Podcasts about biologics

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are organized and why that structure matters for drug and drug-device combination products.Subhi walks through the four main ICH guideline families, Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M), and explains how each fits into the broader product lifecycle. The episode places particular emphasis on the Quality guidelines, which form the backbone of pharmaceutical development, manufacturing control strategies, and lifecycle management.Rather than a deep dive into requirements, this episode is designed to orient listeners to the full ICH landscape. It helps teams understand where different guidelines apply, who typically owns them, and how they collectively shape regulatory expectations. Future episodes in the series will explore individual Quality guidelines in detail.In this episode, you will learnWhat an ICH guideline is and how it differs from regulations and standardsWhy guidelines still matter during inspections and enforcementHow ICH organizes its guidance into Q, S, E, and M categoriesA high-level overview of the Quality Guidelines (Q1 through Q14), including:Stability (Q1)Analytical validation and development (Q2 and Q14)Impurities (Q3)Quality by Design and risk management (Q8 and Q9)Pharmaceutical Quality Systems and lifecycle management (Q10 through Q12)Continuous manufacturing (Q13)How different functional teams interact with different parts of the ICH frameworkThe next episode begins the deep dive into the Quality Guidelines, starting with ICH Q1 on Stability.Timestamps00:00 Introduction to the Series00:48 Overview of ICH Guidelines01:36 What an ICH Guideline Is and Is Not03:04 The Four ICH Guideline Categories04:08 Quality Guidelines Overview08:46 Safety Guidelines Overview09:28 Efficacy Guidelines Overview10:33 Multidisciplinary Guidelines Overview11:28 Wrap-Up and Next StepsSubhi 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.

UFO filmmaker James Fox put together a fascinating film about the 1996 Varginha case. Since then, Fox has revisited with one of the doctors who allegedly sat with one of the creatures in a hospital. that doctor is set to be at a presentation in front of members of congress on jan 20th. Will this move the needle or is it more talk with no evidence? KRistian HArloff gives his thoughts. #ufo #ufos #alien 3aliens 3ufo #Uaps 3uap #news #government #varginha #case 

In this episode of Let's Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and drug–device combination products.Subhi introduces what ICH is, why it was created, and how its guidelines shape global expectations for pharmaceutical quality, safety, efficacy, and lifecycle management. He walks through the historical challenges that existed before harmonization, explains how ICH guidelines are developed through the five-step process, and outlines why these standards matter—especially for teams working at the intersection of drugs and devices.The episode also sets the roadmap for the series, including upcoming deep dives into the ICH Quality guidelines (Q1–Q14) and how they apply in practice to combination products.00:00 Welcome to Let's Combinate00:37 Why ICH Matters for Drug–Device Products02:22 What Is ICH?05:21 Evolution of ICH Guidelines10:18 The Five-Step ICH Guideline Process11:38 How This Series Will Work14:09 Wrap-Up and What's NextSubhi Saadeh is a Quality Professional, Founder of Let's Combinate BioWorks 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.

David Jernigan 0:15Hello! Dr. Deb 0:16Hi there, sorry for all the confusion. David Jernigan 0:19Oh, no worries, you gotta love it, right? Dr. Deb 0:21Oh, I can’t hear you. David Jernigan 0:23No way, let’s see, my mic must be turned off? Dr. Deb 0:27Hang on, I think it’s me. Let’s see…Okay, let’s try now. David Jernigan 0:40Okay, can you hear me? Dr. Deb 0:42Yep, I can hear you now. David Jernigan 0:43Excellent, excellent. And, how are you today? Dr. Deb 0:48I am good, thank you. How about yourself? David Jernigan 0:50I’m good. Well, it’s good to finally meet you and get this thing rolling. Dr. Deb 0:56Yes, yes, I’m so sorry about that. David Jernigan 0:58That’s alright, that’s alright.So… Dr. Deb 1:01Yeah, go ahead. David Jernigan 1:03So, tell me about yourself before we get going. Dr. Deb 1:06Yeah, so I am a nurse practitioner. I’m also a naturopath. I have a practice here in Wisconsin. I’ve been treating Lyme for about 20 years, so I’m really excited to have this conversation and learn what you’re doing, because it’s so exciting and new. David Jernigan 1:21Well, thank you. Dr. Deb 1:22Yeah, so we treat a lot of chronic illness patients, do some anti-aging regenerative things as well, so… David Jernigan 1:30Yeah, I went to your website and saw you guys are killing it, looks like. Dr. Deb 1:35Yeah. David Jernigan 1:35Got a lot of good staff, it looks like. Dr. Deb 1:37Yeah, we’ve got great staff, great patients, busy practice. We have 5 practitioners, so we have about 15,000 patients in our practice right now. David Jernigan 1:46Well, excellent. Yeah. Excellent. Yeah, yeah.So, I’m excited for this discussion. Dr. Deb 1:53Good, me too. So I pre-recorded our intro, so we can just kind of dive right in, and I’ll just ask you to kind of introduce yourself a little bit, tell us a little bit about yourself, and, and then we can just dive right into it. David Jernigan 2:08All right. I’m Dr. David Jernigan, and I own the Biologic Center for Optimum Health in… Franklin, Tennessee, and I’ve been in practice for over 30 years. I shook Willie Bergdurfer’s hand, if anybody knows who that is. It’s kind of infamous now with some of the revelations that have happened about Lyme being a bioweapon and weaponized. But, you know, I’ve been doing this, probably longer than almost anybody that’s still in the business in the natural realm. It chose me. I did not choose Lyme. Matter of fact, there were many times in my career that I was like. You know, cancer’s easier because of the fact that everybody agrees, you know, what we’re dealing with. And in the 90s, it was a whole different reality, where nobody actually understood that you could have Lyme disease and not be coming from New England.You know, so I had actually the first documented case of a Lyme disease, CDC positive.Patient that had never left the state of Kansas before. So they couldn’t say that it wasn’t in Kansas, and so she had actually been, pregnant with… twin boys, and they were born CDC-positive as well, and so it is transmitted across the placenta we know.So, I, you know, the history of how I did all this was, in the 90s, probably 1996, probably, somewhere in there, 97. With this woman, you know, I… if you go into Robin’s pathology books from back then. Which we all used, medical doctors and everybody else studying. you know, there was basically a paragraph about Lyme disease, and on the national board tests, as you recall, it was probably like, what causes, or what is, bullseye rash associated with? And you’d had to guess Lyme disease, of course. Dr. Deb 4:07Female. David Jernigan 4:08But that was, you know, considered to be more a New England illness, and you would never see it anywhere else. But here was this woman. I knew… nothing about Lyme beyond what we had gotten taught in college, which was, like I say, next to nothing. And she would not let me stop feeding me information. I mean, you gotta remember, the internet wasn’t even hardly in existence in those years. I mean, it was brand new. It was supposed to be this information highway, and So I started purchasing, like a lot of doctors do even now, they start purchasing every kind of new supplement that’s supposed to work for bacteria. There was no product in those days that actually was Lyme-specific. I mean, nobody was really dealing with it naturally. It was always a pharmaceutical situation. Dr. Deb 5:04And a very short course at that. David Jernigan 5:06Yeah, 2 weeks of doxy and you’re cured, whether your symptoms are gone or not, which… she’d had the 2 weeks of doxy, and her symptoms and her son’s symptoms were not gone. And so, I absolutely just purchased everything I could find. Nothing would work. I mean, I could name names of products, and you would recognize them, because they’re still out there today. Dr. Deb 5:28Which is. David Jernigan 5:30Kind of a… A sad thing that natural medicine is still riding on these things that have the most marketing. Dr. Deb 5:37As opposed to sometimes the things that actually have the documented research. David Jernigan 5:42Behind it, and I am a doctor of chiropractic medicine, and I specialized all these years in chronic, incurable illnesses of all types. That may sound odd to a lot of people, but doctors of chiropractic medicine are trained just like a GP typically would be. The medical schools, as I understand it, got together, decades ago and said, wow, if all we did was… Crank out general practitioners for the next 10 years, we wouldn’t have still enough general practitioners to supply the demand. Dr. Deb 6:17Right. Everybody in medicine, in medical schools, wanted to be a specialist, because that’s where the money was, and it was… David Jernigan 6:24Easier, kind of, also, to… you know, just focus on one part of the body, and specialize in that. Dr. Deb 6:31Expert in that one area. David Jernigan 6:32So we all now have the same training. We all go through pre-med. We got a bachelor’s degree, I got my bachelor’s degree in nutrition, and through, Park University in Parkville, Missouri. And so, you know, when I ran out of options to purchase, I just used a technology that I developed, which was an advancement upon other technologies, but I called it bioresonance scanning. And I coined the term back in the 90s. It was a way to kind ofKind of like a sensitive test, you know, like you might. Dr. Deb 7:09I wouldn’t. David Jernigan 7:09Of applied kinesiology, then clinical kinesiology, then chiro plus kinesiology, then, you know, you can just keep going with all the advancements that were made. Well, this was an advancement upon those things, so… I developed… I was the first in… in… my known world of doctors to develop a way to detect adjunctively, obviously we can’t say it’s a primary diagnosis. Adjunctively detect the presence of a given specimen. So we could say, thus saith my test. It’s highly likely you have Borrelia burgdurferi. And, but I had to have the specimen on hand to be able to match what I call frequency matching to the specimen. Brand new concept in those days. And so I was able to detect whether or not my treatments were successful or not. This is something even now that’s really difficult for doctors, because antibody tests, even the most advanced ones, it’s still an antibody test. It’s still an immune response to an infection.And accurately, you know, some doctors will slam those tests, saying, well. That doesn’t mean you actually have the infection, that just means your body has seen it before, which is a correct statement, kind of. So being able to detect the presence, and even where in the body these infections are was a way huge advancement in the 90s, for sure it’s kind of funny, I think about a conference I went to, and cuz… I’m kind of jumping ahead. Because I ended up developing my own formula, just for this woman and her children, and it worked. And I was like, wow! Their symptoms were gone, all the blood tests came back negative. In those days, we were using the iGenX. Western blot, eventually. And the, what was called a Lyme urine antigen test. I don’t know if you remember that, because it… Only decades later did I meet, the owner of iGenX, Nick Harris. Dr. Deb 9:17Person. And I was like, whatever happened to the Luwat test? Because I took it off the market after a while. He said, honestly, we lost the antigen and couldn’t find it again. Oh, no. David Jernigan 9:27And so… but that was a brilliant test. It was the actual gold standard in those days. Again, the world… it can’t be understated how different the world was in the 90s. Dr. Deb 9:40Yeah. David Jernigan 9:41Towards natural medicine, even. Dr. Deb 9:44Oh, yeah. We think… we think it’s bad now, but, like, when I started, too, I started in the early 2000s, like, we were all hiding under the radar, like, you didn’t market, we would have never been on social media, we didn’t run ads, we didn’t do any. David Jernigan 10:00Right. Dr. Deb 10:01Because the medical boards were coming for us. David Jernigan 10:04Came after me. Dr. Deb 10:05Because I had the word Lime on my page, my website. David Jernigan 10:10You know, not saying that I treat Lyme. Dr. Deb 10:13Hmm? David Jernigan 10:13Yes Dr. Deb 10:15Just talking about mind. David Jernigan 10:16And it’s funny, because, once I had this formula, it was something… and I trained in Germany, in anthroposophical medicine, and they’ve been trained in herbal… making herbal extracts, making homeopathic remedies in the anthroposophical methodology, and I trained with the Hahnemann versions of homeopathy, which is just slightly different. Yeah. And, so I was well-versed with making some of my own formulas by that time. And so, it was really something that I wrote on the bottle, you know, and I had to call it something, so I called it Borreligin, which is still in existence, and it’s still a phenomenal herbal remedy right now. And to my knowledge, it’s the only frequency-matched herbal formula. Maybe still out there. Because unless you knew how to do my testing, the bioresonent scanning, there was no way to actually do frequency matching. Matter of fact, as a really famous herbalist attacked me online, saying, oh, none of these herbs will kill anything. And I’m like, that wasn’t what I was saying. I was saying, back in those days, I was saying, well, if… what would the body need to address these infections?You know, not, like, what’s gonna kill the infections for the body. Dr. Deb 11:38Right. David Jernigan 11:39Right? So it was a phenomenal way, but the LUAT test was amazing because what you’d do is you would give your treatment, like an MD would give an antibiotic for a week, ahead of time. Trying to increase the number of dead spirochetes showing up in your urine one day out of 3 days urine catch. So you’d wake up in the morning, you’d collect your urine 3 days in a row, and any one of those being positive is a positive. But it was a brilliant test because it wasn’t an antibody test. They were literally counting the number of dead pieces of Lyme bacteria in your urine. I mean, it was pretty irrefutable. So I had a grand slam on the… the Western blot on patients, and I’d also have a grand slam on the LUAT, and their medical doctors would say, oh, that doctor in the lab are probably in cahoots change some lab. Dr. Deb 12:38Of course. David Jernigan 12:39That come in. And I still see that today. You know, it’s like, oh my gosh, the better the tests are getting. There’s still a bias if you do your own research. Well, if you happen to be a doctor who loves research. And you’re a clinician, so you actually treat patients who’s gonna write the research study? Well, of course, the doctor who did the study, well, he’s biased, and I’m like, I still can’t influence lab tests. Well, lab tests aren’t everything. People scream over the internet at me. It’s like, well, a negative lab test doesn’t mean anything. I was like… I get that with the old Western blot testing. Dr. Deb 13:16Right. David Jernigan 13:16The more sensitive tests, which are very close to 100%, Sensitivity, and 100% specificity. So, meaning, like, they can… if you have the infection, they’re gonna find it. Dr. Deb 13:30They’ll find it, yeah. David Jernigan 13:31And if they… if you have the infection, they’re going to be able to tell you exactly 100% correctly what kind of infection it is. Back in those days, you couldn’t, you could just count the dead pieces, which was… Dr. Deb 13:43Yeah. David Jernigan 13:43Significant, but It’s funny, because when medicine does that, you know, mainstream medicine that’s backed by all the nice foundations who donate millions of dollars towards the research. Their negative tests are significant, but if you fund your own, Yours isn’t that significant. Dr. Deb 14:04Right, or what if we call something a seronegative autoimmune disease, like lupus or rheumatoid arthritis, because none of the tests are positive, but you have all the symptoms. Here, let me give you this $100,000 a year drug. David Jernigan 14:19Yeah. Dr. Deb 14:19And instead of looking for what might actually be causing the symptoms. That’s all okay, but what we do is not okay. David Jernigan 14:27Right. Yeah, it’s a double standard, and it’s getting better. I want to do… tell the world it is getting better. Some of the dinosaurs are retiring. Dr. Deb 14:36No. David Jernigan 14:37Way for people who are… Are more open-minded to new ideas. But, getting back to that woman, she… that formula that I made just for her and her son, I… She went online. Dr. Deb 14:54Which, I had never been on a news group. David Jernigan 14:58Not even sure I knew what one was, you know? Imagine, I’m kind of that dinosaur that… Cell phones were, like, these really big things with a big antenna sticking out of it, and… Dr. Deb 15:09Nope. David Jernigan 15:10So I thought I was pretty hot stuff, just that I actually had a computer software program that was running my front desk. And even then, it was an Apple IIe computer. Dr. Deb 15:21Right. David Jernigan 15:22Probably be pretty valuable right now if I’d kept it, but… Dr. Deb 15:25Mmm… David Jernigan 15:26It being an antique. But, suddenly people were calling my clinic, because the lady with the twin boys that was well was telling people on these research, I mean, these Lyme disease forums and boards online. And, I started going, oh my gosh, you know, as a doctor, it’s one thing to treat a person in your clinic, it’s a different thing to have your clinic name on the label. Like, we all do, Even now, and you’re supposed to write everything that’s on the label, and… all these guidelines, and I’m like, wow, I need to split this off. I mean, I def… I definitely want to help people, and this is… I was pretty excited about the results we were getting. Pre-treat… Pre-treatment and post-treatment. And, so… that’s where I developed, my nutraceutical business in the 90s called Journey Good Nutraceuticals. My advice to anybody thinking about doing the same thing, don’t put your last name on it. Dr. Deb 16:25– David Jernigan 16:25You know, because anytime negative anything comes out, there goes the Jernigan name, you know, the herbal, you know, there’s just all these, and especially nowadays, with all the bots that are just designed to slam natural medicine. Dr. Deb 16:38Yeah. David Jernigan 16:39And that is out there in a… and just ugly people. Dr. Deb 16:42Or should we just say, people with a different opinion? How’s that? David Jernigan 16:46Yeah. That are being less than supportive. Dr. Deb 16:49But. David Jernigan 16:51It was amazing, because by 1999, I presented my research, my first research, I’d never done research. This is what I would… I would say to a lot of people who go, my doctor did… I don’t know, my doctor doesn’t know what you’re doing, my doctor… I was like going, you know, most doctors don’t do research. They don’t publish anything. Their opinion is their opinion, but they don’t back it up in peer review, right? And so that’s what I always tried to do, was back it up in peer review and publish. And so, in 1999, I presented at the International Tick-Borne Diseases Conference in New York City. I’m telling you, it was like the country boy going to the city, you know, I got my… I got my suit on, and I looked all right, and my booth was wonderful, and all these different things, and it was just a big wake-up call.Because what we had demonstrated… let’s get back to the… and this was what I demonstrated with that first study. was that… A positive LUAC test, that Lyme urine antigen test for my Gen X, was a score of 32. Meaning, one of those 3 mornings urine had 32 pieces in the amount of urine they checked of deadline bacteria spirochetes. Okay? Okay. With antibiotic challenges, a highly positive was a score of 45. Dr. Deb 18:19Wow when I would give one dropper 3 times a day for a week. David Jernigan 18:24Ahead of time, and then do the person’s LUAT test, We were getting scores 100, 200… And at that point, we only had a couple, but we had a couple that were greater than 400. Yeah, dead pieces, where the lab just quits counting. They just said, somewhere over 400, right? Dr. Deb 18:45Yeah. David Jernigan 18:46Which, when the medical system at the conference, you know, I was the only natural doctor in the world that was… had any kind of proof of anything naturally that could outperform antibiotics. Can you imagine? Dr. Deb 18:59Yeah. And… David Jernigan 19:01They were just, oh my gosh, incredulous. They’re like, I’ve given the most… one guy came up to me, and to my face, and he goes, I’ve given the most aggressive antibiotic protocols And I’ve only seen one patient over 100. I was like, that makes this pretty significant, doesn’t it? But, it didn’t just, like, make us take off, because guess what? In Lyme world, if a pharmaceutical antibiotic made you feel horrible. That meant it was working. Dr. Deb 19:28That’s right. We used to, back in the day, if you didn’t herx. And had that horrible die-off reaction, for those of you who don’t know what a herx is, but if we didn’t make you herx, we weren’t doing our job right. David Jernigan 19:40You’re looking for your patients to feel horrible, and sometimes to the level of committing suicide. Dr. Deb 19:46Yes. David Jernigan 19:47So bad. Dr. Deb 19:48Yes. David Jernigan 19:49And I was the first doctor, I think, in the world to start screaming and hollering and saying, stop using the worsening of your patient’s symptoms as a guide to good treatment, because they’re… I wasn’t seeing it with my formulas. Because I was doing a comprehensive program of care. I think I was also one of the first doctors to say, we need to detoxify these people as we’re doing this. And you would sit there and say, well, sure you were. I was like, well, remember, there wasn’t a lot of communication. There wasn’t anybody on the internet saying, do this, do that. And, It was, it was interesting in those days. It was, how do you… How do you help the world heal from these things? That they don’t know they have. So later, I actually had a beautiful booth at a health… a big health expo in Texas, I remember, and I was like, you know, you spend a lot of money on the booth, and… Dr. Deb 20:43Yup. David Jernigan 20:43And you’re thinking about it because you’re funding the whole thing, you say, wow, if I only sell one case, I’ll at least cover my cost. Dr. Deb 20:51Yep. Yeah, you’re great. David Jernigan 20:52And I had this beautiful banner of, like, a blown-up tick’s mouth under microscope. You know those beautiful pictures of, like, all the barbs sticking out, and how they anchor themselves in your skin, and… And, thousand people walking by my booth, and they’re just like, keep walking, because they didn’t know they had Lyme. There was, like, and they had MS, maybe, but they don’t have Lyme, and so they just would keep walking. Nobody even knew. Why would I go to a conference in Texas? And I’m trying to say, no, guys, it’s everywhere. Dr. Deb 21:24Yeah. David Jernigan 21:24And… and everybody, you know, yes, you probably have this, you know, kind of thing. If you’re… if you… are chronically ill, almost, of any kind of way. You know, kind of trying to tell people this was… Again, in Robin’s pathology textbooks, one of the few things that it did tell you about Lyme was that it was called the Great… the New Great Imitator. Because it would imitate up to 200 or more different illnesses. So, it’s been an interesting journey, of… educating people, writing articles, but it was interesting, the lady who I first fixed, Laboratory verified, everything like that, symptoms went away, all that kind of fun stuff. Her children were fine, they’ve been fine for years now. When she went on the newsboards in the Lyme disease support groups, It created a war. Oh my goodness, it was like, how dare you? And, say that something natural might actually help, right? Dr. Deb 22:30Right, exactly. David Jernigan 22:32And, I even had… A… one of those first calls to… with a marketing company at one point, way a long time ago. And the lady got on the phone, the owner of the marketing company goes, I would have blood on my hands if I actually took your clinic on. Yeah, you can’t treat Lyme disease, and… Even the big, big associations that are out there are still largely that way. I mean, they’re getting better, but it’s just like… you know, a lot of the times, it’s herbs are good. Herbs will help. Good, you know, but they’re safe. So, it’s still a challenge to… to… present in mainstream Lyme communities, even. Because there’s this… Fear of doing anything outside of antibiotics. Dr. Deb 23:32Yeah, so let me ask you this. From your perspective. Why do you think so many chronic infections exist these days, like Lyme and the co-infections, Babesia, Bartonella, mold illness? And we talked a little bit about herbs and why they, antibiotics and things like that fail, but let’s talk a little bit about that. David Jernigan 23:53So, it’s fascinating. When I trained in Germany, they said that we, as humanity, has moved away from what they called the inflammatory diseases. You know, in the old days, it was. Lots of high fevers, purulent, pus-generating bacterial infections. And I said, as a society, we have… Dr. Deb 24:14Have shifted from those to what they call cold sclerotic diseases, which are your… David Jernigan 24:21Cancers, your diabetes, your atherosclerosis, your… and they said, we’re starting to see what used to only be geriatric diseases in our children. That’s how bad it’s gotten. We have suppressed fevers, we don’t… we don’t respect the wisdom of the human body. So, you know, the doctors say, step aside, body, I will fix this infection for you with this antibiotic. And so, what we’ve done with the, overuse of antibiotics, and this isn’t me just talking from a natural perspective, this is… Right, it’s everybody around the world is acknowledging. I’ll show you… I could show you a, a presentation, if we can do a screen-sharing situation. Yeah. About the antibiotic situation in the world, because it’s really concerning. But what I would say, and kind of like an advancement forward, is we are seeing mutated bacteria. You know, they talked about… do you remember when they found the Iceman, you know, the… You know, the prehistoric guy that’s… In the eyes, and he had Lyme bacteria. I was like, he had spirochetes, maybe. Dr. Deb 25:33Yeah. David Jernigan 25:33That isn’t a modified, mutated version. That’s just maybe the… Lyme… you know, Borrelia… call it Borrelia something, you know, it’s a spirochete, but what we’re dealing with today. Even under strep or staph, as you know, you know, Pseudomonas aeruginosa, you name it, whatever kind of infection a person has is not the same bacteria that your grandparents dealt with. Dr. Deb 26:01That’s right. David Jernigan 26:32It’s a much mutated, stronger, more resistant to treatment type of thing. So, I think that’s one reason. I think the, It’s great that we’re seeing, you know, Secretary Robert F. Kennedy Jr. bringing awareness to things that Like it or not, yeah, seed oils do create inflammation, and everyone in the natural realm, as you know. Has been trying to say this for probably how long? Dr. Deb 26:35Yeah, 25, 30 years. 20 years each. David Jernigan 26:48Yes. You know, thank goodness for people like Sally Fallon and her beautiful book, Nourishing Traditions, that started you know, Dr. Bernard Jensen’s books way back in the day, Dr. Christopher’s books way back in the day. Dr. Deb 26:48Damn. David Jernigan 26:49You know, all of them were way ahead of their time, saying, by the way, your margarine is only missing one ingredient from being axle grease. Dr. Deb 26:58Yeah. David Jernigan 26:58I think that was Dr. Jensen saying that at one point, probably 50, 60 years ago, I don’t know. Dr. Deb 27:03Yep. David Jernigan 27:04So, we’ve created this monster. We, we live in a very controlled environment, you know, of 72, 74 degrees at all times, we don’t sweat, we don’t have to work that hard, typically. You know, most of us aren’t out there like our ancestors were, so that’s making us more and more… Move towards the cold sclerotic diseases, of which even Lyme disease is, you know, which… Yes, it has inflammation, yes, but as a presentation, it’s very often associated with some of these Cold sclerotic diseases of mankind that we see now. Dr. Deb 27:46You have it. David Jernigan 27:47Yeah. Dr. Deb 27:48So, tell me, what is phage therapy? David Jernigan 27:52Well, may I show you a cool video? Dr. Deb 27:55Yeah, I’d love that. David Jernigan 27:56I did not make this video, this is just one of my favorites, because it’s from the National Institute of Health. Let’s see if I can just… Click the share screen thing. And get that to pop up. That’s not what I’m looking for, but it’s gonna be soon. Let’s go here… Alright, can you see that? Dr. Deb 28:18Yeah. David Jernigan 28:19Okay. Modern medicine faces a serious problem. Thanks in part to overuse and misuse of antibiotics, many bacteria are gaining resistance to our most common cures. Researchers are probing possible alternatives to antibiotics, including phages. So, bacteriophages, or we like to call them phages for short, are naturally occurring viruses that infect and kill bacteria. The basic structure consists of a head, a sheath, and tail fibers. The tail fibers are what mediate attachment to the bacterial cell. The DNA stored in the head will then travel down the sheath and be injected inside the cell. Once inside the cell, the phage will hijack the cellular machinery to make many copies of itself. Lastly, the newly assembled phages burst forth from the bacterium, which resets their phage life cycle and kills the bacterium in the process. Someday, healthcare providers may be able to treat MRSA and other stubborn bacterial infections using a mixture of phages, or a phage cocktail process would be first to identify what the pathogen is that’s causing the infection. So the bacterium is isolated and is characterized. And then there’s a need to select a phage in a process known as screening of phage that are either present in a repository or in a so-called phage library. That allows for many of the phages to be evaluated for effectiveness against that isolated I don’t know, bacterium. Phages were first discovered over 100 years ago by a French-Canadian named Felice Derrell. They initially gained popularity in Eastern Europe, however, Western countries largely abandoned phages in favor of antibiotics, which were better understood and easier to produce in large quantities. Now, with bacteria like these gaining resistance to antibiotics, phage research is gaining momentum in the United States once again. NIAID recently partnered with other government agencies to host a phage workshop, where researchers from NIH, FTA, the commercial sector, and academia gathered to discuss recent progress. NIH… So… That is… That is what phage therapy in… is. in what I call conventional phage. Let’s see, how do I get out of the share screen? Hope you already don’t see it. Dr. Deb 30:58Yep, at the top, there should just be a button. David Jernigan 31:00I don’t. Dr. Deb 31:00Stop sharing, yeah. David Jernigan 31:01So… Conventional phage therapy, as you just saw, is a lot like what it is that we’re doing, only the difference is they’re taking wild phages from the environment. They’re finding phages anywhere there’s, like, a lot of bacteria. And then they isolate those phages, and like he said, the gentleman at the very end said we put them in a library, and so there are banks of phages that they can actually now use, and One of the largest banks that I know of has about 700 different bacteriophages, or phages. In their bank that they can pull from. Dr. Deb 31:43Wow. Do you want to take a guess? David Jernigan 31:46How many bacteriophages they’ve identified are in the human gut, on average? Dr. Deb 31:52Oh my god, there’s gotta be more… David Jernigan 31:53Kinds, different kinds of phages, how many? Dr. Deb 31:56There’s gotta be millions. David Jernigan 31:57Well… In population, there’s… humongous numbers, numbers probably well beyond the trillions, okay? Hundreds of trillions, quadrillions, maybe, even. But in the gut, a recent peer-reviewed journal article said that there were 32,242 different types of bacteriophages that live naturally in your intestines, your gut. Dr. Deb 32:25Boom. David Jernigan 32:2632,000. Okay, so… If you read any article on phage therapy that’s in peer review, almost every single one in the very first paragraph, they use the same sentence. They go, Phages are ubiquitous in nature. They’re ubiquitous in nature. So my brain, when I find… when all this finally clicked together, and when we clicked together 5 years into my research, I could not get it to work for 5 years. I just kept going. But that sentence really got me going. I was, like, going, you know. If you look at what ubiquitous means, it says if Phages were the size of grains of sand. Like sand on the beach. They would completely cover the earth and be 50 miles deep. How crazy is that? Dr. Deb 33:24Wow. David Jernigan 33:25That’s how many phages are on the planet. There’s so many… they outnumber every species collectively on the planet. So, it’s an impossibility in my mind. I went, huh, it’s an impossibility that… You catching a, a sterile Bacteria, it’s almost an impossibility. Since the beginning of time, phages have been needing to use a reproductive host. And it’s very specific, so every kind of bacteria has its own kind of phage it uses as a reproductive host. Because phages are… and this is a clarification I want to make for people. just like in the old days, we were talking about the 90s, I talked to a veterinarian that had gotten in trouble with the veterinary board in her state. Dr. Deb 34:14Back in the old days. David Jernigan 34:16Because she gave dogs probiotics. And the board thought she was giving the dogs an infection so that she could treat them and make money off of the subsequent infection. Dr. Deb 34:28Oh my god. David Jernigan 34:29Nobody actually had heard of good, friendly bacteria in the veterinary world, I guess she said she had gotten in trouble, and she had to defend herself, that, no, I’m giving friendly, benevolent, beneficial bacteria. Okay, to these animals, and getting good results.So, phages… Are friendly, benevolent, beneficial viruses. That live in your body, but they only will infect a certain type of bacteria. So… What that means is if you have staff.Aureus, you know, Staphylococcus aureus bacteria. That bacteria has its own kind of phage that infects it called a staph aureus phage. E. coli has an E. coli phage. Each type of E. coli has its own phage, so Borrelia burgdurferi has its own Borrelia burgdurferi type of phage, whereas Borrelia miyamotoi alright? Or any of the other Borrelia species, or the Bartonella species, or the… you just keep going, and Moses has its own type of phage that only will infect that type of bacteria. So that’s… You know, when you realize, wow, why are we going to the environment Was my thought. Dr. Deb 35:54Yeah. David Jernigan 34:55Trying to find wild phages and put them into your body, and hopefully they go and do what you want them to do. What if we could trigger the phages themselves that live in your body to, instead of just farming that bacteria that it uses as a host, because what I mean by farming is the phages will only kill 40% of that population of bacteria a day. Dr. Deb 36:20Wow. David Jernigan 36:20And then they send out a signal to all the other phages saying, stop killing! Dr. Deb 36:24It’s like. David Jernigan 36:2560% of the bacteria population left to be breeding stock. It’s kind of like the farmer, the rancher, who… he doesn’t send his whole herd to the butcher. Dr. Deb 36:35Right. David Jernigan 36:36Just to, you know, he keeps his breeding stock. He sends the rest, right? So, the phages will kill 40% of the population every day, just in their reproduction process. Because once there’s so many, as you saw in the video, once the phage lands on top of the bacteria, injects its genetic material into the bacteria, that bacteria genetic engine starts cranking out up to 5,200 phages per bacteria. Dr. Deb 37:06I don’t know who counted all those… David Jernigan 37:08Inside of a bacteria, but some scientists peer-reviewed it and put it out there. that ruptures, and it literally looks like a grenade goes off inside of the bacteria. I wish I’d remembered to bring that video of a phage killing a bacteria, but it just goes, oof. And it’s just a cloud of dust. So, you’re breaking apart a lot of those different toxins and things. So… That’s… That was the impetus to me creating what I did. That and the fact that I looked it up, and I found out that phages will sometimes go… Crazy. I don’t know how to say it. Wiping out 100% of their host. And it could be a trigger, like change in the body’s pH levels, it could be electromagnetically done, you know, like, there’s been documentation of… I think it was, 50 Hz, electricity. Triggering one kind of phage to go… Crazy and annihilate its host population. There’s other ways, but I was, like, going, none of those fit me, you know? It’s not like I’m gonna shock somebody with a… Jumper cable or something to try to get phages to… to do that kind of thing. But the fact that it could be done, they can be triggered, they can switch and suddenly go crazy against their population. But what happens when they kill 100% of their host? The phages themselves die within 4 days. Dr. Deb 38:45Hmm. Because they can’t keep reproducing. David Jernigan 38:47There’s nothing to reproduce them, yeah. Dr. Deb 38:49Yeah. Especially… unless they’re a polyvalent phage, that means a phage that can segue and use. David Jernigan 38:54One or two other kinds of bacteria. To, as a reproductive host. But a lot of phages, if not the majority, are monovalent, which means they have one host that they like to use. And so… Borrelia, so… my study that I ended up doing, and I published the results in 2021, And it’s a small study, but it’s right in there at the high end, believe it or not, of phage research. Most phage research is less than 30 people. In the study. But, we did 26 people.And after one month of doing the phage induction that I invented, which only… Appears to only, induce or stimulate the types of phages that will do the job in your body. I don’t care what kind of phage it is. I don’t care if it’s a Borrelia phage, it may be a polyvalent phage that normally doesn’t use the Borrelia burgdurferi as its number one. Host, but it can. To go and kill that infection. And the fascinating thing is, there was a brand new test that came out at the same time I came out with the idea, literally the same weekend they presented. Dr. Deb 40:1511. David Jernigan 40:15ILADS conference in Boston in 2019. It was called the Felix Borrelia phage Test. So the Felix Borrelia phage test. Because Borrelia are often intracellular, right, they’re buried down in the tissue, they’re not often in the blood that much. And therefore, doing a blood test isn’t really that accurate. But you remember how there’s, like, potentially as many as 5,200 phages of that type erupt from each bacteria when it breaks apart. It’s way easier to detect those phages, because they’re now circulating, those 52, as you saw in the video. 5,200 different phages are now seeking out another Borrelia that they can infect. And so, while they’re out in circulation, that’s easy to find in the bloodstream. So, 77% of the people, so 20 out of 26, were tested after a 2-week period. After only a 4-day round of treatment. Because according to my testing, remember, I can actually test adjunctively to see if I can find any signatures for those kinds of bacteria. And I couldn’t after 4 days, so we discontinued treatment and waited Beyond the 4 days that would allow the phages themselves to die, so we waited about a week and a half.And redid the test. And 77%, so that 20 out of 26 of the people, were completely negative. Dr. Deb 41:50Wow. David Jernigan 41:52Which, you go, well, it’s just a blood test. Well, no, we actually had people that were getting better, like, they’d never gotten better before. We had one woman who was wheelchair-bound, and in two weeks was able to walk, and even ultimately wanted to work for my clinic. I’m just, like, going… Dr. Deb 42:07I didn’t want to write about all that. I wanted to write about the phages. I was like… David Jernigan 42:12article, I probably should have put some of those stories, because, Critics would say, well, you got rid of the infection, maybe, but… Did you fix the Lyme disease? Well, that’s… there’s two factors here that every doctor needs to understand. There’s the infection in chronic illness, there’s the infection, and then there’s the damage that’s been done. Because sometimes I have these people that would come in and say, well, Dr. Jernigan, it didn’t work for me, I’m still in the wheelchair. And I’m like, no, it worked. Repeat lab test over months says it’s gone, it’s gone, it’s gone. It’s like, we would follow, and 88% of the people we followed long-term were still negative, which is amazing to me. Dr. Deb 42:56And then they have to repair the damage. David Jernigan 42:59It’s the damages why you still have your symptoms. And that’s where the doctor has to get busy, right? Dr. Deb 43:06Right David Jernigan 43:06They were told erroneously by their doctor that originally treated them that they’d be well, they’d get out of the wheelchair, if he could actually kill all these infections. Dr. Deb 43:15It’s not true. David Jernigan 43:16Unless it’s caught early. So I love the analogy, and I’ve said it a thousand times.that Lyme disease and chronic infections are much like having termites in the wood of your house. If you find the termites early, then yeah, killing the infection, life goes back to normal, the storm comes and your house doesn’t fall down. But if it’s 20 years later. Killing the termites is still a grand idea. Right. But you have the damage in the wood that needs to be repaired as well. All the systems… when I talk about damage to the wood, I mean, like. All the bioregulatory aspects of the body, how it regulates itself, all the biochemical pathways, the metabolic pathways we all know about, getting the toxins that have been lodged in there for many years, stopping the inflammatory things that have been running crazy. Dealing with all those cytokines that are just running rampant through the body, creating this whole MCAS situation. Which are largely… Dr. Deb 44:21Coming from your body’s own immune cells called macrophages, which are not even… David Jernigan 44:26It’s not… a virus at all, it’s part of the immune system, it’s like a Pac-Man, and research shows that especially in spirochetes. There is no toxin. Now, I wrote 4 books. I think I wrote the very first book on the natural treatment of people with Lyme disease back in the 90s. Why did I write that? Not because I wanted to be famous, it’s a tiny book, actually, the first one was.I was just trying to help people get out of this idea that you will be well when you kill all the bugs. I was saying, it’s… you need to be doing this. If you can’t come to my clinic, at least do this. Try to find somebody that will do this for you. And that ultimately led to a bigger book.as I kept learning more, and I was like, going, well, okay, now at least do this amount of stuff. And you need to make sure your doctor is handling this, this, this, and this. And so, the third book was, like, 500 and something pages long. And then the fourth book was 500 and something pages long, and now they’re all obsolete with the whole phage thing, because this just rewrites everything. Dr. Deb 45:34Yeah. David Jernigan 45:34It’s pretty fascinating. Dr. Deb 45:37Do you think the war on bugs, mentality created more chronic illness than it solved? David Jernigan 45:44Because of the tools that doctors had to use, yes. We’re a minority, we’re still a minority, you and I. Dr. Deb 45:54Yep. Our doctoring… David Jernigan 45:56Methods I never had, and you’d never… maybe you did, but I’d never had the ability to grab a prescription pad and write out a prescription. I had to figure out, how do I get… and this was… and still my guiding thing, is like, how do I identify, number one, everything that can be found that’s gone wrong in the human body. And what do I need to provide that body? Like, the body is the carpenter. That has to do the repair, has to regenerate, has to do everything, has to get… everything fixed right? We can’t fix anything. If you have a paper cut, there isn’t a doctor on the planet that can make that go away. Dr. Deb 46:38Right. David Jernigan 46:39Of their own power, much less chronic illnesses. So, all the treatments are like the screws, saws, hammers, you know the carpenter must be able to use. So a lot of the time, doctors are just throwing an entire Home Depot on top of the carpenter. In the form of, like, bags of supplements, you know, hundreds of supplements, I’ve seen patients walk in my door with two suitcasefuls. And they were taking 70 bottles, 65 to 70 bottles of supplements, and I’d be just like, wow, your carpenter who’s been working for 24 hours a day, 7 days a week. He’s exhausted. There’s chaos everywhere, you don’t know where to. Dr. Deb 47:22Starting. David Jernigan 47:22He goes, you want me to do what with all this stuff? Dr. Deb 47:25Yep, I’ve seen the same thing. People… thousands, you know, several thousand dollars a month on supplements, and not any better. But they’re afraid to give up their supplements, too, because they don’t want to go backwards, either, and… there’s got to be a better way on both sides, the conventional side and the alternative side, although you and I don’t say it’s alternative, that’s the way medicine should be, but… David Jernigan 47:48Right. Dr. Deb 47:49We have to have a good balance on both sides. David Jernigan 47:52And I will say, too, in defense of doctors using a lot of supplements, I do use a lot of supplements. Dr. Deb 47:57Yeah, I do too. David Jernigan 47:58but I want to synergize what I’m giving the patient so that the carpenter isn’t overwhelmed and can actually get the job done. Like, everything has to work harmoniously together, so it’s not that… It’s not the number of supplements, and why would you need a lot of supplements? Well, because every system in your body is Messed up. My kind of clientele for 30 years. Our clientele, yours and mine. Dr. Deb 48:25Yeah. David Jernigan 48:26They have been sick, For decades, many of them. Dr. Deb 48:31Yeah. David Jernigan 48:31And if they went into a hospital, they honestly need every department. They need endocrinology, they need their kidney doctor, they need their… They’re a cardiologists, they need a neurologist, they need a rheumatologist. I mean, because none of those doctors are gonna deal with everything. They’re just gonna deal with one piece of the puzzle. And if they did get the benefit of all the different departments they need, yeah, they’d go out with a garbage bag full of stuff, too. Dr. Deb 48:57Hey, wood. David Jernigan 48:58Only, they’re not synergized. They don’t work together. You’re creating this chemistry set of who knows how much poison. And I want to tell your listeners, and I mean, you probably say this to your patients as well. There is a law of pharmacy that I learned eons ago, and it applies to natural medicine, too. Dr. Deb 49:21Yep. David Jernigan 49:22But the law says every drug’s primary side effect Is its primary action. So, if you listen to TV, you can see this on commercials. I love… I love listening to these commercials, because I’m like, wow. let’s… let’s… I don’t want to say I’ve named Brandon. I don’t know if that’s…Inappropriate to name a name brand, but let’s just say you have a pharmaceutical that is for sleep. After they show you this beautiful scene of the person restfully sleeping and everything like that, they tell you the truth. It’s like, this may cause sleepiness… I mean, sleeplessness. Dr. Deb 50:04Yeah. David Jernigan 50:04Found insomnia. Dr. Deb 50:06And headaches, and diarrhea. David Jernigan 50:08All the other things, and if it’s an antidepressant, what does the commercial do after it finishes showing you little bunny foo-foo, jumping through a green, happy people? They tell you, this may create depression, severe depression, and suicidal tendencies, which is the ultimate depression. So, I want everyone to understand you need to figure out what your doctor’s tools are that they’re asking you to take, and they’re wanting you to take it forever, generally in mainstream medicine, right? In the hospitals and everything. They don’t say, hey, your heart has this condition, take this medicine for 3 months, after which time you can get off. Dr. Deb 50:48Yep. David Jernigan 50:49not fixing it, right? So… That, on a timeline, there is a point, if it was truly even fixing anything. That you… it’s done what it should do, and you should get off, even if it’s a natural product. It’s just like. Dr. Deb 51:03Right David Jernigan 51:03It’s done what it should do, and you should get off, but instead. you go through the tree… the correction and out the other side, and that’s where it starts manifesting a lot of the same problems that it had. So, anti-inflammatories, painkillers, imagine the number one side effects are pain inflammation. So, the doctor says, well. If you say, hey, I’m having more pain, what does he do? He ups the dosage. And if he… if that doesn’t work, if you’re still in a lot of pain, which he would be, he changes it to a more powerful thing, right? But it starts the cycle all over again. So when you ask me, it’s like, why are we having so much chronic illness? It’s because of the whole philosophy. is the treatment philosophy of mainstream medicine that despises what you and I do. Because we’re… our philosophy from the start is the biggest thing. It’s like… We’re striving for cure. That dirty four-letter word, cure, we’re not even supposed to use it. And yet, if you look it up in Stedman’s Medical Dictionary, it just means a restoration of health. Remission. Everyone’s like, oh, I’m in remission. I’m like, remission is a drug term. It’s a medical term. Again, look it up in a medical dictionary. It is a pharmaceutical term for a temporary pause Or a reduction of your symptom, but because it’s just… symptom suppression, it will come back. It’s… remission is great, I suppose, in… At the end of, like, where you’ve exhausted everything, because I can’t fix everything, I don’t know about you. Dr. Deb 52:41No, I can’t either, yeah. David Jernigan 52:43you know, on my phone consults, I try to always remind people, as much as I get excited about my technologies gosh, I see so much opportunity to fix you. I always try to go, please understand, I’m gonna tell you what most doctors may not tell you on a phone consultation. I can’t fix everything. Dr. Deb 53:03Yeah. David Jernigan 53:03For all of my tricks, I can’t fix everything. Not tricks, but you know, all my technologies, and all my inventions. Phages, too. They are a tool. You know, antibiotics. I think I wrote a blog one time, it should be on my website somewhere, that says, Antibiotics do not… fix… neurological disease, or… I don’t know, something like that. You know, you’re using the wrong tool. I mean, it does what it does. Dr. Deb 53:32Yeah, you’re using a hammer to do what a screwdriver needs to. David Jernigan 53:35Yeah, you know, it’s like it’s… And yet, you can probably tell her… that you’ve had patients, too, that they go, Dr. Jernigan. My throat was so sore, and as soon as I swallowed that antibiotic. I felt better, and I’m, like, going… How long did it take? Oh, it was immediate! I was like, dude, the gel cap didn’t even have time to dissolve, I mean… Dr. Deb 53:58SIBO. David Jernigan 54:00But, it’s not going to repair the tissues that were all raw. kind of stuff. So, I mean, that ulceration of your throat that’s happening, the inflammation, there’s no anti-inflammatory effect of these things. So, I digress a little bit, but phages, too… I wrote an article that’s on the website, that’s setting healthy expectations for phages, because they want… we can see some amazing things happen, things that in my 30 years, I wish I had all my career to do over again, now having this tool. It’s just that much fun. I… when doctors around the country now are starting to use our inducent formulas, there’s, 13 of them now, formulas. For different broad-spectrum illness presentations. I tell them all the same thing, I was like, you are gonna have so much fun. Dr. Deb 54:53That’s exciting. Women. David Jernigan 54:54Winning is fun, you know? I was like. You know, mainstream medicine may never accept this, I don’t know. I feel a real huge burden, though, to do my best to follow a, very scientific methodology. I’ve published as much as I can publish at this time by myself. I never took money from the… the sources that are out there, because what do they do? They always come… money comes with strings. Dr. Deb 55:22Yes, it does. David Jernigan 55:23I don’t trust… I don’t trust… I mean, if you listen to the, roundtable that Our Secretary Robert F. Kennedy Jr. Dr. Deb 55:35Yeah. David Jernigan 55:36On Lyme disease last week the first couple of speakers were, like, pretty legit. I mean, all of them were legit, but I mean, they were, like, senators and congressmen or something like that, I think. And then you have… RFK Jr. himself, who’s legit. Yeah they were fessing up to the fact that, yes, they were suppressing anything to do with Lyme. Dr. Deb 56:00Yeah. David Jernigan 56:00Our… our highest levels of, marbled halls and pillars and… of medicine were doing everything the way I thought they were. They were suppressing me. I was like, how can you ignore the best formulas ever, and still, I think Borreligen, and now, induced native phage therapy are still, I believe, I don’t… I’ve never seen it, I could be wrong. The only natural things that have been documented in a medical methodology. Dr. Deb 56:34Hmm in the natural realm. I mean, all the herbs that we talk about. David Jernigan 56:39You know, there’s one that was really famous for a while, and it said, we gave… so many patients. This product, and other nutritional supplements. And at the end, X number of them were… dramatically better. That’s not research. Dr. Deb 56:57Right. That’s observation. David Jernigan 56:59The trick there was we gave this one thing, and then we gave high-dose proteolytic enzymes, we gave high dose this, we gave high dose that, but at the end of the study, we’re going to point back at the thing we’re trying to sell you as being what did it. Dr. Deb 57:12Which is what we do in all research, pretty much. David Jernigan 57:15Well… Dr. Deb 57:16tried to… David Jernigan 57:17Good guys, I hope. Dr. Deb 57:18Do the way we want, right? In… in conventional… David Jernigan 57:22Yeah. Dr. Deb 57:22Fantastic David Jernigan 57:23Very often, yeah, in conventional medicine, definitely. Yeah. And, it’s kind of scary, isn’t it, how many pharmaceuticals are slamming us with, because they’re… Dr. Deb 57:33Okay. David Jernigan 57:34There’s a new one on TV every day, and there’s. Dr. Deb 57:36Every day, yes. David Jernigan 57:37It’s like, who comes up with these names? They’re just horrible. Dr. Deb 57:40Yeah, you can’t pronounce them. David Jernigan 57:41I want to be a marketing company and come up with some Zimbabwehika, or something that actually they go with, and I’m like, I just made a million bucks coming up with it. I’ll be glad when that’s not on the TV anymore, which… Oh, me too. Me too. Dr. Deb 57:54Dr. Jaredgen, this was really wonderful. What do you want to leave our listeners with? David Jernigan 58:00Well, you know, everyone’s calling for a new treatment. Dr. Deb 58:05Yeah. You bet. David Jernigan 58:08I have done everything I can do to get it out there, scientifically, in peer review, so that if you want to look up my name. Dr. Deb 58:16I published an open access journal so that you didn’t have to buy the articles. Like, PubMed, you have to be a member. If you want to look at a lot of the research, you have to buy the articles. David Jernigan 58:26I’ve done everything open access so that people had access to the information. I honestly created induced native phage therapy to fix my own wife. I mean, I… I was… I used to think I could actually fix almost anything. Gave me enough time. And, I could not fix her. You know, the first 10 years, she was bedridden. Dr. Deb 58:49Wow. David Jernigan 58:50People go, oh, it’s easy for you, Dr. Jernigan, you’re a doctor. Dr. Deb 58:54Oh yeah, right? Yeah. David Jernigan 58:56Oh my gosh, how many tears have been shed, and how much heartache, and how much of this and that. I mean, 90% of our marriage, she was in, bed, just missing Christmas. All the horror stories you hear in the Lime world, that was her, and I could not get her completely well. And, she’s a very discerning woman. I say that in all my podcasts, because it’s. Dr. Deb 59:19Just… David Jernigan 59:16Amazing. It’s like, every husband, I think, should want a wife that’s… Always, right? Not that you surrender your own opinion, but it’s like, it’s… it was literally, I don’t know what, 6 months before the ILADS conference in Boston in 2029… in 2019 that She said, are you going to the ILADS conference this year? And I’m like, I’ve been going for, like, 15, 20 years, however long it’s been going on, and I was like, I’m not gonna go to this one. And, 3 days before the conference, she says, I think you should go. And I go, okay. Like I say, she’s generally right. And that… I bought a Scientific American magazine at the newsstand in the Nashville airport. Started reading a story about phages in that that copped that edition of the Scientific American, and It was a good article, but it wasn’t super meaty, you know. very deep on those, but I just was stimulated. Something about being at elevation. Dr. Deb 1:00:02Yeah. Your own mountains, I don’t know, I get all inspired. David Jernigan 1:00:25And I wrote in the margins and highlighted this and that until it was, like, ultimately, I spent the entire conference hammering this out. And it worked. And it’s been working, it’s just amazing. It’s… We’re over 200 different infections that we’ve… we’ve clinically or laboratory-wise documented. There’s a new test for my GenX called the CEPCR Lyme Panel. like, culture. 64 different types of infections, and I believe right now the latest count is something like 10 for 10 were completely negative. Dr. Deb 1:01:03Wow. David Jernigan 1:01:03These chronically infected people. And so, that hadn’t been published anywhere. So, in my published article, remember I was talking about that 20 out of the 26 were tested as negative for the infection? That doesn’t mean they’re cured, okay? Remember, they’re chronically damaged. That’s how we need to look at it. Dr. Deb 1:01:23funny David Jernigan 1:01:24damaged. You’re not just chronically infected. And, but with 30-day treatment.24 out of the 26 were tested as negative. Dr. Deb Muth 1:01:34That’s amazing. David Jernigan 1:01:35So 92% of the people were negative.Okay? The chances of that happening, when you run it through statistical analysis.The chances… when you compare the results to the sensitivity percentages, you know, the 100% specificity and 92% sensitivity of the…Of the lab testIt’s a 4.5 nonillion to 1 chance that it was a fluke. Isn’t that amazing? Now, nearly… I’m not even sure how many zeros that is, but it’s a lot. Dr. Deb Muth 1:02:08That’s is awesome. David Jernigan 1:02:09Like, if I just said, well, it’s a one in a million chance it was a fluke.Okay.So, lab tests don’t lie. You’re not done, necessarily, just because you got rid of the infections. Now that formula for Lyme has grown to be 90-plusmicrobes targeted in the one formula. So, we figured out we can actually target individually, but collectively, almost like an antibiotic that’s laser-guided to only go after the bad guys that we targeted.So, all the Borrelia types are targeted, all the Babesias, for,the Bartonellas, the anaplasmosis, you name it, mycoplasma types are all targeted in that one formula, because I said.Took my collective 30 years of experience and 15,000 patients.that I would typically see as co-infections and put them into that one formula, so…When we get these tests coming back that are testing for 64, it’s because of that.So, there’s a lot of coolnesses that I could actually keep going and going. Dr. Deb Muth 1:03:15That’s exciting. David Jernigan 1:03:15I love this topic, but I thank you for letting me come on. Dr. Deb Muth 1:03:18Thank you for joining us. How can people find you? David Jernigan 1:03:22Two ways. There’s the Phagen Corp company that is now manufacturing my formulas.That is P-H-A-G-E-N-C-O-R-P dot com. Practitioners can go there, and there’s a practitioner side of the website that’s very beefy with science, and… and all the formulas that were used, what’s inside of all the formulas, meaning what microbes are targeted by each one. Like, there’s a GI formula, there’s a UTI formula, there’s a SIRS formula, there’s a Lyme formula, there’s a central nervous system type infection formula, there’s… And we can keep going, you know, SIBO, SIFO formula, mold formula… I mean, we’ve discovered so many things that I could just keep going for hours, and… Dr. Deb Muth 1:04:05Yeah. David Jernigan 1:04:06About the discoveries, from where it started in its humble beginnings, To now, so… There’s another way, if you wanted to see our clinic website, is Biologics, with an X, so B-I-O-L-O-G-I-X, Center, C-E-N-T-E-R dot com. And, if somebody thinks they want to be a patient and experience this at our clinic, typically we don’t take just Easy stuff. All we see is chronic.Chronic cases from all over the world. Something like 96% of our patients come from other states and countries. And typically, I’ve been close to 90% for my whole career.About 30-something percent come from other countries in that, so… we’ve gotten really good and learned a lot in having to deal with what nobody else knows what to do with. But if you do want to do that, you can contact us. And, if you… If you don’t get the answers from my patient care staff, then I do free consultations. With the people that are thinking about, whether we can help them or not. Dr. Deb Muth 1:05:13Well, that’s excellent. For those of you who are driving or don’t have any way of writing things down, don’t worry about it, we’ve got you. We will have all of his contact information in our show notes, so you will be able to reach out to him. Thank you again for joining me. This has been an amazing conversation. David Jernigan 1:05:30Thank you, I appreciate you having me on. It was a lot of fun. The post Episode 252 – Induced Native Phage Therapy (INPT) & advanced natural therapies first appeared on Let's Talk Wellness Now.

Peripheral artery disease has been called the ‘silent circulatory crisis'—affecting millions, limiting mobility, and quietly raising the risk of heart attack, stroke, and limb loss. For decades, treatment focused on walking programs, aspirin, and sometimes a stent or bypass. But today, the landscape is changing. From PCSK9 inhibitors that drive cholesterol to record lows, to GLP-1 agonists like semaglutide improving walking distance, to novel antithrombotic strategies that balance bleeding and clotting—PAD care is entering a new era. In this episode, we'll explore the breakthroughs, the evidence behind them, and what they mean for patients who just want to keep moving forward." Hosted by the University of Michigan Department of Vascular Surgery: - Robert Beaulieu, Program Director - Frank Davis, Assistant Professor of Surgery - Luciano Delbono, PGY-5 House Officer - Andrew Huang, PGY-4 House Officer - Carolyn Judge, PGY-2 House Officer Learning objectives:  1.  Describe the current evidence-based recommendations for multifactorial medical management of peripheral artery disease (PAD), including lipid, glycemic, and antithrombotic strategies per 2024 SVS/AHA guidelines.  2. Interpret the clinical implications of the FOURIER trial regarding the role of PCSK9 inhibition in reducing cardiovascular events in patients with atherosclerotic disease, including PAD.  3.  Evaluate the emerging role of GLP-1 receptor agonists, such as semaglutide, in improving walking performance and quality of life among patients with diabetic PAD based on findings from the STRIDE trial. Sponsor URL: https://www.goremedical.com/ References:  H. L. Gornik et al., “2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease,” JACC, vol. 83, no. 24, pp. 2497–2604, June 2024, doi: 10.1016/j.jacc.2024.02.013. L. Mazzolai et al., “2024 ESC Guidelines for the management of peripheral arterial and aortic diseases: Developed by the task force on the management of peripheral arterial and aortic diseases of the European Society of Cardiology (ESC) Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS), the European Reference Network on Rare Multisystemic Vascular Diseases (VASCERN), and the European Society of Vascular Medicine (ESVM),” Eur Heart J, vol. 45, no. 36, pp. 3538–3700, Sept. 2024, doi: 10.1093/eurheartj/ehae179. https://pubmed.ncbi.nlm.nih.gov/40169145/ M. S. Sabatine et al., “Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease,” N Engl J Med, vol. 376, no. 18, pp. 1713–1722, May 2017, doi: 10.1056/NEJMoa1615664. https://pubmed.ncbi.nlm.nih.gov/28304224/ M. P. Bonaca et al., “Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial,” Lancet, vol. 405, no. 10489, pp. 1580–1593, May 2025, doi: 10.1016/S0140-6736(25)00509-4. https://pubmed.ncbi.nlm.nih.gov/40169145/ N. E. Hubbard, D. Lim, and K. L. Erickson, “Beef tallow increases the potency of conjugated linoleic acid in the reduction of mouse mammary tumor metastasis,” J Nutr, vol. 136, no. 1, pp. 88–93, Jan. 2006, doi: 10.1093/jn/136.1.88. https://pubmed.ncbi.nlm.nih.gov/16365064/ Please visit https://behindtheknife.org to access other high-yield surgical education podcasts, videos and more.   If you liked this episode, check out our recent episodes here: https://behindtheknife.org/listen Behind the Knife Premium: General Surgery Oral Board Review Course: https://behindtheknife.org/premium/general-surgery-oral-board-review Trauma Surgery Video Atlas: https://behindtheknife.org/premium/trauma-surgery-video-atlas Dominate Surgery: A High-Yield Guide to Your Surgery Clerkship: https://behindtheknife.org/premium/dominate-surgery-a-high-yield-guide-to-your-surgery-clerkship Dominate Surgery for APPs: A High-Yield Guide to Your Surgery Rotation: https://behindtheknife.org/premium/dominate-surgery-for-apps-a-high-yield-guide-to-your-surgery-rotation Vascular Surgery Oral Board Review Course: https://behindtheknife.org/premium/vascular-surgery-oral-board-audio-review Colorectal Surgery Oral Board Review Course: https://behindtheknife.org/premium/colorectal-surgery-oral-board-audio-review Surgical Oncology Oral Board Review Course: https://behindtheknife.org/premium/surgical-oncology-oral-board-audio-review Cardiothoracic Oral Board Review Course: https://behindtheknife.org/premium/cardiothoracic-surgery-oral-board-audio-review Download our App: Apple App Store: https://apps.apple.com/us/app/behind-the-knife/id1672420049 Android/Google Play: https://play.google.com/store/apps/details?id=com.btk.app&hl=en_US

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

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.

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!