Podcasts about biologics

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what's changing in FDA pre-approval and pre-license inspections—and why the “inspection side” of approval is becoming a bigger conversation.They cover how PAIs and PLIs fit into the approval pathway, why Complete Response Letters (CRLs) can be driven by inspection outcomes, and what it would mean to “decouple” approval decisions from inspection timing. The conversation also explores the pros and cons of unannounced inspections, the realities of FDA capacity and scheduling, and how FDA's PreCheck program is shaping the onshoring/manufacturing-readiness narrative in the U.S. Finally, they zoom out to compare international inspection approaches and what global trends could signal for industry.What you'll learn-The difference between Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs)-How inspection outcomes can lead to CRLs—even when the application looks strong on paper-Why industry is talking about decoupling approval from PAI timing-The idea behind FDA PreCheck and what “facility readiness” looks like-Unannounced inspections: where they help, where they create risk-How inspection expectations compare across global regulatorsChapters00:00 Introduction and Guest Welcome00:10 Understanding Pre-Approval and Pre-License Inspections01:54 Challenges and Industry Perspectives03:08 FDA Complete Response Letters (CRLs)05:23 Unannounced Inspections: Pros and Cons08:55 Economic and Regulatory Considerations12:37 Onshoring and the PreCheck Program22:51 Global Regulatory Landscape25:11 Conclusion and FarewellBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Dr. Isabelle Amigues unpacks why patients often recover better, faster, and more deeply in a supportive group. From mirror neurons and oxytocin to vagus nerve activation and the power of clinician belief, she explains how community and medicine accelerates remission—then previews UnabridgedMD's upcoming physician-led healing cohorts.What You'll Learn:From competition to collaboration: How traditional, competitive medical training contrasts with the superior outcomes of team-based care—and why adding patients to the care team elevates results.The brain science of group healingMirror neurons: observing others practice skills (e.g., injections, PT) improves your own learning and adherence.Oxytocin up, cortisol down: group practices (breath, chant, yoga) boost bonding hormones and reduce stress chemistry—fertile ground for recovery.Vagus nerve / parasympathetic activation: group rituals nudge the nervous system into “rest-and-repair,” lowering inflammation.Placebo power, reframed: Why clinician belief and a supportive cohort measurably enhance outcomes (a reason trials are double-blind)—and how to harness that effect ethically.Mindset shapes pain: Attention directs perception; scanning for what's working reduces pain. Group programs for chronic pain (e.g., back pain) consistently show greater relief and fewer relapses than going solo.Medication and milieu: Biologics and DMARDs are powerful tools, but outcomes improve further when paired with community practices that activate anti-inflammatory pathways.Safety, accountability, momentum: Groups create a psychologically safe space to try new habits, show up consistently, and stay on track—especially valuable in rheumatologic conditions.What's next at UnabridgedMD: A webinar and physician-led community cohorts designed to help patients reach and sustain remission through evidence-based medical care plus group-based nervous-system and lifestyle practices.If a trusted group could help you heal 25–40% faster, what habit or symptom would you choose to transform first?

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. As we close out the year 2025, it's clear that the pharmaceutical and biotech industries have experienced a period of significant transformation. This year has been marked by groundbreaking drug approvals, strategic partnerships, and a focus on innovative therapies that promise to redefine patient care.One of the standout achievements this year comes from GlaxoSmithKline, which received approval from the U.S. FDA for its ultra-long-acting biologic, Exdensur, aimed at treating severe asthma with an eosinophilic phenotype in adolescents and adults. This approval underscores the growing trend toward personalized medicine and biologics, offering new hope for patients with chronic respiratory conditions by providing more sustainable and personalized treatment options.In the oncology sector, Merck's Keytruda and Astellas Pharma's Padcev have demonstrated significant overall survival benefits when used as perioperative treatments for cisplatin-eligible muscle-invasive bladder cancer. This combination therapy of a PD-1 checkpoint inhibitor and an antibody-drug conjugate highlights the evolving landscape of cancer treatment, emphasizing the role of immunotherapy and targeted therapies in improving patient outcomes in challenging cancer subtypes.However, not all developments have been positive. Hansa Biopharma faced challenges with its kidney transplant drug, imlifidase. Despite success in kidney transplant trials, it failed to achieve desired results in treating anti-glomerular basement membrane disease. This serves as a reminder of the complexities involved in drug repurposing efforts within autoimmune diseases.Alnylam Pharmaceuticals announced a significant investment to enhance its Norton, Massachusetts facility into a dedicated site for small interfering RNA (siRNA) production. This move reflects the industry's shift towards RNA-based therapies that offer targeted gene-silencing capabilities and positions Alnylam at the forefront of RNAi therapeutics production.In another promising development, ImmunityBio reported positive data from its QUILT-3.032 study on Anktiva for BCG-unresponsive non-muscle-invasive bladder cancer with high-grade papillary disease. The potential expansion of Anktiva's use reinforces the importance of personalized immunotherapies in oncology.The launch of Ambros Therapeutics with $125 million in Series A funding highlights efforts to develop non-opioid pain medications already approved abroad. This initiative addresses chronic pain management without relying on opioids, potentially advancing analgesic therapies amidst the ongoing opioid crisis.In China, Fosun Pharma's acquisition of a majority stake in Green Valley Pharmaceuticals aims to revive a controversial seaweed-derived Alzheimer's medication. Despite skepticism over its efficacy, this investment signals continued innovation efforts amid growing demand for effective Alzheimer's treatments.Siemens Healthineers' partnership with Alzpath to incorporate pTau-217 antibodies into its Atellica immunoassay platforms marks a significant step forward in Alzheimer's diagnostics. This collaboration aims to enhance biomarker detection capabilities crucial for early diagnosis and intervention strategies in neurodegenerative diseases.On the strategic front, Bristol Myers Squibb entered into a substantial research agreement with Harbour BioMed valued at up to $1.1 billion. This deal underscores Big Pharma's ongoing pursuit of alliances to advance therapeutic pipelines and antibody technologies.Finally, Cencora's acquisition of OneOncology for $5 billion underscores consolidation trends within specialty practice networks. By valuing OneOncology at $7.4 billion, this acquisition reflects the growing importance of integrated oncology care models and collaborative netSupport the show

Retatrutide is years away from FDA approval and yet the fight over access, price, control of this medication is already well underway. That's what this podcast is going to be about today. There's well over a hundred thousand people by my estimates who are already on some form of this medication today. And that should tell you enough about how disruptive this molecule is and will be. It is a game changer among game changer. We've been talking about it for three years here at On The Pen, well before any of your favorite gym bros were talking about Retatrutide. We were talking about Reta, who tried Retatrutide here at On The Pen. And that's because we identified this triple agonist as a game changer among game changers. So This is going to be a very Retatrutide heavy episode, and so I hope you'll join us and stick with us if this is a topic you enjoy, because I think this is really going to effectively lay the groundwork for what accessibility to this medication will look like. So let's get into it. Welcome to the On The Pen Podcast with your host, Dave Knapp. Welcome to the On The Pen, the weekly dose podcast. This is our weekly roundup in incretin memetic news. And frankly, there's no news that is bigger than Reta-Trutide news. Just find me any news that is bigger than the data that we got on Reta-Trutide. Now, we already did a video about the Triumph Phase II clinical trials that we got in osteoarthritis of the knee. You can go back and check out that video if you'd like more data. So we're not gonna super... rehash the data. We'll go over at a high level what the data showed us. We're not going to go over how the medicine works, because by now we all know that it's the triple agonist, right? If terzapatide was a dual agonist, GLP-GIP, Retatrutide is the triple agonist that adds to it a glucagon component, which is absolutely just shredding, shredding liver fat. It is absolutely revving up people's metabolism and showing a tremendous amount of weight loss. So let's get into what the weight loss looked like in this first trial, because there are longer obesity trials where, where the primary outcome is the weight loss this was again a specific trial in measuring pain reduction in folks with osteoarthritis of the knee but check out these numbers these are placebo adjusted meaning it's taking the two percent out that people lost on placebo but looking at these numbers Folks on one milligram over forty eight weeks lost seventeen percent. They bumped up to four milligrams. Those folks lost twenty two percent. So right there at the lowest dose, you're already reaching the efficacy of today's drugs that are on the market, like triseptide and semaglutide in their various forms. If you bumped up to eight milligrams, you saw twenty four percent placebo adjusted weight loss and at twelve milligrams, twenty six point four percent weight loss. Adding back in that two percent of the placebo that those on placebo loss, that's twenty eight point four percent weight loss in these forty eight weeks at the highest dose. When you adjust for some of the more real world outcomes, you kind of ding the numbers a little bit based upon people who quit the drug, et cetera. Those numbers look more like a twenty percent weight loss and twenty three point seven percent weight loss at the highest dose. But even then, you're still seeing a drug that is better than the current drugs that are on the market. around forty eight percent of patients on Retatrutide lost greater than twenty five percent. And then if you were at that twelve twelve milligram dose, that highest dose patients lost fifty nine percent of patients lost more than twenty five percent of their body weight. There was a subset that lost thirty percent of their body weight and some even over thirty five percent of their body weight on Retatrutide. So the lower doses compete with today's best drugs and the upper doses are entering into bariatric surgery level weight loss. And that's putting the whole obesity system on notice and probably a lot of surgeons nervous because typical body weight loss was something like the street sleeve gastrectomy. For example, it's about eighteen to twenty five percent body weight. The Roux-en-Y gastric bypass twenty five to thirty five percent weight loss or the duodenal switch thirty to forty percent weight loss. So the upper doses of Ritutrutide overlap with sleeve and bypass outcomes without any surgery. It's incredible. It is a game changer among game changer. It is the new benchmark in obesity medicine. And there's actually more data, like I said, landing in later twenty twenty six. The longer duration will historically, if history is a marker, equal more weight loss than we even see here at this forty eight weeks. We have an interview that will be airing later this week on our channel and on our podcast with our friend Mimi from Australia who just wrapped up her clinical trial on Retatrutide. They ended it like ten weeks early on her, which was a huge bummer to her. So we're going to hear from her because she had to end abruptly. We're going to hear her story, an incredible story. She's one of those folks that got up that thirty five percent body weight loss in the time that she was on Retatrutide. So, this is just showing you that these drugs are not simply an alternative to bariatric surgery. We are approaching a point in time where these are on par with bariatric surgery, and as people are on this Reta-Trutide trial, you see that these numbers aren't plateauing either. So we will see stronger weight loss numbers the longer that these folks are on this trial. And I think you'll see some of those numbers in that population of folks on the higher doses eclipse maybe even some of what we see with some of these bariatric surgeries. the real story that i think is taking shape here is not in how powerful Retatrutide is because we've literally been expecting or anticipating this kind of data for more than three years at on the pin we've been talking about this and i think that's sort of reflected in the fact that you didn't see this massive spike in eli lilly stock wall street was expecting this as well Um, so it was on par, I think with expectations, but the expectations are astronomical compared to previous options that were available to patients and all the innovation in the world. All of these drugs, we talked at last week about WV, E double Oh seven, the James Bond of weight loss that targets fat, not only targets fat loss, but it also targets the promotion of building of, of lean muscle mass. We're talking about an insane future in obesity medicine. But none of it means anything if people can't access it. And that's really where we are today in terms of ensuring that there's going to be an option for everyone. And that's sort of what I want to get into today, because Lilly wants Retatrutide to be classified as a biologic, so not a traditional small molecule drug like you've seen every other incretin and nutrient-stimulated hormone-treating obesity on the market to date. They're trying to get this classified as a biologic. Now, we talked about this before on the podcast. That matters in three major ways. It affects the exclusivity length of time that a pharmaceutical company has on a drug. That goes from, I believe, five years of market exclusivity to twelve. It affects compounding rules because biologics cannot be compounded. And then that gives the pharmaceutical companies a tremendous amount of pricing power in the marketplace, because essentially there's no competition and there's no competition for a long time. But this whole argument about getting this classified as a biologic is not about safety. It's about protection and we're going to get into it. So let's explain this here. This is why Retatrutide really is not a biologic arguably. So biologics are large proteins. There are hundreds of or even thousands of amino acids grown in living cells that are sensitive to tiny manufacturing changes. Retatrutide is a short chain peptide. It's chemically synthesized and it is below the traditional biological size thresholds when it comes to how those things are defined. We'll just leave it at that. So even though it acts like a biologic in the body, it's made like a drug. It's made like a small molecule drug. And if it's treated as a drug, they get, like I said, five years of market exclusivity. Now, really a lot of confusion around what this means, but essentially the first five years of the life of a drug, the patent can be challenged for a number of reasons. We've seen patent challenges right now are going on in the courts for both semaglutide and terzepatide. But these companies are guaranteed that five years of market exclusivity, no matter how those patent lawsuits shake out. That five years jumps to twelve years with the biologic. So ultimately, there's no biosimilars that are allowed during that twelve year window. Again, with terzapatidin and semaglutide, it's five years. They could lose their market exclusivity within five years of the release of the patent. twelve years with a biologic. So if they lose their patent challenges on Trezabitide, they still have some time left with market exclusivity for the drug. They likely will not lose those, but that jumps to twelve years. And I think the most important thing to understand about the reclassification of Reta-Trutide to a biologic would mean that, 503A and 503B pharmacies are effectively locked out of compounding this medication, 503Bs would have some latitude arguably, but they would face extreme barriers. Routine compounding becomes legally and technically restricted because biological status doesn't slow compounding down. It actually shuts the door or almost completely shuts the door. Biologics not only would allow Lilly to have longer market exclusivity, no compounding, but it would allow them to command a higher price in the marketplace because A, they get this designation and there's an assumption when they bring this to market that they're harder to manufacture, that they're harder to copy, that there are fewer negotiating alternatives for payers. They can command a higher price with the insurance companies, and the price pressure stays muted for much longer because, again, you don't have those pressures of compounding. You don't have the pressures externally from lawsuits that could end your market exclusivity in that first five years of the drug's existence. So there's just a lot of price pressure upwards on a biologic compared to a normal small molecule drug. And when there's no credible alternative or backup option, which to Retatrutide, there wouldn't be, it'd be the first drug that has bariatric surgery level results. The prices won't come down. They'll command a massive price and the prices won't come down. So let's talk about where this currently stands because ultimately the Eli Lilly went to the FDA. We've been covering this for well over a year, maybe close to two years now, a year and a half at least. Lily went to the FDA, they said, we want this classified as a biologic, here are the reasons why. The FDA initially said, no, we're not gonna do that. So Lily challenged that decision in court. So the point that we're at today is the court told the FDA to reconsider and better explain itself So the first no given to the FDA to Lilly didn't stick. The courts looked at it and they said, you need a better, you need to reconsider your decision and you need to explain your decision better to Lilly. So ultimately we're sitting now at the point where the court has made its decision that the FDA has to go back and now we await basically what the FDA has to say on this. But if this thing is classified as a biologic, that would be a massive massive loss for patients. Now, again, we're, we're focusing on the accessibility of this drug into the future. And, and I think that this is an important conversation to have. One of the interesting points that I have to bring into the conversation is the fact that I got to sit in on a, on a closed session question and answer with the media. I didn't get to answer or, excuse me, excuse me, ask a question at this time, but shortly after the most favored nations announcement, with eli lilly and the trump administration in the oval office that day there was a press briefing that i was invited to dave ricks was asked by max bayer reporter of endpoints who we've interviewed here on this very podcast and he was asked was Retatrutide included in the most favored nations discussions meaning will we get a cash pay version of Retatrutide uh that is you know circumventing the pbms uh will we get these cheaper prices will will it be be two hundred fifty dollars also and there was a hard no there was a hard no like no that was not included that was not part of these discussions even though what we heard from the trump administration was that those these companies that were jumping on to the most favored nations agreement were also agreeing to offer future drugs at most favored nations pricing now was lily saying that no they're not going to offer it at the it wasn't part of the negotiations in terms of the price points that they had discussed for triseptide maybe or did it mean altogether there won't be a cash pay option of this medication i don't know um that we would love to get clarity on But I highly doubt we're going to get any more information than necessary at this point in time. So, Reta-Trutide is being positioned to be a drug that, and well so, should be offered at a premium. This is a drug that is far exceeding the current drugs that are on the market. I think that we're gonna see even the indications of Reta-Trutide far beyond simple obesity, but it is going to be their crown jewel for the next decade, more than likely. Reta-Trutide is going to be a massive drug, and so they're attempting to build a moat around it. And these are things that we need to be aware of as a community so that we can hold our positions and conversations about these and basically, you know, be able to articulate to people in positions of power like this is an important thing to us. This is an important thing in the advocacy of obesity and sort of the next frontier of the fight of accessibility, which marches on. each and every day because of course the current drugs, while as great as they are and as much as access is expanding, there are still people with sicker or rather more advanced versions of metabolic disease that are gonna need these newer treatments and price is going to be a huge factor. So let's talk about the gray market right now because I think it's also nearly impossible to talk about this topic without including a discussion about the gray market because there are, as I mentioned at the outset, hundreds of thousands of people on this medication already. So research grade Retatrutide exists. It's in the gray markets of the Internet. It's where people are going and they're buying, you know, basically versions of these these peptides that are made in factories overseas. They're being imported into the United States, oftentimes illicitly in shipments that are marked as something else. The FDA has tried to crack down. There's no doctor involved in this. It's a very, that's why it's called the gray market, right? So it's not a prescription medicine, but the demand for this is massive. And all you have to do is really scroll your TikTok for about fifteen minutes. You're going to come across a insane amount of content on the topic of Retatrutide. An insane amount of, and oftentimes, you know, what I find most disturbing is oftentimes it looks like very young people. very young people taking Retatrutide. Crazy, it's crazy. But the demand is massive and there's a whole gray market for it proliferating over on TikTok and in the far reaches of the internet. And I would estimate that tens, if not hundreds of thousands of people are already or have already used it. And I think it's a testament to a to to the effectiveness of this drug. It's also a testament to the fact that there needs to be more guardrails, I think, around this stuff than there currently is, because gray markets appear and they thrive when legal access lags the reality of the demand for the medication. And you saw this earlier this week as we launched a petition to fight back against the Safe Drug Act of twenty twenty five, a drug, a drug act that is in theory designed to put guardrails around compounding. But in practice, I think is creating a new battlefield for Eli Lilly and Novo Nordisk to shut down compounding on the current classes of medications, which is why We as a community need to be loud about our opposition to it. If they were really concerned about the safety of compounds, they would do two very simple things. They would require reporting around the active pharmaceutical ingredient of a compound. Patients ought to be able to know where the actual source of their medication is coming from. And they should know that those places are FDA approved and inspected. And the second thing is they should require adverse event reporting. Those are required of 503Bs. They should be required of 503As as well. 503As are making a tremendous amount of money. They're making thousands and thousands of these scripts. So when there are adverse events, they should be required to report those to the FDA. Simple. None of that is in this bill. None of it. None of it. Instead, it seeks to put caps on the amount of compounds that can be made by a compound pharmacy without them having to report to the FDA. And then it seeks to codify the definition of essential copy. Again, all of these things that will become law and then argued in court and then a battlefield for Lilly to potentially win a legal battle and thwart compounding. It's creating a new battlefield for them. They're losing in the courts. They're losing with the current language that exists in the Food, Drug, and Cosmetic Act. So we create new language. We create new law. Just vague enough to pull some threads and hopefully win something in court. That's how I see it. You may see it differently. If you do, curious to hear from you. But if you want to fight back against this legislation, you can go to otplinks.com and fight back against that. piece of legislation, because I think that we need as a community to have our voices heard on this, especially those who have gotten healthier by way of compounded medications. So the rumor on the gray market, to get back and close the thought loop here, There's been no specific FDA cutoff announced, but what the rumors going around are that that the compounded versions of GLP ones, especially obesity medicine in the gray market, are all going to turn off like a sieve on January first. Now, I seem to feel like this is probably more of a marketing tactic by these companies to sell a whole bunch of peptides at the end of the year. I think that's probably creating some panic and probably panic buying on people's parts. And so these companies are benefiting greatly. Again, that's why there should be guardrails around this. There's no guardrails around this at all. I mean, at the end of the day, they can say whatever they want to say, so long as they cloak everything in research grade. And these rumors proliferate around and people spend thousands, tens of thousands of dollars. I've heard of people having twenty years worth of Retatrutide in their freezer. Why? For what purpose do you need that? So just a massive amount of money made in this gray market. And that's not to knock people who use it. I say this all the time, but I think it's worth qualifying the statement. It's not knocking people who use it. I get it. But at the same time, we're talking about an industry that is, there's no altruism here. They're in it for money just as much as Eli Lilly is, except they have actually done nothing in the way of advancing medicine. They've just taken intellectual property, copied it, and sold it to you with a label that says, don't put this in your body. So you know where I stand on the gray market. I've heard from many people who've been injured by gray market stuff. It's just what it is. It's a gray market. You're taking your health into your own hands. Please, whatever you're doing out there, as risky as it may be, please involve your doctor and let your doctor know what you're doing so you can be monitored for the things your doctor believes you should be monitored for if you're using this. But this all underscores, again, the need for accessibility to these medications, the need for us to be aware of the fact that a moat is already being built around the most advanced metabolic drug in the pipeline. And we just need to be aware so that when it comes time to fight, we're all ready and informed. And that's what this podcast is serving to do. Before we jump into the next topic, I do want to thank our sponsor, our headline sponsor of this podcast. is a company called Shed. Now, if you are looking for access to care for obesity, then look no further than our partners at Shed who believed in this podcast enough to help us do it full time. You can go to Trished.com and use code OTP25 to save twenty five percent at Trished.com, where you're going to get connected to a doctor who will when medically necessary prescribe medication to treat your obesity. You also get access to coaching. You'll get access to all sorts of medication, whether it's the branded or the compounded versions, depending on your specific situation. All of it is available at Trished.com. They use one of my favorite compound pharmacies in the game, Strive Pharmacy, which I've gotten the chance to dig into on my own. I really love what they do there. They're a It functionally operates a lot more like a 503B. Uh, and I think that they're doing great work over at a strive pharmacy. They partner with shed. So I just love this, this, and when we were looking for somebody to offer a compounded versions, I wanted to make sure that I trusted the pharmacy. People always ask me, Dave, who, who should I go to? I'm like the pharmacy matters more than anything because you want to trust the source of your medication. So try shed.com use code OTP25. Listen, you're going to want to learn about taking any new medication before you take it. Learn about the potential side effects. Learn about the trade offs. There's no free lunch, but all of the information that you're going to need, you can find it. Try shed.com and be familiarizing yourself with all of your options there. So thank you to Shed for being a wonderful partner here at On The Pen. Now let's talk about some data that dropped. We're talking about accessibility and all of the sort of advancements in the world mean very little if people can't access it. That's why I think this data that dropped this past week from our friends over at Rowe is incredible. Absolutely game changing data. So check out this data. Real world telehealth data looking at sixty eight weeks. This is looking at patients who were enrolled in their row body program and on a GLP one specifically some maglutide mean weight loss in this study looked at again patients in over sixty eight weeks. The mean weight loss was sixteen point six percent on average. Thirty three percent of patients lost more than twenty percent and the safety in this study and looking at this data match the clinical trials. So what we're seeing here is that care for obesity can be delivered through a telehealth platform at scale and match clinical trial results. So that scalability decides how many people get access. There are not enough doctors out there to serve the over hundred million people in the United States living with overweight or obesity. so when you hear these blowhard doctors online calling all telehealth platforms except their own a pill mill or as i like to say pin mill the data is actually showing something quite different in that this type of obesity care can be delivered at scale through telehealth platforms it can meet people where they're at and allow people to get care without the shame, without the stigma, without their doctor just pointing to the door and saying, if you want a GLP-I, get out of my office. I ain't going to get it here. How ridiculous. But these people can go to platforms like Rho or Shed or any number of telehealth platforms that are out there and not only get access to medicine, but get access to care. So of course, not all telehealth companies are created equal. Of course, not all compound pharmacies are created equal. You want to do your homework and all of that. But this is data that shows that This kind of care can be delivered at scale via a virtual platform and show similar results to a clinical trial. I think, and this is peer reviewed data, and I think that this is just absolutely great news because when we talk about the problem, we need scalable solutions. The old brick and mortar ain't going to work when you don't have enough doctors to serve enough patients. If we want to get life-changing treatments like ritatratide or terzapatide, semaglutide, whatever, into the hands of the people who need it the most, we need companies to innovate scalable tech platforms that can meet patients where they are, that can leverage current technologies to find people the care that they need. And in this case, it's access to a doctor. It's access to a platform. It's access to prescription medication when appropriately prescribed. And it can be done, and it is being done. So I think this is great news, and will play a huge part in the future. As we talk about Retatrutide, even though it's a year and a half away, maybe a little bit longer, it's already exposing – the issues around accessibility and pricing. Hopefully there will be compounded versions available if they're medically necessitated, if there are shortages. We hope that the battleground for that is not already set and won by Lilly before this drug even comes to market. But there are strategies being done to keep people boxed out But I can tell you that whatever happens with Retatrutide, the future of obesity medicine is in virtual care. And platforms are rising to the occasion. Retatrutide hasn't reached patients yet, but it's already forcing the system to show us, you know, are you ready? Are you ready to deliver bariatric surgery level results at scale to the people who need them? So I am so thankful that you joined me here on this podcast today. Again, we love to talk about we're at a Retatrutide. If you're interested, we've been going live every Monday, Wednesday and Friday at eleven a.m. Central Time here on our YouTube channel, on our tick tock, on our X platform. We're doing that because there's enough news to bring you just about every single day. And we've been doing it for the last couple of weeks. If you've enjoyed it, let me know in the comments of the video on YouTube. Send me an email at David on the pen dot com. Uh, so every single Monday, Wednesday, Friday, and then we do a weekly rundown of the obesity medicine news every Tuesday. That's what this is. The weekly dose podcast. You can catch this on all of the platforms that you listen to your podcasts on, and please make sure to leave us a five star rating and review before you log out of your podcast app. That helps so much. I don't think you guys understand how much that helps, uh, the work that we do here to just train the podcast algorithms that this one is worth listening to. I hope you enjoyed today's podcast. If you did, drop it a thumbs up, five-star review, subscribe on YouTube, do all the things. Thank you for being here, and thank you for being the best part of what we do. We will catch you on the next one. Thank you, my friends. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Today Justin talks to retired FBI Special Agent Sheldon Fung. Sheldon has a Bachelor of Science Degree in Biochemistry from the University of California Davis, and a Master's Degree in Criminology and Weapons of Mass Destruction from Indiana University of Pennsylvania. spent more than 21 years with the FBI as a bomb technician and a WMD coordinator. He's here to discuss one of the biggest WMD cases he ever worked on, which began in Irvine, California in March, 2000, after a local man named Dr. Larry Ford attempted to have his business partner killed in a professional hit. Sheldon and his team became involved when the investigation took a shocking turn when biological agents and a buried arms cache were discovered in his home, along with evidence that connected Ford to the South African government and even the Central Intelligence Agency. Justin covered this case himself already for episode 93 of the podcast back in May 2023, which you might remember if you're a longtime listener, but today we'll hear from one of the primary investigators. Connect with Spycraft 101: Get Justin's latest book, Murder, Intrigue, and Conspiracy: Stories from the Cold War and Beyond, here. spycraft101.com IG: @spycraft101 Shop: shop.spycraft101.com Patreon: Spycraft 101 Find Justin's first book, Spyshots: Volume One, here. Check out Justin's second book, Covert Arms, here. Download the free eBook, The Clandestine Operative's Sidearm of Choice, here. Kruschiki The best surplus military goods delivered right to your door. Use code SPYCRAFT101 for 10% off! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Catch up on some of the most interesting and impactful developments of 2025, from research and new treatments for chronic hand eczema, emerging oral therapies for psoriasis and AD, and even advances in cosmetic dermatology. DEF Faculty and Advisory Council members weigh in on some of the key developments with an emphasis on clinical implications. And they look ahead to 2026. Plus, updates on trichoscopy and AI.Featuring: Brad Glick, Darren West, Hillary Baldwin, Roman Bronfenbrener, Kara Gooding, Sandri Johnson, Linda Stein Gold, Joe Gorelick, Lisa Swanson, Ted Rosen, Gilly Munavalli, Matt Bruno, David CotterLike what you're hearing? Want to learn more about the Dermatology Education Foundation? Explore assets and resources on our website.

Developing complex biologics and advanced therapies is historically time-consuming and material-intensive—but computational modeling is reshaping the formulation landscape.In this episode of Life Science Solutions, host Chris Adkins is joined by Andrea Arsiccio, PhD, Senior Scientist and Team Lead In Silico at Coriolis Pharma, to discuss how in silico modeling is revolutionizing the assessment of developability and formulation strategies for new drug products.Andrea breaks down how Coriolis Pharma combines physics-based models and Artificial Intelligence with traditional wet lab experimentation to predict molecule behavior, identify liabilities early, and solve complex problems like aggregation and viscosity.Topics Include:Defining In Silico: Understanding the spectrum from mechanistic models and molecular dynamics to AI and machine learning.Accelerating Development: How computational tools reduce the need for animal testing and save precious material in early-phase development.The "Why" Behind the "What": Using modeling to uncover the specific mechanisms causing instability or aggregation.The Hybrid Approach: Validating digital predictions with high-throughput wet lab screening for a robust formulation strategy.Regulatory Perspectives: How the FDA and EMA are viewing AI data and the importance of establishing model credibility.Expansion: Coriolis Pharma's growth into the US market and their new capabilities in Research Triangle Park.Whether you are a formulation scientist, a CMC leader, or a regulatory professional, this episode provides a fascinating look at how digital twins and computational strategies are de-risking the path to market for life-saving therapies.

For more information regarding this CME/CE activity and to complete the CME/CE requirements and claim credit for this activity, visit:https://www.mycme.com/courses/responding-to-the-science-biologics-in-practice-in-copd-10511SummaryThis enduring podcast activity provides pulmonologists and clinicians managing COPD with timely updates on the evolving role of biologics management. Featuring expert discussions, the program explores recent GOLD guideline revisions, the integration of new and emerging biologic therapies, and evidence-based decision-making based on clinical trial data and real-world practice.Covering guidelines, clinical trials, and clinical scenario, this activity emphasizes the translation of complex data into practical strategies. Learners will gain improved knowledge and competence related to patient selection, eosinophil thresholds, and clinical decision making.This podcast was recorded and is being used with permission of the presenters.Learning ObjectivesDiscuss recent evidence surrounding the use of biologic agents in the management of patients with COPD, including patient populations and outcomesIntegrate the use of biologic agents into the management of patients with COPD based on guidelines and clinical evidence for new and emerging agentsThis activity is accredited for CME/CE CreditThe National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The National Association for Continuing Education designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.The National Association for Continuing Education is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 121222. This activity is approved for 0.25 contact hours (which includes 0.25 hours of pharmacology).For additional information about the accreditation of this program, please contact NACE at info@naceonline.com.Summary of Individual DisclosuresPlease review faculty and planner disclosures here. Disclosure of Commercial SupportThis educational activity is supported by an independent medical education grant from GSK and an independent educational grant from Regeneron Pharmaceuticals, Inc and Sanofi.Please visit http://naceonline.com to engage in more live and on demand CME/CE content.

Please visit answersincme.com/860/MED-RESP-03658-replay to participate, download slides and supporting materials, complete the post test, and get a certificate. In this activity, experts in pulmonary medicine discuss how to integrate biologics into individualized treatment plans for chronic obstructive pulmonary disease (COPD), featuring insights from a patient advocate. Upon completion of this activity, participants should be better able to: Specify the rationale for targeting eosinophilic inflammation in COPD; Differentiate available and late-stage emerging biologic therapies based on the latest clinical evidence in COPD; Identify patients with COPD who are appropriate candidates for biologic therapy; and Outline strategies to optimally incorporate biologic therapies into treatment plans for patients with COPD.

Please visit answersincme.com/860/MED-RESP-03658-replay to participate, download slides and supporting materials, complete the post test, and get a certificate. In this activity, experts in pulmonary medicine discuss how to integrate biologics into individualized treatment plans for chronic obstructive pulmonary disease (COPD), featuring insights from a patient advocate. Upon completion of this activity, participants should be better able to: Specify the rationale for targeting eosinophilic inflammation in COPD; Differentiate available and late-stage emerging biologic therapies based on the latest clinical evidence in COPD; Identify patients with COPD who are appropriate candidates for biologic therapy; and Outline strategies to optimally incorporate biologic therapies into treatment plans for patients with COPD.

In this episode of the Medical Sales Podcast, Samuel sits down with regional director Rashago Kemp to explore the world of biologics and regenerative wound care, revealing how amniotic tissue is transforming outcomes for diabetic foot ulcers, venous leg ulcers, pressure injuries, and complex wounds that traditional care can't heal. Rashago breaks down the science behind why this tissue works, why amputations are rising in the U.S., and how patient compliance can make or break recovery. He shares powerful real-world cases, including a patient who healed after living with a wound for 20 years, and explains what it takes to succeed in this relationship-driven specialty. From managing more than 60 independent reps to navigating the differences between W2 and 1099 structures, Rashago delivers a rare inside look at sales, leadership, and patient impact in one of the most meaningful corners of medical technology.   Connect with Rashago Kemp: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How »

In this podcast, we spoke with Troy Ostreng, Senior Product Manager and David Burdge, Director of Cell and Gene Therapy at CPC about the development of the MicroCNX® aseptic micro-connectors and how they're helping biopharma teams streamline closed-system operations for cell and gene therapies. What unfolded was a detailed and forward-looking conversation that touched on CPC's 47-year legacy, the technical demands of advanced therapies, and the company's plans to drive the future of automation and sterility in manufacturing. A Legacy That Positioned CPC for Today's Advanced Therapy Boom When asked how CPC's long history in biologics and hospital environments prepared the company for today's cell and gene therapy landscape, David took us back to CPC's roots. “CPC was founded in 1978, so that's 47 years of innovation within connection technologies,” he said. “The first biologic was released in 1982, synthetic insulin, and we were there supporting the industry with open-format connectors on single-use bags.” From the early development of biologics through the shift to single-use and the rise of stainless-steel/single-use hybrid systems, CPC continuously evolved its connection technologies. They launched steam-through connectors as bioprocessing grew more complex, released their first aseptic connector in 2009, and introduced their first connector specifically targeted for the cell and gene therapy market in 2017. David explained how that history matters today: “Biologics has about a 35-year head start on advanced therapies. So the question becomes, what lessons can we transfer from biologics to cell and gene therapy as that industry grows at three to four times the rate biologics did in its first decade?” That perspective, combining biological manufacturing experience with the needs of new therapy modalities, forms the foundation for CPC's MicroCNX platform. MicroCNX: The First Aseptic Connector Built for Small-Format Tubing As cell and gene therapy developers began scaling up manufacturing, they quickly discovered a problem: the connectors used for biologics were not designed for small-volume, patient-specific therapies. Troy described it plainly: “Several years ago, we started hearing rumblings that current connectors weren't meeting what cell and gene therapy required.” CPC responded with a deep Voice of Customer (VOC) initiative, interviewing process engineers, operators, manufacturing leaders, and platform developers. Over and over, the same needs emerged. Operators wanted something simple. “Ease of use was the number one requirement,” Troy said. “Operators needed a product that was easy to use so they could make sterile connections in a short amount of time.” Processes demanded robustness. “Customers needed a connection they could trust—no contamination, no failures, no weak spots in the connection process,” he added. Small-volume precise applications required connectors actually designed for them. With autologous therapies, he noted, “We aren't talking about 1,000 liters; we're talking about 250 milliliters. And if there's a mishap, that could mean the difference between life and death for a patient.” All of this laid the groundwork for MicroCNX, which became the first aseptic connector engineered for small-format tubing. The “Pinch-Click-Pull” Process: Sterility Meets Speed One of the standout features of MicroCNX is its elegantly simple pinch-click-pull operation. Troy explained how simplicity came directly from user feedback. “As operators walked us through their pain points, what they needed was clear: a connector they could learn immediately. So MicroCNX has a three-step process—pinch, click, pull. You can literally do it as fast as I say it.” He continued,“Once someone does it one time, they're basically an expert. That ease of use dramatically reduces operator error.” For an industry where operator variability remains one of the biggest sources of risk and batch loss, eliminating complexity is critical. Cryogenic Challenges Call for Cryo-Rated Solutions As the conversation shifted to cryopreservation, a critical component of cell therapy manufacturing,Troy introduced the MicroCNX® ULT and MicroCNX® Nano variants. “These were really developed because therapies were being frozen to –150°C, even –190°C. You need a connector that can be frozen to those temperatures, thawed, and still be as robust as it was before.” The ULT and Nano were engineered with: Low-profile geometries to fit inside freezing cassettes Specialized materials to withstand thermal stress Chemical compatibility with DMSO and other cryoprotectants Enhanced durability to survive impacts while frozen Troy emphasized how critical it was to get the materials right: “We searched extensively for a material that could handle those harsh chemicals and temperatures. What we landed on was PPSU—polyphenylsulfone. It's chemically sound, and it's incredibly impact-resistant at very low temperatures.” CPC built these connectors because customers repeatedly told them: existing solutions were cracking, leaking, or becoming brittle. MicroCNX was engineered to overcome all of that. True Closed Systems vs. Functionally Closed Systems: Why the Difference Matters A substantial part of the conversation focused on the differences between closed, functionally closed, and open systems—distinctions that are often overlooked but critically important. Troy broke down the differences clearly: “An open system is exposed at some point. A functionally closed system is inherently open but gets closed temporarily to let fluid transfer. In comparison, a closed system is never open at any point.” Examples of functionally closed systems include: Biosafety cabinets (BSCs) Luer-based connections Closed system transfer devices These approaches require: Sanitization Careful environmental controls Operator expertise And, as Troy noted, “a mishap in one of these can mean losing a very valuable therapy.” CPC's sterile connectors—including MicroCNX minimize these risks: “Our connectors allow the system to remain closed 100% of the time. That greatly reduces contamination risk.” This distinction isn't merely academic—it has direct regulatory implications as well. David added,“In Annex 1, they refer to intrinsically sterile connection devices—like sterile connectors and tube welders—that allow operations normally requiring Grade A or B to occur in a Grade C or D environment.” That ability to operate safely in lower-grade spaces is increasingly critical as the industry tries to overcome facility and labor bottlenecks. Why Teams Are Moving Away from Tube Welding Tube welding has been part of bioprocessing for decades, but David explained why its era may be ending for CGT. “Tube welding was born out of the blood banking industry when no other solution existed. But sterile connectors don't require capital investment. They're faster. They eliminate issues like tubing alignment or pinhole leaks. They're simply more reliable.” As biologics manufacturers have already done, CGT teams are now transitioning toward connectors like MicroCNX® that provide sterile, consistent, low-burden operations. The MicroCNX® Luer Variant: Supporting Transitional Workflows Not all workflows are ready to move away from luer-based devices. That's where the MicroCNX Luer variant fits in. Troy described how it works.“You connect a syringe or bag with a luer inside the BSC, but then because the MicroCNX® connector itself is sterile, you can take it outside the hood and make a sterile connection elsewhere.” This capability bridges legacy workflows and fully closed systems—critical during process development, technology transfer, or when working with specific devices. Co-Development: The Heart of CPC's Innovation Process As the conversation returned to CPC's broader philosophy, David highlighted how important customer collaboration is. “It's all about the customer for CPC,” he said. “We start with Voice of Customer. Our business and applications managers are out in the field understanding real applications and guiding them to the right products.” This feedback fuels CPC's two major development tracks: Catalog product development (platforms like MicroCNX) Custom-engineered solutions for unique applications David added: “We maintain a full new product introduction roadmap. Some products will be released broadly. Others will be developed specifically for one customer. But both are driven by real application requirements.” This process ensures CPC's products evolve in lockstep with the needs of advanced therapy teams. Looking Ahead: Designing Connectors for Robotics and Automation Toward the end of the conversation, David turned to one of CPC's biggest focus areas: the future of automation. “The ultimate customer in this industry is the patient,” he said. “And right now we face barriers—capacity, speed, accessibility, cost. Process automation can significantly reduce those barriers.” Automation requires connectors designed not just for human hands but for robotics: Predictable geometries Features optimized for machine vision Forces and actuation steps compatible with robotic grippers Designs intended for automated loading and unloading David summarized CPC's future direction: “We're taking a fresh look at our connectors, reimagining them as something designed for robotic manipulation. It's a high priority for us.” Troy echoed the sentiment: “Our connectors are awesomely designed for humans. But automation is coming, and we're focused on the features robots need.” A Future Built on Innovation and Patient Impact The interview closed with both guests reflecting on CPC's mission. “We're incredibly passionate about innovation and meeting the needs of our customers through thoughtful product development,” Troy said.

Jefferey unpacks a leaked FDA memo written by Dr. Vinay Prasad, head of the FDA's Center for Biologics and Research, which revealed at least 10 child deaths linked by internal analysts to the Covid vaccine, an admission the agency has never made publicly. He exposes how career scientists quietly raised alarms, how corporate media scrambled to distort the story, and why this marks a turning point in government transparency on vaccine safety.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

To receive my free and daily newsletter, go to: www.SmartDigestion.com Would you like to schedule a consultation? Call 586-685-2222 To try Dr. Christine's Smart Carb-45 for go to: www.smartcarb45.com To work directly with Dr. Christine: https://gutcall.thedigestiondoc.com/consult

Send us a textOn the latest WTR Small-Cap Spotlight podcast episode, we welcomed Jan Eryk Umiastowski, CFO of GenSight Biologics (Euronext Paris: SIGHT), a late clinical-stage biopharma company based in Paris, France, primarily focused on developing and commercializing novel disease-modifying gene therapies aimed at reversing vision loss from severe neurodegenerative retinal diseases. He discusses GenSight's development pipeline, what's unique about  the company's approach to gene therapy and upcoming target milestones.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways.They discuss:- The hidden costs of regulatory failure and how to avoid them- Why early engagement with regulatory agencies is critical- Global regulatory models, including emerging markets like China and the UAE- A clear explanation of UDI and serialization- How regulatory impacts extend beyond compliance teams- The role of LinkedIn and storytelling in regulatory careers- Steven's experience running for the European Parliament and what it taught him about policyTimestamps00:00 – Introduction and Guest Welcome00:38 – The Hidden Costs of Regulatory Failure03:47 – Engaging with Regulators Early05:26 – Global Regulatory Models and Emerging Markets10:07 – Understanding UDI and Serialization15:16 – The Power of LinkedIn and Personal Stories17:11 – Running for European Parliament and Policy Insights21:18 – Conclusion and Contact InformationConnect with Steven O'RourkeWebsite: https://clarifi.fiLinkedIn: https://linkedin.com/in/sorourkdeSubscribe to Let's Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy.Stephen O'Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Please visit answersincme.com/860/99066167-replay2 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, experts in nasal polyps discuss the efficacy and safety of late-stage biologics in the treatment of CRSwNP. Upon completion of this activity, participants should be better able to: Interpret the clinical evidence for late-stage emerging biologics in the context of approved agents; and Design strategies to select the appropriate biologics for patients with CRSwNP, as more become available.

Please visit answersincme.com/860/99066167-replay2 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, experts in nasal polyps discuss the efficacy and safety of late-stage biologics in the treatment of CRSwNP. Upon completion of this activity, participants should be better able to: Interpret the clinical evidence for late-stage emerging biologics in the context of approved agents; and Design strategies to select the appropriate biologics for patients with CRSwNP, as more become available.

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of impactful events and breakthroughs that are shaping patient care and drug development.The U.S. Food and Drug Administration recently granted early approval for a combination therapy using Padcev and Keytruda for the perioperative treatment of bladder cancer, a decision made months ahead of schedule. This approval represents a significant advancement in the therapeutic landscape for this type of cancer, offering new hope to patients who have had limited treatment options. The combination of these two therapies underscores the growing trend of integrating multiple mechanisms of action to tackle complex diseases like cancer more effectively. It also highlights the potential of combination therapies to provide enhanced clinical benefits by leveraging different therapeutic targets.In another notable development, Merck's partner Kelun announced successful Phase 3 trial results for an antibody-drug conjugate combined with Keytruda in treating PD-L1-positive non-small cell lung cancer (NSCLC). The trial results demonstrated statistically significant improvements in progression-free survival compared to Keytruda alone. This finding reinforces the expanding role of antibody-drug conjugates in oncology and emphasizes the importance of biomarker-driven therapies in personalizing cancer treatment. These advancements reflect a broader industry shift towards precision medicine, which aims to improve patient outcomes by tailoring treatments based on individual patient profiles.Meanwhile, Novo Nordisk experienced setbacks as its shares fell nearly 9% following two unsuccessful Phase 3 trials of semaglutide for Alzheimer's disease. Despite these disappointing results, this outcome highlights the persistent challenges and complexities inherent in developing therapies for neurodegenerative diseases—areas where unmet needs remain substantial. The market's reaction reflects investor sensitivity to clinical trial outcomes, particularly in high-stakes areas like Alzheimer's where breakthroughs are eagerly anticipated.Switching gears to AstraZeneca, the company is making a strategic move by expanding its manufacturing capabilities with a $2 billion investment in Maryland. This expansion reflects an ongoing trend among pharmaceutical companies to enhance their production infrastructure, driven by increasing demand for biologics and complex therapeutics. Such investments are crucial for supporting large-scale production needs and ensuring robust supply chains that are essential for meeting global health demands.In regulatory news, a collective letter from biotech CEOs addressed to FDA director Marty Makary has raised concerns about regulatory stability in the U.S., with 82% of biopharma respondents expressing apprehension over the FDA's ability to function predictably. This plea underscores how regulatory volatility can hinder innovation and emphasizes the importance of consistent policies that support long-term research and development efforts.In clinical trial updates, Bayer's oral FXIa inhibitor asundexian has shown promise in reducing stroke risk during Phase 3 trials. These findings revive interest in FXIa inhibitors as potentially blockbuster drugs after previous setbacks in this class. This development illustrates ongoing efforts to identify novel anticoagulant therapies that balance efficacy and safety, offering new hope for improved therapeutic options.Now turning our attention to Johnson & Johnson's recent setback with their anti-tau antibody posdinemab in a phase 2 trial targeting Alzheimer's disease. The trial was unable to demonstrate a significant slowing of clinical decline, leading JSupport the show

In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how it boosted his confidence and expertise in quality engineering. They explore the practical applications of Design of Experiments (DOE), including a real-life example where Andy applied DOE concepts at work. Andy also discusses the value of various ASQ certifications, including CQE, CQA, CQM/OE and Six Sigma Green Belt, emphasizing their importance for career growth. The conversation extends to non-ASQ certifications such as PMP, highlighting their relevance for leadership roles. By comparing practices from various industries, including automotive and medical devices, they underscore the importance of cross-industry learning. Andy concludes by inviting listeners to join his courses to further their own professional development.00:00 Welcome and Introduction00:48 The Impact of CQE Certification02:23 Applying DOE in Quality Engineering05:42 Top ASQ Certifications13:35 Non-ASQ Certifications and Leadership15:55 Cross-Industry Learnings18:45 Conclusion and Contact InformationAndy Robertson is the founder of CQE Academy and a leading educator in the quality profession. With a background in medical devices and years of hands-on experience as a quality engineer, he built a global audience through his practical, passionate approach to teaching CQE, Green Belt, and quality systems fundamentals. Andy's work centers on helping professionals gain confidence, accelerate their careers, and master the core tools of quality through clear, accessible education.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Please visit answersincme.com/860/100752367-replay to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, experts in the management of psoriatic disease discuss challenges in treatment, emerging TYK2 inhibitor therapies, and evidence-based strategies to optimize patient care. Upon completion of this activity, participants should be better able to: Recognize how nurse practitioners and physician associates can help address barriers to care and enhance outcomes for patients with moderate to severe plaque psoriasis; Differentiate TYK2 signaling from JAK pathways and explain the relevance of these distinctions in clinical outcomes; Evaluate the impact of emerging data on TYK2 inhibitors in shaping therapeutic strategies for psoriatic disease; and Apply strategies for aligning TYK2 inhibitor therapy with patient needs and multidisciplinary care plans.

Please visit answersincme.com/860/100752367-replay to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, experts in the management of psoriatic disease discuss challenges in treatment, emerging TYK2 inhibitor therapies, and evidence-based strategies to optimize patient care. Upon completion of this activity, participants should be better able to: Recognize how nurse practitioners and physician associates can help address barriers to care and enhance outcomes for patients with moderate to severe plaque psoriasis; Differentiate TYK2 signaling from JAK pathways and explain the relevance of these distinctions in clinical outcomes; Evaluate the impact of emerging data on TYK2 inhibitors in shaping therapeutic strategies for psoriatic disease; and Apply strategies for aligning TYK2 inhibitor therapy with patient needs and multidisciplinary care plans.

Co-hosts Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, interview Evan S. Dellon, MD, and Elizabeth T. Jensen, PhD, about a paper they published on predictors of patients receiving no medication for treatment of eosinophilic esophagitis. Disclaimer: The information provided in this podcast is designed to support, not replace, the relationship between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [:52] Co-host Ryan Piansky introduces the episode, brought to you thanks to the support of Education Partners GSK, Sanofi, Regeneron, and Takeda. Ryan introduces co-host Holly Knotowicz.   [1:14] Holly introduces today's topic, predictors of not using medication for EoE, and today's guests, Dr. Evan Dellon and Dr. Elizabeth Jensen.   [1:29] Dr. Dellon is an Adjunct Professor of Epidemiology at the University of North Carolina School of Medicine in Chapel Hill. He is also the Director of the UNC Center for Esophageal Diseases and Swallowing.   [1:42] Dr. Dellon's main research interest is in the epidemiology, pathogenesis, diagnosis, treatment, and outcomes of eosinophilic esophagitis (EoE) and eosinophilic GI diseases (EGIDs).   [1:55] Dr. Jensen is a Professor of Epidemiology with a specific expertise in reproductive, perinatal, and pediatric epidemiology. She has appointments at both Wake Forest University School of Medicine and the University of North Carolina at Chapel Hill.   [2:07] Her research primarily focuses on etiologic factors in the development of pediatric immune-mediated chronic diseases, including understanding factors contributing to disparities in health outcomes.   [2:19] Both Dr. Dellon and Dr. Jensen also serve on the Steering Committee for EGID Partners Registry.   [2:24] Ryan thanks Dr. Dellon and Dr. Jensen for joining the podcast today.   [2:29] Dr. Dellon was the first guest on this podcast. It is wonderful to have him back for the 50th episode! Dr. Dellon is one of Ryan's GI specialists. Ryan recently went to North Carolina to get a scope with him.   [3:03] Dr. Dellon is an adult gastroenterologist at the University of North Carolina at Chapel Hill. He directs the Center for Esophageal Diseases and Swallowing. Clinically and research-wise, he is focused on EoE and other eosinophilic GI diseases.   [3:19] His research interests span the entire field, from epidemiology, diagnosis, biomarkers, risk factors, outcomes, and a lot of work, more recently, on treatments.   [3:33] Dr. Jensen has been on the podcast before, on Episode 27. Holly invites Dr. Jensen to tell the listeners more about herself and her work with eosinophilic diseases.   [3:46] Dr. Jensen has been working on eosinophilic gastrointestinal diseases for about 15 years. She started some of the early work around understanding possible risk factors for the development of disease.   [4:04] She has gone on to support lots of other research projects, including some with Dr. Dellon, where they're looking at gene-environment interactions in relation to developing EoE.   [4:15] She is also looking at reproductive factors as they relate to EoE, disparities in diagnosis, and more. It's been an exciting research trajectory, starting with what we knew very little about and building to an increasing understanding of why EoE develops.   [5:00] Dr. Dellon explains that EoE stands for eosinophilic esophagitis, a chronic allergic condition of the esophagus.   [5:08] You can think of EoE as asthma of the esophagus or eczema of the esophagus, although in general, people don't grow out of EoE, like they might grow out of eczema or asthma. When people have EoE, it is a long-term condition.   [5:24] Eosinophils are a type of white blood cell, specializing in allergy responses. Normally, they are not in the esophagus. When we see them there, we worry about an allergic process. When that happens, that's EoE.   [5:40] Over time, the inflammation seen in EoE and other allergic cell activity causes swelling and irritation in the esophagus. Early on, this often leads to a range of upper GI symptoms — including poor growth or failure to thrive in young children, abdominal pain, nausea, and symptoms that can mimic reflux.   [5:58] In older kids, symptoms are more about trouble swallowing. That's because the swelling that happens initially, over time, may turn into scar tissue. So the esophagus can narrow and cause swallowing symptoms like food impaction.   [6:16] Ryan speaks of living with EoE for decades and trying the full range of treatment options: food elimination, PPIs, steroids, and, more recently, biologics.   [6:36] Dr. Dellon says Ryan's history is a good overview of how EoE is treated. There are two general approaches to treating the underlying condition: using medicines and/or eliminating foods that we think may trigger EoE from the diet.   [6:57] For a lot of people, EoE is a food-triggered allergic condition.   [7:01] The other thing that has to happen in parallel is surveying for scar tissue in the esophagus. If that's present and people have trouble swallowing, sometimes stretching the esophagus is needed through esophageal dilation.   [7:14] There are three categories of medicines used for treatment. Proton pump inhibitors are reflux meds, but they also have an anti-allergy effect in the esophagus.   [7:29] Topical steroids are used to coat the esophagus and produce an anti-inflammatory effect. The FDA has approved a budesonide oral suspension for that.   [7:39] Biologics, which are generally systemic medications, often injectable, can target different allergic factors. Dupilumab is approved now, and there are other biologics that are being researched as potential treatments.   [7:51] Even though EoE is considered an allergic condition, we don't have a test to tell people what they are allergic to. If it's a food allergy, we do an empiric elimination diet because allergy tests aren't accurate enough to tell us what the EoE triggers are.   [8:10] People will eliminate foods that we know are the most common triggers, like milk protein, dairy, wheat, egg, soy, and other top allergens. You can create a diet like that and then have a response to the diet elimination.   [8:31] Dr. Jensen and Dr. Dellon recently published an abstract in the American Journal of Gastroenterology about people with EoE who are not taking any medicine for it. Dr. Jensen calls it a real-world data study, leveraging electronic health record patient data.   [8:51] It gives you an impression of what is actually happening, in terms of treatments for patients, as opposed to a randomized control trial, which is a fairly selected patient population. This is everybody who has been diagnosed, and then what happens with them.   [9:10] Because of that, it gives you a wide spectrum of patients. Some patients are going to be relatively asymptomatic. It may be that we arrived at their diagnosis while working them up for other potential diagnoses.   [9:28] Other patients are going to have rather significant impacts from the disease. We wanted to get an idea of what is actually happening out there with the full breadth of the patient population that is getting diagnosed with EoE.   [9:45] Dr. Jensen was not surprised to learn that there are patients who had no pharmacologic treatment.   [9:58] Some patients are relatively asymptomatic, and others are not interested in pursuing medications initially or are early in their disease process and still exploring dietary treatment options.   [10:28] Holly sees patients from infancy to geriatrics, and if they're not having symptoms, they wonder why bother treating it.   [10:42] Dr. Jensen says it's a point of debate on the implications of somebody who has the disease and goes untreated. What does that look like long-term? Are they going to develop more of that fibrostenotic pattern in their esophagus without treatment?   [11:07] This is a question we're still trying to answer. There is some suggestion that for some patients who don't manage their disease, we very well may be looking at a food impaction in the future.   [11:19] Dr. Dellon says we know overall for the population of EoE patients, but it's hard to know for a specific patient. We have a bunch of studies now that look at how long people have symptoms before they're diagnosed. There's a wide range.   [11:39] Some people get symptoms and get diagnosed right away. Others might have symptoms for 20 or 30 years that they ignore, or don't have access to healthcare, or the diagnosis is missed.   [11:51] What we see consistently is that people who may be diagnosed within a year or two may only have a 10 or 20% chance of having that stricture and scar tissue in the esophagus, whereas people who go 20 years, it might be 80% or more.   [12:06] It's not everybody who has EoE who might end up with that scar tissue, but certainly, it's suggested that it's a large majority.   [12:16] That's before diagnosis. We have data that shows that after diagnosis, if people go a long time without treatment or without being seen in care, they also have an increasing rate of developing strictures.    [12:29] In general, the idea is yes, you should treat EoE, because on average, people are going to develop scar tissue and more symptoms. For the patient in front of you with EoE but no symptoms, what are the chances it's going to get worse? You don't know.   [13:04] There are two caveats with that. The first is what we mean by symptoms. Kids may have vomiting and growth problems. Adults can eat carefully, avoiding foods that hang up in the esophagus, like breads and overcooked meats, sticky rice, and other foods.   [13:24] Adults can eat slowly, drink a lot of liquid, and not perceive they have symptoms. When someone tells Dr. Dellon they don't have symptoms, he will quiz them about that. He'll even ask about swallowing pills.    [13:40] Often, you can pick up symptoms that maybe the person didn't even realize they were having. In that case, that can give you some impetus to treat.   [13:48] If there really are no symptoms, Dr. Dellon thinks we're at a point where we don't really know what to do.   [13:54] Dr. Dellon just saw a patient who had a lot of eosinophils in their small bowel with absolutely no GI symptoms. He said, "I can't diagnose you with eosinophilic enteritis, but you may develop symptoms." People like that, he will monitor in the clinic.   [14:14] Dr. Dellon will discuss it with them each time they come back for a clinic visit.   [14:19] Holly is a speech pathologist, but also sees people for feeding and swallowing. The local gastroenterologist refers patients who choose not to treat their EoE to her. Holly teaches them things they should be looking out for.   [14:39] If your pills get stuck or if you're downing 18 ounces during a mealtime, maybe it's time to treat it. People don't see these coping mechanisms they use that are impacting their quality of life. They've normalized it.   [15:30] Dr. Dellon says, of these people who aren't treated, there's probably a subset who appropriately are being observed and don't have a medicine treatment or are on a diet elimination.   [15:43] There's also probably a subset who are inappropriately not on treatment. It especially can happen with students who were under good control with their pediatric provider, but moved away to college and didn't transfer to adult care.   [16:08] They ultimately come back with a lot of symptoms that have progressed over six to eight years.   [16:18] Ryan meets newly diagnosed adult patients at APFED's conferences, who say they have no symptoms, but chicken gets caught in their throat. They got diagnosed when they went to the ER with a food impaction.   [16:38] Ryan says you have to wonder at what point that starts to get reflected in patient charts. Are those cases documented where someone is untreated and now has EoE?   [16:49] Ryan asks in the study, "What is the target EGID Cohort and why was it selected to study EoE? What sort of patients were captured as part of that data set?"   [16:58] Dr. Jensen said they identified patients with the ICD-10 code for a diagnosis of EoE. Then they looked to see if there was evidence of symptoms or complications in relation to EoE. This was hard; some of these are relatively non-specific symptoms.   [17:23] These patients may have been seeking care and may have been experiencing some symptoms that may or may not have made it into the chart. That's one of the challenges with real-world data analyses.   [17:38] Dr. Jensen says they are using data that was collected for documenting clinical care and for billing for clinical care, not for research, so it comes with some caveats when doing research with this data.   [18:08] Research using electronic health records gives a real-world perspective on patients who are seeking care or have a diagnosis of EoE, as opposed to a study trying to enroll a patient population that potentially isn't representative of the breadth of individuals living with EoE.   [18:39] Dr. Dellon says another advantage of real-world data is the number of patients. The largest randomized controlled trials in EoE might have 400 patients, and they are incredibly expensive to do.   [18:52] A study of electronic health records (EHR) is reporting on the analysis of just under 1,000. The cohort, combined from three different centers, has more than 1,400 people, a more representative, larger population.    [19:16] Dr. Dellon says when you read the results, understand the limitations and strengths of a study of health records, to help contextualize the information.   [19:41] Dr. Dellon says it's always easier to recognize the typical presentations. Materials about EoE and studies he has done that led to medicine approvals have focused on trouble swallowing. That can be relatively easily measured.   [20:01] Patients often come to receive care with a food impaction, which can be impactful on life, and somewhat public, if in a restaurant or at work. Typical symptoms are also the ones that get you diagnosed and may be easier to treat.   [20:26] Dr. Dellon wonders if maybe people don't treat some of the atypical symptoms because it's not appreciated that they can be related to EoE.   [20:42] Holly was diagnosed as an adult. Ryan was diagnosed as a toddler. Holly asks what are some of the challenges people face in getting an EoE diagnosis.   [20:56] Dr. Jensen says symptoms can sometimes be fairly non-specific. There's some ongoing work by the CEGIR Consortium trying to understand what happens when patients come into the emergency department with a food bolus impaction.   [21:28] Dr. Jensen explains that we see there's quite a bit of variation in how that gets managed, and if they get a biopsy. You have to have a biopsy of the esophagus to get a diagnosis of EoE.   [21:45] If you think about the steps that need to happen to get a diagnosis of EoE, that can present barriers for some groups to ultimately get that diagnosis.   [21:56] There's also been some literature around a potential assumption about which patients are more likely to be at risk. Some of that is still ongoing. We know that EoE occurs more commonly in males in roughly a two-to-one ratio. Not exclusively in males, obviously, but a little more often in males.   [22:20] We don't know anything about other groups of patients that may be at higher risk. That's ongoing work that we're still trying to understand. That in itself can also be a barrier when there are assumptions about who is or isn't likely to have EoE.   [23:02] Dr. Dellon says that in adolescents and adults, the typical symptoms are trouble swallowing and food sticking, which have many causes besides EoE, some of which are more common.   [23:18] In that population, heartburn is common. Patients may report terrible reflux that, on questioning, sounds more like trouble swallowing than GERD. Sometimes, with EoE, you may have reflux that doesn't improve. Is it EoE, reflux, or both?   [24:05] Some people will have chest discomfort. There are some reports of worsening symptoms with exercise, which brings up cardiac questions that have to be ruled out first.   [24:19] Dr. Dellon mentions some more atypical symptoms. An adult having pain in the upper abdomen could have EoE. In children, the symptoms could be anything in the GI tract. Some women might have atypical symptoms with less trouble swallowing.   [24:58] Some racial minorities may have those kinds of symptoms, as well. If you're not thinking of the condition, it's hard to make the diagnosis.   [25:08] Dr. Jensen notes that there are different cultural norms around expressing symptoms and dietary patterns, which may make it difficult to parse out a diagnosis.   [25:27] Ryan cites a past episode where access to a GI specialist played a role in diagnosing patients with EoE. Do white males have more EoE, or are their concerns just listened to more seriously?   [25:57] Ryan's parents were told when he was two that he was throwing up for attention. He believes that these days, he'd have a much easier time convincing a doctor to listen to him. From speaking to physicians, Ryan believes access is a wide issue in the field.   [26:23] Dr. Dellon tells of working with researchers at Mayo in Arizona and the Children's Hospital of Phoenix. They have a large population of Hispanic children with EoE, much larger than has been reported elsewhere. They're working on characterizing that.   [26:49] Dr. Dellon describes an experience with a visiting trainee from Mexico City, where there was not a lot of EoE reported. The trainee went back and looked at the biopsies there, and it turned out they were not performing biopsies on patients with dysphagia in Mexico City.   [27:13] When he looked at the patients who ended up getting biopsies, they found EoE in 10% of patients. That's similar to what's reported out of centers in the developed world. As people are thinking about it more, we will see more detection of it.   [27:30] Dr. Dellon believes those kinds of papers will be out in the next couple of months, to a year.   [27:36] Holly has had licensure in Arizona for about 11 years. She has had nine referrals recently of children with EoE from Arizona. Normally, it's been one or two that she met at a conference.   [28:00] Ryan asks about the research on patients not having their EoE treated pharmacologically. Some treat it with food avoidance and dietary therapy. Ryan notes that he can't have applesauce, as it is a trigger for his EoE.   [28:54] Dr. Jensen says that's one of the challenges in using the EHR data. That kind of information is only available to the researchers through free text. That's a limitation of the study, assessing the use of dietary elimination approaches.   [29:11] Holly says some of her patients have things listed as allergies that are food sensitivities. Ryan says it's helpful for the patients to have their food sensitivities listed along with their food allergies, but it makes records more difficult to parse for research.   [30:14] Dr. Dellon says they identify EoE by billing code, but the codes are not always used accurately. Natural Language Processing can train a computer system to find important phrases. Their collaborators working on the real-world data are using it.   [30:59] Dr. Dellon hopes that this will be a future direction for this research to find anything in the text related to diet elimination.   [31:32] Dr. Jensen says that older patients were less likely to seek medication therapy. She says it's probably for a couple of reasons. First, older patients may have been living with the disease for a long time and have had compensatory mechanisms in place.   [32:03] The other reason may be senescence or burnout of the disease, long-term. Patients may be less symptomatic as they get older. That's a question that remains to be answered for EoE. It has been seen in some other disease processes.   [32:32] Dr. Dellon says there's not much data specifically looking at EoE in the older population. Dr. Dellon did work years ago with another doctor, and they found that older patients had a better response to some treatments, particularly topical steroids.   [32:54] It wasn't clear whether it was a milder aspect of the disease, easier to treat, or because they were older and more responsible, taking their medicines as prescribed, and having a better response rate. It's the flip side of work in the pediatric population.   [33:16] There is an increasingly aging population with EoE. Young EoE patients will someday be over 65. Dr. Dellon hopes there will be a cure by that point, but it's an expanding population now.   [33:38] Dr. Jensen says only a few sites are contributing data, so they hope to add additional sites to the study. For some of the less common outcomes, they need a pretty large patient sample to ask some of those kinds of questions.   [33:55] They will continue to follow up on some of the work that this abstract touched on and try to understand some of these issues more deeply.   [34:06] Dr. Dellon mentions other work within the cohort. Using Natural Language Processing, they are looking at characterizing endoscopy information and reporting it without a manual review of reports and codes. You can't get that from billing data.   [34:29] Similarly, they are trying to classify patient severity by the Index of Severity with EoE, and layer that on looking at treatments and outcomes based on disease severity. Those are a couple of other directions where this cohort is going.   [34:43] Holly mentions that this is one of many research projects Dr. Jensen and Dr. Dellon have collaborated on together. They also collaborate through EGID Partners. Holly asks them to share a little bit about that.   [34:53] Dr. Jensen says EGID Partners is an online registry where individuals, caregivers, and parents of children affected with EGIDs can join.   [35:07] EGID Partners also needs people who don't live with an EGID to join, as controls. That gives the ability to compare those who are experiencing an EGID relative to those who aren't.   [35:22] When you join EGID Partners, they provide you with a set of questionnaires to complete. Periodically, they push out a few more questionnaires.   [35:33] EGID Partners has provided some really great information about patient experience and answered questions that patients want to know about, like joint pain and symptoms outside the GI tract.   [36:04] To date, there are close to 900 participants in the registry from all over the world. As it continues to grow, it will give the ability to look at the patient experience in different geographical areas.   [36:26] Dr. Dellon says we try to have it be interactive, because it is a collaboration with patients. The Steering Committee works with APFED and other patient advocacy groups from around the world.    [36:41] The EGID Partners website shows general patient locations anonymously. It shows the breakdown of adults with the condition and caregivers of children with the condition, the symptom distribution, and the treatment distribution.   [37:03] As papers get published and abstracts are presented, EGID Partners puts them on the website. Once someone joins, they can suggest a research idea. Many of the studies they have done have come from patient suggestions.   [37:20] If there's an interesting idea for a survey, EGID Partners can push out a survey to everybody in the group and answer questions relatively quickly.   [37:57] Dr. Dellon says a paper came out recently about telehealth. EoE care, in particular, is a good model for telehealth because it can expand access for patients who don't have providers in their area.   [38:22] EoE is a condition where care involves a lot of discussion but not a lot of need for physical exams and direct contact, so telehealth can make things very efficient.    [38:52] EGID Partners surveyed patients about telehealth. They thought it was efficient and saved time, and they had the same kind of interactions as in person. In general, in-state insurance covered it. Patients were happy to do those kinds of visits again.   [39:27] Holly says Dr. Furuta, herself, and others were published in the Gastroenterology journal in 2019 about starting to do telehealth because patients coming to the Children's Hospital of Colorado from out of state had no local access to feeding therapy.   [39:50] Holly went to the board, and they allowed her to get licensure in different states. She started with some of the most impacted patients in Texas and Florida in 2011 and 2012. They collected data. They published in 2019 about telehealth's positive impact.   [40:13] When 2020 rolled around, Holly had trained a bunch of people on how to do feeding therapy via telehealth. You have to do all kinds of things, like make yourself disappear, to keep the kids engaged and in their chairs!   [40:25] Now it is Holly's primary practice. She has licenses in nine states. She sees people all over the country. With her diagnosis, her physicians at Mass General have telehealth licensure in Maine. She gets to do telehealth with them instead of driving two hours.   [40:53] Dr. Jensen tells of two of the things they hope to do at EGID Partners. One is trying to understand more about reproductive health for patients with an EGID diagnosis. Only a few studies have looked at this question, and with very small samples.   [41:15] As more people register for EGID Partners, Dr. Jensen is hoping to be able to ask some questions related to reproductive health outcomes.   [41:27] The second goal is a survey suggested by the Student Advisory Committee, asking questions related to the burden of disease specific to the teen population.   [41:48] This diagnosis can hit that population particularly hard, at a time when they are trying to build and sustain friendships and are transitioning to adult care and moving away from home. This patient population has a unique perspective we wanted to hear.   [42:11] Dr. Jensen and Dr. Dellon work on all kinds of other projects, too.   [42:22] Dr. Dellon says they have done a lot of work on the early-life factors that may predispose to EoE. They are working on a large epidemiologic study to get some insight into early-life factors, including factors that can be measured in baby teeth.   [42:42] That's outside of EGID Partners. It's been ongoing, and they're getting close, maybe over the next couple of years, to having some results.   [43:03] Ryan says all of those projects sound so interesting. We need to have you guys back to dive into those results when you have something finalized.   [43:15] For our listeners who want to learn more about eosinophilic disorders, we encourage you to visit apfed.org and check out the links in the show notes below.   [43:22] If you're looking to find specialists who treat eosinophilic disorders, we encourage you to use APFED's Specialist Finder at apfed.org/specialist.   [43:31] If you'd like to connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [43:41] Ryan thanks Dr. Dellon and Dr. Jensen for joining us today. This was a fantastic conversation. Holly also thanks APFED's Education Partners GSK, Sanofi, Regeneron, and Takeda for supporting this episode.   Mentioned in This Episode: Evan S. Dellon, MD, MPH, Academic Gastroenterologist, University of North Carolina School of Medicine   Elizabeth T. Jensen, MPH, PhD, Epidemiologist, Wake Forest University School of Medicine, University of North Carolina at Chapel Hill   Predictors of Patients Receiving No Medication for Treatment of Eosinophilic Esophagitis in the United States: Data from the TARGET-EGIDS Cohort   Episode 15: Access to Specialty Care for Eosinophilic Esophagitis (EoE)   APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/specialist apfed.org/connections apfed.org/research/clinical-trials   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, Regeneron, and Takeda.   Tweetables:   "I've been working on eosinophilic gastrointestinal diseases for about 15 years. I started some of the early work around understanding possible risk factors for the development of disease. I've gone on to support lots of other research projects." — Elizabeth T. Jensen, MPH, PhD   "You can think of EoE as asthma of the esophagus or eczema of the esophagus, although in general, people don't grow out of EoE, like they might grow out of eczema or asthma. When people have it, it really is a long-term condition." — Evan S. Dellon, MD, MPH   "There are two general approaches to treating the underlying condition, … using medicines and/or eliminating foods from the diet that we think may trigger EoE. I should say, for a lot of people, EoE is a food-triggered allergic condition." — Evan S. Dellon, MD, MPH   "I didn't find it that surprising [that there are patients who had no treatment]. Some patients are relatively asymptomatic, and others are not interested in pursuing medications initially or are … still exploring dietary treatment options." — Elizabeth T. Jensen, MPH, PhD   "We have a bunch of studies now that look at how long people have symptoms before they're diagnosed. There's a wide range. Some people get symptoms and are diagnosed right away. Other people might have symptoms for 20 or 30 years." — Evan S. Dellon, MD, MPH   "EGID Partners is an online registry where individuals, caregivers, and parents of children affected with EGIDs can join. EGID Partners also needs people who don't live with an EGID to join, as controls." — Elizabeth T. Jensen, MPH, PhD

Please visit answersincme.com/860/99066167-replay1 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, experts in nasal polyps discuss the ongoing burden of CRSwNP and the rationale for exploring novel biologics. Upon completion of this activity, participants should be better able to: Specify the rationale for targeting epithelial cytokines to address unmet needs in the treatment of CRSwNP; and Interpret the clinical evidence for late-stage emerging biologics in the context of approved agents.

Subscribe to our channel:    / @optispan  Get Our Newsletter (It's Free): https://www.optispan.life/Join me for a fascinating conversation with Dr. Jamie Justice, Executive Director of the $101 Million XPRIZE Healthspan. In this podcast, we discuss the world of longevity science, from the ambitious goals of this global competition to the lessons learned from the stalled TAME trial.Dr. Justice explains how the XPRIZE is structured to find real-world solutions to extend human healthspan.Chapters:00:01:31 - Jamie's Role & The Mission of XPRIZE Healthspan00:02:29 - What is the XPRIZE Foundation?00:05:36 - The Genesis of the Healthspan Prize00:09:39 - Why Commercial Success Matters for the Prize00:10:51 - How to Win: The Competition Structure & Timeline00:18:50 - The 3 Key Healthspan Pillars: Cognitive, Physical, and Immune Function00:22:03 - Clinical Trial Design: Crossover Trials & "Responder" Analysis00:27:12 - The Types of Teams & Interventions (From Gene Therapy to Public Health)00:32:06 - Handling "Wild West" Clinics & The Importance of Data Transparency00:35:02 - How Many Teams Will Make it to the Finals?00:37:41 - Safety, Ethics, and Regulatory Hurdles00:43:42 - The FDA's Role and the Challenge of Approving "Aging" Interventions00:51:18 - The Story of the TAME Trial: Goals, Design, and Why It Stalled00:58:23 - The Real Reasons TAME Wasn't Funded (NIH Peer Review & More)01:07:09 - The Future of Large-Scale Aging Trials01:13:25 - The Good, The Bad, and The "Pheromones": Crazy XPRIZE Submissions01:16:49 - Breakdown of Finalist Categories: Drugs, Biologics, Supplements, and Multimodal Approaches01:22:20 - A Companion Prize for Biomarker Discovery01:27:30 - The Problem with "Biological Age" and Epigenetic Clocks01:31:44 - The Ethics of Using Direct-to-Consumer Age Tests in ClinicsAbout XPRIZE:XPRIZE's mission is to inspire and empower humanity to achieve breakthroughs that accelerate an equitable, abundant future.Website: https://www.xprize.org/Get Involved: https://www.xprize.org/get-involvedLinkedIn:   / x-prize-foundation  YouTube:    / xprize  X: http://x.com/xprizeInstagram:   / xprize  TikTok:   / xprize  Facebook:   / xprize  This video was produced by One Billion Media, an agency that specializes in YouTube virality for health brands and experts. Learn more about their work here:https://onebillionmedia.com/DISCLAIMER: The information provided on the Optispan podcast is intended solely for general educational purposes and is not meant to be, nor should it be construed as, personalized medical advice. No doctor-patient relationship is established by your use of this channel. The information and materials presented are for informational purposes only and are not a substitute for professional medical advice, diagnosis, or treatment. We strongly advise that you consult with a licensed healthcare professional for all matters concerning your health, especially before undertaking any changes based on content provided by this channel. The hosts and guests on this channel are not liable for any direct, indirect, or other damages or adverse effects that may arise from the application of the information discussed. Medical knowledge is constantly evolving; therefore, the information provided should be verified against current medical standards and practices.More places to find us:Twitter: https://x.com/Optispan_IncTwitter: https://x.com/mkaeberlein Linkedin:   / optispan  Instagram:   / optispan_   TikTok:   / optispan  https://www.optispan.life/Discover how teams worldwide are competing to prove they can reverse human aging by 10+ years, and why the winner might not be a drug at all.

Please visit answersincme.com/860/99066167-replay1 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, experts in nasal polyps discuss the ongoing burden of CRSwNP and the rationale for exploring novel biologics. Upon completion of this activity, participants should be better able to: Specify the rationale for targeting epithelial cytokines to address unmet needs in the treatment of CRSwNP; and Interpret the clinical evidence for late-stage emerging biologics in the context of approved agents.

What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first year?In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Usman Ahmad, former CEO of Nexus Pharmaceuticals and now CEO of Quetzal Therapeutics. Together they trace his journey from corporate finance to building a generics powerhouse with his parents, scaling a sterile injectable facility, and ultimately selling it to Eli Lilly for just under one billion dollars.They discuss the philosophy of finding the "right to win," what most companies miss about manufacturing capacity and equipment selection, how to build a team with deep industry know-how, and why Usman is now focused on bringing therapies to patients with rare diseases.This is a practical, personal, and strategic look at building something from the ground up, deciding not to sell too early, and learning how to do the hard things with intention.Topics include:-How to select the right generic molecules beyond patent expiry-Early success with isoproterenol and API sourcing-Why Nexus turned down acquisition offers-Building a commercial salesforce from scratch-Designing a facility with high speed prefilled syringe and lyo capacity-Why most other sterile sites failed-The billion dollar sale to Lilly-Launching Quetzal and developing oral arsenic for APL-The brain-eating amoeba drug and ultra rare disease strategy-Faith, confidence, and decision making under pressureTimestamps: 00:00 Introduction and Guest Welcome00:24 From Wall Street Finance to Pharma01:42 How Usman Selected Winning Generics02:58 Early Challenges Building a Generics Company05:29 Family R&D Expertise and Business Dynamics11:44 First Generic Launch and Commercial Impact16:28 Building Sterile Injectable Manufacturing Capacity18:16 Sterile Facility and Equipment Strategy22:40 Prefilled Syringe and Vial Line Capabilities23:07 Big Pharma Interest and Selling the Facility26:02 Nexus Pharma Services and the Lilly Deal27:23 Post‑Sale Reflections and New Ventures28:30 Launching Quetzal Therapeutics and Rare Disease Focus33:30 New Challenges and Confidence in Drug Development39:55 Importance of People, Teams, and Relationships41:40 Books That Shaped Usman's Thinking42:29 Where to Connect with UsmanLearn more: https://quetzaltx.comConnect with Usman: https://www.linkedin.com/in/usman-ahmed-a351b928More episodes: https://letscombinate.comUsman Ahmad is the Founder and CEO of Quetzal Therapeutics, and former CEO of Nexus Pharmaceuticals, where he led the company through explosive growth and the billion-dollar sale of its manufacturing facility to Eli Lilly. With a background in finance and a deep passion for healthcare innovation, Usman now focuses on bringing treatments to patients with rare and underserved diseases.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines.The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development.⏱ Timestamps00:00 – Welcome & Introduction00:52 – Integrating GLP, GCP & GMP02:22 – Challenges in Developing Combination Products04:02 – Device-Led Combination Products07:35 – Working with Rare Diseases09:58 – GMP & Process Validation15:08 – Clinical Trials: Drug vs Device19:22 – Cost of Quality & Six Sigma25:12 – Conclusion & Contact InformationLeonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs.

Elizabeth Vernon is a beekeeper-activist, herbalist, and founder of Queen Bees Farmacy, dedicated to bringing together the world of wild-crafted remedies, advocacy, and deep terrain insight.In this episode, we dive into the hidden dimensions of health and resistance — from how screen time is reshaping our bodies and nervous systems to the untested and unknown dangers of biologics. Elizabeth pulls no punches as we unpack how certain systems of “controlled opposition” (yes, we talk about RKF Jr., Elizabeth's experiences with him and his team, and what it means) muddy the waters of health freedom, and how reconnecting with nature's rhythms — bees, herbs, terrain, community — is the original rebellious medicine.Look beyond the surface and discover what really supports your body, mind, and environment in a world of distraction and distraction's design. This conversation with Elizabeth will challenge you — and empower you — to take back your terrainLearn more about Elizabeth at https://www.queenbeesfarmacy.comSupport Terrain Theory on Patreon! Our recently-launched member platform gives you access to a ton of free & exclusive content. Check it out: https://www.patreon.com/TerrainTheoryHelp support Ryan and Briana's road to recovery by donating to our GoFundMe set up in their name. Every penny will go to cover the costs of associated with healing their terrain using alternative, terrain-friendly methods. Donate here: https://www.gofundme.com/f/help-ryan-briana-heal-from-pfas-exposureTerrain Theory episodes are not to be taken as medical advice. You are your own primary healthcare provider.If you have a Terrain Transformation story you would like to share, email us at ben@terraintheory.net.Learn more at www.terraintheory.netFollow Terrain Theory:Instagram: https://www.instagram.com/terrain_theory/Facebook: https://www.facebook.com/Terrain-TheoryX: https://twitter.com/terraintheory1YouTube: https://www.youtube.com/@terraintheoryMusic by Chris Merenda

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA's Office of Combination Products (OCP). Mark takes us on a deep dive into the history of how combination products have been regulated in the U.S., starting with the Safe Medical Devices Act of 1990 and how the process evolved into the formation of OCP in 2002.We explore questions such as: What challenges did industry and the FDA face in the early days of combination products? How did the “Request for Designation” process come about, and how is regulatory identity determined? What is the “Primary Mode of Action” (PMOA) rule and why does it matter? How do user fees, cross-center coordination, and post-market regulations shape how combination products get to market and are monitored? Mark also highlights current regulatory gapssuch as cross-labeling and site registration issues that continue to impact developers.Whether you're working in med-tech, pharma, or regulatory affairs, this episode offers historical perspective, technical insights, and strategic take-aways for navigating the combination-product space. Tune in for a candid conversation with one of the leading figures in this field.Timestamps:00:00 Introduction & Guest Welcome00:35 Historical Background of Combination Products03:05 Creation of Office of Combination Products (OCP)04:29 Early Challenges and Developments04:54 MDUFA, PDUFA, User Fee Programs & Legislative Impact14:24 Defining Primary Mode of Action (PMOA)18:35 OCP's Role & Responsibilities26:49 Industry Adoption & Challenges38:48 Regulatory Gaps & Future Directions46:00 Conclusion & Contact InformationContact & Resources:Connect with Mark Kramer on LinkedIn or via email at Mark.Kramer@greenleafhealth.comMark Kramer is Principal of the Medical Devices & Combination Products regulatory practice at Eliquent Life Sciences (formerly Greenleaf Health). He has more than 35 years experience at FDA and in regulated industry. At FDA, he established and directed the Office of Combination Products and was a scientific reviewer and later supervisor of the premarket review of devices in a variety of medical discipline areas. Following his FDA career, he served as Regulatory Affairs Executive and Chief Regulatory Strategist at GE Healthcare and then as an independent regulatory consultant for over 10 years before joining Greenleaf. Mark served as a board member of the Regulatory Affairs Professionals Society (RAPS) and in 2021, he was awarded the RAPS Founders Award, the profession's highest honor, recognizing exemplary regulatory professionals who have shaped regulatory policy and practice and have made a positive impact on the profession.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some of the most significant shifts and strategies shaping our industry.Novartis's acquisition of Avidity Biosciences for a staggering $12 billion marks a pivotal moment in the pharmaceutical landscape this year. With this acquisition, Novartis underscores its commitment to bolstering its neuromuscular disease pipeline. Avidity Biosciences has made a name for itself with its cutting-edge RNA therapeutic technologies, particularly its Antibody Oligonucleotide Conjugates (AOCs). This platform uniquely combines monoclonal antibodies with oligonucleotides, enhancing precision in targeting specific cell types. The integration of Avidity's technology into Novartis's research efforts could accelerate the development of new therapies, potentially transforming patient care with more effective and targeted treatment options. This move not only highlights the industry's focus on specialized therapeutic areas but also anticipates future advances in RNA therapeutics, extending beyond neuromuscular disorders to areas like oncology.In a similar vein, the FDA has shown its willingness to reconsider drugs that previously faced setbacks. GSK's Blenrep has made a return to the U.S. market after receiving approval for treating certain myeloma patients. This approval is particularly noteworthy given the drug's earlier negative advisory committee vote and postponed decision. It marks a significant rebound for GSK's oncology portfolio and reflects the FDA's dynamic approach towards drugs that show potential in specific therapeutic combinations.Meanwhile, Sanofi continues to make waves with Dupixent, achieving over €4 billion in quarterly sales due to its expanded indications. This success contrasts with a decline in Sanofi's vaccine sales, demonstrating shifting dynamics within pharmaceutical portfolios where biologics and specialty drugs are increasingly pivotal. Sanofi's recent financial report highlighted a notable 17% drop in vaccine sales due to reduced demand and pricing challenges in Europe. In response, companies must navigate fluctuating public health demands and economic pressures effectively.On the global stage, efforts to make transformative therapies like Vertex's Trikafta more accessible are gaining momentum through innovative trade-policy workarounds. A buyers club aims to introduce a lower-cost alternative produced by Bangladesh's Beximco, highlighting ongoing challenges and creative strategies in global drug accessibility.Roche's expansion through Chugai's $200 million M&A deal for an IgA nephropathy asset underscores the strategic importance of regional markets in driving growth. Similarly, Lonza's acquisition of a California biologics site aligns with its goals to meet increasing biomanufacturing demands.The industry is also adapting to technological advancements, with AI integration into life sciences commercialization being touted as a frontier for growth. Despite this potential, many organizations remain unprepared to harness AI fully. Leading companies embedding AI solutions aim for measurable outcomes that could significantly drive strategic decision-making and operational efficiencies.Eli Lilly's acquisition of Adverum Biotechnologies aligns with its strategic interests in gene therapy, focusing on promising therapeutic programs that address unmet medical needs. This acquisition centers around Ixo-vec for wet age-related macular degeneration (AMD), highlighting broader industry trends towards investing heavily in innovative therapies that address unmet needs.Conversely, Sanofi's halt on an RSV vaccine development highlights the inherent risks in vaccine development pipelines. Meanwhile, Regeneron's decision to discontinue a CAR T candidate acquired from 2seventy bio showcases ongoing reassessment witSupport the show

In Western countries, type 2 inflammation is the underlying cause of CRSwNP in ~ 80% of patients. Credit available for this activity expires: 10/24/2026 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/chronic-rhinosinusitis-nasal-polyps-reimagined-bridging-2025a1000saf?ecd=bdc_podcast_libsyn_mscpedu

Your process works perfectly at two-liter bench scale. Then you hit fifty liters and titer drops 20%. By two hundred liters, aggregation appears and charge variants shift. Your management team asks: "How long to fix this?" The honest answer? Three to twelve month, because you're flying blind.In Part 2 of this Quality by Design Master Class, David Brühlmann reveals why scale-up chaos isn't inevitable. It's a solvable engineering problem. Drawing on experience leading bioprocess innovation at Merck and guiding biotech companies through CMC development, David delivers the process control framework that transforms reactive troubleshooting into predictive manufacturing.The core truth: eighty percent of quality problems stem from twenty percent of your process variables. David shows how to identify Critical Process Parameters, implement intelligent control strategies, and leverage hybrid modeling that reduces experiments by 60-80%. With case studies from Genentech and Amgen, you'll gain the blueprint that turns QbD requirements into competitive advantage.Part 1 taught you what to build and measure. Part 2 shows you how to control your process to consistently deliver commercial-scale quality.Topics Discussed:The common pitfalls of scaling up manufacturing from bench to production, and why process control must go beyond end-product testing (02:10)Overview of the QbD framework: Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and the focus of this episode - Control Strategies for manufacturing (05:00)Identifying and monitoring Critical Process Parameters (CPPs) and their impact on quality, with real-world examples from Genentech's monoclonal antibody platform (08:20)Structure of an effective manufacturing control strategy: Input, process, and output controls - including practical details on real-time monitoring and release testing (11:00)The role of hybrid modeling and machine learning in accelerating process optimization, and how this approach can dramatically reduce the experimental burden (13:30)Real examples of improved outcomes and efficiency through model-based control strategies, and why training and process understanding are essential for team success (16:10)A quick, actionable exercise biotech teams can use to map process risks and identify critical control points (16:55)Whether you're part of a start-up or a large biotech firm, this episode offers clear, strategic steps for implementing QbD and improving process reliability. Don't forget to listen to Part 1 for more on QTPP and CQA, and visit www.bruehlmann-consulting.com for additional resources.Next step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We're building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105

I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What's Regulatory Affairs? How does R&D fit in?In this video, I walk through eight of the most common roles you'll find in pharma, medtech, biotech, and diagnostics companies. We'll talk about what each team does, how they connect, and how to think about which one might fit your strengths and interests.If you're trying to figure out where you belong in industry, this one's for you.Please like, share, and subscribe if you find it helpful!Timestamps00:00 Introduction and Background01:07 Overview of Industry Roles02:43 Quality Assurance06:14 Regulatory Affairs08:22 Research & Development09:46 Clinical Affairs11:07 Manufacturing & Operations12:09 Quality Control / Analytical Testing14:05 Supply Chain & Procurement15:13 Validation & Technical Services16:39 Career Path Insights and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Description: Listen as NPF Medical Board Members, dermatologist Dr. Robert Kalb and rheumatologist Dr. Sergio Schwartzman discuss the connections between psoriasis and psoriatic arthritis, from cytokines to triggers, current and future treatments.   Join moderator Alan Simmons as he gains insights on what connects psoriasis and psoriatic arthritis with leading experts in psoriatic disease and NPF Medical Board members, dermatologist Dr. Robert Kalb with Buffalo Medical Group Dermatology, and rheumatologist Dr. Sergio Schwartzman from Schwartzman Rheumatology, as they discuss the known drivers of psoriasis and psoriatic arthritis, common triggers, benefits of targeted treatments, remission of disease, and upcoming treatment trends. The intent of this episode is to identify potential connections between psoriasis and psoriatic arthritis, and how targeted treatments have changed the outlook for management of psoriatic disease. This episode is sponsored by Novartis. Timestamps: (0:41) Intro to Psoriasis Uncovered and guest welcome dermatologist Dr. Robert Kalb and rheumatologist Dr. Sergio Schwartzman who are both involved in clinical care and research of psoriasis and psoriatic arthritis.  (1:15) Current known pro-inflammatory cytokines and cells found in psoriasis and psoriatic arthritis.   (5:33) Types of psoriasis that may lead to a higher risk of developing psoriatic arthritis. (9:33) Common triggers for psoriasis and psoriatic arthritis that could cause flares of the disease. (12:59) Key factors that are considered when choosing a treatment plan for any individual with psoriatic arthritis and psoriasis. (18:04) What treatment remission means for psoriasis. (19:36) Use of minimal disease activity (MDA) in psoriatic arthritis and what it means. (22:14) How a better understanding of the disease has led to more effective treatment choices and what choices are used by Dr. Kalb and Dr. Schwartzman for the management of psoriasis and psoriatic arthritis. (28:39) New developments in treatment and research in psoriatic arthritis and psoriasis. (36:01) Given treatment advancements it's a wonderful time to treat psoriatic disease. 3 Key Takeaways: ·       Cytokines are chemicals in the body that moderate various processes. In psoriasis and psoriatic arthritis,  an unknown trigger stimulates some cells to overproduce pro-inflammatory cytokines such as TNF-alpha, IL-17 or IL-23 leading to the development of skin and joint disease.  ·       Treating psoriasis and psoriatic arthritis helps move the body towards normalizing the over reactive immune system especially with more targeted treatments that safely and effectively block specific cytokines without affecting other organ systems.  ·       Given advancements in targeted treatments the goal is to reach and maintain remission of psoriatic disease. Guest Bios:   Leading dermatologist Robert Kalb, M.D. is the Chair of the Buffalo Medical Group Dermatology Department and the Director of the Buffalo Medical Group Phototherapy Center, one of the leading centers for psoriasis care in Western New York. He is also a Clinical Professor of Dermatology at the State University of New York at Buffalo School of Medicine and Biomedical Sciences (SUNY Buffalo), as well as an Adjunct Professor of Dermatology at the Perelman School of Medicine at the University of Pennsylvania where he plays a significant role in medical education, mentoring both medical students and dermatology residents. Dr. Kalb has extensive experience managing psoriasis, atopic dermatitis, and other inflammatory skin diseases. He has authored 70+ publications and is actively involved in clinical research, particularly focused on new treatment options for psoriasis. He is a member of the NPF Medical Board, American Academy of Dermatology, and is a member of the International Psoriasis Council.  Sergio Schwartzman, MD, is a world-renowned rheumatologist based in New York City who brings almost 40 years of experience and personalized clinical care for those who have psoriatic disease. Along with being in private practice at Schwartzman Rheumatology, Dr. Schwartzman is a Clinical Associate Professor of Medicine at Weill Cornell Medical College of Cornell University, the New York-Presbyterian Hospital, and the Hospital for Special Surgery in New York City where he has played a role in educating medical students, residents, fellows, and peers in rheumatology. Additionally, Dr. Schwartzman is the emeritus Franchellie M. Cadwell Clinical Associate Professor at the Hospital for Special Surgery. Dr. Schwartzman's current research interests include psoriatic arthritis, the spondyloarthritis group of diseases, ankylosing spondylitis, rheumatoid arthritis, as well as defining and treating autoimmune diseases of the eye. He has authored, co-authored, and edited over 150 papers, abstracts, books and book chapters on topics including psoriatic arthritis, ankylosing spondylitis, axial spondylarthritis, rheumatoid arthritis, lupus, autoimmune eye disorders, and other rheumatological and autoimmune conditions. He is a member of the NPF Medical Board. He is also a member of the American College of Rheumatology, the Association for Research in Vision and Ophthalmology, the Spondyloarthritis Research and Treatment Network (SPARTAN), the American Uveitis Society, and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Resources: Ø  “Redefining Remission. A new definition for patients, providers, and payers.” Advance Online, National Psoriasis Foundation. S. Schlosser. July 14, 2025.   Ø  Treatment and Management of Psoriasis     Ø  Treatment and Management of Psoriatic Arthritis  

Over 40% of biotherapeutic failures during clinical development stem from stability problems—and most trace back to protein aggregation that could have been prevented. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann exposes the hidden manufacturing crisis that derails promising biologics programs and delivers the systematic Quality by Design framework that elite biotech companies use to build quality into every process step.David brings two decades of bioprocess expertise from his time leading technology innovation at Merck and now guiding emerging biotech companies through CMC development as Managing Director of Brühlmann Consulting. Drawing on FDA and EMA regulatory guidance as well as landmark industry case studies he transforms complex QbD principles into an actionable roadmap for IND submission.This isn't theoretical regulatory compliance. It's competitive survival. Companies implementing these QbD foundations achieve predictable manufacturing scale-up, accelerated regulatory approval, and significant cost advantages. If your team is navigating CMC development for the first time or struggling with scale-up challenges, this episode provides the blueprint to transform process uncertainty into manufacturing confidence.What You'll Learn in This Episode:The high clinical failure rate for biologics due to protein aggregation and stability problems, and one company's costly lesson in the scale-up phase. (00:00)An introduction to Quality by Design (QbD)—how it differs from traditional development and why “the process is the product” in biologics. (03:09)The three foundational pillars of QbD, with today's focus on product understanding and quality requirements. (05:46)Constructing your Quality Target Product Profile (QTPP): what to include and why starting with the patient is key. (07:05)A real-world QTPP example—the AMAP case study—and how it shaped formulation, packaging, and critical quality standards. (09:45)Defining and prioritizing Critical Quality Attributes (CQAs): measuring what truly matters for safety and efficacy. (11:50)Lessons from Roche/Genentech's QbD journey: regulatory insights and the business value of robust CQA identification. (15:55)The “CQA Reality Check” exercise: a step-by-step method to focus your team on attributes that impact patients. (21:05)How early, candid dialogue with regulators and using management tools like the Notion CMC Dashboard can streamline the development roadmap and reassure investors. (23:30)Ready to flip the odds in your favor and make QbD your competitive edge? Stream this episode to catch actionable strategies and real-world cautionary tales that could change your CMC development playbook for good.Next step:Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callPreparing for your IND? We're building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105

Pushing biologics beyond 200 mg/mL isn't just a formulation challenge - it's a delivery, manufacturing, and regulatory challenge too. Aggregation, precipitation, and sky-high viscosity make scaling these therapies a gauntlet for drug developers.In this episode of Life Science Solutions, host Chris Adkins continues the conversation on hyper-concentrated biologics with Ryan Doxey, VP of Tech Ops & CMC at Kymanox, and Nick Letourneau, PhD, Associate Director of Product Development & Commercialization. Together, they unpack how dehydrated protein microparticles suspended in hydrophobic carriers (like MCT oils or ethyl oleate) can dissolve instantly upon injection, and why this breakthrough could dramatically ease the patient experience.The conversation dives deep into what this means for manufacturing, device compatibility, and regulatory pathways, revealing how the future of injectables depends on solving problems once thought unsolvable.Topics include:Why ultra-concentrated biologics often fail in aqueous solutionsHow microparticle suspensions dissolve rapidly in vivo to avoid depot effectsRheology 101: viscosity curves, shear-thinning fluids, and device designThe shift to aseptic manufacturing when sterile filtration isn't an optionPreclinical safety considerations and scaling studies from rodents to NHPsWhy early conversations with FDA's Emerging Technology Program matterThis is part two of our deep dive on concentrated biologics - picking up where our Podcast Marathon live episode left off.  This episode offers a rare look inside the formulation frontier — where drug science, delivery design, and patient experience intersect.

Episode Description:  Not sure if you should receive a vaccine given your psoriasis or psoriatic arthritis medication?  Dermatologist Dr. Jason Hawkes explores this question along with vaccination recommendations for adults receiving biologics and oral therapies for psoriasis and psoriatic arthritis. Listen as hosts Jeff Brown and LB Herbert discuss key questions about vaccine use and psoriatic disease with dermatologist and NPF Medical Board member Dr. Jason Hawkes who is co-owner, Chief Scientific Officer, and investigator with the Oregon Medical Research Center. Hear what the difference is between live and non-live vaccines, how type of vaccine and immunosuppressive medications impact the timing of vaccines in relation to treatment half-lives. Get your questions answered. The intent of this episode is to offer answers to questions about vaccine use for people with psoriasis and psoriatic arthritis who take immunosuppressive treatments.   Timestamps: (0:23) Intro to Psoriasis Uncovered & guest welcome dermatologist Dr. Jason Hawkes. (1:15) In general, what is a vaccine and how it works in the body. (2:08) Will vaccines provide the same level of protection in people with psoriatic disease who are         on treatments that influence the immune system. (4:53) The difference between live and non-live vaccines.   (8:57) Summary of NPF Vaccine Recommendations in relation to live and non-live vaccines and             specific medications for psoriatic disease, including a definition of medication half-lives. (13:38) Vaccines that may be recommended prior to starting a systemic medication or biologic. (18:27) The mRNA vaccine – how it works in comparison to other vaccines. (22:31) How long immunity lasts from childhood vaccines. (25:24) The vaccine guidelines apply to both psoriasis and psoriatic arthritis with some nuances.      (28:38) Which healthcare provider to turn to for advice about vaccines and why. (31:54) Questions to ask your health care provider about vaccines. (33:26) How clinical trials and registries are evolving to assess the effect of vaccines with specific             medications and the need for greater understanding. (36:44) Develop a good relationship with your health care provider and don't be afraid to ask                 questions about your psoriatic disease, vaccines, or specific medications. Key Takeaways: ·       Vaccines work to help protect the body or stimulate protection against common infections or pathogens. There are different types that can be classified as either live or non-live vaccines.   ·       Evidence-based vaccine recommendations are available for people with psoriasis and psoriatic arthritis to help guide timing of when to receive live and non-live vaccines when taking immunosuppressive oral systemic medications and/or biologics.   ·       It's important to discuss which vaccines to consider, and how current psoriasis medication could impact the intended response and timing  with your health care team which includes a primary care physician, a dermatologist, and/or rheumatologist.    Guest Bio: Dermatologist Jason Hawkes, M.D., MS is Co-owner, Chief Scientific Officer and Investigator with Oregon Medical Research Center (OMRC) in Portland, Oregon. He is also a Clinical Assistant Professor of Dermatology at Oregon Health and Science University and the President and Sole Member of Hawkes Dermatology. Prior to joining the Oregon Medical Research Center, Dr. Hawkes held academic faculty appointments in the Departments of Dermatology at the University of Utah School of Medicine, Icahn School of Medicine at Mount Sinai, and University of California-Davis. Dr. Hawkes' principal clinical and research interests are the treatment of complex inflammatory skin diseases, such as psoriasis, hidradenitis suppurativa, chronic urticaria (hives), and eczema. He has a special interest in translational human research and the development of novel biologics and small molecules used for the treatment of inflammatory conditions. Dr. Hawkes is also a Councilor of the International Psoriasis Council (IPC) and serves on the Medical Board and Scientific Advisory Committee of the National Psoriasis Foundation (NPF) where he participates in the development of clinical consensus statements. Resources:         “Does Having Psoriatic Disease Impact Vaccine Choices?” Psound Bytes™ podcast with Dr. Sandy Chat (University of California) and Dr. Christoph Ellebrecht (Dept. of Dermatology, University of Pennsylvania).       Medical Board Clinical Statements                

As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the promise and the challenges of applying intelligent systems in regulated environments.Key topics covered:- Current applications of AI in GMP, including CAPA and deviation management- The role of validation and why algorithmic opacity poses regulatory challenges- How Process Analytical Technology (PAT) enables real-time release decisions- The importance of Design of Experiments (DOE) for process optimizationContinuous manufacturing and how yield can signal process performanceChapters00:00 Introduction to AI in Pharma00:40 Current Applications of AI in GMP02:32 Challenges and Validation in AI03:22 Process Analytical Technology (PAT)09:50 Design of Experiments (DOE) in Pharma13:27 Continuous Manufacturing Explained15:40 Yield Calculation in Manufacturing22:12 Conclusion and Contact InformationBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Summary In this truncated replay, Dr. Shyam Joshi explores the intersection between allergy and dermatology—focusing on how chronic spontaneous urticaria (CSU), atopic dermatitis, and food allergies often overlap. Learn how emerging biologics like omalizumab and dupilumab are reshaping treatment decisions, why comorbidities matter, and how collaboration between allergists and dermatologists creates better outcomes for patients with complex allergic and dermatologic conditions. This episode dives into real-world case studies, FDA updates on antihistamines, and the multidisciplinary approach to managing eczema and CSU in pediatric and adult populations. Takeaways - FDA Advisory on Antihistamines: Long-term use of cetirizine or levocetirizine can lead to rebound pruritus upon discontinuation—but gradual tapering minimizes symptoms. - Biologic Selection Depends on Comorbidities: - Omalizumab is effective for IgE-mediated food allergies and chronic urticaria. - Dupilumab is preferred for patients with eosinophilic esophagitis (EoE) or moderate-to-severe atopic dermatitis. - CSU Is Systemic: Symptoms may extend beyond hives—impacting joints, sleep, and energy levels. - Comorbid Conditions Are Common: Up to 20 % of CSU patients have asthma, allergic rhinitis, or food allergies; identifying these helps guide treatment and patient education. - Unified Messaging Builds Trust: Consistent communication from both dermatologists and allergists reduces unnecessary testing and supports adherence to treatment plans. Chapters 00:00 - Introduction: Bridging Allergy and Dermatology 00:45 - Case Study: An 18-Year-Old with Chronic Urticaria 02:00 - FDA Warning: Antihistamine Withdrawal Itch 03:45 - Selecting the Right Biologic: Food Allergy Considerations 04:45 - Eosinophilic Esophagitis and CSU         05:35 - The Systemic Nature of CSU 06:40 - Comorbidities in CSU and Atopic Patients 07:30 - Multidisciplinary Collaboration in Practice 08:00 - Closing Thoughts & Educational Disclaimer

Most people think about heart disease and metabolism when they talk about longevity, but too few talk about joint health. In this episode, you'll discover how to biohack your joints to prevent pain, reverse damage, and move like you're decades younger. Host Dave Asprey reveals how functional movement, core stability, and recovery can transform joint health, helping you maintain pain-free performance for life. Watch this episode on YouTube for the full video experience: https://www.youtube.com/@DaveAspreyBPR Dr. Jason Snibbe is a globally recognized, board-certified orthopedic surgeon and a pioneer in advanced, minimally invasive, and robotic surgeries of the shoulder, elbow, hip, and knee. Fellowship-trained in Sports Medicine and Robotic Joint Reconstruction, he has achieved the lowest complication rate at Cedars-Sinai Medical Center and is the official orthopedic surgeon for the Los Angeles Clippers. He also serves as an orthopedic consultant for the Los Angeles Lakers, Los Angeles Sparks, Los Angeles Angels of Anaheim, and Los Angeles Kings. As a founding and managing partner in DOCS Spine and Orthopedics and Docs Surgical Hospital, Dr. Snibbe lectures and trains surgeons around the world in his specialized techniques. Host Dave Asprey and Dr. Snibbe uncover how weak glutes, poor core engagement, and bad footwear accelerate joint aging, and how functional movement training and fascia care can protect your body from surgery. You'll learn why proper biomechanics are central to human performance and longevity, how hypermobility and fascia impact neuroplasticity, and the latest biohacking tools for recovery and joint regeneration. You'll Learn: • The real cause of joint damage and how to prevent it • How to build a stronger core and glutes for long-term joint stability • Why footwear choices can make or break your movement quality • The truth about fascia, stretching, and strength training • When to use PRP, stem cells, and biologics for healing • How hypermobility affects your joints, brain, and longevity • Daily mobility and recovery habits that prevent future surgery They explore how biologics like PRP, stem cells, and exosomes are changing orthopedic recovery and joint repair, and why functional medicine is moving beyond surgery toward regeneration. You'll hear how precision movement, fascia work, and strength training protect your joints and enhance human performance and longevity. This is essential listening for anyone serious about biohacking, hacking human performance, improving mobility, and extending longevity. You'll also learn how neuroplasticity, metabolism, and brain optimization all connect to the way you move. Dave Asprey is a four-time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade brings you the knowledge to take control of your biology, extend your longevity, and optimize every system in your body and mind. Each episode delivers cutting-edge insights in health, performance, neuroscience, supplements, nutrition, biohacking, emotional intelligence, and conscious living. New episodes are released every Tuesday, Thursday, Friday, and Sunday (BONUS). Dave asks the questions no one else will and gives you real tools to become stronger, smarter, and more resilient. Keywords: Joint biohacking, Orthopedic regeneration, Functional movement patterns, Core stability training, Glute activation exercises, Fascia mobility, Hypermobility syndrome, Ehlers-Danlos collagen disorder, Foot biomechanics, Pronation and supination, Arch support orthotics, Barefoot gait training, Stem cell joint repair, PRP knee therapy, Exosome orthopedic recovery, Meniscus tear alternatives, Robotic joint surgery, Posture correction, Gait analysis technology, Pain-free longevity Thank you to our sponsors! TRU KAVA | Go to https://trukava.com/ and use code DAVE10 for 10% off. BON CHARGE | Go to https://boncharge.com and use code DAVE for 15% off. OneSkin | For a limited time, try OneSkin for 15% off with code DAVE at https://www.oneskin.co/DAVE Business of Biohacking Summit | Register to attend October 20-23 in Austin, TX https://businessofbiohacking.com/ Resources: • Learn more about Dr. Snibbe's work: https://www.drjasonsnibbe.com/ • Danger Coffee: https://dangercoffee.com/discount/dave15 • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Upgrade Collective: https://www.ourupgradecollective.com • Upgrade Labs: https://upgradelabs.com • 40 Years of Zen: https://40yearsofzen.com Timestamps: • 0:00 — Trailer • 1:28 — Introduction • 2:38 — The Kinetic Chain • 9:34 — Core and Glutes • 12:18 — Stretching and Fascia • 17:32 — Sleep and Recovery • 18:49 — Vibration Therapy • 23:47 — Gait and Compensation • 30:47 — Robotic Surgery • 34:28 — Future of Medicine • 39:23 — Footwear Mistakes • 48:48 — Wearables and Tech • 55:13 — Stem Cells and Biologics • 1:01:20 — Final Takeaways See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Time is of the essence when it comes to drug discovery. MindWalk (NASDAQ: HYFT) combines bio-native AI with in-house wet lab capabilities to accelerate therapy development, making the process safer, faster, and more reliable.President and CEO Dr. Jennifer Bath shares the strategy behind the company's rebranding, the competitive edge of their LensAI™ platform, and the impact of AI-driven immunogenicity on patient care. From their proven track record to their precise AI technology, discover how MindWalk stands out in the healthcare industry. To learn more about their technology, explore their website: https://www.mindwalkai.com/Discover MindWalk as an investor: https://ir.ipatherapeutics.com/overview/default.aspxWatch the full YouTube interview here: https://youtu.be/07jQObacjvEAnd follow us to stay updated: https://www.youtube.com/@GlobalOneMedia?sub_confirmation=1

Time is of the essence when it comes to drug discovery. MindWalk (NASDAQ: HYFT) combines bio-native AI with in-house wet lab capabilities to accelerate therapy development, making the process safer, faster, and more reliable.President and CEO Dr. Jennifer Bath shares the strategy behind the company's rebranding, the competitive edge of their LensAI™ platform, and the impact of AI-driven immunogenicity on patient care. From their proven track record to their precise AI technology, discover how MindWalk stands out in the healthcare industry. To learn more about their technology, explore their website: https://www.mindwalkai.com/Discover MindWalk as an investor: https://ir.ipatherapeutics.com/overview/default.aspxWatch the full YouTube interview here: https://youtu.be/07jQObacjvEAnd follow us to stay updated: https://www.youtube.com/@GlobalOneMedia?sub_confirmation=1

In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the process of discovering molecules that modulate biological pathways, the difference between structure-based and phenotype-based drug design, and the role computational methods play in drug development. The conversation also explores the challenges of crossing the blood-brain barrier, the importance of validating target response, and the complexities of progressing from a theoretical compound to preclinical studies. Additionally, Jesse touches on the significance of target product profiles, CNS drug design characteristics, and the iterative nature of medicinal chemistry. He concludes by discussing his current projects at Cortex, including fundraising strategies and timelines for drug development.00:00 Introduction to Medicinal Chemistry00:37 Drug Discovery Approaches02:01 Computational Methods in Medicinal Chemistry03:21 Challenges in ALS Drug Discovery04:23 Blood-Brain Barrier and Drug Design05:29 Key Properties for CNS Drug Design08:58 Day-to-Day in Drug Discovery09:45 Early Stage Drug Development12:28 Validating Drug Targets16:15 From Theory to Animal Testing22:46 Funding and Timeline Considerations25:45 Regulatory and Manufacturing Considerations28:32 Conclusion and Contact InformationDr. Jesse Gordon-Blake is an independent biotechnology and drug discovery consultant with expertise in medicinal chemistry and neurotherapeutics. He has led efforts in small molecule and peptide therapeutic development, AI-enabled drug discovery, and biotech startup formation, and currently serves as the CSO of Cortexa Therapeutics. He earned his PhD in Medicinal Chemistry from the University of Illinois at Chicago, focusing on developing innovative small-molecule enzyme modulators for Alzheimer's disease.https://www.linkedin.com/in/jesse-gordon-blake-phd-52a26274/https://www.cortexatherapeutics.com/Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Listen in as we discuss considerations, challenges, and strategies related to the use and switching of biosimilars in clinical practice.  You'll hear communication tips to address patient and prescriber concerns as well as operational considerations for integrating biosimilars into practice.  Special guests:Bharati Bhardwaja, PharmD, BCPS, LSSBBRheumatology Clinical Pharmacy SpecialistKaiser Permanente ColoradoMegan May, PharmD, BCOP, FHOPA, FAPOClinical Oncology Pharmacy SpecialistBaptist Health Lexington/Hamburg Cancer Care CenterYou'll also hear practical advice from TRC's Editorial Advisory Board member:Craig D. Williams, PharmD, FNLA, BCPSClinical Professor of Pharmacy PracticeOregon Health and Science UniversityFor the purposes of disclosure, Dr. Megan May reports relevant financial relationships [lung cancer] with Amgen, AstraZeneca, Pharmacosmos (speakers bureau). The other speakers have nothing to disclose.  All relevant financial relationships have been mitigated.This podcast is an excerpt from one of TRC's monthly live CE webinars, the full webinar originally aired in August 2025.TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist's Letter, Pharmacy Technician's Letter,or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.Claim CreditThe clinical resources mentioned during the podcast are part of a subscription to Pharmacist's Letter, Pharmacy Technician's Letter, and Prescriber Insights: FAQ: Facts About BiosimilarsChart: Comparison of Insulins (United States)Chart: Biologics for Rheumatoid ArthritisChart: Biologics for Crohn's DiseaseUse code mt1025 at checkout for 10% off a new subscription.Send us a text****

In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA introduced it in their 2020 draft guidance, and what it means for life-saving products like epinephrine and naloxone injectors.Alan explains how manufacturers can demonstrate reliability through fault tree analysis, robust process controls, and challenge testing—without needing impossible sample sizes.If you work in pharma, medtech, or quality, this episode will help you understand what “five nines” really means and how to meet FDA expectations while ensuring patient safety.Chapters00:00 – What is Five Nines Reliability?Intro to 99.999% and why it matters for medical devices.00:33 – FDA Guidance & Common Misconceptions2020 draft guidance, sample size myths, and industry confusion.01:17 – How to Demonstrate ReliabilityFeasibility, practical approaches, and FDA expectations.02:31 – High-Stakes Use CasesEpinephrine, naloxone, glucagon injectors.04:00 – Fault Tree Analysis ExplainedBreaking down failures and linking to design/manufacturing.05:25 – Why FDA Chose Five NinesBalancing feasibility, safety, and ISO 14971 influences.09:02 – Verification vs. ReliabilityDesign verification testing vs. true reliability demonstration.23:16 – Key Takeaways for IndustryClosing thoughts on meeting and maintaining reliability standards.Alan Stevens CAPT is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of the Braun Performance & Rehab Podcast, Dan is joined by Dr. Jason Scopp to discuss biological agents such as PRP and their use in sports medicine.Dr. Scopp is a board certified orthopaedic surgeon and a pioneer in the field of cartilage restoration, a procedure for joint pain available in only a handful of medical centers across the country. In addition to his biotechnology research on joint preservation, Dr. Scopp specializes in the treatment and prevention of sports-related injuries. He is an internationally featured speaker on the topics of joint preservation, cartilage defects and restorative treatment options.Fellowship trained in Sports Medicine and a lifelong athlete himself, Dr. Scopp has been team physician for the United States Soccer Team, University of Maryland Eastern Shore, Salisbury University and the Delmarva Shorebirds (a Baltimore Orioles organization), among others.Dr. Scopp received his medical degree from the Hahnemann University School of Medicine in Philadelphia. His residency in orthopaedic surgery was completed at University of Maryland Medical Systems, and he completed his fellowship in sports medicine, arthroscopy and articular cartilage restoration at the Santa Monica Orthopaedic and Sports Medicine Group in California. For more on Dr. Scopp and his team at POA, be sure to check out https://www.peninsulaortho.com/*SEASON 6 of the Braun Performance & Rehab Podcast is brought to you by Isophit. For more on Isophit, please check out isophit.com and @isophit -BE SURE to use coupon code BraunPR25% to save 25% on your Isophit order!**Season 6 of the Braun Performance & Rehab Podcast is also brought to you by Firefly Recovery, the official recovery provider for Braun Performance & Rehab. For more on Firefly, please check out https://www.recoveryfirefly.com/ or email jake@recoveryfirefly.com***This episode is also powered by Dr. Ray Gorman, founder of Engage Movement. Learn how to boost your income without relying on sessions. Get a free training on the blended practice model by following @raygormandpt on Instagram. DM my name “Dan” to @raygormandpt on Instagram and receive your free breakdown on the model.Episode Affiliates:MoboBoard: BRAWNBODY10 saves 10% at checkout!AliRx: DBraunRx = 20% off at checkout! https://alirx.health/MedBridge: https://www.medbridgeeducation.com/brawn-body-training or Coupon Code "BRAWN" for 40% off your annual subscription!CTM Band: https://ctm.band/collections/ctm-band coupon code "BRAWN10" = 10% off!Ice shaker affiliate link: https://www.iceshaker.com?sca_ref=1520881.zOJLysQzKeMake sure you SHARE this episode with a friend who could benefit from the information we shared!Check out everything Dan is up to by clicking here: https://linktr.ee/braun_prLiked this episode? Leave a 5-star review on your favorite podcast platform!

About 1-in-6 Americans suffer from an Autoimmune Disease, which is actually a growing problem.  In this episode, we talk about:—How Dr. Prather's career was inspired by his own battle with Graves' Disease, which is an Autoimmune Disease.  And why making sure the Atlas is in proper place is "critical" for Autoimmune Disease and needs to be corrected first before there can be any progress.—The various categories of Autoimmune Disease:  Joints and Muscles (Rheumatoid Arthritis, Lupus, Myositis), Skin and Blood Vessels (Sjogren's Syndrome, Psoriatic Arthritis, Vitiligo), Digestive (Celiac Disease, Crohn's Disease, Ulcerative Colitis), the Endocrine System (Type I Diabetes, Addison's Disease, Hashimoto's, Thyroiditis, Graves' Disease), the Nervous System (Multiple Sclerosis, Myasthenia Gravis, Guillain-Barre), the Lymphatic System (Fibromyalgia), and many more.—The different infections that can kick off Autoimmune Disease, including Viruses, Bacteria, Parasitic, or Fungal.   And how Heavy Metal Toxicities and Stress can cause of Autoimmune Disease.—Why the underlying cause of the Autoimmune Disease is more important to determine in Dr. Prather's Structure-Function Health Care model, while the Disease Care approach focuses on managing and suppressing the symptoms.  And the "huge" role that the Gut plays in Autoimmune Diseases.—The new cutting-edge area of drugs called Biologics and how they work.  And how Vaccines are actually classified as Biologics.—How Immunosuppressant Drugs can be helpful and life-saving, but can also increase your chances of Cancer and a shortened life-span.  And why Dr. Prather says, "The more drugs that you take, the longer you take them, the more likely you are to have an issue."—Why your ability to fight infections, viruses, fungal, and parasites "go way down" if you are taking an Immunosuppressant Drug.—How Dr. Prather himself and many of his patients are a "testament" that Medical Doctors are wrong when taught to believe that there is no hope of getting well from Autoimmune Disease.  And how the Structure-Function Care results he sees in his office disprove the Medical model's belief that symptoms should just be managed and that the patient will always get worse.—Why Dr. Prather says "we're not going to get anywhere" with an Autoimmune Disease if you have Heavy Metal toxicity.  And the importance of thorough diagnostics in Structure-Function Care to determine the root cause of the Autoimmune Disease that needs to be corrected.—The effectiveness of Structure-Function Care, which is "the only way you're going to make headway in an Autoimmune Disease".  And the reason Homeopathics are described by Dr. Prather as "a real key" for making dramatic changes in Autoimmune Disease.http://www.TheVoiceOfHealthRadio.com

Drs. Dall'Era and Chaichian discuss earlier use of targeted biologics for treating lupus.