Podcasts about biologics

Chronic rhinosinusitis with nasal polyps, or CRSwNP, is a condition driven by ongoing inflammation. That is why treatment is not a one-time fix and why polyps can come back even after surgery. In this episode, Dr. Payel Gupta and Kortney are joined by Dr. Maeve O'Connor, a board-certified allergist and immunologist, to walk through CRSwNP treatment options. This episode is released around World Anosmia Day because loss of smell is one of the most frustrating and most common symptoms of CRSwNP, and one that treatment can actually help with. What we cover in this episode about nasal polyps treatment Nasal therapies as your base management: Saline rinses and nasal steroid sprays are the foundation of CRSwNP treatment. They need to be used consistently as part of your daily routine, not just when symptoms flare. Why nasal polyps keep coming back: CRSwNP is driven by ongoing inflammation, not just the polyps themselves, so removing them does not address the root cause. When surgery is the right choice: Sinus surgery can open blocked passages and help nasal sprays reach deeper into the sinuses, but works best as part of a long-term plan, not a one-time fix. What biologic medications actually do: Biologics target the underlying inflammation causing CRSwNP. Four are currently approved for CRSwNP: dupilumab, omalizumab, mepolizumab, and tezepelumab. Why follow-up care matters even when you feel better: Inflammation can return before symptoms become noticeable, so regular check-ins with your allergist or ENT are key to catching early signs of polyp regrowth. About our guest  Dr. Maeve O'Connor, MD, FACAAI, FAAAAI, is a board-certified allergist and immunologist and founder of Allergy Asthma & Immunology Relief (AAIR) of Charlotte, North Carolina. She treats patients of all ages, practices integrative medicine, and has been named a Top Doctor by Charlotte Magazine since 2007. More resources What is Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)? What are nasal polyps? What is AERD? Biologics for Allergic Disease What to know before starting a biologic  Oral Corticosteroid Stewardship   ********* Made in partnership with The Allergy & Asthma Network. Thanks to Sanofi-Regeneron for sponsoring today's episode.  This podcast is for informational purposes only and does not substitute professional medical advice. Always consult with your healthcare provider for any medical concerns.

In this episode of Creating Your Ageless Future, Regan Archibald offers a high-level, educational walkthrough of regenerative medicine—covering commonly discussed categories like biologics, cellular therapies, signaling molecules, PRP, and exosomes—while emphasizing the importance of separating marketing from evidence. He shares why public interest has accelerated (including demographic and cultural factors), describes how product variability and regulatory action have shaped the landscape, and explains why research concepts like cell sourcing, handling, and testing are central to quality and safety discussions. Regan also outlines how teams often approach decision-making in this space—using diagnostics, careful sourcing, and lifestyle context—while cautioning against one-size-fits-all claims and DIY experimentation.RESOURCES:Book Comprehensive Labs: https://agelessfuture.com/longevity-labs/FREE copy of The Peptide Blueprint: https://agelessfuture.com/blueprintSign up for future Health Accelerator Challenges calls LIVE! https://us02web.zoom.us/webinar/register/WN_YZsiUMOzSyqcE8IinC5YEQ#/registrationBooks: https://www.amazon.com/Books-Regan-Archibald/s?rh=n%3A283155%2Cp_27%3ARegan%2BArchibaldArticles: https://medium.com/search?q=Regan+ArchibaldLIKE/FOLLOW/SUBSCRIBE:YouTube -https://www.youtube.com/@ReganArchibald / https://www.youtube.com/@Ageless.FutureLinkedIn: https://www.linkedin.com/in/regan-archibald-ab70b813Instagram: https://www.instagram.com/ageless.future/Facebook: https://www.facebook.com/AgelessFutureHealth/DISCLAIMER: This video is for educational purposes only and does not provide medical advice, diagnosis, or treatment.  Many of the molecules discussed in this video are research compounds and are not approved by the U.S. Food and Drug Administration (FDA) for any specific medical use, indication, or condition. They are mentioned only in the context of existing scientific literature and ongoing research and are not being recommended, prescribed, sold, or offered through this video.  This content does not endorse or recommend any specific tests, products, procedures, or treatment protocols.References to our clinic are for general educational context only; investigational or non‑approved products are not available for direct ordering or prescribing based solely on viewing this content.  Do not start, stop, or change any medication, peptide, or supplement based on this video. All medical decisions must be made with a licensed prescribing clinician after a proper evaluation. No provider–patient relationship is created by viewing this content or contacting our clinic.  Regan Archibald is a Licensed Acupuncturist and longevity coach. He is not a medical doctor. Cade Archibald is COO and Co-Founder of Ageless Future, also not a medical doctor. All medical decisions, lab ordering, and prescribing in our clinic are performed only by our licensed medical team (MD, APRN, PA).  Viewers should follow the guidance of their own licensed clinicians and local health authorities regarding diagnosis and treatment decisions.

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Biologics have changed how patients with asthma are able to handle their symptoms and prevent them from getting worse. Host Amy Attaway, MD, Cleveland Clinic, talks with Monica Kraft, MD, Icahn School of Medicine at Mount Sinai, and De De Gardner, DrPh, Allergy and Asthma Network and member of PAR about depemokimab, the newest biologic for those with severe asthma. Learn how this novel treatment is used once every six months to improve patient outcomes, as well as the research behind this biologic and the future of asthma treatment. Read Dr. Kraft's paper on depemokimab: https://journal.chestnet.org/article/S0012-3692(25)00855-4/pdf  Editor's note: During this episode, Dr. Kraft mistakenly said that depemokimab was approved for treating nasal polyps. Please note that depemokimab is not approved for treating this condition. 

Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.Timestamps00:00 Welcome and Guest Intro00:53 The Hairiest CAPA Case03:02 Human Error Root Cause04:58 Common CAPA Misconceptions06:11 Why Root Cause Fails12:16 When to Open CAPA17:26 CAPA Inputs and Triggers19:28 One Process or Two22:28 How to Investigate Properly25:09 Tools for Root Cause26:20 Problem Statement Basics27:48 Wrap Up and Where to FindGeorg Digel is the founder of Elevate CAPA and works with medical device quality leaders to make nonconformance and CAPA systems faster, stronger, and more audit-ready. He brings hands-on experience from early work on the production line through roles across consulting, startups, and larger organizations, with a focus on root cause and investigation quality. He also shares practical NC and CAPA breakdowns and training content with the MedTech community. LinkedIn: https://www.linkedin.com/in/georgdigel/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, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA.The conversation explores why Western companies often underestimate China's regulatory expectations — particularly when assuming EU or U.S. approvals, ISO standards, or FDA clearances will translate directly. Elaine explains how China requires demonstration of safety and effectiveness against applicable local standards primarily GB (national standards) and YY (medical device industry standards) including both mandatory and recommended variants (e.g., GB vs GB/T, YY vs YY/T).The episode dives into China's local type testing model and the role of Product Technical Requirements (PTRs) in defining test methods, parameters, accessories, and applicable standards for registration.Elaine also outlines how China's quality system expectations align to China Medical Device GMP rather than ISO 13485 including major GMP updates taking effect in November 2026 and discusses implications for foreign manufacturers.Additional discussion topics include China agents and authorized representatives, clinical evaluation expectations, post-market reporting requirements, and how China's device classification system can influence regulatory strategy.⏱️ Timestamps00:00 Welcome + Meet Elaine (MedTech Chopsticks)00:38 Why China Is Different: Local Standards vs EU/US Assumptions03:35 GB & YY Standards Explained (National vs Industry Standards)05:07 Local Type Testing & PTRs: Building China Product Technical Requirements06:52 China GMP Updates: Key Differences vs ISO 1348512:42 China Agent vs EU Authorized Rep: Roles & Responsibilities15:19 Choosing Local Test Labs: NMPA-Designated Testing Considerations18:42 Planning Early: Standards Gaps, Clinical Evaluation & PMS Risks24:43 China Certification & Device Classification Changes (Class I/II/III)28:38 Where to Find Elaine + ClosingSubhi Saadeh is the Founder and Principal at 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.

As biologics grow more complex, cell line development remains a key driver of speed, yield, and manufacturability. What was once a technical milestone is now a competitive differentiator, directly impacting time to Investigational New Drug (IND), cost of goods, and long-term scalability. In this episode of Off Script, we spoke with Brett Verstak, director of cell line development at Abzena, to discuss how advanced Chinese hamster ovary (CHO)-based platforms, glutamine synthetase (GS) knockout systems, automation, and AI-driven workflows are accelerating clone selection and reducing downstream risk. The conversation explores persistent bottlenecks in hard-to-express proteins, the value of integrated upstream development models, and how smarter platform design is helping drug developers move complex biologics to the clinic faster.

In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 framework, Q4A, Q4B, and the Q4B annexes work together to determine when pharmacopeial test methods are considered interchangeable across ICH regions. The episode also explains the role of the Pharmacopoeial Discussion Group (PDG) in technical harmonization and walks through practical examples, including ICH Q4B Annex 3.ICH Guidelines (Quality): https://www.ich.org/page/quality-guidelinesICH Q4B Annex 3(R1) – Tests for Particulate Contamination (Subvisible Particles): https://database.ich.org/sites/default/files/Q4B%20Annex%203%28R1%29%20Guideline.pdfTimestamps00:00 Introduction to the ICHQ Series00:03 What Pharmacopeial Harmonization Means00:42 Why ICH Q4 Exists01:55 ICH Q4 Framework and Structure02:54 Understanding Q4A, Q4B, and the Annexes03:59 Practical Examples (Particulates, Disintegration)08:05 Conclusion and Next StepsSubhi Saadeh is the Founder and Principal at 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.

With a carnivore diet, Phillip improved over 30 years of skin issues including eczema, severe plaque psoriasis, palm and plantar psoriasis, and scalp psoriasis. Phillip also improved his pre-diabetes. Instagram: https://www.instagram.com/mrphillipwin/ TikTok: https://www.tiktok.com/@mrphillipwin X: https://x.com/MrPhillipWin Timestamps: 00:00 Diet's role in autoimmune health 04:49 Topical steroid concerns in dermatology 09:49 Medication concerns and side effects 12:43 Psoriasis treatment self-discovery 14:49 Persistence with psoriasis treatment 17:49 Carnivore diet benefits and downsides 20:19 Health concerns and cultural food 24:02 Dairy tolerance and eczema 29:28 Biologics push for psoriasis treatment 31:11 Drug cycle and muscle loss 35:01Overcoming chronic illness Join Revero now to regain your health: https://revero.com/YT Revero.com is an online medical clinic for treating chronic diseases with this root-cause approach of nutrition therapy. You can get access to medical providers, personalized nutrition therapy, biomarker tracking, lab testing, ongoing clinical care, and daily coaching. You will also learn everything you need with educational videos, hundreds of recipes, and articles to make this easy for you. Join the Revero team (medical providers, etc): https://revero.com/jobs ‪#Revero #ReveroHealth #shawnbaker  #Carnivorediet #MeatHeals #AnimalBased #ZeroCarb #DietCoach  #FatAdapted #Carnivore #sugarfree Disclaimer: The content on this channel is not medical advice. Please consult your healthcare provider.

Observations from the James Webb Space Telescope and Hubble Space Telescope indicate a 2.6 km or 1.6 miles nucleus, with methane emerging only after perihelion, suggesting it was buried under outer layers.Rogue planets, also known as free-floating planets, are celestial nomads that wander through interstellar space without being gravitationally bound to any star. Once thought to be rare, recent studies suggest our galaxy may be home to trillions of these lonely worlds, potentially outnumbering the stars in the Milky Way. Become a supporter of this podcast: https://www.spreaker.com/podcast/the-tempest-universe--4712510/support.Follow the #podcast on YouTube: https://youtube.com/@thetempestuniverse

Observations from the James Webb Space Telescope and Hubble Space Telescope indicate a 2.6 km or 1.6 miles nucleus, with methane emerging only after perihelion, suggesting it was buried under outer layers.Rogue planets, also known as free-floating planets, are celestial nomads that wander through interstellar space without being gravitationally bound to any star. Once thought to be rare, recent studies suggest our galaxy may be home to trillions of these lonely worlds, potentially outnumbering the stars in the Milky Way. Become a supporter of this podcast: https://www.spreaker.com/podcast/the-tempest-universe--4712510/support.Follow the #podcast on YouTube: https://youtube.com/@thetempestuniverse

In this episode of Let's ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substances and drug products.Subhi explains what impurities are, why zero impurities is unrealistic in scalable manufacturing, and how ICH Q3 establishes a risk-based framework to protect patient safety and product quality. The episode walks through the structure of Q3A through Q3E, covering impurities formed during drug substance synthesis, degradation in drug products, residual solvents, elemental (metal) impurities, and extractables and leachables highlighting where drug delivery systems and combination products explicitly come into scope under Q3E.This episode is a high-level, practical overview focused on how to read ICH Q3, how the sections fit together, and where the guideline applies and stops across the drug product lifecycle.⸻Timestamps00:00 Welcome to Let's ComBinate00:12 Introduction to ICH Q300:25 What Are Impurities and Why They Matter00:51 Sources of Impurities and Risk-Based Control02:11 Structure of ICH Q3 (Q3A–Q3E)05:30 How to Read and Use ICH Q307:22 Q3E, Extractables & Leachables, and Drug Delivery Systems09:21 Wrap-Up and Next Episode PreviewSubhi Saadeh is the Founder and Principal at 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.

Designing proteins that have never existed in nature is no longer sci-fi — it's becoming a real drug discovery strategy. In this episode, Kashif Sadiq, Founder & CEO of DenovAI Biotech, explains how AI is powering a shift from searching for biologic binders to intentionally designing new proteins from scratch.Kashif shares his journey from studying physics at University of Cambridge into computational biophysics, and how breakthroughs like AlphaFold from DeepMind helped unlock the next frontier: de novo protein design. Instead of hoping evolution has already produced a usable molecule, Kashif describes how modern AI can engineer bespoke proteins for specific functions, including challenging targets where traditional approaches come up short.The conversation dives into the sheer scale of “protein space” and why evolution has only explored a tiny fraction of what's possible. Kashif outlines how this opens the door to targeting diseases and biological mechanisms that have historically been considered undruggable, especially where flat protein interfaces or complex signalling pathways have made small molecules ineffective.Finally, Kashif explains why combining generative AI with physics-based methods is essential to reduce false positives, improve real-world binding performance, and enable “one-shot design” — where discovery and optimisation become a single integrated process. He also shares what keeps him up at night: clinical trial attrition — and why designing better earlier may be the key to improving success later.Topics CoveredDe novo protein design vs traditional biologics discoveryWhy evolution explored only a tiny fraction of protein space“Programmable biologics” and intentional molecular designAlpha Design and designing proteins from the inverse problemAntibodies, nanobodies, and therapeutic protein engineeringCombining generative AI with physics-based validationReducing false positives in protein binding predictions“One-shot design” and compressing discovery timelinesUndruggable targets, flat interfaces, and intracellular signallingClinical trial attrition and what's missing at the preclinical stageWhen the first de novo-designed therapeutic could enter trialsAbout the PodcastAI for Pharma Growth is the podcast from pioneering Pharma Artificial Intelligence entrepreneur Dr Andree Bates, created to help pharma, biotech and healthcare organisations understand how AI-based technologies can save time, grow brands, and improve company results.This show blends deep sector experience with practical, no-fluff conversations that demystify AI for biopharma execs — from start-up biotech right through to Big Pharma. Each episode features experts building AI-powered tools that are driving real-world results across discovery, R&D, clinical trials, market access, medical affairs, regulatory, insights, sales, marketing, and more.Dr. Andree Bates LinkedIn | Facebook | X

Most biotech breakthroughs don't fail in the lab.They fail when science meets manufacturing reality.And by the time this bottleneck appears, tens of millions are already sunk.This episode examines the most under-discussed failure point in modern biotech: the gap between scientific discovery and scalable, usable healthcare solutions.While science has never been stronger—and big pharma excels at market access—companies that can translate breakthrough biology into industrialized medicines remain rare. Manufacturing, regulation, clinical design, usability for patients and physicians, and global scalability still form a narrow bottleneck where most value is lost.In this conversation, Björn Cochlovius, CEO of Eleva, explains why so many promising biologics fail late—and how Eleva deliberately built a platform designed not to replace existing systems, but to rescue projects that would otherwise be abandoned.Drawing on decades across immunology, biotech leadership, and translational medicine, Björn offers a grounded, operator-level view on what it actually takes to move from elegant science to real-world impact.As he puts it:(00:28:59) “In biotech, courageous decisions often look wrong—until years later.”This discussion goes beyond manufacturing alone. It explores why turning scientific concepts into ready-to-deploy healthcare solutions—complete with clinical data, regulatory pathways, scalable production, and high usability—remains one of the hardest industrial challenges of our time.What You'll Learn in This Episode1️⃣ Why biologics often fail late—after science already worked2️⃣ Why manufacturing is only one part of a deeper industrial bottleneck3️⃣ How Eleva approaches risk when others walk away4️⃣ Why courage, not optimization, drives breakthrough biotech decisions5️⃣ How AI supports discovery—without replacing human judgment6️⃣ What Europe gets right—and still gets wrong—about scaling biotech

Good 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 significant announcements and strategic initiatives that are shaping the landscape of drug development and patient care.Starting with a notable investment move, Eli Lilly has announced a $3.5 billion manufacturing facility in Pennsylvania, marking a significant milestone in their "Lilly in America" initiative. This facility is set to focus on injectables and devices, reinforcing Lilly's dedication to expanding its manufacturing capabilities within the United States. These types of investments are increasingly crucial as they aim to enhance supply chain resilience and support the production of complex biologics and innovative therapies—a step that could prove pivotal in maintaining a competitive edge in the global pharmaceutical market.Meanwhile, Regeneron's Eylea franchise is encountering challenges with declining sales, even with the introduction of Eylea HD. This situation highlights the difficulties companies face in maintaining market share amidst fierce competition and evolving treatment paradigms in ophthalmology. It underscores the importance of continuous innovation and effective lifecycle management strategies to sustain product competitiveness in a rapidly changing industry environment.Takeda is also navigating turbulent waters with its ADHD medication Vyvanse facing generic competition. Despite this, Takeda maintains an optimistic outlook for future growth by narrowing the revenue gap between declining Vyvanse sales and contributions from new products. This transition is reflective of a broader industry trend where companies pivot towards novel therapeutics to offset revenue losses from patent expirations, exemplifying strategic adaptation in response to market dynamics.AstraZeneca's ambitious $18.5 billion obesity deal with China's CSPC exemplifies the growing focus on metabolic disorders driven by rising global obesity rates. This partnership not only reinforces AstraZeneca's expansion strategy into China but also highlights the increasing importance of addressing obesity—a major public health challenge with significant healthcare cost implications. The deal marks a strategic push to leverage advanced therapeutic approaches, particularly targeting GLP-1 and GIP receptors with long-acting dual agonists. Additionally, AstraZeneca's further $15 billion pledge for investments in Chinese cell therapies and radiopharmaceuticals is expected to enhance its capabilities in personalized medicine and expand its global presence across key therapeutic areas—a reflection of a broader industry trend towards asset-centric deals prioritizing targeted acquisitions over traditional mergers.Novo Nordisk's ongoing legal challenge against drug pricing provisions in the Inflation Reduction Act (IRA) is gaining momentum, with support from the U.S. Chamber of Commerce urging the Supreme Court to review the case. This legal battle underscores ongoing tensions between pharmaceutical companies and regulatory frameworks aimed at controlling drug prices, reflecting broader debates on healthcare affordability and access—a critical issue that continues to shape policy discussions across the industry.Across the Atlantic, CDMO Vetter's €480 million investment in a new plant in Germany signals robust growth in contract development and manufacturing services. This expansion aligns with increasing demand for outsourcing solutions in biopharmaceutical production, driven by complex manufacturing processes and capacity constraints faced by many biotech firms. Such investments are pivotal as they aim to enhance production capabilities and meet growing demands for innovative biologics.Quince Therapeutics recently experienced a setback with its steroid delivery technology for ataxia-telangiectasia, illustrating the Support the show

Do new UAP sightings mean alien contact is imminent? Lue Elizondo is a former U.S. Army counterintelligence special agent and a former senior intelligence officer for the Office of the Under Secretary of Defense for Intelligence. With decades of experience in national security, he conducted and supervised clandestine operations worldwide, specializing in counterterrorism, espionage, and advanced aerospace threats. He is best known for his role as the former head of the Pentagon's Advanced Aerospace Threat Identification Program (AATIP), where he investigated unidentified aerial phenomena (UAP) and pushed for greater transparency on non-human intelligence (NHI). In this show, Elizondo reveals the existence of a decades-long “Legacy Program”—a covert operation investigating unidentified aerial phenomena that operated without congressional oversight for more than 80 years. This isn't about blurry lights in the sky. It's about crash retrievals, exotic materials, and physical craft allegedly in U.S. possession dating back to Roswell and beyond, quietly studied by the military-industrial complex while the public was fed weather balloon and swamp gas cover stories. He describes the Cold War you never learned about—not just a race to the moon, but a race to reverse-engineer technology so advanced it makes nuclear weapons look primitive. Then comes the phrase that changed everything: “non-human biologics.” The conversation shifted from metal to flesh. Not drones—occupants. Craft that were piloted. Pilots that didn't survive. The science is even more unsettling. These UAPs demonstrate capabilities that defy known physics: instantaneous acceleration, hypersonic speed without sonic booms, and right-angle turns that would liquefy a human body. The implication? They may not be “traveling” at all—but warping space-time itself, moving inside a gravitational bubble. And what if they aren't coming from far away? Elizondo weighs theories that these entities may be interdimensional, not extraterrestrial—originating not light-years away, but right here, just beyond our perceptual bandwidth. While we smash particles at CERN to glimpse the fabric of reality, these craft appear to move through it. From the Tic Tac incident, to swarms over Langley Air Force Base, to a recent triangle-shaped craft sighting over Area 51, the phenomenon is becoming more visible, more aggressive, and harder to dismiss. Elizondo's message—echoed in the title of his book, Imminent—is clear: the clock is ticking. If contact is coming, the real question isn't whether we're ready technologically—but whether we're ready socially, psychologically, and spiritually. A relationship with a non-human intelligence wouldn't mean trade agreements. Elizondo explains what it could mean for a fundamental rewrite of physics, religion, power, and humanity's place in the universe. Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of Let's Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation characteristics, and how ICH Q2 applies to drug delivery systems and drug-device combination products.Subhi explains how the revised ICH Q2 guideline aligns with ICH Q14 and what that alignment means for harmonizing analytical validation expectations across regions and regulatory authorities. The episode walks through key validation characteristics including accuracy, precision, specificity, linearity, and range, and clarifies the relationship between ICH Q2 and ICH Q14. Practical guidance is also provided on how to read and apply ICH Q2 efficiently, particularly for teams working with combination products.Timestamps00:00 Introduction to Let's ComBinate00:42 Purpose and importance of ICH Q203:11 Scope and product coverage06:10 Key validation characteristics08:15 Practical application and reading ICH Q210:23 Conclusion and next stepsSubhi Saadeh is the Founder and Principal at 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 SCW for Pharma, Evren Ozkaya welcomes Kevin Sharp, Executive Vice President and Head of Sales and Operations at Samsung Biologics. Kevin shares his more than 20 years of experience in the pharmaceutical industry, spanning procurement, manufacturing, supply chain, and business development roles across companies such as GSK, Contract Pharmacal Corp, and Samsung Biologics. With the last decade focused on biologics, he offers a broad and practical perspective on how the industry has evolved.The conversation begins with an overview of Samsung Biologics and its position in the CDMO market. Founded in 2011, Samsung Biologics has rapidly become a leader in biologics manufacturing capacity, leveraging Samsung's deep engineering expertise and manufacturing DNA. Kevin explains how the company's end-to-end CDMO model addresses one of the biggest pain points for biopharma companies: the cost, risk, and time associated with tech transfers across multiple suppliers.Evren and Kevin then dive into the unique complexity of biologics supply chains. Kevin highlights how longer planning horizons, strict quality requirements, and capacity slot management make timing and end-to-end coordination critical. As molecules become more complex and new drug modalities emerge, even small disruptions in sequencing or release timing can have significant consequences for quality and supply reliability.The discussion expands to broader biopharma trends, including the growing share of combination therapies and novel modalities. Kevin notes that a significant portion of products expected to be approved in the coming years will fall outside traditional standards, putting pressure on CDMOs to invest in modern facilities, scalable platforms, and standardized yet flexible production processes. He emphasizes that while there is room in the market for CDMOs of all sizes, larger players differentiate themselves through integrated, one-stop-shop capabilities and scalable capacity.Digitalization is another key theme of the episode. Kevin explains how Samsung Biologics applies its technology-driven heritage to biologics manufacturing, drawing parallels between semiconductor production and biopharma in terms of precision and environmental control. He discusses the use of MES, supply chain visibility tools, AI, and digital twins, and how real-time data transparency creates value for clients while improving consistency and operational performance.Finally, Evren and Kevin explore why digital transformation remains slow across much of the pharma CDMO landscape. Kevin points to investment requirements, long implementation timelines, sunk costs, and concerns about technology obsolescence as major barriers. He also shares advice for younger professionals in the industry, encouraging early exposure to different functions and the importance of building strong, long-term relationships.They conclude by reflecting on how capacity, technology, and adaptability will continue to shape the future of biologics manufacturing, and why companies that commit early to scalable platforms and digital foundations are likely to widen the gap in the years ahead.

Full Show Notes: https://bengreenfieldlife.com/lavalle/ In this episode, I sit down with the legendary clinical pharmacist Jim LaValle for a fascinating exploration of some of the most innovative approaches to health, performance, and longevity. We discuss everything from peptides and small molecules for mitochondrial and kidney support to the science behind improving VO2 max, brain function, sleep, and more. Jim LaValle unpacks his decades of experience, shares cutting-edge research on metabolic health, and explains the power of his Metabolic Code test—which I recently tried myself—for identifying and addressing the biggest bottlenecks in your health journey. Throughout our conversation, we swap stories about nutrition missteps (think gallons of dairy and endless antibiotics), dive into the practical application of peptides like KPV, BPC-157, and lorazotide for healing the gut, and examine trends Jim repeatedly sees even in high performers—like stress-driven hormone changes and sneaky signs of inflammation. If you’re curious about how personalized lab testing, wearable data, and smart supplementation can help you feel better, perform better, and age powerfully, you’ll love the insights in this episode. James "Jim" B. LaValle, B.S.Pharm, CCN, MT, DHM, DHPh, is an internationally recognized clinical pharmacist, author, and board-certified clinical nutritionist, with over 40 years of clinical experience in natural products, lifestyle, drug/nutrient depletion, compounding pharmacy, and peptides. Episode Sponsors: Truvaga: Balance your nervous system naturally with Truvaga's vagus nerve stimulator. Visit Truvaga.com/Greenfield and use code GREENFIELD30 to save $30 off any Truvaga device. Calm your mind, focus better, and recover faster in just two minutes. ZBiotics Pre-Alcohol Probiotic: The world's first genetically engineered probiotic that helps break down the toxic byproduct of alcohol, Zbiotics Pre-Alcohol allows you to enjoy your night out and feel great the next day. Order with the confidence of a 100% money-back guarantee and 15% off your first order at zbiotics.com/BEN15. TRIUMPH Coaching: Join me for one-on-one coaching with me and my hand-picked team, custom-built around your labs, your lifestyle, and goals, until you actually hit them. No guesswork. Just results. If you’re finally ready to stop wasting time and money and start living the boundless life you know is possible, go to jointriumphcoaching.com and book your call. Just Thrive: Take the Just Thrive FEEL BETTER challenge today, and save 20% on your first Gut Essentials Bundle. Just Thrive Probiotic is the only probiotic clinically proven to arrive 100% alive in your gut, reducing bloat, better energy, and even clearing skin. Digestive Bitters packs 12 science-backed herbs in one tasteless capsule that jumpstarts your digestion and supports GLP-1 production so cravings don’t control you. Visit justthrivehealth.com/BEN and save 20% with promo code BEN. See the difference for yourself or get a full product refund, no questions asked. Boundless Bar: If you’re ready to fuel workouts, sharpen your focus, and support whole-body vitality, grab your Boundless Bars now at boundlessbar.com —and save 10% when you sign up for a Boundless Bar subscription.See omnystudio.com/listener for privacy information.

In this episode of Let's Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and what has stayed the same.ICH Q1 is the core stability guideline, and with the consolidation of multiple legacy guidelines into a single document, many readers have found the draft overwhelming. In this episode, Subhi steps back from line-by-line commentary and instead focuses on how to think about ICH Q1, how to read it efficiently, and how stability decisions are expected to be made.The discussion covers why stability was one of the first topics harmonized by ICH, the fundamental stability concepts that still anchor the guideline, and how the revised structure emphasizes lifecycle management and data evaluation rather than introducing new science. Subhi also explains how ICH Q1 applies to drug-device combination products, including the role of the device as part of the container-closure system and why in-use stability often matters more than long-term storage.This episode is part of an ongoing series walking through the ICH Q guidelines and is intended to help listeners navigate regulatory expectations with clarity and confidence.Timestamps00:00 Introduction00:36 What ICH Q1 Is and Why It Exists02:59 Core Stability Concepts in ICH Q104:51 What's Changing in the 2025 Draft05:35 How to Read ICH Q107:16 ICH Q1 and Drug-Device Combination Products09:09 Closing and What's NextSubhi 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 a dynamic phase shaping the industry, marked by scientific advancements, regulatory changes, and strategic shifts within major companies.Teva Pharmaceuticals is making significant strides under the leadership of CEO Richard Francis. The company is transitioning from its traditional focus on generic drugs to a more innovative biopharmaceutical approach. This strategic pivot aims to position Teva alongside industry giants in the biopharma sector, highlighting the increasing importance of innovation over generics in today's competitive landscape.Similarly, Fujifilm is enhancing its competitive edge by capitalizing on its biologics capacity. Rather than pursuing large mergers and acquisitions, Fujifilm is focusing on internal growth, underscoring a broader industry trend where companies are investing in organic growth and technological enhancements to maintain their market positions. This shift reflects a growing recognition of the value of leveraging unique facility designs and capabilities to boost production and efficiency.In regulatory news, the U.S. Food and Drug Administration (FDA) has mandated that pharmaceutical companies like Sanofi, GSK, AstraZeneca, and CSL include warnings about febrile seizures on flu vaccine labels. While these seizures are typically brief and harmless, transparent communication is crucial to maintain patient trust in vaccination programs. This regulatory update exemplifies the FDA's proactive efforts to enhance drug safety communications and address potential adverse effects associated with vaccines.The FDA has also issued untitled letters to Beone and ImmunityBio for promotional materials that potentially violated advertising guidelines. This action underscores the agency's vigilance in ensuring pharmaceutical marketing practices meet required standards of accuracy and transparency.Meanwhile, former Emergent BioSolutions CEO Robert Kramer faces insider trading allegations related to the sale of company shares before public disclosure of contamination issues at a production facility. This legal action brings to light ongoing scrutiny within the industry regarding corporate governance and ethical practices.In terms of advertising spending, AbbVie's Skyrizi topped annual TV ad spending charts for pharmaceuticals, closely followed by J&J's Tremfya. This highlights the continued emphasis on direct-to-consumer advertising as companies compete for market share in therapeutic areas.Internationally, companies like AbbVie are making strategic moves into emerging therapeutic spaces such as bispecific antibodies. AbbVie's recent deal to enter the PD-1xVEGF bispecific space signifies a growing interest in novel therapeutic modalities that offer potential breakthroughs in cancer treatment.At the policy level, former President Donald Trump announced "The Great Healthcare Plan," targeting insurance industry reforms and drug pricing. Although specifics remain sparse, this initiative reflects ongoing political discourse around healthcare affordability—a critical issue shaping industry strategies and public expectations.Turning our attention to Vedanta Biosciences, the company is reallocating resources toward its lead live bacteria cocktail program by significantly reducing its workforce. This move highlights growing interest in microbiome-based therapies as a novel approach to treating diseases by modulating gut microbiota. Vedanta's focus could have substantial implications for future therapeutic options, particularly in immune-related conditions.At the J.P. Morgan Healthcare Conference (JPM26), Chugai Pharmaceutical emphasized enhancing its recognition in the U.S. biopharma sector through new scientific avenues. This strategy underscores the importance of innovation and collaboration for Support the show

Are aging, chronic pain, and inflammation truly inevitable or have we been approaching them the wrong way? What if the future of medicine isn't about stronger medications, repeated steroid injections, or masking symptoms, but about removing inflammation, restoring biological signaling, and helping the body relearn how to heal? In this powerful episode of the Uncover Your Eyes podcast, Dr. Meenal Agarwal sits down with Dr. Chris Renna, founder of LifeSpan Medicine, and one of the world's leading voices in longevity and regenerative medicine. Over the last decade, elite athletes from Kobe Bryant and Tiger Woods to professional soccer and NFL players have quietly sought out treatments most people have never heard of, including Regenokine, platelet-rich plasma (PRP), and advanced biologic therapies. Many traveled overseas after being told their pain, inflammation, or decline was simply "part of aging." In this conversation, we ask a different question: What if it doesn't have to be?

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.

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/860/99066167-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.

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.