Podcasts about biologics

Andy gives his immediate post-press conference thoughts following David Grusch, members of Congress, Leslie Kean and others speaking on the steps of Capitol Hill.This episode covers the key moments from the event, including calls for whistleblower protections, pressure on President Trump to waive NDAs, renewed talk of non-human biologics, and Grusch's striking comments about a spectrum of life ranging from corporeal bipedal beings to “sentient plasmoid life.” Andy also looks at the mixed reaction to the event, the role of mainstream media, what this could mean for future disclosure efforts, and where things may go next.Plus, Andy shares thoughts on upcoming interviews with Jeremy Corbell and Richard Dolan, the wider media landscape, and why this moment may be more important than it first appeared.

At this year's PEGS Boston, industry experts gathered on a panel to explore how AI and machine learning are deployed in biologics R&D today. Moderated by Peter M. Tessier, Ph.D., Albert M. Mattocks professor of pharmaceutical sciences and chemical engineering at University of Michigan, the panel consisted of Andrew Buchanan, Ph.D., head of discovery at a stealth-mode biotech company; Norbert Furtmann, Ph.D., head of biologics AI and design of large molecules research at Sanofi; Konrad S. Krawczyk, Ph.D., founder and CSO at NaturalAntibody SA; Andrew C.R. Martin, Ph.D., emeritus professor of bioinformatics and computational biology at University College London; Melody Shahsavarian, Ph.D., senior director of data strategy and digital transformation of biotherapeutics discovery research at Eli Lilly & Company; and Bernhardt L. Trout, Ph.D., professor of chemical engineering at Massachusetts Institute of Technology.  Links from this episode:  Pharmaceutical Sciences & Chemical Engineering, University of Michigan University of Michigan Sanofi NaturalAntibody SA Bioinformatics, UCL Biosciences Computational Biology, UCL University College London   Eli Lilly & Company 

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 series of significant advancements shaping the landscape of our industry. As technology continues to redefine traditional paradigms, the collaboration between Pfizer and Chai Discovery exemplifies this trend. By harnessing artificial intelligence, particularly through custom models like Chai-3, this partnership aims to revolutionize drug discovery. The integration of AI promises not only to accelerate the identification of biologics and antibodies but also to optimize resource allocation in research and development. Such technological integration could pave the way for an enhanced pipeline of innovative treatments, marking a transformative shift in how therapeutic candidates are developed. In the realm of regulatory developments, Lupin's Ranluspec has recently received FDA approval as an interchangeable biosimilar targeting VEGF-A for various retinal conditions. This move underscores the importance of biosimilars in providing cost-effective alternatives to expensive biologics, thereby expanding patient access to essential treatments for conditions like macular degeneration. Additionally, the MHRA's marketing authorization for Aujemflu, an adjuvanted trivalent influenza vaccine for adults aged 50 and over, reflects ongoing efforts to bolster protection against infectious diseases among vulnerable populations. Clinical trial advancements continue to highlight significant progress in therapeutic development. Otsuka Pharmaceuticals' Phase 3 data on Voyxact has shown promising stabilization of kidney function in patients with Immunoglobulin A nephropathy. This protein therapy targets autoimmune pathways, offering new hope for managing this chronic kidney condition. Similarly, Autobahn Therapeutics' Elunetirom has advanced to a pivotal trial following Phase 2 success in treating bipolar depression. This showcases the potential of small molecule therapies targeting thyroid hormone receptors. Meanwhile, Hikma Pharmaceuticals' victory in a landmark patent case regarding skinny labels marks an important development in pharmaceutical intellectual property rights. The unanimous Supreme Court ruling against Amarin supports the legitimacy of using skinny labels to market generic versions of drugs for non-patented indications. This decision could enhance market competition and drive down healthcare costs, setting a precedent for future intellectual property disputes. On the business front, strategic partnerships and mergers continue to shape industry dynamics. Gilead Sciences' acquisition of Ouro Medicines for $1.675 billion strengthens its autoimmune inflammation pipeline. This transaction exemplifies how major deals are reshaping therapeutic portfolios in response to growing demand for treatments targeting rare diseases. Financially, Solix Pharmaceuticals' success in raising $71 million to advance its siRNA pipeline across multiple therapeutic areas demonstrates investor confidence in RNA-based therapeutics as a promising frontier for innovative treatments. Conversely, challenges persist as evidenced by Takeda's $2.5 billion legal provision over an antitrust case related to Amitiza, underscoring ongoing financial risks associated with litigation in the pharmaceutical sector. Corporate restructuring also signals shifts within the industry landscape. Fulcrum Therapeutics' decision to lay off 85% of its workforce following the discontinuation of its sickle cell disease candidate highlights the volatility and high stakes inherent in drug development. Overall, these developments illustrate a dynamic landscape where scientific innovation is propelled by AI-driven approaches and strategic collaborations while regulatory victories and financial maneuvers shape market dynamics. These trends have profound implications for patient care by potentially accelerating the availability of novel therapies and fostering a competitive environment that drives down costs. As we look ahead, stakeholders must navigate these complexities effectively to harness opportunities and address challenges within this rapidly evolving industry landscape. The ability to adapt and capitalize on emerging trends will be crucial as these sectors continue to evolve, ultimately enhancing patient care and advancing therapeutic frontiers globally. Thank you for joining us today on Pharma Daily; stay tuned for more insights into the ever-changing world of pharmaceuticals and biotech.Support the show

In this episode of BioTalk with Rich Bendis, Jeffrey N. Hausfeld, M.D., Chairman of the Board and Chief Medical Officer of BioFactura Inc., and Darryl Sampey, Ph.D., President and Chief Executive Officer of Capitol Biologics, join the conversation to discuss the launch of Capitol Biologics as BioFactura's CDMO division. Jeff and Darryl explain how BioFactura's experience building biologics development and clinical manufacturing capabilities created the foundation for a more personalized CDMO model. The discussion explores the gap Capitol Biologics is designed to fill for emerging biotech companies that need integrated development support, scientific depth, analytical expertise, phase-appropriate quality, and early GMP manufacturing without being pushed into a large commercial-scale CDMO model too soon. The conversation also highlights what biotech CEOs and CMC leaders should consider before choosing a CDMO partner, including developability assessment, cell line and process development, analytical characterization, quality systems, cost of goods, regulatory readiness, and timing. Jeff and Darryl also discuss the growing importance of U.S.-based biologics development and manufacturing capacity, especially for emerging biotech and government-aligned programs. Editing and post-production work for this episode was provided by The Podcast Consultant. Jeffrey N. Hausfeld, M.D., M.B.A., F.A.C.S., is a physician entrepreneur, biotechnology executive, investor, and healthcare innovator whose career spans clinical medicine, life sciences, healthcare real estate development, and entrepreneurial leadership. A graduate of Yale University School of Medicine and recipient of an M.B.A. from Johns Hopkins University, Dr. Hausfeld is an Associate Clinical Professor of Surgery at George Washington University and has been actively involved in national medical societies and healthcare leadership organizations for more than four decades. He currently serves as Chairman of the Board and Chief Medical Officer of BioFactura Inc., Chairman of Capitol Biologics, and Chairman and Co-Founder of the Society of Physician Entrepreneurs. His work focuses on advancing healthcare innovation, biotechnology commercialization, physician entrepreneurship, and the responsible adoption of emerging technologies that improve patient care. Darryl Sampey, Ph.D., is a biopharmaceutical executive and company builder with more than 30 years of experience advancing biologics from discovery through clinical development and commercial manufacturing. He co-founded BioFactura in 2004 and has guided the company from start-up through incubator stages into a fully integrated biopharmaceutical product development and clinical manufacturing company. At BioFactura, he has raised more than $90 million in non-dilutive and strategic funding, built cGMP manufacturing capabilities, and led development of novel therapeutics, biodefense medical countermeasures, biosimilars, and cell therapies. Dr. Sampey is an inventor of the VeriCyte™ Discovery and StableFast™ Biomanufacturing Platforms and previously held process development and manufacturing leadership roles at Human Genome Sciences and North American Vaccine.

Allergy treatment is evolving beyond antihistamines. Discover how new biologics, immunotherapy, and microbiome-based therapies are targeting the root immune response for long-term relief, and what you should ask your allergist about these game-changing options. WhatAreAllergies.com City: Dallas Address: 3145 Olive Street Website: https://whatareallergies.com

The Journal of Rheumatology's Editor-in-Chief Earl Silverman discusses this month's selection of articles that are most relevant to the clinical rheumatologist. Nurse Practitioners and Physician Assistants in Spondyloarthritis: A Narrative Review and Expert Commentary - doi.org/10.3899/jrheum.2025-0484 Unilateral Versus Bilateral Ultrasound of the Hands in Patients With Clinically Suspect Arthralgia: What Is the Difference? A Longitudinal Study - doi.org/10.3899/jrheum.2025-0373 Comparative Risk of Osteoporosis and Osteoporotic Fractures According to Exposure to 2 Groups of Biologics in Patients With Radiographic Axial Spondyloarthritis - doi.org/10.3899/jrheum.2025-0988 Performance of Risk Score Calculators in the Identification of Coronary Artery Calcification in Patients With Systemic Lupus Erythematosus - doi.org/10.3899/jrheum.2025-0465 Screening for Anxiety, Depression, and Fibromyalgia in Routine Care of All Rheumatic Diagnoses on a Multidimensional Health Assessment Questionnaire (MDHAQ) - doi.org/10.3899/jrheum.2025-0969

Founded in 2010, the Institut Pasteur spinout PathoQuest sold to top CRO Charles River for $70M this year, a product of years of collaboration and stepwise investments.Jean‑François tells us how the exit unfolded, as well as the importance of biosafety and CMC as pharma and biotech outsource heavily and cell and gene therapies mature. We also cover how animal testing is disappearing from CMC and how France must nurture its biotech ecosystem.---For transparency, this episode has been sponsored by PathoQuest.---⭐️ ABOUT THE SPEAKERJean-François has more than 20 years of pharma leadership under his belt. Before his ten years at PathoQuest, he was a Senior Vice-President in charge of Ipsen's GI-oncology and endocrinology franchise.He has an engineering degree and a master's degree in Foreign Trade.

When it comes to treating chronic sinus disease with nasal polyps…what's the best approach, surgery or biologics?Well, the answer is it's usually not either-or anymore.When patients are trying to manage these challenging conditions, some people opt for one or the other. But more physicians are finding that surgery and biologics aren't different paths. They are actually treatment protocols that complement each other.Surgery may remove the growths, but it doesn't necessarily stop the process of creating them in the first place. Biologics may suppress the inflammatory pathways driving recurrence, but they don't physically restore blocked sinus anatomy or remove bulky disease.We're entering a new phase of care where the question is no longer “surgery or biologics?” but how both can work together as part of a personalized strategy.Instead of treating every patient the same way, physicians are now looking deeper at the inflammatory pathways driving disease, recurrence risk, quality of life, and even how different biologics target different parts of the immune cascade.The shift is moving chronic sinus care away from a one-size-fits-all model and toward precision medicine that's designed around the individual patient.In this episode, I'm joined by Dr. Tassos Hantzakos, staff physician in otolaryngology and residency program director at Cleveland Clinic Abu Dhabi, and Dr. Deepa Sheth, allergy and immunology specialist.Together, we break down how the treatment landscape for chronic rhinosinusitis with nasal polyps is evolving, why collaboration between ENT and allergy specialists is becoming essential, and how biologics are reshaping the future of inflammatory airway disease management.Things You'll Learn In This Episode Not just a surgical problemFor decades, treatment focused on physically removing nasal polyps, but many patients still experienced recurrence. Why does surgery alone often fail to stop the disease?Biologics are changing how we think about airway diseaseNew biologic therapies are targeting different parts of the inflammatory cascade. How do physicians decide which biologic is the best fit for a specific patient?The future of treatment is collaborative, not competitiveThe conversation is shifting away from “surgery versus biologics” toward integrated care between ENT surgeons and allergists. When should surgery come first, and when should biologics be introduced?Precision medicine is reshaping chronic inflammatory careDifferent patients may require different treatment approaches. How does identifying the root inflammatory driver completely change long-term management outcomes?Guest BioDr. Tassos Hantzakos is a staff physician in the Otolaryngology Department at Cleveland Clinic Abu Dhabi's Integrated Surgical Institute, where he also serves as Program Director of the Otolaryngology Residency. His clinical expertise spans otolaryngology, rhinology, phonosurgery, laryngeal laser surgery, and voice disorders. Before joining Cleveland Clinic Abu Dhabi, Dr. Hantzakos served as a consultant within the Hellenic National Health System, Director of the Voice Clinic at NUKA, and Clinical Associate Professor at Cleveland Clinic Lerner College of Medicine in the US. He has contributed to numerous international journal articles and textbooks and is actively involved in several professional societies, including the European Laryngological Society, the International Association of Phonosurgeons, the Voice Foundation, and the European Society for Swallowing Disorders. Outside of medicine, he enjoys spending time with his family, long-distance running, triathlons, and playing guitar and drums. Connect with him on LinkedIn. Dr. Dipa K. Sheth is an allergist-immunologist based in Washington, DC, and an Assistant Professor of Medicine at Uniformed Services University of the Health Sciences. Her clinical work focuses on allergy and immunology, with experience treating conditions such as chronic sinusitis, rhinitis, atopic dermatitis, drug hypersensitivity, and food hypersensitivity. Dr. Sheth received her medical degree and completed her internal medicine training at George Washington University, followed by a fellowship in Allergy and Immunology at the University of Colorado School of Medicine and National Jewish Health. Her research has been published in journals including Frontiers in Allergy and Current Opinion in Allergy and Clinical Immunology. Connect with her on LinkedIn. About Your HostHosted by Dr. Deepa Grandon, MD, MBA, a triple board-certified physician with over 23 years of experience working as a Physician Consultant for influential organizations worldwide. Dr. Grandon is the founder of Transformational Life Consulting (TLC) and an outspoken faith-based leader in evidence-based lifestyle medicine.Disclaimer ​​TLC is presenting this podcast as a form of information sharing only. It is not medical advice or intended to replace the judgment of a licensed physician. TLC is not responsible for any claims related to procedures, professionals, products, or methods discussed in the podcast, and it does not approve or endorse any products, professionals, services, or methods that might be referenced.Work With Me Learn More About My Soon-to-Launch Telemedicine PlatformExciting news. My virtual medical platform is launching soon! If you're looking for personalized, evidence-based care in allergy, immunology, and lifestyle medicine, stay tuned. Visit drdeepa-tlc.org and click on “Learn More” to join the waitlist and be the first to receive updates about services, membership options, and launch details.Precision care. Personalized guidance. Wherever you are.Devotionals Want to receive a devotional every week from Dr. Deepa? Devotionals are dedicated to providing you with a moment of reflection, inspiration, and spiritual growth each week, delivered right to your inbox. Visit drdeepa-tlc.org to subscribe for free.Trauma Courses Ready to deepen your understanding of trauma and kick-start your healing journey? Explore a range of online and onsite courses designed to equip you with practical and affordable tools. From counselors, ministry leaders, and educators to couples, parents, and individuals seeking help for themselves, there's a powerful course for everyone. Browse all the courses now to start your journey.

Send us Fan MailSome of the most important cancer and autoimmune disease drugs in the world still require patients to sit in infusion chairs for hours - but that model may be about to change entirely.Matthew Huddleston is Chief Commercial Officer at Enable Injections ( https://enableinjections.com/ ), a medical device company focused on rethinking how large-volume biologic drugs are delivered to patients.Enable's core technology, the enFuse® on-body delivery system, is designed to shift certain therapies from traditional intravenous infusion to subcutaneous, wearable administration - potentially transforming treatment from something that requires a clinic visit into something that can be done at home, more comfortably and more conveniently.What makes this particularly interesting is where Enable sits in the broader biopharma ecosystem. The company is actively partnering with major pharmaceutical innovators including Sanofi, Roche, Incyte, and Viridian Therapeutics to support the transition of complex biologics into subcutaneous delivery formats.One of the clearest signals of momentum is that Sanofi's Sarclisa combined with Enable's on-body injector has been recommended for approval in Europe by the CHMP, with FDA review ongoing - highlighting that this is no longer theoretical innovation, but an emerging commercial pathway.Enable is also extending its platform through collaboration with Aptar Pharma and its digital health division, integrating companion software to support patients throughout therapy - bringing drug delivery closer to a connected care ecosystem, where device, data, and treatment adherence increasingly converge.On this episode we will unpack how this platform works, what it enables for pharma partners, and how wearable drug delivery could reshape the future of biologics.#biotech #medtech #drugdelivery #biologics #pharma #oncology #multiplemyeloma #medicaldevices #healthtech #wearabletech #subcutaneous #infusiontherapy #drugdevelopment #pharmaceuticalindustry #innovation #digitalhealth #enableinjections #sanofi #roche #incyte #clinicaltrialsSupport the show

What's changing in rheumatoid arthritis treatment in 2026? In this powerful conversation, Dr. Isabelle Amigues and Dr. Diana Girnita discuss the latest breakthroughs in rheumatoid arthritis care, including precision medicine, biologics, remission strategies, tapering medications, vagus nerve stimulation, stress reduction, and the future of autoimmune healing. They explore how rheumatology is evolving from simply managing symptoms to helping patients achieve full remission and improve overall quality of life. From methotrexate and biologics to meditation, breathwork, and nervous system regulation, this discussion highlights a more personalized approach to autoimmune disease treatment.If you're living with rheumatoid arthritis, autoimmune disease, chronic inflammation, or searching for new hope beyond traditional treatment models, this episode is for you.Topics discussed:• Rheumatoid arthritis treatment updates• Biologics vs JAK inhibitors• Precision medicine in rheumatology• Can patients taper off medication?• Vagus nerve stimulation for inflammation• Stress, nervous system & autoimmune disease• Direct care rheumatology• Full remission in RA• Lifestyle medicine & autoimmune healing• Future of rheumatology care

Former Pentagon AATIP director and whistleblower Luis Elizondo joins Jillian Michaels for one of the most explosive UAP conversations ever recorded. warning: the scientists connected to America's most sensitive aerospace and defense programs are disappearing. Some are dead. There is an active FBI investigation. In this episode, we break down everything Congress and the mainstream media are quietly confirming: alien hybrid breeding programs, UAP escorted by U.S. military jets, a secret government operating outside the constitutional chain of command, and CIA officers waking up on their back lawns with foreign objects embedded in their bodies. We also go deep on Project Stargate — the U.S. Army's classified remote viewing program that successfully located a crashed Soviet aircraft in Africa and beat the stock market by $2 million — and why Elizondo believes consciousness itself may be a quantum process. Topics covered: • Missing and murdered scientists linked to classified aerospace programs • Congressional testimony on alien hybrid breeding programs • The “shadow government” operating outside presidential oversight • CIA abduction cases with physical evidence • Remote viewing, Project Stargate, and why the Pentagon quietly still uses it • Trump's UAP declassification — and why people are furious it's not enough • Are UAPs demons? What the Vatican told Elizondo • Why full disclosure may already be happening — and what comes next Chapters 00:00 — Intro: Missing Scientists 01:24 — Whistleblower Security Threats 04:13 — Alien Hybrid Breeding 09:44 — Ocean-Dwelling Intelligences 13:00 — Illegal Shadow Operations 17:44 — Suspect Scientist Assassinations 24:13 — Directed Energy Weapons 28:47 — Military Industrial Complex 37:33 — Global Defense Murders 41:41 — Spacetime Physics Theories 47:29 — Quantum Entanglement Mechanics 49:38 — CIA Remote Viewing 58:02 — Stock Market Exploits 01:01:58 — Managing Public Panic 01:21:20 — Physical Intelligence Implants 01:40:16 — Real Mandela Effects Shopify: Launch your dream business with Shopify. Sign up for your $1/month trial at https://Shopify.com/Jillian and start selling today! Superpower: Stop guessing about your health—get $20 off Superpower at https://superpower.com/JILLIAN with code JILLIAN Learn more about your ad choices. Visit megaphone.fm/adchoices

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In a rapidly evolving industry landscape, artificial intelligence has emerged as a game-changer, transforming how major pharmaceutical companies approach drug development and diagnostics. Roche's strategic acquisition of PathAI for over $1 billion exemplifies this shift, highlighting the growing importance of AI-driven diagnostics in digital pathology. This move signals a broader trend where AI is no longer just a theoretical concept but a practical tool enhancing healthcare delivery. Alnylam's recent challenges with its web-based presentation of Amvuttra data underscore the need for accuracy in representing clinical data digitally—showing that while AI can offer innovative ways to present data, it also demands rigorous standards to ensure clarity and prevent misleading claims. On the regulatory front, the FDA's evolving stance on cell therapy Ebvallo, alongside its new one-day assessment pilot program, is shaping the industry's regulatory environment. The reconsideration of Ebvallo's earlier rejection due to single-arm trial data concerns illustrates the FDA's willingness to adapt its regulatory framework to accommodate innovative therapies. This adjustment could potentially pave the way for other gene therapies in development, including those by UniQure. Moreover, Sanofi's withdrawal of Tzield from the FDA's contentious Commissioner's National Priority Voucher program reflects ongoing debates about expedited review processes, underscoring the need for transparent and efficient pathways for bringing new therapies to patients swiftly. Additionally, the FDA's AI-guided inspection pilot aims to modernize compliance strategies and enhance pharmaceutical manufacturing oversight. In clinical trials, companies continue to face both triumphs and setbacks. Entrada Therapeutics experienced a significant decline in stock value following underwhelming Duchenne Muscular Dystrophy trial results, potentially reshaping competitive dynamics in favor of rivals like Novartis. Conversely, Angelini Pharma is making strategic moves with its $4.1 billion acquisition of Catalyst Pharmaceuticals, targeting market expansion in the U.S. through Firdapse, which is poised to make significant impacts in treating rare diseases. MingMed Biotechnology's promising phase 2 results for QA102 could signal new treatment paradigms for dry AMD—a condition with limited current interventions. Therapeutic innovation is also being driven by policy shifts that encourage research into psychedelic drugs for mental health treatment. Optimi Health's IPO indicates growing investor interest in this area, fueled by regulatory easing under recent executive orders aimed at facilitating psychedelic research. Strategic pipeline adjustments are evident as companies realign their focus based on emerging data insights. Ascendis Pharma's decision to halt its IL-2 oncology program marks a shift toward more promising avenues, while Beone Medicines' restructuring reflects a similar strategy by discontinuing several early-stage cancer programs. The industry's dynamism is further illustrated by Eli Lilly's substantial $4.5 billion investment in expanding its Indiana campus. This move not only enhances Lilly's capacity for genetic medicine and metabolic disease manufacturing but also underscores a broader industry commitment to precision medicine and biologics—fields anticipated to play pivotal roles in future healthcare solutions. Meanwhile, Bayer's acquisition of Perfuse Therapeutics seeks to bolster its ophthalmology portfolio, addressing significant unmet needs in eye disease treatments. Novo Nordisk's success with Wegovy highlights strong market demand for effective obesity treatments, demonstrating an industry-wide shift towards addressing lifestyle-related diseases. LegislSupport the show

UFO whistleblower and former Air Force official David Grusch appeared in a podcast interview recently to discuss the ongoing push for UFO disclosure, and said things will be ramping up over the next 60 to 90 days.Links/Sources:UAP Whistleblower David Grusch on “Non-human” Biologics & Craft - YouTube(1) Red Panda Koala on X: "David Grusch says there are a lot of attention seeking charlatans in the UFO space selling books and right now he's focused on the disclosure fight and would like to return to normal life “This subject brings out a lot of charlatans, a lot of people who want attention, a lot of https://t.co/uH5dY1Dhyj" / XJeremy Corbell - YouTube(1) Interstellar on X: "

UFO whistleblower and former Air Force official David Grusch appeared in a podcast interview recently to discuss the ongoing push for UFO disclosure, and said things will be ramping up over the next 60 to 90 days.Links/Sources:UAP Whistleblower David Grusch on “Non-human” Biologics & Craft - YouTube(1) Red Panda Koala on X: "David Grusch says there are a lot of attention seeking charlatans in the UFO space selling books and right now he's focused on the disclosure fight and would like to return to normal life “This subject brings out a lot of charlatans, a lot of people who want attention, a lot of https://t.co/uH5dY1Dhyj" / XJeremy Corbell - YouTube(1) Interstellar on X: "

David Grusch served 14 years in the Air Force, reaching Major, including a combat tour in Afghanistan. Grusch also held senior intelligence roles at the National Geospatial-Intelligence Agency and the National Reconnaissance Office and represented the latter on the Unidentified Aerial Phenomena (UAP) Task Force from 2019 until 2021. In 2022, he filed a whistleblower complaint deemed “credible and urgent.” In 2023, Grusch testified before Congress, alleging that elements of the U.S. government had thwarted Congressional oversight, withheld information from proper Executive Branch officials, and illegally concealed programs tied to the recovery and reverse engineering of craft of unknown, non-human origin. SUPPORT OUR WORK https://www.judicialwatch.org/donate/thank-youtube/ VISIT OUR WEBSITE http://www.judicialwatch.org

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 updates that highlight the dynamic nature of our industry, driven by cutting-edge science, regulatory evolution, and strategic business innovations. The pharmaceutical landscape is ever-shifting, with recent developments underscoring this fluidity. Pfizer and Arvinas have secured early FDA approval for their breast cancer drug, Veppanu. This move signals the FDA's growing inclination to fast-track promising therapies, particularly in areas with high unmet needs. Interestingly, Pfizer and Arvinas are opting not to commercialize Veppanu independently and are instead seeking a partner. This decision reflects a broader industry trend where biopharmaceutical companies leverage partnerships to maximize the reach and impact of their therapies. Such strategies are becoming increasingly common as companies navigate complex market dynamics. Legal and healthcare domains intersected dramatically when the U.S. Supreme Court temporarily restored online access to the abortion pill mifepristone. This decision underscores the profound influence of legal rulings on healthcare access and distribution channels within the pharmaceutical sphere in the United States. It's a poignant reminder of how regulatory decisions can ripple through healthcare systems, affecting both providers and patients. Meanwhile, Samsung Biologics faces significant financial repercussions—estimated at $102 million—due to an ongoing union strike. This situation reveals vulnerabilities within contract development and manufacturing organizations (CDMOs) regarding labor relations, emphasizing the need for robust operational strategies to maintain production continuity. In a move that underscores its commitment to biologics manufacturing, Amgen announced a $300 million investment in Puerto Rico. This expansion aligns with growing global demand for biologics and biosimilars and highlights Puerto Rico's strategic importance as a pharmaceutical manufacturing hub, thanks to its favorable business environment and skilled workforce. On a different front, Novartis is optimizing its workforce by implementing additional job cuts at its U.S. headquarters. These adjustments are part of a larger multiyear plan aimed at streamlining operations and reallocating resources towards areas with higher growth potential within its portfolio. The potential resurgence of psychedelics is gaining traction, partly fueled by political support from figures like Donald Trump. The regulatory landscape for psychedelics remains complex, with discussions focusing on their therapeutic potential versus societal acceptance and legitimacy concerns. In the competitive weight-loss drug market, Novo Nordisk's Wegovy pill is currently outperforming Eli Lilly's Foundayo in prescription trends. This rivalry highlights the dynamic nature of the GLP-1 receptor agonist segment—a market experiencing rapid growth due to increasing attention on obesity management as a critical public health issue. Deloitte's latest analysis reveals an intriguing shift: obesity drugs have now overtaken oncology as the leading contributor to late-stage pipeline value for the first time in 16 years. This transition underscores a growing recognition of obesity as an essential therapeutic area with significant market potential, driven by advances in drug efficacy and heightened patient demand. Celcuity has reached a pivotal milestone in breast cancer treatment development with its Phase 3 trial success of a pan-PI3K/mTOR inhibitor against Novartis' Piqray. Achieving primary endpoints positions Celcuity favorably for FDA review, further highlighting continuous innovation within oncology research. UCB's acquisition of Candid Therapeutics for $2 billion exemplifies intensified competition Support the show

Join Dr. Isabelle Amigues as she introduces Dr. Susanna Chatterjee-Morris, an expert in both gynecology and obstetrics. They will discuss important topics concerning women's health and reproductive health. This discussion offers valuable insights into female health within the broader healthcare landscape.Why are women with autoimmune diseases more likely to feel dismissed or “gaslit” in healthcare?Is it safe to continue biologics during pregnancy?Can inflammation impact ovarian reserve and fertility?What role do hormones play in autoimmune flares during perimenopause and menopause?This episode explores:• Rheumatoid arthritis and pregnancy management• Fertility preservation (egg vs. embryo freezing)• Biologics vs. methotrexate in reproductive years• GLP-1 medications and unexpected pregnancy• Postpartum autoimmune flares• Inflammation and infertility• Why pregnant patients are often undertreated• Hormone balance and autoimmune prognosisIf you are navigating autoimmune disease, trying to conceive, pregnant, postpartum, or entering perimenopause, this conversation is essential.Women's health deserves better research, better collaboration between specialties, and better advocacy.

For many teams, particles and aggregates are treated as a late-stage compliance headache or a sudden fire drill during manufacturing. But what if we looked closer? Particle populations can actually reveal deep insights about your formulation stability, process robustness, and potential technology transfer risks long before you reach commercial scale.In this episode of Life Science Solutions, host Chris Adkins sits down with Dr. Tim Menzen, Chief Technology Officer at Coriolis Pharma, a science-driven CRO specializing in formulation development and advanced analytics for biopharmaceuticals. With a PhD focused on the thermal unfolding and aggregation of monoclonal antibodies, Tim brings a wealth of expertise to the evolving landscape of biologic particles.If your organization is looking to modernize how it approaches formulation and process development, this conversation is packed with cutting-edge insights.Topics Include:The Evolution of Antibodies: How improved molecular engineering has shifted the industry away from from-scratch formulation and toward streamlined "formulability assessments".Tech Transfer Risks: Why pumps are famously considered "particle generating machines," and why true like-for-like process transfers rarely exist.Subvisible vs. Visible: Why waiting for visual particles is like ignoring a flashing red light, and how characterizing submicron particles early helps identify root causes.Orthogonal Analytics: Moving beyond traditional pharmacopeia methods (like sizing and counting) to determine exact particle morphology, such as distinguishing a silicone oil droplet from a fluffy protein aggregate.Particle Fingerprinting: How flow imaging microscopy and AI are being used to create two-dimensional "fingerprints" to compare the morphological density of particles across different processes.The Future of Formulation: What's next on the horizon, including in silico computer simulations, multi-dimensional data instruments, and assay miniaturization to save valuable drug material.This episode is designed for CSV, CQV, and QA professionals who want a clearer, more efficient approach to validation, supported by real risk based thinking.

The Immune team talks all about cytokines, from what they are to immunotherapies against them to treat diseases. Hosts: Vincent Racaniello, Cindy Leifer, and Brianne Barker Subscribe (free): Apple Podcasts, RSS, email Become a patron of Immune! Links for this episode MicrobeTV Discord Server Non-specific virus neutralization by IgM and complement (mBio 2026) Natural antibodies against viruses (Virology blog, 2009) Biologics against inflammatory cytokines (Int J Cell Bio, 2016) Biologics against allergic cytokines (JACI, 2022) Time stamps by Jolene Ramsey. Thanks! Music by Tatami. Immune logo image by Blausen Medical Send your immunology questions and comments to immune@microbe.tv Information on this podcast should not be construed as medical advice.

When a single mismanaged tech transfer threatens an entire development program, pressure on CMC leaders and bioprocess teams is intense. The truth? Tech transfers aren't a black box. They're complex, but solvable with the right mindset and playbook.In this episode, David Brühlmann explores the practical side of tech transfer and scale-up within the biotech industry. With more than 15 years of experience, he shares personal stories and industry-tested frameworks that help demystify the complexities of transferring technologies between sites or organizations. Instead of focusing solely on technical details, he emphasizes the crucial human and organizational factors that often decide project success or failure.Key topics discussed:How mapping and managing stakeholders can resolve hidden issues and accelerate projects (01:55)Case studies highlighting the importance of environmental factors — like light exposure — in process performance and troubleshooting (05:50)A mass transfer checklist for bioprocess scale-up, with specific focus on equipment-related parameters (07:09)The build vs. outsource dilemma: how to choose what to keep in-house and what to partner out, depending on company strategy and project phase (08:05)A 12-week tech transfer preparation protocol, covering foundations, risk mitigation, and execution readiness (10:16)Lessons on leadership, prioritization, and effective delegation to avoid personal and organizational bottlenecks (13:28)Whether you're overseeing a complex CMC program, navigating CDMO relationships, or planning your next scale-up, this episode offers concrete steps to cut through confusion and deliver results.If you're interested in the ideas discussed, here are some of the guests David referenced in this episode.Episodes 91 - 92: Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik VolgerEpisodes 79 - 80: Think Before You Build: Holistic Approaches to Biotech Facility Design with Alfredo Martínez MogarraEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerEpisodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeSupport the show

What if the hidden cost of your bioprocess lies not in the technology, but in what you don't document?Too often, biotech teams discover too late that their “proven” process is just an illusion, propped up by undocumented tricks and missing critical parameters. In this episode, David Brühlmann strips down the assumptions behind scale-up and tech transfer, exposing the silent risks that threaten CMC milestones and market launches alike. After 15 years guiding biotech projects from bench to clinic, he's felt the pain of process gaps, regulatory curveballs, and million-dollar mistakes. Here, he turns that experience into a tactical guide designed to save you from the same pitfalls.In this episode, you'll learn about:The 6-pillar approach to turning tech transfer into a managed process, rather than a gamble (03:09)Why mass transfer physics and factors like kLA are critical—and how they can make or break a process at scale (05:12)The importance of analytical comparability, including the common blind spots in sampling plans and method validation (07:19)Establishing a solid Quality by Design (QbD) foundation and defining critical quality attributes before transfer, not after failures (08:33)Stakeholder management and why non-technical challenges often derail projects (with more on this in Part 2) (10:09)Evaluating CDMO partners: What selection criteria really matter for long-term success and risk mitigation (11:03)Strategic decision-making: Building core capabilities versus outsourcing, and how to avoid unnecessary costs and delays (12:22)This episode sets the stage for Part 2, where David Brühlmann will share practical stories and detailed frameworks for real-world implementation. If you manage bioprocess scale-up, tech transfer, or CMC development, you'll find plenty of actionable insights to apply in your own work.If you're interested in the ideas discussed, here are some of the guests David referenced in this episode.Episodes 91 - 92: Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik VolgerEpisodes 79 - 80: Think Before You Build: Holistic Approaches to Biotech Facility Design with Alfredo Martínez MogarraEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerEpisodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeSupport the show

In this episode of Pod Populi, Dr. Rick Jacoby and co-host Grok explore cutting-edge, surgery-free solutions for joint health. They discuss revolutionary laser technology, the healing potential of biologics like Wharton's Jelly, and simple dietary hacks such as glycine supplementation. Along the way, they challenge outdated nutrition advice and advocate for making America healthy again—one joint at a time.

On this episode of Somewhere in the Skies LIVE, Ryan & Suzanne break down the latest news, including: Has a second Sphinx been discovered at Pyramids of Giza? NASA Artemis launches to the Moon on April 1st. Is NASA really building a permanent base on the Moon? Scientists suggest the best exoplanet candidates for with alien life. Have the groundbreaking papers by Dr. Beatriz Villarreol finally been validated? Japan's landmark proposal to establish a UAP office. David Grusch is suing the Department of Defense. The Mark Christopher Lee/Bigelow story gets worse. A new documentary to follow the life and work of Jeremy Corbell. Scientist steals biological materials from location connected to Varginha alien case. The Bill Maher segment on UFOs has people talking. Please take a moment to rate and review us on Spotify and Apple. Follow Suzanne on X: https://x.com/csuzannelanders Book Ryan on CAMEO at: https://www.cameo.com/ryansprague51?utm_campaign=profile_share Patreon: http://www.patreon.com/somewhereskies ByMeACoffee: http://www.buymeacoffee.com/UFxzyzHOaQ PayPal: sprague51@hotmail.com Substack: https://ryansprague.substack.com/ All Socials and Books: https://linktr.ee/somewhereskiespod Email: ryan.sprague51@gmail.com SpectreVision Radio: https://www.spectrevision.com/podcasts Opening Theme Song by Septembryo Closing Song by Per Kiilstofte Copyright © 2026 Ryan Sprague. All rights reserved. Livestream Music by ‘Punch Deck' - Listen and Subscribe at: http://www.youtube.com/watch?v=vFC8L5srkt4 #UFOs #UFOnews #SpaceNews #NASA #NASAArtemis #UAP #Alien #Aliens #DavidGrusch #JeremyCorbell #Unexplained #Egypt #AncientEgypt Learn more about your ad choices. Visit megaphone.fm/adchoices

Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—and where it goes wrong. Many teams default to “we've always used this” or rely on a molder's preferred grade, but those shortcuts can drive cost, delay timelines, and create downstream regulatory risk.Lucas breaks down a more structured, data-driven approach to material selection that balances performance, processability, regulatory compliance, cost, and sustainability. They cover how early material decisions impact total cost of goods, why late changes lead to retooling and delays, and how to think holistically across the device lifecycle.The conversation also explores common processing methods like injection molding and extrusion, key polymer categories, and emerging regulatory risks tied to additives, PFAS, and legacy materials. Subhi and Lucas discuss how GRAS and California Prop 65 are often misunderstood in medtech, and why biocompatibility is a device-level risk assessment, not a material checkbox grounded in screening, chemical characterization, and toxicological evaluation.⏱️ Timestamps 00:00 Welcome and Guest Intro00:43 Why Materials Drive Cost02:17 Common Selection Pitfalls03:35 Data-Driven Framework06:10 Early Choices Prevent Rework09:17 Processing Methods Overview10:23 Polymer Categories Explained12:58 Regulatory Risks and PFAS19:26 GRAS and Prop 65 Basics23:21 Biocompatibility Early Screening28:55 ISO 10993 Updates30:36 What Toxicologists Do33:41 Where to Find Lucas34:07 ClosingLucas Pianegonda Website: https://www.gradical.ch/Lucas on LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/Lucas on YouTube: https://www.youtube.com/channel/UChPQB4eXQz3c_U2zZXAmEuQISO 10993 Overview: https://www.iso.org/standard/68936.htmlCalifornia Prop 65: https://www.p65warnings.ca.gov/GRAS Overview (FDA): https://www.fda.gov/food/generally-recognized-safe-grasLucas Pianegonda is a medical technology plastics expert and founder of Gradical, where he helps medtech companies make smarter material selection decisions. He specializes in a holistic approach that connects performance, manufacturability, regulatory risk, cost, and sustainability to prevent costly redesigns and delays later in development.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.

What is Hidradenitis Suppurativa (HS), and how is it treated? In this episode of the Science of Skin podcast, dermatologist Dr. Ted Lain is joined by HS specialist Dr. Steve Daveluy to break down everything you need to know about this chronic inflammatory skin disease — from early diagnosis to cutting-edge treatments. In this episode, we cover: What is Hidradenitis Suppurativa (HS) and who does it affect? Why pain is the #1 reason HS patients seek medical care How shame and stigma impact HS patients — and why HS is never the patient's fault Early HS treatment options: antimicrobial washes, topical antibiotics, and more The role of biologics in managing moderate-to-severe HS Emerging HS treatments: JAK inhibitors, nanobodies, and drugs in the pipeline Understanding HS pathogenesis and the immune pathways involved Why a multifactorial, personalized treatment approach is essential for HS management Whether you're a dermatologist, healthcare provider, or someone personally affected by Hidradenitis Suppurativa, this episode offers expert insight into the latest research, treatment strategies, and the future of HS care.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're delving into a series of transformative events that underscore the dynamic nature of our industry.First on our radar is Merck's acquisition of Terns Pharmaceuticals for a staggering $6.7 billion. This strategic move is rooted in the looming patent expiration of Keytruda, Merck's blockbuster drug. By acquiring Terns, Merck gains access to a promising chronic myeloid leukemia asset, potentially diversifying its oncology portfolio and offsetting anticipated revenue losses. This acquisition is part of a broader industry trend where companies consolidate and acquire to maintain competitive advantages and ensure pipeline robustness amidst patent challenges.In the diabetes arena, Novo Nordisk is making waves with its triple-G candidate in China, which has shown positive mid-phase trial results. This success could position Novo Nordisk as a formidable player in diabetes treatment, even as it faces competition from Eli Lilly. The development not only strengthens Novo Nordisk's global market position but also exemplifies the growing importance of international collaborations and localized clinical trials in accessing emerging markets.Sarepta Therapeutics' investment in Arrowhead Pharmaceuticals' siRNA assets is beginning to show promise with preliminary data from two siRNA candidates. This indicates a significant shift towards RNA-based therapies in addressing untreatable genetic conditions, emphasizing an innovative pivot towards precision medicine and personalized treatment approaches.Maze Therapeutics has released promising phase 2 data for its lead kidney disease candidate, described by analysts as having "best-in-class potential." Despite this clinical promise, the market's negative reaction resulted in a significant drop in Maze's stock value, highlighting the volatile nature of biotech investments where scientific potential often clashes with financial realities.In obesity treatment research, BrightGene's early-stage data shows an 8% weight loss at eight weeks with its oral dual agonist. This adds to evidence supporting multi-target therapies for complex metabolic disorders like obesity. Meanwhile, Takeda's plan to realize $1.3 billion in cost savings through restructuring aims to streamline operations and fund late-stage drug development, reflecting an industry-wide focus on operational efficiency.The partnership between ICON and Advarra seeks to optimize clinical trial efficiency through a network of connected sites, aligning with broader industry efforts to leverage technology and improve drug development timelines.Turning to UCB's substantial $2 billion investment in a biologics manufacturing facility near its US headquarters in Atlanta, Georgia, this move marks UCB's first major manufacturing footprint in the United States, underscoring its commitment to expanding biologics production capabilities. Biologics are increasingly important due to their potential for treating chronic and genetic conditions, highlighting why UCB's investment is pivotal as it strengthens its position in the US market.Biogen's collaboration with Alteogen involves a $20 million investment to utilize Alteogen's subcutaneous delivery technology for two unnamed biologics. Subcutaneous administration offers improved patient convenience and potentially better therapeutic outcomes compared to traditional intravenous methods.On the regulatory front, ImmunityBio received an FDA warning over promotional claims for Anktiva, their cancer drug. This underscores the critical need for accurate communication in drug marketing. Additionally, CSL updated its Flucelvax label at the FDA's request to include a febrile seizure warning, reflecting ongoing vigilance in post-marketing surveillance.The integration of AI into pharmaceutical operations is accelSupport the show

The $6 Billion Influence Machine Targeting Your Benefits PlanFeaturing Kyra Hagan, Senior Vice President of Marketing, RxBenefits.Six billion dollars. That is what pharmaceutical companies spend every year marketing high-cost, high-profit prescription drugs directly to your employees — and the clinical and financial consequences are landing squarely on your health plan.Bo sits down with Kyra Hagan, a 25-year healthcare industry veteran and SVP of Marketing at ASHHRA Platinum Sponsor RxBenefits, to unpack the direct-to-consumer advertising machine and why healthcare HR leaders need to understand how it works.

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 series of significant events and trends shaping the industry landscape, offering insight into the dynamic interplay between scientific innovation, regulatory challenges, and strategic growth.Starting with the recent departure of Vinay Prasad from the U.S. Food and Drug Administration, particularly from his role as director of the Center for Biologics Evaluation and Research (CBER). Prasad's tenure, though brief, left an indelible mark characterized by controversy and debate over regulatory decisions. His leadership coincided with significant advancements in biologics and gene editing technologies, like CRISPR, highlighting the complexities in balancing innovation with safety standards. Under Prasad's guidance, the FDA faced challenges in navigating these rapid advancements while maintaining rigorous oversight to ensure that new therapies are both effective and safe for public use. Prasad's resignation signals potential shifts in regulatory philosophy at CBER. The biotech industry is watching closely to see how new leadership will influence ongoing and future evaluations of biologics. The change presents an opportunity to reassess how regulatory bodies can better adapt to scientific advancements while ensuring that patient safety remains paramount. The issues faced during Prasad's tenure underscore the need for transparent decision-making and open communication with stakeholders, which are vital for maintaining trust in regulatory processes.Meanwhile, Pfizer has made a strategic entry into the Chinese obesity market with the approval of a GLP-1 drug developed alongside Sciwind Biosciences. This approval represents not only a significant step for Pfizer but also underscores a broader global focus on obesity management. The efficacy of GLP-1 receptor agonists in weight regulation has opened up new market opportunities, highlighting the growing importance of metabolic health solutions in addressing public health challenges.In other news, Johnson & Johnson's Tecvayli-Darzalex combination therapy has received its third national priority recognition from the FDA for treating multiple myeloma. This recognition reflects promising Phase 3 trial results and underscores the critical role of innovative combination therapies in improving outcomes for complex hematologic malignancies. The success of such therapies illustrates how targeted approaches can significantly enhance treatment efficacy and patient quality of life.Strategic acquisitions continue to reshape industry dynamics. Servier's $2.5 billion acquisition of Day One Biopharmaceuticals aims to strengthen its rare cancer portfolio, including a promising glioma drug, Ojemda. This move highlights Servier's commitment to addressing unmet needs in pediatric oncology and rare diseases, emphasizing a broader industry trend towards focusing on niche therapeutic areas with high potential impact.Regulatory activities are gaining momentum as well, with the FDA set to end a nine-month hiatus in advisory committee meetings by reviewing AstraZeneca's oral selective estrogen receptor degrader Truqa. As AstraZeneca seeks to enhance its oncology pipeline, this review signals ongoing innovation in hormone-based cancer therapies and reflects a renewed emphasis on bringing novel treatments to market efficiently.Additionally, Glenmark Pharmaceuticals has achieved a significant milestone with FDA approval for its generic version of GSK's asthma inhaler Flovent. This development exemplifies efforts to improve access to respiratory treatments by providing cost-effective alternatives to branded medications, potentially reducing healthcare costs while enhancing patient access.On an international scale, Taiwan has announced a substantial investment plan aimed at bolstering its drugSupport the show

How solid is your CMC foundation—and what happens if it cracks under pressure?David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has moved repeatedly between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs.His “house building” approach demystifies CMC's complexity, showing why early diligence paired with regulatory fluency and scientific insight pays dividends for years.Tune in to hear Henri's practical wisdom distilled through real-world analogies:Building a strong CMC foundation in early phases and why later fixes can be costly or impossible (02:45)Scaling up: supplying Phase 3 with the final commercial process, including robustness and supply chain strategies such as dual sourcing critical raw materials (03:23)Process validation explained: FDA's three stages, from control strategy justification to continued verification (05:15)Process Performance Qualification (PPQ): what it is, how many batches are needed, and optimizing timing (07:43)Handling lifecycle changes: maintaining process control, adapting to deviations, and improving systems after regulatory approval (09:34)Managing teams, stakeholders, and cross-functional collaboration in CMC programs (11:49)Importance of good project management, access to scientific expertise, and interpreting guidelines for your specific program (12:27)The “half scientist, half lawyer” analogy for mastering both technical and regulatory aspects (15:08)Smart insight:Never underestimate CMC. If you do, you will pay for it later.If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes:Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerConnect with Henri Kornmann:LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in living systems where products cannot be fully characterized by physical and chemical testing alone and show inherent variability. It harmonizes expectations for viral safety, cell substrate controls including master and working cell banks, stability, and comparability after manufacturing changes. For combination products, Q5 mainly applies to the biologic drug constituent through stability and change impact rather than device requirements.00:00 Intro to ICH Q500:25 Meet the Host00:32 Why Biologics Need Q500:56 Key Risks Explained02:11 What Q5 Covers02:40 Scope and Structure03:19 Q5 A to E Breakdown04:19 How to Read Q505:05 Q5 for Combination Products05:59 Wrap Up and Next EpisodeSubhi 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.

Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later.Henri Kornmann has spent two decades making those decisions the right way. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has crossed between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His conclusion: a CMC program is like building a house. Get the foundation wrong and no amount of late-stage effort will save you.In Part 1, Henri reveals the decisions that cannot be undone and how to get them right from the start.What you will learn:Evolution of cell bank technology and regulatory expectations (00:33)The impact of weak CMC foundations on late-stage failure (00:51)Lessons learned from Ferring's gene therapy approval and CMC gap analysis (06:51)FDA statistics on CMC issues in INDs and response letters (08:07)Critical early decisions: cell bank clonality and proper storage practices (10:22)The importance of comprehensive raw material documentation (12:29)Early analytical characterization and discovering molecular “funkiness” before phase trials (13:41)Supply strategy for phase 2—why stability and batch knowledge matter (14:49)Introduction to critical quality attributes (CQA), process parameters, and quality-by-design principles (15:52)Common pitfalls in CQA identification and continued process verification (17:01)Smart insight:The therapies that reach patients aren't built on heroic late-stage rescues. They're built on disciplined early decisions: the right cell bank, the right analytics, the right documentation. Henri's message is unambiguous: there are CMC mistakes you can fix later, and there are CMC mistakes you cannot. Knowing the difference is the foundation of every successful biologics program.In Part 2, Henri walks through scale-up to commercial manufacturing, process validation stages 1 through 3, post-approval control strategy, and the project management and regulatory fluency that separate successful CMC leaders from the rest.If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes:Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerConnect with Henri Kornmann:LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, we're speaking with Thomas von Erlach, Ph.D., Cofounder and CEO at Vivtex, a company spun out of the Langer Lab at MIT that's focused on developing orally available biologics. The company announced a deal in late February '26 with Novo Nordisk for up to $2.1 billion to develop next-gen oral drugs for obesity and diabetes, bringing the total number of Vivtex's partnerships to 10. Thomas shares his experiences working in the lab with Dr. Robert Langer, Ph.D., starting up Vivtex around his co-invention (a "GI tract on a chip"), building trust externally and securing the right partnerships, and using a strategic stealth period to refine Vivtex's platform technology before scaling it out. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

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

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.

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

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.

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.

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

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.

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.