in kind of armed with information and say, "Are you sure that you feel confident in that diagnosis? And have you seen this journal article?" And you kind of pull out your pad of paper with notes or you pull out your phone with notes and the doctor looks at you and kind of rolls their eyes.   Eden Lord: (18:42) And you know what they're thinking, "Oh, you're one of those." But that's really the key in rare disease, is you have to press, you have to know that you're doing the best thing for yourself as a patient or your loved one as a patient. And there's all this information out there. So now it's a question of health literacy and how do we educate people on the best medical information that is out there? So while they're empowered and while they're taking action and they're taking control of their diagnosis, that's fantastic. But how do we teach people what information is really medically sound and the stuff that you should be relying on?   Janet Kennedy: (19:16) So I was gonna ask you a question about that. We know that COVID has proved to be very challenging because of misinformation, but do you find that in other rare disease situations?   Eden Lord: (19:28) Unfortunately. I think there are still a lot of misconceptions about what might constitute a valid medical resource. So we do a lot of work to dispel what's qualified and what's not. We teach people how to evaluate a resource. It's the old saying, "teach someone to fish," right? Teach them how to evaluate those resources for them selves and really be able to make judgements and decisions based on the quality information from people who are working in the field.   Janet Kennedy: (19:59) Yep. I think that health literacy and critical thinking skills are going to be more and more important as we go forward. It's such a challenge now that the internet is such a giant ball of string; trying to figure out where the end is and what's relevant, what's accurate, what is going to help you? That is such a challenge for everyone. So it's bad enough that you have this complicated diagnosis you don't understand. You also then have to have the mindset to read everything with a grain of salt and make sure you're getting valid, accurate information.   Eden Lord: (20:35) Exactly.   Janet Kennedy: (20:36) Well, let's ask folks how they can reach out to engage with you. What's the best way to find you on the interwebs?   Eden Lord: (20:44) We are across social media. Obviously I think everyone is now, but the best way, depending on what your needs are, is just to reach out to us through thedashalliance.com. That's kind of our main hub and portal that leads to everything else.   Janet Kennedy: (20:59) Excellent. Well, to officially kick off on Rare Disease Day, a focus on conversations with rare disease, patients, advocates, and those working to improve the state of health and medicine for rare disease patients, I couldn't have thought of a better person to have on the podcast. Eden, I find you so inspirational and the work you're doing is hard, hard work, and I am really, really proud of what you're doing and, in a very small way, proud to help elevate your message. So thank you very much for being on the podcast.   Eden Lord: (21:37) Thank you so much. And you know, thanks for making me tear up because, you know, you saying you're proud of me - that goes a long way, kid. Thank you so much, cause I value what you add to the conversation. And you know, if you recall, you came in on that one panel and saved all of our backsides and really guided the discussion on media and rare disease in a very eloquent way. And I'm still very grateful for that.   Janet Kennedy: (22:02) Well, it's a pleasure working with you and I consider it an honor to continue to do so in the future.   Eden Lord: (22:08) I will see you very soon.

Join Arielle and her cousin Candice as they welcome Dr. Janet Kennedy, a licensed clinical psychologist specializing in treatment of numerous behavioral sleep disturbances, founder of NYC Sleep Doctor and author of The Good Sleeper: The Essential Guide to Sleep for Your Baby (And You). She answers questions like, "Why does sleep matter?" and "How much sleep does a child—or adult—really need?" Plus, they chat about some helpful solutions for a child struggling to sleep through the night. Hopefully you're getting enough sleep, but if not, tune in to get some tips to help you get a good night's rest.Follow @ariellecharnasand @somethingnavy on Instagram!See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Spencer Health Solutions was founded knowing that pharmacies are an integral part of the patient's health journey. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Pharmacy partners are key to supporting Spencer in patient homes for clinical trials and commercial programs, especially specialty pharmacy partners. To dig deeper in the specialty pharmacy and learn about some of the challenges and changes coming to the industry, we invited Sheila Arquette, CEO of the National Association of Specialty Pharmacy to come onto the podcast. I hope you enjoy this conversation with Sheila and our host, Janet Kennedy, on People Always, Patients Sometimes.   Janet Kennedy: (00:43) We are honored to have as our guest, Sheila Arquette. She is the president and CEO of the National Association of Specialty Pharmacy. She joined NASP in 2017 and has been focused on increasing the value of the NASP membership. Some of her initiatives under her tenure have resulted in a substantial increase in their membership, also in member benefits and value, and she's expanded the annual meeting at expo that's held every year in the fall. Specialty pharmacy has a critical role to play in helping patients live their best lives, and I'm thrilled to have her on the People Always, Patients Sometimes podcast. Welcome Sheila!   Sheila Arquette: (01:24) Thank you so much, Janet. It's a pleasure to be here with you today.   Janet Kennedy: (01:27) Now I gave a very quick high level look at your background, and I'd love for you to fill it in a little bit more for us. Your relationship with NASP didn't start in 2017, did it?   Sheila Arquette: (01:37) No, it didn't. I started in a volunteer capacity with NASP way back in 2013, in 2014, and I started off volunteering to serve on the membership committee. And then I was asked to co-chair our government affairs committee and just really loved the mission of this organization and the incredible group of people that were so passionate about specialty pharmacy and patient care. And so I started to get more and more involved and then helped with our first ever specialty pharmacy law conference. And one of our board members, Rebecca Shanahan, it was her vision to establish the Specialty Pharmacy Law Conference and provide continuing legal education credits for lawyers and specialty pharmacy, because it was really challenging to try to find those credits. And then she was also incoming president of the NASP board. And so she knew at the time that she was gonna need help running the organization. And so that's when they reached out to me and asked if I would consider coming on board, full-time.   Janet Kennedy: (02:38) You know, Spencer joined in the not-too-distant past, and we're now members of NASP, and one of the first and frequent emails I get is about what's happening in Congress. And that is amazing, all the work that you're doing there. So what are the big topics that you're covering in the political affairs and government committee?   Sheila Arquette: (02:58) We're very, very focused on ensuring that we have a competitive landscape in a fair imbalanced marketplace. That specialty pharmacy patients have access to the medications that they need and appropriate access, meaning that it's the right drug for that patient at the right time during their clinical treatment. But we also want it to be from the pharmacy of their choosing, right? So we wanna make sure that our pharmacies have access to networks. That reimbursement is fair, and it's not being used to keep them from participating in different payer networks. And we wanna make sure that patients have access and choice. And we're very focused on pharmacy DIR fee reform, right? And ensuring that pharmacies are compensated or paid for their performance and that, you know, that we're all driving to the same end goal, right? We're looking at enhanced clinical outcomes. And we also wanna decrease total cost of care because it's a huge issue, right? We don't have an infinite amount of money or resources.   Janet Kennedy: (04:01) And do you feel like the pharmacy section of healthcare has got a voice that they need to have, or is this something you're trying to build and sustain to a higher level?   Sheila Arquette: (04:13) So with respect to specialty pharmacy, it is something that, you know, we had to start from ground zero, right? When we would meet with members of Congress or, you know, different offices of the administration, or even CMS, when we would talk about specialty pharmacy, there really was a huge learning curve and a lot of education that we had to do because fortunately not very many folks still to this day are treated with specialty medications. It's only still around two or two and a half percent of the total number of prescriptions that are dispensed. So when you would talk about pharmacy, the image that comes to everybody's mind is that corner drug store, right? Your community pharmacy in the middle of town, or that you've always frequented. Then when you started talking to them about, you know, specialty pharmacy and the nuances and the distinctions, there was this kind of scratching of their head. Like, no, not sure what they're talking about. So we really had to start and lay the foundation about, you know, this is what specialty pharmacy is. This is why it's different. And pretty much, this is why you should care about it.   Janet Kennedy: (05:11) Is that NASP's primary goal, or do you have multiple goals for the organization?   Sheila Arquette: (05:17) We have multiple goals, Janet. We have four foundational pillars. One of which is advocacy, but then we also are focused on education, certification, and then also on the membership. And what I mean by the membership is providing all of the resources, the tools, fostering the connections and the networking that leads to enhanced patient care, right? It takes a village, right, to make a specialty pharmacy patient. So we wanna make sure that our members have at their fingertips, everything that they need to better care for their patients.   Janet Kennedy: (05:51) So I am a layperson in the conversation. I don't come with a pharmacy background. I've more of a marketing background. So I'm gonna ask a couple of questions because I know there are a few other folks out there like me who need to ask this deeper level of question. So a 'specialty drug' is something that I couldn't walk into my corner drug store and get?   Sheila Arquette: (06:10) Well, and this is a challenge because we don't yet, still we don't have an established definition of specialty drug. And typically what happens is it's the payers, right? It's the health insurance companies, it's the PBMs. They determine what medications are in their specialty drug program. So back in 2016, members of Congress approached NASP and asked for us to put forth some definitions that they could use as a reference. So with respect to specialty drug, what we focused on was complexity. Specialty medications are complex. It's either in the way that they're administered, dosed, their side effect profile; it could be in the insurance coverage process, that's required to gain approval for patients to receive these medications. There can also be financial barriers that have to be overcome. So typically specialty medications are complex. They may have to be stored or handled in a particular way. Oftentimes you can't get what we consider a specialty drug at your local community pharmacy. However, there are always exceptions to the rule, and as the payers continue to redefine what medications they include in their specialty drug program, sometimes then all of a sudden, you know, these medications are available at your community pharmacy. But typically no, they're restricted to these pharmacies that, you know, manufacturers have selected to work with because of the capabilities, the inherent capabilities that specialty pharmacies have.   Janet Kennedy: (07:38) So how does it work out numbers wise? Is there a specialty pharmacy in everyone's community?   Sheila Arquette: (07:44) No, there's not. And typically most of these pharmacies are closed door. And what I mean by that is patients don't walk in and out, right? There's not a transaction at a pharmacy counter. Most of these patients are managed remotely. You may have a specialty pharmacy with a central fill location where all of the prescriptions are dispensed. And then they have an enormous patient service center type area where all of the patient management services are carried out. So we have folks that will take care of the insurance verification and the benefits investigation, and helping you to understand as a specialty patient, what is your copay for this medication? And if you can't afford it, what are the available options? Then we also will have folks reach out to you to schedule your delivery of the medication and help you with refill reminders. Pharmacists and nurses will also counsel patients, right?   Sheila Arquette: (08:33) Review the medication, take a detailed history, talk about your disease process, make sure that that patient understands what it is they're being treated for and why it's so important to take this medication as prescribed. And what do you do if you have side effects and what are the side effects to look out for? And then specialty pharmacies will also help to coordinate all of this information and interact with other members of the patient's healthcare delivery team. Also, caregivers are really important too. And specialty pharmacist and pharmacy personnel will also interact with those caregivers. So oftentimes no, there isn't going to be a specialty pharmacy in your community, but you will have access to the medications that you need and the support services that you need.   Janet Kennedy: (09:13) Here I was gonna ask my next question about "Gee, are specialty pharmacies patient centric?" and that actually sounds like the very definition of a specialty pharmacy.   Sheila Arquette: (09:24) Absolutely. The patient is at the center of all that specialty pharmacy does. And it's with that mindset that I often say, you know, to my members, you know, you're the reason that specialty pharmacy is special, right? But it is with that patient at the center of all that they do. And that's what drives all of the service offerings, all of the patient counseling, all of the interactions. And it's really interesting because when I took this job at NASP and started learning more about the relationships that develop, you wouldn't think that folks would develop such a fondness for their pharmacist and the pharmacist for the patient, when a lot of this is done telephonically, right? Or now, you know, since COVID, you know, either via zoom, some patients have even elected to be supported through text messaging and emails, but they do develop these relationships.   Sheila Arquette: (10:11) I would tour some of our specialty pharmacy members and, you know, the patient service representatives in their cubicle, they would have pictures that patients sent to them. You know, that they reached a milestone because they were able to be successfully managed on a therapy and get part of their life back. They were able to see their granddaughter graduate from high school, or they were able to attend a wedding or some special event. There'd be Christmas cards. But it was just really interesting just to see how that relationship develops and how important it is. And, you know, most specialty pharmacies have dedicated representatives in patient service folks who will interact with that same patient month after month after month. So they really do develop a deep and personal relationship.   Janet Kennedy: (10:49) You know, while my parents are in their nineties, now, they don't necessarily have any unique medications. And for many years they got their medications at the grocery store. But at this point, their medications are switching up with frequency; It's difficult to keep track of it all. And when they finally said they moved to a specialty pharmacy, I felt so much more relief knowing that they were at an organization that had that administrative functioning that could support them with this deeper level of support. I was always a little bit worried that when they were with a more traditional type of pharmacy, that it was just about, well, what am I feeling right now, as opposed to having a group that was really focused on this big picture, kind of a care management focus of their medications.   Sheila Arquette: (11:40) I'm a pharmacist by training as well. And so I think our community pharmacies do a tremendous job, right, of trying to manage the patient. And oftentimes some of these medication changes are as a result of insurance requirements, formulary decisions. And so sometimes have to wonder, geez, how do they keep it all straight? So I think specialty pharmacy does a really, really great job of managing those patients with these life altering - and oftentimes life threatening - conditions and these specialized medications that perhaps our colleagues in, you know, our community pharmacies, they're just not as familiar with, right? Because they don't see them all the time either. They don't have access to the medication because of a manufacturer restriction or it could be due to a payer restriction. So I think there's a lot of synergy that happens and that we can continue to build on between specialty pharmacists in our community counterparts.   Janet Kennedy: (12:31) You mentioned that certification is a big part of what NASP does, and I'm curious, do you need a higher level of certification expertise, education in order to be a specialty pharmacist?   Sheila Arquette: (12:44) Currently, Janet, that's not required. However, when NASP was founded, the visionaries who knew enough way back in 2012 - because next year we're coming up on our 10th anniversary - they knew that specialty pharmacy was something, right? Nobody knew to the extent at which it was going to grow, but they knew that the pharmacists that were practicing needed access to more education and more resources and more tools to manage these specialty pharmacy patients, because again, right, the incidence is low. So, you know, if you fill a hundred prescriptions, maybe you might have one specialty medication, while the folks who started NASP, they were very focused on the educational component. They also saw a major role for certification and in wanting to be able to demonstrate that pharmacists taking care of these specialty patients did have that level of competency and expertise and knowledge to effectively manage these patients. And so we are the only association that offers a credential, the Certified Specialty Pharmacist Credential, that allows those pharmacists to demonstrate that proficiency.   Janet Kennedy: (13:48) Well, let's talk a little bit about the certification and the programs that you do. How is the patient journey folded into the mission and the activities of NASP?   Sheila Arquette: (14:00) So I like to tell people that our role here at NASP is to provide the educational tools and the resources and the support that our members need so that then they can focus on caring for their patients, right? That's our number one goal. Sometimes, you know, when I'm talking to my team and they talk about our patients and, you know, the patients that we serve, I try to remind them, well, we don't really take care of any patients, right? But we are the support arm of this model, right? Where we're trying to provide what our pharmacies need so that they can better care for patients and try to lessen the load on them, right? Have this information available at their fingertips. So that they can always ensure that their patients are getting best in class care.   Janet Kennedy: (14:39) Well, I know that next year you are going to actually have an award to recognize a caregiver of the year. What is that?   Sheila Arquette: (14:48) It was an idea from our membership committee. And we realized that, like I said, you know, a little bit tongue in cheek, but it really does take a village to help manage these specialty pharmacy patients. And while it is amazing that a lot of these patients, maybe 10 or 15 years ago, they would've been treated in a hospital, or maybe an outpatient clinic or an infusion center. But because of all of the new medications that have been improved, and a lot of them are able to be self administered, either orally or through, you know, an injection that somebody can do at home, these patients are managing these life threatening, life altering conditions at home. And so oftentimes have to rely on caregivers and that support structure around them to manage day to day. So we just really wanna shine the spotlight on the incredible job that our caregivers do. And I think sometimes it's harder to be the caregiver than to be the patient. So we are going to have our first ever caregiver of the year award next year at our annual meeting and expo in September.   Janet Kennedy: (15:48) Oh, that's so deserved and so important because the caregiving role is exhausting and huge burnout. It's something you can't literally walk away from in many cases.   Sheila Arquette: (16:02) No. And, they're oftentimes, you know, they're balancing being that caregiver perhaps with employment, right? And the responsibility of being either a full-time or a part-time employee somewhere, and then their own, you know, other family responsibilities; if they have children or maybe elderly parents. So yes, it is. It just never turns off for them. And so definitely want them to know how very much appreciated they really are.   Janet Kennedy: (16:25) I am curious about the pharmacist patient relationship. When I think about how often I see my doctor - could be three times a year if I'm having a healthy year. Whereas I see my pharmacist every single month. How has that changed in the last 10 years? What kind of things have evolved in pharmacy and the business of pharmacy and the relationship of the pharmacist to the patient?   Sheila Arquette: (16:49) So I think especially, you know, with respect to specialty medications, we've had a boom in specialty drug approvals over the past few years. Like I said, we have now cancer patients being treated in the comfort and convenience of their own home when maybe just 10 short years ago, that would not have been possible just because of the available treatments. So I think we now have a deeper appreciation of the role, the vital role that the pharmacist and specialty pharmacist plays in that healthcare delivery team. As I said, they're responsible for ensuring that this patient receives the maximum benefit from this medication and knows what to do in the event that there's, you know, a side effect or there's some type of issue; the patient's not feeling well, they need a dosage reduction. Also, a lot of these medications - we hear lots about this in the news - are very, very expensive, and patients have difficulty affording them. So specialty pharmacists, step in and try to bridge that gap. And not only do you want a patient to start on their medication, but you want them to be able to afford to stay on their medication. And, you know, not having to choose between some of the other things that they have to spend money on, like rent or heat or food and their medications. So I think that we continue to see that, that important pharmacist patient relationship, and it just continues to grow. It's an exciting time to be in specialty pharmacy.   Janet Kennedy: (18:08) I'm curious about some of the changes coming outside the industry being, in essence, pushed toward pharmacy: things like digital health, and the ability to capture a lot more data than we've ever been able to have in the past. So for instance, the collection of patient reported outcome data and pharmacists' role in monitoring that information. What kind of things are happening in the industry and what are you excited about and what are you concerned about?   Sheila Arquette: (18:36) Sure so I think, you know, patient reported outcome data is critical. You can take, you know, not only the data on the surface, but then as you kind of peel back the layers of the onion and you can see what's driving patient behavior. And then how, how do I use that information to tailor my approach to this patient, right, with respect to medication adherence and compliance, and what can I do better to help this patient along their journey? And so I, I really find it fascinating. And as we continue to see such a focus on personalized and precision medicine, I think the way that we approach patients right, has to be that as well, because what works for you may not work for me. And so I think just taking some of what patients report back to you and really studying it and trying to get at what they're telling you is very, very impactful.   Sheila Arquette: (19:22) And I think it's exciting, right? We're, we're gonna treat patients as the individuals that they are. We continue to learn more and more about the human genome, right? What medications you might respond to, and I'm not going to respond to. And it's really just gonna turn healthcare upside down, right? No longer will we be requiring that people try and fail a medication because we think it may work for you. We're gonna know that it's gonna work or it's not gonna work. And if it's not gonna work, why would we subject you to it? So I think there's tremendous opportunity to do things differently and to really enhance some of the processes and some of the things that we do in healthcare that aren't so efficient right now.   Janet Kennedy: (19:57) Have you looked at an opportunity to bring more awareness of digital health initiatives to your annual conference?   Sheila Arquette: (20:05) We do. You know, I continue to focus on how do I diversify my membership? And right now we're close to 150 corporate members, 2100 members in total with our individuals. But again, how do I bring more organizations into NASP, into our community, so that our specialty pharmacies know what's available to them and who can they engage with to make their jobs easier? We hear all the time, you know, we want you to practice at the top of your license. Well, that's what I'm trying to do. I'm trying to put in front of them resources and organizations that have come up with just incredible technology, right? To help them so that they can work smarter, not harder.   Janet Kennedy: (20:42) So tell me a little bit about some of the other programs and benefits that NASP offers your members.   Sheila Arquette: (20:47) All of our benefits tie back in some way to those four foundational pillars on which our organization is built; those being advocacy, education, certification, and the needs of our membership. Then our annual meeting that we've talked about a little bit is the opportunity to bring together all of the industries, the best and the brightest, just kind of share best practices and to network and to participate in educational sessions, and just shine the spotlight on what makes specialty pharmacy special. So, as you said, since I joined NASP back in 2017, I've been very focused on how do I increase the value of NASP membership, both for our corporate members, and then also our individuals. So we now have a plethora of membership benefits that in my opinion, we do offer something for everybody. So we have best in class educational programs and we offer CE credit for pharmacists nurses and pharmacy technicians.   Sheila Arquette: (21:41) We also have a specialty pharmacy law conference that we host. I mentioned to you, that's how I got brought into the fold here at NASP. And we also offer continuing legal education credits in conjunction with that pre-conference workshop. We offer our members annual meeting discounts for registration and sponsorship and exhibitor packages. Also preferential speaking opportunities at our annual meeting that goes to members, that always applies to members. Next year, something new: part of our certified specialty pharmacist credential, part of earning that is taking an exam. And you have to submit an application, or we're gonna have discounts on those fees for members for new applications, and then recertifications. We also have federal and state opportunities to advocate and to get involved, to meet with your elected officials. We also have grassroots advocacy tools that make that easier. And we try to amplify our collective voice and make sure that our elected officials know that these are our issues, and we really need your help with them.   Sheila Arquette: (22:43) And we also have ways that we try to increase our members' visibility, not only, only with other NASP members, but across the industry. So we have lunch and learn programs. We have our corporate member of the month program. We have our round table webinar series. Something new that we're starting next year is our lunch with the lawyer webinar series. We have six or seven law firms that are members of NASP who are so willing to share experience and their expertise with our members. We also have a student chapter program and a scholarship program just demonstrating our commitment and our investment in our future leaders of specialty pharmacy. We have a job board. We have the NASP marketplace, which is a forum for NASP members to showcase their product and service offering and offer other NASP members a discount. Next year, we're starting our own women's leadership book club. So there's so much that we have available for our members and that's not all of it.   Janet Kennedy: (23:41) Well, and you couldn't have all of that if your members weren't engaging. And I think that's key to any professional organization. Is it just something where you can put a logo on your website, or are you actually going to grow and improve your skills and network with other people and really make it a valuable membership?   Sheila Arquette: (24:00) Oh, absolutely, Janet. Right now we have nine active committees and we have close to 300 members that volunteer to serve on one or more committees. And it's really this volunteer army of folks that we have these members who are so passionate and dedicated and committed. It's the backbone of our association. It's the reason why we get done what we do: because of their support and their involvement.   Janet Kennedy: (24:24) I did think it was neat that when we joined earlier in the fall, you actually have a member who kind of walks you through the process. And it's really neat to feel like you're being welcomed into the fold.   Sheila Arquette: (24:35) Absolutely. It's called our membership buddy program. Another idea of our membership committee. And I think something that's unique to NASP too, is if you join NSAP and you, you sit on a committee, you really do have the ability to not only shape the future of the industry, but of our organization. And the membership buddy program was, again, our membership committee said, "Well, geez, what more could we do to make people feel welcome and to make sure that they have an additional point of contact?" People can always reach out to me. And, you know, I love to chat with our members and to get to know them just helps me to better serve on their behalf. But sometimes it's nice to know somebody who's not an NASP team member. And so, you know, the membership buddy program has been wildly successful.   Janet Kennedy: (25:15) Well, that's great. Well, now let's get people excited about joining. How do they find out more about the Organization?   Sheila Arquette: (25:20) They can visit our website, www.naspnet.org, or they can always reach out to me directly. I'm always happy to chat as you know. Love to chat with folks, love to learn more about them and just to discuss the benefits that we have and what I feel that would be helpful to them. So they can reach me at sheila.arquette@naspnet.org.   Janet Kennedy: (25:45) And to make it easier for everyone, we will have your email, your social media profiles, and the website in the show notes. Well, Sheila, thank you so very much for joining us. It has been a wonderful conversation and I look forward to an exciting year in 2022 being a member of NASP!   Sheila Arquette: (26:03) Oh, and thank you so much, Janet, for not only inviting me to join the podcast today, but for your support and for your membership. And I'm very excited as well for you to be part of NASP, and to leave your handprint on the organization and help us to move our initiatives forward.   Janet Kennedy: (26:17) Thank you. You've been listening to People Always, Patients Sometimes. This is Janet Kennedy, and I look forward to speaking with you on a future episode.

The last two years have been driving many discussions of the need for change in the pharmaceutical industry, particularly in the clinical trial arena. Discussions have not always led to actions, however. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. As we look towards 2022, I believe we will record this as a year of make it so. The time for moving on from debate is here, as patients are demanding action and forward momentum on today's episode of People Always, Patients Sometimes, our host Janet Kennedy has a conversation with the new executive director of the Clinical Trials Transformation Initiative, Sally Okun. Sally brings a unique and essential perspective to CTTI, as a former nurse and VP of Patients Like Me. They have a detailed discussion of the Transforming Trials 2030 initiative, one that Spencer Health Solutions is 100% behind. I hope you enjoy this episode of People Always, Patients Sometimes.   Janet Kennedy: (00:59) It's very exciting for me to have today's guest. Sally Okun is now the executive director of the Clinical Trials Transformation Initiative. The last time I spoke with her was on the Get Social Health podcast, where she was the vice president of Patients Like Me. So interesting that we're going to have another conversation, but in a totally different role, and yet, still very patient centric. So please join me in welcoming Sally Okun to the People Always, Patients Sometimes podcast. Sally, I'm so glad to have you here. I know it's been very, very odd over the past few years in working and collaborating and life transitions, but we had an opportunity to talk to your predecessor, Pamela Tenaerts, who was the executive director of the Clinical Trials Transformation Initiative. We spoke to her pre-COVID. So now we're in the middle and maybe hopefully heading towards the end. And there are a lot of exciting things happening at CTTI. So welcome to the podcast, and I'd love to hear a little bit about how you ended up joining CTTI.   Sally Okun: (02:09) Janet, it's so nice to be here, and I really appreciate the opportunity to talk more about the Clinical Trials Transformation Initiative, and certainly the shoes that Pam left are large, and I'm still trying to find ways of filling them, and I think that's gonna take some time. How did I get to my current role? Well, interestingly enough, I had left Patients Like Me in 2020 and I was working on a variety of interesting projects at the time across the health spectrum. You know, I was consulting on a variety of different things and also enjoying some newfound freedom of semi-retirement, which was an interesting experience for the first time in my career. You know, by about mid 2021, maybe in light of the time that we were all spending at home as opposed to spending out enjoying each other's company socially or professionally, I started thinking more and more about the next chapter of my professional career.   Sally Okun: (02:57) So it wasn't long after that, that I was approached about the position of executive director at CTTI. And frankly, initially I didn't see the fit for me. You know, I've not spent my career in clinical trial work. I've spent a lot of my career in research and clinical research with patients and others, but hadn't really focused specifically on clinical trials and the clinical trial enterprise. So at first I really wasn't exactly sure it would be a good fit for me. However, after talking with some trusted colleagues and others, including the chairs of CTTI's executive committee, I was truly intrigued by the organization's impressive portfolio of work. I really hadn't been aware of just how much they have done over the last 15 years, 14 years, in terms of contributing to the improvement overall of the clinical trial experience, not just for participants, but for investigators as well as sponsors and others.   Sally Okun: (03:48) So, you know, I then looked a little more closely at the transforming trials vision, and I thought, you know what, here's an organization that is setting goals as a priority to be seeing clinical trials as patient centric and easily accessible as its number one pillar. And I thought, well, you know what, I think maybe this fit might be just right. So I spent a bit more time thinking about it and then made the leap in October of just a couple months ago - just hit my two month anniversary.   Janet Kennedy: (04:13) You mentioned something just now about the Transforming Trials 2030 program. What is that?   Sally Okun: (04:20) Well, you know, a couple of years ago, again, under Pam's leadership, they discussed the need to set some milestones to really stop sort of talking about improving clinical trials, but actually putting some stakes in the ground or pillars up to suggest that we need to have a goal for that transformation; that have to have things that we're working towards as a community in order to be able to achieve a better experience for everyone involved in clinical trials.   Sally Okun: (04:49) So what came out of that initial discussion was a set of five pillars that actually articulate quite specifically what we believe clinical trials should be like by 2030. And each one of them has a host of different objectives beneath the goal, that actually really describe how we might ultimately get to the point where we can say, "Yes, indeed, we have clinical trials that are now patient centered and easily accessible," for example, for the first pillar. But each one of them is complex. Each one of them requires a lot of understanding of what needs to get unpacked to better get at the kinds of things that need to get changed. So we are in the process right now of beginning a strategic plan for doing just that: taking each of the pillars and starting to think about how will we know that we've achieved success on this pillar? What will be the metrics we need to start thinking about for those.   Janet Kennedy: (05:42) Alright. So let's do some metrics here. What are the other four pillars?   Sally Okun: (05:46) Number one, as I said, is that clinical trials will be patient centered and easily accessible. And if we don't reach that, then some of the others are almost irrelevant. So that is actually the place to begin. But then the second one is that they're fully integrated into health processes. So that gives us an opportunity to really begin thinking about the continuously learning health system, where we embed within the care environment, the opportunity to research and learn, and then put that learning back into the care environment again, so that we have a full circle loop. The third one is that they are designed with a quality approach, and CTTI has done an incredible amount of work on something called quality by design.   Sally Okun: (06:27) It has a whole set of recommendations around how to determine how the quality of your trial based on a variety of different things - whether it's your recruitment numbers or other aspects of what the trial efficiency looks like. The fourth one is that clinical trials take full advantage; they maximally leverage all available clinical and nonclinical data, including data that's collected now with digital technologies to ensure that we max - minimize - the collection burden of getting data and actually improve the opportunity to make data more meaningful and impactful as part of the trial experience. And then lastly, although not least, is that clinical trials contribute knowledge to how to prevent diagnosis and treat disease. And that becomes something that's an objective around improving population health and the health of our people.   Janet Kennedy: (07:12) Okay. Those are very large topics, very large goals. Who is the Clinical Trials Transformation Initiative? Who's going to do this work?   Sally Okun: (07:23) We are a group of people who have come together within the organization that includes project managers who oversee our projects, and then strategic and engagement and communications team that oversees all of our communications with our steering committee members in our member organizations. So to give you an idea of what that structure looks like: we have a steering committee that includes about 80 organizations who are actually members of CTTI, Clinical Trials Transformation Initiative, and they commit to have a person assigned as a steering committee representative. So as we begin to think about tackling a new topic or a new initiative, we go to the steering committee and we make available to them the opportunity to join the project team. That project team then starts to create the infrastructure for accomplishing that project, which can include, first of all, the project plan and setting the aims and the objectives.   Sally Okun: (08:17) In many ways, it's creating a research study for the topic under consideration with that. Then they set out to consider what's the literature already say? Who are the expert people we need to be speaking to? So there's a lot of qualitative interviewing that goes on as part of the social science team from the Duke Clinical Research Institute; that is a connection for our team to be able to work with. And then the findings from those interviews begin to shape the recommendations that will come out about a particular topic area. For example, thinking about trials in healthcare setting; what do we need to know about the various barriers for those and the opportunities for those as well as the current landscape within which the clinical experience might or might not include participation in research activities? So there's an entire project management approach that is put on any topic we tackle.   Sally Okun: (09:08) The problem with it; it's an incredible opportunity for us to be able to map out these topics and really think about the issues as a group, but it's a labor intensive and time consuming. It can take up to two years to complete some of our projects because they are so intense in terms of diving deep into the problem and trying to come up with resources and tools to address it. So where we are faced today is thinking about how will transformed trials by 2030 if we continue to take this much time to get through our project? Which is why we're now starting to focus quite specifically on each of the pillars, and in many ways, making a project around that pillar. So if we take the first one, for example, and we say trials will be patient centered and easily accessible. The first question I have is how will we know that?   Sally Okun: (09:55) So we're starting to look at ways of being able to measure whether clinical trials today are, or are not patient centered. And that can be evidenced by whether or not patients were involved in the design of the trial, which is work we've already done in some other projects that we've done. Also, how is the enrollment handled? Did it include a diverse population? A variety of different ways of able to measure patient centricity around a trial. But you're right, each one of these has a lot embedded in it and our strategic approach to it right now is taking each one. I've assigned a project manager to every pillar. And we are now just beginning the process of setting a goal for the metrics for each one, and then identifying where we will go next in terms of what resources we know exist already within CTTI that we can map to it, and then what resources may exist in related efforts, whether it's transCelerate or the Multi-Regional Clinical Trials Initiative, others that are related efforts and aligned with our work, and starting to see where their resources could help to get us closer to realizing that particular vision or that pillar.   Janet Kennedy: (10:59) Now, I know your members represent nonprofit organizations, for profit organizations; I think you even have some patient volunteers who are part of your program. But where does the funding come from to make these things happen?   Sally Okun: (11:12) Well, you know, we are a public/private partnership with the FDA. We have been very fortunate to have an excellent relationship with the FDA over the last number of years, their interest in having us be available to tackle some of the more problematic issues that they are not in a position to do on their own. So the funding comes through a grant that supports that public/private partnership. Also our members, depending on the type of organization or company that they are, pay a membership fee to participate. And so that helps to offset some of the costs as well for maintaining our team and the other resources that we put to bear to get the work done on a regular basis.   Janet Kennedy: (11:50) And then how does it actually get done? So if you come up with these guidelines or these recommendations, is there a commitment on the part of these for-profit organizations that they'll actually start to modify, or is the science and the evidence so evident that it makes no sense not to implement these changes?   Sally Okun: (12:10) Yeah, that's a good question. It would be nice if everything seemed that intuitive. That yes, indeed, this is something we ought to be doing because it's just the right thing to do, right? And many of our recommendations would fall into that category. And I think many of our organizations commit to ensuring that they make attempts to incorporate those recommendations into the work that they're doing. Right now, we do have a method of identifying as part of the project itself. Towards the latter part of it, opportunities for adoption of the recommendation. So what that project team will think about is, so now what? How will we see these things come to life in the real world? So opportunities for providing some insights into how they might be best adopted are offered as part of the overall project deliverable at the end of the day. Now at the same time, we don't have an accountability measure to be able to say, "Yes, we believe these recommendations should be incorporated into the clinical trial on this particular topic area, and we expect that you will deliver on that."   Sally Okun: (13:09) So that is, I think, a professional courtesy that we afford to our members to say, "We appreciate that you committed a lot of time to helping us get to the point where we have these recommendations; now what we'd like to ask of you is to start sharing your experiences of using these recommendations and resources." So we actually - just this past year created the Building Better Trials case study exchange. And it's a portal where our members and non-members actually can contribute their experiences of using CTTI tools and resources for a particular purpose within their organization to advance or improve the efficiency and quality of clinical trial experiences. And those have been great. It's a wonderful opportunity for us to showcase how members and even non-members, as I said, use the CTTI resources in a way that actually do have an impact. And it's also a place where, from my perspective, most importantly, we can have continuous and shared learning. So what one group might have learned as a result of incorporating the recommendations for a single IRB, for example - that can be brought forth for others who are now facing the need to do that, the kinds of challenges and other ways that the organization actually met the recommendations that were set forth.   Janet Kennedy: (14:23) And for those listening, if you visit the website and go to this podcast episode, I'll make sure that there is a link there. Tell me a little bit about the patient's role; obviously you come in with a very unique background and a very wrong patient-centric experience and support system set up. So how are patients involved? Because let's face it, they don't have the kind of money it would take to join an organization. They may not even have the time to commit to some of the work that's being done here. But how do you incorporate the patient voice into the work of CTTI?   Sally Okun: (14:55) Well, it is an incredibly important voice and we pay a lot of attention to ensuring that we have mechanisms to get that. We actually have three members of the steering committee who are patient representatives and they come into the role with that responsibility. So they are - similar to being an organization - they have been identified through an application process as people who are willing and interested in contributing in a very substantive way to our understanding of what it means to be a patient in the context of clinical trials. So there's three of them on our steering committee itself, and one of them is actually a caregiver and the other two are patients, one living with breast cancer and the other with ALS, or Lou Gehrig's disease. And so the opportunity for them to be a part of the steering committee team, when a project comes up is wide open.   Sally Okun: (15:44) So we're always looking for ways of having them be involved. Now at the same time, we have many patient organizations that are members. You're so right; these organizations and patients individually don't have the resources to be able to pay a membership fee that would be sort of out of their range. Our membership fees vary on a sliding scale depending on the organizational type and the revenue that those organizations have. So a patient organization would - I think the highest amount is a $500 membership fee. And I think, you know, obviously, thinking about other organizations that may even be a challenge for, we would certainly work with them and talk with them about how we could make a membership opportunity come to fruition. So the other thing that we do is we do have a relationship with the FDA in terms of being able to help them support their patient engagement collaborative.   Sally Okun: (16:31) Now, this is a group of sixteen individuals who again, apply to be a part of the patient collaborative, and we actually help support that group. And it's an opportunity for us also to work more closely with FDA on how they can have access to patients in a way that helps them better understand the patient experience. So I think we try really hard to ensure that all of our projects have a patient representative on them, whether it's a patient individual or a patient group, or potentially having some relationship back to the patient engagement collaborative at FDA itself.   Janet Kennedy: (17:03) I think the work you're doing is so exciting and so important. I worry a little bit that your projects are huge, and you do have, you know, your goal of transforming trials by 2030. However, you know, in order to get there, you gotta take a few steps. So will you be releasing work along the way?   Sally Okun: (17:24) You know, as I said, one of the things that I did right from the very first day I arrived was to start talking with the team about measurement and data. As you know, coming out of Patients Like Me, one of the things that was a hallmark of our work with data, and we just felt like we needed to be data driven in order to be able to answer important questions for patients. It's no different here. It's very much the same. In order to be able to achieve these lofty goals of this transforming trials vision, we have to know where we're at now. What's the baseline data we know about the percentage of trials that are currently patient-centric? I really have no idea. We have to start thinking about ways of being able to find metrics that will tell us some of that. What's the evidence of a trial being patient-centric?   Sally Okun: (18:04) And there are tools out there that we will be starting to inventory and start to determine whether or not these will be ones that we'll put into the ways that we think about this. The short answer to your question is my objective with taking each pillar and intentionally unpacking it, is to better understand where do we need to begin? How will we know that we're making some progress? And that will be metrics and data. And then what are the resources that we are gonna need to start thinking about beyond just adoption? So it's not simply gonna be enough to say, "Here's the recommendations we're making about patient-centric trials for you to be able to, you know, have available to you." We'd like very much to start thinking about the ways of being able to have a bit of a scorecard on that. How do we know we've made a difference?   Sally Okun: (18:49) How do we know that some of the work and the learnings that we've been generating are actually going to translate into something that happens at the clinical trial level itself? And those are still things in development, but they are very important, to me personally, as part of my own work, but also for me as the executive director of the organization today to say, "Let's start measuring how well we're doing on every one of these," and better understand at what point we believe we've actually shifted the needle enough to be able to say, "We're reaching closer to that goal." Now, will we get there by 2030 on every one of them? You know what, I'm gonna remain optimistic. But I also recognize that there's so much that can happen between now and then that could interrupt our progress. And just taking into example, the COVID pandemic over the last year and a half, that stopped so many other kinds of research because we had to focus on that.   Sally Okun: (19:40) Our hope is that in some of the things that we've taken away and learned from that, as we look at each of these pillars, we wanna be able to say, will this stand up during a time of public emergency. Also are the things that we're coming up with applicable beyond the US. That's another important aspect that we have to start thinking about; clinical trials take place everywhere. And in fact, more people are recruited outside of the US than they are in the US. So we have to be thinking about that quite intentionally. And then lastly, the one area that we have not worked specifically in integrating into our prior projects is how can technology itself enable the success on this particular pillar? What are the opportunities that are available today and even tomorrow or two years from now that weren't available previously, that we can start to take advantage of that, help us move that goal closer to achieving it?   Janet Kennedy: (20:30) Well, you come in at an interesting time where you probably were interviewing during the process of all the stopping and starting and having to rethink about how clinical trials were going to go ahead in the midst of the pandemic. And now you've started when, you know, we thought we saw the light at the end of the tunnel and things have managed to pick up, and a lot of companies were able to pivot and use digital technology to move some clinical trials forward. However, I'm curious to know, as you come in and you were getting feedback from your steering committees, did you hear them say that this pandemic has accelerated our vision for decentralized clinical trials for the use of digital health technology?   Sally Okun: (21:14) Yes. And I may not have been hearing that because I wasn't here at the time, but definitely the projects that we had that as a result of some of the work being done through COVID and some webinars that we ran with some of our esteem colleagues - including Rob Califf and Harlan Krumholz, and Deb Estrin - just the idea that we have learned a lot as a result of the COVID experience, and we do need to ensure that what we've learned and those things that actually have benefited the clinical trial experience, not only for participants, but potentially for investigators as well, and outcomes more coming more quickly, that we have to ensure that these are not compromised as we move forward. That we don't fall back simply because it's a little easier to fall back and then it might be to fall forward. And that we take advantage of the things that we've learned, especially that technology is now a new enabler for improving the efficiency and quality of clinical trials. When used appropriately, when used in the right context, and when used with tools that actually have the ability to be used for regulatory decision making. You know, we have to ensure that we're not just simply falling back onto technology for technology's sake. We have to ensure that we're using the kinds of tools that actually can be helpful and useful for regulatory decision making.   Janet Kennedy: (22:30) Tell me a little bit about incorporating patient voice through patient reported outcomes and real world evidence. Is that something that is now you would almost consider mandated as part of a clinical trial?   Sally Okun: (22:42) Not so sure we're at mandated yet, but I think we can recognize just how important and valuable real world data is to understanding the real world experiences of real people, right? And yet I think we still have a fair amount of work yet to do on translating that - all of those different types, disparate types of data - into the totality of evidence, within which real world evidence will be one piece of it, that then contributes to a regulator's understanding of the sponsors data. So I think, yes, I think real world data and real world evidence have definitely achieved the validity of being important as part of the clinical trial and clinical research experience. And we're seeing, increasingly, opportunities where that's now starting to become more important to regulators. For example, you know, FDA is continuing to meet its mandate from the 21st Century Cures Act, where it was required to issue guidance on the use of real world data and real world evidence for regulatory decision making.   Sally Okun: (23:42) So they now have I think issued, I wanna say four of the four, but the last one or two are still in draft and will have no final rule yet. But those are important considerations; to think that the regulator themselves has now put forth what they feel will be required for the use of real world data and real world evidence for their ability to make good decisions. Additionally, EMA just recently stated a vision that enabling the use of real world evidence and establishing its value for regulatory decision making is going to be required in Europe by 2025. So these, you know, different entities are putting a stake in the ground and they're saying okay, similar to what we're doing with our vision, right? The idea is that we need to ensure that all the data that could contribute to our understanding of what it takes to have a medicine or device developed so that it can be used to improve outcomes for people needs to come to bear.   Sally Okun: (24:37) And we can't simply just look at it and say, "It's too complicated, or it's too difficult to translate that data into something that's understood by the regulators." We have to figure that out. And I think there's going to be a lot of work in the coming year or two on that very topic. You know, there's a lot of work being done. For example, Duke Margolis has had a point of care working group now for some time that I've actually enjoyed being a part of, and they're aligned very much with our work being done in trials and healthcare settings. So you can see those two things are both totally aligned and related. We're working at it from a different perspective. Duke Margolis, a little more from the policy side and CTTI, a little more from sort of the actual operational side, and bringing those groups together, some of which actually - some of our senior committee members sit on the Duke Margolis's working group too. So there's definitely starting to see this overlap of the attention paid to the value and the importance of this data. So I don't think it'll be long before it becomes something that's just a part of clinical trial experiences. But I think we still have a little ways to go before we actually see it integrated into every clinical trial.   Janet Kennedy: (25:41) Now before we started recording, we talked a Little bit about where and when we'll be able to interact with CTTI in public, and it sounds like you're shooting for a live meeting about a year from now?   Sally Okun: (25:53) The meeting we were talking about in fact was our steering committee meeting. So we have two meetings a year where we gather our executive committee and our steering committee for two days of meetings. One will be in March, which we're going to be doing virtually. And the other will be in September. In the meantime, throughout the course of the year, we actually do a number of webinars and other events that actually are open to the public to learn about some of the work we're doing. And we will definitely continue to do those. Those right now are quarterly, but we might likely start to increase those depending on how the work is going on. Each of the pillars for the transforming trials vision. But the September meeting will be the first time our steering committee and executive committee see each other in person since the pandemic. So we're very excited to shoot towards that. And obviously we'll be flexible and adaptable as needed, but right now we've made that commitment that we will see each other in person in the fall.   Janet Kennedy: (26:44) That is exciting. And I hope we get to meet in person sometime in 2022. The conference season looks like it's kicking back in with protocols in place, but that we're gonna be face to face more than we have been in the last two years. So hopefully I will get a chance to run across you at one of the conferences coming up in the spring.   Sally Okun: (27:05) I would enjoy that very much, Janet. Yes, I've actually just recently had my first foray out into the professional traveling again. And that was a quick trip to Boston and followed by a quick one to D.C. Both of which felt very odd, but also at the same time felt very good. And it was wonderful to see friends and colleagues that I just haven't seen in way too long.   Janet Kennedy: (27:26) It is surprising what good friendships are developed in the professional environment. We talked a lot about family and COVID'S impact on family units. But for many of us, our colleagues are also just as much our family members, and not being around these people who stimulate our minds and get us really interested in new ideas; it really is very draining and disappointing not to be near some of these amazing people.   Sally Okun: (27:55) That's such a good point. I mean, I know I thrive on just having conversations with people face to face and hearing their ideas about what they're doing or giving me some feedback on a presentation I just did. You know, I just always loved the after experience of being a part of a panel or part of a, you know, presentation that was being held at a conference, and just the feedback you would get from people on the things that you talked about is, was just - really provided me with professional learning that I couldn't get anywhere else, frankly.   Janet Kennedy: (28:22) Absolutely. Alright, well, hopefully a cup of coffee in real life is going to be on our agenda sometime in 2022. Well, Sally Okun, executive director for the Clinical Trials Transformation Initiative, thank you so very much for joining me on the People Always, Patients Sometimes podcast.   Sally Okun: (28:40) Janet, it has been my true pleasure to connect with you again, and I look forward to many times of having the opportunity to see you and spend some time again. Thank you so much. And thank you for the highlight for the Clinical Trials Transformation Initiative and our work. We really appreciate it.   Janet Kennedy: (28:55) Absolutely.

Pharmacy companies are an important part for Spencer Health Solutions, and pharmacists are an integral part of fulfilling our mission to serve patients in their homes. Hi, I'm Tom Rhodes, CEO, Spencer Health Solutions. We have had the opportunity to bring patient pharmaceutical and digital health thought leaders to previous podcasts. However, today we're speaking with our first pharmacist, digital health advocate and analyst, Timothy Aungst, also known as the digital apothecary. He joins our host Janet Kennedy for an insightful conversation and a call to action to the pharmacy industry on the People Always, Patients Sometimes podcast.   Janet Kennedy: (00:45) Welcome to People Always, Patients Sometimes. I'm very excited that today's guest is Timothy Aungst, the digital apothecary. He is an associate professor of pharmacy practice and also a clinical pharmacist. Timothy, welcome to the podcast.   Timothy Aungst: (01:03) Thank you, Janet, I'm really excited to be here today to talk about, you know, all this stuff that's been going on.   Janet Kennedy: (01:08) It's been a crazy couple of years and that's one of the things that I wanted to talk to you about. I found you because I read your primer, "Digital Health Primer for Pharmacists." You published it in February of 2019. At that time you wrote, "after being involved in the digital health space for almost a decade, I can say with complete sincerity, that the topic is still relatively out of the realm of the general pharmacy profession grasp." Okay. You put a challenge out there. 10 years you've been involved in digital health and you're saying pharmacy is still not up to speed. Would you say that that's true two years later?   Timothy Aungst: (01:52) Yes. I still would stand by that. I would argue that we have seen entrepreneurship within the pharmacy profession gravitate towards digital health at large, but I would also conversely say that as a profession for pharmacists, we have not really actually actively engaged in this area. We still lack a large number of educational roles and trying to get people aware of the space. There is a lack of discussion around it. Most of our public organizations that provide guidance on what our next steps for the profession don't really think about it in, I think it's for that reason, I still would say the gap is there. Now that is changing. I would say that there has been a semi call to action amongst several pharmacy organizations, whether it's say PHA, ACP and several others who are now trying to get the profession up to speed on what digital health is.   Timothy Aungst: (02:44) And that's been a big focus of mine serving as so-called subject matter expert or key opinion leader to help get information out there regarding the topic. But very, at this time it's quite topical just because we are not actively highly engaged with it. I would probably say we're maybe like two or three years behind other healthcare professions, such as the medical community. The American medical association has an active digital health component that they've been pushing, I would say probably for about two or three years at this point, have reports coming out, organizations associated with it. And I think pharmacists have to play catch up to that. And depending on key stakeholders at this current time that may or may not go fast or may go slow. And that's one thing I'm actively keeping my eye on.   Janet Kennedy: (03:27) Well, I'm curious about whether pharmacists or the pharmacy is even included in some of this digital health development.   Timothy Aungst: (03:36) I'm always a person who would've actually separate the two. The pharmacist and the pharmacy, I think are no longer synonymous organizations. You don't need a pharmacy to have a pharmacist. I think it's going to be what we see in the 2020s or 2030s at this point. I think those two things will actually diverge and that will just come down to logistics and also some legal parameters I think people are pushing right now. Technicians will be empowered to take on most of the stuff on site and pharmacists will probably feel remote. That being the case then to accomplish that, and also to get pharmacies up to speed where healthcare is going, I think the pharmacy businesses will engage in digital health activities. For good or for bad. The big news right now, right, is that Elizabeth Holmes is in court with Theranos. And if we look at Thernos, who was one of the biggest backers? That was Walgreens. And I always looked at what happened with Walgreens being burned there is a reason why they actually had a huge number of digital health initiatives back in the 2010s. And I think they pulled back because they got burned so heavily.   Timothy Aungst: (04:31) In the meantime, we see, let's say a business like CVS Health going down a whole vertical pipeline. Now we got Aetna involved, we got long-term care stuff, we got them pushing to go into kidney disease with dialysis treatments. They are partnering up with digital health companies all over the place. One of the biggest ones, for example, was Sleepio for a digital therapeutic that they've been piloting out there, which has actually initial positive results I'm actually reading through right now. So some of these companies are more involved than others. And I think it's going to come down to, you know, what assets they have to really push that. Whether they see the market going a certain way and they want to meet consumer demands because they are also aware of that, with the changing dynamics within healthcare, pharma is going down the digital health path. Payers are looking at this. Employers are looking at this and even the big tech companies are pushing this stuff out there. So are they going to let other people dictate to them the incumbents of what to do, or are they going to be the drivers themselves? And I think that's going to be something that's going to be interesting to watch.   Janet Kennedy: (05:34) Well, so you mentioned the need to separate the pharmacist from pharmacy. So speaking from the individual's perspective, do you hear pharmacists talking about wanting more and better tools to be able to help their patients or are they just basically the Amazon employee at the warehouse where they're just cranking out the work?   Timothy Aungst: (05:57) See, I used to think we're still on the razor's edge between two possibilities: one was pharmacists finding some kind of clinical services they pay for under some, say, value-based care agreements. And by providing clinical services would receive renumeration that would allow them to be so-called clinicians in health care. Or the other one was being fully remote and being consigned to these activities, to these virtual workshops where they basically just review medications that have been turned out by Amazon or other companies like true pill, et cetera. There might be a third path, which is a mix between the two. And that's kind of where I'm more leaning towards right now from a pharmacist perspective. Yes, there is a huge interest in digital pathway as a means to basically call back clinical services and kind of like be able to provide services that could then actually have objective feedback in terms of what they did, that they could then bill for services and, you know, make money from it.   Timothy Aungst: (06:51) But I don't know if that's going to be enough at this current point to actually say, "oh, well, you're now a remote clinical pharmacist that overviews these data's on people's adherence or their information on disease states, and you get this much," because one of the issues is actually even though they're like remote patient monitoring services that we're seeing CPT codes being pushed up by CMS and such, they're in the physician still. So the pharmacist almost has to still be partnered with someone else in order to receive the renumeration. And then at that point in time, you know, it was kind of like, what slice of the pie are you going to get? And I think that's really what concerns me is that from a healthcare perspective, the pharmacist is still really trapped in their other engagements, which has traditionally held us back. And I think this is because we again have very little stakes in digital health and we were coming to the table kind of late. The other people have already kind of figured this out and have already been making inroads. Making propositions to other organizations to get themselves ahead. And we're kind of almost, I don't want to say asking for crumbs, but we're going to have to really do our best claw back some of this stuff for ourselves. And that's going to delay, I think those aspects.   Janet Kennedy: (07:56) And do you see the trade associations being the ones that should be leading this charge?   Timothy Aungst: (08:01) I think the trade associations unfortunately all have different stances out why they would want to engage in this stuff. The trade associations value pharmacists to different extents. And within a pharmacy community, we know with the alphabet soup of different pharmacy organizations, they don't all have one central voice. They don't all have one central take on what is the role of pharmacists. I've heard some people say we have a pharmacist practice at the top of their license. I don't know what that means. To be quite honest, whenever I hear that I kind of have to roll my eyes, because what is the top of their license? I think in their eyes probably is just, you know, sending off for prescriptions. So that's great. That's what they see as the business that they have to focus on. I could see definitely some trade associations making an argument to empower technicians, to move back at scale back the role of the pharmacist as a, you know, as a rate limiting step in terms of evaluating prescriptions and getting them out the door.   Timothy Aungst: (08:53) And also because there are high cost margin right there, and that would reduce the overhead versus some other trade associations are definitely more clinically focused and would push that down too. So within pharmacy, the unfortunate thing right now is there are some tenuous arguments going on about, you know, who has the right step for the profession or which to be used, how to utilize them. And I think those are the conversations, the hard conversations to have to occur now versus later, because this whole approach of them to let's say digital health and such could become very fragmented. You could see some people that operate large corporations would probably want to use digital health for alternative means versus maybe some smaller companies. And I think that's going to really, for me, I have to bemoan them is that's gonna really muddy the waters and I guess, slow down the process of any adoption by the profession. So yes, I think the trade professions will probably be key here, but I would also, or you, because historically they don't always get along or had the same thought processes that this is going to be another area. That's going to be a sticking point where argue about how to do this.   Janet Kennedy: (09:57) You know, I find that health care was still slow to come to digital tools and platforms. I'm curious to know whether, with your ear to the ground, do you find that patients are pushing their desire for digital health into the healthcare system? And do you find that that's being impacted or felt on the pharmacy side?   Timothy Aungst: (10:21) And this is a good question because you know, who's the drivers for change. I think it's one of the things that always comes up. Patients are often said to be one of the major drivers, and I do believe that to a certain points payers are probably one of the biggest drivers I would argue though, overall, because they ultimately are paying the money. Patients themselves are vocal population that can dictate those favorable or unfavorable role, lots of different programs and services at the end of the day. So from that perspective, I think with the ongoing pandemic, we saw this huge push for, you know, delivery of services for the ability to have a so-called digital front door. And you know, what was in the news the other day was that Walgreens got in trouble apparently because they're whole vaccine signup and testing site wasn't secure. And the data is now - someone's getting into it. And this, I think is going to give some feedback to people like, you know, if we have to do remote practice, sign up and go through an app or make an account and et cetera, but you can't even keep my data secure - Is that good or bad?   Timothy Aungst: (11:17) You know, is that a company I'm going to trust? And those are the things that they're hitting people now it's not so much like, oh, you know, I have a brick and mortar business. People come and buy things and they leave. I just had to worry about the credit cards now I have to worry about their online accounts. I have to worry about health history that's been uploaded or shared. This is definitely a new area I think people are considering. Hospitals and health systems have been dealing with this for years. They've been getting hit by malware attacks for a long time. Now people will ask you for cryptocurrency just to unlock their systems, for goodness sake. And because of this, the population does expect a digital front door, digital services. And I think ultimately businesses have had to pivot to address an answer to that.   Timothy Aungst: (11:57) But I don't think they traditionally had that as a, you know, as something that is a high concern for them in the pandemic was a force multiplier that really had to make them rush into, this for good or for bad. I mean, the pandemic is going to go on for awhile. We're going to see this go up in waves, in different parts of the United States. So these companies are going to have a long time to pilot certain programs, but I think many of them have recognized, no matter what, post pandemic, this is going to be a status quo. So whatever works now has to work in the future as well.   Janet Kennedy: (12:27) Well, certainly the pandemic has made a lot of things happen faster; that we have seen an acceleration of the interest in some kinds of digital health, particularly tele-health, which sounds new to a lot of people, but it's been around for 20 years. And I know you've been around in the digital health space for over a decade. So let's step back for a second. Could you tell me a little bit about the digital apothecary and why did you start it?   Timothy Aungst: (12:54) Sure. So the digital apothecary was kind of like just a little passion product, a little thing that I spread out based on my interests. So I started off as a resident during my PGY1. I got an iPad in 2011. So keep in mind the iPad came out 2010. So one of the things that I did was I actually started processing orders in the hospital using my iPad through Citrix. And this is funny because this is a period where we had so-called COWs, or computers on wheels, or WOWs, workstation on wheels, as they're often called now, and people would argue over these things to process orders in the hospital, et cetera. And I just basically started using my iPad to do all this stuff. And people started catching attention, like why is he doing this stuff faster? He's looking for information faster in there and blah, blah, blah.   Timothy Aungst: (13:36) And I was like, yeah, cause I had this device that can do this. I start thinking of something, what is a good app? What is a good thing? And so I started reviewing and looking at stuff and then I joined another group called iMedicalApps and we start reviewing mobile apps. We actually wrote a bunch of papers about how to quantify what is and what is not a good app and to use clinically for patients in patient care. And we gave presentations all over place on this topic. And that was a huge thing for me. And this was when it was mobile health that was my focus. And then circa 2014-15, I moved on to just the bigger digital health space and started writing for different organizations and serving as a speaker advisor consultant for different companies actually were asking a lot of these questions. The years I started thinking with remote patient monitoring, questions about tele-health, pharmacy, how to adopt medication adherence is a big one for me as well.   Timothy Aungst: (14:20) And it kind of really changed my thought process in terms of like, you know, this stuff's just kind of adjunctive to care versus, okay, this is going to be actually part in driving care. Eventually digital health, I kinda thought to myself, is just a interim term. I think digital health eventually turns into just health. It's kind of the same period we went through with like digital banking. We don't call it digital banking anymore, we just call it banking. When you go onto your app cash or check or use Venmo, like no one calls it really digital banking. I think that's where healthcare is at. So I noticed there wasn't that many people around the space. There is one person I look up to is Kevin Clawson, who's now into blockchain for healthcare down at Lipscomb. He was a great mentor for me early on. And it was a few other people I've talked to them such as Brent Fox about this too.   Timothy Aungst: (15:01) And, but the reality is in the academia circles, that generally there was not a lot of pharmacists, I think, into digital health or into this technology thing. So I kind of got into it, talking about it. I had a lot of people say this was like a waste of time. And I really had to take a thought for myself academically - do I really want to dedicate all my time towards investigating and research in this space. Or should I start moving towards something else as an academic? And I chose to keep on it. And I'm actually pleased because now with the, you know, things are really changing the payment like that, people really want to talk more about it. People aren't real into telehealth. And they were like, who even knows about this in pharmacy? Then my name comes up because that's been something I've been talking about for so long.   Timothy Aungst: (15:39) People are looking at different digital health technologies and like, okay, who's in digital talking about, oh, Timothy's talking about it. Timothy's been talking about it for so long now. So it's kind of just in many ways for me, unfortunately, the pandemic has been a driving force around trying to actually get my message out more than it was in the past. I think if the pandemic had not happened digital health would not have seen the rampant advancements that it has, and probably would have been towards the tail end of 2020s that I foresee that would have taken off in versus the early 2020s at this time.   Janet Kennedy: (16:09) One of the things you mentioned in your primer was that digital health definitely isn't informatics. Can you tell me what you mean by that?   Timothy Aungst: (16:20) Oh, this is, this is, this is a good one. Okay. So this is unbearably one of the hardest questions I had to deal with in terms of talking within my community. So there's always been a push in pharmacy, informatics, you know informational management information, using different data streams and such, EHR management, et cetera, et cetera. And that's been a group that's been around for decades. I would probably say early two thousands, 1990s. We saw them out there and there's always been pharmacy informatics people. And it's the, you know, the American informatics Association and such, or AMIA. But you know, when, when I started talking about digital health, one thing that I actually got in trouble with early on was people like, isn't it just informatics. I was like, what do you mean? Like this is technology. I was like, "technology is not synonymous with informatics." Informatics definitely plays a role in digital health and managing all the data streams that come down.   Timothy Aungst: (17:04) But I would argue that the traditional informatics thought processes around management of health. It does not mean lik,e this whole digital health kind of ecosystem. And that's actually where I would have conversations with people like, oh, they'll get all this person, their informatics person, we have the conversation and people will talk about, you know, KPIs, C-Colon and different things in programming. And they'll be like, "Yeah, I don't do any of this stuff. That's not my business. I'm more interested in the clinical workflow design associated with this stuff and how to actually evaluate one technology versus another and blah, blah, blah." And so that does overlap. Yes, it does. But I think some people have assumed that, especially in pharmacy and for pharmacists, that informatics would subsume and take over digital health. And that's one area I'm not too sure on. I think some people may want that. And some people don't. I for one don't. I think informatics works within digital health space in that it's definitely a conversation and there's been other publications around this that kind of delved into a little bit more different therapeutic areas like oncology. But early on, It was very, very difficult actually to separate the two. I think at this time, most of it is separated, but I, that was a early conversation I had had with people.   Janet Kennedy: (18:13) Okay. I'm interested in the amount of data that could be available through digital health apps and how a pharmacist might actually interact with that. So I'm really getting around to a conversation about adherence. Right now, when we think of adherence, it's the next fill - did you get the next prescription filled? But there's 30 or even 90 days in between those fills. If you had that data and it was daily, would a pharmacist be able to actually manage that information, and would they want to?   Timothy Aungst: (18:48) So here is a loaded question. And I mean this, cause this is an area that I'm fully invested - I love this topic. It is too many stakeholders, I think we can go over in detail about maybe some, the big ones like, you know, who cares about adherence at the end of the day? You know, is it, the patient, is it the clinician, is the payer? I would argue payers recognize there's enough research out there saying that on average, a patient takes for medications, hopefully their diseases won't progress and they'll get better. Same with the clinicians and same with the patients who probably think that to a certain extent. But when we look at adherence data, if we look at HEOR and stuff like that, like what do they use as their metrics? Half the time it's like medication possession ratio, right? And I am not convinced that thing is actually really, really useful.   Timothy Aungst: (19:29) I think globally? Yes. I think scalable factor for most organizations, that is the go-to way to doing this. And yet I think about all the patients that I visit in their homes that have boxes of medications still stacked away. And it's like, why are they getting it? Well, you know, I just buy it because I'm told I have to buy it. So you buy your medication and then you store it away, but you're not taking it? And you know, I can't help it go walk away and thinking back my head, like, you know, what? If they show up in a report, people are going to say they're adherent. I just walked into their house and they had like 12 Advair discuses sitting there, and their COPD is still not doing good. Why? No, they're not probably taking and using it correctly, right? But anyone else would probably see that and not make that tie together.   Timothy Aungst: (20:10) So I think the biggest problem we've focused and seen in adherence is there's been no way to actually really assess if people have been taking their medications. So we argue about a topic that is potentially anywhere between $300 and $500 billion, which is really, I think, around medication optimization - which adherence is one of those things. But we've had very little quantitative data to back up our arguments. We've had qualitative data; but from a quantitative side, we've never really been able to scale. Even pharma has struggled with this in their clinical trials. You know, we've seen things like MEMSCAP and everything else out there for years trying to make a market here, and they've never really blown up. And then the 2010s, we had a flood in the market of all these different digital health devices because they recognize that stuff, but not all of them have been successful.   Timothy Aungst: (20:54) And the question is why? And I think it's because we've come to realize that adherence is very, very, very challenging. Human behavior is very challenging. I think humans are very chaotic in terms of adherence and such. So it comes back to the key stakeholders, you know? Why does the pharmacy care about, you know, adherence? To me, if pharmacy cares about adherence, instead of talking about value for the pharmacy, is the more prescriptions that are dispensed equal more profits. So if a patient's taking their medication on time, theoretically and filling on time, then that profit margin, at least is correct - 12 refills a year for a monthly supply versus if they're not, then they're not refilling and then you're not billing and you're not making money from it. So as a pharmacy, clinicians I think also have kind of a mixed feeling around adherence. To be honest, I think this might be actually one of the biggest conversations that should occur is there are therapeutic areas where we want a hundred percent adherence or at least above 90%.   Timothy Aungst: (21:47) There are therapeutic areas where I think we could be fine if people were not truly adherent. If you miss your Metformin a few days a month, am I going to care? Probably not? Your statin, and probably not? You know, and this comes down to, you know, how maybe severe a patient is, you know, how high their co-morbidity is. But there's certain diseases where, you know, what if I miss getting a biologic therapy by a day or two? Is I can really ruin me? Some day, we'll say yes. Some day we'll say no. But there's other therapeutic areas. Like let's say schizophrenia; you know, if they miss your medication, will it be problematic? Yeah. Probably. And the payers are going to be concerned about that. Cause that increases ER visits and hospitalizations, right? So often when we talk about adherence I feel like it's such a global issue that people focus on when it's very granular and it's really around different sensitivities associated with therapeutic areas that I don't really see a lot of people talk about, at large, associate with that technology.   Timothy Aungst: (22:40) That technology always seems focused just on trying to solve adherence from a very global perspective. While I think clinically we've had a lot of research talking about adherence from a very small perspective in terms of what diseases and such does it really impact. And so there isn't this mismatch behind there. So there's a financial aspect, there is the clinical aspects I think. And then there's some design aspects, you know, solving adherence, you know? What does it take to do that? And is actually the money invested really worth it? I think it's one thing that's often not discussed like, you know, just because we can solve adherence; should we? And again, they come back to the fact that we blocked a lot of objective information in many ways. If this goes to your question, would we want to actually have this data?   Timothy Aungst: (23:21) We are opening Pandora's box. We now know more about people's habits than we have in the past. So to gives some examples would be, let's go with inhalers. Propeller both have this interesting study where they evaluated people's utilization of inhalers and found them, I think they found 60, 80% of people were using their inhaler or Saba rescue inhaler incorrectly. Okay. That's actually really, really concerning, right? Because that's higher than what we probably have historically noted in research. Secondly, if these are patients that we've been signing off saying that they've been adherent or a technique is good, this really calls into question what and how well we've actually been approaching this area for decades. And I think that's actually one of the big things I'm actually concerned about. And I think many companies are kind of thinking about is, you know, we're getting a more objective information about people's habits than we ever had a past.   Timothy Aungst: (24:09) And in many ways this could be good, or it could be downright terrible if we're not prepared for the ramifications that everything we thought we knew may be wrong. And I think that's actually an area that most of us may be concerned about because that calls in attention like; okay, we find out that we've been wrong and we've not doing things perfectly. That's great. Well now we've got to fix it. No fix is going to come out overnight. So solving adherence also probably means finding out this data and understanding it while also trying to solve the underlying questions about how do we address some of these issues? Thinking about it clinically, thinking about our workflow. So when pharmacists want to see adherence on a daily basis, I don't think that'd be a problem, but I would throw back then this, what is the value of it? What is the value knowing if someone took their medication on a daily basis? Do they skip through the center pro clinically, is that meaningful? Maybe, maybe not depending on how bad their hypertension is, right? Or maybe heart failure or some other condition? From a peer perspective then maybe yes. And then along with that though, could also be focused on the money that you get for people not refilling on time. So these are the things I think that need to really be questioned.   Janet Kennedy: (25:17) Well, it's also the question of the firehose or the very specific stream of data that's relevant. So yes, any digital solution is going to gather all the information, but you wouldn't need all the information. What you would need is the alert that says based on the parameters for this patient, with these meds, now we need to worry about adherence and it could be on day four or five for a lesser impactful drug. It could be on day two for something that is of imperative nature that they take it. So that's the benefit of course, of being overwhelmed by analytics and informatics is that you can also then design the algorithm that sets the actions.   Timothy Aungst: (26:02) And that is the biggest issue then at this time, because who decides what the algorithm looks like? And this is a question that I throw most companies. And when I actually hear back, is well do it. But do you actually have the clinical staff and know how to do it? That's the issue. So I'm actually very curious if a company will come along, and actually would build this in their backend. You know, like we already have drug information databases out there, right? You know, is someone going to make something like this that they could then sell out to other companies to then utilize? Are they going to build it in-house, or would these alerts be optionable for a clinical site or a business? That would be nice. But you know, if you gave me a package deal and say, "you know, we could default this or you can change it, whatever you want."   Timothy Aungst: (26:46) Then I think that might change the conversation because it's just, you know, how many medications are out there? It's like, you know, NDC codes sitting on the shelf in pharmacies, enormous. So from a theoretical perspective, yes, this could be very possible. For practical perspective, who's going to build it and the timeframe it's going to take to build that is going to be enormous because the fact of matter is we can't build it because we don't know the data around some of this stuff, these questions. And that's the, that's a factor with Pandora's box. It opened up this huge conversation because we have the objective data to back it up now, compared in the past. But we don't know really, you know, what is the right answer? We don't know. If you go through like the literature and start like, you know, going into like pubmed and other things, how many days can you go without skipping his medication? It's not like there's gonna be a publication saying, oh, you can do this, this, this. That stuff doesn't exist, because we've never known.   Janet Kennedy: (27:34) All right. Well that sounds like the call to action to the industry, is we've got to start talking about, you know, when you have this data from digital health, how are you going to apply it and make it be not just an endless stream of numbers, but something that is actionable that supports the patient's health journey?   Timothy Aungst: (27:53) Actionable data is key. The when to have an action is the unknown. And this is where I think companies could freak out users; because it's easy enough for a patient to call me and say, you know, I've missed my medication past three days, and be like, okay, well you should take your medication or titrate back up, or let's have you in the off spot. And having the patients take that on. All right. Cause they self activated and they chose to do this. I didn't know that until they told me, right? So my liability or whatever we want to call it is limited on a patient discretion, because they own what happened to them. The minute you start putting this subjective information out there, that means the ownership and responsibility shifted to some group that never was responsible in the past. So to expect that people like selling them, want this data and use it, you may hear people say, no, not really.   Timothy Aungst: (28:43) And if you peel back the layers, you'll probably eventually find out it's this trepidation around, "I don't know what to do with this data." And I don't really trust the company to tell me what to do with this data, because I don't know where they're pulling that from. So there's gotta be some kind of evidence-based approach around there, but where is the evidence? And then this is where the ground falls out from all of us is, that Aetna says it exists. And that to me, I think is the overwhelming issue around truly objectifying medication here is the fact that we don't know what to do with it this time. And it's very troubling. So for me personally, I think this is great. This is what we should do. Are we there yet? I don't think so. And I think one of the biggest problems has been, it's not the technology. It's not even like the process of logistics; I think it's the overloading clinical scenarios that we never really hadn't think about in the past, and who's going to be responsible for what?   Janet Kennedy: (29:37) Okay. You have now laid some pretty big questions that could take us down another rabbit hole for at least an hour. So I'm going to hold those thoughts for our next conversation. And Timothy, just thank you very much for joining us on People Always, Patients Sometimes. Would you mind sharing how they can find you online?   Timothy Aungst: (29:58) You can find me on LinkedIn, you can find me on Twitter. Usually just my name. If you look it up, you'll find it. My website, thedigitalapothecary.com is also out there where I write about a lot of stuff. A lot of it is theory crafting, a lot of it is focused on next steps and such or issues I see in the industry. So you're welcome to come and contact me and reach out.   Janet Kennedy: (30:17) Excellent. Well, I think we're going to have a part two of this conversation. So I look forward to seeing you on the podcast again soon.   Timothy Aungst: (30:24) Thank you very much for having me.

What happens to a person who finds out they have a rare disease? When you're diagnosed with a condition that affects one in a thousand or one in ten thousand, where do you turn to find information, help, and support? Recognizing the need for that resource, a team of dedicated individuals on Rare Revolution, a magazine dedicated to spotlighting the rare disease community. Their goal is to bring about a dramatic and wide reaching change in conditions and attitudes for the rare disease community. We are honored to bring Rebecca Stewart, CEO of Rare Revolution Magazine, to the podcast. Her conversation with our host, Janet Kennedy, truly reflects our philosophy - People Always, Patients Sometimes.   Janet Kennedy: (00:50) Welcome to People Always, Patients Sometimes. Today we're really taking a patient perspective and we're taking a unique look at patients who really need some attention right now, and those are the patients that reflect the rare disease community. With me is the CEO and founder of Rare Revolution Magazine, Rebecca Stewart, and we're going to be talking about the thousands of patients who may not be getting the attention they deserve and need - those with rare disease. Rebecca, welcome to the podcast.   Rebecca Stewart: (01:24) Thank you very much for having me Janet. It's a pleasure to be here.   Janet Kennedy: (01:27) I would like to think that we really are having a Rare Revolution, but is yours a call to action or a reflection of what's actually happening in the rare disease community?   Rebecca Stewart: (01:39) So to give you some context, there are over 7,000 known rare diseases, which affect globally 350 million people. So we're the biggest, rare community that there is. It's a huge number of patients, but of course, individually, each individual disease affects a small number. But globally it's a huge health crisis.   Janet Kennedy: (02:05) How about how the community is being served? Is this something where individual patients are truly having to learn how to advocate for themselves, or are they growing together as a community to speak and support each other?   Rebecca Stewart: (02:20) I think there's both. So, as a community, the rare disease community have both really good individual disease communities, mostly. Of course, there are those rare diseases that are so rare that there aren't support groups, there aren't patient communities. And so those people find themselves really quite isolated. And then collectively the rare disease community comes together to really help influence policy, to help influence healthcare, to help push for things like interest in orphan diseases, from pharmaceutical companies and research, and to support each other because individually, the individual nuances of each rare disease, whilst those might be very different, collectively people with rare diseases tend to have very similar problems; that's access to expertise, access to healthcare, education, meaningful employment, social services. These are all shared problems. And so they can really support each other across disease. So, you know, really disease, agnostic support as well as the absolutely amazing job that individual support charities and organizations provide on a specific disease level.   Janet Kennedy: (03:34) So what is the Rare Revolution Magazine role in all of this? What is your mission and how do you become involved in this community?   Rebecca Stewart: (03:43) In 2012, my sister, who's also my co-founder, and I actually began a disease-specific support group called Teddington Trust, which is to support families affected by the ultra rare disease Xeroderma Pigmentosum. And through that, what we found was a real gap in our ability to raise meaningful awareness for the work that we did and for the condition and that it was done in a way that we felt was sensitively dealt with and valuable to us as an organization and a community. And we thought, well, we can't be the only people that struggle with this. And of course we discovered we weren't. So Rare Revelation Magazine was founded out of a real gap in rare disease education and awareness materials. And what we wanted to do was to become a platform where it didn't matter whether you were a patient, a caregiver, an advocacy leader, someone from industry, someone from research, or a healthcare professional: right across the ecosystem, you could come to us and both be heard, talk about the work that you're doing, but also gain value and find information and education in what you read. But it was really important to us that the tone, the design, the curation was something that added value and was sensitive to people's lives. And that's really, our mission is to be a source of awareness, education, signposting, so that people can find each other and really be a platform to elevate the voices of our communities. So we don't speak for our community. We're just here to elevate the voices of the community that exists and already do a great job.   Janet Kennedy: (05:24) Well, you know when I look at the magazine, which is digital only, is that correct?   Rebecca Stewart: (05:28) It is. We do occasionally print them if we're going to conferences in pre-COVID times, but you know, it's a digital e-reader and then a website as well. So web based content, and then the magazine itself has produced as a digital e-reader.   Janet Kennedy: (05:42) Well, kudos to you. It is a fabulous looking magazine. It is so professionally produced. The photography's incredible. Your design is great. This is not a newsletter typed out in your backyard. This is an amazingly beautiful magazine.   Rebecca Stewart: (05:59) Thank you. And you know that was actually really important to us that, I think when you have a rare disease or a chronic illness, you spend a lot of your time online carrying out research. And it was really important to us that when we produce this magazine, it was something that told a story, but it was really, it was, we spent enough time on our screens. We wanted something that was really lovely to look at that it was an enjoyable process. Because to us, that means people spend longer in the publication, looking at things and reading articles that they might not normally read and that we have found to be true. Certainly our average time that people spend on the magazine is much longer than you might expect people to spend in digital content. And I think that is down to the amazing job that our two designers and also to our editor and chief creative director, Nicola Miller, who curates and has a hand in overseeing all of the publications that we do.   Janet Kennedy: (06:58) Tell me a little bit about the process of putting the magazine together. You've mentioned over 7,000 rare diseases; well you'd think it would end up being something as big as the Encyclopedia Britannica. So how do you curate and where do you get your content and how is it put together?   Rebecca Stewart: (07:14) Well, we do between three and four core additions of the magazine each year. And then on top of that, we do a number of spotlights additions, which tend to be smaller and more focused. And we will do three of those perhaps in a year. And then we have our online content as well. And when it comes to what themes we're going to tackle, we keep quite a close ear in the community. We see where people are talking, what they're talking about, what the current challenges are. But also people will reach out to us and say, you know, we have this condition, have you ever thought about covering it? And so we'll put together an editorial calendar over the year that are topical things that are going on in the community or areas where we feel we can really reach out to the community and add value.   Rebecca Stewart: (08:03) For example, we have just done an edition on inclusion, equity, and diversity. Prior to that, we have looked at rare bone diseases or rare cancers, rare kidney diseases. You know, what we're trying to do with those core additions is have a very broad topic that we can encompass many rare diseases in under that. Obviously we're never, you know, Nicola and I will not live long enough to cover every rare disease at 7,000 plus, but we're giving it a good shot and we're doing it as best we can with these topics. And then with our spotlight additions, those really allow us to get very, very detailed on very specific subjects. And generally those additions are brought to us by sponsors who have got a particular need to talk in an area and they want to really shine a light on something. And so we will work with those sponsors to produce those spotlights.   Janet Kennedy: (08:56) And how do you vet out in essence, the difference between say paid and editorial content?   Rebecca Stewart: (09:02) In our core additions, we have an editorial sponsor, but that editorial sponsor only has any control over the articles that they give us for that particular edition. Everything else is the copyright of the contributor and of Rare Revolution. So they don't have any editorial control there, which really allows us to make sure that the conversations that we're having are genuine and are not influenced by a sponsor. And even when we do our spotlight additions, which tend to be solely sponsored still in that situation, the sponsor does not have editorial control. And what we generally do in that situation is we will carry out all of the patient patient group and healthcare professional interviews; which again, allows us to make sure that we're asking appropriate questions, that we're keeping all of that content compliant and valuable. And we understand what our readers are looking for. So, you know, we very much have an input in any brief that's being laid out for the spotlight edition. But in our core additions, over 90% of the content will be from individuals and charities. There's very little paid for content actually makes its way into those additions.   Janet Kennedy: (10:16) Which makes it even more amazing that this is a free publication.   Rebecca Stewart: (10:21) Yes. It is a challenge, I won't lie. Our revenue stream for the magazine - we are a not-for-profit organization - but we're not funded by grants. So all of the funding that we receive is through paid for content. So things are tight. We're not sitting here with a big fund or a huge team. We're a very small team of eight. So we have four full-time, four part-time members of team, and they do an incredible job of delivering all of the content that we do.   Janet Kennedy: (10:50) I'm so impressed with the quality of the content. I think it's really amazing considering what a small team you have. It's just absolutely gorgeously put together. So kudos to you. Let me ask you a question about sponsors. And when we say sponsors, what I'm really asking is about some of the pharma community, some of the organizations that are involved in drug development for rare disease; how do you think that they can be more involved in supporting patients? I definitely see that there are more and more companies that are starting to have patient advocates. They're starting to have patient engagement titles, but how are they connecting with the rare disease community?   Rebecca Stewart: (11:36) I think you're right. The role of patient engagement within pharmaceutical companies we have seen, I mean, although it's been something that has been around for more than twenty years, I think really in the last five years, it has really grown and there has been more pressure on companies to really include the patient voice in what they are doing. And it is done very well and it has done very poorly. I think there's still a long way to go, but we are definitely heading in the right direction in terms of how pharma is engaging with patient communities. I think it's a really challenging area for them. Obviously, pharmaceutical companies, quite rightly so are heavily regulated and there are tight controls on how pharmaceutical and biotechnology companies can engage with patient communities. And that is all correct. And as it should be, I think there is a gap in that while patient engagement has grown and become better and become more prolific, the regulatory environment that surrounds that has not matured at the same rate.   Rebecca Stewart: (12:43) And so I think there is still a bit of a disconnect between what could happen and what should happen and how comfortable pharmaceutical companies feel about doing it. I also think that in terms of where pharmaceutical companies go next, there's a huge burden on charities and support groups in engaging with pharma. And they want to do it. Don't get me wrong, It's a burden that they want to take on. However, it's a really complicated landscape and there's an education gap there both for patient groups when it comes to navigating these complex pathways and also pharma and what's appropriate in the way that they should engage. So I think there's definitely some more education piece there that can be looked at to improve that. And I think some of that can be driven and come from regulators and overarching bodies in the space. I think the other area that we need to collaboratively look at is the one of innovative medicines.   Rebecca Stewart: (13:43) You know, we are in an era where we have gene therapies, gene editing, some really innovative therapies and treatments, which are making their way into rare disease, which is absolutely fantastic and amazing. However, with this kind of research and with these kinds of developments, there comes high prices for drugs and at the moment, there's little, that's understood about the way that these drugs will be paid for by payers. And so I think we are beginning to see the problems where we have, you know, I don't know what it is, I think it's several hundred gene therapies now in the pipeline through the FDA and EMA, but we're very, very unclear as to how these will be paid for, especially in countries like the UK, where we have a national health system and we have an approvals process for that. So I think access to innovative medicines is really an emerging problem that really we need to tackle collaboratively.   Janet Kennedy: (14:44) Well, the reality is patients can't afford any of them. So somebody has got to figure that out.   Rebecca Stewart: (14:50) Exactly. I mean, when you've got a single medicine in the region of over a million dollars and upwards, we have to look at how these are going to be paid for because to not have a treatment - only 5% of rare diseases have a licensed treatment. So we are desperate for more treatments within the field of rare disease. However, the only thing that is more desperate than not having a treatment is having a treatment, which has proved to be efficacious and safe and you cannot access it because either insurers or health boards won't pay for it. And so there is a responsibility for everybody, I think to work this out before we suddenly have all of these drugs on the market and patients still not being able to access them.   Janet Kennedy: (15:32) I can't imagine a more heartbreaking situation is to know that there is a potential solution that you cannot afford to have.   Rebecca Stewart: (15:42) Yeah. Yeah, exactly. And I think that's something that really is a matter of priority. We need to be looking at. And some countries are. For example, we've just done some work in the Middle East with a particular additional focused on the MENA region. And some of their health boards are having dedicated advanced therapy panels so that they can look at it, become expert in that particular field of medicine and start looking at it from an advanced therapies point of view. So I think there are countries that are starting to tackle and address this, but we do need to move with some speed, I think, if we're not going to have this kind of potential problem with access.   Janet Kennedy: (16:24) Well it sounds like advocacy has to extend beyond the easy advocacy. Sounds like the media, for instance, could step up and instead of focusing just on heart disease or diabetes or the well-known well-understood, and to be honest, well-funded diseases to really start to shine a spotlight on the rare community.   Rebecca Stewart: (16:49) Yeah. And I think along with that, there is a responsibility for health journalism. And this is one of the reasons we exist is because typically health journalism, when you come outside of those well-known diseases, is relatively poor. And what we tend to find within the rare disease community is that what journalists are looking for is a human interest story. And of course they always want a very sad account of somebody's life. And the problem we were facing with our communities and why we founded was because our patients weren't finding that that was reflective. And they were giving lots of access to journalism to help raise awareness, but then they didn't feel that they were being treated sensitively at the other end of that with some, you know, quite sensational headlines perhaps, or an account of their lives that they didn't really feel was reflective. And I think for journalism, what would be beneficial I think is to move away from just focusing on those human interest stories, to talk about some of the really big challenges that we have within the rare disease ecosystem and start looking at things like drug prices, access, equity, for those with rare diseases.   Janet Kennedy: (17:59) All right. I consider that a challenge now to mainstream journalism, to pharmaceutical companies and to the regulatory bodies that are out there. So folks it's time to step up and let's really take a deeper look and not just look at the cover.   Rebecca Stewart: (18:16) Absolutely.   Janet Kennedy: (18:17) So Rebecca, I'm so impressed with the work that you are doing. How can we as private citizens, as individuals step up and help you?   Rebecca Stewart: (18:28) Well, I think if we think of it globally, one in seventeen, or in the U.S. one in ten people has a rare disease. So pretty much everybody will know somebody that is living with a rare chronic disease. I think in terms of what individuals can do is just help to spread that awareness, be aware that there might be somebody within your community that is living with a really complex and challenging condition. I think we need to be, as we do with all disability, keep ourselves really open-minded really check ourselves to making sure that we're not being discriminatory. You know, it's one of these things that can be so ingrained in us that sometimes we don't even know that we are being discriminatory in our actions. So I think always keeping that in the forefront of our mind and making sure we're being fair. We're giving people fair opportunities and helping our friends and our neighbors and our communities have access and the same sort of life that we would all want. So I think just being very open-minded and aware of who's in your community and who your neighbor is, and just being good members of society.   Janet Kennedy: (19:38) Excellent point. And actually let's do a little focus here on COVID and the Corona virus and how that's impacting the rare disease community. And you get to educate me a little bit here. I am assuming that there are members of the rare disease community, obviously immunocompromised, but who potentially couldn't even take the vaccine. Would that be correct?   Rebecca Stewart: (20:00) Yes. There will be some who can be vaccinated and some who can't. I think we were still in the early days of data from COVID vaccines. And so some of that is unknown. I was involved along with quite a few other people in a project called ARDEnt, which was Action for Rare Disease Empowerment. And what we did was we came together very early on because we could see that potentially COVID 19 was going to have a disproportionate effect on the rare disease community. And we wanted to carry out a longitudinal study to see what that impact might be. And that as things opened up for everyone else, with things and services open up for those within the rare disease community, the same, and actually the information that we collected and the data that we looked up was quite harrowing. The rare disease community felt very, very left behind, very isolated. A huge portion of the rare disease community, where - certainly in the UK, where we had big isolation policies - where for the initial 12 weeks, anyone who was compromised had to completely isolate: as in, they could not step out of their property, not even for shopping.   Rebecca Stewart: (21:12) So I have both my dad and I have a nephew who have a rare disease and they both spent initially 12 weeks and then longer because it was extended. So I think by the time they were able to get out in any capacity, it was about 16 weeks spent entirely just in their home, reliant on people dropping food off on their doorsteps. And so very, very isolating and alone. And then I think as the rest of us have kind of come out and about, there are still those that are very immune compromised that are still very, very cautious. We've also seen, you know, returns to services. So from a hospital point of view, when all elective treatments were stopped to make space for COVID wards, that also applied to many people's rare diseases. And while some of these treatments might be deemed elective and non-essential, actually they are essential in terms of rare disease.   Rebecca Stewart: (22:12) And one example of that is that consultants saw a big decline in those with neurological conditions, not because of disease progression, but because of the lack of things like physio, speech therapy, sensory play. Because these are deemed non-essential of course these were all cuts, all services that were cuts. And we understand why they were cuts. And I don't know that there was a solution to not do it, but the effect has been very detrimental to those people that have not had those therapies and services, which are really essential in their development and disease management. And that's just one example of where loss of services has been really detrimental.   Janet Kennedy: (22:58) And continuing today because of our low vaccination rates.   Rebecca Stewart: (23:03) Well, here in the UK, we are not too bad in terms of vaccination rates. I believe we've had a very successful vaccination program and I think the uptake has been pretty good. We are seeing a return to some hospital services, not as they were for sure, still very much telemedicine triaging, but it's starting to make its way back. However, I think the wait lists now for many things are now running into the years, because there is a huge backlog of things that, of course couldn't happen during COVID.   Janet Kennedy: (23:38) Well, it sounds like Rare Revolution Magazine is serving such an important connection for people to help find their communities to support those within their communities. And to even just educate both the newly diagnosed and those who have been dealing with their condition for many years. What I'd love for you to do is to tell people how to find you.   Rebecca Stewart: (24:02) Yeah. You can find us online at rarerevolutionmagazine.com. We're also on Facebook and Twitter and Instagram and LinkedIn. We are like I say a small dedicated team, but we are very approachable. So do reach out, connect with us on social, connect with us online. Or emails, or you can reach us through email, so do get in touch. And if we can help and support your organization or your voice or your company in anything that we do, then please do reach out and say, hello.   Janet Kennedy: (24:33) Rebecca, thank you so much for joining me for People Always, Patients Sometimes.   Rebecca Stewart: (24:39) Thank you. It's a pleasure to have been here.

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Decentralized trials are here to stay, says Dr. Isaac Rodriguez-Chavez, our podcast guests today. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We are delighted to have Isaac join the podcast to discuss decentralized clinical trials and why pharma companies should embrace digital technology for the benefits of patients. A former FDA officer who was instrumental in the review and approval of digital health technology in clinical trials, Dr. Rodriguez-Chavez is now the Senior Vice President for Scientific and Clinical Affairs and Head of Strategy for Decentralized Clinical Trials for Icon. I hope you enjoy this conversation with our team member, Janet Kennedy, on the People Always, Patient Sometimes podcast.   Janet Kennedy: (00:46) I can't tell you how thrilled I am to have finally landed Isaac Rodriguez-Chavez as a guest on the People Always, Patient Sometimes podcast. He is an industry leader that is someone that everyone listens to, and it's really exciting to have him here today. He is formerly the FDA officer focusing on clinical research methodology, regulatory compliance, and medical policy development, and recently joined the private sector as the Senior Vice President of Scientific and Clinical Affairs, Head of Global Center of Excellence, DCT Strategy for PRA Health Sciences. So he's got a foot in both camps and it's going to be a very exciting conversation. Isaac, welcome to the podcast!   Isaac Rodriguez-Chavez: (01:30) Thank you, Janet for having me and all the listeners, I am delighted to be here with all of you, sharing some thoughts on information that is really, I hope, pertinent for all of us.   Janet Kennedy: (01:43) You have been very active as an FDA member and as a member of the PRA Health Sciences in promoting and discussing decentralized clinical trials, and it's time is now. However, for the one listener who might not realize who you are, I'd love to explore a little bit of your background, what work you did with the FDA, and then what made you decide to come over to the private sector. So can you tell me a little bit about your background and how you came to be where you are today?   Isaac Rodriguez-Chavez: (02:14) Absolutely. I'd be happy to do so. The FDA, I was a senior officer for clinical developing medical policy and working internally. Also leading a program on decentralized clinical trials and supporting the modernization of clinical trials in general, including the implementation of digital health technologies in modern clinical investigations. The FDA is an amazing place. And my colleagues there are really wonderful, friends more than colleagues, because the work that we do really matters and impacts the entire nation. Essentially, I was a professional consulting internally and externally on decentralized clinical trials implementation of decentralized clinical trials. I believe in the modernization of clinical research. So I am a basic scientist by training with specialties in immunology and biology, but I became a clinical scientist also by training and experience over 20 plus years ago, conducting clinical trials, doing clinical research, being a sponsor, being the auditor, being essentially in multiple capacities, engage in investigations.   Isaac Rodriguez-Chavez: (03:32) So for me, my passion is really what I discover is the direct impact on the patients and their lives, and clinical research, along with the infectious diseases, which is at the end of the generic or the bigger umbrella where my expertise lands, are the things that I like and I enjoy doing. Direct impact to patients and their lives in clinical investigations, with novel products and in infectious diseases and even in vaccines, which are also a love of my life. And that's what I did at the FDA. And then I transitioned to PRA Health Sciences to lead the strategy of a newly created global center of excellence for decentralized trials. The idea really for me was about to transition from the regulatory world and diversify into the real world in how the trials are conducted and essentially lead the strategy and implementation. We are in a transformative time in clinical research because of all of these modernization efforts that are happening building decentralized trials.   Isaac Rodriguez-Chavez: (04:43) So I ended up believer in doing things better, and for the benefit of the patients, and PRA offered me essentially the venue to do so. So I am truly excited to be here with a group of professionals that are outstanding and they believe as strongly as I do in providing essentially end to end solutions and creating partnerships with multiple vendors, so that together and in unison, we can deliver the best in class and in the field in regarding decentralized clinical trials enabled by digital health technologies. And for the benefit of the patients and with efficiencies on the trials and the steps that can represent benefits for the sponsors, for the science - benefits for everyone engaged in the clinical investigation. This is the place, right now, as you said - now is the time, now is the place - in which everyone benefits. It's positive. There are multiple advantages for everyone, so, excited to be here. And my journey has been the one of love and passion for what I do and believing in doing things better for our people everywhere.   Janet Kennedy: (05:55) I'm very interested in the three-legged stool of the organizations that are involved in clinical trials. You have, of course the FDA, you have the pharmaceutical company, and then you have the groups like PRA, the clinical research organizations, that really are much more involved in the implementation of the clinical trials. What I'm curious about is, is that stool steady? In other words is one leg, a lot shorter than the others? Are all three of these organizations moving forward at the same speed? Or do you find that maybe the CROs might be ahead of the game and trying to get pharma to catch up a little bit with decentralized clinical trials? Or are you finding that partnerships with pharmaceutical companies - that everybody is about at the same place?   Isaac Rodriguez-Chavez: (06:42) I could say I see these more as a round table with multiple legs and multiple parties being engaged. One thing that is happening right now that is historically never seen is a different type of collaborations and the level of collaborations and the frequency of the collaborations between multiple entities is unprecedented. The COVID-19 pandemic really has put everyone on the discussion table to find ways to continue the traditional clinical investigations that were happening when we were hit by the pandemic. So the way to do it was the implementation of elements of decentralization. And with that, the creation of hybrid decentralized clinical trials in which some elements of decentralization are happening, and others are still happening in the brick and mortar site - the traditional clinical research site. Now days. And what we're seeing is essentially the business beyond the pandemic. The transformation that is happening really is permanent, is driven by multiple factors, and the engagement is at all levels.   Isaac Rodriguez-Chavez: (07:58) So the industry, the regulatory agencies, the clinical research organizations, such as PRA health sciences, are really making huge efforts to work together, to drive this transformation. Of course we are in a learning curve and a learning process. All of these happened suddenly. And though we are embracing decentralized clinical trials and technologies to modernize clinical research, we're still in the transition time, we're still in the changing of how to do things. Everyone is not at the same level. Everyone's not at the same speed. There is a spectrum in terms of the uptake and implementation and racing, decentralized clinical trials and technologies; that kind of goal. Everybody's thinking about how to do it in the pharmaceutical industry, in the biopharmaceutical industry - small, mid-size, large size pharmaceutical industry - but the implementation is different. So there is a whole spectrum that can go anywhere between 20% to up to closer to 80%.   Isaac Rodriguez-Chavez: (09:08) And the surveys show that information. But everyone is having conversations and the projections are very strong, that decentralized clinical trials really will become the mainstream of clincal research within the next two to five years. So this is happening, it is irreversible, it is transformative for everyone engaged in the clinical investigation. And the conversations are happening and the collaborative work is happening between multiple parties. So I not only see the regulatory agencies and the pharmaceutical industry and the CROs; I see the vendors, I see multiple vendors engage. I see the science engaged. I see the patient advocacy groups engaged. It's really multiple entities engaged in the conduct of these kinds of investigations. And it's for the benefit of everyone, as I said.   Janet Kennedy: (10:06) So you're saying you really don't think we're going to go backwards to the way it always used to be done - that people have learned, not just that patients want a new way of participating in clinical trials, but this is actually a better way?   Isaac Rodriguez-Chavez: (10:21) Pretty much. Though decentralized clinical trials are not the universal solution for every single medical product that is going to be tested, it is very common to see decentralized clinical trials in multiple therapeutic areas, and in all phases of the clinical investigation. There are multiple reasons and benefits for doing this. Essentially, the potential for enhancing convenience to the participants is a main driver for the implementation of decentralized clinical trials, the opportunity to improve recruitment and retention of participants, participants in the ecosystems where they live - meaning their homes, their towns, their cities, their countries - and not having them to fly or travel to distant places to go to a clinical research site to participate in clinical investigations is a major advantage, is a major driver. The use of technology as never before is amazing. And though technology has been utilized in traditional clinical investigations, the uptake of technology by modern clinical trial designs is very powerful, and it's happening.   Isaac Rodriguez-Chavez: (11:41) And it's happening here to stay. The opportunity to essentially monitor participants remotely with the use of technology, the opportunity to break socioeconomic barriers and geographic barriers are very powerful. And this is all because of technology. Also, if you have technology, which is one of the elements that enable these trials, but you also make plans, proactive plans to increase diversity and inclusion, you break the geographic barriers right there. And if you optimize and you think proactively from the get-go in how to design these trials and not to retrofit a traditional trial, you have a huge potential for cost savings - something that is really appealing for the sponsors. So there is an opportunity to improve efficiencies at all levels of the modern clinical trial design, decentralized clinical trials, use technologies to enable them and maintain the quality. And the regulatory agencies, particularly the FDA, is tuned to all of this. So I think, again, this is enabled by the cities or digital health technologies are here to stay. Traditional trials, they're still exist. They will continue to exist. There will be just an increase in the use of these cities enabled by the colleges. That's what I'm saying.   Janet Kennedy: (13:10) Sometimes I feel like people oversimplify and think of decentralized clinical trials as just the use of tele-health. And yet there is so much more in your current work, or even in what you were looking at when you were at the FDA, what kind of technologies do you think enhance a clinical trial?   Isaac Rodriguez-Chavez: (13:31) There is not a universal answer for your question. Your question is very important, but essentially all technologies are important. And the key point in regards to the use of technology really is the adaptation that has to happen on that technology to support the specific needs of every clinical trial. And that is the point. Each technology has to be verified. It has to be validated to the end user. It has to be justified to measure, for example, the specific end points that are relevant for the clinical investigation that is being conducted. And it has to be usable. Nobody wants to have a two pounds watch on the wrist because it's going to be really difficult to wear that on a daily basis. So the technology has to be usable. It has to be user-friendly. It has to be something that everyone from the clinical staff, to the investigator, to the actual patients need to use in a meaningful way. So technology is here to enable the trials. Technology has to be adopted on a fit for purpose basis, according to the needs of the trial, the specific end points, the specific communication plans that are put in place, depending upon the nature of the disease that we're dealing with. There are many ways of dealing with technology and the bottom line really is to optimize it, to adapt it, and to make it meaningful fit for purpose technology that supports clinical trial. That's what it is.   Janet Kennedy: (15:14) I'm very curious to hear your thoughts on the overwhelming potential for real-world data to come into play. Not that many years ago, the data from patients was sitting in the parking lot of the clinical site where they're filling out their paper diary and going, "yeah, I think I took it that day, and I think I take it that day." And now we're in a situation where not only do we know that you've taken a medication, but we also know your blood pressure or your weight or your glucometer results, things of that sort. Well, that is an overwhelming amount of data. Are the scientists that are dealing with this data, thrilled and excited to have all of this, and is it leading to a whole new level of analysis and analytic skillsets coming into clinical trials? Or do you think people really aren't prepared to know how to manage this? Because I'm thinking from a primary care physician. If I were to turn over my Fitbit data to my primary care physician, they might go, well, what do I do with this?   Isaac Rodriguez-Chavez: (16:18) Definitely the real world data and the real world evidence are important trends that were clearly supported by our legislation. When the 21st Century Cures Act was passed in 2016. That is a different work stream and trend compared to decentralized clinical trials enabled by digital health technologies. They both have in common, the use of the real world settings to collect clinical data to assess the safety and efficacy of investigation or medical products. So in that regard, they both are really powerful. And the FDA uses real world data and real world evidence to monitor, for example, post-market safety and adverse events, and also to make regulatory decisions. And that's what they actually mentioned on the website In the real world data, real world evidence space. They also use computers and mobile devices and wearables sensors. And the idea is to gather big amounts of data - data that is related to clinical research - and that is health-related data that essentially is collected, can be collected at the clinic at the doctor's office.   Isaac Rodriguez-Chavez: (17:38) And so this data can be adapted to allow for better designs and the conduct of clinical trials and studies. And essentially is, in addition to that, it really is a way of developing more sophisticated, new analytical capabilities. And essentially the data can be applied to resolve and do analysis of medical products in ways that were not done before. The same is with decentralized clinical trials. They are conducted in the real world setting. They are utilizing all of these technologies, and there is a need to create new ways of doing data analysis. The data analysis can be done with the use of, for example, artificial intelligence, machine learning, and new ways of doing these and ways of doing it quickly in almost real time or in any real time sometimes. For example, the capacity to see in any of these two in real world evidence trials, or in these CTs an outlier detected by artificial intelligence analytics that might represent, for example, an adverse event and if their protocol that is being monitored, there is an opportunity right there to react in more real time compared to for example, a traditional clinical trial. So yes, these are modernization of clinical research happening in the real world setting with new analytics, a lot of power in place to do things in real time or almost real time. Very powerful.   Janet Kennedy: (19:24) What do you think are the challenges for implementing DCTs or decentralized clinical trials and DHTs?   Isaac Rodriguez-Chavez: (19:32) I could say because we're in a transition time, though the FDA is supporting - and strongly supporting - the implementation of decentralized clinical trials and the assessment of the safety and efficacy of clinical investigations with decentralized clinical trials, and they have a history of supporting these CTs by creating a regulatory framework. That is not the same case for own regulatory agencies in the world. The EMA is in the process of understanding, for example, in Europe the EMA developed COVID-19 related guidances to enable remote activities of trials. The EMA is partnering with the Innovative Medicine Initiative, and they have implemented a center of excellence that is called "Trials at Home" to explore the use of DHTs - or digital health technologies - in decentralized clinical trials. They are developing methods to streamline data collection, as well as to essentially understand patient recruitment and retention in Europe, and use these five trials that they have put in place to inform the development of policy that is supportive of these CTs and technologies in Europe.   Isaac Rodriguez-Chavez: (20:54) The Swedish Medical Products Agency received a grant of about 2 million Swedish, I don't remember their currency, but essentially they received a lot of money to conduct preliminary studies on decentralized clinical trials and examine the conditions and the requirements to conduct safety and efficacy studies using the CT approaches in Sweden. The Danish Medical Agency went ahead of the pack and they just issue in May of 2021, their guidance on the implementation of decentralized elements in clinical trials with medical products. And so there is a clear movement from the European regulatory agencies. In Asia, there are conversations between the regulatory agencies and multiple stakeholders to inform them on the implementation development and implementation of policies that support clinical trials. So we have a spectrum that is led by the US FDA that is really advanced in the regulatory framework that they have developed followed by Europe and the European regulatory agencies followed by the Asian regulatory agencies in the development of policies for decentralized clinical trials.   Isaac Rodriguez-Chavez: (22:20) Meanwhile, we have to go on a country basis to understand the regulatory intelligence and the possibility of deploying multiple elements of decentralization required on each study to implement decentralized clinical trials. So a major challenge really is having the harmonization of policies, procedures, the regulatory framework, the legal framework, across multiple jurisdictions to implement the CTs globally - that it stays there. Another challenge is the digital health divide; we all know and talk about the digital health divide. And so democratizing having equal access to technology by diverse populations everywhere in the world represents a challenge. And it's also an important ethical marker. We are not supposed to include populations because of the lack of access to internet. For example, the lack of access to technology. This is something that becomes a costly enterprise because then the sponsors of the trials may need to provide that technology, that access to internet, while the participants are part of the clinical investigation. Another source of challenge is to bring your own device. For those who already have some of these devices, the use of those devices may represent sources of variability if it's not carefully looked at and controlled before deploying decentralized clinical trials. So these are some of the items that I could say represent the challenge in implementing decentralized clinical trials globally; they are surmountable if we think carefully and we plan carefully. These trials are not again, to retrofit traditional trials with a decentralized solution.   Janet Kennedy: (24:25) Well in thinking about the process of every country having their own regulatory process, their own design; are we at all in the same place with what the data means, or do we also have to worry about the interpretation of the data coming from a decentral trial?   Isaac Rodriguez-Chavez: (24:42) Decentralized clinical trials is all about mapping communications and mapping the data flow to have continuity on the data flow and to mitigate sources of variability. The data can be characterized and understood as coming from remote locations, coming from central locations. And we're in the process of learning right now, sources of variability, but that's one of the beauties of decentralized clinical trials - you can implement and design multiple solutions to mitigate the sources of variability of the data in these trials. And there has to be a customized statistical plan put in place to analyze the data in a meaningful way. We are yet to learn how the regulatory agencies will take all of this data and essentially what level of tolerance they may have, in regards to some level of variability that might exist in the CTs, as exist in any clinical investigation.   Janet Kennedy: (25:48) Now that you've left the FDA and you're working in the private sector, how in your role as the Head of the Global Center of Excellence for DCT Strategy, how does that impact your ability to get conversations going, and what is your role in that?   Isaac Rodriguez-Chavez: (26:05) My conversations are not impacted. I respect and maintain the confidentiality of the work that I did at the FDA. I essentially recuse when I need to recuse from specific conversations with specific entities or products. But other than that, I am not impacted in my daily work by leading the strategy of decentralized clinical trials at PRA Health Sciences. In fact, my level of activity is, I would say very high; I'm very engaged with multiple entities in the industry and in the clinical research field at large. And so one of the things that I do - I wear multiple hats - is to essentially assess the suitability of trials and opportunities to implement end to end solutions from the start to the very end, using decentralized clinical trials, assess technologies that can be put in place in decentralized clinical trials, partner with a great team that we have in PRA Health Sciences, including the team of operations, regulatory affairs, technology team, quality control, quality assurance, the legal team, the qualified vendors that we have to holistically assess the suitability of every opportunity that we engaged on to implement meaningful, customized high impact to end solutions on decentralized clinical trials.   Isaac Rodriguez-Chavez: (27:42) So that is a very dynamic work. I also engage on protocol design, protocol review, protocol assessment for decentralized clinical trials, and I engage on training and education - internally and externally. I am engaged on being a spokesperson for PRA Health Sciences regarding decentralized clinical trials for the industry at large. I also provide consultation services to assess the pipelines of multiple partners and pharmaceutical companies who would like to have a holistic view of their pipeline, and leverage one clinical trial with future possibilities, and to essentially participate as a leader in the field, sharing knowledge and information regarding decentralized clinical trials technologies, the modernization of clinical research in multiple areas, including the areas of infectious diseases, vaccines, immunology, virology, oncology.   Janet Kennedy: (28:50) Well, I have to admit, I am both proud and amazed at your workload and exhausted thinking about all the things that you do. I'm thrilled that you are over on the private side and working for a company that has an office in our area, in the Raleigh area, and I can't tell you how fascinated I am with our conversation so far. And I feel like there's a lot more that I'd love to ask you about, particularly in regards to CRAACO, the Clinical Research As A Care Option, and how patients have both factored into the changes that happen as a result of COVID and also going forward with how they're embracing decentralized clinical trials, but we're going to have to save that conversation for another day. You've been listening to People Always, Patients Sometimes, and my guests, Dr. Isaac Rodriguez-Chavez, who is the Senior Vice President of Scientific and Clinical Affairs, and also the Head of the Global Center of Excellence for DCT Strategy at PRA Health Sciences. Isaac, thank you so much for joining me here today.   Isaac Rodriguez-Chavez: (29:57) And thank you, Janet and listeners for the opportunity to share some thoughts with all of you in regards to the modernization of clinical trials, our services at PRA Health Sciences, on the use of digital health technologies technologies in general, and the unification of clinical research with the standard healthcare systems using the CRAACO principle that we applied to. I look forward to future conversations, and please connect with me in LinkedIn if you would like to continue the conversation. Thank you again for listen.

Understanding the patient journey is an important part of clinical trial development. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. On today's podcast, we welcome Shazia Ahmad, Senior Director of Patient and Physician Services at UBC. She is a thought leader in the space of patient communities and supporting the patient throughout the clinical trial process. I hope you enjoy this conversation on People Always, Patient Sometimes.   Janet Kennedy: (00:31) Hi I'm Janet Kennedy and I am your host for People Always, Patient Sometimes, a production of Spencer Health Solutions. I am really looking forward to a conversation today with thought-leader Shazia Ahmad. She is the Senior Director of Patient and Physician Services at UBC. Welcome to People Always, Patient Sometimes, Shazia!   Shazia Ahmad: (00:52) Thank you Janet! Thanks so much for having me today.   Janet Kennedy: (00:54) I've been trying to track you down for a conversation for actually a number of years, and I'm so glad I finally captured you today.   Shazia Ahmad: (01:03) Yes, absolutely! So excited to be on.   Janet Kennedy: (01:06) Well, I want to be talking to you a lot about the work that you do specifically as a director of patient and physician services; but first I think we need to set the stage. Can you tell me a little bit about UBC?   Shazia Ahmad: (01:18) UBC was founded in 2003 by industry experts with a passion for innovation and a commitment to working with pharmaceutical and biotech organizations in proving the safety, efficacy, and value of pharmaceutical medicine products. UBC is a leading provider of pharmaceutical support services, and we partner with life science companies to make medicine and medical products safer and more accessible.   Janet Kennedy: (01:46) Now, would you consider U B C to be a C R O?   Shazia Ahmad: (01:51) I would say we're CRO, but we really are proud to kind of stand out as a service provider, I would say.   Janet Kennedy: (01:59) Okay. Well tell me a little bit about what that means to be directing patient and physician services.   Shazia Ahmad: (02:05) At UBC, I have the honor of leading a team called patient and physician services. And what that is, is we're involved in supporting biotech and pharmaceutical sponsors in different services around patient recruitment, engagement, compliance, retention. We offer different services around making sure that we engage patients early on in research to ensure that the sponsor captures everything they need to, to really understand the patient journey and the development of whether it's the protocol design, developing the right strategies for recruitment retention. We're also able to integrate capabilities and services around awareness campaigns, where we use social media, digital outreach, and traditional advertising. A lot of programs that we do work on now at UBC involve the rare disease space. And I think Janet, that's where you and I really connected most over the last few years; a lot of the rare disease work that I lead. So we're able to also integrate different capabilities to really work with patient advocacy groups and really involve them early on in the launch of our programs to ensure that we're not just getting the patient voice by making sure that we work with the patient advocacy group as a partner, and really we work as a bridge to the sponsor with the patient advocacy group to ensure that we have the right strategies in place to support recruitment and retention for our program.   Janet Kennedy: (03:41) So are you actually bringing in these advocacy groups so early that they're participating in evaluating or contributing to the protocol design?   Shazia Ahmad: (03:49) Exactly. Exactly.   Janet Kennedy: (03:51) Well, that's kind of exciting. I'm curious - what sort of feedback have you seen coming from these groups that actually made the sponsors rethink how they had written a protocol?   Shazia Ahmad: (04:03) It's been interesting because there's been cases where we're able to learn something. And this could be in a rare disease indication where something was not thought about before, on what mattered to the patient, even the caregiver or care partner around different end points that were not considered. For example, they've not thought about maybe walking up the stairs would be something important to think about in the protocol design or certain visits to come to the study site and learning those things early on have really helped us integrate solutions to really make it easy for the patient caregiver care partner to participate in the study. And also we're able to integrate the solutions that really make sense for that protocol. For example, we have a clinical trial nursing service offering that we provide to different sponsors, where it makes sense to integrate home nursing for a clinical trial. The other thing that we're starting to do now based on our learnings, working with advocacy groups is integrate more decentralized solutions for clinical trials, which really has been going on a lot pre pandemic. But I think the pandemic has now really invigorated that even more and making sure that we can really bring in innovative solutions.   Janet Kennedy: (05:25) Certainly if you're dealing with a rare disease community that probably has multiple comorbidities - maybe a suppressed immune system - they're definitely gonna want to stay at home. So I'm very curious about the decentralized part. Are you finding that what you ended up developing was just more opportunities to gather data from the home, or were you working around fewer visits to a clinical office, but you tried to get more done at the time you were there? How that actually impact the work that you did in 2020?   Shazia Ahmad: (06:00) Actually it's a combination of all those things where we've been able to do more home visits and be able to really capture real world evidence and really real end points that couldn't be captured before; even things in between visits. So that's been very valuable, especially with the home nursing. And then also with the decentralized trials. One avenue we're actually looking to go to now is we've often had challenges in getting referrals from referring providers to really open up the pool of participants in areas where they want to participate, but are unable to, because they're not near a study active study site. So that's another way that we're able to connect participants patients to trials in their communities and really going to where patients are at.   Janet Kennedy: (06:53) Well, that's interesting. So in other words, in the past, we tended to have our principal investigators in larger metropolitan areas near maybe hospital systems with robust research, but the patients aren't necessarily there. They could be out in the boondocks somewhere. And what you're saying is now with this emphasis on decentralized solutions, you've been able to incorporate more patients - maybe even a broader range of patients from a diversity perspective - because these solutions made that possible.   Shazia Ahmad: (07:26) Exactly, Exactly.   Janet Kennedy: (07:29) So when you talk a little bit about real-world evidence and real-world outcomes, what kind of information are you gathering?   Shazia Ahmad: (07:35) We're looking at, and this could be any therapeutic area, but specifically in the rare disease space, we look at different - and this is more a question, I think, clinical operations, we work with the clin-ops team and developing the outcomes that matter - but what we do is we work with the patient advocacy groups to really hone in on a protocol and make sure the questions that are being asked, whether it's the patient reported outcomes, those things are really elements that matter to the patient. And it could be just the normal six minute walk tests. That's part of usually a pulmonary hypertension study or whether a cystic fibrosis patient had to take a day off from school. So it could be any of those things.   Janet Kennedy: (08:17) Shazia, what kind of key trends are you seeing in the industry regarding patient engagement in clinical trials and in healthcare work?   Shazia Ahmad: (08:27) That's a really good question, and something I'm really excited about. We're starting to see the need and the importance of integrating virtual patient communities. Something I'm really proud of that we've been able to actually start at UBC many years ago with a partner sponsor where we've developed patient communities, where patients can be part of a clinical trial and be engaged in part of a community. And they really, they feel then that they're really being, not just a contributor to the research, but then it's like a community building where they can be brought back or given information, not just about the research they participated in, but they can be informed on other trials that go on and they may be interested to participate in, in the future. So that's something I'm really excited about. I think there's more and more sponsors wanting to do that. And the other thing is the importance of giving back to the participants and making sure that they know what they contributed to participants often many, many years ago, did not receive information about the clinical trial they participated in, but now more and more sponsors are seeing the importance of needing to do that by giving back to participants, by providing lay summaries and a lay summary is really just summarizes the clinical trials, the results in a very patient friendly format.   Janet Kennedy: (09:58) Recently, there were two different Huntington's disease studies that did not come to fruition and announced in the same week, which was, I think very, very disappointing for the HD community. And that I think proves the point that not all research is going to work. But you have to acknowledge the contribution that patients have given and support them, even when things don't work out; help them understand why and explain what was it about the research that didn't allow it to move forward.   (10:29) Exactly.   Janet Kennedy: (10:29) So tell me a little bit about social media and leveraging online communities. How does that take place?   Shazia Ahmad: (10:37) We are able to do this all in-house and we're able to leverage social media, different avenues like Facebook, Twitter, different platforms to really engage potential participants for clinical trial, but also to create education and awareness about a particular disease or indication. Because the touch points are so different, we want to make sure that we are working in a way, not just to recruit patients, but a lot of our campaigns are around education and awareness as well. And we're able to do that by identifying even potential participants, leading them to a pre-screening depending on the program. And as a result, we're able to send qualified participants to a study site, but a lot of the rare disease programs what's really important is leveraging those strategies with patient advocacy organizations. And we do that by working together to create that information.   Janet Kennedy: (11:35) Now I know from experience in managing social media platforms and particularly closed groups, that's a lot of work that takes a lot of information, a lot of moderation. I'm curious when you are working, are you working as a member of an existing community? Or are you actually hosting the organization or the social media group yourselves?   Shazia Ahmad: (12:00) We're hosting them ourselves, but we have to work very carefully and we have to leverage guidelines that are in place with the sponsor and ensure that everything is in accordance of all guidelines with their medical legal, and then we have to follow the IRB.   Janet Kennedy: (12:18) That's Something that takes a long-term commitment. You can't just throw up a group for six months and then be done with it. This is really a very strategic role that needs a lot of support over time.   Shazia Ahmad: (12:30) Exactly. And the importance is making sure that we get the buy-in from the patient advocacy group, because a lot of the education awareness really, we wouldn't be able to get so far without having that collaboration in place. So we work hand in hand with the patient advocacy group in a lot of cases, the sponsors already have a lot of relationships already in place. So a lot of it is done in a very much collaborative manner, so that we're all working together.   Janet Kennedy: (12:59) You've been in the industry for a few decades. So we won't do an age test here, but you've been around the block a little bit. I am curious that, gee, at least a decade ago, pharma was talking about going beyond the pill. And I think slowly coming to acknowledge that there's a bigger role that they need to play in engaging and supporting patients. So just broadly speaking, I'd be curious about your thoughts on the evolution of the pharma patient role over time and where do you think we're going?   Shazia Ahmad: (13:34) Yeah, I think, and I'll kind of answer that question backwards because it's just so exciting. I feel like pharma is going in a way where every single patient that walks into a clinic will have the opportunity to be able to consider a clinical trial. And that's pretty amazing because 10, 15 years ago, that would not even be possible to think about because of not just different geographic locations and other challenges and barriers, but I really feel that every patient that walks into a door will be offered a clinical trial to participate in. And there's been so much invigoration of technologies coming forth now to allow for that, which is really exciting, especially with the decentralized approach to clinical trials. But that's the most exciting thing that I see. But because I started my career early on as a research coordinator at the National Institutes of Health, I spent about five years early in my career at the NIH cross Naiad. Yes, I worked under Dr. Fauci! Really better than that!   Janet Kennedy: (14:41) Yay!   Shazia Ahmad: (14:43) And across different institutes, including the NINDS, but really exciting is to see with the recent pandemic, even more of an awareness amongst the public community, to what clinical trials can bring and do for the communities to amazing. And I think because of that, we'll see more, more interest and just more urgency to help drive progress for all diseases.   Janet Kennedy: (15:13) Absolutely. I have never heard so many people in my Facebook group, in my Twitter group going, "Hey, I got to be in a clinical trial for a vaccine!" Anything that got them a teeny bit closer to being able to experience a vaccine, even if there was a, whatever, the percent - 50, 50% chance - that they weren't getting it; very, very interesting. Plus in this particular instance, people got savvy really fast. "I'm in a clinical trial, and now I'm going to go get a quick test to see if I got anything." And they had to really rethink how they were working with patients in that regard, because you can only be so blinded when I can go to a local drug store and get my antibody test.   Shazia Ahmad: (15:53) Right. Exactly.   Janet Kennedy: (15:55) Well, it's horrible, what happened and is happening as a result of COVID. But unfortunately, when you look back at the history of medicine, it is usually something like a pandemic or a world war that has advanced quickly medical changes and medical innovation. And so as horrible as this has been, and we don't want to minimize it in any way, it has shown a light on a very important aspect of healthcare, and that is early stage medical development, and really brought it front and center to a lot of people who would never have thought about it one way or the other. I think the other thing that's interesting is it has also focused on the rare disease community very early on when we were talking about the need for masks may not have been to protect you, it's to protect people from you, and particularly those that were immunocompromised. I think that's a word that a lot of people had never heard of. And I believe it has raised awareness that there are a lot of people who've been impacted and are impacted by rare disease.   Shazia Ahmad: (17:04) Absolutely, absolutely. And I think what really, what the other lesson learned from there is if we continue to work as hard as we did for the amazing vaccines that were created for COVID-19, we can make even more greater progress for the rare diseases or any other disease.   Janet Kennedy: (17:24) It is going to be a curious conversation that we'll have, is this vaccine was turned around in a year - under a year. I mean, that's amazing, that's unheard of! Some of the rare disease community have been waiting decades for something to happen. Now, again, money is the root of a lot of the issue and that obviously there was a massive global incentive to really support development of a vaccine for coronavirus. However, the process I hope is going to raise that awareness and that look at the difference. For instance, the ALS community faced when you had this viral ice bucket challenge go out, they raised a significant amount of money and they were able to make some significant impact on the study of the Lou Gehrig's disease.   Shazia Ahmad: (18:13) Exactly. Amazing!   Janet Kennedy: (18:15) Well fingers crossed that we will definitely see some good come out of this horrible situation with Corona virus. One of your special expertise is ensuring that the patient journey and the pathway to diagnosis is understood in every program that you implement at UBC. I don't know what that means. Can you explain that?   Shazia Ahmad: (18:37) Absolutely. This is an area I'm extremely passionate about and really something that I like to always take the team to think about early on looking at the disease, from diagnosis to really mapping out the whole patient journey. Because rare diseases often take many years to be diagnosed, it's really important that we look at every indication, look at the different care patterns, which doctors the patient is going to for that particular indication, and then also looking at the involvement of the caregiver/care partner. It's just really important for us to do that, to really develop the right strategies and solutions, to support a specific protocol with a sponsor. And then also take it a step further. It helps us to really develop the right engagement tools for our program. We develop all full house materials to help recruit, retain patients. And we want to make sure the materials we developed to support a participant during the clinical trial also resonate with that patient journey.   Janet Kennedy: (19:49) I'm in marketing, so this is something I can relate to is developing communications materials. And we are changing. Our younger generations - they're all about video and they're not going to want to read a brochure. So are you actually looking at producing materials in all different formats so that whoever, whatever age somebody is, they can find the way that they can relate to?   Shazia Ahmad: (20:12) Absolutely. So we develop video, we do video services where we are able to develop educational videos to not just identify patients or create an education about a particular study or registry, but we also develop videos to really help understand the protocol. And the informed consent process, for example, is really cumbersome and hard to understand. So a lot of our tools, we engage digital technologies like videos and other technologies to really, once the patient's even enrolled. For the younger patients, we've used gamification to keep patients retained during a clinical trial. So a lot, a lot of those things really, really important.   Janet Kennedy: (20:57) Okay. And I know a little bit more about the gamification, because I think that's very cool and I've definitely followed that in other industries, not so much in healthcare. So how would that apply?   Shazia Ahmad: (21:11) Basically, depending on the number of visits for a particular protocol, once the visits completed or prior to a visit there's questions. And this could be for example, on a pediatric program where we could incorporate gamification technologies on completing a particular questionnaire - some tokens are sent through the platform, and then at the end of the study, or during the study, depending on how we have it set up, the participant can redeem a certain gift card, or there could be some kind of value added to something where that could be provided as a donation in their name to a particular cause or organization.   Janet Kennedy: (21:52) I think that is cool! I really like that idea, and definitely want to see an image or a video of what that looks like. So hopefully it will be something we can link into the show notes when this is done. You are going to be speaking, coming up at DIA, what sort of things are you going to be talking about?   Shazia Ahmad: (22:08) Yeah, So I'm really excited. We are looking into speaking on how we have developed patient communities and that platform, and the importance of patient community building for particular sponsor.   Janet Kennedy: (22:24) That's going to be good. I am so fascinated with the work of patient communities and the fact that they now are starting to have a very strong role in drug development. That is just one of the best innovations is the recognition of the patient advocate as an individual or as a group.   Shazia Ahmad: (22:41) Yeah, very excited about that. Thank you.   Janet Kennedy: (22:45) Well, Shazia, I am fascinated with your work and I very much appreciate your presence in social media because I've been able to follow you and learn a lot of things about what you are up to and your thought leadership in the space is very appreciated. And I thank you.   Shazia Ahmad: (23:01) Thank you so much. Thanks for having me on today. Really appreciate.   Janet Kennedy: (23:05) It was our pleasure. And thank you for downloading this episode of the People Always, Patient Sometimes podcast. If you enjoyed our conversation, a review and a rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions.

Huntington's disease is a rare genetic condition that impacts over 30,000 people in the U S and 200,000 worldwide. It is a neurological disorder that impacts movement mood and the thinking process. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. On this episode of our podcast, we ask patient advocate BJ Viau, co-founder of the Huntington's Disease Youth Organization, to join us in a conversation about patient advocacy on People Always, Patients Sometimes.   Janet Kennedy: (00:35) Hi, my name is Janet Kennedy, and I am your host for People Always, Patients Sometimes, a production of Spencer Health Solutions. I'm really looking forward to a conversation today with BJ Viau. BJ is passionate about positively changing the lives of people impacted by rare conditions. He has a history of working to support patient advocacy and rare disease non-profits by holding grassroots fundraisers. BJ also helped create an international nonprofit for Huntington's disease, the HD Youth Organization, or HDO. He has an MBA and has been working in the pharmaceutical industry for over a decade. Currently he's the Director of Patient Advocacy at Horizon Therapeutics. Welcome to People Always, Patients Sometimes BJ.   BJ Viau: (01:20) Hey Janet, thanks for having me. Excited to be here, look forward to a conversation.   Janet Kennedy: (01:24) Absolutely. Well, I think one of the things I'm most interested in learning about right now is what is Huntington's disease and how does it impact young people?   BJ Viau: (01:35) Yeah, I mean, it could be a 20 hour answer, but essentially broken down, Huntington's is a rare genetic disorder impacting about 40,000 individuals across the United States. It's a neurological disorder that unfortunately takes over one's ability to do anything and everything in life. Most commonly described the combination between more common conditions like ALS, Alzheimer's, and Parkinson's all wrapped into one. How it affects young people is typically symptom onset starts for individuals later in life, probably in their thirties or forties, although it can vary. Although that's not technically a young person, where it starts to affect the young person is it's their parents. So you start to see decline in your parents, they lose their jobs, they lose their ability to function. Young people end up having to be caregivers for their parents. And what some might say the worst part about Huntington's is its autosomal dominant genetics, so every child of a parent who has Huntington's has a 50% chance of also getting Huntington's disease later in their own lives. So it's a little bit of looking in the mirror and wondering, am I going to have this future of my parents, or am I going to have a future of no Huntington's? And that's a really emotional decision that young people have to make.   Janet Kennedy: (02:50) Now you mentioned it's genetic. So does that mean you can take a little test and find out, or do you have the sword of Damocles hanging your head your whole life?   BJ Viau: (03:00) Yeah, take a little test. It sounds very simple and easy. Essentially it is. It's a blood test or saliva test that will provide you pretty much, if you will have Huntington's or if you will not have Huntington's. But even though it's simple, it's got huge social, emotional, psychological kind of bucket that comes with such a simple task.   Janet Kennedy: (03:22) I'm curious about the fact that you're focusing on young people. Is this to help prepare them for a future of thinking through how does Huntington's going to affect them, or is this actually helping them deal with their parents?   BJ Viau: (03:38) Yeah, a little bit of both. 15 years ago, when we were kind of dreaming up the Huntington's Disease Youth Organization A few of us young people were attending conferences and all the sessions and all the meetings were really focused for our parents, and there wasn't much support or education for us young people. In fact, a lot of people said, "Well, we don't even want to talk to young people about it because they shouldn't even be in the conversation." They were afraid to bring young people into this conversation, and that's where we thought that's not the case. We need to learn. We need to get educated. We need support. Not just to understand how to deal with our parents today that are going through Huntington's, but how we can start to shape and plan for our own future, which may or may not have Huntington's in it. So how do you prepare for school? How do you prepare for a job? How do you prepare for having kids, getting married, buying a house? Those are all really tough decisions that young people in Huntington families have to make very different from kind of the the normal person.   Janet Kennedy: (04:35) Absolutely. And I think it begs the question - do young people consider that they have to make a lot of different decisions than other people because their issue is genetic in nature?   BJ Viau: (04:48) I think they do. A lot of it relies on when the parents tell the child that Huntington's is in the family. Unfortunately in some families it's still a hidden secret and parents hold that secret from their children until the last possible day. And then, you know, the kids end up finding out some improper unique way. So what HDO's model is all about, not just helping the kids, but also helping the parents have that conversation with their kid to say, "Hey, you know, mom or dad has Huntington's. And that unfortunately means you may get Huntington's one day, but it's okay. You know there's people out there who can support you. We can get education, we can do this together." And it's creating that safe environment to have safe conversations that we truly believe at HDO is really best for everybody.   Janet Kennedy: (05:36) On your website, you actually have a section for kids. Is there an age that is too young to learn about this, or does that actually take away a lot of the veiled mystery or concern by just making it part of a natural conversation at a very young age?   BJ Viau: (05:54) It's a tough question. You're going to get a lot of different answers on who you talk to. I mean, I can speak from my personal experience. My parents told my sister and I, when we were about eight, nine, ten years old. And I would say them sharing that information with us. So young helped shape conversations that happened over many years to help my sister and I have the knowledge to create power for our own lives and feel motivated and empowered to understand what we're facing. I know a lot of other young people whose parents treated it similarly, and I see them these days dealing with HD in a very positive manner. I've seen a lot of families do the opposite. They hold it till the last possible minute until their kids are out of college, have their careers in front of them, are about to have a kid, and then they drop what I would call the HD bomb on them. And I've seen it go really poorly. So I would love for there to be a true research paper on when is the right time to talk to young people and tell them about Huntington's we don't have any statistical data to show when the right time is, but it would be great to provide that kind of statistical evidence to the parents who are unfortunately gonna face this decision with their children in the coming future.   Janet Kennedy: (07:09) That sounds like something the NIH ought to fund, because it isn't just hard conversations about HD that parents need to have. There are innumerable number of conditions or diseases that are genetic, that have a serious connotation. Even things that aren't genetic - it might be considered a disease that isn't quite visible - and at what point do you share with your children a serious condition that they need?   BJ Viau: (07:33) Totally. Yeah. It always seems like probably in the parent's perspective that tomorrow is a better day than today, but looking back, yesterday was always the best day. But that's just really difficult. It's tough. We're not trained in school, to have those conversations or trained as professionals. So it's a tough situation, but yeah, that'd be a great research study to get funded by somebody.   Janet Kennedy: (07:55) Alright. Well, you've planted a seed there. We'll see where we go with this. Well, let me ask you a personal question, If you don't mind. I know that you are a new dad. How did that conversation go with your then fiance?   BJ Viau: (08:08) Well, I'm pretty open and honest about my involvement with Huntington's. I am one of the few. There's actually a statistic that does show that about 90% of the people who are at risk for Huntington's choose not to get tested because there's, unfortunately, there's not much you can do about it as far as medication treatment wise today. So there's only about 10% who say, "Hey, I'm ready to know, even though I can't necessarily do something about it medically." But I, when I got tested, I learned that I would not get Huntington's in my future, which would eliminate the ability for my wife and I to pass Huntington's on to any of our children in the future. So it was a little bit of an easier conversation to have with my wife versus many decisions or many conversations that a lot other HD impacted family members have to have with a spouse. But anyway, her understanding of my involvement was very positive. So she got HD. She understood it. And I do think even if I had HD, we would have made a decision to have a kid, same way we did.   Janet Kennedy: (09:10) Okay. I'm a little bit shocked here. And I, I want you to reiterate - you said that nine out of ten people do not take a test to confirm whether they're going to actually experience Huntington's or not?   BJ Viau: (09:21) Yeah. Before they have symptoms. I mean, it's a tough question. I think if you ask the general public, would you want to know if you're going to get Huntington's disease or not? I think the general public you'd probably get the opposite. You'd probably get nine out of ten, who would say, "Heck yeah, I'd want to know." But when you live in a family with HD and you understand HD, you don't want to know. That that's a life changer. That's a game changer. That that is incredible weight on your shoulders, knowing that you will one get HD and not everybody's ready for that. So it is a true stat. I hope it will change in the future because there'll be something that people can do about it. We're still a long ways from truly a disease modifying treatment. But I do believe that when we have some more progress in the medical field that everyone's going to want to know if they will one day get HD, because there's something they can do about it.   Janet Kennedy: (10:14) Absolutely. Well let's talk a little bit about a big disappointment that came to the HD community over the past year, and that was that not just one, but two studies were canceled regarding treatments for Huntington's. How did that go over in the community, and is there still hope out there for other types of interventions?   BJ Viau: (10:36) Janet, as you know, as you've talked with a lot of other people on this podcast about trials, it's an experiment. There's a hypothesis that people have that if you do X at Y time at this amount, it will do this, and we think that if it will do this, it will slow a disease down or decrease symptoms. One of them was a phase three trial. It was the largest trial ever run in the Huntington's community with over 800 people around the world. So we were hopeful. We put a lot of our marbles into this bucket, hoping it would lead the way. It was supposed to go until next year. And kind of out of the blue, it was a little bit of a gut punch to the HD community. Not just because it wasn't the results we wanted, but also because we didn't really, as a community, understand that this was even an option to get stopped halfway through for the reason it got stopped.   BJ Viau: (11:28) So I think if we would've known a little bit more as a community, it may not have been as much of a gut punch. It still would have hurt, it still would have stung, but it just came out of nowhere. That was kind of part one, and then part two was just the trial with another company for totally separate reasons - no correlation between the two - their trial showed that there was no significant efficacy in their medicine doing what it was trying to do. So two in a week - that hurts. Is there still hope? Yeah, there's a ton of hope, and we still have a lot of companies invested in the community whose programs are built fully enrolling and moving forward. But it's sets us back. For those who needed that treatment today, some of them may be out of luck and that hurts. That hurts a lot of us. It was tough. It'll be tough for awhile.   Janet Kennedy: (12:18) Where does the HD community go to find support?   BJ Viau: (12:23) Yeah, I think everybody has their own ways of finding support. This is Huntington's, or this is just any rare condition. There are patient advocacy groups, a lot of people reach out and have connections with each other through those advocacy groups. A lot of people go to their physician, their healthcare professionals to find support, and they want the most up-to-date relevant medical information and they want to hear it from a licensed practitioner. And I think others turn to social media. They turn to Facebook, private Facebook groups to find support and education from those that are going through the condition or going through the battle themselves. And I'm sure everybody else has other ways too. But I would say those are probably the three most common ways of finding support for the HD community, but in general, probably anywhere disease.   Janet Kennedy: (13:08) I'd like to talk a little bit about patient advocacy. You have been involved in patient advocate programs, whether it was fundraising or helping to found HDO for a long, long time, and you also interestingly work in the pharmaceutical industry. So you have a unique view on the inside of how complicated it is to set up and run clinical trials, to test out drugs and things of that sort. A lot of patients don't have that vision, and a lot of patients probably have never even heard of patient advocacy. So if you were talking to someone who is maybe new to a disease, new to a condition, newly diagnosed, how would you explain to them what a patient advocate is and how they can be their own patient advocate?   BJ Viau: (14:03) I don't think that's a one-answer-fits-all. Everyone's situation is so different. So there's different forms of patient advocacy. I would say there is being your own patient advocate, which is advocating for yourself, for your child, or your loved one, your mom, dad, whomever. And that can be done in many ways. That can be done in the doctor's office, advocating and communicating what's going on and what may be needed with the physician. It could be I think of advocating regulatory-wise, going to your governmental folks and advocating for change based on rules and regulations that aren't what's best for your personal condition. And then I think you could also then quantify or qualify that there's professional patient advocacy, which is also a large bucket, but that can be working as a professional. Your paid job, either for a patient advocacy organization, typically nonprofit organizations in the US that have 501c3 designation, or you start to see it and not just pharmaceutical companies, but healthcare companies in general have folks who are titled as patient advocates internally, which can have a lot of different hats to themselves. But I guess long-winded answer: the word patient advocacy Isn't a very clear definition, but it's definitely either advocating for yourself or for others based on the health condition that they're battling.   Janet Kennedy: (15:26) What about your work as a professional patient advocate and the other ones that you have met from other companies? Is there a particular focus that you're in, for instance, if there are meetings, are you sitting in there saying yes, but from the patient's perspective, or is a little bit broader than that?   BJ Viau: (15:47) Yeah, I think that's part of it. I mean, companies are learning the more we can partner with the patient communities - the earlier the possible - I just think it's best for everybody. It's best for the company in my mind, because they're going to hopefully create a product that's most meaningful for the patient community, and it's beneficial for the patient community because they're getting a product that they really want and they really need, and hopefully it makes a big difference. So I think there's just so much overlap and benefit of working together. And I would say as a professional in the pharmaceutical patient advocacy space, the more that that role can work with patients and caregivers and advocates and loved ones and patient advocacy groups, and make sure that their voices heard and make sure that their needs are heard, that their problems are heard, that their abilities are heard, the better off in the long run for everybody.   Janet Kennedy: (16:47) I sense that there's a little bit of a sea change with the impact of the Corona virus on the clinical trial community that a year and a few months ago, pretty much pharma companies, sponsors, CROs sort of set the procedure and the protocol, and this is how it works. And the inability and the now lack of desire of patients to actually come to an office has really spurred decentralized clinical trials, has spurned virtual trials and hybrid trials. And I think has really put the patient front and center. You cannot have clinical trials without patients, and as desperate as they may have been in the past, they have also stepped up and said, I have to consider my own health. From your perspective, as both a patient advocate, a professional patient advocate, and someone who has experienced the pharmaceutical industry - what are your thoughts on what the past year has done from the patient's perspective?   BJ Viau: (17:54) I think we, as just a general community, trying to bring new medicines to market that fit an unmet need -we were going in that direction. COVID maybe sped it up a little bit and maybe made folks change the way they think a little quicker than what they were hoping for. This is all my personal opinion. I really, as a patient advocate, just transparently, I've never participated in an actual clinical trial. I've participated in observational trials. And in my professional space, I have worked more on the commercial side with products that have already been approved. So don't have a ton of clinical experience, but I just think in general, we should have been always, and we should always, and we should always in the future always be asking the question "What's best for the people that this medicine is meant for, and how do we get it approved and find out if it's truly providing value with that person in mind?" So if that's the centralizing clinical trials, is that what's best for the patient and the advocate and the loved one that are participating? Is that best for the clinicians that are collecting the data? Is it going to provide as much data is it needs to be provided remotely? Can it still be the same positive influence? I don't know. that's not my expertise, but those are the questions I think we should be having.   Janet Kennedy: (19:18) Well, let's talk about going beyond the pill. It's really becoming much more a conversation about the full patient experience. And I have to wonder if somebody just writing a script is enough. Do you think that the pharmaceutical industry should actually be taking a bigger role in a patient's full experience with their disease state, whether it's providing educational videos or support tools or digital health tools to help them manage and monitor? Is there a need to do more than just provide a medication? And really what I'm asking is if you could wave the magic wand and tell pharmaceutical companies, "Hey, you really need to be thinking outside this pill box." What would you actually recommend and suggest that companies think about as they want to work with patient communities?   BJ Viau: (20:16) I mean, in general, especially in the rare disease community, which I know best, I think pharmaceutical companies actually do a really good job trying to provide information, education, resources, and programs beyond the pill. There are a lot of legal and regulatory firewalls that unfortunately doesn't make it as easy as we would love it to have. But I would say in general, the rare disease companies know that if they're going to get into this space, that's part of it. Part of it is education beyond the medicine - disease education. I would say they can always do better. Not everybody is perfect. It's definitely creating those with the patient or the patient advocacy group at its forefront; making sure that the materials they are creating are relevant and actually needed. But I would also say it's a job as a patient advocacy organizations, the nonprofit businesses, and the physician to step up their game as well, because pharmaceutical companies don't always have a great way of getting the materials out to the patients and families that need it.   BJ Viau: (21:17) And the advocacy groups or the physicians are the ones that typically have the better reach with families. So instead of just prescribing a medicine, can a physician prescribe that a patient goes to XYZ website, or prescribes that this patient participates in a camp or an education day put on by an advocacy group. I always had this idea that I wanted to create the Huntington's Disease Youth Organization to create a script pad, and we would send it to doctors and the doctor would actually give out a script and the script would be, "Hey, go to HDO's website and look at all their resources." And it's not just, I'm here to write a medicine, it's I'm here as a physician or healthcare provider to provide you with the best resources to help you navigate your condition. So we can all do better for sure. But hopefully we're headed in the right way.   Janet Kennedy: (22:09) I agree. I think one of the things that we do face is that there are so many pieces of information. There are so many conditions and disease states. There's so much information out there. How do we help the physician? Now, if you're a specialist, that's fine. This is the area you're focusing on. But when I think about some of the folks that are maybe the first to diagnose, which is our internists, our family physicians, to try to find out everything there is to know about everything is really tough. And I think that's why organizations like HDO are so essential. That you can get them started on their journey, but patients really need to learn how to do smart research online and get to the authoritative critical sites that can really provide them, that kind of interaction.   BJ Viau: (23:00) I'm with you. And again, I'm just brainstorming right here, but do hospital systems or physician's offices, like, are they thinking maybe we need a patient advocate? Who can work in our office to help find and then disseminate the information out there, especially for rare diseases? I, as a doctor, as a nurse - I may not have the time to spend an extra 15 minutes on Google looking this up for one patient or two patients who I see in my practice. But is it worthy of an investment to find somebody else who can do that? Who can truly help that physician's office be the best resource for each family who walks in the door, regardless if it's a condition they see regularly or conditions, and they might see, you know, once in a lifetime?   Janet Kennedy: (23:44) Oh I love that. And I know it's come up in other conversations I've had on podcasts about the idea that, in essence, you need like a librarian. You need someone who is a health strategist or a health care manager who can then take that conversation further and really help get the patient off on the right foot, as opposed to hearing any kind of devastating news. I know for a fact as a college educated professional, once we get past the second data point, I'm not hearing a thing you're saying. It'd be really awesome if I felt like I could call someone at the office to say, "Okay, help me out here. How do I get started?"   BJ Viau: (24:26) Exactly. Yeah, how can you connect me with somebody else I can talk to in the community that, beyond my physician's visit, once every six months, where do I turn? How do I find that group of people who understand me and understand my needs, who can help me along that journey? So anyway, there's a lot of technology that's improving and a lot of online communities that are forming, which I think are great, truly just helping all people involved, become engaged if they want to be engaged. I truly believe an engaged person is someone who's going to be more successful when battling their condition.   Janet Kennedy: (25:00) Absolutely. Excellent words to the wise there, BJ. It was a great pleasure having you on the podcast. And I really look forward to learning more about HD and supporting the community and getting the word out about HDO. And I hope you have an absolutely wonderful time as a new dad.   BJ Viau: (25:22) Thanks, Janet. Yeah, a lot of fun, but appreciate the opportunity to come on and speak, and yeah, I look forward to staying in touch and continuing to listen to the rest of your podcast, guests who have a great knowledge around the continuous hurdles we come up with, but it's great to see the conversation try to come up with a solution. So thank you.   Janet Kennedy: (25:40) You're welcome. Hey, thank you for downloading this episode of People Always, Patients Sometimes podcast. If you've enjoyed our conversation, a review and rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions.

It is always a great pleasure to engage with clinical trial innovator and thought leader Craig Lipset. We asked Craig to join the People Always, Patients Sometimes podcast to share more information about DTRA, which stands for Decentralized Trial and Research Association. As an industry, we have embraced more fully the idea of serving patients better with a decentralized clinical trial. As we bring the corona virus under control, it's important that we don't become complacent and return to business as usual. Give a listen to the podcast and I hope you'll join us in declaring there is no going back.   Janet Kennedy: (00:43) It is always a pleasure to welcome Craig Lipset to the podcast. He is a man that really needs no introduction, but I'm going to give him one anyway. As the former head of clinical innovation and venture partner at Pfizer and on the founding operations committee for TransCelerate Biopharma, Craig is recognized as a leader at the forefront of innovation in clinical research and medicine development. He is a frequent speaker at healthcare and pharmaceutical conferences, and he has also led the call to innovate and recognize that there is #nogoingback to improve clinical trials. Today though, we're talking about DTRA, Decentralized Trials and Research Alliance. Welcome to People Always, Patients Sometimes Craig.   Craig Lipset: (01:29) It is such a pleasure to be back with you, Janet, thank you for everything that you're doing to give so many voices the opportunity to share.   Janet Kennedy: (01:38) Oh my great pleasure. This is always a learning opportunity for me. I am not a journalist, but I do play one on this podcast and I get to ask all the air quotes, dumb questions, that I'm sure a lot of people want to know about, but sometimes they get caught up, that something's already rolling ahead. And they're like, did I miss it? Did I have a fear of missing out what's going on?   Craig Lipset: (02:00) Absolutely. You know, there's so many different ways for people to stay current and stay connected. And you know, sometimes we have to hit a lot of different channels to make sure that everybody gets that opportunity to, to connect and to stay current with what's going on out there.   Janet Kennedy: (02:18) So on the connection aspect, we obviously have been dealing with the pandemic for gosh, a year now, and this time last year we were preparing for the last in-person event, which might've been SCOPE, and then suddenly things spun out of control and we were all sent home. I think things have changed a lot for you as well. So I'm curious, being able to look back a year over how things happened in 2020, what do you think has really impacted clinical trials with folks being sent to their rooms?   Craig Lipset: (02:56) You know, I think a lot of people will expect me to say things telemedicine and remote monitoring and risk-based monitoring. I would say that the thing that's really impacted us is willingness to adopt. And what I mean by that is so many of the things that have been so important for business continuity this year, the things that have kept our trials running weren't solutions that had to be cooked up in a lab in the year 2020. Most of these were solutions that already existed. They were just struggling for adoption, usually struggling for adoption because we operate in a very risk averse environment. But when the risk changed in the environment and all of a sudden, some of these things that might've been viewed as risky, suddenly became risk mitigation, they became the way to maintain business continuity. 2020 became a story about adoption, about so many great solutions that had been at our feet that had been at the doorstep suddenly seeing their moment in the sun when study teams and organizations were able to pick them up and bring them into their studies and bring them into their portfolios. And that's an exciting way for us to now get 2021 going, because now our organizations have seen that we can bring these different things to life, whether it's risk-based monitoring decentralized trials or whatever other solution your listeners were able to bring into their organizations to keep their work going.   Janet Kennedy: (04:23) Well I think that's an interesting point and you've been fortunate in that you've been able to sit a little bit in the cat bird seat because you've had an opportunity to participate in a lot of virtual conferences. You advise a number of companies. So you've been able to get feedback from a lot of different sources, as opposed to, if you were solely ensconced at Pfizer, you might not have access to the kind of information I'm thinking of. So here's my question. Do you believe that all companies, saw that opportunity to innovate and to accept and to accelerate? Or do you see that there's been a, sort of a separation of the wheat from the chaff and there are the companies that already had a innovation growth mindset, and then there are the folks that are just struggling to keep up?   Craig Lipset: (05:11) I think that in that April, May, June timeframe, a lot of organizations were all in the same boat. They were all trying to scramble to keep their portfolio going. They were rushing to introduce whatever countermeasures they could to keep patients being monitored, keep drug supply flowing, and keep capturing data. So that studies didn't wind up futile. But, Janet, I do think that we start to see some separation when we look to the latter half of 2020, because in that latter half of 2020, then we start to see that there are some sponsors out there that are starting to commit to some of these changes they're putting in place, new resources, they're relooking at some of their SOP and processes. They're expanding their vendor and partner lists some really starting to rethink how they write protocols and introduce some new training. These are the companies that are really starting to show commitment. They're really looking at the things that were adopted earlier in the year and being thoughtful about what's needed now to instantiate these and make them a part of our organization going forward. And that's different from some others that just maybe haven't been able to step forward to make those kinds of organizational commitments yet because they're hard.   Janet Kennedy: (06:35) Well, not only, they're hard; you may not even have the environment within your company that can embrace that kind of change and thought process. You really do need leadership that is willing to invest in that kind of information and that kind of structure, those kinds of individuals.   Craig Lipset: (06:53) Absolutely right, Janet. If there's one thing we saw in 2020, it's that these new approaches, well, they don't need special regulatory permission. Yes. The FDA produced some really important guidance for the industry about running clinical trials during the pandemic. But I encourage people to take a close look at that guidance. They didn't lower the bar on what technologies or approaches to introduce. They just said, use them and use them thoughtfully engage with your regulatory reviewers. And so from a regulatory perspective, these solutions were available; from a technical perspective, they were available. What does that leave? Exactly where you're pointing - culture, and our organizations ready in terms of their own internal culture and receptivity and willingness to change, or is it the culture that will ultimately stand in the way of those organizations being able to commit to and adopt these new approaches that were introduced last year?   Janet Kennedy: (07:51) I imagine that's a big part of what you do as a consultant is helping companies revision how they look at the growth of their company and expanding their capabilities through innovation.   Craig Lipset: (08:04) You know, Janet, I can only help organizations that are ready to be helped, but when they call, I'm certainly happy to be there. And mostly what I do professionally, whether with pharma companies, tech companies, or with others, is to help them make their strategies fabulous. And to help them make their implementations resilient. I can't fix the culture on my own. I can't show people solutions that they're not ready for. And so, you know, I can really only come in if leaders are ready to commit to these areas.   Janet Kennedy: (08:39) So you had a lot of time on your hands where you might've been traveling on airplanes, going places, and you obviously found a nice little hobby on the side where you decided to get together with some other thought leaders and launch a new initiative, the DTRA, the Decentralized Trials and Research Alliance. So I'd love to know the backstory. How did that come about?   Craig Lipset: (09:04) With all of that free time? Really Janet. So, it's interesting. DTRA is planning actually preceded the pandemic. It dates back to just prior to the pandemic when a friend and colleague Amir Kalali, who is well known in the industry from his time at Quintiles leading the neurosciences, and his time as the leader for the CNS summit Amir reached out and that he was exploring some different convening opportunities around decentralized. And we both appreciated that the world didn't need another conference on this topic. But when we have talked about decentralized in different meetings and events, there was always something left on the table. There was something that would come up at every one of those conversations about an opportunity to make the field better together. That was then left behind when that conference ended. And so we started to explore together what could be really sustaining and help to change this field.   Craig Lipset: (10:02) And then, the pandemic emerged. Which, in many ways, amplified everyone's attention around decentralized, but also was pretty distracting in terms of people needing to be heads down and keeping their portfolio going. And so while there was a lot of interest from a lot of my network around coming together with the DTRA, we did have to push some of our plans out to later in the year and give people in their organizations time to make the adjustments that they needed to, internally. By the end of 2020, in early December, we were ready to go live. And so made a public launch of DTRA, the Decentralized Trials and Research Alliance. We had over 50 founding organizations as members. These were groups that really took a chance with us believing that there would be a community that came together to try to make adoption of decentralized research, easier and help drive the scale that we know as possible, but it's hard.   Craig Lipset: (11:04) And so with that, we launched DTRA. Now we're at about 85 members. I think we'll probably be at a hundred member organizations and over the next month or so, we keep posting those updates on LinkedIn and Twitter. So what is DTRA? There's really two aspects to the decentralized trials research Alliance that I speak to. One is the work that we're doing together. The initiatives that we're taking on, and the second is the network and the community that we're creating that can support B2B transactions and raising more awareness and activity in the field. For the initiatives, our leadership council, our members, defined four priority areas together. The first is around definitions and how we agree on archetypes and key performance indicators to help reduce some of the tower of Babel in this category and help make sure that we're talking about the same things in our conversations with one another.   Craig Lipset: (12:06) The second area has been around best practices considering that our members, whether pharma, whether CROs, tech companies, site networks, advocacy groups, and the FDA themselves, our members have been involved in most all of the decentralized research studies that have gone out in the last few years. What are the learnings, the best practices that we can identify together to help make implementation easier? The third area for us is themed around education, because so many of us get stuck needing to bring our organizations along or other stakeholders, like investigator sites or patients and their caregivers. What type of educational resources can we begin to aggregate and share, and in particular, use data and evidence to drive that education? As an example, we all talk with enthusiasm about the potential for decentralized research to improve diversity in clinical trials. But where's the data and the evidence to back that up?   Craig Lipset: (13:10) We believe that by having a multi-stakeholder initiative in a nonprofit space like this, we'll have the opportunity to gather the data and evidence across our members. A fourth area, the fourth priority for us is around removing the remaining obstacles that stand in the way to meaningful adoption. And so those might start to include topics like interstate licensing or global regulatory variability, or other priorities. that our members are working together right now to identify and prioritize. Now I know firsthand from my time at Pfizer that we are not the only initiative collaboration consortia operating in this environment. And in fact, we have identified and begun to engage with over a dozen different initiatives, consortia, collaborations that cover a number of different topics, but might have a work stream, a taskforce, a work group that's looking at decentralized trials together and trying to solve a specific problem.   Craig Lipset: (14:12) We've begun to reach out to each one of those organizations and have been really well received in our call for transparency and collaboration. And by that, what we're looking to do is pull together the overall roadmap across the different collaborations in this space, because when it comes to decentralized trials, it's the only thing DTRA cares about. It is our sole priority. And so we're very well positioned to help show our members and others what different work is already happening here. Make sure there's no redundancy. Make sure that there are handoffs when it makes sense. And Janet, I mentioned earlier that there are really these two areas; one around our initiatives, and the second is a bit the leans in more around network. We realized that our members are the buyers, the sellers, the implementers of decentralized research. Our initiatives are very specifically a non-selling zone there to get work done together.   Craig Lipset: (15:09) But people in our community want to know about the capabilities of one another. It might spark business to business collaboration among different tech companies or tech and service providers or opportunities to engage with sponsors that might not have otherwise known of certain capabilities. We're also starting to explore opportunities to help some of the younger companies in this category with access to capital, and what ways we can create showcases for investors that are very interested today in decentralized research, and make sure that the spotlight is shown on those that are growing new capabilities here. And so whether for these initiatives or for these network opportunities, or a little bit of both, that seems to be what's drawing this community together.   Janet Kennedy: (15:53) Gosh, have you said this before?   Craig Lipset: (16:00) Maybe in my sleep. I'm sure my kids are sitting in the other room saying, "Really dad? Again?"   Janet Kennedy: (16:07) Okay. So I have a couple questions. I'm curious about the membership. You said you're hoping to grow to about 85 to a hundred members and maybe beyond that, but that sounds like it's all pretty corporate members. Is there an opportunity for individuals to engage in this?   Craig Lipset: (16:25) That is a fabulous question, Janet. And right now our members are organizations. They can be corporations, they can be nonprofits. We have a number of advocacy groups, and obviously we have the FDA and our opening engagements with other regulatory agencies. The idea of individual members is something that our leadership and our board have been very actively exploring. Individuals might be between gigs. They might be independent contractors. Maybe they're just great advocates for this field, that want to grow their career in this direction, but their current employer isn't a member because it doesn't align to their employer's goals. We are finding ways to engage with these individuals. Today, those might be roles that are based a little bit on sweat equity, where some individuals want to step forward and help to manage and lead some of our initiatives and work streams. Going forward, though, we are going to be looking later this year for other ways, to open our doors for individual members. And so I would encourage those who are individuals whose organizations might not be members today to visit dtra.org and click to sign up for more information, so that you'll be on our email list. And as new opportunities emerge, you'll be right there among the first to see them.   Janet Kennedy: (17:47) Obviously just the concept, a decentralized trial, I would assume, that its foundation is 'because that's what's best for the patient'. How are patient advocates and the patient experience part of the DTRA planning?   Craig Lipset: (18:04) While in 2020, a lot of implementation had to be rushed to try to salvage and maintain studies, in general, our clinical research community is eyes wide open today to actively including patient input and insight from day zero of the earliest plans, whether for a protocol, or if they're smart, for a new technology they're looking to implement. And so for that reason, we wanted to make sure from the very beginning patient voices were an active part of our community. Two of our earliest member organizations, the FasterCures TRAIN Network and the Genetic Alliance joined in many ways, because they're not representing a single disease, but represent a community of different disease specific advocacy groups. And so in each of those instances, while that is a seat of one organization, that one organization is disease agnostic and includes constituents across a broad range of different therapeutic areas. Now, as more patient groups have been reaching in, many of them are actively offering to help serve as a channel for patient input and insights as DTRA initiatives and other priorities start to identify, be they educational needs or other areas to go after. I think we're developing a very nice stakeholder base of patient groups that will be there by our side and help to serve as a fresh channel for getting patient input into our work.   Janet Kennedy: (19:36) Is there a concern at all that if this is primarily fueled by and funded by for-profit organizations, even though DTRA is a nonprofit organization, that there might be an imbalance of the size of the voice?   Craig Lipset: (19:53) It's a very fair question. Right now, every organization, whether for profit, nonprofit, whether service provider, tech provider, sponsor or otherwise, every member has one seat in one voice in our leadership council. But to your point, we do want to maintain fairness and equity and the different voices that are out there. I think that we have enough active leaders in this organization that are keenly aware of thoughtful of, and sensitive to patient voice today, that well, shall I say in most cases when the patient voice is raised, most people are smart enough to take a step back and make sure that voice is being heard. And if they don't, they're probably going to hear about that from their peers today.   Janet Kennedy: (20:41) Excellent. I am curious about how does a company, a member actually engage? Are you having monthly zoom calls? Are you actually working via email? How do you plan and implement some of the programs that you're doing?   Craig Lipset: (20:59) Every member organization has a seat on our leadership council, which has a quarterly business meeting. In these business meetings where we're reviewing the status of the various initiatives and other work that may be happening. We also have a quarterly community meeting for that leadership council. This is a bit softer. It's not covering the hard topics such as what initiatives progress and status is looking like. But in contrast, these are a bit softer topics that our members have flagged to us as being important to them. One great example there is exactly where you started this conversation, Janet, around culture. Are there tactics that different organizations have been able to introduce in their organizations, large or small, that have been particularly successful or unsuccessful that we can use this community to help share and propagate with others? As I mentioned, in addition to our leadership council, we do have several initiatives that are underway and those initiatives will meet much more frequently. As they get going, they're meeting weekly. And as they get moving that cadence may back off a bit. But right now we're very much in the prioritization stage. It's a pretty busy time right now, as these initiatives are getting going. And so the cadence is a bit busier than it probably will be as we move into more of a steady state.   Janet Kennedy: (22:26) So the pandemic has gone on long enough and will continue to go on long enough that anybody who was hoping to wait it out, I'm sure has learned that, to their detriment, that they were slow off the starting blocks. I assume now it's sort of full steam ahead for the concept of decentralized trials, or are you still feeling that there are folks hoping that the good old days will be back again?   Craig Lipset: (22:53) You know, Janet, I think that our community is like any other and we have a distribution of individuals. I think that we have individuals in all of our organizations at the far right of the adoption spectrum; they want to be the first, they want to embrace the new. I think then we have a bolus of colleagues that are receptive to doing the new, if it feels safe, and if it feels supported. we have others that may be a little more indifferent. And then we'll always have that tail of the other end of the continuum who are very comfortable that really don't want their cheese moved, and well, to be honest, are perhaps most likely to trade out, given how dynamic and how much change occurs in all of our organizations every year. You know, I often think about, Janet, the Ted Talk with the video of the dancing man.   Craig Lipset: (23:45) And if folks in your audience haven't seen this one after the podcast, they should go Google this one up because it's a great voiceover of a story of a concert taking place on a hill. And in this video, you start off with a bunch of people that are listening to the music, sitting on their picnic blankets. And then there's a guy who just gets up and starts dancing. Well people are looking at this guy, and he's the only one standing there dancing. And you know what you're probably thinking - he's looking like a nut. But after that, there are two or three other people that start to get up and dance. Once they do, it validates for everyone else on the hill. Now it's not just a story of one nut dancing by himself, but it's a story of a small crowd that is much safer. And once that happens, it's that rapid tipping point. Everyone else on the hill is now off their picnic blankets and up and dancing. And so I think about it that way with so much of our change in this space. There'll be some people that don't want to get up and dance ever, but once it's made to feel safe, once there's just a couple that are getting up and making it happen, the rest of our community does step forward. They will be up there dancing as well.   Janet Kennedy: (25:04) Well, on behalf of a dancing man representative, I believe that that is an exciting place to be - out there, by yourself, trying, doing what feels right, feeling that emotion of just doing the thing that really is right for you. And when other people join you, that just makes it that much sweeter.   Craig Lipset: (25:29) Sometimes it takes time. Sometimes you might feel like you're out there dancing for a while, but I totally agree with you, Janet. We are so fortunate to work in this industry. Our community does amazing work, developing medicines for patients with unmet medical needs. But even within this space, we know there's so much more we can do. And we know that there are things that we can do just because they are the right things to do. And so a lot of us do, you know, get up and dance and take that chance. And sometimes it takes a little while, but if you're doing the right thing, others will get up and dance with you. It just may take a little time.   Janet Kennedy: (26:07) Absolutely. Well, I would love to get more people involved in DTRA and also following the news that you're going to be sharing. So tell folks a little bit about how to find out more about Decentralized Trials and Research Alliance.   Craig Lipset: (26:22) Three ways for folks to do that. For those who are social, the first two ways are LinkedIn and Twitter. We're really committed to keeping content flowing, to helping to serve as a trusted news and resource for folks on LinkedIn and Twitter about activity in the decentralized trial space. And then finally, check out dtra.org. If you're interested in learning more, either about organizations participating or just yourself staying current, go ahead and sign up there to stay connected with DTRA.   Janet Kennedy: (26:55) Thank you so much for sharing that, Craig. I had a lot of questions and you were very patient about answering all of them.   Craig Lipset: (27:02) You're fabulous Janet. Thank you, and thanks to your audience for spending some time this day.   Janet Kennedy: (27:07) So if you want to find the link to the dancing man video, or of course, a lot more information about DTRA, please go to spencerhealthsolutions.com and you will find the post of this podcast on our website, under podcast. And we'll have all the links there as well as the links to find Craig in social media as well. Craig, thank you so much for joining People Always, Patients Sometimes.

One of the foremost conferences in the field of clinical trials is SCOPE, which stands for the Summit of Clinical Ops Executives. While held virtually this year, the conference was packed with interesting and innovative presentations. Spencer Health Solutions served as a premier sponsor of the event and co presented at the conference with a client and collaboration partner, Otsuka Pharmaceuticals. Our content was presented in the track, focusing on accessing and generating real-world data. The presentation was titled Implementing a Transformative Medtech Device Program to Gather Real World Data. Our co presenters were Tom Rhoads, CEO of Spencer Health Solutions and Kelly Roland, Associate Director, Otsuka. In planning this presentation, we decided to show a little bit behind the curtain of how a large pharmaceutical company evaluates digital health technology before it is written into a patient protocol. Let me set the stage. My name is Janet Kennedy and I'm the host of the People Always, Patients Sometimes podcast. Coming up is a conversation between Tom and Kelly walking through Otsuka's reasons for creating an internal focus group to evaluate the Spencer SmartHub. As part of the evaluation, Spencer health look forward to having Otsuka learn about and experience our deeper data and a more comprehensive look at how patient real-world evidence can be used to support the patient and improve outcomes. I hope you enjoy this candid conversation between Tom Rhoads and Kelly Roland on People Always, Patients Sometimes.   Tom Rhoads: (01:42) Hi, I'm Tom Rhodes, CEO of Spencer Health Solutions. Spencer is and FDA class one medical device for use with medication management, patient engagement and data collection. The Spencer SmartHub is being used in care management for about three years now. And in 2019, we added the clinical trial and commercial pharma division and launched Spencer SmartHub into both the clin trials, as well as post approved commercial farm applications. We're really pleased to be presenting at SCOPE this year, and we're very proud to be joined in the discussion today by our partner in an innovative internal focus group program. With me is Kelly Roland, Associate Director of Otsuka Pharmaceuticals. Hello Kelly, how are you doing today?   Kelly Roland: (02:23) Hi Tom. Thanks so much for inviting me to join you today. I'm excited to be here.   Tom Rhoads: (02:28) Well, that makes two of us. Kelly, our presentation in the SCOPE track is focused on accessing in generating real-world data, which is having a greater impact on the design and clinical trials and patient programs more than ever before. But before we jump into a discussion of our focus group, could you share any insights on why real-world data is a priority for Otsuka Pharma?   Kelly Roland: (02:49) Happy to. So as you know Tom, real-world data, real-world evidence - it's really information that creates action. So using this information, we're able to not only look at the improved design of clinical trials, but also conduct those clinical trials in new and different ways. Better data really lends itself to potentially faster analysis and better drug development overall, with really the aim advancing towards understanding both patients and drugs sooner. So from an operational standpoint, real-world data real-world evidence can enable more efficient, effective clinical trials and hopefully remove any friction for patients, investigators, and sponsors.   Tom Rhoads: (03:37) Well, it's interesting cause you know, as we were designing Spencer, the ability of patients to provide data back to the SmartHub was always central to our design. In fact, whether we're capturing biometric data passively through a Bluetooth connection, or from the patient's direct response for survey questions. We always wanted to be able to provide multiple layers of health data beyond the moment of medication dispensing, and our program today is really to share a rare insight into how a large pharmaceutical company can bring new technology to their patients and ensure that the internal team has buy-in on the new program. So Kelly, with digital health apps have been around for quite a while; why is the team at Otsuka interested in designing an internal evaluation before introducing Spencer to your patients?   Kelly Roland: (04:21) Otsuka is a company that's really dedicated to serving those with unmet medical needs, and we really strive to innovate and defy limitations. When we first evaluated Spencer, we felt it could really help us put the patient at the center of the trial first and foremost. And at the same time, we also knew it would break those current processes and operational logistics that you have for more traditional ways of running a clinical trial. So by getting out of our comfort zone and kind of embracing this new way, this new technology, a new way of doing things, we decided to pilot our own internal focus group, Otsuka only. We could have easily outsourced this to another group to research for us. However, we thought that this internal approach would allow Otsuka functional area champions really, or subject matter experts with that really in-depth personal experience with the device. They could experience firsthand what the patient would experience and help to develop new processes and new solutions based on those insights.   Tom Rhoads: (05:29) You know, you remind me, as we went to develop Spencer, we developed it from the patient out. So to see pharma taking the same position of understanding firsthand what the patient would experience is truly innovative, and we were obviously thrilled to learn you'd be interested in having your team experience Spencer in person. So maybe let's break down a few reason why that's a good idea.   Kelly Roland: (05:52) Holding that internal focus group served a few key purposes for us. First, as I mentioned, gather those insights very quickly and you get that firsthand knowledge that you wouldn't have otherwise. We wanted our teams to look through the lens of the patient, the site, and actually their own functional area when evaluating Spencer. So in the case of Spencer, it's a new technology, it requires a bit more organization, a little more prep work on the part of the team. And we thought this could be an exciting new approach for us. So our goal was to really set up a focus group so we could better evaluate everything end to end from the program set up, data integrations, training materials, and overall how Spencer worked.   Tom Rhoads: (06:38) So when you think about really the protocol that you're outlining, why was it important for Otsuka to kind of evaluate Spencer in each of the different roles?   Kelly Roland: (06:47) So when we're planning protocols or planning our programs, we really want to anticipate as much as possible where there could be difficulties where there could be challenges. One such area are those new roles and skill sets, quite honestly, that need to emerge when you layer technology and roll real-world data into the mix. In the past, we've relied heavily on, I'd say more manual processes together feedback from patients and sites. But with new digital platforms like Spencer, we can be much more proactive in assessing how a patient's doing between their clinic visits, especially as decentralized trials become much more common here in the future. But that said, we can better respond as a company if we've lived the experience in those key roles. It makes our team more intuitive in designing a protocol, and also a little more creative in the support materials that they bring along as well. So a focus group like this creates a lot of change in the company, but it also creates change agents, I'll call them, because now they've lived the experience, they can spread the word to their colleagues and other functions about the tool. They can be that subject matter expert in their function and help others to understand either the value and or challenges of this particular tool. So I think a focus group is really interesting and great way to start that change management activity.   Tom Rhoads: (08:15) That's a great point. So as we kind of break down the roles, maybe we can take a deeper dive into the patient role for a moment. What were you interested in evaluating as a patient using Spencer in a clinical trial?   Kelly Roland: (08:27) I said it before. I'll say it again - I really think this is going to give us invaluable experience from that patient perspective for our greater team. You know, we know we're working with a tool that has really interesting data around adherence and engagement, and we really wanted to explore that further. You know, we're asking ourselves questions like, "could Spencer cause annoyance or frustration for a particular indication?" "Are there other indications that may lend themselves more readily to a Spencer device versus another?" Would the collection of biometric data in the home be more desirable to a patient or caregiver versus having to go to the doctor's office?" I think if COVID has taught us anything that does seem to be a much more desirable functionality that people are looking at now. All this to say, it's very different reading about a tool and assessing capabilities versus actually experiencing them and walking in the patient's shoes.   Tom Rhoads: (09:22) So when we look at some of the aspects of the platform, how does the ability to gather patients' answers, to post medications, dispense survey questions, factor into your plan for utilizing real-world evidence? For instance, we found some eliminating data on how different individuals - in fact, two different individuals, both were basically 98% adherent - can reveal very different situations for those patients. Just curious, how do your plans factor in for that real-world evidence?   Kelly Roland: (09:50) So I think, as you indicated, medication adherence is only part of the story. So the questions we ask patients via the Spencer device could potentially provide, I think, some interesting real-world data on how the patient is not only doing from a physical standpoint, but also a mental standpoint. I think the data can help us to potentially create algorithms that allow for some of these deeper insights. Wouldn't it be interesting to have the ability to predict a manic event in a patient with bipolar disorder, for example, using both biomarker data and survey questions before the event even happens? So finding ways to identify signals related to relapse, potentially diabetes control, et cetera. I mean, this would be something that could be explored by asking the right questions at the right time. And these types of scenarios I think are really what excites our team as we kind of look to take those data insights to the next level.   Tom Rhoads: (10:47) Oh, that is great. It does remind me of the story I mentioned a moment ago. We had two different individuals currently on platform. From a high level, they were picture perfect. They were both basically a hundred percent adherent. They were 98.9% adherent taking their medications during the time prescribed. So you think at this point, check the box and move on; nothing more to see here. When we dug in and began looking at answers to questions, we saw two very different individuals. In fact, there was about a 10 year difference in their age. One was female, one was male. Suffering from depression as a primary and other disease and comorbid. And when you dug down into the questions you found that one person was sleeping well, eating well, exercising; in many other aspects, basically was on a very good path, consistent with a high adherence rate. Yet the other person, even with the high adherence rate, was experiencing a totally different outcome. They were not sleeping well, not eating well, not exercising. And their depression was a bit spiraling. Those are the types of data and insights that we all hope to collect. And I think working with a leader like Otsuka to be able to apply, as you said, algorithms, so that we can begin to notice these patterns and alert against these patterns, are critical really for healthcare's future.   Kelly Roland: (12:11) Totally agree, Tom. I think that that's something that our team looks forward to learning more as we push forward. This is exciting.   Tom Rhoads: (12:18) The funny thing for me is often times we all go out and have a third party evaluate something for us; and then they give us a report and we read our reports and we make assumptions and decisions around those reports. You know, cause we're all busy. I think what's truly unique here is that Otsuka has decided to have their team do it. And I'll tell you, from my experience - just my past in marketing - having your own hands on, you're going to see things, ask things, question things more deeply than you ever could coming from a report. I think that's a really interesting aspect of this where companies really do roll up their sleeves to understand what it is they're evaluating.   Kelly Roland: (13:01) So Tom, we talked a little bit about the Otsuka focus group and the program that we've developed, and the partnership that we have. From your perspective, was creating the focus group program the same as launching into a new clinical trial? You know, were there many differences or any similarities you could speak to?   Tom Rhoads: (13:21) Well, overall it was a terrific experience for us. I guess on the firsthand we followed the same procedural pathway that we would use for clinical trial: treating it as a protocol and really following the regimen and structure and review process with very deep collaboration across the teams. By approaching it in this manner, I think we were better aligned with your team, certainly, with the expectations and the outcomes that you were seeking. I think the difference for us in this was that the focus group program really centered on feedback and modification to best support your long-term needs. And so for us, it was very refreshing, maybe not as nerve-wracking either - given that we had opportunities to modify and change - but being able to go in with a mandate to learn and collaborate was really critical, I think to the teams to provide honest feedback, questions, and have the necessary dialogue and how we can make things better overall, from an onboarding, a management, you know, a site management, and general support throughout the entire trial. It was a great experience for us, for sure.   Kelly Roland: (14:25) Thank you for that. And I agree, I think that some of the ease of the focus group was really around being able to be creative and work together in that kind of creative fashion, where if something didn't work or we wanted to pilot something different or add this or switch that, we had the flexibility to be able to do that. So I agree. I think that this was refreshing from all angles - ours as well. So definitely appreciate that. One other question for you. What do you think, again from your perspective, is an important thing that clients, pharma companies in particular or researchers, need to experience when working with new technology?   Tom Rhoads: (15:07) You know, digital health has been around for gosh, a decade now, I guess we've been talking about it materially, and I think clients, or really anyone looking at technology really need to understand how to best apply the technology, kind of what the upper and lower limits of the technology are. You know, where is it best used? Who best responds to it? How is it supported? Does it work for their needs or not? And you know, I think one of the things that Otsuka did such a really refreshing kind of remarkable job of is rolling up their sleeves and experiencing it themselves. I think too often clients look to third parties to evaluate technology and give them condensed reports on it. And it's hard to make decisions from that. But when you experience a technology firsthand, you're going to have a really insightful and deep understanding of the good and the bad, and be able to make decisions - and I think more informed decisions - and directionally support your strategy longer term. That was something that as we move forward, we'll certainly be sharing that as an important aspect to evaluating new technology.   Kelly Roland: (16:15) Perfect. Thank you.   (16:17) Well, thank you for having us and allowing us to present at SCOPE. We certainly hope you come and visit us in the virtual trade show hall. And it's really exciting to be able to share our focus group study. We very much look forward to sharing the findings that come out of this, maybe in the next SCOPE.   Kelly Roland: (16:35) Thanks Tom. I appreciate being here and agreed. I think we look forward to sharing our learnings in the future.

Welcome to People Always, Patients Sometimes, a podcast production of Spencer Health Solutions. I'm Tom Rhoads, CEO of Spencer. This year, we are pleased to be presenting a series of interviews with patient advocates, inspiring leaders, and influential patient organizations to ensure that we always live our motto of people always, patients sometimes. On the podcast today, is Brian Lowe, the founder and CEO of Inspire. Brian created Inspire 15 years ago with a goal of accelerating clinical trial recruitment, using safe, trusted online social networks, organized by medical condition for patients and their caregivers. Today Inspire has 110 health association partners and over 2 million members. I hope you'll enjoy our conversation with Brian on People Always, Patients Sometimes.   Janet Kennedy: (00:56) There are over 200 million people living with one or more of over 7,000 identified rare diseases around the world. Rare diseases have a wide diversity of disorders and symptoms that can vary not only from disease to disease, but also from patient to patient suffering from the same disease. Hi, I'm Janet Kennedy with Spencer Health Solutions. I am so pleased to welcome a special guest from the rare disease community to the People Always, Patients Sometimes podcast. With me today is Brian Loew, who is the founder and CEO of Inspire, a patient community unlike any other. Brian, welcome to the podcast!   Brian Loew: (01:39) Thank you. It's really great to be here.   Janet Kennedy: (01:41) You really have been quite instrumental in pulling together patients who have rare diseases and providing them an online community. And that is an amazing thing and an important aspect of caring for patients in this crazy world that we're in right now. I'd love to know a little bit more about how you came to found Inspire, and then let's talk about what you're up to.   Brian Loew: (02:08) Sure. When we started Inspire about 15 years ago, it was out of our observation that there was a real need for patients and caregivers to connect safely online. And that there weren't great spaces for them to do so way back then. And it seems like a long time ago, what you found at that time was online message boards, discussion groups. Many of them were kind of Yahoo message boards. A lot of them are unmoderated, and yet you saw the need was enormous. Patients and caregivers were trying to connect around their health. And we saw that there was a real opportunity, I think, to provide this safely and with scale, a reliable platform or patients and caregivers could join and talk about their medical conditions.   Janet Kennedy: (02:49) You brought something interesting to the table in that your background is in technology. You are not a medical professional perse.   Brian Loew: (02:57) That's right. I had a lot of interest in health and so did my co-founders, but I didn't come at this from the perspective of a doctor or a scientific researcher. It was more of a technology background. That's right.   Janet Kennedy: (03:07) So that probably gave you a great leg up in creating something that was going to work. And you're much more aware of the issues involved, but how did you handle the medical side and even the legal and HIPAA related side?   Brian Loew: (03:21) Sure. One of the things we did from day one was we partnered with experts in this case, national patient advocacy organizations, which is, you know, there are about 2000 of these in the United States and they're organized often by specific disease. A very large number of these non-profit organizations are in the area of rare disorders. And in fact, our very first partner was the Children's Inn at the NIH, which is this extraordinary place at the National Institutes of Health to help support the families of children who are undergoing treatment, usually for rare disease or cancer at the NIH. This expanded to other national patient advocacy organizations like women, heart and the ovarian cancer research foundation and osteoporosis foundation. And over time, we now have 110 of these partners and about half of them are in rare disease.   Janet Kennedy: (04:13) So for instance, something like American Heart Association or American Cancer Society, those are very, very large organizations. But on the other hand, I imagine there's obviously more than one kind of cancer or one kind of heart issue. So do they have subgroups underneath an umbrella of their organization?   Brian Loew: (04:33) You're absolutely right. That as you said, if you look at the 7,000 or some estimates are now that there are as many as 9,000 rare disorders, there was enormous overlap with rare types of cancer. For example, where people have rare conditions that might be, you know, historically called a kind of cancer and now recognized as a rare subtype. And then there are other things that have always been thought of is rare disorders, things like Wilson disease or Von Hippel-Lindau syndrome or scleroderma or sarcoidosis or Ehlers Danlos syndrome. And we have partners in all of those areas. And I think what we're coming to realize is that kind of, as you pointed out, rare diseases are quite prevalent, even though they're officially defined as conditions for which there are less than 200,000 people in the United States with a disorder. It's estimated that one in 10 humans have one or more rare disorders. And so, you know, we're talking in the United States of over 30 million people who have a rare disease.   Janet Kennedy: (05:26) I'm going to ask a lay person's question here, and I know you are not a medical professional, but I'm going to take a great leap. It's not that there are now nine or 10,000 rare diseases that are new it's that our science is getting better and better, And we're able to much more specifically identify what these issues are?   Brian Loew: (05:45) Exactly Right. Exactly Right. And a lot of this is due to incredible advances in genetics over the past 20 years, the identification of things, which before weren't known to be conditions, syndromes, or disorders as such. One of the things that we see in Inspire all the time is what's come to be referred to as the diagnostic odyssey. Patients will have a collection of symptoms. It's clear that something is going on and what the patients are wondering is, do I have something that's recognized as a disease for which hopefully there's treatment? Or am I alone? Am I an 'N' of one? There's some things that are often observed only in a single person. And this is actually kind of an incredible aspect of rare disease, which is that many of the patients who find Inspired do so because they're searching online, searching for their own symptoms and what they discover is conversations going on in Inspire among other people who have the same rare disease that they do. And so there are many people on Inspire who have written to us and said, I discovered that I have this certain condition by connecting with others in your communities, and then going to my doctor and then getting genetically sequenced and discovering that I had a certain condition and that's really gratifying.   Janet Kennedy: (06:55) Well, and while it's nice to finally put a name to the thing that you're feeling, it must be incredibly frustrating if there isn't actually a treatment or a cure for that. So how is Inspire really helping to change the game?   Brian Loew: (07:11) Right. As your listeners may know, only about 5% of rare diseases, 5% of those, you know, seven or eight or 9,000 actually have a treatment. And so the vast majority are known to be real conditions often with genetic markers, but there are not good treatments for them. So there's a real effort by scientists and industry to help find treatments for as many of these disorders as possible. One of the ways we're trying to help is we developed something called the Inspire Research Accelerator, and you can check it out at Inspire.com/accelerator where we've offered to academics, to scientists around the world. If they're working on a particular disease and they need help finding patients to participate in the research, we will invite our patients to participate in their research. There's no charge for this. Our goal here is really to help advance the science. It's something that the patients are happy about as well, because by and large, if you ask members of Inspire what they want most it's to be as healthy as they can possibly be. And so they are very motivated to help support scientific discovery.   Janet Kennedy: (08:13) How long does scientific discovery really take? If you are approached by a pharmaceutical organization or even one of your partner organizations to say, "let's try and get a solution here." I mean, it's years and years?   Brian Loew: (08:28) Years and years. In some cases, decades, right? To sort of understand the condition and the underlying mechanism, and then to begin to explore what treatments are possible. And then as you know, once a drug candidate is identified on average, it takes 12 or 13 years to bring that new treatment from concept to market. And there are many failures along the way. So it's a marathon for sure. It takes a long time to figure these things out. Most of the time, by the way, one of the biggest bottlenecks historically has been that a researcher who has great ideas, isn't able to find enough patients to participate in research. And then in rare disease, sometimes the number of patients required could be dozens that it's fairly small, absolute number, but the conditions are so rare that it can be difficult to find 10 or 20 or 30 people for the rarest of conditions.   Janet Kennedy: (09:19) Have you found that you are building a community where the patients are predominantly coming to you or do you actually have to actively recruit patients with a certain disease or condition?   Brian Loew: (09:29) It's mostly the former. So the way that a lot of patients discover Inspire because they're searching online. And as I mentioned, they find these conversations that are already going on. The second way is that these patient advocacy organizations. So for example, one of our partners is the Wilson Disease Association, Wilson disease affects 10 or 11,000 people in the United States. And it's characterized by excess copper in the bloodstream. This is an extraordinary organization that we work closely with many of the patients with Wilson disease learn about Inspire through the community that we provide with the Wilson Disease Association. And then, you know, finally many members tell their friends and family about the community as well. And so there's growth that way also.   Janet Kennedy: (10:11) So this isn't necessarily a community that is exclusively for patients?   Brian Loew: (10:17) Correct. I'll stand on my soapbox for a minute and say, I think all of us in society need to recognize caregivers for a moment. Every single one of your listeners probably either is, or has been, or will be a caregiver at some point in their life. In some cases, half of the members of Inspire are caregivers. And many people of course, are the caregivers for one condition and the patients for another condition. So very much so Inspires a place for patients and caregivers and researchers and medical professionals.   Janet Kennedy: (10:45) Well, that sounds like a very supportive organization of people. And I think one of the things that you, our newest members would find is the support system.   Brian Loew: (10:56) Right, right. A lot of people arrive shortly after they're diagnosed. There's this fire hose of new information. They're trying to learn as fast as they can and make decisions oftentimes with all this fresh information. And the support is incredible. People often say to us that they no longer feel alone or for the first time they found other people who really understand what they're going through. And there's a ton of support there. I want to point out here that what we're doing is not a substitute for the doctor patient relationship or medical treatment. I think what we're helping support is the practical and emotional support as well as patients understanding how to deal with this flood of information and what questions they should ask their doctors and how they should think about their treatment decisions.   Janet Kennedy: (11:41) I imagine that whatever condition you have, eating the right things or avoiding the wrong things, even simple things like how to exercise or whatever - that's not the kind of information you're going to find from your doctor simply because they're busy. They might give you a link or they might give you a handout. But a lot of the very specific "I have problems with my sleep," or "what can I be eating that won't taste bad?" or those really day-to-day living things you want to be talking, not necessarily to your doctor, because you don't expect them to solve that problem. This is about living. And I think only somebody who's been in that situation would be able to give you that kind of detailed advice.   Brian Loew: (12:28) That's exactly right. If you were trying to figure out how to get on an airplane with your wheelchair, you know, how do I travel with a wheelchair? Who's the best person to help you with that? It's probably someone who has done that before, who understands it. If you're trying to get reimbursed - and there's a lot of discussion about trying to get reimbursed for conditions from insurance companies and that kind of thing. There are a ton of practical tips about that. On a related note, we recently looked at the question of what should I know before I go into the hospital, if you have a planned hospital visit and we had this incredible outpouring of really, really practical tips about how to deal with your hospital stay. And a lot of these things are just better told from people who have been through them before and giving practical advice. I think most doctors would agree that that's not meant to replace what the doctors are providing it's to help support it.   Janet Kennedy: (13:16) Well, we are obviously dealing with COVID and will be for a while. Your community theoretically, should be at the front of the line for the vaccine. Have you found that to be true or does it vary from state by state?   Brian Loew: (13:31) We're in the midst of a really, really wide survey of all of our members about the COVID vaccine. And if you'd like, I can share with you afterwards and you can put it in the show notes. It's really extraordinary. What we're finding is that - this is an important point I should mention is that when you listen to the news about the COVID vaccine, oftentimes we're told things like on average, people are experiencing the following. And what we found is that those averages oftentimes are not really as useful as specific situations. So we're asking members of Inspire about their willingness and attitudes about getting the vaccine, their difficulty in getting, getting it when they've decided that they want it. And then there are concerns about getting it. And oftentimes these concerns are very different for different diseases. For example, we have many members who are taking immunosuppressive therapy, and there's a lot of question and concern about whether the COVID vaccine will affect them differently than people who are not taking immunosuppressive drugs and those kinds of conversations. We're still so early in the vaccine, there is not a great deal of published data about the relative risk for people with different diseases. So there's a real thirst for information and people with different medical conditions have different, but very specific questions.   Janet Kennedy: (14:43) So I imagine that that survey anecdotally is going to be extremely valuable, but is there any organization that's actually funding research into how the rare disease patient is dealing with COVID?   Brian Loew: (14:56) We're funding the survey ourselves, and we've also decided to make it a kind of gift to the world. So we're going to open source the data, and we're going to make all of these available to the general public, to browse through the aggregate anonymized results. And then we're also going to make the data sets available to the public and to researchers who want to explore it more deeply. One of the ways I think we'll be able to contribute is that we're breaking all of these data out by specific disease. So if you want to understand the experiences of patients with one rare disease versus another versus cancer versus chronic conditions, and looking at by age, gender location, experience with treatments and diseases, you'll be able to look at all of these data and kind of interactively explore them. I think it'll be a really great research experience.   Janet Kennedy: (15:41) How many patients have participated in the program so far? And are you specifically looking at patients, are you asking caregiver information as well?   Brian Loew: (15:49) As of today, we have about 25,000 who've participated in over a million data points, but we're only part way through. So I expect that number to grow a great deal and for it to be a, hopefully a really valuable resource.   Janet Kennedy: (16:02) Oh, this sounds pretty impressive to me. I think it's going to be exciting.   Brian Loew: (16:05) I'd love to share it. We're a couple of weeks away from sharing it publicly and I'll give you the information for that.   Janet Kennedy: (16:11) All right. That'll be very exciting. And I look forward to reading some of it myself, not with full understanding necessarily, but I definitely would appreciate getting that inside look. So tell me about clinical trials in general; is that the primary focus of Inspire?   Brian Loew: (16:27) When we started, that was a lot of what we did and we still do that. You know, the problem remains that recruitment for clinical trials is never as fast as, as everyone wants it to be, right? The patients, the scientists, doctors, companies that are developing treatments all want it to move faster. One of the biggest problems has been finding the patients and inviting them to participate. So we still do that, but equally important. And maybe a big focus for us now is understanding the health journey that all of us are on understanding the information about diseases and their progression and which treatments work and why. And so we're putting a lot of our resources towards these health journeys by disease, with equal of helping patients understand their own journey and helping science with the data that's required to help make discoveries. So I would say actually more of our energy now is in that area and it's producing great results.   Janet Kennedy: (17:17) You know, COVID has forced a big sea change in how clinical trials operated in those that were able to embrace a more decentralized experience for the patients seem to be rebounding a little faster than those that are classic come into the clinic. What's been the response from your community, and do you think that the patients have spoken and we're going to see a lot more decentralized trials in 2021 going forward?   Brian Loew: (17:50) Yeah, I would say yes, yes, yes. Some people have pointed out, this is maybe a silver lining of COVID. If there is one, is that what began years ago? And people like Craig Lipset have been involved in helping this happen more quickly. What began years ago is now jumped ahead by maybe 10 years or even more the idea of doing remote trials when possible is something which is now happening much, much more than it was one year ago. I think it's a great thing. Patients like it, most researchers like it, and I'm just thrilled that it's happening so much faster now.   Janet Kennedy: (18:22) I think that it's going to make a huge difference in being able to recruit particularly in the rare disease community.   Brian Loew: (18:29) That's right with rare disease, geography is a huge factor. In some rare diseases, the number of scientists working on the diseases is tiny, and if those people live a thousand miles away from patients that can be a real barrier to participation. And to the extent these trials can be done remotely, it solves that geography problem oftentimes, and can really accelerate progress.   Janet Kennedy: (18:50) If you had the opportunity to share with researchers one core piece of advice on working with the rare disease community, what would you recommend?   Brian Loew: (19:02) I would say please work with the patients in designing your research, and do that as early as you possibly can. If it's clinical trials, that means inviting patients to participate in protocol design. If it's developing therapeutics, work with the patients themselves and ask them questions and ask them to co-create solutions. There is an enormous amount of wisdom among the patients themselves, and also a huge amount of willingness to participate in. What we hear from patients oftentimes is that they wish they were consulted or involved in developing these because they have a lot to contribute and often are not asked.   Janet Kennedy: (19:35) All right. So that's, I think the key thing is consider your patients partners, and not numbers.   Brian Loew: (19:44) Right. Absolutely.   Janet Kennedy: (19:45) Alrighty. Well, I can't thank you enough for joining me on People Always, Patients Sometimes to share the story of Inspire, and I will definitely look forward to getting the link to the study that we will post, even if it's after we publish on the podcast, because I'm very excited to hear how that turns out.   Brian Loew: (20:06) Thank you, Janet. I really enjoyed talking with you.   Janet Kennedy: (20:08) Thank you very much for being here, Brian.

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Today we have invited Jake LaPorte co-founder and global head of The BIOME by Novartis to return for a second conversation on the People Always, Patients Sometimes podcast. On the previous episode, Jake spoke about The BIOME by Novartis and digital health innovation in clinical trials today, Jake shares his thoughts with our host Janet Kennedy on COVID-19 innovation, digital health, and more. I hope you enjoy their conversation on People Always, Patient Sometimes. Janet Kennedy (00:36): Hi, my name's Janet Kennedy and I am your host for People Always, Patients Sometimes, a production of Spencer Health Solutions. Today we have invited Jake LaPorte to join us again for part two of a podcast episode, where we are discussing The BIOME by Novartis as well as patient centricity in clinical trials. Jake, welcome back to the podcast. Jake LaPorte (00:57): Thank you, Janet. It's great to be back. Janet Kennedy (01:00): So for the folks that might not have caught the previous episode, can you give us your elevator pitch on what The BIOME project is? Jake LaPorte (01:08): I'll do my best. So the thesis behind The BIOME is that Novartis has made a big commitment to become a company powered by data and digital, but yet we're not digitally native. So we almost always rely on an external partner to some extent, to help us build digital solutions. And we recognize we need to get a lot better at partnering with companies in the digital and tech ecosystems. And so The BIOME was developed to break down the natural friction that exists between a large multinational pharmaceutical company and the data and tech ecosystems and help us partner with those companies more effectively to develop digital health solutions that have an impact on patient's lives. Janet Kennedy (01:54): You know, there are a lot - like a lot - of digital tools out there. How do you even sift through and figure out who is a good potential partner? Jake LaPorte (02:04): Yeah, that's a great question, Janet. And that's frankly, what our process is all about, to be honest, because what is not often acknowledged in digital health is there's a scarcity of evidence that is available to understand whether a specific digital solution is going to be scalable if that's even feasible. And that it's going to have a meaningful impact if it is scaled. And so The BIOME is really an evidence generating mechanism so that we can make better more data-driven decisions about how we allocate our resources within Novartis to make sure that we're allocating more resources to those things that are more likely to be successful and have an impact on patient's lives. So for instance, we're doing a lot of work to figure out how we can sift through this complex ecosystem more effectively and more systematically to even surface the right partners. We're doing a lot of work to think about how then we onboard those partners more quickly and how we do what I call healthy proof of concept work with them. So we're really thinking about what are the real meaningful hypotheses, the questions that we really need to answer so that we can get more comfortable, that we need to put more resource behind certain companies and solutions in order to scale them a lot of that discipline. And I think this is true of most of the industry did not exist in the digital space. And frankly, it was a paradox, right? Because we have a very healthy innovation management process when it comes to developing medicines, we certainly just don't plunk a tremendous amount of resource into medicines that haven't gone through certain stages of trials. And we certainly know about our portfolio of trials and allocating resources to those ones that have gone through certain milestones, like stage one, stage two and stage three of clinical trials. However, we weren't doing that as systematically with our digital solutions and The BIOME is really that innovation management process. That's helping us do that with external partners. Janet Kennedy (04:13): All right. So one of the pushbacks that so many young new startups get is how many clinical trials have you done? Well, you know, none because we need you to try us take a risk believe in us. Is that something that's hard to overcome internally? Jake LaPorte (04:33): There are still challenges because there are so many solutions that exist out there. It's impossible for Novartis to make a bet on every company from the very get-go and be the ones that are really sponsoring their initial work. We're trying to make as best decisions as possible. So we spread our bets. So there are some that are kind of very early on companies and we have to do our best to figure out if we believe in what they're doing without the evidence behind them. And that fits well into what we're trying to achieve. And we make a bet on them. There certainly are companies that we do that with there's others, where frankly, we might need to see a little bit more evidence behind them before we make a bigger bet. And so it's a balance that we need to strike as much as we would like to try to support everyone in the very early stages, it's just not feasible for us to do that. Janet Kennedy (05:24): Digital is a pretty broad word. So when you're talking digital, are you literally talking about apps, platforms, medical devices? What kind of things are you looking at? Jake LaPorte (05:35): So for us, we take a fairly loose definition of digital. It could be any and all of those things. Distinctively we don't play in an area where we're partnering with conventional biotechnology partners to, for instance, co-develop assets or license, an asset from them. That's a clear place that we play, but any where there is data to be generated or devices to be tinkered with. I think that's a natural area where the bio model that we developed can be very effective. Janet Kennedy (06:11): Before we jump into the bigger conversation, can you remind folks how they can find out more about The BIOME? Jake LaPorte (06:17): Sure. They could probably Google Novartis BIOME, and we have a page that will give you a little bit more information about what The BIOME is, give you links to some of the leadership team, and you can always feel free to reach out to me or others to get more information. Janet Kennedy (06:36): Alright. And we will include a link to that in the show notes. Jake LaPorte (06:39): Perfect. Janet Kennedy (06:40): So Jake, one of the things that I was very curious about is the sea change that has happened and we're golly, nine months into a COVID process. How has The BIOME changed from this time last year? Jake LaPorte (06:57): It's been a meaningful change, not so much to the operating model that we developed, because we think that's a good one for us to facilitate digital innovation and meaningful partnerships to create digital solutions that have an impact. But certainly when you factor in COVID-19, which is first and foremost, a human tragedy, it's also certainly surfaced some of the challenges of the healthcare ecosystem. And we have really focused on helping develop solutions that solve some of the challenges presented by COVID-19. So for instance, we have a big initiative as a company on helping to think about developing telemedicine solutions that improve the continuity of care for folks that now cannot necessarily set up regular doctor's appointments, right? So there's a whole second level issue occurring in healthcare, which is that people that normally should be going to the doctor and getting diagnosed with other diseases, simply aren't going to the doctor or their physician as much and are suffering from diseases that they normally wouldn't have suffered from. So how do we help patients and physicians connect more effectively? So we're working a lot on solutions like that, making them scalable and effective and providing more convenience to patients and physicians that are challenged in this new era. We're also re-diverting some of our resources to focus on specific COVID 19 challenges that have been posed by certain government. So for instance, we have a BIOME in the UK located in London and they work with the NHS and the NHS has defined some specific challenges that they wanted to try and solve. And so our entire innovation program that we have in the UK this year was diverted to helping solve some of the challenges that the NHS has presented. So I think COVID-19 has given us a new problem set if you will, to focus on. And it certainly accelerated a lot of people to really think about how to use digital solutions creatively to overcome some of these challenges. Janet Kennedy (09:20): Well, I think that's really exciting because in many cases we think about pharma as being the big engine. That's only rolling forward at a certain pace and suddenly the flywheel of COVID-19 has accelerated that. And I think it might be really exciting to be working in a company to know that this is not a solution five years down the road. We're solving something today. Jake LaPorte (09:45): Yeah, certainly. I think again, although it's first and foremost, a human tragedy, it's sad that this is the catalyst behind some of this digital transformation. I think the solutions that are being developed are solving some more fundamental challenges in healthcare that will have longer term benefits after we get to a better place with COVID-19. Janet Kennedy (10:05): I agree. Totally. And I think telemedicine, which has been in development for over 20 years is finally seeing its day. Do you see any other type of digital health solutions that we're going to be treating more as an everyday use that might not have been accelerated so quickly? Jake LaPorte (10:25): Yes, certainly the biggie out there is telemedicine, as you already alluded to Janet. But I think that frankly opens up a platform for a lot of other digital solutions to be incorporated into a telemedicine backbone. I think as telemedicine gets more widely adopted it's, there will be ecosystems of digital devices that collected data that can be used in a telemedicine forum to make better more data-driven decisions by a physician remotely. I think you'll see these ecosystems of devices spring up that are expressly designed to fit within telemedicine scenarios. So almost like a virtual checkup room, for instance, that the doctor can use to deliver care more effectively. And in remote scenarios, I think we'll also see more creative ways to do digital clinical trials. For instance, I think we'll be using data more often as telemedicine kind of increases. So does the data that's being collected. And as the data improves that we have on patients, the smarter we can be around developing hypotheses for clinical trials that make them more honed and more focused on answering the questions we need to answer and nothing more than that. So I think we'll see trials get more effective. So I think there will be a number of knock on effects that we'll see as this increase happens. Janet Kennedy (11:55): Do you see personalized medicine becoming something much more central to our healthcare system? Jake LaPorte (12:01): Certainly over time. You know, I think there'll be a certain amount of catalytic event that happens through COVID-19 with personalized medicine. But I think that will generally occur over time with more development. One of the things with personalized medicine is that we've often looked at what we've can do on the molecular level with the evolution of Omix. And we've seen that as a flagship for what we're going to be able to do with personalized medicine, but the conversation is often not focused on the other part of personalized medicine. What we really need is that really well, curated longitudinal data set of healthcare outcomes across a population that allows us to really link up what it means on the molecular level, to what it means for healthcare outcomes. And I think once we start getting these more curated longitudinal healthcare outcomes, datasets, possibly through digital technologies and starting to make those links back to the Omix, we'll be able to make greater strides in personalized medicine. So I'm very optimistic about the future of personalized medicine. I don't know if COVID 19 per se is going to accelerate a lot of that right now. Janet Kennedy (13:17): Alright, now understand that I'm speaking to a PhD in chemistry, which is not the degree that I have. So I'm going to ask a little bit of a 101 level question here. When you talk about getting more data, are you looking at beyond adherence and persistence? This is really digging a little bit deeper and how can patients be involved in providing that kind of information? Jake LaPorte (13:41): So if I relate it back to the question posed around personalized medicine, I think, again, this is something where the healthcare community could really come together and make great strides in how we advance personalized medicine. So personalized medicine has been a concept that's been around almost since we started the human genome project, right? The aspiration of course, is that we can deliver therapeutics and interventions that are personalized to a person's genetic makeup. But what we've realized over time is that we need more information to really interpret different gene sequences that people have and be able to better predict what that actually means for their health and how they will actually experience a particular therapeutic or intervention. And then more over, we have to also incorporate environmental effects that those people experience because different environmental effects obviously have different impacts on patient's health. So therefore the grand challenge, I think in personal health is to create a large dataset across a wide population of folks that is able to basically detail what their health care experience and outcomes have been over a long period of time, as well as their genetic makeup and their proteomic signatures and sequences to them be able to make that Rosetta stone translation, if you will, between certain sequences of DNA that might exist with one person and not the other, certain protein expressions at one person as versus the other, certain environmental effects that a person experiences versus the other, and then say, Oh, this is what that means in terms of how their health care and their outcomes have been. Right. And so this is where actually patients can make a tremendous contribution, right? And the amazing thing about it is there's long been this concern about privacy, right, privacy, around the types of data people are sharing. And that is a very big concern and people are very right to have that. But now with the advent of some of these newer technology paradigms, like blockchain technology, and distributed ledgers, there now becomes an opportunity for patients to own their data, their healthcare data, and share what they want when they want with whom they want and revoke access when they want. And not only that, it then becomes possible for this learning technique machine learning technique called federated learning, which allows you to kind of anonymously sample data from patients that may be on part of a distributed ledger and not have to take a lot of their personal healthcare information, but just take the information they've generated health and therefore anonymize that, and still be as effective in developing new, more sophisticated algorithms. So again, this is more of a grand challenge, but I think it's something that the community is the answer is how do we develop technology platforms that allow patients to be involved in contributing data throughout their lifetime, in a safe and effective way where they're recognized for their contribution, right? Cause that's another piece of it. They need to be recognized for the contribution that they're making, but it allows us to advance medicine and ultimately get better at treating people. Janet Kennedy (17:14): In the rare disease community - and I am not familiar with everything you all are developing - but are you working in rare diseases at all? Jake LaPorte (17:21): So we don't have a big focus on rare diseases per se. I think what you'll find is we work in rare diseases in a targeted way, and it's more platform driven. Like we have a cell and gene therapy business unit. And so one of our major products that we just got approved last year is Zolgensma, which is a gene therapy to treat spinal muscular atrophy - SMA - it's miracle, right? Because if you are able to get a treatment to a patient within a certain amount of time, it pretty much cures them from a disease where they would definitely die. So we work in rare disease, but we don't have like a rare disease business unit per se. Janet Kennedy (18:02): So one of the things that we're hearing from people who have COVID-19 is there long-term health concerns that may be a result, whether it's heart impact on lungs, et cetera. So co-morbidities become a much more important part of understanding how the data works together and then it gets really complex. So are you finding in The BIOME or in the industry at large, this awareness of the importance of pulling together very disparate pieces of data to try and understand health issues? Jake LaPorte (18:34): Yeah, so I think this conversation is starting to become more prominent throughout the entire healthcare sector. The understanding that we need to be able to have more datasets, talk to each other and be joined together in order to power things like machine learning and AI, right. We often talk a lot about the promise of AI and machine learning in healthcare. And it turns out that one of the biggest barriers to seeing more impact from this very impressive technology paradigm is just being able to have the structured datasets to train these algorithms. And so I think there's more recognition that number one, the healthcare data that we do have tends to be very fragmented and incomplete and that we need to as a community come together and be able to do something about that. So what that means is we need to come together and develop data standards and an ontology, which is basically a language or a way to relate data sets together in order to join datasets that we already have. And then in the future, we need to think about ways in order to collect data more effectively to sort of power some of these powerful technology paradigms like AI and ML. Janet Kennedy (19:54): And I think as you said earlier, digital health literacy is essential. Helping patients understand that their data is really needed to help themselves and others. Jake LaPorte (20:05): That's exactly right. It really boils down to ultimately increasing digital literacy, but also developing solutions that make sense, right? So I think we need to be very focused on the patient, what their problem is, how do we solve that problem and how do we protect their privacy? And then how do we communicate that to them to help them understand that that's what we're trying to do. Janet Kennedy (20:30): Well, and that's what should always be right? Focused on the patient for the patient, because that's what we're trying to do. Jake LaPorte (20:36): Exactly. Janet Kennedy (20:37): Well, Jake, what a fascinating conversation. And I appreciate your spending the extra time to do a part two episode of our conversation. I appreciate your being here very much. Jake LaPorte (20:48): My pleasure, it was fantastic conversation for me and I hope you and the audience enjoys it. And again, if there is any questions about the bio that folks want to follow up, please feel free to do so. Janet Kennedy (20:58): Thank you for downloading this episode of People Always, Patients Sometimes if you enjoyed our conversation, a review and a rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions.

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. Our podcast People Always, Patients Sometimes was created to feature innovators, disruptors, and patients driving new ways of doing things in clinical trials. Little do we know that the coronavirus would escalate the need for transformation and demonstrate which organizations were prepared to move ahead more quickly. Today we've invited Jake LaPorte, co-founder and global head of The BIOME by Novartis. Jake has spoken on the topic of digital innovation and health tech startups, and impacting patient's lives. We enjoyed our conversation with Jake so much that we have a second episode with him on the schedule. Join us for this episode of People Always, Patients Sometimes as we listen to Jake's insights on The BIOME by Novartis in digital health and clinical trial innovation. Janet Kennedy (00:52): Hi, my name is Janet Kennedy and I am your host for People Always, Patients Sometimes, a production of Spencer Health Solutions. Today we have invited Jake LaPorte to join us. He founded and leads The BIOME by Novartis, also known as Novartis BIOME, the company's first ever externally branded innovation lab. The BIOME has garnered global recognition for supporting innovative tech and digital health companies and connecting them to Novartis's vast network of expertise and resources to accelerate solutions that improve and extend patients' lives. I really love that and I can't wait to find out more about it. Jake, welcome to the podcast. Jake LaPorte (01:32): Thank you so much, Janet, for having me. I appreciate it. Janet Kennedy (01:35): You know, you've had a very interesting back from before you got to Novartis. So do you mind bringing us up to speed and telling us how you ended up where you are? Jake LaPorte (01:43): I started off my career as a scientist. I was actually an organic chemist. I did a little bit of medicinal chemistry, but early on, I sort of learned that while I loved talking about and learning about science, I didn't necessarily love the bench work. So after graduate school, in order to get a different experience and try to figure out what I wanted to do with the rest of my life, I joined a global consulting firm, McKinsey and company, but there I focus primarily on the pharmaceutical industry and even within the pharmaceutical industry, primarily on R and D. And I got really obsessed with trying to make a contribution to what was starting to be discovered at the time as the R and D productivity problem, right in pharma. And now obviously there was data suggesting that we were on an unsustainable path and I generally believe in bringing technology and science to society to improve human health. So I want to make a contribution to solve the RD productivity problem. During my time at McKinsey, I sort of learned a tremendous amount, but at some point I got tired of kind of talking about it and wanting to try to do something about it. So that led me on a journey to work at a global CRO called PPD with one of the clients that I had at McKinsey. Her name is Kristine Bigaven. She was the chief medical officer at PPD at the time. We learned a tremendous amount from her. She ultimately was hired at, into Novartis to lead a big part of their global drug development organization. And I followed her there to Novartis, to lead digital strategy and innovation for our global drug development organization. And then ultimately then created The BIOME within that. And now we're trying to grow The BIOME into an enterprise wide solution for all of Novartis. So that's, that's sort of my snapshot of my journey to where I'm at today. Janet Kennedy (03:33): Okay. So I want to talk about the good old days of 2017 and digital development. What did that mean in 2017? Jake LaPorte (03:44): Digital development meant to us, which was the name of my organization was really thinking about how to harness these digital technologies and solutions that were starting to arise and incorporate them into future clinical trial paradigms that made them that made clinical trial is a better experience for patients and the healthcare providers that were participating in our trials and frankly, as well as to make them more efficient and effective and faster so that we could more effectively develop our portfolio of medicines just to make a concrete, right. We were looking at paradigms like decentralized trials, for instance. And how do we bring those about in a scaled way into our portfolio? We were looking at things like digital end points and evidence, and how do we incorporate digital technologies to capture new information in trials to make the development of our medicines more effective. Janet Kennedy (04:41): And tell me a little bit about the sense of urgency then versus now, was it something that like this was on our five-year plan or were you really trying to focus on things that, how can we get some tests going sooner? Jake LaPorte (04:55): So I'm sort of where we're at today. Obviously we've had a huge catalyst in this area also known as COVID 19, which has obviously challenged the conventional way to do clinical trials pretty significantly. So I think the urgency to do something in this area is unparalleled now compared to where were at 2017. However, we, you know, as Novartis, we had a pretty aggressive schedule to transform the way we did trials back in 2017. And it was more about how do we do some of these digital solutions at scale versus continuing to do them in pilots. But of course the urgency, now that folks have to transform as a matched, due to this new challenge in health. Janet Kennedy (05:42): Now, when you were looking at digital platforms in 2017, 2018, even early 2019, were you looking at things that you would absorb within your ecosystem or were these more partnership opportunities? Jake LaPorte (05:58): So I think most of the time, what we were looking at is for partnership opportunities. So many of these solutions and digital, and by the way, I think this also applies to the broader part of the enterprise are not things that are naturally owned by a specific pharmaceutical company, because most of the time for digital solutions to be meaningful, they need to be adopted at scale within the healthcare sector, right? Which necessarily requires that multiple pharmaceutical companies are using these things as a standard that multiple healthcare systems are using these things as a standard. So oftentimes that almost suggests that there's a partnership that needs to happen. Janet Kennedy (06:40): So what made you decide that the work you were doing in general needed this big investment of time and effort and physical location in creating The BIOME. Jake LaPorte (06:53): What it ultimately came down to is a little bit of what I said before that that partnerships are often so critical to building meaningful digital solutions that solve complex healthcare problems. And if you really reflect on where we're at as an industry, the pharmaceutical industry is not digitally native, but obviously we need to transform. And so we almost always require a partner to some extent, to help us build a digital solution. The complication is that we have just never, as an industry, built a capability to partner with the external digital health ecosystem effectively. And so there tends to be these barriers or this friction that naturally exists between a major multinational pharmaceutical company and the digital health and tech ecosystems. And The BIOME is really a focus on how do we break down those barriers and allow our internal teams to more fluently partner. And co-create with the digital health and tech ecosystems. That's really what The BIOME is about. We knew we needed to get better at partnering and that's what The BIOME is focused on. Janet Kennedy (08:03): So I'm really envisioning here, you have the big giant pharma company, and then you've got the fly by the seat of their pants startup. Those don't seem like they would mesh very well? Jake LaPorte (08:14): Perhaps not, but in a lot of instances, if you partner with younger companies that are maturing in the right ways, they can bring about beautiful solutions that can really have an impact on healthcare, but it's the key, the devil's in the details. How do you partner with them in the right way? A lot of the expectation tends to be that that partners are going to come with a fully baked solution that can easily be plugged in to an environment and deployed at scale. In the reality, what we found is that you need to be able to be committed and make an investment in these companies to really adapt their solution and help them co-create their solution so that it can be adapted into our, the context of the pharmaceutical industry. So let me give you an example of what I mean by that, that we've come out with publicly. And we talked about right, is a BIOME project that we did in support of our global health organization. And they had already launched an initiative to increase access to medicines for sickle cell disease patients in Sub-Saharan Africa. What we did is we helped them find a technology that by the way existed in Portland, Oregon, with this company called Hemex Health, that would allow them to identify patients in Sub-Saharan Africa, more effectively, diagnose them more effectively, and therefore allow them to get medicines to these patients more effectively. But that of course required that we make an investment in this company. They weren't for instance, approved by the FDA in Ghana, which is where we were launching this initiative. So we put some regulatory resources around this company to accelerate the regulatory approval onto the Ghana market to allow them to participate in this initiative. And now they're involved in this initiative and hopefully through this partnership, we're going to be able to get more medicines to the patients that need them faster with regards to sickle cell disease. So again, when you partner and you think about how to partner in an effective way, it can really, really increase your ability to extend and improve patient's lives. Janet Kennedy (10:28): And in that example, it really sounds like you were utilizing skillsets, experience, existing departments within Novartis to help advance. So you were giving really a helping hand to a company who maybe didn't have that deep experience or capabilities. Does that sound right? Jake LaPorte (10:44): Yes. That's a fantastic observation, Janet. That's exactly right. And I think that you can extend that to a more general Axiom that as a pharmaceutical company, you need to think about the complimentary resources and expertise that you have, that you can bring to bear and how to connect that effectively to the partners that you're working with and be able to make that investment in them in order to co-create solutions that are really going to have an impact. Janet Kennedy (11:10): Alright now, I want to talk about culture and mindset a little bit. Yes. We've been talking about digital for a long time. How long has telehealth been in the market, 20 years? And we are just now due to, COVID seeing this exponentially explode. Well, it's about time, but too bad. It took a global pandemic to change our mindset in working with a large company that has, I'm using my little air quotes here, always done it that way before, have you had to work with your internal existing team about helping them be more flexible in their mindset and think about not solving the one problem, but solving the multiple problems, looking for the multiple right answers. Has that been a challenge? Jake LaPorte (11:54): So culture and mindset are so fundamental to any kind of transformation that one undergoes, whether it's a digital transformation or some other transformation we've placed a big emphasis in Novartis on the appropriate cultural transformation that we need to undergo in order to successfully transform into a company that's driven by data and digital. We thought a lot about that. We're making a lot of investments in that space. In fact, we have a whole learning organization that is focused on how we upskill our organization with regards to digital skillsets and a mindset, right. That needs to be accompanied with that. When you say it's a challenge, I think, yes, it is a challenge. It's more of a journey that we need to go on. We see it as a journey that we're on in order to up-skill and change the mindset of all of our associates within Novartis to embrace data and digital, and be able to think about how to take smart risks with how they implement digital solutions to really improve the way they do their work. Janet Kennedy (13:04): What about the speed of drug development? And maybe that's an oxymoron right there versus digital tools. Digital is advancing at exponential rates and yet protocol design isn't there yet. Where does digital come into play? Are you trying to work at it from the very base level, or is there a way even with an existing protocol, you can find ways to bring digital tools in? Jake LaPorte (13:29): I think it kind of requires both approaches really Janet. So I think there's ways right now that you can have an impact on the way you design trials from a conventional standpoint, by being able to bring in more meaningful datasets and really think about, and challenge how you did design inclusion, exclusion criteria, right? To make your trial more amenable to a broader population without sacrificing the scientific objectives you have, and the questions that you need to answer that certainly can be done today. I think going forward, there's an opportunity to reimagine how one, for instance, designs a trial, and frankly how one acquires the data needed to answer their scientific questions. There's been discussion in the community around some people call them digital twins, other people roughly allude to the same concept as in silico trials and our ability to acquire more sophisticated information, either through just tapping into existing populations, without them being in a trial, for instance, like in real-world evidence or even using new systems like organoids that can replicate the functionality of complex human systems will only grow over time. And you can start to imagine where some of the stuff we do in trials today with human patients will not need to be done in the future because that data can be acquired by different means. Janet Kennedy (15:01): So using simulation technology? Jake LaPorte (15:03): For instance, yes. So you can imagine we'll get more sophisticated over time with how we acquire and our ability to acquire real world evidence, and then how to translate that into meaningful ways in which we can simulate pieces of a trial or pieces of a development program. So it doesn't burden the ecosystem as much. And we're starting to see this happen already. This happens already with virtual control arms, for instance, and people have been applying this successfully in the oncology space already, right? So not having to stand up an entire control arm for studies can reduce the burden on the healthcare sector in a pretty significant way. Janet Kennedy (15:46): I'm curious about the 'I don't know what I don't know' issue. Are you finding that your data scientists are coming to you saying, man, wouldn't it be nice if we knew this next level of information and let's go find a digital platform that's building that, or are you finding that the digital folks are coming to you with, "Hey, but if you had this kind of information, you could do even more with it?" Jake LaPorte (16:11): Yeah. I think there's always a tension, right? I think it kind of happens both ways in different scenarios. I think there's what we try to do is we try to work with our business teams to understand what their challenges are and the questions they're trying to answer and try to take more of our activity based off of solving those challenges. But there's always that dynamic as you alluded to, you don't know what you don't know. So we also make an investment in trying to understand what is happening in the digital health and tech ecosystems and make our associates within Novartis, more aware of what's going on so that they're able to have a better understanding of how those new things could be applied to how they work. It happens in both directions I would say. Janet Kennedy (16:59): Are you finding that patients are embracing digital and I'm thinking more specifically of more mature patients that aren't necessarily still smartphone enabled, et cetera, et cetera. How does that impact some of the decisions you're making? And again, you mentioned going to Ghana where I actually imagined cell phone adoption is relatively good because it serves as the primary computer for those that have it. But I'm curious about the disparity between the patient's ability to utilize digital tools. Jake LaPorte (17:31): Yeah. So this brings up a fantastic point that I think the overall sector needs to think more about, and that's building digital literacy across the entire population in order for us to use these healthcare technologies more effectively. And that not only includes patients by the way, but it also includes healthcare providers. So how do we build that literacy? How do we build into the natural way in which people experience their lives and practice medicine, that ability to really select the right tools for them that work that makes sense for their lives. You can almost think about it as an analogy of how do you build the app store for digital health solutions, right? Because that's a great analogy where it's very customer centric. You go in with a particular need, you're able to search the solution set pretty quickly. You're able to download and try a solution. If that doesn't work, you're able to kind of find another solution. And so how do we get to that point? It's a tougher question, obviously in healthcare and as an entire sector, including the payers and providers, as well as pharma, I think we need to think more about how do we build this literacy within different populations. You mentioned Ghana, for instance, as a perfect example, there is a huge adoption of cell phones, but they're not necessarily state of the art smartphone. So you have to think about building digital solutions that work on more basic flip phones, for instance, and think about there, there that there might be different partners that are needed to build those solutions. And in fact, we have a very good partner called Dimagi, who thinks a lot about how to build data architecture and solutions that allow people to capture healthcare data on a more basic cell phone so that you can really take advantage of the technology that exists in an area. Thinking about that in a meaningful way is important. Thinking about how to increase the digital literacy within populations that are older, that may not have kind of grown up with technology is important. So all of these things factor into how we increase the impact of digital health. And frankly, that I think boils down to culture and mindset shift, not only within companies, but within the broader population as well. Janet Kennedy (19:51): So who has that responsibility then? Drives from pharma primary care providers from the patients themselves advocating? Jake LaPorte (19:59): I think we need to find a way to work together as a community to bear that responsibility. I think it's a shared responsibility amongst everyone that participates in healthcare. I think it's a responsibility of the payers. It's a responsibility of the healthcare professionals and the providers and the organizations that focus on them. It's a responsibility of pharma, for sure. It's a responsibility of patients and patient advocacy groups to be thinking about that. And the only thing I can say, and I hope people could take away from this podcast is if we can find more ways to work together as a community to advance digital health, I think we'll all be better off for it. Janet Kennedy (20:41): Well, I couldn't agree more. Let's focus back on The BIOME for instance, if I'm a digital health startup and I was involved in startup weekend for health a few times in the Raleigh Durham area. Very exciting. Sometimes people came in with ideas that they felt very strongly about and they just needed tech teams to help them develop them. Others were just throwing spaghetti up on the wall, but ended up with something kind of solid. When you have people come into The BIOME, are they literally coming into a working space? Jake LaPorte (21:11): In some cases they can be, but we actually are trying to really think about models, which really are accessible to everyone and anyone in the world, because really what The BIOME focuses on is how do we help companies, external partners work with our internal teams to build solutions. And so a lot of that work can frankly be done virtually. And a lot of the support that we give companies can be done virtually. We certainly have physical locations and certainly companies that are local to our physical locations can take advantage of them to the extent that they want to or need to. But the nature of us focusing on digital technologies suggests that there's certainly a lot that can be done virtually as well. And so we're adapting our model to take that into account. One thing that you asked about was how do companies really engage and get involved with Novartis and the Novartis BIOME? And we certainly recognize as a company that the journey for an external partner to find the right people within Novartis to support them and match what they're trying to do can be chaotic. We're on a journey as a company to make that faster and more effective and a better experience for our external partners. And one of the things that we're developing actually frankly, has been developed already is called the Novartis digital brain. The easiest way to explain is it's a partner relationship management platform so much like customer relationship management. We want to have a way to track all the interactions we're having with our external partners, for the purposes of trying to understand how we match the right internal teams with the right external partners. Ultimately, we want to open this platform up so that it's accessible to any external partner in the world that can update and manage their profile on the Novartis digital brain. And tell us all of the great things that they're doing potentially within Novartis or outside of Novartis and help us match them to a team in Novartis. That's trying to do something where their solution makes sense to be matched to, and therefore kind of cut through all of the arduous process of trying to knock on 20 different doors and figure out the right person to work with within a large complex organization. Janet Kennedy (23:42): Well, that's exciting. Is it by invitation only right now, or how do companies get to your attention? Get to the platform? Jake LaPorte (23:50): We don't have the module yet where external companies can access the Novartis digital brain. It's definitely on our product roadmap right now. We're building profiles of all the companies we already work with through a combination of third-party external databases like tech crunch or health Excel, as well as internal inputs into those profiles that have been already developed through teams that are working with these partners. But over time we have the aspiration of inviting partners onto this platform, and it's not going to be something that's exclusive where we only invite a select few people. We, again, we really want to democratize access to this platform as a way to cultivate the best relationships with our external partners and match them to the right scenarios in order to work with teams and develop solutions that make sense. Janet Kennedy (24:40): Okay. So right now it's still door knocking for some folks, but you are systematizing and organizing companies you are currently in partnership with. Jake LaPorte (24:49): Yeah, that's right. I mean, we're on a journey. So certainly I don't want to give the impression that we solved all of these problems in The BIOME yet we're on a journey. And frankly, we always like to talk to external partners and understand the challenges that they're having. As we really seek to build out our services and products, we eat our own dog food, if you will. And that we're trying to really become more customer centric and get feedback from our external partners and therefore use that feedback to inform the next series of products that we develop. But we're definitely on a journey. Janet Kennedy (25:25): Alright. Well, I know that we'll have your contact information in the show notes of this podcast episode. So I'm sure you don't mind if people reach out to you via LinkedIn and get to know you there. Jake LaPorte (25:35): I do not mind. No. Janet Kennedy (25:37): Well, I can't thank you enough for being here. We have a lot more to talk about. So I give the audience a heads up that there's going to be a part two conversation, when we talk more specifically about COVID-19 and the acceleration of digital trial initiatives. So for now, Jake, thank you so much for joining me and I thank everyone for downloading this episode of People Always, Patients Sometimes. If you enjoyed the conversation, a review and rating on iTunes will help us find more listeners. This podcast is a production of Spencer Health Solutions. Thanks again, Jake. Jake LaPorte (26:09): Thank you. It was a pleasure being here and I look forward to part two.

Tom Rhoads (00:02): Welcome to "People Always, Patients Sometimes." I'm Tom Rhoads, CEO of Spencer health solutions. Our podcast is focused on many of the thought leaders and executives that are calling for change in how we design and run clinical trials. This episode is the second in a series of interviews with patient advocates, influencers, and organizations dedicated to putting the focus in healthcare where it belongs, on the patient. Our mission at Spencer health solutions is to ensure that patients are at the center of everything we do. So we are pleased to introduce Carly Flumer to the podcast. She was a young adult survivor of thyroid cancer and author and a health data scientist. I know you will enjoy her conversation with Janet Kennedy on "People Always, Patients Sometimes." Janet Kennedy (00:51): The people always patients sometimes podcast is about the change agents in healthcare who are focused on patient experience, patient engagement, or disrupting the process of clinical trials to become more patient centric. Our guest today is Carly Flumer. She's a patient advocate, a data geek, a change agent, and one of Spencer's voices of disruption. If you have not read our ebook yet, in which Carly's comments are featured, look for a link in the show note. Welcome to "People Always, Patients Sometimes", Carly! Carly Flumer (01:22): Hi, thank you so much for having me. Janet Kennedy (01:25): I have been. So looking forward to talking to you, because while you provided a great insight to our voices of disruption ebook, we really didn't have a chance to have a conversation at the time. So now I'd like to get to know more about you. Carly Flumer (01:40): Wonderful. What questions do you have? Janet Kennedy (01:43): Let's start with, we invited you here because you have a very active patient advocacy focus in your life, and it is not everything you do, but it is an important part of who you are and what motivates you. So can you tell me a little bit about how that all came about? Carly Flumer (02:01): Sure. I was diagnosed with thyroid cancer in 2017 when I was 27 years old. So I was considered an adolescent and young adults or an AYA patient. And those are very few and far between, it feels like to me, in terms of where age lies on the cancer spectrum I feel like there are a lot of younger patients and then there are, are a lot of older patients, but we really don't hear much about AYA's, which are considered between 18 and 39. And so I wanted to get my story out there and I figured out the best way to do that was to become a patient advocate and to write, which is one of my passions. And so I have been writing about my story and my perspectives in healthcare from a patient perspective, and then from a perspective of somebody who works in healthcare. So it's kind of, two-fold where I can share it from in front of the doctor while also behind the scenes. And so I think if that gives me a unique look into all of the nuances of healthcare and how it can be changed to make better out patient outcomes. Janet Kennedy (03:11): How long was your cancer journey and where are you today? Carly Flumer (03:15): So I was diagnosed the second week of January of that year. And I was in treatment until the end of November of that year. So almost a full year. I am in remission at the moment. The magical words that every cancer patients want to hear is no evidence of disease. I have not reached that status and I may never reach that status, but I was told that I was in remission and I'm checked every so often to make sure that I remain in remission and I don't relapse. Janet Kennedy (03:52): Well, I think that's one of the huge challenges with cancer is while you might beat it, that's not necessarily a forever thing. Carly Flumer (04:02): Exactly. It's something that is always on the mind of every cancer patient, because it's so different for everybody. You hear that no patient is the same, but also no cancer is the same either. Whether it's considered the good cancer, which is what thyroid cancer is considered, or whether it's a cancer, that's more serious, but it's an ongoing thing. It's something that we all think about in the back of our minds. So just something to be cognizant about always, Janet Kennedy (04:34): And is getting thyroid cancer at such a young age, pretty unusual? Carly Flumer (04:39): I would say yes, yes and no. It is on the rise in terms of how many cases are discovered. But I have found, I guess, through my research and through my advocacy work, that it is more common among females. And I would say the majority of the women who I have found in support groups, they're in a wide age range. So from the early teens up to, I would say, you know, 60's - 70's, we are all over the place in terms of age. But the majority of patients I have found are women. Janet Kennedy (05:12): Let me ask you something about your advocacy as every cancer might be different. I imagine every patient advocate would give themselves a unique job description. So what exactly does your advocacy encompass? Carly Flumer (05:27): From my own perspective, my goals are to impact health literacy, patient education, oncology research, and patient provider communication, to create a better health outcomes in the oncology space. That's what my work, that's what my writing involves around those specific topics. But then my job, I wouldn't say it's necessarily advocacy work, but it's certainly within the oncology space is where I receive protocols from cancer centers across the United States for clinical trials. And it's written in this language that no patient could understand. What I do is I translate that information into language that patients can understand. And so that information goes onto website clinicaltrials.gov, which is where patients go to find clinical trials. Should they be interested in enrolling? And so it does kind of encompass that advocacy piece, where I am making that language clearer for patients in order for them to make the best health decisions for themselves. But it's more on the scientific ground, more so than I would say most advocacy jobs are. Janet Kennedy (06:44): So this is something that's a higher level information than webMD per se, but also making that scientific language very accessible. Carly Flumer (06:53): Right. Janet Kennedy (06:54): So how did you end up writing for clinical trials.gov? Carly Flumer (06:59): Well, the way our process works is we receive the protocol and we have a program that we use for our job and we abstract certain parts of the protocol that the patient is going to be most interested in, such as what are the objectives of the trial, meaning what are the researchers looking to do? What is going to be happening? What type of treatment are you going to be receiving? Whether it be chemotherapy, immunotherapy, radiation therapy, what have you, and for how long, what are the outcomes? What are the researchers looking to gain from this experience and what are they looking for patients to experiences, outcomes, including quality of life, survival, things like that. Eligibility of course, is a huge one to make sure that you are eligible to enroll and then things such as biomarkers, which are confusing at first to understand and I still get confused by them sometimes. But those are really key and understanding how a cancer can progress or how our cancer is found. But that's another topic with genomics. So yeah, that's the type of information that I am looking for in these protocols in order to translate that for, for patients so that they can understand what these clinical trials are going to be about. And if they want to enroll this as the information that they need to know in order to participate. Janet Kennedy (08:29): And this is through your work as a scientific data analyst for the National Cancer Institute? Carly Flumer (08:35): That's correct. So I contract with a company outside of the government and we work with the NCI and then these clinical trial protocols are coming from cancer centers across the United States. Janet Kennedy (08:49): You have experience with a clinical trial, do you not? Carly Flumer (08:53): I do. I feel like thyroid cancer is very rare in terms of clinical trials. I very rarely see them in my work and I'm not sure if it's because thyroid cancer has such a great survival rate, but there are variants of thyroid cancer that are more serious, such as medullary, which are the trials mainly revolve around that type. The trial that I participated in was a quality of life trial. And those, I feel like are so important. We see a lot of trials that are focused on treatment and prevention, but then those trials that focus on quality of life and how patients really are doing, whether they're in treatment or after treatment are so important. This one focused on the quality of life of thyroid cancer patients, which I loved because thyroid cancer is considered the good cancer, you don't really consider what can happen with patients who live without a thyroid. And I didn't know what a thyroid was when I was diagnosed with this type of cancer and, and, you know, any bodily function that you can think of the, I feel like the thyroid has a part in playing. And so living without one has really impacted my quality of life in ways that I wouldn't have thought of and ways that were not really described to me when I was diagnosed. And so really focusing on the, on the quality of life of these patients with this type of cancer, I thought it was really important to open the eyes of researchers and pharma and other advocates as to what living with thyroid cancer is really like, as opposed to what the media or, or other organizations or other doctors have termed it as they've termed it as the cancer you would want to get if you were diagnosed. And that is absolutely not true. And so I really appreciated the trial that I was a part of. Janet Kennedy (10:47): I think it's insane that somebody would even use the two words good and cancer in the same phrase. It's an oxymoron that makes no sense whatsoever. Carly Flumer (10:56): Absolutely. Yeah. Janet Kennedy (10:58): What, what exactly were they testing? Were you getting surveys on just how you felt? Was this anything related to a drug specifically, or was it more about surveys and feedback about how your daily life was going? Carly Flumer (11:12): So it was mainly a questionnaire about how daily life was going, the symptoms or the side effects that I experienced. I feel like I have not felt them, or I didn't feel them until after my thyroid was gone because when I was diagnosed, I didn't have any symptoms at the time. And the biomarker and the lab levels that are measured for thyroid were completely normal for me. And so now without a thyroid, I am feeling more tired. My temperature, my body temperature fluctuates a lot. My mood is altered, hair loss. So different things like that, that I wouldn't thought about have started happening as a result. And so I don't think that those are really talked about when a patient is diagnosed, you know, because the majority of treatments for thyroid cancer is removal. And then for some patients who have, metastases including myself as a form of oral radiation, I feel like that encompasses the majority of treatments. And so it feels kind of like it's a one and done thing as opposed to other cancers where they go through chemotherapy and radiation therapy, which may have significantly more harsher side effects. And so when you think about it, outsiders may think, Oh, well, you know, they just had a surgery or quality of life. Must've not been too impacted, but when you're really losing a small gland, a small organ that helps you function on a daily basis, it really does impact how you live. And so I don't have a thyroid. And so I take a medication to replace those hormones that I've lost. However, the medication dosage, which is prescribed by my endocrinologist is based on a bunch of different factors. So it's based on my lab values. And it's also based on how I feel during the past few months or so, it's kind of strange to have a dosage based on that kind of information. It's kind of like a playing with numbers game. I was told that, you know, when the beginning, when they choose the specific dose of what patients mainly take is called Synthroid, when they choose that dosage, when you first come out of treatment, it's really a guess based on your lifestyle, your gender, your age, your weight. And then it's just an up and down system based on how your lab results go over time and how you're feeling over time. So it can take many years to find the dose that's right for the specific patient. And I don't think most people realize that I've been on the same dose for a while now, but that could change at any time, which is why I am checked all the time to get back to your original question. I think focusing on how patients are doing after this type of diagnosis is, is very important because you don't realize how much cancer can impact you, even if the treatment seems simple. Janet Kennedy (14:32): Absolutely. I mean, you've been impacted for the rest of your life. This is something that was part of your daily regimen that you have to deal with. One of the things I hear from patients who have participated in clinical trials or a concern about participating is they've kind of feel like a number, that's great, I'm here, but I don't ever get any feedback about how that turned out was my participation valuable. What if it didn't work? So do you know what happened to the feedback that you gave them in this clinical trial and how it was applied, or are you also in the dark? Carly Flumer (15:10): I am also in the dark with my work. I received the consent forms as well, which are given to patients. And that's more of a lay friendly language based protocol, if you will. That, it's basically what I am doing with my work, but it's physically handed to patients as a form, if you will, which they have to sign saying, I understand what I'm going to be going through with this trial. So the consent forms, I think the majority of them do say, well, I know the results of my research and the majority of them do say no. And I do think that is very frustrating to know whether or not this has affected you, especially if this is a more intense trial, you want to know if something worked or not, or if something was found, because I mean, you are not just a number in this trial. This is your life that's being impacted. And so I think patients do have the right to know what happened in this trial. How did my role in it play a part and creating a greater impact for future patients? Janet Kennedy (16:19): Absolutely because even a trial that does not result in a successful drug launch still has a lot of important learnings. And generally speaking, it tends not to be so much about the drug efficacy. It's about getting enough patients engaged in the trial for a long enough time that they get truly valuable statistical data. Carly Flumer (16:40): Right. The other thing about that is that I feel like health literacy is such an important aspect in clinical trials as well. And I think one of the reasons why clinical trial enrollment is so low nowadays is because patients are not understanding the information that is given to them. And if they don't understand it, then they're not going to want to enroll. And then if these clinical trials, they cost millions of dollars to put on, they end up falling through because they can't get patients. And clinical trials are the way to new drug development and new drug development is how we create better treatments, which is how we create better outcomes. So it's like a rolling ball of catastrophes. If you will, that if something doesn't happen in the beginning, then it just keeps falling through towards the very end where you really cannot find treatments that will create these better outcomes for patients. If you can't get the patients in the door in the first place. And I think one of the nuances that is impacting that is health literacy and just clinical trials being available in general. I feel like most patients don't have, or they don't hear clinical trials as an option. Patients are, I feel like they're given very limited choices when it comes to treatment. But my view is that patients should be given options based on a variety of factors, including their culture, their lifestyle, their financing, because clinical trials can cost a lot of money and just taking into account who the patient really is as a person, rather than seeing them as just a plus one. And that clinical trial, you really have to take into account who they are and their life, because this is their life that they're entering into a trial. It's you don't really hear about how patients are feeling as they go through a trial. You just hear about the results sometimes, maybe even not, not even that. And so I would be really interested in hearing other patients and how they experienced clinical trials and what it was like for them. And how did, how do they even get started? How did they learn about it? Do they hear about it from a doctor? Did they have to be their own advocate and research it for themselves? Were they able to understand the language and what made them want to enroll things like that? Janet Kennedy (19:17): My next question actually pulls that thought together and the situation that we're dealing with right now, which of course is, is COVID-19, and we will be for awhile. As a patient advocate, you are very savvy in social media, you've got your ear to the ground and you're hearing a lot of things. And I have been hearing mixed messages about COVID's response to the awareness of clinical trials. One thing that if there is a good side to COVID, it has been making people aware of the disparity in communities of color or chronic disease and how they're not involved in clinical trials. I think it has raised the opportunity for people to be more aware that they could be participating in clinical trials. Certainly people who have experienced COVID and are providing plasma. So the awareness level to me feels very high. And initially I think there was research that said people were more interested in participating in a clinical trial, but then just a few weeks ago, I saw another survey that said, Nope, no, they were concerned. So your ear to the ground, what are you hearing from the patient communities? Or are you already talking to folks who are pretty much on the advocate scale so they would be engaged anyway? Carly Flumer (20:35): Well, in my work, I have seen many clinical trials that are COVID related come through, and I cannot remember if they were specifically focused on people with health disparities, but I do think that that is incredibly true and important. I think COVID has opened up everybody's eyes into the downfalls of healthcare that need to be worked on including health disparities, where people in rural areas have a harder time getting testing, or they have a harder time finding clinical trials because they don't live near a hospital. And how there are populations such as the African-American community who are affected more because of COVID-19. I feel like that could be the same with cancer it's just talked about more. I think COVID has really opened the healthcare's eyes as if it were a person too, I guess, just everything that is wrong with healthcare and how it can be fixed because healthcare is an ongoing process. It's something that will never end and that's something that can always be improved, but I think COVID has really amped it up. And it's really forcing all aspects of healthcare to really focus on what can we do to make patients better, I guess, at an increased rate, but also focusing on the patient outcomes as well. Janet Kennedy (22:06): I think that's a thoughtful and excellent answer. And I hope as well that we are going to see the tide turn from the standpoint of supporting more communities that are disadvantaged and not getting involved in clinical trials, as well as just raising awareness of it. And I think that also goes back to your point about the importance of health literacy and plain language in what we're trying to share with people. Yes, exactly. Well, I would like to thank you very much for being with me today and to everyone listening. Thank you for hearing this fascinating interview with Carly Flumer on the "People Always, Patients Sometimes" podcast. We look forward to hearing your thoughts about the episode. You can tweet us @Spencerhealth, or just send me an email. jkennedy@spencerhealthsolutions.com. Carly, thanks for being here today. Carly Flumer (22:57): Thank you so much. It was a blast.  

Tom Rhoads (00:03): Welcome to "People Always, Patients Sometimes". I'm Tom Rhodes, CEO of Spencer Health Solutions. Our podcast is focused on many of the thought leaders and executives that are calling for change and how we design and run clinical trials. We have also had patient advocates on the program like Jen Horonjeff, of the Savvy Cooperative, Pam Gavin of NORD and Barby Ingle of the International Pain Foundation. Our mission at Spencer Health Solutions is to ensure that patients are at the center of everything we do. So we are pleased to kick off a series of interviews with more patient advocates, influencers, and organizations that are focused on bringing the patient experience to the forefront of the conversation in healthcare. Kicking off our series is a conversation with Lilly Stairs and leading patient advocate advisor and founder of Patient Authentic. I know you'll find her conversation with Janet Kennedy, as interesting as I did. Janet Kennedy (01:01): "People Always, Patients Sometimes" podcast is about the change agents in healthcare who are focused on patient experience, patient engagement, or disrupting the process of clinical trials to be more patient-centric. Our guest today certainly fits that bill. Lilly Stairs is a nationally recognized patient advocate, speaker, author, and innovator. She has recently founded a new company, Patient Authentic, which I look forward to hearing more about on "People Always, Patients Sometimes." Welcome to the podcast. Lilly! Lilly Stairs (01:33): Thanks so much for having me, Janet. It's always a pleasure to connect with you. Janet Kennedy (01:38): I think entrepreneurship is a big challenge and as a patient advocate where you're already facing a series of your own personal challenges, as well as challenges in the workforce. Wow. What made you think about starting your own company? Lilly Stairs (01:55): Well, Janet, I will also say that I didn't plan to start a company the year that we ended up with a worldwide pandemic, but here we are to add that challenge to the list too. But yeah, I've always had an entrepreneurial spirit. From a very young age, I was always creative and started choreographing for a kids' theater program and took the helm there. And then in high school, I started an anti-bullying program that ended up touring around our local schools in Massachusetts. When I got to college that is when I started my patient advocacy work. And because I was diagnosed with a few different auto-immune diseases I started a campaign to raise awareness about people who were living with auto-immune diseases. There are an estimated 50 million Americans who are living with auto-immune diseases. It was called the 50 cents for 50 million. I have spent most of my career in health tech startups. It just felt right to jump in and take the plunge and make a bet on myself and start Patient Authentic. Janet Kennedy (03:17): I imagine your first 30 days you were feeling pretty euphoric and then February came and you probably started to be a little nervous. So COVID, how has that impacted your life and impacted your work? Lilly Stairs (03:31): Well, I think it's really, and I don't think this is an exaggeration, it's turned my life and everyone's lives upside down. And I, as somebody who is considered high risk because I am immunocompromised due to the medication that I am on, which depresses my immune system to treat my auto-immune diseases is certainly scary and carries a lot of weight. I am fortunate that from a work perspective, all of us in healthcare, I think have been quite busy, which is important. We've stayed busy trying to do what we can to support patients. And so from a work perspective, all has been really good. It's just that we've got a lot of COVID focused projects now. And then from a personal perspective, I think that honestly, it's been hard because it's isolating and I think a lot of people are feeling that, and there's always the fear that people are not taking it seriously enough, especially as someone who is high risk. Janet Kennedy (04:30): I understand totally what your experience is. Like my two nieces are in New York City who works at Trader Joe's and unfortunately, the misapprehensions and the willful lack of understanding is really frightening for them. One of them actually did get COVID, was fortunate that it felt like the flu, and got over it, but then found out later she had definitely had it. It has changed everything in our lives. So I'm curious as a patient advocate, and I know you are talking to patients constantly, what is the general mood among the folks that you're talking to? Are they finding that this is an incredibly scary time or are they finding that even the discussion of "at-risk" is raising awareness and making people a little more sensitive or empathetic to folks who have challenges? Lilly Stairs (05:27): Well, I have to say, I think it's a mix. And I would say generally speaking patient communities across their pubic areas have certainly been vocal about concerns that people are not taking COVID seriously enough. And I think that there are some really baseline things that everybody could be doing, like wearing a mask that would put a lot of those fears at ease. I will say warranted fears because for some contracting COVID is really a death sentence when you are somebody who's high risk. I'll be honest in saying that for me personally, I live in balance. I live in breathe and balance. That's how I operate. And for me, I've been cautiously optimistic and I'm cautious in living my life. So I don't just sit at home. I will go out, I wear a mask, but I'll go do outdoor dining in Boston. We have some awesome outdoor dining and, you know, see friends at a socially distant level because I think what we're seeing with this pandemic is a mental health pandemic kicking in because so many people are struggling with the isolation and the loneliness. So I try to weigh that out. And I think that a lot of other people in the community do that too. And it's really just about finding that mix of being safe and taking care of yourself. Janet Kennedy (06:50): I agree very wise words. Now let's back up a little bit and talk about Patient Authentic. I don't know what your company is doing. So tell me a little bit about it. Lilly Stairs (07:01): Absolutely. Well, you know, Janet, I think that I'm still learning what my company is doing and I don't know if I should be saying that, but here we are. Because I think it's evolved so much since I started in January. And a lot of that is largely because of COVID, but also because I've just ended up in places I didn't expect. And so the way that I like to talk about Patient Authentic is that it is a hybrid of healthcare marketing and patient advocacy. So all of my work is grounded in developing patient-centric deliverables alongside patients. And I'll talk to you about a few projects I'm working on just to give you a flavor of what it is that I'm doing at Patient Authentic. So I am leading patient advocacy for a health tech company and that's Clara Health, which is in the clinical trials space. Lilly Stairs (07:50): And I know that Spencer does quite a bit of work there too. I am developing and running a social media campaign with oncology patient influencers to promote a nutritional supplement, which helps to aid in the healing of mouth sores that have been developed from chemo and radiation. So out of that, we've developed the hashtag #MoreThanASore campaign, which is all about how sores are so much more than just a sore and they really impact the quality of life. And so there's the marketing in me coming out through that campaign. And then, you know, I'm working with some patient advocacy groups as well. So I'm building a masterclass to help train patients from across therapeutic areas and how they can be effective advocates on a policy level. So on Capitol Hill and at FDA advisory committees. Finally, I'm also supporting the development of a COVID-19 resource hub for the transplant patient community. My projects span across therapeutic areas and they are focused, at the heart of them, they are working with patients to create something, Janet Kennedy (08:56): Oh, that's excellent. Now, is this a single consultancy? Or do you have other patient advocates that you will bring in to support some of these projects? Lilly Stairs (09:04): Primarily it's a single consultancy, but I do often bring in patients who are paid because patients should always be paid to support the work. Janet Kennedy (09:14): I totally agree. Well, let's talk a little bit about some of the work that you've done in the past and hopefully in the future related to clinical trials, have you ever participated in a clinical trial as a patient? Lilly Stairs (09:29): I participated in a study that was through my gastroenterologist for my Crohn's disease. And it happened right when I was in the office and it was quick as could be. My gastro said, "Hey, I'm working on this study. We're trying to measure the levels in the liver because the liver is often impacted by treatments." And so I agreed to do it. And it happened all in the same office visit. It was the most convenient clinical trial experience I've ever had. Did the informed consent, all there. Probably happened in 20 minutes Janet Kennedy (10:08): Now from a standpoint of your work as a patient advocate and being around the clinical trial space and helping support companies and organizations that are involved in clinical trials. I want you to put your hat on as a patient advocate. If you were to point out one or two things that are really kind of a roadblock for patients in participating successfully in a clinical trial, regardless of whether the clinical trial is a success, what do you think are the challenges that patients face that the pharma companies, CROs and physicians that are involved in research need to be thinking more about? Lilly Stairs (10:48): I'm just going to pick two - there's a lot. And so two is tough for me to do, but I will do it. I still think that awareness and myth-busting. As much as we talk about it in our community, I think that in the professionals and the clinical trial space, we talk a lot about this, but we aren't reaching the right people. It's still a huge issue. There's still so much misunderstanding about clinical trials and risk associated with them. And am I going to get the placebo? So many questions that really plague the everyday patient when we think about clinical trials. And so I think we have a lot more work to do there. And part of the solution to me is that we need to have more people working together to raise awareness and to get into communities. And so we can't be all working in silos because we continue to work in silos. Lilly Stairs (11:45): We need to work together. That's one piece. The other big barrier that I have seen is honestly, the travel and the distance piece. There are a lot of patients who actually do want to participate in clinical trials, but they are restricted because it is too far for them to travel. And they can't either, you know, financially afford it because the trial is not going to cover the cost of travel, or it's just, it's a distance thing. And they are not well enough to travel. And I can point to through my work with all of the different companies I've worked with, I can point to so many patients from across therapeutic areas that have had this experience. Lilly Stairs (12:28): So I was recently speaking with a woman who was in a breast cancer trial. First of all, her physician didn't even bring up clinical trials to her, which is a problem in and of itself. She did the research on her own and she ended up traveling from the East coast to the West coast for a clinical trial. And she had to do a GoFundMe so that she could raise the money. And she ended up having to drop out of the trial because the GoFundMe only got her so far. So we have patients who are willing to participate in trials, but we're not making it convenient for them. I would say that we need to branch out outside of some of these research hospitals. We also need to, if we can't do that, build money into the budget to help the patients get there in a comfortable manner. Janet Kennedy (13:14): So is the challenge that a lot of the research hospitals are in major metro areas, and if you don't live in New York or Boston or Atlanta or Los Angeles, you're going to miss out on an opportunity. Lilly Stairs (13:26): Yes. Precisely. Janet Kennedy (13:29): All right. Well, what would solve some of those problems? Lilly Stairs (13:33): Again, travel, being able to provide stipends for travel and not just like a $25 Uber, if somebody lives out of state, but they're really willing to participate in the trial. What can you do to facilitate accommodations, to cover the flight, to cover the hotel room? Because I'll tell you something working in the recruitment space, you're going to spend a lot more money trying to recruit patients that are nearby. Versus if you just foot the bill for flying someone out, getting them a hotel room who's eager and willing to participate. So that's one piece. And then also, I think we need to be raising more awareness within some of these community hospitals too so that physicians within community hospitals can refer out to some of the major research institutions. Because again, this is where the awareness piece comes in. There's a lack of awareness and understanding about trials. So patients don't even know they exist in the first place. Janet Kennedy (14:31): So raising awareness is a real key. Now, how are patients finding out about things? They suddenly find out they have a disease and they're just going online and doing a search and then whatever pops up pops up. Lilly Stairs (14:44): I think that online is of course a huge space. I mean, I would guess I, I won't put a statistic because I'm sure I won't be accurate, but everyone's going to Google. Everyone goes to Doctor Google. And I think that the patient advocacy organizations play a role. But I will say that we are seeing patient influencers or individual advocates are becoming more and more prominent in being the trusted go-to resource for sort of your everyday patient. So these are the patients who are sharing their stories on Instagram and TicTok now and Twitter, and they have blogs. They're on YouTube. That's where patients are going because they're able to get that sort of one-to-one support and really hear from somebody who understands them. So I've been trying to really push companies, pharmaceutical companies, biotech companies, CROs, to engage not only with the patient advocacy organizations but also with some of these patient influencers and advocates who are out there and working to fight the good fight and raise awareness. Janet Kennedy (15:49): You know, a few years ago, patient advocates were not that seen, were not that present. And I think as social media has become really an essential part of our lives, patients are realizing that there's real power there. However, there's also the challenge of my gosh, you have a chronic illness, or you have a disease that is very debilitating and social media in many ways, demands that you're up, that you are being positive, that you're being optimistic. How would you balance being someone with a chronic illness or a disease that really makes you feel bad? And these social platforms that sort of demand a much more upbeat presentation of yourself. Lilly Stairs (16:34): That's a great question. And I think it's something that's so many advocates struggle with because when you become a patient advocate and you make the decision to share your story, you're often the type of person who wants to do better and to help others, right? You're out there because you want to support other people and help them not feel like they're alone. And that can become emotionally demanding and physically demanding. Even when, especially when you are going through it in the auto-immune space, what we would call it a flare. So when you are really not well and your disease is under control. And so it's a matter of learning to say no, and to set boundaries. And so I've seen a lot of patients artfully do this, where they say, you know what, I'm turning off the comments on my Instagram because I cannot be every single person's support system. I can put this out into the world and I can try to help them, but I can't possibly respond to every single person because it's too taxing on me. And you know, some maybe sometimes you have your comments on maybe sometimes you have it off, but it's little changes and tweaks like that to help ensure that you're taking care of yourself while you're taking care of others. Janet Kennedy (17:41): I know you mentioned earlier that you're actually doing a course for patient advocates on how to use social media. There are so many platforms now, how are you focusing their energy? When I coach about social media, my advice is you can't do it all. So pick a few and do it well. But I do see some patient advocates with a lot of social platforms going on at the same time. Lilly Stairs (18:06): Oh yeah. It's hard to do. I agree with you, Janet, that picking one or two and focusing on those and making them really great is also my piece of advice. It also feels less overwhelming. I was just giving a keynote at the One Rare young adult's virtual summit. It was their first annual one. Rarer is an amazing organization run by Jen McNary. And so I highly recommend checking them out. It's a rare disease organization for young adults, but we were talking about career planning and how you build your brand as an advocate. And again, one of my key pieces of advice was to pick one platform so that you don't get overwhelmed. And so that you are not emotionally and physically drained and also pick some platforms to have that are private, that is just for you and your friends. I'm really active on Twitter professionally, but I have my Instagram private and closed so that I can just feel comfortable sharing what I want to share there and not feel like I always have to be on. Janet Kennedy (19:05): It is a huge challenge in social media and one that demands the ongoing feeding of the beast. However, do you think you can take a break from social and come back and not lose your audience? Lilly Stairs (19:18): Oh, 100%. Absolutely. If you need to take a hiatus, you can. And I think that what's interesting is that especially in the patient community, people are very forgiving of that because they know exactly what you're going through. And so they understand that it can be really taxing to have to be on all the time and they'll miss you while you're gone, but they'll be just thrilled that you've come back, Janet Kennedy (19:41): Circling back to Patient Authentic and what you had originally intended to be before COVID came. Where did you think that the company was going to take you and what were you hoping to accomplish? Lilly Stairs (19:54): Honestly, what I wanted to do, is still there. And that is to build and work on meaningful projects that support the patient community and make you move the needle in healthcare. And so I am doing that. It's just a bit of a different one than I thought. Because of my background in marketing, I always envisioned that every single thing I worked on was going to be super campaign driven. And now I find that I'm doing a little bit of strategy here, a little bit of project management, a little bit of advocacy engagement. So if anything, it's really more fitting for me because I tend to be the type of person who loves to work on a lot of different things at once. It's very rewarding for me to be able to leverage a lot of my different skills to help better the community. The opportunity to work, not only health tech and biotech and pharma, but also to work with some of these patient advocacy organizations who are really at the ground level fighting the good fight. Janet Kennedy (20:59): Oh, well, that's a great note to end on. So Lilly, tell people how they can find you. Lilly Stairs (21:04): Yes. So you can find a, learn more about Patient Authentic at www.patientauthentic.com. You can find me on Twitter @LillyStairs. You can find Patient Authentic on Instagram @PatientAuthentic. Janet Kennedy (21:24): That's excellent. Well, I can't thank you enough for being here, Lilly and I look forward to hearing more about some of the new programs and projects you're going to be involved in, in 2021. Lilly Stairs (21:35): Thanks for having me, Janet. Janet Kennedy (21:38): Thank you for listening to our interview with Lilly Stairs, founder of Patient Authentic on the "People Always, Patients Sometimes" podcast. We look forward to hearing your thoughts about the episode. You can tweet us @spencerhealth or send me an email at jkennedy@spencerhealthsolutions.com.

Janet Kennedy, VP, North America Regions, Google Cloud joins this episode to discuss how Google is helping customers transform on the edge of technology, being a female leader and cultivating a culture of diversity in tech, and the new Next OnAir digital format. Host: Tony SafoianGuest: Janet Kennedy Connect on Twitter:https://twitter.com/cloudnclear https://twitter.com/SADAhttps://twitter.com/Safoian Connect on LinkedIn:https://www.linkedin.com/company/sada/ https://www.linkedin.com/in/safoian/ https://www.linkedin.com/in/kennedyjanet/ To learn more, visit SADA.com.

The National Organization of Rare Disorders has been helping patients, caregivers, organizations, researchers, and Clinicians for almost 40 years. Introduction by Tom Rhoads (00:02): There are over 300 million people living with one or more of over 6,000 identified, rare diseases around the world. A disease defined as rare in Europe affects fewer than one in 2000 people. Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Hi, I'm Tom Rhodes, CEO of Spencer Health Solutions. We are honored to have a special guest from the rare disease community on the "People Always, Patients Sometimes" podcast. Pamela Gavin is a Chief Strategy Officer for the National Organization for Rare Disorders. NORD has been educating, supporting, advocating, and building a community for the rare disease community for over 38 years. I know you'll enjoy learning more about NORD on the "People Always, Patients Sometimes" podcast. Janet Kennedy (00:56): Hi, my name is Janet Kennedy and I am your host for "People Always, Patients Sometimes," a production of Spencer Health Solutions. We have invited Pamela Gavin, Chief Strategy Officer of NORD, the National Organization for Rare Disorders to join our podcast. Patients with rare disorders often are overlooked by clinical research and drug developers, or have histories of misdiagnoses. Now that Coronavirus is impacting the globe and awareness of the fragility of persons with rare diseases is triggering teachable moments for all of us. Let's dive in! Welcome to "People Always, Patients Sometimes," Pam!   Pamela Gavin (01:33): Thank you, Janet. Great to speak with you today. Janet Kennedy (01:36): I am so fascinated by your organization. I had no idea that literally there were hundreds and hundreds of rare diseases that you all are tracking and cataloging through your organization. Pamela Gavin (01:49): Yes, it's an amazing, exciting time within the field of rare diseases. We have over 7,000 known, identified rare diseases in the world today. And so NORD as patient advocacy organization supports all of them and the work that we do. Janet Kennedy (02:08): Can you tell me a little bit more about NORD itself and how it's structured? Is this an organization that provides information to people or are you proactive in helping resolve and learn and educate people about the diseases? Pamela Gavin (02:24): So we do some of both of those things and an organization established by patients and caregivers and advocates over 37 years ago, for some of the very things that you mentioned in starting your podcast introduction. And that is to advocate for improvements in it, interest in job development, device development, medical care, and services for people with rare conditions because very little was being done in the field. It was very hard to make it work economically for companies and researchers to study rare diseases because the patient populations were so small, but people were suffering tremendously. Pamela Gavin (03:04): So the community, the patient advocates got together and pushed for legislation that ultimately led to the Orphan Drug Act being passed in 1983. And that legislation established financial incentives for those to do research and study and develop products for people with rare conditions, the majority of which even today still live with a disease for which there are no FDA approved treatments. So we advocate for change. We advocate for people living with rare conditions to have access to proper diagnosis, treatment, and care so that they can live their very best life. We advocate for an environment that promotes research and innovation and fairness and equity across the entire community. As part of that advocacy work to promote access to that which is necessary for people to live their best life. We also do a lot of education to collaborate with organizations across the rare disease spectrum. Many of which are members of NORD, other advocacy organizations to educate people, clinicians about rare diseases. We also educate advocates so that they could advocate on their own behalf. Janet Kennedy (04:23): I'm thinking back to when you were founded 37 years ago, and there's no internet there. So I can't imagine how hard it must have been for patients with a rare disease to find other patients with rare disease. It must have been like living in a cave to feel so alone and to feel like they're so unique that nobody cared about them. Pamela Gavin (04:48): They could live their whole lives without meeting somebody with the same condition. You're absolutely right. Janet, the isolation is just an incredible challenge for people to live with such a burden. I can speak personally from my own family's experience, having grown up part of my professional career without the internet, certainly the beginning of it. And now knowing not only that we have the internet, but all the amazing tools to connect people together, to communicate with one another, to bridge people across many, many boundaries across the world. So there still is isolation today, but it wasn't seemingly hard to connect to people. I can remember the first time we saw a newspaper article where there was a story about somebody with a rare genetic condition that was similar to what my nephew had. And it was as if that piece of paper that photograph trying to connect to that community. It was so impactful and so meaningful. Now we don't have to fax things over a fax machine or try to find a phone number by looking in a yellow pages or white pages or calling institutions and calling and calling and calling until you found someone who may know somebody, a family, you sit at your computer or on your cell phone and start searching. Janet Kennedy (06:10): And sometimes you're looking across States across the country, across the globe to find other people with similar conditions. Pamela Gavin (06:18): Absolutely, absolutely. And we work with organizations like ours across the globe. It's a privilege and an honor to represent the rare disease patient and caregiver community. As we try to unite ourselves across the globe. Janet Kennedy (06:35): Let me ask you a question about your organization. It is made up of other organizations that support a very specific rare disease for instance, but do you also support individuals for whom there is no support organization? Pamela Gavin (06:52): That's exactly right. NORD represents all rare diseases that are known. So we work in collaboration with organizations that exist for those diseases that are known. And then if there is no organizational representation, NORD tries its best to fill that gap and representing those communities as well. Janet Kennedy (07:12): Before we move on to discussion of patients and clinical trials, I'd love to know a little bit more about your history and how did you end up at NORD? Pamela Gavin (07:21): It certainly was not a planned professional path. I started my career working in healthcare. I at first wanted to be a clinician. I wanted to be a physician and ended up finding myself, getting involved in healthcare information systems, technology really fascinated by the opportunity to leverage technology, to improve healthcare delivery, healthcare decision making, and the experience for patients so that they had better outcomes. And I was intrigued by the impact that technology could have disruptive in a positive way to empower clinicians, to make better decisions, to have better information, better tools, equipped to do their job better. And so that's really where I started to focus. I ultimately found myself evolving into an advocacy role because of personal experiences. I had members of my family to be involved in medical errors. So I got involved in advocacy for improvements in patient safety and clinical care safety. Pamela Gavin (08:32): And then that led to getting involved in rare diseases. My brother's first son, my nephew, Trevor was born with metachromatic leukodystrophy. Although we didn't know it right away, they took some time for it to be diagnosed. And this is right when the internet was really beginning to be used predominantly for academic and for business to business purposes. So to your point about isolation, I saw that firsthand. We're a pretty close family. And so we all supported my brother and my sister in law through this journey. But one of the first organizations that they were introduced to once they finally got this devastating diagnosis, the disease for which there was no cure and was going to take my nephew over very over a period of time was the national organization for rare disorders. And I remember what it meant to be able to talk to somebody that knew something about what was taking place in our lives. Pamela Gavin (09:31): And NORD connected my brother and sister law in particular to medical information and to clinicians and researchers that were working in the field. So even though there was no treatment or cure and the outcome was going to be inevitably devastating to know that there were people working on, it provided some comfort. So that's how I was first introduced to NORD many, many years later, an opportunity to join the organization came about where I was really marrying my work in healthcare information technology and data and supporting improvements in clinical outcomes. Marrying that with my rare disease experience, I feel very privileged to have this opportunity to work in this space, representing the community and helping to make a difference for those who today live with a rare disease or love or care for someone with a rare condition in the US. Janet Kennedy (10:35): I think that's such an important thing is to have passion for the work you do. And in your case, it's well, really a job. You can never leave, but it sounds like it's a job that also sustains you. Pamela Gavin (10:49): Thank you for describing it that way. I think you are spot on. It is one I could never leave. If I were to ever be working someplace other than NORD, I'd still be passionately connected to the community and concerned about its wellbeing and progress. I could meet anyone with a rare disease or connected to a rare disease, and it doesn't have to be metachromatic leukodystrophy. And I feel connected to that person or persons, but I do feel lucky. I feel very lucky to be able to do this work. Janet Kennedy (11:19): Tell me a little bit about your role as the strategy leader for the organization. What does that mean? And one of my side questions is - you're supposed to be involved in strategy, which should be three, five, 10-year plans. And suddenly COVID-19 comes around. Did your strategy get blown out of the water? And you're having to rethink a lot of things? Pamela Gavin (11:39): So as Chief strategy officer at NORD, I have the privilege to work with members of the community, our board of directors, our scientific and medical advisory committee, our other committees, as well as our staff, other stakeholders that we collaborate with to as you said, look to the future to ensure that we are planning for and evolving and changing to meet the needs of the community in the future from the patient and caregiver perspective. Clearly COVID-19 has had a dramatic impact on the entire community and, and the organizations that operate in this space, including NORD. We are still looking out for the future, but we certainly had to deliver a lot of immediate resources to address the needs of the community, where we could, where it made sense for us to do so around education resources, to help people financially get over hurdles that were completely unexpected. I certainly don't have to tell you that this is a virus of epic proportions, not really anything we could prepare for. Pamela Gavin (12:52): And so we had to stop some of our earlier work in the beginning of 2020 on strategic planning and divert some of those resources to rapid response programs for our member organizations to help raise money to seed money. So they could stay afloat webinars where we brought clinical scientific experts, psychologists, psychiatrists, geneticists, telemedicine, experts, you name it, a variety of people into our community. Through webinars. We did some surveys early on to try to understand what people were thinking of, where they were being impacted. And then some of our existing programs where we help patients logistically get to clinical trials. Some of those were impacted early on. So we definitely put a pause on some of our and immediate quarter, one quarter, two work to ensure that we could pivot quickly to meet the needs of the community because they were hurting. Janet Kennedy (13:53): Based on what we've all seen in social media, it seems as though there are people who really don't understand the terms, high-risk immunocompromised, people who are at risk in regard to reacting to COVID and the persistence of some people to not understand the importance of wearing a mask and implications for this particular population is really rather astounding to me. Has NORD been challenged to help educate the folks who are not really aware of how large this community is and how serious the implications are of not wearing a mask during COVID? Pamela Gavin (14:35): We certainly, you know, work to promote the guidelines that have been put out by the government and promoting, for example, the CDC guidelines and wearing a mask. And we have been promoting our member organizations who have doing that, especially those diseases for which patients are immunocompromised, but it's been a challenge not uniformly across the country, but it's definitely been a challenge nor has had staff working remotely before. COVID-19 clearly all our staff are working remotely. Now we have offices in the Connecticut area, New York area. So we were early on involved in the first epicenter. So we saw the impact and participated in adopting the guidelines. So we were able to promote those best practices by virtue of the fact that they were supported by the federal government, as well as the local state governments, where we actually had offices. So we saw it firsthand. We have an office in the Boston area, not too far from where you probably heard about the Biogen conference. Pamela Gavin (15:47): And so we were very sensitive to what was happening early on in the country around COVID-19 and some of the early epicenters. So I think we were tuned to it from the very beginning and we've promoted the use of masks. You know, we have staff with rare conditions. We have loved ones with that are immunocompromised, some of which are rare and some of which are not rare. So we promote from within and from personal knowledge and experience, but it's concerning to the entire community that this is not something that is necessarily has been adopted across the country as early on, as we would have liked. Janet Kennedy (16:25): Let's pivot for a second. I'd like to talk to you about NORDs involvement in clinical trials. Do you actually have any kind of funding for programs or are you more about facilitating the conversations that could start clinical trial discovery? Pamela Gavin (16:42): Much of our work tends to be early on in that we raise money for researchers who are looking for seed grants to get them from one phase to the other potentially, or get some of their work over a hump. Our seed grants are about $50,000. So not nearly enough to operate large, expensive clinical trials. We also provide resources and tools and support to help patient organizations who want to establish natural history studies. And those may lead to clinical trials or may help inform the design of clinical trials. So we're very much involved in the peripheral activities or the early supporting activities that may lead to clinical trials. But with clinical trials themselves often conducted by industry stakeholders. We will work with them and CROs to help operationalize trials by working on the logistics side. So to help reduce the burden to patients and families, we will help them with their travel arrangements. We will help them with their costs associated with their participation in the child. And we'll also work to help promote trials and inform people of trials to help with trial recruitment. We're doing a lot in that ecosystem if you will, but we don't conduct the clinical trials ourselves. Janet Kennedy (18:09): I would imagine it'd be very difficult for you to pick one rare disease to focus on. Pamela Gavin (18:16): Yes, they care about them all. That would be a hard decision that's like saying I love one child more than the other, picking a favorite child. Janet Kennedy (18:30): Within your organization do you have the opportunity for patients to actually talk to each other? Do you have a platform for them to engage anonymously or otherwise with people of a similar disorder? Pamela Gavin (18:43): We did have a platform called rare connect that we worked with our colleagues in Europe. Over time, that platform, it was hard for us to participate and continue to support it financially and the different languages and folks tended to gravitate to the more commercial robust platforms like Facebook. So a lot of the direct communication amongst patients are with platforms like that. We'll connect people in other ways to augment that we have meant that by bringing people together around perhaps their educational needs, where we have a patient and caregiver annual forum, and this year it's virtual, it's called living rare living stronger forum, where we bring patients and caregivers, family members together, and they could be a various backgrounds, different diseases represented. Pamela Gavin (19:41): Some of them may be strong policy advocates. Some of them may be, have different areas of interest, but we bring them together. We also bring together clinicians that are providing educational opportunities. They bring their experiences and really trying to provide resources so that people can feel stronger, more empowered to live a better life, and have more successful opportunities to engage in the community, share their experiences, develop friendships, relationships with people. And we were doing this by bringing people physically together and we rotate around the country a different place each year. So we were supposed to be in Cleveland this past year, this past may and said, we're going to do it virtually in a couple of weeks in July. And we're going to go back to Cleveland next year. And we end our event with an annual award ceremony where we, and this has been part of NORD's history since I can't remember over 25 years, where we bring researchers, academics, patients, patient advocates, organizations, members of industry, government, federal, state policymakers, together to celebrate the successes of the previous year. So we will do it virtually this year. And we'll go back to Cleveland and the Rock and Roll Hall of Fame next year. Janet Kennedy (21:12): Oh, well, rock on. That's all I can say. Well, Pam, I can't tell you how important I think your work is and how proud I am of the whole organization. The amount of services and activities, information that you all have is really quite astounding. And let me ask you this. If somebody wanted to be more engaged, whether they are an individual person or they represent an organization, is there a place for them at NORD? Pamela Gavin (21:43): Absolutely. At both of those levels, there is, there's always a place there's so much opportunity, so much to do so much positive energy and opportunity to bridge gaps that exist in the community. And we'll find something for everyone to get involved in. So they shouldn't hesitate to reach out to us. Our website has forums where people can submit questions, comments, requests, or they could call our main number, which will route you to the right department program or project within the NORD. Janet Kennedy (22:15): That's excellent. All right. We'll be sure to have the links to the website and your social media properties in the show notes. So I encourage everybody to please check that out so you can find the links to both Pamela as well as all the organization social media platforms, Pam, I thank you so much for being here for "People Always, Patients Sometimes." It was a great pleasure to talk with you. Pamela Gavin (22:40): It's been my pleasure. Thank you, Janet. Safe and healthy. Connect with Pamela and NORD LinkedIn Website Twitter NORDpod (NORD's own podcast hosted by Matthew Zachary Facebook Instagram

The pandemic has sent our sleep patterns into a spiral. Many are having trouble sleeping, while others are having incredibly vivid dreams. Pat Kiernan, Annika Pergament, and Jamie Stelter speak with psychologist and sleep expert Dr. Janet Kennedy about how COVID anxieties are slipping into our sleep. IMPORTANT LINKS Learn more about “One New York,” our resources, and ways to show your support: http://ny1.com/onenewyork Get the latest Coronavirus news and updates: http://ny1.com/coronavirus Join the conversation, ask questions, or share your photos, videos, and notes using #OneNewYork If you like what your hear, share this podcast with your friends and family—it’s free for all New Yorkers and beyond. Leave us a rating and review where ever you listen.

Introduction by Tom Rhoads, CEO Spencer Health Solutions (00:03): This past January, I had the pleasure to speak at the open innovation and health event at the JP Morgan healthcare conference. The event was sponsored by Mount Sinai Innovation, Ogilvy Consulting and Humble Ventures. Our panel discussed the consumerization of healthcare delivery, which was led by Ritesh Patel, Chief Digital Officer of Health at Ogilvy Consulting. Ritesh is an amazing thought leader in the digital health space and has been kind enough to accept our invitation, to be a guest on our podcast. And frankly provide is timely healthcare insights who could have known then the dramatic changes we've experienced over the last six months in healthcare. Simply remarkable. I hope you enjoy this conversation between Ritesh Patel and our senior digital brand manager, Janet Kennedy on the "People Always, Patients Sometimes" podcast. Janet Kennedy (00:52): Welcome to people, always patient, sometimes a podcast production of Spencer Health Solutions. Healthcare has come to a crossroads and it's time to start listening to new ideas. That challenge are always done it that way, thinking we hope you enjoy our conversations with the disruptors, the innovators and the transformers in clinical trials in healthcare. My name is Janet Kennedy and with me today is Ritesh Patel. He's the chief digital officer for health at Ogilvy Consulting. Welcome to the podcast, Ritesh. Ritesh Patel (01:22): Thank you, Janet. Thanks for having me. I hope you're having a good morning. Janet Kennedy (01:26): Everything is going great here a little bit rainy, but uh, I'm very happy to have that. Ritesh Patel (01:31): Absolutely. Janet Kennedy (01:33): We've had a chance to run into each other. A number of times in social also engaging in the digital medicine society, which I find the Slack channel to be very, very engaging and very full of exciting people wanting to do new things. Ritesh Patel (01:49): Yeah. You know, I was funny when, when I first became a member and got invited to be a member of it, I thought, Hmm, that's an interesting way of engaging with your membership using Slack, but I'll tell you what you're absolutely right. It's a fantastic tool. And a lot of other member or societies should really look at that because the engagement level is fantastic. There's so many ideas being exchanged, people, helping each other announcements being made. I think it's a really smart move by the Dime Society to do that. So I'm very impressed. Janet Kennedy (02:23): I have used Slack for a couple of other organizations and companies that I've been in. And I constantly am surprised when people are like, Oh, just text me. You know, it's a conversation that just gets lost. It's very hard to have a group text with anybody and not drive folks crazy. And you are pushed by text, whereas Slack, you can engage with at your own pace and at your own level. So I don't know why they would prefer that, but I love the way Slack has enabled me for instance, to meet and engage with folks. And in our case to reengage after podcast interview over four years ago. Ritesh Patel (03:02): I know. We use Slack as a collaboration tool for Ogilvy Consulting for many years now. With the youngsters that we have coming in from universities, they're used to that. They're not used to us old fogies using email and mainly email. So it was interesting for me, and eye opening society would use it the way that are using it. It's very well done. Janet Kennedy (03:26): Well, I think the other interesting thing about the Digital Medicine Society is you don't join as your brand or company. You join as a person and everybody in essence is equal because it's only $50 to join. And it's an individual membership and you may or may not be speaking on behalf of your company. If you want to innovate, you can come in there and be part of the conversation. Ritesh Patel (03:47): Yeah, exactly. Exactly. I love it. Open Innovation in Health Pop Up on Sunday 12 Jan 2020 in San Francisco, CA, USA. Janet Kennedy (03:50): Well, let me ask a little bit about Ogilvy Consulting for the folks who don't mind for the folks who don't know. Do you mind giving folks a little elevator pitch on what Ogilvy Consulting is? Ritesh Patel (04:01): Certainly. About seven years ago, we noticed that the big consulting companies like Accenture and Deloitte are getting into the creative agency space and buying up agencies. I think Accenture Interactive is huge now because they've acquired so many interactive digital agencies. And so we, as Ogilvy, with our deep 75-year heritage of advertising decided to get into the consulting world. We wanted to make sure we could claim an area because of the brand Ogilvy to help our clients with. And it's really around brand customer experience and positioning in this new digital world that you're living in. So three years ago, it was all about digital transformation. And what we would do is say, well, that's all good. You're transforming your business, but how does your brand fit into that? How are customers experiencing your brand or your products or your service in that digital world, you may be transforming internally, but there is an impact that it has on the revenue that's being generated. Ritesh Patel (05:02): So that's what we focus on. We have a, quite a large group of folks around the world 400 or so that do that for big brands, as well as healthcare where I sort of read on the digital health practice is what can we do from that perspective, if you're a pharma company or a health system or a payer or a medical device company, we're doing a lot of work in that area that way. Janet Kennedy (05:26): And I understand that the work you do is also very collaborative. It isn't Ogilvy coming in to do strategy and we'll do all these other pieces for you. What you're actually doing is basically "cat herding". Ritesh Patel (05:39): You know, a lot of the times one client we're working with a global pharma company where we're creating a digital business framework, et cetera. We then work with, you know, I think they have you name it. They have McKinsey in there, Cognizant in there, Wipro in there, Accenture in there 80 in there. And then on the agency side, they have 13 different agencies they work with. And we're the Switzerland in the middle of that basically works with the business units to create all these things. And then we educate the agencies and the partners to say, this is how we need to operationalize this. So we're very much focused on what is that you're trying to achieve, how will it get achieved? And then who are the players we can help you get there. And that's not necessarily Ogilvy on the sign. Janet Kennedy (06:25): I'm curious about brand with a pharma company because some people may know a drug name better than they know the pharma company when drugs are being designed. And they're going through the naming process and the logo design process. Do they take a lead from the corporate branding or did they view each of these drugs as independent brands? Ritesh Patel (06:47): Well, I don't know if you know, it's a little secret here in the U S that there's only two companies that have the market for naming drugs, that they split between them 50/50, and it's all around the product. It's never around the parents. It's never around, it's a Pfizer products or Novartis products or a Merck product. It's all around the molecule and the medicine. And there's some taxonomy that's been created as a gentleman's agreement between the two organizations that they adhere to and the scientists adhere to. But, you know, I think Inventive owned one of those companies back when I used to work for Inventive that did that naming and they actually, they were based in Raleigh. Actually, if I'm not mistaken, I have to look them up. Now my brain is as melted around all that, but I think most cases, they look at it from the product, never the parents. Janet Kennedy (07:38): That is absolutely fascinating. And I learned my something new today. So I definitely want to find out more about that. That's awesome. Well, I know one of the things Ogilvy Consulting has been doing is some big thought leadership programs from an in-person program at the JP Morgan pre event, where my CEO, Tom Rhodes, was able to participate to a whole series of webinars that you've been doing. Tell me a little bit about how you go about selecting what you're going to be talking about and what are you getting out of these webinars, Ritesh Patel (08:12): I'll take those industries. So the first one is sort of how do we select we select based on what's happening. There's not a sort of a global annual content calendar we create. It really is around what is the interest in? And do we have enough thought leader capability or partners or people we know we can reach out to, to pull that together. And so recently you've seen an uptake on the webinar simply because we're seeing a huge amount of interest from our clients on the topics that we've covered so far. The first one we did was around the open data walls. You know, CMS announced the open data rules and interoperability rules that people like Epic were fighting for a bit and the President signed them into law not too long ago. So there was a huge amount of interest from a lot of our clients. What does that do for me? And what's the impact on my business? We thought it'd be good to bring some people together who knew about that stuff so they can get into the nitty gritty of it a little bit. So that was then, and similarly, the next one was around virtual trials, huge amounts of interest in virtual decentralized trials because clinical trials have come to a bit of a grinding halt since the pandemic. And so what can we do? I was getting frustrated because I was attending a number of these, whether it was all about the technologies, it really wasn't about how do you do this and what are the pitfalls like, really, if you're going to go do this, it's not just a matter of putting some remote patient monitoring tools in the patient's hands and digitizing the investigator. There's a huge amount of change that has to occur. So we brought some people together who are doing that at the cliff face, like Moe, from Boehringer and Craig from Pfizer, or formally from Pfizer to impart their knowledge about what you need to think about. If you're going to go down this route. And the same thing, patient centricity, we've been hearing the worst patient centricity from our healthcare pharma clients for 10 years. Now, everybody says the words, but what really does it mean? And how are you going to actually make it happen? And with the pandemic, everybody's even amplified the patient centricity verbiage, but nobody's really doing anything about it by things like, including patients in the trial design or including patients and figuring out how you can engage in a trial or how you discover a trial, or what do you do if you want to enroll in one or whatever. The rare disease community has figured it out a little bit, but in general, they haven't. Ritesh Patel (10:41): So we said, you know what? Let's bring some people together around that. So that's how we sort of have been putting them together this year. And then on the, on the popup side, it really is around innovation. We wanted to, one of the biggest issues I have is when I call people to see how, if I can help the word Ogilvy qualitate in their mind an ad agency, we really needed to reposition Ogilvy Consulting in the marketplace, particularly within the healthcare environment, as the consulting organization that can help you think through these hard problems from a digital perspective. So that's how we started doing those innovation popups. And it's really around positioning, Ogilvy Consulting as the guys to come to. If you're really thinking about some of these challenging things, we can certainly help you there. Janet Kennedy (11:25): Well, I definitely think that Coronavirus has accelerated a lot of conversations regarding decentralized trials. And I'm curious to know in hosting all of these webinars and having a chance to listen to all of these thought leaders, do you think digital health and innovation are really going to change clinical trials? Ritesh Patel (11:47): Yes. With a caveat, the caveat is how do you get the IRB on board? Because they are a gatekeeper and increasingly the ones that say no to most of these things. Number one, number two is how are you convincing the sponsors who are led primarily by the CRO to do this as well because the CROs have a view and a difference of opinion on how things need to be done because there's revenue involved there, right? You always have to look at the money, follow the money. Here's why I think it'll change. The pandemic has forced a fundamental change in the way we consume healthcare anyway. In a recent study from cancer, 70% of the doctors that they interviewed, I think it was about three, 400 of them in the U S C 30 to 50% of their practice being completely tele-health after the pandemic is over. Ritesh Patel (12:43): So what has been adopted as a way of working in the interim is becoming normal going forward. And if that's the case, then I'm going to start looking at other ways that I can apply this technology and these ways of working into what I do. And so a lot of these doctors are also primary investigators. So they're going to start asking, well, hell if I can see a patient using telehealth, why can't I see a patient on a clinical trial using the same technologies. And I'm already starting to hear some of those rumblings from a few investigators that we're working with. So I think this force digital for the pandemic is going to change and create new norms that a percentage of the population will expect. And therefore that will drive the innovation within clinical trials. Janet Kennedy (13:32): I think that's an interesting point because you were talking about innovation at the convenience of the investigator. And I think one of the things that the patients have been saying all along, but with Coronavirus, they can finally say, 'no, I'm not leaving my house. You have to figure out how to get to me if you want me to participate'. So I think we've seen a sea change in that patients were requesting asking demanding, but they were just a smaller part of the equation. And now we have clinical trials with no patients because people won't come here. I've got to figure out how to accommodate them. Ritesh Patel (14:10): And the sponsors have to, right. We are talking about billions of dollars at stake here. So if an investigator, if she uses to do it, it's incumbent on the CRO or the sponsor, or whoever's running that trial to figure out a way to either change the investigation or figure out a way to give the investigator the tools and the capabilities to do all of these technologies that we're talking about now have been around for five years. The pandemic has forced the use of them. And I think that's the biggest thing here. That's the mindset change and it's personalize the box suffocation of our lives. You know, there are taboo subjects that never were spoken about. I remember working on Cialis in 2012, I think. And you know, it was the, what they call the doorknob conversation that the man had with the call with the doctor. Oh, by the way, I've got a little problem as they're leaving the office along comes hymns and Romans, and now it's perfectly acceptable to go to a website, talk to a doctor via video, get a prescription. And it arrives in a box every three weeks. So these new norms, and now that we've gone through pandemic and we're used to having Instacart deliver our food to us Uber deliver our takeout to Doordash and GrubHub doing the same thing, Amazon doing the same thing, Hey, this stuff actually works. I press a button and things are over at my door. So why can't I apply it to healthcare? Janet Kennedy (15:37): That makes so much sense. Well, I'm curious where you think if you wanted to make impact and get your innovation into a clinical trial, would you be talking to pharma people or would you be really working the CRO route? Ritesh Patel (15:53): It's an ecosystem, I think. The sponsors have a responsibility to make sure that the trial is successful, obviously because there's revenue at the end of it or bring you a new product to market, right? A lot of us struggling because their business model is not conducive to the new world that we're living in the business model was a army of people managing this thing for you, making sure the CRS were trained, making sure the investigators were set up when the site was done. Even the feasibility study work, right? There's enough data out there today that you can create a dashboard around, say, you're doing a trial for a new diabetes thing. You can take the care set data, which is five years or eight years up to date have Medicare or Medicaid data overlay with IQVIA data and some other data. And you can find the referral patterns between hospitals and the investigators within those areas. Ritesh Patel (16:46): And also the patient population within a two mile radius of that facility. You don't need an army of people going around doing that. Feasibility has to change as well. So there are processes that are embedded in the CRO, particularly the bigger ones, that need to change as well. And then the third area is around the investigators and the IRB. The IRB is particularly the one. Those independent review boards. It depends on the digital acumen of the person reviewing. We all proposal as to whether you're going to get it done or not. So really need to educate those people and engage with them and show them that the EKG that's handheld, that the patient is using that's FDA approved device is as good as the patient going into the office and having a nurse do the EKG. Janet Kennedy (17:36): Now, the other thing too, is the ability to get the information much more frequently. If your patients who are having to come in every week, well, that's a huge burden for the patient. If you were only seeing the patient once a month, that's a long time between datasets. If you're not gathering information digitally. Ritesh Patel (17:52): I believe there are certain trials where you can do this completely remotely today, where you have the ability for a patient to use a device in their home to be able to report data. And it's not the eCOA, forget the eCOA is actual real data, right? So the EKG, for example, the cardio mobile product from AliveCor is a six and a 12 lead as good as any EKG you will find in any academic center. So I think the lower end product is on sale for $89, right in Walmart. So you can get an $89 product as a sponsor, give it to a patient and you can collect the data on a daily basis. You can do it on an hourly basis if you wanted, and then have the patient come in once a month, you can do the same thing with a bunch of other tool sets. Ritesh Patel (18:40): Now, Propeller just got approved for the AstraZeneca. I think it's AstraZeneca is inhaler product, where they are now going to collect the data for every squeeze of that inhaler for the patient. So why can't we apply that to a COPD trial? Right? So I think there are some places where we have to sit through and things that journey through and say, where's the application of data collection or connectivity with the patient. And then instead of saying, I'll get you an Uber because you don't have a car or we'll figure out a way to pay for your journey on public transport. Well, his $89 kit go do it yourself and we'll collect it every morning and every evening as you use it. Janet Kennedy (19:22): Just a really relatively easy solution that pays for itself in minimal amount of time. When you just add up the Uber trips or the however else, things are being funded. Ritesh Patel (19:33): It's not that hard to find the money for something like this. I mean, look, what is the cost of a trial these days? Do you have any idea, roughly? Do you take a product like a COPD product, right? The trials gotta be at least a couple of hundred million dollars by the time you're done. Right? So if you're going to get 10,000 patients times, 200 bucks, not that much money for the trial to be successful, the problem is the collectors of the end point data. It's like researchers in an agency, the researchers in an ad agency, I used to using four tools. If you come across and say, here's a new digital tool that can give you 600 mums at scale on an app that can tell you instantly within 10 minutes, what they think of your product, they're looking at you like you're from Mars. It's not possible. It's not research. It's not statistically viable. Who's going to do the tabulations, how aren't going to know, which is... All of the questions come up of the traditional way of doing things. And we have the same issue with the people who manage the end points of the data collection. A lot of them say, well, you know, the investigator nurse didn't actually check it. How do we know it was not them, really, could they give it to their child in the house? All of those things come up. Janet Kennedy (20:50): Absolutely. Well, I think we're going to have a conversation that's going to happen multiple times over the coming months and years regarding digital health innovation and clinical trials, because it is, I hope as exciting for those folks in pharma, as it is for those of us working with pharma, there are so many opportunities to do a better and more efficient and more cost efficient job in clinical trials. By engaging with digital health. Ritesh Patel (21:20): I'm even more optimistic because I've seen how R&D has embraced AI already for discovery. And I think that step has been taken and the culture within the sponsors to use AI and AI capabilities for drug discovery will bleed over into trials fairly quickly I think. Janet Kennedy (21:40): Awesome. Well, Ritesh, I cannot thank you enough for being a guest on People Always, Patients Sometimes it is always a pleasure to talk to you. And I think this is a conversation we should have on a regular basis because the innovation that's going on in pharma and in healthcare is one that's literally changing every day. Ritesh Patel (22:00): I'm thankful to you and happy to be a part of the conversation anytime you need Janet. It's always a pleasure to speak to you. Janet Kennedy (22:07): Thank you so much. Ritesh Patel (22:08): Thanks. Have a great day. Connect with Ritesh Patel Twitter LinkedIn

This podcast features a discussion about IQVIA Technologies with team members Harpreet Bedi, Vice President of IT; MaryAnne Rizk, PhD, Senior Vice President, Digital R&DS Strategy; and Nagaraja Srivatsan, Chief Digital Officer, R&DS Solutions. Learn more about IQVIA’s recently launched COVID-19 solutions including: IQVIA CARE, an opt-in registry available to anyone to advance understanding of COVID-19; C19Trials.com, an online platform that matches individuals with specific COVID-19 studies; and their Back-to-Work App for employees to transition safely back to the office. Also discussed is the newly launched Orchestrated Clinical Trials (OCT) cloud platform to improve the efficiency and effectiveness of clinical trials. The three stakeholders in clinical trials are sponsors, sites and patients, and OCT includes suites for trial management, sites, patients and data. Our podcast host is Janet Kennedy of Get Social Health.

Tom Rhoads: The patient perspective is an integral part of how we at Spencer Health Solutions approach our work from UX and human factors testing and designing Spencer all the way through our customer interactions. We always look at how the patient evaluates their experience with our system. In this episode of our podcast, we asked chronic pain patient advocate Barby Ingle, founder of the International Pain Foundation, to share her perspective on improving clinical trials. I know you enjoy this episode of "People Always, Patients Sometimes". Janet Kennedy (00:37): Hi, my name's Janet Kennedy and I'm your host for "People Always, Patients Sometimes", a production of Spencer Health Solutions. I am really looking forward to my conversation today with Barby Ingle. Barby is a bestselling author, a reality live-streaming personality, she lives with reflex sympathetic dystrophy, Migralepsy, endometriosis, and other pain disorders. Not a surprise. Barby is also a chronic pain educator, a patient advocate, and president of the International Pain Foundation. I am very, very excited to have Barby here today and also because she is an avid user of social media to share her story. Barby, welcome to People Always, Patient Sometimes. Barby Ingle (01:21): Thank you so much Janet for having me. I'm so glad to be with your audience today. Janet Kennedy (01:26): You know, we talked to a lot of different people in pharma, in health care and clinical research, and I have spoken with some other patients, but I have to say in reading your bio and the things that you're dealing with, while the title of our podcast is people always patients, sometimes I have to think that sometimes it feels like a flip for you, that it's really patient. Always people sometimes. Yeah. Well, I think I'm both all the time. Is it a situation where you literally can never not think about what you're feeling? Barby Ingle (02:02): I absolutely have to pay attention. I have to plan and be prepared, and luckily before I was chronically sick, I was already organized, so I definitely used the skills that I learned in cheerleading, including organization and responsibility in dealing with the healthcare challenges that I'm faced with every day. For sure. Janet Kennedy (02:22): Now, have your challenges come as a result of your adult life, or is this something you dealt with even as a teen or preteen? Barby Ingle (02:30): I was actually pretty healthy growing up and when I was 26 I developed endometriosis. And then at 29, I developed reflex sympathetic dystrophy, RSD for short, and really endometriosis was something I got through really quickly. You know, it was like, Oh, this didn't work. These shots didn't work. What's the next thing? A laparoscopy. Okay. That made my insides very mad and the spread. And then the final thing was a hysterectomy and I was like, take it out. I'm done. I can't take this. I got past it and I thought if I could pass that I could get through anything. And then I got hit with RSD and secondary conditions after a minor car accident, which triggered it. It's actually an autoimmune disease, but it was triggered by an automobile accident and that changed my life forever. That eight seconds. Janet Kennedy (03:26): Wow. Okay. I'm going to take a moment and really think about that eight seconds. And your life has changed forever. So what does that mean day to day? How are you impacted by RSD? Barby Ingle (03:38): So prior to the impact, I was in my vehicle, a small vehicle, and I was hit by a 16 passenger van. I saw the van coming, I saw him in my rearview mirror and I twisted my body and the van impacted my car and I blacked out after that. I went to court and he testified, he said he had never, he didn't see me and he never took his foot off the gas. So after he hit me, so from that moment I started having burning fire pain. It was in my face, neck, and shoulder area. But it was so overwhelming with my thoughts, with my actions. I was, I went from being a collegiate cheer coach at a division 1A university to, I still was trying to keep coaching, but my coaching suffered, my team suffered. Barby Ingle (04:26): We were in the top five in the country rankings for cheerleading. And you know, I really was living my best life and that eight seconds that it took for this accident to happen, everything changed. And I went from well to being bed-bound for the next six months or so. I tried to continue to work and I would go to practice and I at practice would lay down on the floor and have our team doctors taking care of me. Instead of taking care of my student-athletes. I would go back to my office and lock the door and sleep because I was in so much pain, but I also was quite fatigued maybe just from having that much pain. If I turned my head to the right, I would pass out. Just literally everything in my life changed. I was married for 10 years. It's my first marriage. Barby Ingle (05:15): Did not survive the auto accident. I couldn't explain why they told me I had whiplash, but yet I had this burning fire pain. I started going from doctor to doctor to figure out what was wrong. I went to chiropractors, physical therapy, anything and everything that was suggested. I tried and then what? Oh goodness. Then I ended up over a three year period moving from Washington state down to Arizona per doctor's instructions. They said I would get better care here. I ended up seeing 43 doctors in a three year period. And finally, that 43rd doctor stopped and he had me bring in, at that time all of my medical records, which took three, three-inch binders. I'm now on binder nine of medical records. And before he even came in to meet me or see me or anything, he went through every single record from all 42 providers before him from all the different specialties. Barby Ingle (06:12): And he came in and said, I think I know what's wrong but I'm not sure and I want to run a test. And I said, well tell me about the test and I'm going to go home and study about it. And that was the first time I advocated for myself instead of just listening to and doing what the doctors told me, I stopped and said, you know, I want to go research on my own. And I and I took a week to research and talk to other patients that had had this procedure and decided to do the test and went in seven days later had the test done and I was tested positive for RSD, which is now known as central pain syndrome. Janet Kennedy (06:50): And what, is this a situation where you have to be medicated all the time? Is there a different kind of physical therapy that works for you? Barby Ingle (06:59): I'm allergic to Oxycontin so I didn't know how I would do with other opioid medications for pain. So I also didn't want to be like out of my mind so much mentally foggy cause I was already mentally foggy from the RSD symptoms. So I tried to do other treatments, but I was on pain medication for a lot of that time. Although I was on a lot lower dose and strength than many of my friends are. I supplemented it with radio frequency ablations as well as nerve box. And I even tried epidural steroid injections. I tried physical therapies. I went through a whole bunch of different, I've done three clinical trials, two medications and also a medical device and I still actually am using the medical device that I did throughout the trial and there's actually a book written and I have another family member who has the same condition as I do and he actually uses the same medical device that I used and we're both in this book that has come out about the device. Janet Kennedy (08:11): You went from literally suffering every day needing multiple physicians, changing your life totally moving to a new area. Finally got a diagnosis. You got some things maybe a little more manageable? Barby Ingle (08:24): Yes, so I was in the accident on September 26th, 2002 and I finally started doing all of these treatments and trying all of these options. I ended up in a wheelchair. I went from being face, neck, and shoulder; through surgeries, I didn't need I had a rib removed. The doctor made a mistake on that and ended up damaging my right lung and just one thing after the next went bad, I ended up in a wheelchair and bed bound to the right side of my body. My hand was curled up, my foot curled up and really just was trying to maintain being alive. In 2009 I finally went through infusion therapy in seven days in ICU infusion. I went in in a wheelchair in seven days later I walked out, I teeter-tottered out cause my legs were quite a bit atrophied and my whole body was. Barby Ingle (09:18): But I was able to walk out on my own and I was so proud of that moment. I had to come in and out of remission since December 2009 and I still have a scooter that I use when needed, but I am managing much better now that I have a good group of treatments that are working for me. Janet Kennedy (09:39): So help me understand how you made the transition from being focused on your own health to helping other patients deal with their issues. Barby Ingle (09:50): I advocate for myself first and then I joined a local support group and realized that I had a lot to offer to the group because of everything I had been through, but I didn't quite get what I needed out of it. So I reached out to a larger organization for RSD and said, you know, I'd like to be a mentor to mentor other patients. Barby Ingle (10:15): And I took on mentoring three patients, one of whom is still to this day, my best friend, and we keep in touch almost daily and it worked out. But I started by mentoring other patients and just being someone that they could talk to and someone that I could talk to and growing that into - I started to get asked to speak at events, at other people's support groups at different conferences and things that are happening in the pink community at large, not just for my disease specifically. And in sharing my story, it just really opened up a whole new Avenue of reach of people that didn't know what this is somewhat, you don't know that you need it until you're in the midst of it. And sometimes when you get into a situation where you're challenged, it's hard to see all the tools that are around you. Barby Ingle (11:09): So I kind of found them slowly moving through my own story and I said I have to help other people. No one should go through what I went through. Janet Kennedy (11:18): So I'm curious, how do we refer to chronic pain? Is it a disease? Barby Ingle (11:22): Well, chronic pain is actually now in the ICD 11 a diagnosis in and of itself. You can be diagnosed with chronic pain as an ICD code and insurance covers different treatments and things that are pertaining to that code. So it actually is a disease in itself or it can be secondary to another condition. Janet Kennedy (11:41): Well Barby, tell me about the International Pain Foundation. What is that organization? The International Pain Foundation started back in 2006 and that was just when my advocacy was starting and it was started in my honor by family members, but it soon grew to something that's much bigger, which at first it was called the power of pain foundation because I believe that pain made me a better person and more patient. Barby Ingle (12:08): And that's the message that I was spreading. My family every year would pick a charity project going into a nursing home or serving food at a homeless shelter that we could do as a family, and that year the family said, look, if Barby had this much trouble there, have to be other patients out there having trouble, so let's do something that will help them. And it's grown from just a small family organization in my honor to me actually running it and now it's an international organization with people from all over the world submitting articles, submitting quilt project pieces and crafts and education and all kinds of awareness opportunities. It really has grown from this little small family idea and project into this global network. Janet Kennedy (12:59): Oh, that's awesome. Because I think that's what patients have really demonstrated to the industry is that they will find their solutions. They will find their networks, they will join together with peer groups and solve their own problems if you won't solve them for me. Barby Ingle (13:17): Absolutely. Sometimes I wonder and now I work with pharmaceutical companies to help with clinical trials and help people become aware of those clinical trials that are going on. But before it was involved in, I didn't quite understand the clinical trial process. I would wonder why are they not listening to the patient's voice? And I think over the last few years the pharmaceutical industry has made a special effort to pay attention to what the patient voices and have patients and caregivers on their advisory boards for a clinical trial. Getting it set up and getting it organized and all the way through to the end when the results are produced or their item medication came to market or I've been involved with trials that actually didn't make it to market, but I've seen that whole entire process and been a part of it and was one of those patient voices in that process. Janet Kennedy (14:13): Tell me a little bit about your experience as a patient in a clinical trial. You don't have to name names, but I'm more curious about what did you feel was done well and what do you feel may be missed the mark as far as considering the "patient first" perspective? Barby Ingle (14:29): There's so many things. The biggest, thing is the disparity. Clinical trials should mirror the patients that will be the end-user and so many times clinical trials miss that mark and they want people in their trial who will do well on the medication, but it doesn't necessarily serve the population. For instance, we know that people that are African American or black will have sickle cell disease more often than somebody who's white, but less black people will participate in the clinical trials so when they come up with a solution that could be viable for sickle cell, it hasn't been tried on the actual population. That's the majority population for that disease or condition. So I think that's one of the things is the disparity. Also, a lot of people are limited from being a part of the clinical trials because they don't have transportation or access to the trials themselves. Barby Ingle (15:33): They're usually held in the bigger cities and that has a certain population and income level and education level. So you get less of the smaller town, rural patient population. Being a part of those clinical trials? Janet Kennedy (15:49): Well, I think from your experience too, you probably weren't solo-ambulatory, so you needed someone's help. So that's two people. Barby Ingle (15:58): Yes. And that's what I meant by transportation because I have a seizure disorder. My seizures disorder didn't start until 2014 but I had migraines right after my auto accident, but I wasn't able to drive for many years because when I twisted my head to the right, I would pass out while to change lanes, you need to be able to look and see what's next to you. So I didn't drive a lot. So I do, I rely on my caregiver and now I have a seizure disorder. Barby Ingle (16:28): So I drive even less. But if he wasn't able to take me and have a vehicle to put my scooter in or my wheelchair in, then I wouldn't be able to go. I did try to take a taxi once to a doctor's appointment and it was $126 to go less than 20 miles. Wow. And my husband now. I was able to find love in the midst of all of that pain and chaos and he's the most amazing caregiver ever. He said, you know, I will take off work for $126 like this is ridiculous. Never, ever, ever take a taxi again. We just had to find ways around it and work out a better way, but if you don't have somebody that can do that or their job doesn't let them off, then getting to the appointments can be quite a challenge to participate in the clinical trial. Janet Kennedy (17:20): Barby, you're very savvy out there in the wide world, following social media, following the innovations that are happening. Do you see any improvements for patients with all of the digital health technology that's being developed? Barby Ingle (17:34): Absolutely. I think that some of the clinical trials are coming on board and they're allowing patients to do the trials from home. They're sending them kits where they can do the monitoring from home and it can work on an app on their phone and report the results to the researchers and or their providers. If the researchers find something, they can report it back to the patient's provider to get immediate care. So we're starting to see some of those types of trials come into fruition and I think this year especially telehealth has exploded and hopefully the clinical trial process follows that same path and works in telehealth into their system so that patients that are more rural can get involved in the clinical trial so that the trials can mirror better the types of patients that are the end-user of that product. Janet Kennedy (18:32): Well, that is exactly what we hope at Spencer health solutions as well. Our Spencer device allows for medication delivery also allows for patient engagement via asking questions after someone has taken their med delivery and there's a telehealth feature and can even tie into biometric devices. So there are a lot of options there to hopefully make it easier for in-home clinical trials. Before I go, I want to know a little bit more about the Ken and Barby Show. Tell me what this is. I don't think I've ever spoken to a reality TV star. So I want to know what this program is and how it got started. Barby Ingle (19:11): Yes. So I've been on multiple television stations, like game show network and TLC and WB, CBS, ABC, NBC. But my husband, Ken and I were "Ken and Barby", and we participate in the Ken and Barby Show. It is a show that is lighthearted. It covers our adventures together and raises awareness, but not necessarily in an upfront, in your face kind of way. So we talk about different conditions and things that I'm personally going through with my health or Ken as a caregiver, some of the challenges that he's faced. But it's also, we found ourselves because of the advocacy work in quite some interesting positions and situations and have been able to meet a lot of great people who have also use their platforms to raise awareness and spread the information that they need about their condition. So we're very funny together, very interactive with our viewers. Barby Ingle (20:11): Sometimes we play games, we give out prizes. We're on season nine some of our seasons. We've had sponsors this season that we're on right now. We decided to not have a sponsor for this season. It's just Ken and Barby raw all summer long and we just want to bring positivity into everybody's life and be cheerleaders of hope - or Ken calls himself a "Care Leader of Hope". We do that in a lighthearted, fun, positive way and it gets people's minds off of the pain, but we also have people that don't have chronic pain of any kind and they're tuning in and watching and we're reaching a larger audience than just our silo of patients and their caregivers. So we're actually planting seeds and we're hoping that when that person needs the information one day that they will remember some of the topics and things that we brought up during the show. Janet Kennedy (21:07): Oh, that sounds great. Well as people know who listened to the podcast, I will have links in the show notes that will take people to not just your social media profiles, but we'll make sure that we've got a link to a couple of your cool blog posts about clinical trials and of course to the Ken and Barby Show. Barby Ingle (21:24): Thank you so much. Janet Kennedy (21:25): Oh, Barby, thank you so much for being here and I really, really enjoyed having you as a guest on "People Always, Patients Sometimes", and really look forward to meeting you in real life when we get back into face to face situations. Barby Ingle (21:41): Awesome. I can't wait to meet you as well. Thank you so much, Janet. This has been a great time. Contact Barby Ingle Website LinkedIn Twitter: International Pain Foundation Twitter: Barby Ingle

Tom Rhoads (00:03): Welcome to the "People Always, Patients Sometimes" podcast. Our guest is Aiden Flynn. The founder of Exploristics. We worked with Aiden and his team to look deeply into how Spencer, in a simulation study of 6,100 cardiovascular patients, would impact both adherence and engagement. We wanted to determine that if adherence were increased dramatically as seen with the Spencer platform if we could improve the endpoints of stroke and persistence across the medication study. The results were outstanding and we have a white paper detailing that. Now we're excited to present Aiden as this is a very captivating interview. I know you'll appreciate Aiden's insights on "People Always, Patients Sometimes". Janet Kennedy (00:49): Hi, my name is Janet Kennedy and I'm your host for "People Always, Patients Sometimes" a production of Spencer Health Solutions, we're speaking with the Managing Director of Exploristics, Aiden Flynn. Exploristics provides analytics, statistics, exploratory data analysis, modeling, and simulation services. There is so much more to cover. So let's get started. Welcome to "People Always, Patients Sometimes", Aiden. Aiden Flynn (01:13): Thanks, Janet. It's a pleasure to be here. Janet Kennedy (01:15): We've actually worked with Exploristics at Spencer Health Solutions. And we're going to get into that in a little bit, but I'm sure your company does a lot more than the work you did with us. So do you mind taking a moment to tell us a little bit about yourself and about Exploristics? Aiden Flynn (01:29): I've been working in the pharmaceutical industry for close to 30 years now. I had an academic background. Then I worked at GlaxoSmithKline for 10 years, and then I set up Exploristics 11 years ago. We work with small and large biotech and pharma companies to help them optimize the designs of their clinical trials to make sure they're generating the right data, to turn that data into the evidence that they need to apply for approval for the drug or to support further investment in development. Janet Kennedy (02:06): So are you working with companies in a pre-protocol stage? Aiden Flynn (02:10): Ideally? Yes. I think one of the bugbears of many statisticians is that they don't get involved early enough in the protocol development stage. Our preference is to get in as early as possible on in doing that. We can actually influence many aspects of the protocol on not just the statistics section, where we might justify a sample size, for example. Janet Kennedy (02:36): So are you working with them to make sure that their drug is actually potentially viable or are you working with them to make sure that they're asking the right questions and gathering right data in order to prove better how the drug is performing? Aiden Flynn (02:50): Yeah, yeah, it's both. Ultimately everybody knows the kind of rate of attrition and clinical development, you know, more than 90% drugs feel to reach the market. Having already entered clinical trials on, I believe a large part of that is, you know, studies are not appropriately designed and I believe that statistics and statisticians have a big role to play in that. And I think the way we think the kind of logical and quantitative approach can impact lots of aspects of the clinical trial. So yeah, we get involved early to make sure the study is designed appropriately. We're measuring the right things. We're measuring them in the right way and making sure that we're doing the right analysis. We also work at the end of the process as well. So we'll take the data that are generated as part of a clinical trial and we'll do our statistical analysis to demonstrate that the drug works or, or otherwise. And actually we complete the feedback loop. So anything that we get in terms of the results from a clinical trial, we try to feed that back into the design process so that we're, we're learning from the success and the failures of clinical trials so that we avoid making those failures in future. Janet Kennedy (04:17): Part of what you're doing here is if you can get involved early enough, you're not having a situation where they're saying here's our data, try to put this square peg in a round hole and prove that we did a good thing. Aiden Flynn (04:28): Yes, that's exactly why we want to get involved early. I can't say that that still doesn't happen. You know, it is common that we will be approached by a customer who will say, can you recover something from this wreckage? And at that point often there's really very little you can do Janet Kennedy (04:49): is that because they're not gathering enough data, the right data, what would be the problem there? Aiden Flynn (04:55): It's a whole range of issues. I, common approach I find is our customer are a sponsor of the study is often very optimistic about the effects of their drug on response. They will always be too optimistic about that. And therefore they have not designed the study in such a way that, well, what happens if your drug isn't quite as good as you think it's going to be? Because, you know, when you go into a clinical trial and you start introducing issues such as adherence and persistence or missing data, or just some noise that is being introduced from the operational side of clinical trials, they haven't accounted for that in the design process. And that adds to a lot of variabilities and the response and it at to a failed study. The other thing I find is just the endpoints that many people measure are measured in the way that there's kind of, they have them, the content for that. You know, I think there are a few reasons why these studies feel, and we try to work with customers to help them think through the issues and to make sure that they have a plan in place to manage them. Janet Kennedy (06:11): So even if a drug doesn't perform as well, you can probably, if it's set up appropriately on the front end, get some valuable data that will feed into the next process. Aiden Flynn (06:23): Absolutely. You know, I think it's important that even if a study failed or is ambiguous that we try and learn as much as we can from that. And if the sponsor is in the fortunate position, in that they have enough funding to learn and then to look at designing the next study, then we will absolutely help them to do that. Janet Kennedy (06:47): Well, tell me exactly what is a simulation service? Aiden Flynn (06:51): Okay. Well, I can tell you what our own Kerus Cloud platform does. The word simulation is quite broad. So our Kerus platform, the way it works is it builds a large virtual or in silico patient population, a patient population that comprises the features that you believe to be important in a particular indication. So that will include things like what are the outcomes or the endpoints of interest, what are the patient-level risk factors that might impact those outcomes, and also how they all relate to each other? So we're building a kind of a complex data set where there are lots of interrelationships. But the point here is if you can get a good virtual patient population, you can mimic the way a clinical trial would work. And you can ask lots of "what if" questions, you know, "what if I design a study where I have this particular set of inclusion, exclusion criteria, why should I sample from that population"? Aiden Flynn (07:59): "How many samples do I need? Do I sample all at once? Or do I take a sample, do some analysis, and then adapt the study? What are the key endpoints that I need to measure, please? Should I analyze those on how should I define success for the study?" And what we've shown from our simulation is if you get the right combination of study population, study design, endpoint analysis approach on decision criteria, you make a massive difference in the likelihood of success of the study or the cost of the study or duration of the study. And it's not kind of multi-dimensional optimization that we are bringing to the table. Janet Kennedy (08:44): So it's the seven P's right? Proper prior planning prevents, et cetera, et cetera. Aiden Flynn (08:50): Indeed, indeed. And so it's rather than thinking as statisticians as a group of people who will justify a sample size is thinking much more broadly than not I'm using the available data that can help decisions across all of those dimensions. Janet Kennedy (09:09): Where does the data come from? Aiden Flynn (09:11): That's a good question. And they come from a range of sources. We will typically, for any indication, we will troll through the literature. We will pull population-level statistics relating to endpoints and risk factors. So we'll pull that data together. What you don't get from that is typically the interrelationships between those variables or measurements. And so we'll often supplement that with patient-level data where we can get access to it. What we find is with many of our clients, they will have done previous clinical trials in this space, so we can get access to that patient-level data and work out the interrelationships. Aiden Flynn (09:55): If they don't have their own data, they will often know an investigator or they'll have access to a real-world registry where we can get the patient-level data. And again, quantify the strength of those center relationships. Those are the two primary sources of information. We will also get an expert opinion, particularly in relation to what is a meaningful treatment effect in this indication. And this relates to my comment earlier about many sponsors being overly optimistic about either treatment will perform in a clinical trial. So we'll take all of those sources of information and we'll integrate them to build this virtual patient population. Janet Kennedy (10:44): Now patients are well people, so numbers are great and all this data is fascinating, but people have the potential of throwing a monkey wrench into the best formulas. How do you account for that? Aiden Flynn (10:58): Yeah. And again, good question. So this relates to the ability to ask "what if" questions you really need to make sure that the study that you design is robust against some plausible scenarios on one of those plausible scenarios is absolutely what happens if something happens, some patients and you have outliers or whatever, and you need to make sure that what you're doing in this study will not be derailed just because you're getting these discordant measures or outlying values. Janet Kennedy (11:35): Because that's inevitable, right? Aiden Flynn (11:37): It is. It's, it's rare that you have a study where, where you don't have something like this, but the truth is when many statisticians are designing the study, they don't account for it at all. Janet Kennedy (11:49): So they're assuming in a perfect world, I'll start with a patients and I'll end with a hundred patients? Aiden Flynn (11:55): Well, that's one assumption that is often made, or there's maybe a simple extension of that, where they will assume that 10% of the patient population might drop out. So they will just end flipped the, a number of patients recruited into the study by further 10%. But even in that instance, you are making an assumption that you know, that the dropout rate is balanced across the treatment groups, which isn't necessarily the case, particularly if dropout is in relation to non-response. Janet Kennedy (12:32): So the challenge here is being able to predict a little better, how many patients you would need, how long they would adhere or be persistent with their medication, and how many you'd end up with so that you still have a valuable data set in order to move forward. Aiden Flynn (12:49): Indeed. I think it's important to start asking, well, what if you know this study, isn't perfect. What's the likely outcome in the event that, you know, we have a lack of adherence and we have non-persistent patients. What sort of adjustments do we need to make in order to cover those eventualities? Janet Kennedy (13:09): Now I know you did a simulation study for Spencer Health Solutions. Can you describe that a little bit and what really did it show? Aiden Flynn (13:16): Yeah, sure. So in the work, we did, with Spencer, we looked at the impact of adherence and persistence on the likelihood of success in clinical trials. And we took a case study in stroke and we built a virtual patient population. And within that population, we start to introduce various rates of non-persistence and nonadherence. And then we work out what's the likelihood of success, given those underlying assumptions. And then the next step was, well, what sort of adjustments would we need to make in order to overcome those issues that are introduced because of lack of adherence and persistence and on how much would we need to increase the sample size in order to maintain the same level of likelihood of success. And you won't be surprised to know, lack of persistence and adherence can make a massive difference in terms of the number of additional patients needed to maintain the same level of likelihood of success. Aiden Flynn (14:24): And one of the scenarios we looked at in the stroke case, you know, when you compare just looking at adherence alone, leaving persistence aside, looking at adherence and adherence is complicated because all it's doing is changing the variability of response in a case where, you know, we compared a study where there was very good, high adherence as you might achieve by using something like Spencer versus a case where there was very low adherence. Actually to maintain the same level of success you needed to double the size of the study. And in the case of the stroke example, it accounts for something like a thousand additional patients recruited into the study, which that would cost a lot of money to try and account for that appropriately within the study. New Speaker (15:17): Oh, that's amazing. I mean, that's millions of dollars. Aiden Flynn (15:20): Well, you know, depending on the indication, the disease area, you know, it's a 20, $30,000 a patient at times, you know, so yeah. You're saving millions of dollars just by improving the adherence rate. Janet Kennedy (15:37): So it's true that announcer prevention saves a pound of cure! Aiden Flynn (15:41): For sure. For sure. That's what we keep telling people. Janet Kennedy (15:44): What's different about version two of the Karus cloud? Aiden Flynn (15:49): Version one came out 18 months ago and what we find was, as the simulations were becoming more and more complex, we needed to redevelop the way the software works. It runs on AWS. So the way version two works is it's got a very clever way of handling the computational power that is needed to run a set of simulation. So it will do a, an initial check as to the complexity of the simulations that are being requested on. Then it will fire up lots of essentially parallel processing units in order to make sure that all of those simulations are run within, you know, within minutes rather than, you know, setting them off on a Friday and coming back after the weekend and hoping that they're finished. That's one key difference. Aiden Flynn (16:48): The other was the kind of interactivity that I user has with Kerus because we are presenting box quite a lot of results over a range of different scenarios. We felt that we users wanted to have a lot more interactivity to be able to drill down into specific aspects of the results. And so we made that much more interactive the look and feel of the software is very different as well. And we've, added new capabilities around being able to generate more realistic virtual populations. So we we've included subgroups within that population so that we can start to design studies that are related to precision medicine. It's an area that I have a lot of interest in, but I felt that again, we talked a lot of precision medicine, but progress has been somewhat limited. And I believe a lot of that is to do with the limited ability of clinical product design tools to really account for the requirements of precision medicine studies. Janet Kennedy (18:01): Is this something that your clients are able to actually manage all themselves, or does it come with a level of consulting or instruction or analysis from your team? Aiden Flynn (18:12): It depends on the customer. If we work with a large pharma company, they will have a large statistics group. They generally speaking will have the capability in highest to do it themselves. At that said, they often ask us to work with them in order to deliver our broader suite of services in addition to the software. If we work with a smaller company, they typically don't have the in house resource or skill set to run the software. So we will run it for them. Janet Kennedy (18:49): Excellent. Well, you've worked with a lot of different companies and you've been in the field for a really long time clinical trials. It's in chaos now from where you are right now, what do you see and where do you think that the industry is going? Are they interested in using this opportunity for long term innovation or are they just trying to band-aid the situation and get through it? Aiden Flynn (19:14): I think it's fair to say. We see all sorts. The COVID-19 world has created a lot of chaos. A lot of the projects that we were working on, non COVID projects, a lot were delayed, postponed. I think some of our client companies into some difficulty, because they had raised money to reach a certain milestone within a certain period of time and they may not be able to do that. So, actually they have been reacting to that, to work with us, to see what we can do, given that they might not be able to complete the study or they're going to have lots of missing DFS and missing visits. So things like that, we've been doing a lot of work hand in the COVID world as well. We've been getting a lot of requests to support COVID studies, and of course, everything needs to be done urgently and needs to be finished yesterday. Aiden Flynn (20:12): But what I think, what is interesting is the world is looking at the industry right now and saying, okay, what can you come up with? And I think it has forced a change in behaviors, you know, and I'll give you a good example in a COVID study that I've been working on, we've gone from a blank piece of paper, a blank protocol to getting it approved and getting it funded by the [inaudible] here in the UK for the regulatory in a period of six weeks and a large pharma company. That's, unheard-of a protocol might take months, many months if not years, to develop. And I think just this urgency has been helpful. It's shown the spotlight on the importance of the industry at a time like this. And I feel the industry really needs to take this opportunity to react and to deliver something back to the public. Aiden Flynn (21:14): What we're seeing as well as some of the larger companies, because a lot of their studies are on hold. They're kind of taking stock a little bit to say, okay, what can we do? And the level of, what can we develop? Um, they're looking at solutions like our software as a way to overcome the challenges they face in clinical trials. I'm hopeful that in this COVID world, the industry, I feel, has talked about innovation for a long time. It is not truly a conservative industry. It doesn't change quickly. It will talk about innovation, but I think it's slow to adopt innovation. I think COVID has forced them to look at new ways of doing things. And I'm hopeful that some of that will stick as we come out of it. It will just become the way that we do things in the future. Janet Kennedy (22:10): Pharma could definitely take a look at the startup process and think about becoming more of an agile-based investigation and embracing "fail fast". Aiden Flynn (22:22): Absolutely. You know, it's, it's interesting that in a large company, just that the kind of things that get rewarded, the kind of behaviors that get rewarded don't necessarily encourage the "fail fast" mentality. Janet Kennedy (22:35): Well, we'll just cross our fingers and hope that we really are seeing a sea change in how clinical trials are innovated and modified or embraced new ideas going forward. And that this isn't just a momentary stasis. Aiden, thank you so much for being here on people, always patients, sometimes a great pleasure to talk to you and I am so much more knowledgeable now about what Exploristics does and, and how you worked with Spencer Health Solutions. It was very enlightening. Aiden Flynn (23:05): Thanks for giving me the opportunity to come and talk to you today. It was a pleasure. Janet Kennedy (23:09): Thank you for downloading this episode of "People Always, Patients Sometimes" podcast. If you've enjoyed our conversation, a review and a rating on iTunes would help us find more listeners. This podcast is a production of Spencer Health Solutions.

Hi, I'm Tom Rhodes, CEO of Spencer Health Solutions. Our podcast guest today is Joseph Kim, who is a member of the digital health office at Eli Lilly and the host of Lilly's podcast, The Elixir Factor. On our podcast, he talks about digital health innovation, the IBD challenge, sponsored by Eli Lilly, his podcast and cross-departmental drug development. We're proud to welcome a fellow podcaster to "People Always, Patients Sometimes". Janet Kennedy (00:34): Welcome to the "People Always, Patients Sometimes" podcast, a presentation of Spencer Health Solutions. Healthcare has come to a crossroads and it's time to start listening to new ideas that challenge our "always done it that way" thinking we hope you enjoy our conversations with the disruptors, the innovators and the transformers in clinical trials and healthcare. With me today is Joseph Kim from Eli Lilly. He has a title that's quite a mouthful. Senior advisor, digital health office, translational technology and innovation and we're going to talk about all of those things on the podcast today. Joe, welcome to the conversation. Joe Kim (01:12): It's great to be here. Janet, thanks for having me. I know it's been a little bit of a challenge to get our schedules to line up, but we're here now. Janet Kennedy (01:19): And I'm absolutely thrilled to have you here. We talk about you a lot over at the office because you are putting out a lot of great new ideas on your podcast, which we're going to talk about in a little bit and at events, conferences and trade shows. You're often a keynote or panelist member, but also imagine you're doing some pretty exciting things that Eli Lilly. You've certainly had a couple of changes in your title in the past few years, so things are very exciting where you are and I'd love for you to tell me a little bit about your history and how you got to Eli Lilly and then what you're doing now. Joe Kim (01:53): Yeah, sure. I mean I've only been at Lilly for about five and a half years, a little longer than that, which is a long time for me at any one company, but a very short time for anyone at Lilly. A lot of people who joined the company are there for 2030 35 years. So I'm still, despite for me, this being the longest role I've had at any one company, it's short time for others, so I still feel like the new kid on the block, but I joined their clinical innovation group when it was still in forest and that was run by Jeff Kasher who was the VP and well known in the industry. Still has, he hasn't faded into the background after leaving Lily, so he's still got his fingers in a number of pies helping other clinical research entrepreneurs and other pharma folks. I think I'm making sense of how to do things better. Janet Kennedy (02:41): Does that mean you have an intrepreneurial system going on at Eli Lilly where you are sort of embracing that spirit of entrepreneurship within the company? Joe Kim (02:50): Yes, but that's not really about how the company is set up, but there is plenty of room for people with that kind of ambition to develop new things and make the place better and better. Which is kind of a hallmark quote from our founder, which was to make Lilly a better and better place as you work here. So there's no like formal mechanism to do that per se, but everyone is encouraging it. It often happens and Jeff was one of those guys, created a big function where we spent a few years really focusing a lot of resources on trying to make clinical research to revolutionize it. And so that was, that was a great run for me. I did that for about three and a half years and then the company sort of switched gears to start trying to get some of these innovations in place so you can only dream for so long before you have to actually get some stuff done and apply it. Joe Kim (03:42): So there was a transformation that happened awhile back and I ended up moving into something called the design hub. In my role there for about a year was patient experience and design innovation, which is really about helping all the molecule teams figure out how to do things from a patient experience. Everything from awareness to recruitment to participation in learning. Anything we could do responsibly as it pertained to patients after the study, which is a thorny issue for a lot of good reasons. And then most recently in may, I moved into the digital health office shortly thereafter, started the podcast. So I'm always taking on new challenges and it's been a really great ride so far. Janet Kennedy (04:23): Well that's the definition of an exciting job, right? Where things are evolving and changing and new challenges come your way. But tell me what is the digital health office? Joe Kim (04:32): Yeah, the digital health office was born last year and it's basically a new team of a bunch of different kinds of folks, UX designers, developers, commercial strategists, and my group, which is translational technology and innovation and the remit has kind of evolved over time. It's a bit like a startup company within the company. And at first we were trying to figure out really the way to bring new digital health solutions to patients and doctors and health systems and that sort of thing. But we've also realized that you can't turn your back on digital health for drug development either. And so now we have these two sides of our work that we're really excited about and can reinforce each other. So for example, if you figure out a digital biomarker for a new way to measure drug efficacy, that could be repurposed as a, as part of a total digital health solution for a similar disease or something of that sort. Joe Kim (05:34): I can't talk in too much detail about those sorts of things, but I can give you some sort of hypothetical examples. So for example, if we think about asthma, is there a way you could forecast some sort of asthmatic flare using a bunch of different sensors and real world data and can you start to develop drugs that can alleviate those flares before they happen? Sounds great and you can use this to help the drug development process, but then it could also be part of a total digital solution where it's coupled with an inhaler or some sort of other mobile app that works in conjunction with the drug to do a lot more than just deliver medicine. We don't do anything in asthma, so I pick that as a safe topic. But you, you sort of can hopefully it gives you a sense of what the digital health office is here for Janet Kennedy (06:23): Would I be correct in assuming you're not trying to reinvent the wheel and design digital apps from the ground up, that you're actually looking for companies or startups to partner with to look at their technology? Joe Kim (06:36): Well, me personally, I don't do any of that actually. So translational technology and innovation is something slightly different, which I'll get into in a moment, but I'll say this much, as a company, we want to obviously use the best ideas and that doesn't mean we shut ourselves off from those ideas that are already out there in the world. We acquire companies, we in licensed compounds, and there's no reason why we wouldn't also consider external innovation as well. In fact, we just finished a external innovation challenge in IBD. That winner was selected last year. We actually have a podcast episode on that story itself, so you'll hear more about that hopefully in the next couple of weeks. Janet Kennedy (07:18): The IBD challenge was really fascinating and when I read through all the applicants, which I don't know, I'm even guessing 60 or more, they were so different from physical products to supportive apps, to medication delivery systems, to support groups and peer groups. It was fascinating how many different ways people imagined how to solve the problem of the IBD challenge. Joe Kim (07:43): Yeah, and that's a, that's a therapeutic area that hasn't gotten a lot of attention compared to something like diabetes, let's say with regard to helping patients use technology to help them manage their condition. So yeah, it was a good sort of new space for us and the general community to sink their teeth into. Janet Kennedy (08:03): All right. And I don't want you to have to give away any secrets here of your future podcast episode. But what was the technology that won? What was the idea? Joe Kim (08:11): It's mostly in the public domain. The technology was very simply a VR virtual reality format for children to focus their ability to understand their disease in a way that made sense to them. And specifically after some sort of colonoscopy or invasive procedure that they couldn't get their heads around and leaving that procedure in the fog that they're in. And then trying to learn about what just happened and understand the disease was just a big gap left in the whole health system. And that's no one's fault. It's just some unfortunate set of circumstances that leaves the patient kind of in the dark, so to speak. So this virtual reality application is supposed to really help a patient see exactly inside themselves and understand their disease up close and personal. Janet Kennedy (09:02): Well for children being sick is so frightening and some of the procedures they go through are uncomfortable if not painful. And the more they can try to understand at their level, the better off they're going to be. What was your role with the IBD challenge? Did that come out of your group? Joe Kim (09:19): No. So yeah, our group is pretty, pretty broad and it covers a bunch of different verticals that are required to bring digital health life. Our group is actually translational technology and innovation is really focused on sensor driven digital biomarker development. My team doesn't build apps. What we try and do is look for all the various sensors out there and you know, there are dozens of them. This is not just Fitbit and Apple watch. There's dozens of sensors out there that are all perfect, so to speak. Meaning they all behave a little bit differently. They have different combinations of sensors. They sample at different frequencies. Their battery lives are different, their charging modalities are different, their form factors are different. And what I mean by that, they're all perfect is depending on what you're trying to study, what you're trying to measure, there may be the right device for you. Joe Kim (10:09): Don't think that one device is perfect for all indications and sometimes there are these invisible so to speak. So the sensors that you don't have to wear but are monitoring you in the home. Well that's great too except you know many people leave their homes so for certain diseases and measurements it's not that useful. But if you're going to measure things that happen at night in the home then great. It's even better. So this is part of what our team does is make sense of all those sensors and help figure out new ways to measure things using those sensors. Our team is pretty diverse. It includes biomedical engineers, behavioral scientists, physician scientists, clinical research, operations professionals, data engineers. We're really excited about the team we've put together. I think for too long it's been teams that are just commercially focused or teams that are just technology focused or teams that are just sort of clinical research focused. We believe you can't do this properly unless you have that multidisciplinary team and everyone needs to start learning about each other's worlds because you can't just throw a Fitbit in a study and expect to make hay out of that. If you don't do it responsibly rigorously and understand exactly what you're getting into. Janet Kennedy (11:26): All right, so that leads me to a bookend to question. One is it kind of starts with as you refer protocol design that that if the study isn't written to accommodate this digital technology, then it's kind of hard to squeeze it in later in the trial. You're now working with patients. So I'm curious about protocol designers. Are they part of your team and how are you engaging patients in the evaluation and use of any of this technology? Joe Kim (11:54): To the extent that we are all sort of that protocol designers aren't a role and that we all design them as teams. Yeah, so as a team, because we're focused on this squarely and not, I say this with respect, not distracted by developing a medicine. We're all hired just to do digital biomarker work. We do this together. As you can imagine sometimes doing this early work is a square peg in a round hole, so we've had to really work the system to make sure that the other controls that are around protocol development for us to do this responsibly are sort of dialed into what we're trying to do. We're not giving some money an interventional drug where we don't have to look for a safety signal for that interventional drug. So there's lots of different nuances there. We work hard to really figure out how this will land operationally or pragmatically for a patient, particularly if we do it virtually, and we do a lot of virtual trials too, which is easier to do now because there's no drug, there's no medical procedures. Joe Kim (12:59): In short, you're mailing them a device or devices to where and they have to use apps to participate in the research and the data that gets pulled passively. But as simple as that is, it can be quite a learning process when you start to deploy these things. Something as simple as the way a question is ordered either together on the screen or not can create a lot of confusion. Or you know, if the battery is not charged and they don't know that it's not charged and the data's not streaming to the phone, right? There's only so much all devices can store certain amount of data before it stops collecting. Totally. So then you can end up with these empty spaces of data. It really depends on what you're trying to measure. So if you're trying to measure sleep, maybe a wrist worn thing isn't all that necessary. I don't care about what's happening during the waking hours. You should wear something only at night when it charged during the day. But if you're measuring something like activity and exertion, well then you can take it off at night, right? These are just simple ways to think about it. So it really starts with what you're trying to measure and then you try and design the experiments. Janet Kennedy (14:06): It sounds exciting. This cross functional team that really has kind of a whiteboard open to new innovation ideas. I love that. But it seems to me that's not going to happen unless your C suite is on board. So is this top down or did you guys push up and say we need to have this? Joe Kim (14:26): Yeah, this was a top down approach. Well, not from the very top of the very top. You know our C suite styled into this. It's not easy to just start a new thing called a digital health office and have that be publicly known. So when that happens you can bet that it goes all the way up to the top. You did ask another question around like how we get patients involved. Fortunately here at Lilly we have a pretty good history bringing patients into our drug development design work. You may have heard of something called Co-Lab or Co-Design. It's still happening now, but two of my great colleagues, Megan Laker and Susan Gilchrist, they are at Lilly running that capability now. We actually have a podcast episode on that too. I think it might be podcast number 11 at any rate, and we go into a deep dive of what that actually looks like, but in a nutshell, what that means is we literally bring patients into the company and we sit them down with the scientists and other site personnel and we work through the real issues of how this research may play out on people's lives. Joe Kim (15:32): We start off with a whole empathy session around, you know, what is a day in the life, a week in the life, a year in the life as it pertains to a study and really try and overlay some study design concepts and see where some of these things match up or don't. There's not like a recipe to it. It's really, it starts with empathy and listening and then really great dialogue around trade offs, which surveys can't do, right? You can't do this through a questionnaire or discussion board. It's gotta be live. It's messy. So we'll be using that framework as well or some version of that and just riding their coattails because they've been doing this for a while now. Janet Kennedy (16:12): Well, I understand you also had a podcast episode that I listened to having to do with matching up employees at Eli Lilly who had very serious health issues with individuals in other countries and they did a program together. So you know internally you have your own small ecosystem of people as patients. Joe Kim (16:34): Yeah, that was a very interesting episode. Terri Wingham, she was our guest on the episode. She's the founder of a company called A Fresh Chapter and she connects cancer survivors and brings a few from Lily and we go to developing country who needs help in some way and everyone pitches in and it's just a different way to continue one's healing. Yeah, that was a, that was a really amazing episode. Yeah, you should. You should check it out. It sounds like you did, but others should check it out if you haven't hadn't heard it. Janet Kennedy (17:06): Well, every episode you mentioned, I will put a link into this podcast so people can click right over there and see it. And yes, I love that idea that you are a global company, but it was very, very cool that you had your own employees who had had that serious health experience really going and working with folks in another area which made them feel so much more empowered so much outside of themselves. The problem with any health issue, and it's different for everyone, you get so focused on your own health is sometimes you kind of lose sight of the bigger picture. And this sounded like all of those folks really grew and benefited from the experience. Joe Kim (17:50): yeah. And these connections with patients get very deep and we need more folks in the company to build the right kind of relationships where possible. For example, myself, for a long time I've been building relationships with patient influencers and I gotta be honest. While it made sense to me sort of intuitively for awhile I was struggling with the quote unquote business value of doing that because if I was not responsible enough I could step on a landmine, but when the podcast came up as an opportunity and we really thought about what kind of guests we wanted to share, it was clear to us that in a lot of the other science podcasts out there, there was a lot of scientists on there and that's great, you want, you want experts on there, but there was a lack of the patient representation and we decided that that's a voice we wanted to amplify more and we wanted to bring them on together with scientists often to have a deeper dialogue around the state of medical advancements in that specific disease and what's on the horizon. Joe Kim (18:58): I think it's rare that many patients get to sit down with a leading scientist in that field to have some sort of exchange there. To bring it full circle, all of these patients that I've been sort of building relationships with. All of a sudden now I had people to call on and say, Hey, would you like to be on this podcast to talk about this disease that I know you're an influencer or you have a strong audience for? And because I've built that investment, I made that personal investment over the last five or six years. I wasn't coming in cold as some weird pharma guy, Hey, would you like to be on my podcast? And everyone was just super gracious and if they can fit it in, they did. I have plenty more I want to have on the show. It's really great now that wow, there is a quote unquote business value to me, building relationships with patient influencers. They're happy to talk to me on the podcast, which is, which is fantastic. Janet Kennedy (19:56): Well, I was noticing that the last episode of your first season, Episode 11 is the promise of genetic innovation and cracking the code of ALS as a lay person, not a scientist and not a medical professional, I'm coming at my information to medicine literally through social media, through podcasts, through posts that people put up there and I did think this was fascinating that you had both Brian and Sandra with I AM ALS representing a patient centric viewpoint coming on your podcast and then you also spoke to your Lilly scientist Andrew Adams about some very sciency stuff. That's something I will admit I can't pull off, but I love the fact that you are able to be the interpreter for both groups, enabling patients to speak to scientists and scientists to explain to patients the complexities of of these diseases. Joe Kim (20:48): We partly just got really lucky there in terms of the timing because Brian was in town, but he's really well known in the Alice community and Andrew is just focused on some really exciting genetic modalities to think about helping a number of diseases because this isn't just focused on neurodegeneration. We really want to try and do more of that where we get patients to actually sit down and because they were there across the table from each other and it was really great to have that kind of interaction. We may even do it a little bit more purposefully and just have it just be about the disease and where it's going from a medical, scientific perspective. Certainly not every episode needs to be that way, nor nor do we want to always do those things, but the more we can do that, I think that's a really exciting format because you don't see that. I haven't come across the science podcast that way either. So yeah, this has been super exciting to do. Looking forward to the next several episodes coming up, Janet Kennedy (21:44): You had 11 episodes in your first season. Are you going to do this quarterly, semi-annually? What? What's your plan for the podcast? Joe Kim (21:52): We only launched in May, I think we recorded earlier than that. I think we're really going to shoot for once a month and we've already started recording late last year and early this year because of who we are. It has to go through a pretty rigorous process to make sure we're not getting into trouble for saying the wrong sorts of things, but you know, we're not talking about products. We're really just talking about stories that inspire scientific advancement. We can all identify with some of these diseases because there are people in our lives to have these things. Nearly everything that's been on the show, you know, I've, I've had some sort of personal connection with one of these illnesses. It's great to use some of my background that I've ditched in my early career. I was a science teacher and while I loved to teach working in a school environment, a traditional school environment was just, it didn't fit me. But to your point about having scientists and patients come together, they don't often talk the same language. I mean patients are really sophisticated now, but there is a certain level of biology that if you understand it more deeply, you'll get even more out of it. And then scientists, they've been talking to each other for so long, you know, they're using $5 words that no one else really uses. So if I can be that interpreter, that's really a great place for me to be. Janet Kennedy (23:12): And that's a challenge, not just on the pharma side. That's a challenge in healthcare when physicians are explaining issues to their patients, you know, are they speaking in plain language? Are they easily understood? As a matter of fact, I did an interview with your global health literacy person and that was the focus that we've got to put this information out in a way that people can understand it and take action with it. Joe Kim (23:37): Yeah, I mean just say the word rash, right. Don't, don't use the Latin words that that the five different Latin words that describe rash. Just saying rash. Right, or it works versus it's not working. Janet Kennedy (23:51): Absolutely. Well, tell me a little bit about where you think we're going in clinical trials. When you joined the pharma industry in the late nineties early two thousands you had one experience. If somebody were coming into the industry now, I'm sure it's a totally different experience. So over your 20 years or so, what do you see that has really changed in the industry? Joe Kim (24:14): The use of data to make decisions has been really transformational. I think I recall one of my earliest clinical trials I was working on and we were selecting which sites to go to. We literally had a stack of resumes that'd be go through and say A, B and C like yes, maybe no, which is not a great way to pick sites who might be useful or great at enrolling and conducting the trial. So even from a site selection standpoint, you're using more data to think about who's been really great in the past. Do they have access to patients? What does their demographic look like? So using a lot more data to do that. And then even further upstream thinking about medical informatics to design the patient eligibility criteria. So in the past you'd just be looking for, "give us all men who asked for directions when they're lost", right? Joe Kim (25:07): Not a lot, but now we have data to say, Hey, we want people on drug A not on drug B with this condition and not, and then let's see if that patient actually exists because that might be a perfect one for this study. But if they don't exist, this is not perfect for anyone. So we can use that kind of data to really find the right trade off between stringent enough criteria so that we find a signal, but at least have a enough abundance of patients. So those two things are been really game changing in terms of how we design protocols and set up the operations to do that. I think a lot of people are also thinking about this notion of a sightless trial or decentralized trial. I don't want to use the word virtual. I think that really means to trial without patients. Joe Kim (25:53): So like a simulated trial. So we should, as an industry get away from this virtual notion. I'm really think a bit more about these centralized to some degree or location flexible is probably more even more accurate. But it's the idea of how does a patient participate in the study without always having to go to the clinic. Janet Kennedy (26:11): How do you feel about the word hybrid? Joe Kim (26:14): Well, I'm not sure what you're hybriding what's the two, but really it's about flexibility and location. That's the name of the game. But you know, if you think about medical research as a set of medical procedures that all have to be done within a window, then you can really start to take apart this notion of a visit, visit, one visit to visit, three, forget to visit. Here are the procedures that need to be done, the activities. So you think of more of like an activity based set of medical procedures. Joe Kim (26:46): Now, which one of those can be done with telemedicine? Which one of those can be done with in home health, which can be done at a clinic, which can be done at retail, right? So not everything can be done at home. Not everything can be done through telemedicine. So it's really thinking about which ones can be done in a variety of, of ways. And even then we've discovered at Lilly through some of our research that a good healthy portion of patients don't want anyone coming into their home. They just don't, and I get that. My home is a mess. On Wednesday, I'd rather just go to the doctor. Now, do I want to go to the doctor to do a visit for three hours? No, but it'd be great to do what I can in that window if it takes me 30 minutes. That's how we have to start. You have to dismantle the visit construct and just think about individual activities. Janet Kennedy (27:35): Now you use the word retail. Are you actually thinking like someone going to a CVS or a Walgreens or a Walmart just to have a simple blood draw done or something like that? Joe Kim (27:45): Sure, that's possible. Right? It has to be done responsibly and rigorously, but even in some of our early pilots of flexible location trials, one of the drugs was marketed, so we were able to have patients pick it up from your local drug store instead of having them come into a site. Now this is a very different kind of study. It wasn't part of the efficacy trial, it was more real world evidence, but at any rate, it can be done under the right context. So it's really just about thinking under what context can X, Y and Z be done versus saying this can't be done, so you have to sort of pick and choose. Janet Kennedy (28:21): Are you seeing enough evidence that it's making a difference that it really can impact either the adherence levels of patients or the persistence of taking a drug by incorporating a variety of different ways to engage with a patient? Joe Kim (28:36): I think we are still trying to get good use cases under our belt. We being the industry in terms of what kinds of trials are fit for this kind of thing. The logical argument makes a lot of sense, right, so there is a logical argument there which is if you don't make it too inconvenient on a patient, they'll do more of it. Right? That's the very same thing to say. Now at the same time, there is a component of clinical research where the bond between the patient and the clinic staff is such that that's also a main contributor for why patients either stay in the study or are able to follow along what they're committed to do. Because you've got someone on the other end expecting you to cross all the T's and dot all the i's, and this is a, this is a component and behavior change. Joe Kim (29:31): There is a social component in behavior change and participating in research is behavior. Change is a social component that if that's there, you're more likely to have people stick to it when that's absent and there's no evidence of a larger connection with a person or people. Sometimes you could get really easy to drop off because guess what? No one's watching. No one cares. A research kit study came out years ago. Stanford, the heart health study. I joined that because it was super easy and I was able to do a lot of the stuff because I suppose super easy. I was walking my kids to the school. I did the six minute walk tests, but then after awhile I stopped doing some things. Now I get reminders. I ignore them. It was actually very easy to drop off without anyone calling me on the carpet. So you could argue that if you do everything virtually, you run the risk of people just disappearing because there's no commitment. There's no gym buddy. Right. To help keep you honest. Janet Kennedy (30:27): Right. Definitely. When we talk about patient engagement, a lot of people will think it's about pushing a button and really it's also making sure that that patient feels like their actions matter. Joe Kim (30:40): That's right. Janet Kennedy (30:41): Tell me a little bit about your road show when you hit the road in 2020 I know you're going to be doing some speaking engagements. What are the topics you're addressing this year? Joe Kim (30:51): Well, because of my role as squarely focused on digital health and sensor research, I have to be careful not to be swimming outside my lane, though I have some knowledge and experience with things and traditional drug research. It's not my role anymore, so I have to be careful to let my other colleagues to represent themselves or our company for those sorts of things and having me kind of stay in my swim lane. While I'm happy to do it, I have to do it with integrity, I guess. So I've actually pulled back a little bit because to be frank, I'm not an expert in digital health and sensor research. I'm an amateur here and that's partly why I took the role is I want to be the dumbest guy in the room. Let me learn and get up to speed and grow my skillset and knowledge base. So I'll do a lot more listening actually this time around. But there's plenty of me on the airwaves through the podcast, so hopefully people aren't going to miss me too much. Janet Kennedy (31:49): Well, I think it's going to be a very exciting year, 2020 or 2020 whatever you want to call it. We're going to have, I think a lot of interesting changes come about as we finally fish or cut bait and we, as an industry, really start to include digital health and new technologies into the clinical trial process. 'm very excited about what's going to be coming up in the next year or two. Joe Kim (32:17): Yeah, me too. I think this notion of digital biomarkers is a key enabler of decentralized trials, right? So one thing that anchors people or science to the clinic is the fact that an endpoint needs to be done by somebody in person. And as long as that happens, you're not going to enroll somebody a hundred miles away. They have to be within a driving distance, reasonable driving distance, except for some exceptions like rare disease and oncology. But for the most part, if you're not in a reasonable driving distance, you're not going to enroll because the primary end point has to be done at the clinic. What digital biomarkers enable is for that to be done remotely through a sensor and now you're not tied to the clinic if you don't want to be. Now I'm generalizing, it's not going to happen for every single kind of study, but that is one thing that is definitely anchoring research to the clinic. So the more digital biomarker work we can get, the faster we can get to decentralized flexible location trials. Janet Kennedy (33:18): Absolutely. Well, I'm voting for that, and I really hope that that's going to be something that becomes much more of a reality going forward so that we can get much better representation in diverse communities and in rural communities involved in our clinical trials. New Speaker (33:34): Yeah, likewise. Janet Kennedy (33:35): Well, I can't thank you enough for being part of this podcast. Joe, you've been listening to "People Always, Patients Sometimes" with my guest, Joseph Kim, who's the senior advisor, digital health office, translational technology and innovation for Eli Lilly. Thank you so much for being here, Joe. Joe Kim (33:51): Thanks for having me, Janet. It was a lot of fun. 

Sleep. We talk about it. We worry about it. We long for it. This has long been true for most menopausal women, but now it’s an issue for everyone in this time of uncertainty. So, we called NYC Sleep Doctor, Janet Kennedy, PhD, to find out why we can’t sleep and what we can do about it. Janet explains the difference between physiologic and psychologic sleep disorders and discusses the role estrogen and progesterone play in our slumber. Most of all she teaches us to let go of expectations of sleep. Instead, we need to learn to let go, trust our bodies, and trust that sleep will come.  Look for Dr. Kennedy’s soon to be released podcast The Sleep Tune-Up where she will be working with individuals, walking them through some simple solutions so listeners can learn how these various interventions can make a big difference. If you want to be a guest on The Sleep Tune-Up Podcast contact Dr. Kennedy at thesleeptuneup@gmail.com For more information about Dr. Janet Kennedy's sleep coaching check out her website nycsleepdoctor.com The Good Sleeper: The Essential Guide to Sleep for Your Baby--and You by Janet Krone Kennedy, PhD on Amazon Connect with Dr. Janet Kennedy on Twitter @nycsleepdoctor Connect with Dr. Janet Kennedy on Instagram @nycsleepdoctor Join NYCSleepDoctor on Facebook

Tom Rhoads (00:03): In our previous podcast, we interviewed human factors expert Christina Mendat. Christina worked with us in some of the software design for Spencer. I thought you would also enjoy hearing more about the development team at Spencer Health Solutions. So we invited our software product owner Mary Wrenn to join the podcast and tell us how she works with spencer and our engineering team. I'm Tom Rhodes, CEO of Spencer Health Solutions and I hope you enjoy this episode of "People Always, Patients Sometimes." Janet Kennedy (00:33): You're listening to "People Always, Patients Sometimes" podcast production of Spencer Health Solutions. I'm your host and my name is Janet Kennedy. I am really looking forward to learning something new during the conversation today I have Mary Wrenn who's our software product owner at Spencer Health Solutions with me. Welcome to "People Always, Patients Sometimes." Mary Wrenn (00:54): it is wonderful to be here. I am so excited to talk to you. Janet Kennedy (00:58): Thanks Mary. You know, this is one of the interesting things about a work environment where you see somebody every day, you talk to them every day, but sometimes the actual process of what they do is a mystery. So I'm really looking forward to having a conversation with you. Mary Wrenn (01:15): Absolutely. I think we know each other well from meeting in the kitchen, but I'm excited to chat a little bit more about what I do. Janet Kennedy (01:21): So you are officially titled a software product owner. Do we have more than one software? Mary Wrenn (01:28): Nope. There's just one software platform across the suite of products, the mobile app, the web portal, and the device itself. I am the product owner for all three of those. Janet Kennedy (01:40): So what does that mean? Are you the engineer on the train? Are you the conductor on the train? Are you the caboose on the train? What is your role and how do you keep things moving forward? Mary Wrenn (01:49): Yeah, so I would say I'm kind of like the conductor/cat herder. So I essentially help to keep things moving in the right direction. Sometimes I'll be picking the way the tracks go or sometimes we'll be talking about the best design for the train. So it's a little bit of everything. But for the most part it's executing and kind of getting into the tactical details of how we do what we do. Janet Kennedy (02:14): I imagine when you joined us you really felt like you've jumped off a cliff and now you're in the deep end of the pond as it were. Was it overwhelming or is there something about software product ownership that you can apply skills from your previous experience to here and settle in fairly quickly? Mary Wrenn (02:34): I actually came from another kind of software product owner, product manager role. I was originally at United Health Group working within Optum, so I consciously decided to go from a really large company to a smaller company. I was really enticed by the fact that I could wear a lot of different hats and I've definitely gotten to do that here. I really enjoy getting to do a lot of different across the product suite, whether that's design, technical implementation, or really just getting into the details of how things are going to work and how people are going to use them. Definitely felt like I was kind of going from walking to running a marathon, but I really enjoy it and I liked that the software product ownership really has a lot of different facets to it. Janet Kennedy (03:21): In a sense, we've gotten virtual. We've been able to see a sneak peek into everybody's homes and I was very impressed that you actually had in your home a giant whiteboard that was filled with all kinds of information. So you're a very organized person, Mary. Mary Wrenn (03:37): Thank you. Yeah, the whiteboard is a key. Pretty much anything from any conversation we have is going to get thrown up there. I'm trying to do color coding, but I think that was an ambitious idea that probably got thrown away after meeting number 10. Janet Kennedy (03:50): Well, I can relate to that. So I'm curious, you've been in healthcare then for a while. Is there anything unique or different about software product management in a healthcare realm versus a traditional B2B or B to C business? Mary Wrenn (04:07): Definitely. I think so. I feel like healthcare is really the most intimate industry of any of them. You touch people's lives and really personal places and you really get to see people at their most vulnerable. But that's really what enticed me to healthcare in general. I really liked that you can make an impact on people's lives, whether that's directly or indirectly. So I liked that you can use software as a tool to really help better people's lives, even if you're not directly with them, say like a nurse. So I think healthcare is really special. It comes with a lot of responsibility, but it's, it's really exciting how much change you can drive. Janet Kennedy (04:45): Well, let's talk about change a little bit. The one thing that I know about software is you're always working on something. It is never done and there's always more to do. So when you look at plans for Spencer, for instance, how far ahead are you looking? Is it just trying to get to Friday or is it three weeks, six weeks, six months, five years? How does the planning work for something like that? Mary Wrenn (05:11): It depends on which aspect of the product in general you'll be looking at. So there are some things that when we're designing product features, we're trying to look really far out five, 10 years in the future, even just to make sure that we're making a really flexible design. That's a lot of the architecture decisions, like how we're setting up things in terms of how we'll read bar codes or how we'll add different countries, things like that. Then there are other shorter term goals, like how are we going to wrap up this project to make sure we get this to the right patients at the right time. So our roadmaps, really a mix, we usually are organizing things kind of by release and customer need. So that'll prioritize it in the next few weeks, the next few months. But within that we're trying to make flexible decisions so that way anything we're doing now can be iterated on in the next few years. So our roadmap is weekly, quarterly, and yearly. Janet Kennedy (06:08): And when you're designing something, you need to look out to the future because when you get to two years from now and you want to add this significant element, but oops, if you didn't do something two years ago, does that mean it's impossible or you're just going to have to do all kinds of workarounds to make it happen? Mary Wrenn (06:28): So it really depends. Right now, for instance, we're in the process of really standing up a brand new product software wise. So when I came in we were really in the process of redesigning and rebuilding things from the ground up. So there were a lot of those decisions that were kind of baked in in terms of, well if we change it this way we'll have to go back and completely reconfigure things. Or if we do something this way now then it's going to be set that way, the future. So really we try to make the most flexible decisions we can, but try to align that with some of the goals or needs we know are coming. So for instance, previously we were very much aligned to care management and sort of this thought that every patient is going to have one caregiver and it's going to be a very linear relationship. Now we're trying to make that a flexible architecture where it won't work just for care management but for clinical trials also. And those are very different use cases. So what we're trying to circle back, we're trying to make sure that we don't have to go back and say, Oh well if we had just done this, you know, two months ago, this would be so much easier. We're really trying to make things so they're modular and can fit together. Janet Kennedy (07:37): Oh, that makes a lot of sense. Now you mentioned a cat herding and I do know what that's like because I'm on the marketing side and there's a certain amount of cat herding there as well. I'm curious about how people interact together. Is it a domino effect where if you're flipping the Domino's over and they're running forward, but then a domino is missing, everything comes to a stop or have you got parallel paths and somebody can catch up if they're a little behind but it doesn't stop the whole workflow? Mary Wrenn (08:09): Yeah, so we're currently trying to make the team as cross functional as possible so everyone can do a little bit of everything. Obviously within that there are people who are more embedded in their specialties. For instance, we have some people who are really good at the embedded software or we have some people who were really good with Bluetooth or others who are really good with the UI. So we try to make sure that we can have these parallel paths running, but there will always be some dependencies. So a lot of that comes into how our planning, so we'll use a basically an agile process to go and plan out our sprints. We'll do story points and within that we like to get the workload on people so we can ensure that not everything is just running towards one person and then it's bottleneck did and that person just feels of pressure. So we try to spread the dependencies as much as we can. Janet Kennedy (09:00): I had a great conversation earlier with Christina Mendez, who has a company called human factors MD. And her role is to come in and help put together the relationship between psychology and engineering. So understanding how people as people work, look at things, interact, and then how engineering designs the things to work best with people. So I'm curious, is this an ongoing thing? Do you use human factors in a lot of the decision making you're doing or is it literally just for the interface between the user and Spencer? Mary Wrenn (09:41): So it's really across a lot of the product in general. You know, granted most of that focus is on the interface itself, which is mostly the device, but it also comes into play on the web portal, Spencer care and on the mobile apps, but psoriasis. So we really try to look at the ways that people will use that and the different use cases fair. But even into things like our API is we have some customers who aren't going to be sending us information directly through the API. We want to make sure that those are easy to use as well. So there might not be a graphical interface there who we want to make sure that it's logical and it doesn't need pages of explanation just to use a simple function. Janet Kennedy (10:20): I tried to give Christina credit for the personality of Spencer and she said, Nope, no, that wasn't her. So who came up with and how do you manage the personality? Because I honestly feel like Spencer is a person. He has a fun way of speaking, he's very relaxed, he's very engaging, he's very easy to use. So is there something that you do that your team does that gives Spencer personality? Mary Wrenn (10:49): So we really made sure to work closely with marketing in general. Gail was a huge help in terms of really imparting that personality. I was really lucky when I first got here that I had a lot of time to sit with her and really go over all the wording on the screens and say, you know, how did these look? Even things as simple as error messages saying, does this really fit his personality? And I was really able to get a strong sense of who he is and how he talks to our patients. So we were able to really incorporate that into the design of the screens and all of the logic within that. So anything from the error screens to how he's telling you to take your medication? We really just sat down and went through it step by step on how we want him to communicate with patients. Janet Kennedy (11:33): Speaking of communicating, we're very excited that Spencer has headed across the pond to Europe and that the first country Spencer has been in that doesn't speak English, is the Netherlands and so Spencer's now Dutch speaking, what was it like to take our existing product and redo everything in the Dutch language and then now I guess we're going to be looking at French and German and Spanish, et cetera. What is that like translating a complete platform to another language Mary Wrenn (12:07): in a word difficult, but it was a really great challenge actually, I think for most of us on the team, this was the first time we had done something in another language, so there were a lot of decision points and things that you don't even think about that we really had to consider. So even things like the word, okay, is that going to fit on a button to the colors mean the same thing to the symbols mean the same thing and how do we make that really universal? So we really had to think about how we were architecting the platform and even how the text and the colors and the voice prompts would all interface with each other. There's some important things about the voice prompts as well. You want to make sure that he's actually telling people to take their medication and not to say, well, if you want to do, maybe go take it. Mary Wrenn (12:52): So it was a lot of things like that. The process itself actually I felt like went pretty well. It was a learning experience at first for sure. We realized for instance, that Dutch has a lot of really long words which don't necessarily fit on buttons and the current font size that we have. So we actually had to reconfigure the UI a little bit to accommodate that. We also had to adjust how we were displaying questions when we were trying those out with some French examples just to see how those would look. So it actually informed a lot of our design, the sizing, the display. There were a lot of things we had to account for that we didn't initially in English. Janet Kennedy (13:29): What do you consider some of the biggest challenges that you have to deal with in trying to make Spencer work in multiple types of business environments? Mary Wrenn (13:41): The overall architecture, because if you're taking care of your grandma, you would kind of need a different machine and you would look to it for different uses than you would if you were a clinical trial trying to give a drug to hundreds of patients. But fundamentally it's all the same platform that's going to be used. So you really have to design that very flexibly so that way you can accommodate all of those different things within the same platform. So it's really important to keep in mind the personas of who's going to be using what and making sure that everything will work to align with those use cases and work in their best interest. I think the most challenging piece is just making sure that you are staying flexible enough that the product is usable for all the different personas. Janet Kennedy (14:27): So as a marketer, I haven't been as involved as my boss. She's been very involved in getting Spencer launched over in Europe. But one of the things that I did get to participate in was selecting voices for the Spencer voice. So Spencer is sometimes female and sometimes male, which I think is interesting, but I love the reaction to the voice we chose for Dutch. And I wonder if you had heard the story and can tell everybody a little bit about what we found out once we pick the special voice. Mary Wrenn (15:02): Absolutely. That was definitely one of my favorite parts of the translation. So initially we got to just all sit around and listen to these lovely Dutch voices, read us things we could not understand. We finally landed on this really nice, soft sounding female voice and everybody was like, Oh, I really like her, chose that, didn't think much of it. And as she was reading out the video tutorials, we got a feedback from our Dutch partners that apparently this woman had narrated animated shows for kids in the Netherlands and it was really popular. And so one of our business partners would say, Oh, it's so soothing. You can feel like I'm watching cartoons. It reminds me of childhood. Janet Kennedy (15:41): That's awesome. We found the Mary Poppins of the Netherlands to be the voice of spencer. That's pretty serendipitous. I think Mary Wrenn (15:49): that was my favorite. I think she has a lovely voice. I love that she explains how to use Spencer in Dutch. You're like, I don't know what you're saying, but I love it. Janet Kennedy (15:57): Well, Mary, it sounds like you actually enjoy your job. Mary Wrenn (16:01): I do. I really like a challenge and this always keeps me on my toes. I love that. At a small company like this you can wear a ton of different hats and do a lot of different things, so I think it's been a great growth opportunity. Janet Kennedy (16:12): Well, I look forward to the time when we can all be face to face again in person as opposed to virtually, hopefully covert 19 will be resolving itself in the not too distant future so we can get back to working together a little more closely. Mary Wrenn (16:28): Absolutely. But in the meantime it has been wonderful to speak with you at least virtually. Janet Kennedy (16:34): Thanks, Mary and thank you for downloading this episode of "People Always, Patients Sometimes." if you enjoy the conversation, a review and a rating on iTunes will help us find more listeners. This podcast is a production of Spencer health solutions.  

Understanding human factors is essential when designing technology that people interact with, especially when you're dealing with unique healthcare populations such as the elderly. Our podcast guest is Christina Mendez, Managing Director at Human Factors MD. Christina played a role in the early development of our Spencer device and brought the human factors perspective to our design team. We hope you enjoy listening to Christina's interview on the "People Always Patients Sometimes" podcast. Speaker 1 (00:34): You're listening to "People Always Patients Sometimes" a podcast production of Spencer Health Solutions. My name is Janet Kennedy. I'm really looking forward to learning something new today during my conversation with Christina Mendez. She's the Managing Director at Human Factors MD. Welcome to "People Always Patients Sometimes", Christina. Christina Mendat (00:53): Thank you for having me today. I really appreciate it. Janet Kennedy (00:57): The focus of our conversation is about human factors and some people listening will know what exactly we're talking about and others may not be so sure. So we're going to start at the beginning and can you describe what human factors? Christina Mendat (01:12): Human factors is the marriage of psychology and engineering. And what that means specifically is that on the psychology end of it, we understand the knowledge of human capabilities, limitations, and predispositions. And then on the engineering side of the house, we are focusing on how to apply those understandings to the design of tools, work environments, systems, hardware, and software. Does that make sense? Janet Kennedy (01:38): That does make sense. But let me ask you this. How did human factors even come about? Christina Mendat (01:45): Historically speaking? Human factors started around World War II. A lot of us think of aviation psychology during that time. This is a time when pilots were starting to have issues related to the control panels in their planes and there were some pretty scary crashes that occurred during the time. Our discipline really came on the scene to understand why was this happening, what was out of sorts when it came to the control panels and what could we do to make them better? Basically the discipline started then. They were known as an aviation psychologist or experimental psychologist. Sometimes ergonomics is also another term you might hear quite frequently. But that's where we started and that was quite a while ago. It's always interesting to me that our disciplines started so long ago, but really only embraced in the healthcare industry around the 2010 period. Janet Kennedy (02:36): Oh, that's so fascinating. Two of my brothers were pilots for American Airlines. And when I see pictures of them in the cockpit, I can't imagine knowing how and where and what to push the buttons. And it all has to tie into a sense of logic because you just can't have it everywhere. So that makes perfect sense to me. Christina Mendat (02:57): Exactly. So how should things laid out? How much information is a pilot processing at any given time? And understanding that information, where should things be placed so that it will make sense and so that they can do their job efficiently. And now we're doing very similar things in the healthcare industry. Janet Kennedy (03:13): Well, I envision again, a situation where we are now dealing with COVID-19 there are a lot of moving parts, a lot of pieces of equipment that need to keep people alive from the ventilators to the smart beds to all of that equipment. And it has to work well together and it has to be intuitive because even if you're trained on the equipment, but you're going from place to place to place or patient to patient to patient, it needs to be the same everywhere and it needs to be something that is really straightforward to use. You don't want to be getting the guidebook out when you're trying to deal with a crisis situation. Christina Mendat (03:49): Absolutely. There's one thing to engineer a product, there's another thing to engineer a product for human use, and that's what we're focusing on. We need to be engineering for humans, not vice versa, so, and how do we do that? That's what we're about. Janet Kennedy (04:04): Christina, how did you get involved in human factors and particularly in the healthcare field? Christina Mendat (04:10): Well, that's an interesting question. I ask myself that a lot. I feel like I was very fortunate to find this discipline as an undergrad, actually started as a microbiology major, so very interested in science. As I started to work on that degree, I started to gravitate a little bit more. At the time, my minor was psychology and I started to really start to learn more and more towards psychology. And at some point when I was ready to graduate, I had changed my major, like a lot of us do of course in college to the psychology of the minor is still on the micro. And I was asking myself, how can I marry more of the social science with the hard science? And so I started doing some research and I landed upon a very exciting sounding program at North Carolina State University, which was at the time called experimental psychology and ergonomics and decided that's what I was going to pursue. Christina Mendat (05:01): It was an absolutely perfect fit. It balanced the social and the physical sciences in a way that made me feel like, wow, what can we do with all of this? That there's so there are so many possibilities by marrying these disciplines. And during my graduate degree, I started to teach like a lot of us do. I was doing research and then I started to actually consult on the side as well for a company and really just fell in love with the consulting side. And being able to apply my learnings and helping companies really develop robust products that was taken to account human capabilities and limitations in a very meaningful way and that's where I've been ever since. A lot of us human factors professionals actually started out in software design because at the time that was very relevant. A lot of telecommunications, that's when cell phones were coming out, so a lot of us, including myself, worked in that space and through the years really started just honing in on skill sets and that's when I just fell in love with health care side of things and realize that healthcare is so broad, there are so many opportunities, there are so many lives and they can touch. There are so many products we can touch on systems we can touch on for the last close to 15 years now. That's all I've really been focused on. Janet Kennedy (06:10): Did the human factors come to healthcare by a natural progression of learnings or was it kind of pushed into the field because of government regulations or a need to be more systematic about it? Christina Mendat (06:25): I think it's a combination of both of those actually. There was some early guidance, some FDA guidance in the mid-nineties around human factors that some companies followed and some companies did not follow. Typically when the FDA releases these guidance documents, they always say, you know, this is the latest thinking and this is the current guidance. I say, no, not always a mandate if you will. But then when 2009, 2010 hit, there was a release of a new standard, which was called HG 75 and that's when it really took hold in the industry and people started taking notice that, Hey, integrating human factors in my product development design cycle is no longer nice to have it's really something that we need to be doing. And the FDA is now seeing it as a requirement. And so that's what we really started to see the big shift. Janet Kennedy (07:09): I think that's absolutely fascinating and I imagine a lot of this comes from watching things like the iPhone and how people totally related to the way the technology was interacting with their lives and how Apple and other software companies were really tuning into how people were using their equipment. And it wouldn't take a rocket scientist to realize we've got to make work easier for our clinicians and these are the kinds of thought processes we need to go through. Christina Mendat (07:40): Yeah, and really about understanding their thought processes. Right? We have amazingly smart people in this industry, not just human factors, but engineering, industrial design, you name the discipline. There are so many smart, highly intelligent people that can develop almost anything. It's so amazing. But taking that step back and understanding what are their workflows as they exist today, what are things that we can't forget that works well for them. So it's one thing to develop a disruptive piece of technology that can be very exciting, but we also need to make sure that we're still embracing those things that worked well for that group of users. It really is a delicate balance when it comes to designing a new product or evolving products. To your point, making it effective and efficient, but then also making sure it's not so disruptive that people aren't going to understand it and it's no longer intuitive. Janet Kennedy (08:28): I am curious about the separation based on say a knowledge base. You have clinicians obviously with advanced degrees who've had a lot of extensive training and then you have the consumer that basically has been trained on their smartphone. Do you look at the consumer's perspective? Should we not assume too much? When we're taking human factors into consideration that even though we have doctors, nurses, clinicians who've had a high degree of training, that the interfaces of these machines that they're dealing with still need to be very straightforward and really easy to understand almost without the manual. Christina Mendat (09:07): Absolutely. You bring up a really good point and that's something that we try to emphasize to our clients quite a lot is very intelligent people in all industries. The doctors, you know, the radiologists, the surgeons, these people are so intelligent, but that does not mean that the interface, let's just focus on a software interface for that matter, for right now, it's okay for the software interface to be highly complex because they're so smart. That person who is so smart as also contending with the environment they're working in. They're also contending with various sounds and the environment they're contending with their patient that's in front of them right now. They're trying to figure out in their mind, what should the med order be. They need to input that. There are so many layers to what these individuals are processing at any one given time. To assume that it's okay, quote-unquote, to make the interface complicated because they're so smart, that's a big fail in my book. Janet Kennedy (09:57): It seems that actually if you're designing technology that is intrusive, that requires the attention to be taken away from the task that the clinician really wants to focus on because they have to deal with technology that is a total fail. What it needs to be is so easy to use that it becomes just a natural extension of the work that they're doing, not a distraction from the work they're doing. Christina Mendat (10:22): Absolutely. Absolutely, and that's not to say that there aren't some interfaces or some products that are going to be a bit more complex. You know if you're working with a cholangioscope or something of that nature, there might need to be some complexity that I wouldn't understand. Right because that's not what I do for a living, but I should do the best I can in terms of helping design that cholangioscope for instance, that it will be as intuitive as possible for that user. To your point, they want to be focusing on that tool, but they also need to be focusing on the procedure that they're conducting at that given time. Janet Kennedy (10:53): When you work with clients, are you predominantly working in the B2B space? In other words, designing and looking at human factors related to tools that professionals are going to be using or do you actually help with designing things that consumers or patients might be using? Christina Mendat (11:09): We do both. It's pretty interesting actually. A lot of the products that we've worked with, especially for instance in the combination product space that refers to products that are a drug delivery device, say for instance, so that could be an inhaler or that could be an auto-injector or a pre-filled syringe and there are more examples. I'm just given a few. But in that space, it's surprising how many consumers are using the product as well as healthcare professionals. So a healthcare professional may be responsible for training someone on how to use that product or even administering it themselves in a clinical setting. Whereas you could also have a 10-year-old at home giving themselves an injection once weekly. We look at both sides of that because the needs could vary depending on the user group that we're focusing on at any given point for that product. Christina Mendat (11:54): So for instance, a 10-year-old who is administering an injection product to themselves, we might need to be very sure that we have some very robust on device labeling in case that person needs to reference it to help them with the injection. Say, for instance, that child, the adolescent, whereas a healthcare professional may want to look at different types of information that may not be on the on-device label specifically, but it might be in the prescribing information. So we need to make sure that that information is clearly provided in that form as well. So for a lot of products that we work on, actually we have to look at both sides and sometimes they have similar needs, similar capabilities that sometimes it can be pretty polarized so we have to work with that and understand that. Janet Kennedy (12:36): Have you had a chance to work on products that the elderly might be using? Christina Mendat (12:40): Absolutely. Yeah. We do that quite a lot. You know what's really interesting about that is are just the statistics themselves, right? In our research tells us that 40% of the adult population takes five or more prescriptions a day. Right? Understanding how that affects their life, their mental state and how that affects how we design a product is just as important as being able to hold something in your hand. Again, you know, not to be redundant, but there are so many layers to peel away when you're designing products and helping these companies design the best product. It can be pretty complex. Janet Kennedy (13:14): You know, I'm interested in looking at this over time. You're designing products and you're looking at human factors related to how people are interacting with software and you've got a generation that didn't grow up with it. They didn't even in many cases have to use it in their work lives. They literally could have been analog their whole lives and then two generations from now, that's our "digital always on" generation, and I wonder how the technology in 20 years or 30 years will look versus the technology that we're designing now. Christina Mendat (13:50): Yeah, I mean that's something that can be quite a struggle right now because we are at that weird point right now where we're working with the older adults and even the elderly, to your point that is just learning software interfaces, are still have never really interacted with them because one, they might be fearful, no one's ever really shown them. There could be socio-economic status issues. I mean there are so many different things that could affect that and I'm not just trying to generalize. Obviously I was really interested, I found an article the other day that was saying that reportedly, you know, approximately 60% of older adults are now using the internet. Christina Mendat (14:22): But what was interesting about that status, despite the 60% usage, a great majority of those individuals still reported that they feel uncomfortable with technology and they don't feel proficient. When we think about software products, that could be an embedded software interface or a standalone software interface, how do we, again, not to be redundant, but strike that balance where that product is usable for someone in their seventies but equally usable for someone in their twenties meaning that you're not alienating the 20-year old that thinks they're super savvy and wants something fresh and sexy. Yet you also have the seven-year-old you don't want to alienate in terms of making it too complex either. Janet Kennedy (15:01): It's a very, very fine balance. Yeah. Well before we wrap up, I did want to ask you a little question about Spencer. Sure. Because you were involved in the project of the human factors design of spencer and what kind of things did you keep in mind as you were designing and what kind of observations do you have about how Spencer turned out? Christina Mendat (15:23): Spencer was a really fascinating program and multi-year programs, so it really just demonstrates how much that company is really focused on the patient experience and you know, I applaud them for doing that and we don't always see that in this industry. We would like to, but it doesn't always happen, but I did. I learned a lot from working on that product as human factors professional, you come into these things and I don't want to say that we think we know it all because we know we don't. That's why I never call myself an expert. I learned something new every single day and Spencer is a great example of that. You had some individuals, I'd have a 75-year-old person that could come in, use the interface just fine. Really no issues really early on in the prototype phase. That's when we're still just trying to work out the kinks. Not a problem, then I could have a 55-year-old come in and just struggle. It really just highlighted that I don't want to speak cliché and say age is just a number, but the experience is really the key. So that 75-year-old had a tremendous experience with iPhone, Android, all of that type of stuff. Worked with her daughter until she really felt proficient, really had the drive to understand and want to learn how to use these types of interfaces. Whereas I had a much younger participant who really, really struggled and so I'm trying to understand what that was about and it really just came down to experience still to your point, I wanted to come back to that cause I still was working on a flip phone and there's absolutely nothing wrong with that. But again it comes back to that theme. I think that's emerging here is trying to balance these types of experience levels can be difficult. Christina Mendat (16:52): So we needed to be able to bring that into the interface so that those users could still use the product without any errors. And you know, that's the important part about spencer is while errors aside, they're depending on this for the medication. And we know medication adherence is a problem and that's the whole premise of this product dispenser. So how do we ensure that this interface is going to give them the information they need to one, be able to use it and be as intuitive as possible, but two know when their medication has been provided. Basically what we learned ultimately, and some of it might seem a bit of common sense, but was really decreasing the depth of menus. Again, that can kind of be common sense, but when you have a product that really doesn't have very deep menus in the first place, you have to be smart about it. Christina Mendat (17:38): And that's what we really had to do. We had to really think this through, okay, let's group this information a little bit differently so that we don't have such deep menu items if you will. So that was one of the big learnings that we had to do. And, and in some cases, we actually had to pull some functions out of places where we thought was very intuitive. We said, yep, this feature should go in here. It makes complete sense. That's the way it is on a number of other products. But then when we started working with these users, we realized actually it did not make sense here and so we'd have to move it to a place that actually made sense for these users. And ultimately we think it developed a fairly seamless experience. But there are a lot of different things that we learned from this experience and really about going against sometimes what you thought was best and really, really truly listening to the users and what was going to be meaningful to them when they go home and use this because, remember, even if people are given training at some point, and I imagine they will be for this product, could be by a pharmacist, it could be by a healthcare nurse. They're going to try to come to some training, but that doesn't mean that they're going to retain that training a week later, a month later. It also doesn't take into account their medical condition and potential complications that they have as a result. Are they having any memory issues? Do they have any physical limitations that could affect their interaction with the screen? So again, back to those layers. We needed to bring all of that into the know as we develop this interface. Janet Kennedy (19:00): Do I get to give you credit for the personality of spencer? Christina Mendat (19:05): No, I don't think so. I wish I was just a helper. I'm not a product developer. We just give them information, so I wish I could do that. I just gave them information that we hoped was helpful at the time. I can't say that I gave them the personality. I would love to take that credit, but I think that's some other folks that are in the midst and accountable for that. Janet Kennedy (19:27): Well, I can't thank you enough for being here, Christina. I have always been fascinated by the idea of human factors but didn't honestly understand the thought process that went into it. Talk about a field that is evolving as human beings evolved. It must be fascinating work. It is. It's very rewarding and I wouldn't trade it for the world. Well, I thank you very much for joining me here today, Christina. Christina Mendat (19:50): Thank you for having me, Janet. Janet Kennedy (19:52): Thanks for downloading this episode of "People Always, Patients Sometimes" if you've enjoyed our conversation, please drop a review or a rating in iTunes and that will help us find more listeners. This podcast is a production of Spencer Health Solutions.

This podcast features David Holtzman, Executive Advisor for CynergisTek, who discusses how healthcare providers can remain compliant with the HIPAA privacy, security and breach notification rules during the COVID-19 pandemic. Learn how the HIPAA privacy and security standards have been impacted by the federal government's response to the pandemic; the rules for sharing PHI in a public health emergency; which messaging and video conferencing applications are safe to use for telehealth; the status of HIPAA enforcement; and what constitutes “good faith” in treatment and is not subject to penalty. He recommends healthcare organizations visit the OCR website at https://www.hhs.gov/hipaa/ for the latest information. Our podcast host is Janet Kennedy of Get Social Health.

Tania Malik on the ATA, Telemental health and being an entrepreneur COVID-19 has thrown our healthcare system into disarray. It has created challenges of how to keep patients at home while continuing to deliver them. Quality care telehealth presents a solution whose time has come. The American Telemedicine Association now is known simply as the ATA, has been preparing for this moment for 20 years. Our guest on the podcast is Tania Malik, an entrepreneur, and the telehealth field and the Chair of the Telemental Health Special Interest Group for the ATA. I hope you enjoy this conversation on the "People Always, Patients Sometimes" podcast. Janet Kennedy (00:39): Spencer Health Solutions has invited Tania Malik to join us on the podcast today to have a chance to learn more about telehealth and how it's impacting our health care system. Tania is the chair of the Telemental Health Special Interest Group for the ATA and she's also CEO of Virtual Medical Group. My name is Janet Kennedy and I'm your host for the "People Always, Patients Sometimes" podcast, a production of Spencer Health Solutions. I'm really looking forward to my conversation with Tania on the podcast. Welcome to "People Always, Patients Sometimes". Tania! Tania Malik (01:12): Hi. Thanks for having me. Janet Kennedy (01:13): Tania, you've been involved with the ATA for many years and you're also very involved in running a special interest group specifically on telemental health, but I'm not sure that everybody's really familiar with the ATA, so do you mind giving us a little background on the organization? Tania Malik (01:30): The ATA is the organization that is maniacally focused on the implementation of telehealth. We have been around for over 20 years Ann Mond Johnson is the CEO who has been at the helm for about two years. She is reshaping the organization. One of the things she did was re-brand it. It was the American Telemedicine Association and now we go by ATA. As Anne said, everything was great with our name except the first two words, meaning that it's not just America and telehealth is global and really it's health. It's not necessarily telehealth. We are delivering good quality care to patients where and when they need it through a different medium and that's it.     Janet Kennedy (02:17): Let me ask you a question then. Is there a difference between telehealth and telemedicine? Tania Malik (02:22): If you went and Googled it and looked it up, there would be multiple definitions. In policy? Yes, there probably is and there is definitions and social security act and other places, but in reality, telemedicine and telehealth are basically the same things. Janet Kennedy (02:38): The way I would look at it as an outsider is that telehealth would be focused on keeping people healthy and living good active lives. Whereas telemedicine might be specifically about solving a health or medical problem. Tania Malik (02:53): I like how you did that. Well, you can have it, that's fine, but in what we're saying is we're delivering care via the internet, via telecommunications, basically as what we're saying. Janet Kennedy (03:07): And the organization was founded by the companies that were actually doing the technology or was it a joint partnership with the clinicians who wanted to use the technology? Tania Malik (03:19): It actually large academic and government focus and still does today, but a lot of the research since we are several decades, all came from academics and the government. Then the government was really the VA in particular, one of the first and largest and today is the largest user of telemedicine. So that's where it came from. And then the conglomeration just grew with vendors, individual practitioners, and it's still government, academia. All of that. Janet Kennedy (03:52): Now 20 years ago, I don't even think I had a cell phone, so what kind of tele health would I have had 20 years ago. Tania Malik (04:00): It's funny you say that because some people, when people ask me for evidence that telehealth is effective and patients are satisfied with their interaction, I point to a study that one of our members did. That was in the early 1980s so hello. Psychiatry, in particular, has been around for such a long time. You didn't have to use a cell phone, but the equipment back then was much bigger, much more cumbersome, harder to implement than today. Of course, whereas forward the software is almost ubiquitous and a commodity. Janet Kennedy (04:36): Oh, you know, I just realized I've made a big mental error. I assume telehealth means actually being face to face, but telehealth is as long as you have a communications mode with someone. So it's been obviously via phone and that's how you all got started. Tania Malik (04:53): That's also an interesting question because there's something called store and forward and some of the first telemedicine occurred that way, which means when you think about radiologists, you would send the images, digital images to a radiologist who was remote, who would read them and send them back. So asynchronous store and forward transmission of health data. That includes telemedicine, asynchronous. Asynchronous meaning not at the same time. So synchronous communication can occur via the phone or video and that is state to state. Each state has its own definition of what telemedicine is and sometimes it includes phone and sometimes it does and generally, it does not include email. Janet Kennedy (05:41): Oh, that's interesting. Okay. I hadn't thought about that piece either. Let's go back to the "every state has a different definition". What a nightmare. Tania Malik (05:50): Yeah, in that fun. Also, the practice of medicine is state-regulated period. They can do the definition. They can say whether other clinicians can practice in their state, which of course hardly anybody says, I can almost safely say nobody and why I'm hedging on that. There are a few states that have said if you just say doctor, cause they're all other kinds of providers that do telehealth. Say you're a doctor, there are about 10 and 12 States and say you can get a special telehealth license to try and streamline it. There are compact States for nurses where if they're in a state that's a compact and you can have reciprocity and work in that state, but otherwise each state can talk about who can practice in their state too. It can be complex. Janet Kennedy (06:39): I know we're going to talk about COVID-19 and the effect the Corona virus has had on telemedicine, but since we're talking about licensing, some governors have made outright calls for please come to my state and help as this also impacted the use of telemedicine. Tania Malik (06:57): Yes, 100%! There's so many things that have changed now with this crisis. I just want to tell you what the baseline was. The requirements for telemedicine or telehealth are in 1834AN at the Social Security Act and basically the restrictions because I'm getting ready to tell you what's been waived and this is what ATA was moving forward, asking Congress to waive these restrictions, which was the originating site basically had to be a rural site and the location of the patient at the time, that's what the originating site is, where the patient is. The distant site is where the provider is. Well, the patient had to be sitting in a physician's office or a hospital or a rural health clinic or something like that. There's about eight to 10 on the list of where they could be sitting, but where they couldn't be sitting was their home. Tania Malik (07:48): So that was how we deliver telehealth and the type of provider mattered. You had to be an MD clinical nurse, midwives, psychologist that you couldn't be, say a speech pathologist or even a licensed clinical social worker, but the type of provider mattered. So these were the restrictions that we had. So now the ATA did is to push forward for a waiver of those restrictions. I'm digressing a little bit on your question about state licensing, but now lots of States have these waivers. To get back to your question, there is a March 24th more than 25 States took some actions to address exactly what you're talking about. So in North Carolina in particular, North Carolina has waived the licensure requirements for healthcare and behavioral healthcare personnel who may be licensed in another state to treat North Carolina patients. That North Carolina statement is the same statement that about 25 other states have done. So that is huge because it's opening up physicians or any behavioral health, psychiatrists anywhere that maybe are sitting in Idaho maybe aren't experiencing it as bad as New York is, and they can help deliver care now. So it's a huge sea change. Janet Kennedy (09:07): And we've also changed the patient doesn't need to be in a physical office. Tania Malik (09:12): Yes. So there are lots of other changes. That one's a big one that the patient can be at hunting. So when you think of this crisis and you think of who it's affecting the most, which is our elderly, then they can stay at home and get care. That is another big sea change for us. They have also waived, when I say they, it's either it's happened through congressional action or the Department of Health and Human Services or even when president Trump declared it a national emergency, some other things fell from that through the Stafford Act, but the major waivers have been they waived HIPAA, but let me be clear, they are in waived enforcement of HIPAA and if anybody's in healthcare, you know the Health Insurance Portability and Accountability Act. If you are in good faith trying to maintain HIPAA, then they're going to waive enforcement. Tania Malik (10:05): It doesn't mean that there might be some state other things you need to think about or privacy that the federal government is saying, Hey, we know that you're trying your best here in this crisis to deliver care. We're not going to be all over you about using Skype. Basically things like that. They're saying, I don't wanna throw Skype under the bus and be the only one. They've waived the certain types of technology that can be used for telehealth. They have waived the originating site, which of course is now can be the home. They've also expanded the type of providers that can be reimbursed. So like I was saying, the speech pathologist, physical therapy, those things are now they can be telehealth providers and get reimbursed. Janet Kennedy (10:44): Do you think all of this has been enabled because there is an actual organization that is overseeing the telemedicine side of the equation? Sure. Tania Malik (10:55): I, I mean ATA has really been instrumental in taking the lead in this, but it is a conglomeration and a coalition of other people. Like in our letter to Congress, there were probably five signers on that, the eHealth Initiative and some other partners that we work with regularly. So we're all in the same. But there are a lot of people who are focused on telehealth and we're all in the same boat and trying to get the waivers and other restrictions lessened to be able to combat this crisis. Janet Kennedy (11:21): So I understand people can actually have a telemedicine visit with their clinician via phone now, but is the standard of care trying to go to a video based call? Tania Malik (11:35): It differs and standard of care, like we said is back to the is always in the States. But I think it just depends on what your condition is and what the provider needs to see and what other data may have been transmitted electronically to them already. Remote patient monitoring has a firm hand and in medicine now and there's a lot of data that can get transferred to the physician so they could be on the phone and be looking at a lot of your health data. There could be some other conditions where you have to have video, dermatology and other things may, so it's very helpful in our field and tell them mental health both ways to either have the video or the phone and then the patient could have the choice. And then it also depends on our elderly population. It's sometimes easier for them to just pick up the phone and be able to have a visit as opposed to video. Janet Kennedy (12:27): Well that was actually my next question was about the elderly and how are they dealing with the advent of trying to call in or do a video visit with their clinician? Tania Malik (12:39): Well, I can just speak from my personal experience because I'm in the same which generation and so my mom had a primary care visit and there was just simply no way as she's approaching 80 that I was going to take her in for something that was routine. All of my parent's doctor's offices are offering telehealth visits now that quickly pivoted and did that and then they worked really hard in my mom's got on the phone and had the visit. Of course, the script gets sent electronically now and now on the script, it gets delivered to her door so she never has to leave. So I would say that the transition has been smooth and all of the physicians' offices that I have heard about have taken routine patients off their docket to make room for those that really need to be seen and they're seeing them in telehealth. Janet Kennedy (13:26): I had an appointment canceled yesterday, so there you go. Well, how about from the standpoint of the medical side of the equation? Are there rules or any kind of guidelines about what should and should not be treated via telehealth? Tania Malik (13:43): Well, I think that goes back to what you said about the standard of care. So we're still providing care. We've just changed the medium in which it happens. So all your medical training still applies all your common sense and all applying standard of care. What generally happens is a telehealth visit can occur and then if they so saved this was not a crisis, then they can determine if they needed to come in for a visit and they're all kinds of different ways the money works on that. Maybe your copay gets applied in person. There are lots of different things that happen depending on different rules and regulations, but that's generally what happens. So I wouldn't say that there are conditions that cannot be seen telehealth, and these are the ones that are, and it's always left up to the clinician. Janet Kennedy (14:29): Okay, so the 64,000 or million or billion dollar question is, is the horse out of the barn? And we're not going back. Tania Malik (14:41): It would be great. We've been having this conversation lately, as you can imagine, what will we need to do? What, what this crisis does is afford us the opportunity to track outcomes and provide data showing that this mode can be instituted just like they're doing right now, where patients are satisfied, providers are satisfied, care is where and when people need it and it's good quality care, efficient and effective. So this gives us the chance to provide the data to prove that this is effective. Janet Kennedy (15:20): Oh, excellent. Well, I'm very excited about hearing of the evolution of the ATA and where it's going after this dust settles from the COVID-19 pandemic. I think it's an amazing opportunity for telehealth to really become an integrated daily use service to the patients out there because it solves so many problems, not just for the elderly, but for individuals with co-morbid conditions and have chronic conditions that make it hard for them to get to the office. So I am very excited about the future for the ATA. Tania Malik (15:58): Thank you. And we've anecdotally, we've heard patients say, 'wait a minute, I could have been doing this before?' And, and now instead of getting and waiting in your doctor's office for that long, the sea change now may come from the patients who are extremely satisfied with this way of receiving care. Janet Kennedy (16:16): Well, that sounds great and a positive note in all the difficulty that we're dealing with. Well, Tania, thank you so much for joining me, for "People Always, Patients Sometimes", and I look forward to connecting with you, telehealth wise. Tania Malik (16:31): Yeah, that sounds great. Thank you, Janet.    

Tom Rhoads joins the podcast to talk about telehealth, COVID-19 and protecting patients at home on "People Always, Patients Sometimes." Janet Kennedy (00:02): Welcome to the People Always, Patients Sometimes podcast. A short while ago, our CEO and founder Tom Rhoads, published an article on Med City News called "It's Time to Integrate Telehealth into the Equation". It Was an interesting article about how COVID-19 has kind of changed the game when it comes to telehealth and trying to keep our patients in a nice safe environment: their home. As a result of that, we started to have conversations around the virtual office and decided that we'd like to explore that topic a little bit more, so I hope you enjoy this discussion of telehealth and integrating it into the full healthcare equation here on the people always patients, sometimes podcast. Janet Kennedy (00:49): It's very exciting for me to finally have the CEO of Spencer Health Solutions on the People, Always, Patients Sometimes podcast. You're familiar with Tom Rhoads' voice because he's introduced most of the previous episodes, but he's been so busy it's been very difficult to schedule a time to have him on the show. Well, COVID-19 has certainly changed things for everyone in the world. This global health crisis has forced most people to be working from home except essential workers for whom we have great support, love, and sympathy. But for us as a healthcare company, it's been very interesting and incredibly busy for us even though we have been working from home. I was able to schedule a conversation with Tom and I really want to talk about how is COVID-19 impacting healthcare today and in the future. Tom, welcome to the podcast. Tom Rhoads (01:43): Good morning Janet, and thank you very much. Janet Kennedy (01:46): Well, it's all been very difficult trying to work with each other from afar and it's working out actually very well, although I think we're all working very hard. How are things over at the Rhoads household? Tom Rhoads (01:57): You know it's good. We have two of our children home from college and they're doing their daily classes on video chat and zoom and then we have a senior in high school that it's actually just embarked on the same process and conducting everything virtually. It's a bit of a crowded house, but it's exciting for us to have all the kids home and trying to manage today and the noise and everything else going on. But we're healthy and that's the blessing. Janet Kennedy (02:20): I actually can't imagine what that's like having, in essence, five adults all in the same place, all needing to use the bandwidth to do what they need to do. Is that a challenge? Tom Rhoads (02:29): You know, it is actually. We work around each other relatively well, but there are definitely times when the bandwidth is being used by all five of us at the same time, so it's something that forces us to option, whether we're doing video or just voice, and oftentimes the latter is probably the most, the biggest choice we make. Janet Kennedy (02:49): You and I are both in great situations because we have jobs, we have paychecks, we have comfortable homes to live in, but that's not always the case for a number of people and as follow what's happening in social media. There are an awful lot of individuals who are really, really frightened that they are immunocompromised. They have chronic health conditions. They really feel a little bit in a panic. Are you getting that sense as well? Tom Rhoads (03:15): Without a doubt. I think we see it both in my, my own family where we have several members that have immune-compromised systems and are quite concerned about being in a position of catching COVID, and of course across the public. I believe they estimate that probably six, six to 7% of the population is in that bucket and in a country of 330 million people, that's, that's a high number. So it's scary times for them and for all of us. I think we individually have a responsibility to do our best, which I think we're embarking on to keep them safe. Janet Kennedy (03:46): I know you as a CEO are following both global information coming down as well as trying to manage a company that is in healthcare at this time. What do you see happening on a global or a U.S. perspective regarding healthcare that you find both concerning but also optimistic? Tom Rhoads (04:06): Well, I think the industries are beginning to do a pretty good job communicating and I'm getting information from a multitude of sources. The source of probably is most surprising or are the banks, they are putting together detailed prospectus on the spread of the disease, risks of the disease, leadership opportunities, et cetera, and these are a lot of our investment partners and some of the banks we work with. I think the industry as well as doing a very good and thorough job communicating and making sure information's out there. I think it crossed the world. We're seeing basically two themes. One is why didn't we react earlier to this and then two is how will we navigate our way out of it? On the first question, I think it's pretty difficult to answer. We could say in hindsight that we needed to build 100,000 ventilators and put them in a warehouse, but we didn't know that this would be a respiratory disease, so it's a little bit pie in the sky to assume that you can predict which disease was going to affect the population and how you would respond to that. Tom Rhoads (05:07): That doesn't say that we shouldn't be prepared and then I have deep planning and processes in place. I think based on the response we probably see a lot more of that than people may be given credit for on the other side. How do we navigate out of it? I think we're doing that. I think social distancing is helping tremendously. I think it's keeping a lot of people, you know, safe and out of harm's way. Right now it's an evolving disease. So at first, we thought it was only transmitted via contact and now we're saying potentially airborne. You know, the community right now I think is doing its level best to both identify a vaccine that we may see this time next year as well as give us the time we need and contain the spread as much as possible through social distancing and other types of programs. Tom Rhoads (05:51): I think at the end of the day it's the community's response to it that'll dictate how this goes. I think the tough part to swallow here I believe is the fact that a lot of people are still going to get sick and a lot of people are going to die because of this. It is a, you know, death as they say trails, the infection, you know, seven to 21 days. So it's something that even as we see infections continuing to go up, the one thing we will see as a tail and that's, that's one of the things that we've got to keep our eye on and again continue to not panic ourselves but be in a position to drive that down and that's where everyone talks about, you know, leveling off on this and then driving it back down. Janet Kennedy (06:28): You make a really good point Tom about information changing and I think the hard thing for our citizens to deal with is the fact that something they heard last week isn't the same as something they would hear this week and they have to be open to new information coming in. What's your take on the rapid change of information regarding COVID-19? Tom Rhoads (06:50): I think from a healthcare community standpoint, they're doing a very good job responding to and preparing for both care of those with the disease as well as trying to communicate out how to de-risk the population against getting the disease. I think is a lot harder for the general population to respond to the rapid changes in direction or seemingly rapid changes in direction due to new learnings. I think the healthcare community is uniquely positioned that they're used to that type of ongoing learnings. In fact, they strive for it and so they're expecting changes, new opportunities to position their teams or processes and their responses. But I think for the general population it's, it's tough. It seems like we're kind of swinging from one side of the other. In reality, I believe it's just a normal path that we would see in a response and learnings associated with something as severe as COVID. Tom Rhoads (07:45): I think on the business and banking side, we're used to having a plan B, plan C, and, and I believe they're responding relatively well to the new information that's coming on the scene and some of the new directives for those that aren't in healthcare and aren't used to this type of situation in business. I imagine it can be just hardening. And I, I hope they understand that the response that the healthcare community's taken, I think is a good one, a path well worn over the years by how they go about solving problems as complex as this. Janet Kennedy (08:13): One of the upsides of a challenge like this is that new technologies have a chance to really step up and play an important role in helping solve the problem. And certainly, nothing could be said more about telehealth than it's time has come. Tom Rhoads (08:30): Tele-health has been around for almost 20 years now, and I think the industry 20 years ago may not have thought it would take quite as long to have kind of a sea change, but I believe we're in the midst of it for sure. You know, we've always had a population that seemed right for telehealth, high-risk patients, the potential for disease transmission and mobility issues and all those were ride for, you know, the first movers and the world. I think the technology's done a really nice job migrating itself from something that might've been difficult to use at the beginning of years to something that's very, very easy to use now. And so that being said, I think there's also a lot of new players, but you know, if you're thinking medical visits, clinical research, any person that's at risk of contracting, any kind of contagious disease, he has a very powerful incentive for them to use telehealth in those providers to enable those services so that they can do them remotely. I think some of the challenges, and this is typical in healthcare, is that the, you know, the payment systems have given some incentive but not a lot of incentive to use these type of technologies. Tom Rhoads (09:36): What we've seen in the last two months is a complete about-face on that where telehealth is now seen and reimbursed at the same rates as an office visit. And I think the population is seeing for the first time just how easy it is to use these services and convenient as well as much, much safer both for the patient and their provider team. Janet Kennedy (09:54): Now that the horses out of the barn, do you see any going back to the way things were or do you feel that telehealth has crossed over and may become part of the standard of care? Tom Rhoads (10:05): I certainly think there's an opportunity for it to become a standard of care moving forward. I'd like to think that the horse has left the barn, but the answer will probably lie in the payment structure. If we flip back to a payment structure that you know, marginally incentivizes people and providers to use the service, then I think we'll probably be back where we were prior to the contagion that said, you know, we've talked a lot of years now about being a consumer's economy. Tom Rhoads (10:31): That healthcare is really turning to where you know, the patients are driving the ship, better transparency both in records and pricing, etc. And that there'll begin making more informed decisions. So I think the fact that they've been using it successfully will open the door and expectation at these types of services would be offered more conveniently accessed and we'll see that as the future. So if I was betting, I'd say the horse has left the barn and we'll see these types of services expand dramatically and change, you know, what we would view today as the doctor's office. I think that'll change dramatically in the future. Janet Kennedy (11:06): I can't help but believe it's more efficient on both sides of the equation that obviously for the patient to stay in their home, not have to drive to a doctor's office and put themselves at risk for catching or sharing whatever they're dealing with. That alone is both hours of time and compounding risk. But from the physician standpoint, I imagine it's got to be more efficient to be dealing with telehealth. So I can see that this should be the sea change that many are hoping for. Tom Rhoads (11:35): I would agree. I telehealth offers, you know, from a provider side if we just, if we look at their day and opportunity for a large percentage of their patients to be seen quickly and conveniently so they could not only increase their patient satisfaction, which is a key measurement and the triple aim because you're being seen at the time, you know, you've scheduled, et cetera. But it gives them an opportunity to see more patients, but while not degrading the level of care because they just don't have, you know, a lot of the front end issues and the office issues and things of that nature. Tom Rhoads (12:07): I think there's an interesting opportunity here as well where if you're saying a particular doctor, I think we'll eventually see where I say, well we think you might need to see a specialist of some sort for this particular issue and now they can begin bringing those specialists in line very, very quickly. Possibly even on call, depending on how large office they are to view or have conversations with as individuals. So I think, the future can be very bright and very efficient. And I think for the patient, very satisfying as it relates to where this can go and how they can better connect their care team. I wasn't around when Spencer was formed, so I'm curious about as you were designing the concept of the Spencer device. Was telehealth always intended to be a part of this product? It was telehealth. If you think in terms of someone you're trying to have a direct patient relationship within their home, you need to think in terms of a convergence strategy, meaning that for us to have a proper level of care for that individual, we not only have to kind of address the management issues, which alone can account for about 30, 33%, 35% of hospitalizations for an older patient group, but you have to be able to manage a lot of the other indicators that are associated with adherence or re-hospitalizations or advancement of the disease. Tom Rhoads (13:27): And that's biometrics that you can grab passively, questions and answers so that you can serve them and better understand how things are going if there's progression, et cetera, keeping their family involved, and then most importantly, I think the telehealth. So if you can't turn on the last screen there to allow them to actually conduct a call in the safety of their home and be in a position, to get some advice, then I think you've missed the boat. Tele-health was always an important aspect of our direct to the patient platform and it really opens a door not only for the care management provider based markets but also in the specialty and clinical research markets. Janet Kennedy (14:06): Tom, I understand that one of the reasons that you are interested in founding Spencer Health Solutions was because a personal situation regarding an elder in your own family and the elderly are very, very much in need of an at-home solution. However, they also are the least comfortable with technology. So in designing Spencer, how did you bring in to the technology, the fact that it needed to be easy for the elderly to use? Tom Rhoads (14:35): From an early point, we definitely felt that we had to be relevant across all demographics. So when you look at that range, the first question you got to ask is who's going to have the most difficulty with a piece of technology? I have the least familiarity with it and therefore become your kind of focal point to make sure that it is easy to use for them and if it is easy to use for them, therefore it has a cascading effect across the rest of your demographic. So the elderly definitely pop into that as a population. They typically won't volunteer to use technology. Usually, their families have a lot to do with what they use and how they use it. Tom Rhoads (15:14): As an example of a phone, they probably have smartphones primarily so they can text and video chat with their family and their family's probably demanded, especially the grandkids that they use those so that they can communicate and they do. They use them now very effectively. So for us, it was important to understand that population, make sure that our technology was indeed easy to use by their definition, not ours. And then by doing that, we should be in a solid position to be as relevant to a 20 something population. I think the other misnomer in this type of development is that 20 something year old because they're very technology-centric, are very open to complexity. Because of that, we've not found that to be true. They're looking for technologies that are already easy to use and intuitive as well. So we knew if we could solve for one end of the spectrum, then it should have an effect on the entire demographic. Tom Rhoads (16:03): And I think we've seen that. I think as we move forward and look at other technologies that come into the market or serving this population, they're going to have to live by that standard. We went to a great extent to make sure that we did meet it, with extensive user groups and testing and feedback on human factor studies and things of that nature. And I think we've hit it on the head, at least based on the feedback we've gotten, which is the most important and relevant measurement of whether you have something that will work longterm. Janet Kennedy (16:29): Excellent. Well, I find the Spencer interface out of the box easy to use. While I consider myself a technology person, I'm not necessarily a device person and I don't need to have any of that experience in order to use Spencer. It's very, very intuitive and super easy to interact with, literally right out of the box. Tom Rhoads (16:53): Glad to hear it. Janet Kennedy (16:53): Okay! We've had a great conversation about telehealth today and I know it's one that's going to be front and center in conversations around the world and in the healthcare industry. If you have some questions about telehealth, go into our blog post and you'll find a fact sheet where we give you some updates on what's happening in telehealth right now. Tom, I can't thank you enough for joining me on People, Always, Patients Sometimes.

This podcast features Cheryl Rodenfels, CTO of the Americas Healthcare Division at Nutanix. Cheryl has over 30 years of IT experience in the financial and healthcare industries. She discusses how healthcare executives today don’t need advanced technical degrees as much as they need to understand the business itself, with knowledge of contract law, finances, etc. She finds that healthcare executives are looking for solutions that drive efficiencies: they don’t want to spend money on things that won’t move their business forward. There is also a shift in perceiving the patients as customers, and in improving the customer experience. Nutanix provides a software platform that allows businesses to deliver applications from anywhere. It provides a hyperconverged infrastructure that is secure, reliable and flexible, and can be run on the private or public cloud. Their clients are companies of all sizes: anyone who wants to modernize their infrastructure and provide their organization with a strategic path forward. For more information, visit https://www.nutanix.com/en. Our podcast host is Janet Kennedy of Get Social Health.

Spencer Health Solutions invited Jen Horonjeff, co-founder of the Savvy Cooperative to join our podcast today. We had a great conversation about the JP Morgan conference and a simple statement she made there that got some national buzz. We also dig into the difference between patient centricity and patient-reported outcomes. I hope you enjoy our conversation on "People Always, Patients Sometimes". Janet Kennedy (00:21): With me today is Jen Horonjeff, one of the founders of Savvy Cooperative and this is going to be a really important podcast to listen to if you are a patient or you need patients for a clinical trial. Jen, welcome to the podcast. Jen Horonjeff (00:44): Thank you so much for having me. It's my pleasure. Janet Kennedy (00:47): I love the fact that you are not only putting patients first, but you have built a business that is by and for the patients a true cooperative. Jen Horonjeff (00:59): That's correct. I know people don't necessarily think of what we're doing as being something in the cooperative space that they are used to in farms or co ops or housing, but we decided to use a traditional model. It's been around for several hundred years and apply it to a way to more fairly work with patients. Janet Kennedy (01:17): Now before we get into a discussion of what is the Savvy Cooperative, I'd love to get a little bit of your background because that's the very reason that the Savvy Cooperative exists. So do you mind telling me a little bit about your situation, which I would have to amend to say your health situation that really made you aware of the challenges that patients face? Jen Horonjeff (01:39): Absolutely. I know firsthand the challenges that patients face because I am a patient. That term does not offend me. I have been a patient almost my entire life. I was diagnosed as an infant with juvenile idiopathic arthritis and several other related autoimmune conditions. It's similar to what adults have as rheumatoid arthritis, but now it affects almost every single joint in my body. Now as an adult, I had a brain tumor removed about seven years ago almost exactly. So I'm somebody who just has been living and breathing in the patient space. I actually thought I was going to go into medicine. I was premed and in the college, but truly I saw the limitations of what my clinicians could actually even practice because of our healthcare system. So I became a little bit disenchanted by that and ended up then instead becoming a human factors engineer, so really doing human centered design and how can we better design the world. Jen Horonjeff (02:36): In my case for people with disabilities or other impairments or challenges that the world was not designed for and then I became an academic. I got my PhD just technically in environmental medicine, but that's a really loaded term. I was studying patient centered outcomes and of interest to perhaps your audience. I was looking and doing a lot of research around outcome in clinical trials to make sure that they were including things that mattered to the patients so that if we wanted to, you know, when a drug rolls out, we want the patients to have shared decision making with their clinicians. We need to measure the things at the very beginning that they care about and so that's something that I was really passionate about. Just making sure that we included everybody's priorities, not just the payers and the providers, but also the patients. Janet Kennedy (03:24): Explain a little bit about what exactly all that is. Patient reported outcomes, environmental medicine. That's a really confusing term. And as you mentioned, maybe a little loaded. So what does that mean? Jen Horonjeff (03:38): And I'm glad that you brought up patient reported outcomes because patient reported outcomes are different than patient centered outcomes. Patient centered outcomes, and you could argue whether or not you like the term, but patient centered outcomes are meant to be things that matter to the patient. Patient reported outcomes are something that somebody actually reports. And the reason why they are different is because just because a patient reports something does not mean it's important to them. You could ask the patient, you know what color is your hair? That's not going to change how their MS is. And just because the patient does not report it does not mean that it is not important. So take my expertise in that area. Jen Horonjeff (04:22): I live in arthritis and rheumatic diseases. To them it is very important to understand whether or not there is joint destruction. So that oftentimes means making sure there's some sort of radiograph to track any sort of changes there. But that's not a patient reported outcome. That's not a survey they're doing. So I think it's just important to remind people in the space that just throwing what are known as PROs - a patient reported outcome - in your clinical trial protocol does not mean you've done all the work to understand what patients care about. Janet Kennedy (04:53): That is fascinating. Now I understand patients also care about hearing how the clinical trial went or what was the result that came from their efforts. And I guess rarely do they hear that. Jen Horonjeff (05:05): I think this is something that's being discussed more and more about returning results to patients or just how are we thinking about their participation and valuing it in a meaningful way. Jen Horonjeff (05:15): And that's going to come in a couple of ways of, you know, how are we making sure that they feel taken care of throughout the clinical trial itself while they're doing it, but also what is the end result? Is it, you know, sharing some sort of data back with them. You know, a lot of them are doing it because they're just trying to find new treatments. They're paying it forward to the next generation, but nobody wants to feel like they're being used. Like their bodies are literally being used, like this whole podcast, you're people first. And so I think there needs to be a way to communicate and to value these human beings in a better manner and thanking them for their participation. Janet Kennedy (05:51): Now, Jen, had you been a participant in any clinical trials up to that point? Jen Horonjeff (05:58): I've been participant in several different trials, never to test out a new therapeutic, however, which was a lot of what my research was around. Janet Kennedy (06:07): All right, and I think I've made you jump ahead to some of the exciting stuff we're going to talk about in a minute. Let's go back. I still want to hear the history; of how did you evolve from getting your PhD to founding the Savvy Cooperative? Jen Horonjeff (06:19): Yeah, sure. So as you can tell, I am quite open about my conditions and talking about it. I've been very involved in patient communities, so what started to happen was that when I was on the professional side of the equation, I had a seat at the table. I was low hanging fruit to these other researchers and innovators and colleagues of mine and because I did a lot of work specifically in rheumatology in the areas that I am a patient, people will say, Oh Hey Jen, you're a patient. Will you weigh in on this project or will you be the patient rep on this committee? Jen Horonjeff (06:51): And at first, sure, I was happy too, but there was actually one weekend time that I can remember. I was asked to join several different projects specifically in my disease area and I thought, hold up, this is not right. Clearly this is an access problem and this access problem is a diversity problem because if you are only talking to me who is white with a PhD living in New York city, that is not representative of the 54 million Americans with arthritis, so how can we do better to make sure that we're hearing from all sorts of different participants so that we can make more inclusive innovations. Our research can include people that have diverse backgrounds and so that was kind of like the aha moment. Then I just started playing matchmaker. Organically. When I would get these requests, I would go to my network and say, Hey, does anybody else want to weigh in on this? Jen Horonjeff (07:45): And then I started getting flooded by patients who did want their voices heard because they've never been asked before. And then I had to kind of operationalize it. So I just slowly started piecing this together and then seeing, wow, this is a problem it needs to be solved. It's not actually unique to any one condition. This disease agnostic. And we need to create best practices to make sure that when industry or academics or anybody is working with patients, they're doing so equitably. Because that is what I as a patient have seen over and over again, is that my insights are taken so somebody else can benefit or profit. And yet I am left with nothing. And yet I'm in a position of privilege where I can do that. But not everybody is. And that's part of what's driving the diversity issues. So through our work at Savvy Cooperative, we provide an online marketplace that helps to connect companies and innovators or agencies and firms directly with diverse patients and caregivers so that they can connect and do user research. Jen Horonjeff (08:56): They can de-risked their innovations by talking to the end user. That could be getting feedback on a clinical trial protocol in a certain disease area. It could be giving feedback on a new app that somebody is building for a particular community. It could be developing something new in a rare disease and you just want to talk to people to understand what the heck it's like to live with that. So you can even start to understand where innovations need to happen. So that's what we do is make that part so seamless and easy that there's no excuse not to work with patients. Janet Kennedy (09:27): I've been a member of a variety of communities, both hobbies and for fun as well as in business, and it's a lot like cat herding. So I'm curious how you decided to go from what I assume might be a closed forum or a Facebook group into creating this platform. Jen Horonjeff (09:46): Yeah, really because I am so drawn to making sure that there is more inclusivity and all that we do. We want it to make it open and democratic and there's a lot of patient communities out there they can take on the forums of patient advocacy organizations like you say, closed Facebook groups. There are a lot of other online social networks for patients to, you know, do peer-to-peer advice, et cetera. But the challenge is that not everyone participates in these kinds of things. I thought about it for myself personally. Well I belonged to several Facebook groups. I'm not on there daily chatting about my experiences because that's just not where I am in my patient journey. But if somebody said, Jen, will you do this interview, give your insights and give some feedback. Sure, I'm happy to do that. But we don't want that to get lost in the middle of a discussion about somebody talking about a dire diagnosis that they just had. Jen Horonjeff (10:40): That's not the place to say, Hey, take this survey. So we created a platform that's open and democratic. Everybody can see all of our different opportunities. And then anybody can apply to participate. There are usually some screener questions to make sure it's the right person for the right opportunity. But we really believe on making sure that we want to spread that around so that we can pull in more and more diverse voices into the conversation. Janet Kennedy (11:03): How does it work? I mean you are a business, so there's gotta be a business model here and yet it is a cooperative, so it should be what? Shared efforts. Shared reward. Jen Horonjeff (11:14): Yeah. The way we make money is we charge companies or clients for access to patients, to our network to help promote that. And then let's say a company comes to us and is looking for 20 patients to participate in a series of interviews. Jen Horonjeff (11:31): Well then that then gets posted to our second Trello virtual bulletin board or marketplace. Patients see that they opt in to participate. They then go and do that interview. They then get paid for that opportunity right then. But as a cooperative, people who decide to join the co-op, they're not required to. But for those individuals that do join based on their participation at the end of the year, we look at our surplus profits and we redistribute it back to those members based on their participation through dividends. So a co op is a for profit company that gives its profits away. So that means that we're not a five Oh one C three nonprofit, we just give our profits back to patients. That's our model. Is it a calendar year? So you're right now writing a lot of checks to your members. So it's something that, you know, we're still a young company and we're looking at the best way to continue to grow while distributing dividends. Jen Horonjeff (12:27): But yes, that is the goal that at the end of each year we are looking at and where we're doing our accounting now to look at, you know, what can we distribute out to our members and still make sure we have enough to be able to continue to grow. Janet Kennedy (12:38): I do find it really interesting that this isn't specifically just clinical trials. I need a patient to join a trial or I need a patient to do a survey. You have marketing agencies wanting to know is their messaging on point?. I'm really curious to know how they get that feedback and have they learned lessons where they really thought, Oh gosh, we have this nailed and then we're really surprised to find out that no, you missed the starting gate there. Jen Horonjeff (13:05): Oh yeah. And probably for a point of clarity specifically for your audience, I should be clear, we do not recruit for clinical trials. There's a lot of people that do that. That is not what we do. Our touch point with clinical trials is making sure that people are getting feedback on it earlier on. We of course know that when you have to amend a clinical trial, it can take a lot of time, a lot of money, a lot of lost time getting that drug to market. And so what we're you trying to do is help to connect those researchers or whomever early on so that they can have patients review the protocols, make sure it's feasible for patients. You know, it's, you know, one of the biggest problems is just getting patients to enroll and stay in the trial. So let's flag those issues earlier on. It might be the marketing material even for that trial. Is it something that makes sense to patients? Is it accessible, does it resonate with them? Jen Horonjeff (13:55): Is that the kind of information they want? So that's the kind of way that we interact in the clinical trial space, both on looking at protocols, marketing materials, understanding what should be measured, the clinical outcomes, etc. Janet Kennedy (14:08): Oh, I really appreciate that clarification because I'm sure other folks may not have quite understood the difference there. And that makes you valuable literally to every clinical trial. Jen Horonjeff (14:19): Well we like to think so. I mean that's why it just so many people are guessing and this is what I experienced when I was on that professional side really well. Meaning people trying to do the right thing, they just didn't have all the information and that's not their fault. They're not responsible for they themselves to come up with all of that information. But they are responsible to make sure they're doing the work to go get it from other people. Jen Horonjeff (14:43): And I think that people think about patients as - when you get put with like the patient label, every other bit of intellect that you have often is wiped out. And so people are like, Oh, they don't know anything. Let's go ask the doctors or payers, no, no, no. They have very important information that is as important, if not more important at times to the other types of professional qualifications that you may possess. And it's just complimentary. So we're just trying to encourage more of a multi-stakeholder approach so that everybody wins. In the end, if a clinical trial is successful, that's a win for the patient. So we want to be your partners on this journey to make sure that it's all accelerating so we can get those new treatments, new solutions, new tools to patients faster. Janet Kennedy (15:24): And the patient's role in clinical trials really hasn't been front and center for very long. If it is even something I could say is happening now. Jen Horonjeff (15:34): Yeah, and I think one of the things, and I know you asked about some other ways that we engage with companies as well. One of the things is we've done some really horrible things to people in the past and clinical trials, things that certain communities still really hold on to and we need to earn their trust again. And that's why we offer all different types of opportunities that are not enrolling in a clinical trial. It could be a survey, it could be giving feedback on how does this marketing campaign for Crohn's disease make you feel? Oh, you know, they're talking about my bowels. This is making me uncomfortable or portrays me in a way that I don't see myself. Those are important conversations. So what we find is that if we can give patients different ways to engage in a survey and interview, et cetera, then they start to see, Oh, this things are okay. Jen Horonjeff (16:25): I'm able to engage with this community of professionals and they're valuing me and I'm starting to trust them. You don't have to only do clinical trials to do that. So I think it's important to let people engage in ways that feels appropriate for them, comfortable, culturally sensitive. We need to just be a little bit more thoughtful about how we're working with patients. Janet Kennedy (16:44): How are you able to recruit into diverse populations with people of color or individuals that might be at lower income? Are you finding it easy to reach this via word of mouth? How's the word getting out? Jen Horonjeff (16:59): So it's our secret, but not secret sauce. It's our co-op. Our model incentivizes and empowers our members to go into their communities to places that I shouldn't go. You shouldn't go like it's, you know, it's for them to go in and culturally sensitive ways and share these opportunities. That's how we're able to recruit fast. We're able to recruit quality participants, diverse participants, even though this co-op feels like a cute little warm and fuzzy business model to other people. Our unfair advantage is our fairness of how we treat people and that's what makes us do our job better. Janet Kennedy (17:36): Oh, I love that idea. Well, I know you have advocated for patients in very public ways. You've spoken at conferences, you all are doing a great job putting out content, but recently you kind of laid it all out there. For some folks and I'm very curious to hear more about your experience at the JP Morgan conference. You were on a panel and you were hospital casual. Jen Horonjeff (18:02): Hospital casual. I like that. Not - hospital glam. You will hear that term passed around a little bit. Yeah, I'm in a little wardrobe choice and apparently it resonated with people. Janet Kennedy (18:15): What was the panel about? Jen Horonjeff (18:15): So the panel was actually about innovation in the pharma space, probably conversations that were relevant to your audience. Where do we see this going? And so I served as sort of the provocative patient there and as you and your listeners may know, the JP Morgan healthcare conference is predominantly an investor conference where executives attend and deals are made and people are scoping up trends for the coming year. And I've been attending this meeting for several years now, written about it. When I get back, I've, gosh, you know, there's just a such a lack of patient voice and told every time, Jen, this isn't the place for patients. But again, I just, it doesn't make sense to me. It is a poor business decision to not understand the people who are supposed to be using your product or service. And so I just took a different approach. Jen Horonjeff (19:08): Again, I had no idea that it would blow up like it did, but if people weren't going to listen to my voice, my blogs, whatever it might be, I just wanted to have a visual portrayal of this dichotomy of all of these people talking about how they're going to make money in the next year off of new deals and forgetting that there are humans that are actually affected by their decisions. Janet Kennedy (19:30): I am getting a warm and fuzzy just thinking about this and for those who are listening, if you pop over to spencerhealthsolutions.com to where we're going to post the podcast link, you'll see a picture of Jen on stage wearing a hospital gown and I assume fuzzy slippers? Jen Horonjeff (19:48): Just sneakers. But yes, it was cold and it was meant to be. This is the reality of a patient is that in their scariest, darkest moments, we literally strip them of their clothes, their agency, we put them in a cold room and we tell them what to do and give them a treatment plan and tools that we did not design with them. Jen Horonjeff (20:09): Then we say, you know, you didn't follow your treatment plan. You are noncompliant when they're just trying to first of all negotiate whatever their diagnosis might be and then somehow reconcile integrating these tools or treatments into the life that did not meet their needs. That was the statement that I was just trying to make amongst all the other suits and everybody else in attendance. This is the reality for patients. Janet Kennedy (20:33): Well and I'm very happy that you got a lot of buzz out of that. You got some national media coverage and that is exactly the kind of message that people should be taking away from any healthcare conference. It is about the people who are the patients couldn't agree with you more. I'd love to get your thoughts on how inclusive the conversations are with patients. In your time from launching the Savvy Cooperative to now, are you being approached more consistently by more companies and are there any that in your mind have really stood up and embrace this idea of patient inclusivity? Jen Horonjeff (21:13): Yeah, it's really interesting. We've been doing this both kind of unofficially before launching Savvy and then what became Savvy Cooperative for many years. I would say even last decade people have been throwing around the terms patient centricity for a long time and now the grace period is over. You have to finally do something actionable about it. We even put out a white paper last year that was interviewing people across the life science industries, biotech and pharma companies asking them what does that term mean for them, their company, how do they act on it? And some of the things that we heard were that we don't listen to like the term patient centricity, but we have to say it because if we don't say it, then people will think we're not patient-centered. But it's kind of even lost its value because everybody uses it. And just throws it around. We're trying to say, okay, you care about patients proven now let's go work with them. Jen Horonjeff (22:06): So that's what we're trying to solve. That little piece of the puzzle when they're saying, yeah, we're patient centered, but we just don't know how to work with patients. We don't know where to find them in a way that meets all of our regulatory and compliance needs, et cetera. So we say, Oh, don't worry, we solved that part for you. And to that end, we have really seen an uptick, both of our pharma clients, digital health, we work with a ton of agencies or firms, management, consultancies, investors, all these people need to understand how to de-risked their products, their projects for their clients, their portfolio. And so working with patients as part of that answer. Oh, that's amazing. I love it. Well, what's up for the Savvy Cooperative in 2020 anything new and exciting coming down the pike? Well, we launched towards the end of last year a new model for sustained engagement for companies. Jen Horonjeff (23:01): So where we used to help companies engage in what we call just gigs. So that could be, like I say, putting out a survey or doing 20 interviews or things like this. We now, based on our clients requesting it, have a way for people to have sort of on demand patient insights so that they can have more regular touch points without having to wait six months to convene a focus group. And so that's been really exciting to see how people are utilizing this, both with our startup and digital health clients, our agencies, our big pharma clients. It's been amazing to have them every month getting on the phone with new patients to get insights, just as sort of gut checks to de-risked the steps that they're taking on a weekly basis as opposed like I say, to waiting until they get the next big project and all the contracting and all the framework around it signed off. So that's been really terrific. So we're looking to engage more and more clients and kind of a sustained model going forward as well so that we can help be their partners along the way. Janet Kennedy (24:00): Excellent. Well tell me if you were able to change one thing about clinical trials. Right now. What do you think you'd like to shake up a little bit? Jen Horonjeff (24:09): Well, I don't think that I'm going to have some new epiphany. I think it's a lot of what people have been talking about, about both things like virtual trials and making sure that we can include people that are not around centers where the trials are being conducted. I think that's a really important thing to figure out so that we can get more diverse participants so we can be learning. This is one of the biggest imperatives around AI and machine learning going forward is if we're learning on crappy data sets, then that is not going to be something that's going to create inclusive innovations going forward. Jen Horonjeff (24:42): So we have to start thinking about how to change that conversation now. I think the other aspect that people are already talking about of course is having real world evidence or thinking about what are the inclusion, exclusion criteria of a trial that makes it more applicable to others. I can tell you for me personally, there are certain medications that I cannot be on because of other things that I have had because people have been excluded from trials. So they just don't know how the body would behave because people like me were excluded. And so that's a real problem. So we need to be thinking about that going forward as well. Janet Kennedy (25:17): And I do have a question about protocol design in working with protocol designers, do you find that they are too far removed from the end product? I hear so much from some of the folks that have innovation in their title in pharma and they're all thinking about this is going to be amazing. Oh, but you know what? It still comes down to, if it's not written in the protocol, it's probably not going to happen. So what's up with protocol designers? Are they living in ivory towers? Are they accessible? Are they as a group interested in these digital health innovations? Patient-Centered information and feedback? Jen Horonjeff (25:55): You know, I think that we need to think about it is just there are so many new tools that are being added and we need to make sure that we're leveraging all of them. So thinking about digital tools or what other sort of resources or is it a virtual trial or whatever it is. Those are all great, but they're not great unless it's going to be working for the patient. And so that's sort of my soapbox is let's not design trial protocols in a vacuum and just guess it is not good for your business to do this because you're going to waste time and money if you invest the time and the budget, frankly upfront to work with patients, to get feedback, to have them flag certain things. Jen Horonjeff (26:38): I mean, we've had trials where they're working with communities that frankly, it's very hard to leave the house and to travel and their trials may say, we need you to come in every week to give us feedback on how you're feeling. We've had simple things like that and just flagging this is not feasible. Why do I have to come into the office? Why can't I just get on a phone call? They go, Oh yeah. Simple things. We've looked at what are the inclusion, exclusion criteria of a trial and been able to flag. You are not going to enroll people in this trial. That person that your eligibility criteria was designed for does not exist, so why not have those conversations up front even if it feels scary to somewhat brush against what you may know. Don't you want that information? Our patients are not here to be combative. They're just sharing their experience so that we can do this faster. Janet Kennedy (27:31): Excellent. Well that is definitely going to be a key to making sure that people are adherent, persistent and that they're staying into the end of the trial. It's designed it around their needs, their lifestyle and how they're going to interact with your trial rather than, you know, going to click the box a, B, or C. Jen Horonjeff (27:51): Exactly. Janet Kennedy (27:51): Well, I'm so excited that you joined me on the podcast today, Jen and I really look forward to meeting you in person at an event. I think the Savvy Cooperative is an amazing thing and I would consider myself a very healthy person. I take a little pill for this and a little pill for that. But generally speaking, I'm a very healthy person. Is there a place for me in the Savvy Cooperative? Jen Horonjeff (28:14): Absolutely. I know the term patient is loaded. It means different things to different people. We use that term because it's what resonated with our population early on. But we have all sorts of opportunities as people say, we're all patients and I'm supportive of that when it is galvanizing us all around a common goal. But it's then talking about is that the right patient at the right time. But we get requests for people who care about their fitness and they've used some sort of fitness tracking app. We want to talk to you. We're talking to mothers in underrepresented communities, so we want to talk to you. We even had one that was wanting to talk to people who wanted to improve their sex life. So tell me about the people that this is excluding. So I think that there's opportunities for everybody, whether or not you consider yourself a patient, we encourage you to join Savvy, Cooperative. You can at least just get the different opportunities. And the whole model again, is to be able to share them. So even though it might not be applicable to you, you might say, Oh, my aunt has cerebral palsy, so I'm going to share this opportunity with her. Or my friend was recently diagnosed with breast cancer. I think she'd really like to be able to weigh in on this experience. So that's why we keep it so open. Janet Kennedy (29:27): I love it and I wish you lots and lots of success and do look forward to meeting you. Jen, thank you so much for being a guest on the People, Always, Patients Sometimes podcast. Jen Horonjeff (29:39): It's been a pleasure. Thanks for having me. Reach out to Jen: LinkedIn Twitter Savvy Cooperative website Savvy Cooperative on Twitter

Spencer Health Solutions has invited Dr. Pamela Tenaerts to join us on the "People Always, Patients Sometimes" podcast to learn more about an important initiative to improve clinical trials. Dr. Tenaerts is the Executive Director of the Clinical Trial Transformation Initiative known as CTTI. Tom Rhoads (00:04): Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. In an earlier episode of the "People Always, Patients Sometimes" podcast, we heard about the founding of the DiMe Society from Jennifer Goldsack. The organization was created by participating members of CTTI who wanted to continue their work on the impact of digital health on clinical trials. We thought you would like to hear more about CTTI, the Clinical Trials Transformation Initiative, so we invited CTTI's executive director, Dr. Pamela Tenaerts to join us on the podcast. The program is a public-private partnership is shaping how clinical trials are and must evolve to be more efficient and effective. You'll hear how CTTI is living its mission to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. Thanks for listening to the "People Always, Patients Sometimes" podcast. Janet Kennedy (00:54): Spencer Health Solutions has invited Dr. Pamela Tenaerts to join us on the podcast today to have a chance to learn more about an important initiative to improve clinical trials. Dr. Tenaerts is the Executive Director of the Clinical Trial Transformation Initiative known as CTTI. It's a public-private partnership whose mission is to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. My name is Janet Kennedy and I'm your host for the "People Always, Patients Sometimes" podcast, a production of Spencer Health Solutions. I'm really looking forward to my conversation with Pam on the podcast. Welcome to "People Always, Patients Sometimes," Pam. Dr. Pam Tenearts (01:37): Thank you, Janet and I'm looking forward to it as well. Janet Kennedy (01:40): I understand that CTTI has actually been in existence for quite a while and in the digital health space for about eight years or so. Is that correct? Dr. Pam Tenaerts (01:51): Yes. We were actually lucky enough to celebrate our 10 year anniversary in 2018 so we've been in existence a lot. We've started with more general clinical trial improvements and then we are thinking more and more about the trials of the future Janet Kennedy (02:07): What was the initiative for getting it started in the first place? Dr. Pam Tenaerts (02:11): It was really a group that came together at the time. Remember, this is in 2007 is when we officially started and then we kind of developed an executive committee and went from there. But at the time there really wasn't anyone coming together to improve clinical trials and we really were looking at identifying practices that would increase the quality and efficiency of clinical trials. Over time, we have changed our mission to be more action-oriented because we realized that just identifying ways of doing things better doesn't really, it's not helpful enough for most organizations. So now we also drive adoption of the practices by creating more tools and resources that can help with those recommendations that we create. Yeah. At the time, I think we were one of the only organizations in the field, and we've been lucky enough to have other organizations come along as well, such as MRCC and TransCelerate because there's really so much work to be done. You know, it's a good evolution for clinical trials. Janet Kennedy (03:16): I'm curious about the impetus for this though. Did it come from pharma companies? Did it come from academia? Did it come from healthcare itself? Dr. Pam Tenaerts (03:27): Lessons are that it came from conversations between Rob Califf and the food and drug administration people. And they were talking about how things should be better, how things should be improved. And the FDA decided to put some effort into actually doing something rather than just talking about it. When you bring clinical trials, individuals together, we start complaining a lot and talking a lot about how this could be better or how that could be better. But at the time nobody was actually doing anything about it. So it was really sort of a call to action where then the food and drug administration created a memorandum of understanding with this university to set up this consortium. And from the beginning, it was clear that the only way we could get to solutions was involving everyone. So from the beginning we had organizations and individuals from across the enterprise representing academia, clinical investigators, government regulatory agencies, industry institutional review board, also patient advocacy groups. We've had patients in our efforts from the very beginning on our executive committee. We've also identified individual patient representatives that are folded into the steering committee. So we really bring everyone together and that's kind of how it started. It's a little bit of the Greenpeace model. You have to be part of the solution so I have a solution that is sustainable for the enterprise. Janet Kennedy (04:53): You know, I'm fascinated that from the very beginning CTTI committed to having patients a part of the process and that seems to be something that just now is being fully embraced, not necessarily done but embraced by pharma companies and protocol designers and even conferences on clinical trials. What do you think was really pushing the idea that patients needed to be a bigger part of the process 10 years ago? Dr. Pam Tenaerts (05:23): I think it was really the understanding that patients are a part of this is that participants in clinical trials are a part of some people living with diseases that need medical solutions should be part of how you develop them. When we first started, we had one representative on the executive committee, so that is a body direction and sort of work on strategy. We also had patients, individual patients voted into our member organizations, but in 2000 we actually upped that and I think that's even before a lot of these recent activities happened too. In 2013 we did a patient leadership council where we invited individuals from patient organizations, so this is not individuals but people representing groups like coma and things like that and we asked them to be part of CTTI. We had created a separate body for them, patient leadership council, so that's there a year or two Dave really asked us to become part of the membership organization, so now about 20% of our members are patient advocacy groups. Since then also every time we set up a project, we used to have leaders on a project from industry, government and academia as since 2013 patient leaders became part of our context as well. And I have to say it's changed the way we did things for the better. We've learned a lot and I think our recommendations have become even better than they were before. Janet Kennedy (06:59): I'm very interested in the part of your mission that talks about improving clinical trial efficiency, not necessarily efficacy. So what was inefficient about clinical trials that came to your attention? Dr. Pam Tenaerts (07:13): So at that time, CTTI was founded and I think it's still the case. There was his sunset clinical trials were getting more expensive and that maybe who was doing these. That does not add to the quality of data and integrity of data, which is sort of why we came up with our quality by design project as well. But the efficiency part is really addressing the complexity. Clinical trials are too complex and probably should not be as complex as they are to get to a reliable result. At the time, there was a sense that recruitment was slowing, which I think is still the case that recruitment could be better. Investigators were leaving clinical trials because it got too complex. This was also done at a time where the medical community really felt that we could use better evidence to was critical that we came up with a system that could provide this evidence in the most simple way possible to get the most reliable results that can be used for decision making. Janet Kennedy (08:21): And so you mentioned what the result of that was, the quality by design program. Dr. Pam Tenaerts (08:26): So yeah, the very first project was monitoring, this is in 2008 and this was sort of thinking about all the ways people were monitoring and you know, some people monitor, a lot of people at the time monitor a hundred percent some monitored, zero and some did something in between. And we were really trying to understand, you know, why all these things were happening and what the best ways would be to make sure that you have data. Because that is really the goal of monitoring, right? To make sure that you have quality, reliable data on that PCC was maintaining. You're in the conduct of the trial. So what we found is that if we think we can build it in quality at the back end, we're a little bit mistaken, but we really need to think about quality and that is where quality by design and manufacturing, it's really setting up your system so that you have the least errors, to begin with. And so our quality by design is focused on areas that matter and it's sort of really getting us to recruit a call that is as simple every 10 the and not more complex than it should be to get you reliable data in a systematic way. Janet Kennedy (09:45): And as you develop these programs, who are they accessible to are? How do you provide them to the industry? Dr. Pam Tenaerts (09:53): CTTI has a public-private partnership grants in the food and drug administration, which is kind of unusual because they're not a grant creating organization because we get federal funding. We are very keen on making everything accessible to everyone. So wild member organizations and people working on our team might have slightly earlier access. When we launched things like maybe we do an internal webinar before, once we've launched our recommendations, they become available to everyone on our website. So they are available to everyone. If people ask questions, we answered them, we help them. Janet Kennedy (10:33): Well, that's great. So all the things that you're developing, these resources are openly available to companies from your website. Dr. Pam Tenaerts (10:41): Exactly. And we encourage everyone to use them. And we've actually started a use case library to sort of document in a systematic way how people are using our recommendation members or non-members. It's open to everyone because what we've learned is that people really like our recommendations, but if you're trying to do something new, that's always hard. Right? So what we've learned from our members is that, Oh, we really want to use this, but it'd be so nice if we could see how somebody else has used this first. So this library serves two purposes. First, collecting our impact and selecting how people have used our recommendations, but then at the same time it becomes a resource to other organizations who want to adopt our recommendations or part of our recommendations. And we're hoping to create a community that way that can together improve clinical trials after we've launched our recommendation. Janet Kennedy (11:40): Oh, that's excellent. And this is an ongoing initiative. How do you decide what projects you're going to work on or what kind of content or programs you develop every year? Dr. Pam Tenaerts (11:53): Basically three ways in which we identify projects. One that is a partner with Duke University in the, in the partnership, the food and drug administration has an opportunity to ask us to do work. We call those. That's not of biggest part of our projects. The biggest part of our projects comes from members. So once we have the capacity, we go through an exercise with our members where we asked them what are they thinking about in clinical trials, what are their organization trying to solve? And we created a list of items. For example, last time around what came up was massive protocols people started to see across the enterprise and I remember around master protocols, pragmatism and clinical trial diversity. So those were products that our members identified. Once we create that list, that is the benefit of membership. While our resources are available to everyone. The members do get to vote on what we work on. Dr. Pam Tenaerts (13:02): The last way is sort of something that I can recommend that and that might be an opportunity that comes up or something that we think is really worthwhile and then I recommend that none of the projects are actually approved until the executive committee decides that we should move forward with them. We think about approval of projects. We are very careful in talking to ongoing other initiatives to make sure that we're not duplicating work or that we're not doing things that they're already doing. Our project managers create concept sheets that include talking to experts in the field. Like I said, making sure that we're not duplicating efforts and sometimes it's a little confusing because we might have an on the surface, similar names, different aspects of that issue, like informed consent. We have done some work on a chest, had done some work on it, but we're actually doing very good things that we are very careful because again, we use a lot of federal money. You don't want to waste those tax dollars on things that our people are already doing. We also approved projects. They sort of think about the uniqueness of the strategic impact of clinical trials in the future and sort of the dislocation efforts and things like that. Janet Kennedy (14:27): Now who does the actual work? Is this the members are joining committees to get involved or do you actually have staff there? Dr. Pam Tenaerts (14:34): It's a combination of both. We have a staff of project managers who get assigned these projects and they are really responsible for moving everything along and creating the framework for developing the project plan and things like that. But then reached out to our members. Every time a project has been approved by the executive committee, we send out a newsletter to our members and say, you know, just recently it was pragmatism in clinical trials and qualification of novel endpoints using global technology. So we send out an email, we say this is a concept we're going to be working on this, who would like to join? And then our members respond and then we create team leaders and the team leaders also have to come from member organization. So like I said, we kind of take a look at where while we kind of go for the academia-industry, government and patient advocacy, we also try to just look up a project and see what makes sense for government. Dr. Pam Tenaerts (15:34): It's important that both an NIH component and an FDA component, so once we identify the project's meters, now we also create a scene and then we supplement that team. Sometimes people that are not in our membership or people of organizations that like I said are not in our membership and that is needed for that project. When we work on projects and just people that are already getting paid by their organizations, we don't reimburse for participation on projects, but patients, individual patients, we reimburse for participating in our project so that everybody's on the same plane. So we're very careful about making sure that when you're sitting at the table around these projects, everybody has an equal voice and we see that that requires the individuals who might have to take time off from work to sit on project meetings for two hours or come to our meetings as they're working on the project. But then other people, sometimes academics as well because their lives, their life is a little hard VC and so they need to have research time that we reimbursed on their salaries. Janet Kennedy (16:44): I think that's wonderful. I really think that the challenge in having public-private partnerships and having industry leaders as a part of it is honestly for some of them it's easy to be there because their role is funded. It's just something they work into the workload. And the other thing is that it can mean that in many cases they're overly influencing what's happening. You know, I was on a consumer product safety committee and yet it was all made up of the people who manufacture the product. So there was no representation from the consumer at themselves. So it didn't make sense that the people building it. We're actually building our own safety regulations. Dr. Pam Tenaerts (17:26): Interesting. We're actually doing interviews with finished up project teams, so projects that have ended in the last few years. And one of the questions that is really important to us, if I were talking to representation from everyone on this project team, so patients in the streets, government, everyone. And one of the questions we're really sure of that we create that environment is, is your voice heard? Do you see like your boys have equal weight as everyone else's? Because that is I think, critical and moving the field forward. Janet Kennedy (18:01): I love it. Well, tell me about how does somebody actually join if they want to be a part of CTTI. Is this an open organization anyone can join and how does the fee schedule work? Dr. Pam Tenaerts (18:14): More and more talking about how to best engage with CTTI membership is certainly an option but might not be an option or might not be sort of the best path forward for everyone. People typically reach out to us or we have conversations with them to kind of figure out what the best way to participate is on an organization like CTTI. Because for example, some companies might be really interested in one very specific topic of a project that we're working on, but not quite as much on the others. And then so we have other ways that they can engage as part of our projects. We do interviews that we do surveys, we do expert meetings. So for some organizations and people, it makes much more sense to engage that way. Where people and organizations that really work in the fields of medical product development and have the passion to improve clinical trials. Dr. Pam Tenaerts (19:06): This is obviously not a platform where you can sort of access people that you can sell something to. We are very strict on avoiding that kind of a situation because we really do want everybody to feel like they can and they're not going to be sort of approached about clinical trials as a product. We do a little bit of screening from that perspective, but if you're an organization that has is very key interest on improving clinical trials and it is more than just about one particular thing and then a conversation is the first thing and then we can figure something out. Our fee schedule is online and has since 2007 since we started because when we started I talked about the memorandum of understanding the drug administration. So they basically said, we think this is a very good idea for to start this, but we have no money. So at the time the executive committee came up with a fee structure for people to join as members and it ranges from $70,000 for a global organization that has more than $20 billion in sales, to zero if you're an individual patient advocate. Janet Kennedy (20:18): Fabulous. Again, level playing field, you need to have the commitment coming in that matches your ability to pay. Dr. Pam Tenaerts (20:27): Exactly. You know, it doesn't make sense for everyone to be a number either because one, once you remember, we want to make sure that that's a value proposition for you, that you get something out of it that is not something that you do but you get something out of it that your people in the organization get something out of it and you can contribute. Now having said that, we don't need people that are complete experts, sort of, you know, key opinion leaders. We also want people with boots on the ground. So a lot of our projects include coordinators because you know the PII is one thing. A coordinator on the ground has a very different perspective of how in their day to day life. Janet Kennedy (21:10): That makes so much sense because that's where the efficiency falls apart. Someone can have a grand idea for a project, but if they're not the one implementing and saying, Hey, these two things aren't matching up and they're not working, then they're not getting the kind of information they need to make changes. Dr. Pam Tenaerts (21:26): Exactly. Janet Kennedy (21:28): Well, what about the longer-term vision for CTTI? Where do you hope to be in 10 years? Dr. Pam Tenaerts (21:34): Interesting that you ask that. We're actually working on a vision, we call it vision 2030 and really thinking about what clinical trial should look like 10 years from now with the idea that it should be achievable, but it should be a little bit of a stretch. So we're thinking about what they should look like and then also what we need to do to achieve that vision. Once we are finished with that exercise and we're hoping to have this done last spring, this here and we'll communicate about this of course, and then we want to ensure it's sort of a guidepost for our project activities at that point. We want to make sure that we work on projects that move the clinical trials ecosystem towards that vision. We're also hoping that our vision aligns with other people's religions, so there will be some work and figure that out. Janet Kennedy (22:24): Awesome. You know, one of the organizations that I have recently joined is the DiMe Society, the digital medicines society, and I understand that that came into existence because it's really an extension of a CTTI project. Dr. Pam Tenaerts (22:39): I'm not sure I would characterize it that way, but Jen Goldsack, who was the project manager on our novel digital and mobile technologies ended up becoming the executive director for DiMe, so I'd like to think it has something to do with school lessons of different things that were going on in the world. Right. There's a lot of movement around mobile clinical trials and technology and clinical trials and there wasn't really his feet for what are really two very different industries. If you think about a technology and medicine to come together and they've provided a forum to create that and yes, I think it's very worthwhile. I'm on the scientific leadership board. Janet Kennedy (23:26): Well, I will tell you the Jen gives CTTI a whole lot of credit. When we did a podcast interview discussing the dimes society and they basically said they got inspiration from working on CTTI projects and felt that they wanted to continue after. You'll be proud to know that there are over 800 members in the organization now. Dr. Pam Tenaerts (23:46): You know Jen and I, we used to work together but we still see each other a lot. We actually had to live in the same town and Florida, so now we do yoga together. Janet Kennedy (23:57): How often do you make it up to Duke? Dr. Pam Tenaerts (23:59): We are the distributed team, so about half of the team are remote and we are sort of dispersed from as far as Seattle to Sarasota, Florida and then everything in between. So we're kind of dispersed. We go every month or two days to sort of coalesce the team and bring all of us together. Obviously a lot of our work is on the phone. I have to credit Andy Coravos for doing more of our work on video conferences. We used to never do videos. I'm starting to like it a little bit better when you talk. So internally we do a lot more video conferencing. We do a lot of work on the phone. Obviously your work on a project is on the phone. We do have sort of, uh, opportunities to bring teams together, especially in the beginning so that we can make sure they call a left swell because people have to get used to each other. You know, understanding, learn who is voices and those kinds of things that we come together for two days, once a month. Janet Kennedy (25:04): Oh, that's excellent. Well, maybe next time you're in town I will get a chance to meet you in person. Dr. Pam Tenaerts (25:09): Oh, are you in Durham? Janet Kennedy (25:10): Oh, well I'm in Raleigh. Dr. Pam Tenaerts (25:11): Oh yeah, of course. Absolutely. Janet Kennedy (25:15): One thing I didn't ask you is about your background and how you came to CTTI in the first place. Do you mind telling me a little bit about your history? Dr. Pam Tenaerts (25:24): So I was trained as a general practitioner in Belgium and after a couple of years of doing that, I started working at the university and there's a funny story about that because the day of my interview with the professor of cardiology, I started in cardiology clinical trials. I worked on the Gusto study, which I thought every study was like this. Every clinical trial that had 42,000 patients. That's how I got into clinical trials. But the day of my interview, the professor asked me if I wanted to have dinner with the American. He first said, do you want to have dinner at the faculty club where I went to medical school and as a student, typically you don't have access to the faculty club at all. Dr. Pam Tenaerts (26:12): And then it turns out to be with the Duke folks and Rob Califf that day. The first day I interviewed for a clinical trial job. And so Rob is a constant for many people in the clinical trials world. After I finished the two-year appointment I had in Belgium, I came over to the West to work on the American side of clinical trials in the coordinating setting and that's really how it got started. A couple of years later I left and in 2012 I started having conversations again and then back up at CTTI, which is sign of a nice culmination of different experiences I've had working at a large university in Europe leading the European center for a multicenter, huge clinical trial, going to pharma, going to Duke at the time, then to a community hospital where I ran a research center. Then I went back to a device company to run the European operations and then to Duke. So it was a nice combination of being able to provide solutions to all of the issues I had encountered over what was by then about a 20-year experience in clinical trials. Janet Kennedy (27:24): Thanks for listening to this episode of "People always, Patients Sometimes" with our guests. Dr Pamela Tenaerts, the Executive Director of the Clinical Trial Transformation Initiative. Thanks for joining us, Pam. Dr. Pam Tenaerts (27:36): It was a pleasure. Thank you very much, Janet.

Calling all insomniacs, tossers, turners, blanket hogs, disco nappers and snooze button pushers! This week we are talking to the experts about how to get a good night's sleep. And our advice goes way beyond putting your devices away before bed.Have an idea for a future episode? Call us at 347-687-8109 and leave a voicemail, or write to us at upgrade@lifehacker.com. We want to hear from you!See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Calling all insomniacs, tossers, turners, blanket hogs, disco nappers and snooze button pushers! This week we are talking to the experts about how to get a good night's sleep. And our advice goes way beyond putting your devices away before bed.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Should you podcast? Absolutely yes! Host of the Get Social Health podcast, Janet Kennedy, joins me to make the case for podcasting.

The Healthcare Marketing Network was co-founded by Janet Kennedy, and she'll describe the founding of the company along with how this network can help you. Janet is also the Host of the Get Social Health podcast

Review of the 2018 Mayo Clinic Social Media Conference with guest Janet Kennedy who is the co-founder of the HealthCare Marketing Network and Host of the Get Social Health Podcast

In this episode of Remarkable, I have a conversation with Janet Kennedy, a radio host turned marketer, who came full circle two years ago when she landed behind a microphone to launch a podcast on social media and healthcare. She s had an extensive career in marketing, and in this episode, we talk in detail about […] The post Janet Kennedy on Getting Social to Find Your Audience appeared first on SuperSimpl.