Making Medicine

🇺🇸 Venture capital helped build America's biotech industry, but what happens when that capital stops flowing?In Episode 5 of the How America Makes Medicine series, John Stanford sits down with Michael Rome, Managing Director and Head of Therapeutics Investing at Foresite Capital, to explore the role of biotech venture capital in building America's drug development ecosystem.The episode examines the history of venture capital and biotech investing, tracing how America's unique approach to financing high-risk science helped transform academic discoveries into companies and, ultimately, new medicines. From early investment models to the rise of venture-backed biotechnology companies, the history reveals how investors began taking risks on scientific ideas that traditional pharmaceutical companies were often unwilling or unable to pursue.John and Michael then explore how biotech investors evaluate companies, scientific opportunities, and emerging drug-development technologies today. Their conversation covers early-stage biotech investing, specialist versus generalist investors, biotech IPOs, mergers and acquisitions, capital formation, and the role investors play in determining which scientific ideas move from the laboratory into clinical development.The discussion also examines how drug pricing policy, FDA policy, government regulation, and uncertainty in Washington can influence investment decisions and the availability of capital for emerging biotech companies. John and Michael discuss the importance of maintaining a strong U.S. innovation ecosystem as biotechnology becomes increasingly global, including competition for scientific talent, investment, and drug development between the United States and China.What happens to American drug development if investors become less willing to take scientific risks?We explore🔹 The history of venture capital and American biotech innovation🔹 Michael Rome and the role of therapeutics investing🔹 How venture capital helps fund scientific discovery🔹 Biotech startups and early-stage drug development🔹 How investors evaluate biotech companies and scientific opportunities🔹 Specialist versus generalist biotech investors🔹 Biotech IPOs, mergers and acquisitions🔹 Capital formation and the future of biotech investment🔹 Drug pricing policy and its impact on biotech investment🔹 FDA policy, government regulation and investment uncertainty🔹 America's biotechnology ecosystem and global competitiveness🔹 Competition for scientific talent, investment and innovation🔹 The role of venture capital in bringing new medicines to patientsThis episode is part of How America Makes Medicine, a seven-part series exploring the people, science, institutions, and business decisions behind 250 years of American pharmaceutical innovation.From research universities and biotechnology startups to pharmaceutical manufacturers, investors, regulators and patients, the series examines how America's medicine ecosystem was built and what it will take to keep innovating.Join the Conversation⬇️What do you think is the biggest challenge facing biotech investors today?How important is venture capital to developing the next generation of medicines?Can the United States maintain its leadership in biotech as global competition increases?Drop your thoughts in the comments below👇👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part series celebrating 250 years of American pharmaceutical innovation.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps00:00 Introduction: Venture Capital and the Drug Development Pipeline01:36 Headlines: mRNA Cancer Vaccine and the FDA05:15 History: How Venture Capital Became Part of Medicine07:29 Genentech and the Birth of Venture-Backed Biotech09:30 Michael Rome's Path from Scientist to Biotech Investor 12:40 Why Los Angeles Is Emerging as a Biotech Hub 13:32 Inside Foresight Capital's Biotech Investment Strategy16:00 A Day in the Life of a Biotech VC19:15 Don't Chase the Headlines: How Investors Evaluate Biotech Data21:30 Specialist vs. Generalist Capital in Biotech24:51 What Happens to Medicine Without Venture Capital?27:15 Washington's Growing Influence on Biotech Investment30:44 The IRA and the "Pill Penalty"33:00 China, Biotech Licensing, and Bringing Innovation to the U.S.36:53 How Biotech Capital Gets Recycled in America39:16 Inside a $2 Billion Biotech Exit43:46 Closing: The Day in the Life of a VCDISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #HowAmericaMakesMedicine #biotech #venturecapital #drugdevelopment #pharmaceuticalinnovation

🇺🇸 Why does so much pharmaceutical innovation come from small biotech companies? And how do different parts of America's medicine ecosystem work together to turn scientific discoveries into medicines for patients?In this episode of How America Makes Medicine, John Stanford sits down with Dr. Jeremy Levin, a longtime pharmaceutical and biotechnology leader, to explore the interconnected ecosystem behind American drug innovation and the complementary roles of small biotech companies and larger pharmaceutical manufacturers.Levin's career includes leadership roles at Novartis, Bristol-Myers Squibb, Teva Pharmaceuticals, and Ovid Therapeutics. He also discusses the "String of Pearls" strategy, a targeted approach to acquisitions and partnerships designed to strengthen pharmaceutical pipelines and advance promising innovations.The conversation examines why small biotech companies are an important source of innovation, while larger pharmaceutical manufacturers contribute scientific expertise, capital, manufacturing capabilities, regulatory experience and global infrastructure. Together, these different strengths help move discoveries from research and development toward patients.The episode also explores drug pricing policy, Most Favored Nation pricing, the Inflation Reduction Act, venture capital, pharmaceutical regulation and biotech investment, including how policy uncertainty can affect the development of future medicines.Levin also discusses China's growing biotechnology capabilities and America's global innovation advantage, arguing that the United States must continue strengthening its research infrastructure, technical expertise and investment environment to remain a leader in biotechnology and drug development.We explore:🔹 Small biotech and pharmaceutical innovation🔹 Small biotech and larger pharmaceutical manufacturers🔹 Jeremy Levin and the "String of Pearls" strategy🔹 Bristol-Myers Squibb and biotech acquisitions🔹 Drug discovery and development🔹 Venture capital and biotech investment🔹 Drug pricing and pharmaceutical policy🔹 Most Favored Nation pricing and the Inflation Reduction Act🔹 NIH, FDA and America's research ecosystem🔹China's growing role in biotechnology🔹 America's global biotechnology advantage🔹 Innovation, investment and patient accessHow America Makes Medicine is a seven-part series exploring the people, science, institutions and business decisions behind 250 years of American pharmaceutical innovation.From research universities and biotechnology startups to pharmaceutical manufacturers, investors, regulators and patients, the series examines how America's medicine ecosystem was built and what it will take to keep innovating.Technical note: Near the end of the episode, Dr. Levin loses his internet connection and continues the conversation by phone. His video is temporarily replaced with a still image while the conversation continues.Watch the full episode and let us know your thoughts below ⬇️What role should small biotech companies play in America's future drug-development strategy?Can the United States maintain its biotechnology advantage as global competition increases?Drop your thoughts in the comments below 👇👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps00:00 Jeremy Levin and America's Biotech Innovation Engine00:38 Jeremy Levin's Career in Pharmaceutical Innovation03:04 The "String of Pearls" Strategy05:37 The Birth of America's Biotechnology Industry07:19 Why Patients Drive Drug Development11:56 How Biotech Acquisitions Strengthen Drug Pipelines16:20 Small Biotech and Larger Pharmaceutical Manufacturers20:20 Why Small Biotech Drives Drug Innovation21:43 Drug Pricing, Policy and Biotech Investment28:10 How Policy Uncertainty Affects Drug Development38:35 Biotech in the Balance: America's Innovation Advantage40:57 NIH, FDA and America's Research Ecosystem42:20 China and the Global Biotechnology Race46:58 Protectionism and the Future of Innovation49:09 How America Can Compete Through Innovation50:44 The Football Analogy: Who Will Win?DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.  #HowAmericaMakesMedicine #MakingMedicine #biotech #drugdevelopment #pharmaceuticalinnovation #lifesciences #medicalinnovation #biotechnology

🇺🇸 Every breakthrough medicine begins with a scientific discovery. But turning that discovery into a *treatment* that reaches patients*requires navigating one of the most challenging journeys in medicine.Before a new therapy can change lives, promising science must attract funding, become a startup company, navigate years of development, survive the *"Valley of Death,"* scale manufacturing, and ultimately secure the support of larger pharmaceutical companies capable of bringing lifesaving treatments to patients around the world.In Episode 3 of How America Makes Medicine, John Stanford sits down with Sheila Mikhail, serial biotech entrepreneur and co-founder of AskBio, Bamboo Therapeutics, Chatham Therapeutics, and M34, to explore what it really takes to build a biotech company from groundbreaking science. Drawing from decades of experience gene therapy, Sheila shares how perseverance, early-stage investment, scientific innovation, and smart partnerships help move promising discoveries from university laboratories to patients.We explore:🔹 The real journey from scientific discovery to approved medicine🔹 Why the "Valley of Death" threatens breakthrough innovations🔹 How SBIR funding helps launch biotech startups🔹 Why early-stage companies eventually partner with Big Pharma🔹 The future of gene therapy and Alzheimer's research🔹 Manufacturing innovation and lowering the cost of advanced medicines🔹 America's biotechnology ecosystem and global competition🔹 How AI could transform drug developmentOne of the conversation's strongest themes is that great science alone is never enough. Every successful medicine requires scientists, entrepreneurs, investors, regulators, and pharmaceutical companies working together to move discoveries from the laboratory to patients.This episode is part of How America Makes Medicine, a special editorial series from the Making Medicine Podcast exploring the people, policies, discoveries, and innovations shaping the future of American medicine.Watch the full episode and let us know your thoughts below ⬇️Why do you think so many promising medical discoveries never become medicines?Should America invest more in early-stage biotechnology?What breakthrough technology will define the next generation of medicine?Drop your thoughts in the comments below 👇👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps00:00 Patients Don't Care Where Medicine Comes From00:35 Why Every Medical Breakthrough Needs an Entrepreneur01:54 The Bayh-Dole Act and the Birth of Modern Biotech04:40 How AskBio Was Founded07:05 Betting on Gene Therapy Before Anyone Else11:10 Building Biotech Companies Without Venture Capital16:30 Why SBIR Funding Saves Medical Innovation19:10 Is China Winning the Biotech Race?24:20 Lower Drug Costs Through Better Innovation26:10 AI, Gene Therapy & the Future of Drug Development34:00 Making Gene Therapies Affordable Worldwide39:10 When Should a Startup Partner With Big Pharma?43:40 Lessons From Selling AskBio to Bayer50:15 AI, Innovation & The Next Generation of MedicineDISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#HowAmericaMakesMedicine #biotech #genetherapy #drugdiscovery #medicalinnovation #healthcarepolicy #sbir #biotechnology #pharmaceuticalinnovation #innovation 

🇺🇸 Every breakthrough medicine starts somewhere. Discover how research universities, NIH funding, and American innovation change lives.Every new medicine’s journey begins long before it reaches a patient. In Episode 2 of our How America Makes Medicine series, John Stanford sits down with Kate Hudson of the Association of American Universities (AAU) to explain why research universities are one of America's greatest strategic advantages.From federally funded NIH research to technology transfer, startups, biotechnology companies, and ultimately life-saving medicines, this conversation reveals the innovation pipeline that has powered American pharmaceutical leadership for generations.The discussion explores why curiosity-driven research matters, how the Bayh-Dole Act transformed commercialization and why America faces increasing competition from China in scientific research and biotechnology.Whether you're interested in biotech, healthcare policy, drug discovery, academic research, or the future of American competitiveness, this episode explains why basic research remains one of the country's most important long-term investments.Topics include:🔹 NIH and NSF research funding🔹 Research universities and scientific discovery🔹 Technology transfer and commercialization🔹 Drug discovery and pharmaceutical innovation🔹 Bayh-Dole Act🔹 mRNA vaccines🔹 Basic research versus applied research🔹 America's biotechnology ecosystem🔹 Competition with China🔹 The future of scientific innovationThis episode is part of How America Makes Medicine, a seven-part series celebrating 250 years of American pharmaceutical innovation.If you're passionate about biotechnology, pharmaceutical innovation, healthcare policy, scientific discovery, or the history of medicine, subscribe to the Making Medicine Podcast and follow How America Makes Medicine as we continue telling the story behind the medicines that have shaped our world.Watch the full episode and let us know your thoughts below ⬇️Why should taxpayers invest in basic scientific research?Is America doing enough to maintain leadership in biotechnology?What breakthrough medicine do you think will define the next 25 years?Drop your thoughts in the comments below 👇👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:00:00 Why Research Universities Matter to American Pharmaceutical Innovation01:28 Meet Kate Hudson of the Association of American Universities04:20 The History of America's Research Universities08:32 Why Universities Drive Scientific Discovery10:42 NIH Funding, NSF Grants & Basic Research Explained14:09 Why the Free Market Alone Won't Create Medical Breakthroughs16:05 mRNA Vaccines Took Decades of Research18:55 The True Return on Investment in Scientific Research21:18 Why Scientific Talent Matters More Than Ever24:10 OMB Proposal, NIH Grants & Research Stability29:20 Why Uncertainty Slows Drug Discovery33:12 Technology Transfer & How Universities Create Biotech Startups35:40 Crossing the Valley of Death in Drug Development38:10 Bayh-Dole, China & America's Innovation Advantage41:58 Episode Wrap Up & Next Episode Preview DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #HowAmericaMakesMedicine #biotech #drugdiscovery #ResearchUniversities #innovation #healthcarepolicy #science #pharmaceuticalinnovation #technologytransfer

🇺🇸 How America Makes Medicine begins with the remarkable story of 250 years of American pharmaceutical innovation.Welcome to How America Makes Medicine, a new seven-part series from the Making Medicine Podcast celebrating 250 years of American pharmaceutical innovation. As the United States celebrates its *250th anniversary, this inaugural episode of the series traces the extraordinary journey from the medicine chest of 1776 to today's breakthrough therapies. Throughout How America Makes Medicine, we'll explore the discoveries, scientists, entrepreneurs, manufacturers, regulators, and patients who transformed medicine from simple remedies into one of humanity's greatest achievements.Part I of How America Makes Medicine follows some of the most significant milestones in pharmaceutical history, from the commercialization of insulin and the biotechnology revolution to monoclonal antibodies, HIV therapies, precision medicine, the Human Genome Project, gene therapy, and mRNA vaccines. Along the way, we examine why manufacturing, scientific collaboration, and decades of research are just as important as the discoveries themselves in bringing new medicines to patients. This episode covers🔹 How insulin changed diabetes from a fatal diagnosis into a manageable disease🔹 The biotechnology revolution and recombinant DNA🔹 The birth of modern biotech🔹 Monoclonal antibodies and targeted medicine🔹 HIV therapies and one of medicine's greatest public health successes🔹 The Human Genome Project and precision medicine🔹 Gene therapy and cell therapy🔹 The decades of research behind mRNA vaccines🔹 Why manufacturing, regulation, and scientific collaboration remain essential to the next generation of medical breakthroughsThroughout How America Makes Medicine, we explore not only breakthrough discoveries but also the people, companies, manufacturers, researchers, regulators, and patients who made those discoveries possible. This seven-part documentary series celebrates 250 years of American pharmaceutical innovation and highlights how curiosity, entrepreneurship, manufacturing excellence, and scientific persistence continue to improve lives around the world.If you're passionate about biotechnology, pharmaceutical innovation, healthcare policy, scientific discovery, or the history of medicine, subscribe to the Making Medicine Podcast and follow How America Makes Medicine as we continue telling the story behind the medicines that have shaped our world.Catch the full episode and Join the Conversation ⬇️Which medical breakthrough do you think has had the greatest impact on humanity?What innovation do you believe will define the next generation of medicine?Which chapter of pharmaceutical history would you like us to explore in a future episode?Drop your thoughts in the comments below 👇 👍 Subscribe to the Making Medicine Podcast so you don't miss the next chapter of How America Makes Medicine, our seven-part documentary series celebrating 250 years of American pharmaceutical innovation.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 250 Years of American Pharmaceutical Innovation | Introduction 0:52 Benjamin Rush & Colonial Medicine | America's First Medical Innovator 2:32 American Apothecaries to Modern Drug Manufacturing 4:05 The U.S. Patent System & Pharmaceutical Innovation 5:06 FDA History | Frances Kelsey, Drug Safety & Public Trust 6:23 Eli Lilly, Insulin & the Birth of Modern Pharmaceutical Manufacturing8:53 The Biotechnology Revolution | Recombinant DNA & Genentech11:32 Monoclonal Antibodies, HIV Therapies & Modern Biopharmaceuticals13:15 The Human Genome Project, Precision Medicine & Gene Therapy14:45 mRNA Vaccines | Why Medical Breakthroughs Take Decades16:08 The Five Pillars of American Pharmaceutical Innovation17:35 Clinical Trials, Patients & The Next 250 Years of Medicine19:40 How America Makes Medicine | Episode 2 Preview & SubscribeDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #HowAmericaMakesMedicine #pharmaceuticalinnovation #biotechnology #healthcareinnovation #humangenomeproject

🇺🇸 FDA leadership, China's growing role in clinical trials, NIH research, and biotechnology innovation are shaping the future of American medicine.This week on the Making Medicine Podcast, John Stanford breaks down the latest developments in the search for the next FDA Commissioner, including the three reported finalists: Dr. Heidi Overton, White House health policy adviser; Dr. Jeffrey Vacirca, oncologist and CEO of New York Cancer & Blood Specialists; and Dr. Stephen Ferrara, Deputy Assistant Secretary of Defense for Health Affairs and former CIA Chief Medical Officer. John explores what the next FDA leader could mean for regulatory modernization, drug development, and the future of American biotechnology.This episode covers:🔹 The latest FDA Commissioner search and what the three finalists could mean for the agency🔹 Congressional hearings on FDA modernization and biomedical innovation🔹 China's rapid expansion in global clinical trials and growing biotech competitiveness🔹 Patent eligibility reform, intellectual property protections, and the future of biotech investment🔹 NIH research funding, research security, and protecting American scientific leadership🔹 FDA Approvals Corner featuring new therapies from Rigel Pharmaceuticals, BeOne Medicines, AstraZeneca, Gilead Sciences, AbbVie, Haisco Pharmaceutical Group, Shionogi, Wockhardt, Bayer, GSK, and Viridian TherapeuticsFrom FDA leadership and congressional hearings to intellectual property, research security, and global competition with China, this episode examines the policy decisions shaping the future of biomedical innovation. John also highlights why protecting NIH-funded research, modernizing the FDA, and strengthening America's innovation ecosystem remain essential to delivering the next generation of medicines and improving patient access.The episode concludes with another edition of FDA Approvals Corner, celebrating newly approved therapies across oncology, infectious disease, cardiovascular medicine, rare diseases, anesthesia, and diagnostic imaging, highlighting the continued progress being made for patients around the world.Watch the full episode and Join the Conversation ⬇️Who should lead the FDA?How should America compete with China's growing biotech industry?What role should NIH-funded research play in future drug development?Drop your thoughts in the comments below 👇👍 Like and subscribe for more conversations on biotechnology, healthcare policy, FDA news, clinical trials, pharmaceutical innovation, and life sciences.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:00:00 Why American Biotech Matters01:35 FDA Leadership Search03:14 FDA & China Hearings05:13 Clinical Trial Competition06:25 Patent Reform Explained07:52 NIH Research Security08:58 Why NIH Funding Matters09:19 FDA Approvals Corner11:32 July FDA OutlookDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#fda #biotech #healthcarepolicy #clinicaltrials #NIH

Japan's biotech industry is at a crossroads. Drug pricing reform, clinical trials, venture capital investment, and life sciences policy are all in flux as the country tries to figure out its path forward. This week on the Making Medicine Podcast, guest host John Guy, Incubate's Policy Director, is joined by John Gutierrez of Ascenta Capital and Josh Lipscomb, Incubate’s International Programs Manager, to recap their recent biotechnology delegation to Japan. After meeting with government officials, investors, startup founders, and policymakers across Tokyo, they discuss the challenges Japan faces in strengthening its biotech ecosystem and the open question of whether pharmaceuticals can become a bigger driver of economic growth.This episode covers 🔹 Japan's biotech growth strategy — and its limitations 🔹 Drug pricing reform and the slow pace of pharmaceutical innovation🔹 Drug lag and ongoing barriers to patient access🔹 International clinical trials and the difficulty of attracting startup investment🔹 Venture capital gaps in Japan's life sciences ecosystem🔹 Takeaways from the BIO International ConventionOne of the takeaways is that Japan has moved past simply acknowledging its biotech challenges and has started attempting policy reforms. The discussion explores whether changes to drug pricing, international clinical trial access, startup support, and venture capital could meaningfully accelerate innovation, or whether structural hurdles will continue to slow patient access to new medicines.The conversation also touches on Japan's presence at the BIO International Convention, where government leaders, investors, and entrepreneurs made the case for the country as a destination for biotech investment — even as it continues to compete with more established markets. As global competition for innovation intensifies, it remains to be seen how much ground Japan can gain in the future of drug development.Watch the full episode and Join the Conversation ⬇️Can Japan become one of the world's leading biotech ecosystems?Is drug pricing reform the key to attracting more biotech investment?What lessons can other countries learn from Japan's approach to life sciences innovation?Drop your thoughts in the comments below 👇  👍 Like and subscribe for more conversations on biotechnology, healthcare policy, drug pricing, venture capital, clinical trials, pharmaceutical innovation, and global life sciences.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTmestamps00:00 Japan Drug Lag Explained 01:45 Japan's Biotech Growth Strategy06:10 Drug Pricing Reform08:24 Why Japan Misses New Medicines11:42 Japan's Innovation Advantage13:35 Building Japan's Startup Ecosystem14:42 BIO International Convention16:28 Japan's Global Investment Strategy19:00 What's Next for Japan Biotech22:44 OutroDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#biotech #Japan #DrugDevelopment #ClinicalTrials #HealthcarePolicy #Making Medicine

Georgia's life sciences industry is growing fast. Biotech manufacturing, clinical trials, workforce development, and healthcare policy are reshaping America's innovation economy.This week on the Making Medicine Podcast, John Stanford sits down with Maria Thacker Goethe, President and CEO of Georgia Life Sciences, to discuss why Georgia has become one of the fastest-growing biotechnology hubs in the United States and what it will take to keep America globally competitive.Fresh off the BIO International Convention, Maria shares how policy conversations have evolved from niche discussions to a central focus for biotech leaders. From clinical trial modernization and manufacturing investments to workforce shortages, drug pricing, and China's expanding biotechnology capabilities, she explains why policy decisions now directly influence innovation, investment, and patient access.This episode covers:🔹 Georgia's rise as a national life sciences and biomanufacturing hub🔹 Why workforce development has become biotech's biggest challenge🔹How universities, industry, and government are building the next generation of talent 🔹China's growing influence in biotechnology and global drug development🔹Drug pricing, innovation, and protecting investment in breakthrough medicines🔹 Operation Trial Blazer and the future of faster clinical trials🔹Why collaboration remains America's greatest competitive advantageOne of the biggest takeaways is that biotechnology is no longer just about scientific discovery. It's about building an ecosystem where policy, workforce, capital, manufacturing, and research all work together. Maria explains why states like Georgia are proving that biotech leadership isn't limited to Boston or San Diego, and why strategic investments in people and infrastructure will determine America's future competitiveness.Whether discussing clinical trial reform, rare disease innovation, or the balance between national security and global scientific collaboration, this conversation highlights how today's policy decisions will shape tomorrow's medical breakthroughs.Watch the full episode and Join the Conversation ⬇️Can Georgia become one of America's top biotech hubs?What is the biggest challenge facing US biotech today: workforce, capital, or policy?Should America focus more on innovation than restrictions to stay globally competitive?Drop your thoughts in the comments below 👇 👍 Like and subscribe for more conversations on biotechnology, healthcare policy, FDA modernization, clinical trials, workforce development, drug pricing, life sciences investment, and healthcare innovation.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps00:00 Operation Trial Blazer & US Clinical Trials05:01 BIO 2026 and US Biotech Competitiveness08:46 Georgia's Life Sciences Growth 12:07 Building the Next Biotech Hub18:15 Drug Pricing and Biotech Innovation 21:29 Operation Trial Blazer Reforms22:11 China and US Biotech Competition 26:18 Biotech Workforce Development30:06 Why Biotech Needs Skilled Trades33:21 Georgia Life Sciences Summit35:42 Closing ThoughtsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#biotech #lifesciences #healthcarepolicy #clinicaltrials #drugdevelopment

FDA instability is reshaping biotech investment decisions in real time. Investors are recalibrating risk, pulling back, and even shifting capital abroad.In case you missed it: We are bringing one of our most critical recent conversations to unpack how regulatory uncertainty is shifting the future of medicine. FDA instability is reshaping biotech investment decisions in real time. Across the board, investors are recalibrating risk, pulling back on funding, and even shifting capital abroad.In this episode of the Making Medicine Podcast, John Stanford is joined by Rachel Sher of Manatt Health to unpack new, original research conducted with investors across the biotech ecosystem. The goal was simple: move beyond speculation and understand whether recent leadership changes, staffing cuts, and policy uncertainty at the FDA are actually dictating investor behavior.The signal is clear. Across venture capital, public equity, private equity, and industry investors, the vast majority agree that recent changes at the FDA have fundamentally altered how they allocate capital and view the attractiveness of U.S.-based drug development.This Episode Covers Four Major Themes:🔹 Regulatory Instability: Growing investor concern over shifting FDA standards.🔹 Shifting Portfolios: A reduced appetite for funding complex product categories like gene therapy and vaccines.🔹 Global Competition: Increasing attention and capital flowing toward China and other international markets.🔹 The Innovation Pipeline: Broader fears that instability across agencies like the NIH and FDA will weaken long-term medical breakthroughs.At the center of it all is one core issue: regulatory predictability. When investors lose confidence in policy clarity and institutional knowledge, the consequences extend far beyond individual companies—they dictate where innovation happens next.Even with these concerns, investors still want to back innovation in the United States. The question is whether policymakers and regulators can restore the stability and trust that made the U.S. the global leader in biotech in the first place.Watch for a grounded conversation on what investors are really saying, what it means for the biotech ecosystem, and why FDA predictability matters more than ever. Check out the full report https://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investmentJoin the Conversation ⬇️Do you think FDA instability is already changing the future of biotech investment?Are investors right to look abroad when U.S. regulatory signals become less predictable?What matters more right now: speed, stability, or scientific consistency?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true👍 Like and subscribe for more biotech and healthcare policy coverage.Time Stamps00:00 Intro & Disclaimer00:16 Investors Say FDA Changes Are Impacting Decisions03:22 How We Surveyed Investors (Research Design)07:27 Theme 1: FDA Instability & Investor Uncertainty10:22 Investors Repricing Risk in Biotech12:05 “Chaos Is the Only Thing” – Investor Quote13:00 Theme 2: Pullback from Gene Therapy, Vaccines, Oncology14:28 Theme 3: Capital Shifting Abroad (China & Competition)17:02 Theme 4: NIH Cuts & Long-Term Innovation Risk25:24 Key Takeaway: Regulatory Predictability Drives InvestmentDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#Biotech #FDA #BiotechInvesting #HealthcarePolicy #DrugDevelopment #makingmedicine

China's biotech innovation is accelerating. Clinical trials, NIH funding, and global competition are reshaping healthcare. Biocom’s President & CEO Tim Scott explains why America should focus on "playing to win" rather than "playing not to lose."China’s biotech industry is moving faster than many policymakers realize. From investigator-initiated clinical trials and massive patient registries to government-backed investment strategies, China is rapidly becoming a major force in global drug development. This week on the Making Medicine Podcast, John Stanford sits down with Tim, fresh off a biotech delegation trip to Shanghai. He shares firsthand observations from China's rapidly growing life sciences ecosystem, what surprised him most, and what American biotech leaders should learn from the experience.This Episode Covers🔹 Why major pharmaceutical companies are increasingly sourcing innovation from China🔹 How China’s investigator-initiated trial system accelerates drug development🔹 The role of patient registries and trial-ready cohorts🔹 Why China is becoming a global biotech powerhouse🔹 The debate over biosecurity, protectionism, and global scientific collaboration🔹 NIH funding, workforce development, and America’s innovation advantage🔹 How the United States can remain the world leader in biotechnologyOne of the most thought-provoking moments comes when Tim compares the biotech race to the New York Knicks' championship run, arguing that America must focus on "playing to win" through investment, innovation, NIH funding, and scientific leadership rather than simply "playing not to lose" by slowing competitors down. The analogy becomes a powerful framework for understanding the choices facing US policymakers as China continues to expand its role in global drug development.The conversation ultimately challenges listeners to think beyond today's headlines and consider how the United States can maintain its leadership in biotechnology while continuing to deliver breakthrough medicines for patients around the world.The question is no longer whether China matters in biotech. The question is how America responds.Will the US continue playing to win through investment and innovation, or will it focus primarily on slowing competitors down?Watch the full episode and Join the Conversation ⬇️Do you believe China is now a permanent biotech superpower?Can the United States maintain its leadership in biomedical innovation?Should scientific collaboration continue despite growing geopolitical tensions?Let us know your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true👍 Like and subscribe for more biotech and healthcare policy coverage.Timestamps00:00 China Biotech Competition01:00 California Life Sciences Leadership07:45 Pharma Licensing Deals in China13:10 China Clinical Trials Explained20:00 Drug Pricing and Biotech Innovation23:18 Shanghai Biotech Ecosystem25:28 China's Biotechnology Growth Strategy35:28 Biosecurity and US-China Biotech Policy40:20 Playing to Win in Biotech42:10 Knicks Analogy and Innovation Leadership43:20 NIH Funding and American Innovation47:35 AI, China and the Future of Biotechnology49:58 Outro DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#Biotech #China #DrugDevelopment #ClinicalTrials #HealthcarePolicy

Rare diseases. Patient advocacy. Drug development. FDA partnerships. Clinical trials.Patient organizations have evolved into powerful engines of drug development, building registries, funding research, shaping clinical trial design, and partnering with regulators to accelerate new treatments.This week on the Making Medicine Podcast, John Stanford sits down with Lisa Bonebrake, Executive Director of the Alport Syndrome Foundation, and Janis Naeve, world-class VC and Co-Founder & Partner of Bright Frontier, to discuss the evolving, high-impact role of patient organizations in modern drug development.Patient advocacy groups are building the critical data and clinical infrastructure required to advance medical research. Lisa shares how the Alport Syndrome Foundation is directly de-risking clinical trials, building global patient registries, and driving the ASCENT Initiative, a historic public-private partnership with the FDA to establish surrogate endpoints for kidney disease.The discussion also explores the venture capital perspective with Janis Naeve, highlighting why investors view patient-led data infrastructure as a "highway" for innovation, how pharmaceutical companies can successfully integrate patient feedback into trial design, and why establishing clear regulatory pathways is vital to accelerating rare disease treatments.This Episode Covers🔹 Why patient advocacy groups are the new infrastructure of drug discovery🔹 The real impact of Alport syndrome and the importance of early genetic testing🔹 The ASCENT Initiative and establishing surrogate endpoints with the FDA🔹 The impact of Alport syndrome and the importance of early genetic testing🔹 Why pharmaceutical companies must include patient voices in clinical trial design 🔹 The venture capital perspective on funding rare disease innovation🔹 Regulatory clarity and de-risking biotech investment🔹 How public-private partnerships accelerate the timeline for lifesaving treatmentsPatient advocates are no longer passive charities, they are the essential infrastructure of modern drug discovery. This conversation serves as a blueprint for the future of healthcare policy, exploring how rare disease organizations are partnering with the FDA, saving pharma millions by rescuing flawed clinical trials, and driving venture capital investment to accelerate lifesaving treatments.Join the Conversation⬇️ Should patient organizations have a larger role in shaping FDA regulatory pathways? What's the biggest obstacle preventing more rare disease drug development? How can policymakers better support patient-led research infrastructure?Let us know your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true👍 Like and subscribe for more biotech and healthcare policy coverage.Timestamps0:00 - The Real ROI of Patient Advocacy0:26 - Welcome to the Making Medicine Podcast1:52 - Breaking News in Alport Syndrome Research4:03 - What is Alport Syndrome? 5:58 - Redefining the Role of Patient Organizations9:09 - A VC Investor’s Perspective on Rare Disease11:38 - The ASCENT Initiative & FDA Public-Private Partnership18:03 - Understanding Surrogate Endpoints in Clinical Trials25:19 - How to Build a Fearless Patient Advocacy Group30:26 - Why Pharma Needs to Listen Directly to Patients35:31 - Educating the Biotech Industry on Patient Integration39:35 - Key Takeaways for Policymakers and InvestorsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#rarediseases #drugdevelopment #clinicaltrials #fda #biotech #patientadvocacy #makingmedicine #podcast

Healthcare costs. PBM reform. Drug price controls. FDA stability. American manufacturing.This week on the Making Medicine Podcast, John Stanford sits down with Charles Crain, Vice President of Domestic Policy at the National Association of Manufacturers, to discuss a new report examining the rising cost of healthcare and its impact on American manufacturers.Manufacturers provide health coverage to millions of workers, making healthcare affordability a major business concern. But according to NAM, the solution isn't limiting pharmaceutical innovation. Instead, the conversation focuses on PBM reform, 340B program transparency, regulatory certainty, preventative care, and policies that lower costs without undermining America's leadership in medical innovation.The discussion also explores why FDA stability matters beyond the biotech sector, how regulatory uncertainty affects long-term investment, and what policymakers should prioritize to strengthen American competitiveness in the face of growing global competition. This Episode Covers:🔹 Why healthcare costs are manufacturers' top business concern🔹Why NAM opposes pharmaceutical price controls🔹The real drivers of rising healthcare costs🔹PBM reform and prescription drug transparency🔹The 340B program and hospital incentives🔹Why FDA stability matters for innovation🔹Regulatory certainty and biotech investment🔹Manufacturing, R&D, and American competitiveness🔹Lessons from COVID supply chain vulnerabilities🔹How to compete with China through innovationAt the center of this conversation is a simple question: How do we lower healthcare costs without weakening the innovation ecosystem that develops new medicines? Charles Crain argues that affordability and innovation are not competing goals, and that policymakers should focus on the structural drivers of healthcare spending rather than policies that could reduce future medical breakthroughs.Check out the NAM report: "Prescription for a Healthy Workforce: Manufacturers' Roadmap to Lower Healthcare Costs"https://nam.org/issues/health-care/ Join the Conversation ⬇️Are policymakers focusing on the right drivers of healthcare costs?Should PBM reform be a higher priority than drug price controls?What matters most for U.S. competitiveness: tax policy, regulatory certainty, or innovation incentives? Let us know your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here!Follow us for more:X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true👍 Like and subscribe for more conversations on FDA policy, biotech investing, healthcare innovation, drug development, gene therapy, AI in medicine, and the future of biotechnology.Timestamps00:00 Intro & Disclaimer00:37 Meet Charles Crain & NAM01:03 Why Manufacturers Care About Healthcare Costs03:24 Why Healthcare Costs Keep Rising05:57 What NAM Would Do to Lower Costs08:03 Why Manufacturers Oppose Drug Price Controls09:20 The Innovation Tradeoff Explained10:54 Understanding the 340B Program13:16 PBMs & Healthcare Middlemen15:09 How Powerful Are PBMs?17:13 Why FDA Stability Matters18:16 Regulatory Costs & Uncertainty19:30 Why Biotech Needs Predictable Rules20:43 Building Bipartisan Policy Solutions23:18 Competing With China Through Innovation25:12 Final ThoughtsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#healthcarepolicy #pbm #biotech #drugpricing #fda #manufacturing #makingmedicine

China and biotech competition. Drug pricing reform. The FDA. PBMs. America’s innovation economy.This week on the Making Medicine Podcast, John Stanford sits down with Rep. Scott Peters to discuss the future of American biotech innovation, the importance of ending the “pill penalty,” and why China’s rapid rise in biotechnology is becoming a major strategic concern for the United States.Representing one of the country’s leading biotech hubs in San Diego, Congressman Peters explains why policies tied to the Inflation Reduction Act and investment incentives directly impact whether innovative medicines get funded, developed, and brought to patients.The conversation also explores the future of PBM reform, rare disease investment, FDA modernization, the workforce and scientific talent, supply chain security, and what policymakers must do to keep America competitive in biotech and life sciences innovation.This episode covers:🔹 Why San Diego became a biotech powerhouse🔹 The “pill penalty” and the EPIC Act🔹 How the IRA changed biotech investment incentives🔹 Why rare disease investment rebounded after the ORPHAN Cures Act🔹 China’s growing role in global biotech innovation🔹 FDA modernization and regulatory competitiveness🔹 Immigration, talent, and scientific leadership🔹 PBM reform and healthcare affordability🔹 Why diagnostics and genomics may transform healthcare🔹 The importance of bipartisan problem-solving in healthcare policyAt the center of the discussion is one core issue: competitiveness. Congressman Peters argues that America’s advantage in biotech depends on stable investment incentives, strong scientific institutions, private-sector innovation, and policies that continue attracting talent and capital into the United States.Check out more from Incubate Coalition:https://www.incubatecoalition.org/Join the Conversation ⬇️Do you think the United States is doing enough to stay competitive with China in biotech innovation? Should Congress further reform the IRA to encourage more biotech investment and drug development?What matters most for the future of American healthcare innovation: FDA modernization, PBM reform, or stronger investment incentives?Let us know your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true👍 Like and subscribe for more conversations on FDA policy, biotech investing, healthcare innovation, drug development, gene therapy, AI in medicine, and the future of biotechnology.Timestamps00:00 Intro & Disclaimer00:17 Why China Is Catching Up in Biotech00:31 Meet Congressman Scott Peters01:28 Why San Diego Became a Biotech Hub03:24 The Role of NIH & Research Institutions05:02 Venture Capital & Biotech Growth07:06 The “Pill Penalty” Explained 08:05 The IRA & Medicare Drug Negotiation09:25 Why Investment Incentives Matter11:11 How Small Molecule Investment Was Affected12:20 Political Risks of Supporting Biotech15:17 Why Independence Still Matters in Congress21:26 Rare Disease Investment & Orphan Cures Act24:00 China’s Rise in Biotech Innovation25:27 FDA Challenges & Global Competition27:19 Immigration, Talent & Scientific Leadership30:25 PBM Reform & Healthcare Costs 33:19 Diagnostics, Genomics & Preventive Medicine34:19 Why Congress Needs Better Biotech Education36:35 Closing ThoughtsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#fda #biotech #drugpricing #china #pbm #healthcarepolicy #innovation

What does the FDA actually look like on the inside — and why does its structure matter for drug approvals, rare disease therapies, and biotech investment?This week on the Making Medicine Podcast, host John Stanford is joined by Jef Akst, senior editor at BioSpace, to break down the FDA's key divisions, what each one is responsible for, and how they shape the drug development landscape.Jef walks through the roles of CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) — what each center oversees, how they differ, and why their review processes matter to biotech companies navigating approval timelines. The episode also explains how FDA advisory committees work, what authority they hold, and how their recommendations influence regulatory outcomes.The conversation then expands to the broader policy environment shaping biotech today — including CMS marketplace rule changes that affect patient cost exposure, Section 232 pharmaceutical tariff procedures, Most Favored Nation pricing, and the Orphan Cures Act.The episode closes with data from the INCUBATE Coalition's biotech investment tracker, examining how IRA policy and regulatory uncertainty are influencing capital allocation across the life sciences sector.Check out the full report from Manatt Healthhttps://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investmentCheck out INCUBATE'S biotech investment trackerhttps://lifesciencetracker.com/Join the Conversation ⬇️Do you think FDA leadership turnover is creating too much uncertainty for biotech companies and investors?Should the FDA rely more heavily on advisory committees and outside scientific experts during periods of instability?How should policymakers balance lower healthcare premiums with the risk of higher out-of-pocket costs for patients?Let us know your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPodInstagram: https://www.instagram.com/makingmedicinepod/TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=enLinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true👍 Like, follow, and subscribe for more conversations on FDA policy, biotech innovation, healthcare regulation, drug pricing, rare disease development, and life sciences investment.Time Stamps00:00 Intro & Disclaimer00:17 FDA Instability & Biotech Uncertainty00:39 Meet BioSpace’s Jef Akst01:51 FDA, HHS & RFK Jr. Influence04:13 What CDER Does05:55 Drug Delays & FDA Inconsistency07:23 What CBER Does10:33 Office of Therapeutic Products Turnover13:08 FDA Commissioner’s Role Explained15:17 Advisory Committees & Expert Panels18:00 CMS ACA Rule Changes19:24 Pharma Tariffs & MFN Pricing21:06 Senator Bill Cassidy’s Primary Loss22:50 New Biotech Investment Tracker Data24:41 Rare Disease Investment Trends25:17 Closing ThoughtsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#FDA #Biotech #HealthcarePolicy #DrugDevelopment #RareDisease #CMS #Pharma #LifeSciences #MFN #MakingMedicine

FDA instability. AI in clinical trials. China overtaking the United States in biotech development.Following news that Marty Makary has stepped down as FDA commissioner, questions around regulatory stability, scientific leadership, and the future of biotech innovation are back in focus.This week on the Making Medicine Podcast, John Stanford examines what the FDA needs most during periods of leadership transition: scientific credibility, regulatory expertise, and a stable, predictable process for developing new medicines.Recorded before the latest leadership announcement, this episode focuses less on personalities and more on the broader institutional questions shaping the future of drug development, clinical trials, AI-enabled regulation, rare disease research, and America’s global competitiveness in biotech.This episode covers:  This episode covers:🔹 What Marty Makary’s departure could mean for the FDA🔹 Why FDA stability matters for biotech investment🔹 The qualities that define effective FDA leadership🔹 AI, clinical trials, and the future of drug development🔹 FDA modernization and new approach methodologies🔹 Rare disease development and regulatory predictability🔹 Why global biotech competition is accelerating🔹 How FDA credibility impacts patients, investors, and innovationAt the center of the conversation is one core issue: confidence. Confidence that the FDA remains a science-driven institution capable of supporting innovation while ensuring drugs are safe and effective for American patients. Because uncertainty at the agency doesn’t just affect markets — it affects clinical timelines, capital allocation, and ultimately whether treatments reach patients.Join the Conversation ⬇️Do you think the FDA is becoming less predictable?Should AI play a larger role in clinical trials?Can America maintain its leadership in biotech innovation?Let us know your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you'rehere! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=truehttps://www.tiktok.com/@makingmedicinepodcast?lang=en👍 Like and subscribe for more conversations on FDA policy, biotech investing, healthcare innovation, drug development, gene therapy, AI in medicine, and the future of biotechnology.Timestamps00:00 Intro & Disclaimer00:33 Why FDA Leadership Matters01:00 FDA Leadership Shakeup Explained01:50 Why FDA Stability Impacts Biotech02:14 The Cost Of Regulatory Uncertainty02:59 The Three Qualities Of A Strong FDA Commissioner03:51 Why Regulatory Experience Matters04:40 AI & The Future Of Clinical Trials05:47 America’s Healthcare Data Problem06:17 Why The FDA Must Lead On AI06:41 The Limits Of FDA Authority07:07 Why Investors Need Predictability07:33 FDA Modernization & Innovation07:55 Why This Matters For Patients08:21 Rare Disease Patients & FDA Stability08:41 Passage Bio’s FDA Setback09:27 China Surpasses The U.S. In Drug Trials10:09 What The Industry Wants From The FDA10:32 Why Stable Regulation MattersDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#FDA #Biotech #AI #ClinicalTrials #HealthcarePolicy #RareDisease #GeneTherapy #DrugDevelopment #China #MakingMedicine

Gene therapy breakthroughs. The first oral GLP-1 pill. A troubling signal for scientific talent. And a German pricing move that could quietly reshape global drug development.This week on the Making Medicine podcast, John Stanford breaks down four stories shaping the future of life sciences and biotech investment. From the FDA's landmark approval of Regeneron's gene therapy for genetic hearing loss to new survey data showing immigration policy is already influencing where top researchers choose to build their careers — the pressure on the innovation ecosystem is building from multiple directions at once.This episode covers:🔹 FDA Approvals Corner: Eli Lilly's Foundayo (first oral small-molecule GLP-1 for weight management), Regeneron's Otarmeni (gene therapy for genetic hearing loss), and Merck's Idvynso (once-daily HIV treatment).🔹 Immigration policy and what a new STAT News survey says about the research pipeline.🔹 Germany's drug discount proposal and why it complicates the U.S. Most Favored Nation pricing strategy.At the center of all these conversations is one critical question: can the United States maintain the confidence, in its regulators, its talent pipeline, and its pricing environment, that keeps the biomedical innovation engine running?Check out the full STAT News Reporthttps://www.statnews.com/2026/05/04/trump-immigration-policy-stat-survey-measures-science-impact/Join the Conversation ⬇️Do you think the FDA is becoming less predictable?Should the US rethink its MFN drug pricing strategy?Can America maintain its leadership in biotech innovation?Let us know your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true👍 Like and subscribe for more conversations on FDA policy, biotech investment, drug pricing, healthcare innovation, China competition, and national security.Time Stamps00:00 Intro & Disclaimer00:17 Innovation Ecosystem Runs on Confidence00:33 FDA, Germany & Biotech Headlines Preview01:18 FDA Drug Approvals Roundup01:41 Eli Lilly’s Oral GLP-1 Approval02:16 Regeneron Gene Therapy Breakthrough03:18 Immigration Policy & Scientific Talent Concerns04:56 Germany Challenges MFN Drug Pricing05:57 Why Global Drug Pricing Could Reshape Launch Strategy06:49 Rare Disease Investment Risks07:12 Germany vs Trump MFN Policy08:08 Why Biotech Innovation Depends on ConfidenceDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#fda #biotech #drugpricing #glp1 #healthcarepolicy #mfn #germany #regeneron #EliLilly #MakingMedicine

Biotech is no longer just about medicine. It is now a frontline issue in national security, global competition, and economic independence.In this episode of the Making Medicine Podcast, Senator Todd Young joins us to break down the growing risks of relying on China for critical biotech inputs, why FDA speed and regulatory clarity matter more than ever, and how the US can stay competitive in a rapidly shifting global landscape.From supply chain vulnerabilities to AI-driven drug development, this conversation explores the intersection of policy, innovation, and national defense. Senator Young also shares insights on drug pricing, biotech investment, and why strengthening the full ecosystem from startups to large manufacturers is critical for long-term US leadership.If the US fails to act, the consequences go far beyond healthcare. They shape who leads the next century of innovation.At stake is not just faster cures, but whether America remains the global leader in biotech or falls behind.Join the Conversation ⬇️Should the US decouple biotech supply chains from China?Can the FDA move faster without sacrificing safety?What policy change would most strengthen US biotech leadership?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here!Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps00:00 Intro and disclaimer00:17 Senator Young on China dependency risk00:33 Meet Senator Todd Young01:53 Why biotech is national security03:23 Biotech’s role in defense, materials, and Department of War04:17 Supply chain resiliency and China risk05:16 Biotech threats, food security, and countermeasures06:41 China, biotech standards, and global competition08:04 Why innovators go abroad for speed and cost08:46 FDA optimization, AI, and faster drug development12:16 Indiana’s biotech ecosystem and Eli Lilly16:32 Why small biotech and big pharma need each otherDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#biotech #FDA #China #nationalsecurity #pharma #healthpolicy #innovation #senatortoddyoung

FDA instability is reshaping biotech investment decisions in real time. Investors are recalibrating risk, pulling back, and even shifting capital abroad.In this episode of the Making Medicine Podcast, John Stanford is joined by Rachel Sher of Manatt Health to unpack new original research conducted with investors across the biotech ecosystem. The goal was simple: move beyond speculation and understand whether recent leadership changes, staffing cuts, and policy uncertainty at FDA are actually shaping investor behavior.What emerged is a clear signal. Across venture capital, public equity, private equity, and industry investors, the vast majority said recent changes at FDA have altered how they think about risk, capital allocation, and the attractiveness of U.S.-based drug development.This conversation walks through the four major themes that surfaced in the research: growing concern about regulatory instability, reduced appetite for certain product categories like gene therapy and vaccines, increasing attention to China and other international markets, and broader concern that instability across agencies like NIH and FDA could weaken the long-term innovation pipeline.At the center of it all is one core issue: regulatory predictability. When investors lose confidence in consistency, policy clarity, and institutional knowledge, the consequences extend far beyond individual companies. They affect portfolios, research priorities, and where innovation happens next.This episode also highlights something important. Even with all these concerns, investors still want to back innovation in the United States. The question is whether policymakers and regulators can restore the stability and trust that made the U.S. the global leader in biotech in the first place.Watch for a grounded conversation on what investors are really saying, what it means for the biotech ecosystem, and why FDA predictability matters more than ever.Check out the full reporthttps://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investmentJoin the Conversation ⬇️Do you think FDA instability is already changing the future of biotech investment? Are investors right to look abroad when U.S. regulatory signals become less predictable? What matters more right now: speed, stability, or scientific consistency?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps00:00 Intro & Disclaimer00:16  Investors Say FDA Changes Are Impacting Decisions03:22 How We Surveyed Investors (Research Design)07:27 Theme 1: FDA Instability & Investor Uncertainty10:22 Investors Repricing Risk in Biotech12:05  “Chaos Is the Only Thing” – Investor Quote13:00  Theme 2: Pullback from Gene Therapy, Vaccines, Oncology14:28  Theme 3: Capital Shifting Abroad (China & Competition)17:02 Theme 4: NIH Cuts & Long-Term Innovation Risk 25:24 Key Takeaway: Regulatory Predictability Drives InvestmentDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #FDA #BiotechInvesting #HealthcarePolicy #DrugDevelopment

FDA signals are starting to break down, and biotech is feeling it. One company is collapsing while another is breaking through.As lawmakers return to Washington for a packed schedule of healthcare hearings, the conversation will be shaped by what’s happening inside the biotech ecosystem right now, both the breakthroughs and the breakdowns.In this episode of Making Medicine, we connect the dots between what’s unfolding on Capitol Hill and what companies are experiencing on the ground.We start with the policy backdrop: multiple hearings across the House and Senate, including appearances by HHS Secretary RFK Jr. and a renewed focus on drug pricing, FDA oversight, and the future of biomedical innovation.Then we turn to two stories that highlight what’s at stake.On one side is Replimune, a biotech facing layoffs and a collapsing market response after repeated FDA rejections and what leadership described as inconsistent communication and a slow-moving regulatory process.On the other is Revolution Medicines, whose pancreatic cancer drug is delivering unprecedented clinical results and offering real hope to patients, a powerful example of what the innovation ecosystem looks like when it works.Together, these stories raise a critical question: Can companies and investors still rely on FDA signals?Because when those signals become unpredictable, capital pulls back, risk tolerance shrinks, and fewer breakthrough therapies get funded.We also explore how early-stage investors rely on regulatory clarity, how large pharma acquisitions are helping fuel the biotech ecosystem, and why Congress plays a critical role in shaping what comes next.The takeaway is simple: Biotech doesn’t succeed or fail in isolation. Policy, regulation, and capital all move together.Join the Conversation ⬇️Are we creating a system that rewards safe, incremental drugs over true breakthroughs? If FDA decisions feel unpredictable, does capital move elsewhere, or does innovation slow down entirely?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps00:00 Intro + Why Biotech Policy Matters Right Now00:38 Congress Returns: RFK Jr., Drug Pricing, and Key Hearings03:29 When FDA Delays Kill Companies (Kezar Case)04:01 Replimune Collapse: From Breakthrough to Rejection05:46 The Real Risk: Can Investors Trust FDA Signals?06:51 Revolution Medicines: A Cancer Breakthrough07:49 Historic Results: First Survival Gains in Pancreatic Cancer08:22 How Biotech Actually Works (Startups → Pharma)09:56 Why Big Pharma Deals Matter for Patients10:06 Collapse vs Breakthrough: Which Future Are We Heading Toward?10:22 What Congress and FDA Need to Fix10:50 Faster Drug Development? New FDA Pathway Explained12:25 Final Take: The Stakes for U.S. Biotech LeadershipDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#Biotech #FDA #DrugDevelopment #HealthcarePolicy #BiotechInvesting

Tariffs, MFN pricing, and FDA delays are colliding, and small biotech is paying the price. One company already collapsed. More could follow.In this episode, we break down how Section 232 pharmaceutical tariffs, the push to codify Most Favored Nation (MFN) pricing, and new proposals in the FDA budget are reshaping biotech in real time.The stakes are high. These policies don’t just exist on paper, they directly impact where drugs are developed, how capital flows, and whether small biotech companies survive.We explore how tariffs could strain supply chains and smaller companies, how MFN could change global pricing and investment behavior, and how a proposed expedited IND pathway could help keep early-stage drug development in the United States.But the biggest signal comes from a real-world example: Kezar Life Sciences, a biotech that shut down after FDA delays disrupted its timeline and investor support.This episode makes one thing clear: policy is now one of the biggest drivers of innovation or failure in biotech.When the system works, it accelerates breakthroughs. When it doesn’t, it pushes capital, companies, and science elsewhere.Join the Conversation ⬇️Are U.S. biotech policies slowing down the industry more than global competitors like China?If a company shuts down because of regulatory delays, is that a policy failure or just the cost of doing business?Would you accept higher risk in early drug development if it meant faster innovation and more breakthroughs?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps0:00 Episode Introduction1:36 Section 232 Pharma Tariffs Explained2:47 Onshoring, MFN Deals, & Exemptions4:57 The Impact on Small Biotechs & VC8:17 Why Codifying MFN is Dangerous9:56 Promising FDA Budget Proposals11:32 Expedited INDs to Keep Trials in the US15:49 The Fatal Cost of FDA Delays17:52 Proposed NIH Budget Cuts & Grant Changes20:45 The Big Disconnect in Biotech PolicyDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#biotechpolicy #fda #drugdevelopment #healthcarepolicy #china #BiotechInnovation

Last week, seven leading life sciences investors went to Washington. They met with the National Security Commission on Emerging Biotechnology, walked the halls of Congress, and shared which roadblocks are preventing them from being a part of the next breakthrough. John Gutierrez was one of those investors — and the throughline of nearly every room he walked into was China.Not as a future threat to get ahead of. But as a current competitor that is already having a real impact on how capital decisions are made and exposing just how much American biotech policy is working against itself.On this episode, John breaks down what policymakers are missing and what investors are actually seeing: drug pricing proposals that undermine early-stage innovation, an FDA uncertainty gap that large companies can absorb and small companies can't, and a China that is building a cheaper, faster, better-funded competitor while Washington debates the wrong questions.The U.S. still has the best life sciences ecosystem in the world. Whether that stays true depends on decisions being made right now, and whether the people making them understand what's actually at stake.This is that conversation. Join the Conversation ⬇️What do you think is the biggest risk to U.S. biotech leadership right now?Is policy helping or hurting innovation in this moment?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps00:00 Disclaimer and opening context 00:37 Capitol Hill biotech roundtable with NSCEB 01:25 Meet investor John Gutierrez and Ascend to Capital 02:15 How biotech investors build and scale companies 03:13 The rise of new biotech hubs like Florida 04:58 Why investors are stepping into policy debates 06:29 Biotech as a national security priority 08:31 Is the U.S. losing biotech leadership to China? 10:30 Competing with China vs trying to contain it 11:06 Why innovation is becoming incremental not transformational 13:43 “Tell me the incentive” how policy drives investor behavior 15:01 The pill penalty and shift away from small molecule drugs 17:04 Policy silos vs the real global biotech competition 18:42 Inside Capitol Hill conversations and policy blind spots 21:26 How global pharma deals fund biotech innovation 23:56 Closing thoughts on U.S. biotech leadershipDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#biotech #biotechpolicy #nationalsecurity #biotechinnovation #chinabiotech

In this special re-air of the Making Medicine Podcast, we revisit a timely conversation with Dr. Michelle Rozo of the National Security Commission on Emerging Biotechnology NSCEB, originally recorded live at JPM 2026.We are re-airing this episode in recognition of a recent roundtable hosted on Capitol Hill by the Incubate Coalition and NSCEB, where these same themes took center stage. As policymakers, investors, and industry leaders increasingly focus on the intersection of biotechnology and national security, this discussion offers critical context on how global competition and U.S. policy choices are shaping the future of innovation.Filmed live at JPM, host John Stanford sits down with leaders operating at the ground level, what one panelist calls the “frogs in the mud”, to unpack how capital flows, regulatory signals, and long-term strategy are evolving in real time.Rather than framing innovation as a zero-sum global rivalry, the conversation highlights a more complex reality. The U.S. remains deeply connected to global science, but risks falling behind if domestic policies create friction for innovation.The takeaway is clear. Maintaining U.S. leadership in biotech is not guaranteed. It requires a policy environment that supports discovery, development, and scale while recognizing the growing national security implications of the life sciences.Join the Conversation ⬇️Do you think the U.S. is treating biotech as a national security priority yet?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps0:00 Intro: Is the U.S. losing the biotech arms race?1:10 "Frogs in the Mud": Why D.C. policy misses the mark3:45 The 20-year Chinese strategic plan for biotech6:15 How IRA price controls stifle American innovation9:30 Strategic prioritization: Can the U.S. catch up?12:50 The $350B patent cliff and global market impacts16:20 Navigating the "Valley of Death" for startups20:05 Clinical trial speed: Why China is outperforming the U.S.24:30 SBIR breakthrough: New hope for early-stage funding28:10 The "Playbook for Congress" and the road to 2030DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#Biotech #NationalSecurity #NSCEB #LifeSciences #HealthcareInnovation #BiotechPolicy #Innovation #JPM2026

With Japanese Prime Minister Sanae Takaichi meeting President Trump this week, we are re-airing our special episode from Tokyo. We explore why the U.S. delegation must prioritize a fair pricing agreement that ensures Japan pays its fair share while giving patients access to life-saving cures.As the US and Japan put renewed focus on their partnership in science and the life sciences, we are revisiting a special episode of the Making Medicine podcast recorded on the ground in Tokyo late last year to mark this critical geopolitical moment.This week's summit presents a rare win-win opportunity if the U.S. delegation focuses on securing a fair commercial pricing agreement. For years, arcane and arbitrary pricing schemes have limited the value Japan is willing to pay for medical breakthroughs. By pushing Japan to pay its "fair share" for innovation, U.S. leaders can help solve the severe drug lag that leaves 70 percent of new American medicines unavailable to Japanese patients. A modernized pricing agreement wouldn't just protect early-stage biopharma investments; it would give Japan's aging population access to the breakthroughs they desperately need.During this international panel, John Stanford sat down with a premier group of global investors to discuss the path forward. He was joined by Shaan Gandhi of Pfizer, Patrick Jordan of NovaQuest Capital Management, Heather Berger of Forge Life Sciences, and Johannes Freuhauf of Biolabs.The group explored how the Japanese government is systematically addressing structural challenges through unified agency alignment from the MHLW and METI. A major highlight of the conversation was a remarkably forward-looking program that offers a two-to-one non-dilutive matching grant for accredited international venture capital investments. The panel also discussed the rapid expansion of vital infrastructure, celebrating the announcement of a second Biolabs incubator facility opening in Tokyo in mid-2026.However, the investors agreed that early-stage funding must be paired with a predictable commercial pricing environment. To ensure sustainable global investment, Prime Minister Takaichi's administration must commit to valuing innovation across the entire value chain, allowing for the successful exits and capital recycling that fuel the next generation of medicines.Join the Conversation ⬇️What policy changes would most effectively help Japan reduce its drug lag?Do you believe government matching grants are the most effective way to accelerate early-stage biotech ecosystems?Can Japan build a globally competitive biotech sector without a modernized pricing agreement?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps00:00 Episode disclaimer00:23 Japan episode introduction01:17 Why the US Japan meeting matters01:53 Japan’s drug lag problem02:47 Why Japan missed the COVID vaccine moment03:19 Live discussion from Tokyo06:36 Why BioLabs doubled down in Japan08:00 Japan’s science to startup opportunity14:00 Government alignment on biotech innovation20:23 Japan’s matching grant model25:46 Drug lag, pricing, and patient accessDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#japanbiotech #healthcarepolicy #drugdevelopment #lifesciences #medicalinnovation

The FDA is being asked to keep pace with today's rapid scientific advancements amid ongoing resource constraints. In this episode, we unpack why regulatory predictability and *stability* matters more than ever for the future of America's medical innovation ecosystem.Regulatory uncertainty is reshaping where biotech capital flows. In this episode of the Making Medicine podcast, John Stanford sits down with Cartier Esham of Esham Strategies and Executive Director of the Alliance for a Stronger FDA to examine how budget pressures and workforce challenges at the FDA are affecting investors, innovators, and the companies betting on U.S. regulatory predictability.As scientific complexity accelerates, questions are mounting about whether the agency has the capacity needed to meet its growing responsibilities. For biotech investors, uncertainty around review timelines and approval pathways can quickly influence where capital is deployed – and whether the U.S. remains the preferred marketing for early- stage innovation.Meanwhile, the FDA, industry, and other stakeholders are looking towards the next reauthorization of the Prescription Drug User Fee Act (PDUFA) program. These five- year user fee agreements are more than just a funding mechanism; they are a key pillar of the predictable, science-based regulatory framework that underpins biotech investment. When that framework is in doubt, review timelines stretch, approval certainty erodes, and risk calculations for early-stage investment changes.The global context raises the states. While the U.S. continues to lead in clinical trial activity, other countries like China are investing aggressively to narrow the gap. A strong, well-functioning FDA is not just a domestic priority: it is a signal to global capital that the U.S. remains committed to regulatory excellence and innovation leadership.Join the Conversation ⬇️Is FDA instability already showing up in your investment decisions or deal timelines?As China scales its clinical trial infrastructure, how long can the U.S. afford regulatory uncertainty?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps0:00 Legal Disclaimer and Making Medicine Introduction1:42 Cartier Esham’s Journey to Health Policy4:08 The Mission of the Alliance for a Stronger FDA6:44 Understanding FDA Funding: User Fees vs. Appropriations7:48 Managing Operating Reserves During Government Shutdowns10:10 Navigating the 4% FDA Budget Cut and Staffing Levels15:55 Evidence-Based Assessment: 2025 CDER Drug Approvals18:01 Inside the PDUFA VIII Negotiations21:27 Establishing Financial Stability for the FDA's Future27:00 Keeping Pace with China's Biotech and Clinical Trial Growth31:05 Tracking Global Clinical Trial Starts as a Barometer for Success  DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #BiotechPolicy #FDAResources #PDUFA #MakingMedicine #ChinaCompetition #HealthcareInnovation

China has now overtaken the United States in new drug clinical trials. At the same time regulatory uncertainty and funding lapses are raising new questions about the future of the American biotech leadership.In this episode of the Making Medicine Podcast, host John Stanford examines three developments shaping the future of the biotechnology ecosystem.First, the Senate passed a bipartisan agreement to reauthorize the Small Business Innovation Research and Small Business Technology Transfer programs. These programs have long served as a launchpad for biotech startups and early-stage medical innovation across the United States.The reauthorization comes after the first lapse in the program’s 44-year history, which paused billions in potential research funding for months. Restarting SBIR is a major development for small biotech companies developing new therapies.Recent regulatory decisions and declining approval numbers are raising new questions among investors and researchers about the stability of the regulatory environment.Finally, new global data shows China has now overtaken the United States in new drug clinical trials. Faster recruitment, national biotechnology policy incentives, and streamlined regulatory review are helping China accelerate its clinical research ecosystem.The United States has been the global leader in biomedical innovation for decades. Maintaining that leadership will require strong research funding, regulatory clarity, and policies that continue to support innovation and investment.#BiotechInnovation #HealthcarePolicy #ClinicalTrials #DrugDevelopment #MedicalInnovationJoin the Conversation ⬇️Do you think the United States can maintain its leadership in biomedical innovation? What policies are most important for supporting biotech startups and early-stage research? How should regulators balance speed and safety when approving new medicines? Drop your thoughts in the comments below 👇Link to WSJ Reporthttps://www.wsj.com/tech/biotech/maha-is-bringing-chaos-to-biotech-investment-beyond-just-vaccines-fbb82c6b?gaa_at=eafs&gaa_n=AWEtsqek_Ljd3Z49rusYI-f_MECgRKwStXEjR6_pP7SqdkNhBeyB-fywedtgZKvdRLg%3D&gaa_ts=69a8660d&gaa_sig=FMTHTFVHKAw_gdNro4NTyS35w2SRxhfgz7If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps0:00 Biotech policy and innovation overview 1:05 SBIR reauthorization passes the Senate 2:45 Why SBIR matters for biotech startups 4:40 The five month SBIR funding lapse 5:23 FDA accelerated approval pathway explained 6:10 Accelerated approvals drop in 2025 7:30 Regulatory uncertainty and biotech investment 8:26 Rare disease treatment gap9:02 China overtakes the U.S. in clinical trials9:30 Why China recruits trial patients faster10:11 China biotech policy advantageDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

About 90–95% of rare diseases still lack an FDA-approved treatment, underscoring the urgency for continued innovation on behalf of the estimated 30 million Americans — and families — affected by these conditionsDuring Rare Disease Week, this special episode of the Making Medicine podcast focuses on the patients, caregivers, and policy choices shaping the future of rare disease research. Host John Stanford is joined by Lisa Schlager (FORCE), Elaine Towle (Prader-Willi Syndrome Association), and Josh Trent (Save Rare Treatments Task Force) for a thoughtful discussion on the scientific, financial, and regulatory realities of developing therapies for small patient populations.The conversation explores how federal incentives, reimbursement frameworks, and regulatory clarity can influence whether promising treatments move forward, as well as the broader ripple effects rare diseases have on families and support networks. The panel also reflects on ongoing policy discussions, including proposals such as Most Favored Nation (MFN) drug pricing, and how stakeholders are evaluating their potential impact on future innovation.Progress in rare diseases depends on sustained collaboration among patients, advocates, researchers, investors, and policymakers. This episode highlights both the scale of unmet need and the growing momentum to deliver new treatments and hope to millions of Americans.Do you believe the Orphan Cures Act went far enough to protect rare disease research?Should the Pediatric Priority Review Voucher program be made permanent?What rare disease policy reform should Congress address next?If you're new to the Making Medicine Podcast, we're happy you'rehere! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Rare Disease Week and disclaimer0:43 Rare disease innovation, 30 million Americans2:46 Hereditary cancer and rare genetic subtypes7:36 Prader-Willi syndrome, hyperphagia and hypothalamus11:14 First Prader-Willi FDA approval and Phase 3 pipeline12:54 FDA patient focused drug development meetings14:39 Save Rare Treatments Task Force and advocacy strategy17:20 95% lack FDA treatments and pediatric rare disease stakes21:05 Orphan Cures Act, IRA negotiation, second indications26:17 PARP inhibitors, ovarian cancer and pancreatic cancer33:01 Rare disease investment rebound after Orphan Cures Act37:36 Pediatric PRV reauthorization and faster FDA reviewDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

FDA reversals and price controls are handing biotech dominance to China. We expose the national security crisis in drug development.The FDA is facing a crisis of confidence that threatens the stability of the entire US biopharmaceutical industry. In this episode, John Stanford is joined by Jef Akst, Managing Editor at BioSpace, to expose how recent "regulatory reversals" and inconsistent decision-making are rendering major vaccine and therapeutic programs "uninvestable". We analyze the shocking "Moderna gate" incident, where the FDA issued a "refuse to file" letter for an mRNA flu vaccine only to reverse course days later, a chaotic move that sent stock prices flying and disrupted timelines for the entire vaccine sector.Beyond the FDA, a new national security threat is emerging in the form of "Most Favored Nation" (MFN) pricing proposals. We unveil data from the Incubate MFN Tracker, which catalogs how these European-style price controls are now being flagged in quarterly SEC filings (10-Ks and 10-Qs) as material risks to business operations. Companies large and small are warning that MFN policies will compress expected returns and force a reprioritization away from riskier, high-impact R&D. This creates a vacuum that allows adversaries like China to further develop their own pipelines and grow a stronger foothold in the global market.This episode also covers the shifting center of gravity in clinical research. While 58% of industry professionals still choose the US as the best place to start a career, 27% now look to Asia-Pacific, while only 9% choose Europe—a stark warning of what happens when regions adopt restrictive pricing policies. We discuss Senator Bill Cassidy’s new "Patient and Families First" white paper, which proposes solutions like an Australia-style pilot for faster Phase 1 trials and updated pathways for digital health and AI tools.Finally, we look ahead to the State of the Union, where polling reveals that only 2% of Americans believe Congress should prioritize lowering drug costs, with the vast majority focused on grocery and insurance affordability instead.Join the Conversation Does the current FDA instability make you worry about the future of new medicines reaching patients? Do you believe importing foreign price controls is worth the risk of losing American biotech leadership to China?Should Congress focus on insurance reform instead of drug price caps to help with affordability?Drop your thoughts in the comments belowIf you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueLink to articleshttps://endpoints.news/pharma-is-done-negotiating-as-trump-pushes-to-codify-deals/ https://www.biospace.com/business/opinion-2026-could-mark-a-turning-point-for-american-innovation https://endpoints.news/even-europeans-dont-see-a-future-in-euro-biopharma-anymore/ Timestamps0:00 Making Medicine disclaimer, no medical advice and no investment advice 0:42 Making Medicine Press Pass with BioSpace Managing Editor Jeff Akst 1:16 What BioSpace covers, biotech news, drug development, VC funding, FDA approvals 3:42 Is the FDA functioning properly, transparency and communication problems 4:17 FDA reversals and the Moderna mRNA flu vaccine refuse to file letter 6:19 Ripple effects, Moderna stock, vaccine timelines, and mRNA platform investment risk 8:37 FDA shifting to stricter approvals, risk benefit changes, and trial design uncertainty 10:35 Drug development timelines, regulatory instability, and investor confidence 12:17 Inside FDA culture, leadership turnover, layoffs, and decision making uncertainty 12:50 National priority vouchers, review delays, and why companies hesitate to apply16:11 Psychedelics for depression and Alzheimer’s drug development with tau targeting26:13 State of the Union, drug pricing politics, insurance reform, and voter affordability prioritiesDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. 

TrumpRx has quickly become part of the broader drug pricing conversation, not as a new insurance program or pharmacy, but as a government website highlighting direct-to-patient cash pricing options for certain brand-name medicines.In this episode of the Making Medicine Podcast, host John Stanford walks through what TrumpRx is, what it isn’t, and why it’s generating attention right now. Rather than setting prices or replacing insurance, the platform points patients toward manufacturer-listed cash prices for select innovative drugs, bringing another pathway to medicine outside traditional insurance channels.The episode also steps back to examine the larger shift this represents. Cash markets for prescription drugs have been growing in visibility, from coupon platforms like GoodRx to cost-plus pharmacy models like Mark Cuban Cost Plus Drugs. TrumpRx enters that landscape from a different angle, one tied, at least rhetorically, to “Most Favored Nation” policy discussions and broader debates about international price comparisons.We discuss early reactions and critiques, including questions about whether some listed products are actually the lowest available option, particularly when lower-cost generics exist. That tension underscores a bigger point: patients often have to shop around, and the system remains opaque enough that even policymakers, manufacturers, and payers frame pricing differently.More broadly, this moment reflects a structural reality in American healthcare. High deductibles, rebate dynamics, and insurance design can make paying cash cheaper than using coverage, a counterintuitive outcome that continues to fuel debate.Finally, we touch on how pricing policy conversations intersect with innovation. Short-term affordability tools, cash-market visibility, and long-term price regulation debates are often discussed together, but they have different implications for investment, drug development, and patient access over time.TrumpRx may or may not be transformative. But it is a visible signal of where the drug pricing conversation is headed: toward transparency, toward cash markets, and toward renewed debate over how the U.S. balances cost, competition, and innovation.Join the Conversation ⬇️Is Trump RX a meaningful transparency tool or just a temporary fix for a broken insurance system?Do you find it cheaper to pay cash for prescriptions rather than using your insurance copay?Do you believe price controls will help affordability or hurt the development of new cures? Like and Subscribe on YouTube ▶️If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps0:00 Disclaimer: Not Medical, Financial, or Legal Advice0:42 Introduction: What Is Trump RX?0:59 How Trump RX Works as a Drug Discount Hub1:56 Trump RX vs GoodRx vs Mark Cuban’s Cost Plus Drugs3:03 Early Criticism and Generic Price Comparisons5:03 Trump RX vs Most Favored Nation (MFN) Pricing6:12 Free Market Tool or Price Control Policy?7:29 Why High Deductibles Changed the Drug Market8:22 Insurance Opacity and the Rise of Cash Markets9:34 PBMs, Gag Clauses, and Hidden Pricing Structures11:24 Why Cash Can Be Cheaper Than Insurance12:13 Final Takeaways: Reform, Transparency, and InnovationDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor

Washington is navigating a period of significant change in health policy, with implications for how new medicines are developed, reviewed, and paid for.In this episode of Making Medicine, we take a closer look at several recent developments shaping the life sciences landscape. We discuss the FDA’s new priority review voucher pilot and the debate around how the agency can balance speed, scientific rigor, and public trust as it works to accelerate patient access to therapies.We also break down new reforms aimed at increasing transparency in Medicare Part D and reining in pharmacy benefit manager (PBM) practices, exploring what these changes could mean for patients, payers, and innovators across the system.Finally, we examine emerging international reference pricing proposals, including the GLOBE and GUARD concepts, and the broader conversation about how the U.S. can maintain its leadership in biomedical innovation while addressing affordability and global competition. If you care about the future of medical innovation, and the policy decisions shaping it, this episode offers context, clarity, and a balanced look at what’s ahead.Link to article: https://www.washingtonpost.com/opinions/2026/02/03/vaccine-development-moderna-rfk-china-drug-prices/Join the Conversation ⬇️Do you believe the government has become the biggest obstacle to the next American cure? Will the U.S. lose its status as the world leader in medical breakthroughs by 2030? Is the FDA's new 'National Priority' pilot a necessary evolution for 21st-century medicine, or is it a dangerous bypass of the scientific checks and balances that protect us all?Drop your thoughts in the comments below 👇If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps0:00  The 1,000-pound predator and the regulatory coup0:23  Science, policy, and a destabilized ecosystem1:10  The controversial FDA town hall2:20  Skipping Congressional approval3:54  Reforming PBMs in the funding package5:10  How PBMs siphon half the cost of your medicine6:55  Why "sunlight" isn't lowering pharmacy prices yet7:54  GLOBE, GUARD, and foreign price controls8:32  Why biotech is fleeing to rival markets9:30  Shifting from price controls to insurance reform10:12  Addressing out-of-pocket costs 10:45  FDA Approvals CornerDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

The race is being won by someone else. While the headlines focus on the prestige of JPM 2026, a much quieter and more dangerous shift is happening behind the scenes. In this special edition of The Making Medicine Podcast, John Stanford sits down with Terzel Vasquez of STAT Brand Studio to discuss why the American biotech engine is beginning to stall. Stanford argues that capital flows like water, and right now, poorly designed Washington policies are acting like boulders in the stream, forcing vital investment away from life-saving small molecules and rare disease research.The conversation pulls back the curtain on a massive cognitive dissonance in modern policy. By attacking the end of the value chain, specifically the large manufacturers who bring drugs to the finish line, lawmakers are inadvertently starving the early-stage startups they claim to protect. From the Pill Penalty to the looming shadow of China’s bio-dominance, this episode explores why biotech has officially moved from a healthcare issue to a critical national security prerogative. Join the ConversationIs U.S. biotech leadership still a "national security priority," or have we already ceded the lead?If “unintended consequences" force a choice between a $100,000 injectable biologic and a $200 oral pill that never gets funded, who actually wins?Is Washington "fixing" the price of medicine, or just distracting us from a broken insurance system?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps0:00  Policy Warning & Headlines 0:23  JPM 2026: Incubate Briefing 0:36  Capital Flight: Policy Barriers 1:24  The IRA "Pill Penalty" 2:22  Rare Disease Funding Gap 2:32  The $1 Billion Fix 3:18  The Innovation Relay Race 4:24  The Movie Studio Paradox 5:28  China’s "Green Light" Strategy 6:58  Biotech: National Security Asset 9:20  The $3 Billion Drug Cost 10:18  Insurance Breakdown & Access 11:36  Fixing the Root IssueDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

Is the U.S. at risk of losing its edge in biotech innovation?Filmed live at JPM 2026, host John Stanford sits down with industry leaders who are deep in the work,what one panelist calls the “frogs in the mud”, to unpack how long-term global strategies, shifting capital flows, and U.S. policy decisions are reshaping the biotech landscape.Rather than framing innovation as an all-or-nothing rivalry, the conversation focuses on a harder truth: the U.S. cannot isolate itself from global science, but it can fall behind if domestic policies make innovation harder at home. While Washington often debates from 30,000 feet, this panel dives into the operational realities founders and investors face every day, from the implications of the National Security Commission’s recommendations, to the looming $350B patent cliff, to the “Valley of Death” threatening early-stage companies.We also examine how pricing uncertainty under the IRA, regulatory friction, and capital constraints intersect, and highlight a recent breakthrough in SBIR funding that offers a glimpse of what pro-innovation policy can look like when it’s done right. The takeaway is clear: safeguarding U.S. biotech leadership isn’t about cutting science off at the knees or cutting off collaboration, it’s about championing policies that keep America the best place in the world to discover, develop, and scale new medicines.Watch to understand the real, ground-level forces shaping the future of biotech, and what policymakers need to get right next.Join the ConversationIs the U.S. still the global center of gravity for biotech innovation, or are we relying too heavily on past momentum?What poses the greater long-term risk to patients: short-term cost controls, or policies that reduce where and how new medicines get developed?In the biotech “Valley of Death,” what matters more for survival: access to capital, or regulatory speed and predictability?Drop your thoughts in the comments below.If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps0:00  Intro: Is the U.S. losing the biotech arms race? 1:10. "Frogs in the Mud": Why D.C. policy misses the mark 3:45  The 20-year Chinese strategic plan for biotech 6:15  How IRA price controls stifle American innovation9:30  Strategic prioritization: Can the U.S. catch up? 12:50  The $350B patent cliff and global market impacts 16:20  Navigating the "Valley of Death" for startups20:05  Clinical trial speed: Why China is outperforming the U.S.24:30  SBIR breakthrough: New hope for early-stage funding28:10  The "Playbook for Congress" and the road to 2030DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

Filmed live at the JPMorgan Healthcare Conference 2026, this episode of the Making Medicine Podcast examines how global power shifts are reshaping the pharmaceutical industry. This Part 1 conversation features host John Stanford with former Senator Richard Burr and EU Commissioner Phil Hogan as they discuss whether the pharmaceutical industry is losing its long-held “geopolitical immunity.” As thousands of leaders gather in San Francisco for the year’s biggest healthcare event, the discussion offers a roadmap for navigating the shift from business as usual to a new era of geopolitical scrutiny.What do you think is the biggest "opportunity in the chaos" for biotech in 2026?Do you believe the FDA will become more or less predictable under the current administration?How should global pharma companies prepare for the rise of "MAHA" and lifestyle-focused health policy?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps0:00 Welcome to Making Medicine0:47 Meet the Panel: Senator Richard Burr & Commissioner Phil Hogan2:21 2026 Outlook: The Disruptive Impact of the Second Trump Admin3:51 Finding Opportunity in Policy Chaos6:06 Why Pharma Lost Its "Geopolitical Immunity" in Trade8:44 Most Favored Nation (MFN) and Global Pricing Realities10:14 Defining "MAHA" and the Future of Health Policy11:43 The Power of Direct Engagement: Bringing CEOs to the Hill15:02 The FDA in 2026: Stability vs. Disruption17:49 AI and Robotics: The New Subsectors of Medicine19:08 China, Russia, and the Protection of the Single Market25:15 2026 Predictions: Cultural Shifts and Economic Roller CoastersDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode of the Making Medicine Podcast, John Stanford previews new CMS drug pricing proposals and explains how they could shape biotech investment and innovation. The conversation looks ahead to the JPMorgan Healthcare Conference, where policy, capital formation, and global competition are expected to drive discussion. The episode breaks down the Globe and Guard Medicare models, their potential impact on R&D, and what founders and investors are watching next. It also explores how pricing uncertainty can influence early-stage biotech and global competitiveness. Finally, the listener Q&A highlights where AI is gaining traction across therapeutic areas.Join us in San Francisco:https://www.eventbrite.com/e/innovation-at-a-crossroadsbiopharma-policy-in-an-era-of-global-competition-tickets-1965538834565?aff=oddtdtcreatorClick here to be featured in an Incubate short:https://calendly.com/grace-incubatecoalition/incubate-shorts-jpm-2026?month=2026-01 What should innovators and investors watch most closely as these proposals move forward?How might policy signals from JPM influence biotech decision-making in 2026?Where do you see the biggest opportunities for AI in medicine right now?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 Welcome and disclaimers0:17 Episode overview and JPM preview0:50 Why Incubate produces Making Medicine1:43 Why policy matters at JPM 20263:30 CMS announces new drug pricing proposals4:26 Globe Part B and Guard Part D explained5:53 Comment period and policy intent6:45 Global pricing and international context8:47 Implications for biotech innovation10:17 Listener Q&A: AI in drug development11:56 Closing thoughts and JPM logisticsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this New Year episode of the Making Medicine Podcast, we revisit a full-length conversation with U.S. Senator Thom Tillis of North Carolina, focused on the policies shaping US life sciences. The discussion explores intellectual property, drug pricing dynamics, regulatory balance, and how innovation ecosystems grow at the state and national level. The episode examines approaches to sustaining research and development while maintaining global competitiveness. It also considers the long-term implications of regulatory uncertainty and international competition.Which policy issue do you think most impacts biotech innovation today?How should decision-makers balance affordability and long-term R&D investment?What does the US need to maintain leadership in life sciences?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Episode disclaimer 0:17 Welcome to Making Medicine and episode overview0:30 Why this conversation matters for 20261:24 Introducing Senator Thom Tillis2:16 Building a life sciences ecosystem in North Carolina3:43 Economic impact of biotech investment4:27 Tax and regulatory strategy for innovation7:52 Balancing reform and economic stability9:58 Why intellectual property matters for life sciences 12:18 Government involvement and innovation risks13:51 Drug pricing policy and unintended consequences17:05 R&D investment impacts and innovation trade-offs20:26 Global competition and China’s growing role22:55 Changing the narrative around life sciences26:52 What’s next after public service28:58 Closing reflections and future outlookDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this special holiday episode, the Making Medicine Podcast looks back at standout conversations since the show’s July relaunch, covering biotech innovation, research funding, and global competitiveness. Highlights include discussions with industry leaders on venture capital, R&D stability, manufacturing, and the importance of a connected life sciences ecosystem. The episode also revisits conversations on international competition, commercialization challenges, and how policy choices shape innovation outcomes. Together, these moments underscore why long-term investment and coordination across the value chain matter for patients and progress.Which conversation stood out most to you this year?What policy or innovation topic should we explore more deeply in 2026?How do you see global competition shaping the future of biotech?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 Show disclaimer and welcome0:23 Holiday greeting and episode overview1:00 Industry snapshot and biotech competitiveness3:36 R&D funding, NIH, and innovation stability5:36 Global competition and maintaining leadership8:23 Risks and resilience of the innovation economy8:46 Policy ideas to support US biotech14:12 Global perspectives on commercialization and pricing17:20 Integrating early innovators and large pharma21:27 Policy, pricing, and innovation trade-offs27:37 IP, R&D incentives, and unintended consequences28:23 Closing reflections and looking ahead to 2026DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this year-in-review episode, we break down key biotech investment trends from 2025, major policy developments in Congress, and what they mean for innovation and patients. The conversation covers defense-related biotech priorities, healthcare affordability challenges, PBM reform efforts, and capital access for early-stage companies. We also preview new data on venture investment, emerging therapeutic areas, and AI-enabled drug development. The episode closes with a look at recent FDA approvals that highlight real progress reaching patients. What stood out to you most in the 2025 biotech investment data?How do you see policy shaping innovation and capital formation in the year ahead?Which FDA approval gives you the most optimism for patients?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Disclaimers and welcome0:23 Year in review overview: biotech, policy, and innovation0:45 Congress wraps up the year and the FY2026 NDAA1:32 Healthcare legislation and premium pressures3:19 PBM reform efforts and legislative outlook5:39 Capital access update and the Invest Act7:32 2025 biotech investment data preview8:00 Leading therapeutic areas and rare disease trends8:41 Geographic investment highlights by state9:21 Investment by congressional district10:16 AI-enabled biotech investment trends10:46 FDA approvals corner12:31 Closing thoughts and year-end reflectionsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

This episode breaks down how Congress is turning biotechnology into a core national security priority. John Stanford explains the biggest shifts in the 2025 defense bill, why China-focused guardrails are expanding, and how new investment rules could reshape biotech funding. We also cover a new bipartisan proposal to create a government-backed investment fund, and a high-stakes battle over ACA subsidies.What NDAA change do you think will impact biotech most?Should the U.S. invest directly in emerging biotechnologies?How should policymakers balance security with scientific innovation?  If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true   Timestamps:0:00 Disclaimers & Intro0:23 NDAA Overview and Why It Matters1:54 Biotech as a Strategic National Security Capability2:54 Domestic Biomanufacturing & Supply Chain Priorities3:19 DoD Bioindustrial Base & New Biotech Office4:34 Data Standardization, AI Readiness & Security5:07 Guarding the U.S. Biotech Ecosystem from China7:09 Intelligence Community’s New Biotech Role8:00 Outbound Investment Regime Explained10:12 Implications for Investors & Biotech Leaders12:42 The Independence Investment Fund Act14:37 Why Congress Wants a Government-Backed Biotech Fund14:40 Senate Showdown on ACA Subsidies & Healthcare Costs17:36 Why Access and Innovation Are Interconnected18:17 Closing Thoughts & Call for QuestionsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode of Making Medicine, host John Stanford sits down with Senator Thom Tillis, the first sitting U.S. Senator to join the show. Tillis opens up about his relationship with President Trump, the impact of Most Favored Nation (MFN) drug pricing on U.S. innovation, and the forces shaping America’s biotech competitiveness. They discuss why predictable intellectual property and regulatory frameworks are critical for investment and how the U.S. can maintain a leading edge in life sciences. Don’t miss Tillis’s insights on why he chose not to seek reelection and what might come next for his career.This is a must-listen for anyone interested in biotech policy, life sciences innovation, or U.S. global competitiveness.What do you think about MFN-style pricing in the U.S.?How can policymakers best support biotech innovation?Which part of the life sciences ecosystem do you think needs the most attention right now?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Introduction to Making Medicine and Senator Thom Tillis1:12 Tillis joins the podcast as the first sitting Senator2:05 Early career and motivations in public service4:20 Relationship with President Trump and MFN drug pricing7:35 Potential impacts of MFN-style controls on U.S. innovation 10:10 America’s global biotech competitiveness and China13:50 Importance of IP and regulatory predictability for investment16:25 Reflections on policy successes and challenges18:40 Decision not to seek reelection 20:30 What’s next for Senator Tillis22:00 Key takeaways on biotech policy and U.S. innovation24:15 Closing thoughts and call to actionDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode of the Making Medicine Podcast, John Stanford sits down with Daphne Zohar, Founder, CEO, and Board Member of Seaport Therapeutics to explore the forces shaping today’s biotech ecosystem. Daphne shares her entrepreneurial path from PureTech to Seaport, offering a rare inside look at building companies, catalyzing innovation, and scaling breakthrough science. The conversation dives into the Massachusetts biotech flywheel, competitiveness with China, U.S. policy risks like the pill penalty and MFN, and how regulatory uncertainty ripples through capital formation and patient impact. Daphne also highlights why she’s bullish heading into 2026 and offers tactical advice for founders gearing up for JPM. What part of Daphne’s perspective resonated most with you?Which policy issue do you believe will most affect biotech innovation in 2025?What should we ask her next time she joins the show?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Welcome & Introduction1:12 Daphne Zohar’s Path into Biotech3:05 The Seaport Therapeutics Story6:10 Biotech Hangout & CEO Sisterhood8:42 Why Massachusetts Leads in Biotech10:55 The M&A Flywheel & Metsera Deal13:40 China’s Biotech Strategy & U.S. Competitiveness16:20 Pill Penalty, EPIC Act & Drug-Pricing Distortions18:55 MFN Proposals & Impact on Early-Stage Biotechs21:30 FDA Uncertainty: Regulation, Capital & Patients24:00 Positive Signals Heading Into 202626:15 JPM Outlook & Advice for FoundersDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this special Tokyo edition of the Making Medicine Podcast, John Stanford hosts a powerhouse panel of biotech investors, founders, and industry leaders to break down Japan’s emerging life-sciences boom. Together, they explore Japan’s regulatory shifts, government incentives, and rising startup momentum. This episode unpacks how Japan is positioning itself as a global hub for regenerative medicine, gene therapy, and bioeconomy innovation. Whether you're a policymaker, entrepreneur, or simply curious about global biotech trends, you'll get a front-row seat to Japan’s life sciences ecosystem, and why the rest of the world is watching.What part of Japan’s biotech ecosystem surprised you the most?Do you think global biotech companies should be paying more attention to Japan? Why or why not? Where do you see the biggest opportunity for Japan to lead in biotech?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps:0:00 Introduction: Why We’re Recording in Tokyo2:45 Japan’s Biotech Vision: From Strategy to Reality6:10 Role of Government & Public-Private Partnerships9:20 Innovation Hubs: Shared Labs & Incubators12:05 Investment Landscape: VCs, Funds & Incentives15:30 Regenerative Medicine & iPSC Development18:45 Gene & Cell Therapy Trends in Japan22:00 Regulatory Reform & Drug Approval Acceleration24:45 Global Biotech Partnerships: Japan’s Reach Abroad27:10 Challenges: From Risk-Averse Culture to Commercialization29:50 The Bioeconomy: Beyond Pharmaceuticals32:15 What’s Next: Predictions for Japan’s Biotech FutureDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

Former Sutro Biopharma CEO Bill Newell joins host John Stanford to discuss the realities of leading a biotech company through economic uncertainty, long development timelines, and a shifting policy landscape. Bill shares lessons from 16 years at the helm, raising over $1.6 billion, navigating clinical trials, and building partnerships with global pharma leaders. The episode dives deep into the challenges of price controls, intellectual property reform, and the importance of FDA consistency for innovation. A must-watch for anyone interested in how science, policy, and investment intersect to bring new medicines to life.What surprised you most about the biotech development process?How do you think policymakers should balance access and innovation?Do you agree with Bill’s stance on price controls and IP reform?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode, John Stanford breaks down the surge in U.S. biomanufacturing investments, including Virginia’s new $500B hub, and what it means for the nation’s workforce. He contrasts this expansion with the recent closure of Arena BioWorks, raising questions about the balance between onshoring and sustaining innovation. The discussion also dives into major rumors of a potential Medicare-GLP-1 deal with Eli Lilly and Novo Nordisk and explores the possible implications of new CMS demonstration projects that could impact Part B manufacturers. Finally, John reflects on the growing pressure of tax and pricing policies that could reshape the biotech landscape. Do you think the U.S. is striking the right balance between manufacturing and innovation? How might Medicare coverage of GLP-1 drugs change the healthcare system? What policy signals should Congress send to protect early-stage biotech?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true0:00 Disclaimer and introduction0:23 Welcome to the Making Medicine Podcast0:57 FDA leadership shakeup and industry uncertainty2:06 Arena BioWorks closure and policy contrasts2:32 FDA predictability and regulatory challenges3:28 Medicare and GLP-1 coverage discussion4:08 New FDA guidance on biosimilars and gene editing5:00 FDA moves to reduce biosimilar development costs5:49 Gene editing progress and regulatory flexibility6:53 Impact of pricing and revenue policies on innovation7:48 Arena BioWorks shutdown and biotech investment climate10:40 Virginia’s new manufacturing hub and workforce initiative13:14 White House drug pricing rumors and CMMI demonstration projects17:39 Closing thoughts and call for engagement DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode of Making Medicine, host John Stanford unpacks the Senate HELP Committee hearing on “The Future of Biotech.” From China’s accelerating investment to U.S. policy uncertainty, he explores what’s needed to protect American leadership in life sciences. The episode also covers new White House biosimilar announcements, gene therapy market challenges, and early insights from Incubate Policy Lab’s investment analysis. With over $14 billion invested in early-stage biotech this year, the conversation turns to what’s next for U.S. innovation.Do you think U.S. biotech can stay ahead of China? What policies would best support innovation? Should biosimilars have faster, simpler approvals?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 – Intro and disclaimer0:23 – Senate hearing: “The Future of Biotech” overview1:19 – China’s biotech rise and U.S. competitiveness concerns2:10 – IP protection, FDA modernization, and investment flight3:30 – NIH funding stability and bipartisan support4:00 – PBM reform and patient access challenges6:00 – John Crowley’s warning: U.S. could lose biotech leadership in 2–3 years8:00 – Incubate Policy Lab report: “Red lights in the U.S., green lights in China”10:00 – Policy solutions: pricing predictability and IP certainty12:00 – White House biosimilars announcement explained14:00 – Gene and cell therapy market struggles15:30 – AI-driven biotech investments and top-performing states17:00 – Incubate at JPM 2026 + FDA during government shutdown18:12 – Closing thoughts and audience shout-outsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John breaks down the White House headlines, the FDA’s new wave of priority review vouchers, and September approvals, then celebrates National IP Month with guest Joshua Kresh. We dig into criteria for the new wave of CNPVs, domestic manufacturing pushes (Augmentin XR and ketamine), and why some approvals matter for patients who’ve run out of options. John also unpacks the Orphan Cures Act debate, the latest CBO chatter, and what it all means for long-term innovation. Finally, Joshua explains why IP is the backbone of biotech and flags fixes on eligibility, injunctions, and PTAB. Tell us what you think and we may feature your comment next week.What’s your take on the FDA’s new voucher selections - smart acceleration or risky subjectivity? Should Congress protect the Orphan Cures Act or revisit it in light of CBO’s estimates?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 Disclaimers0:23 Welcome & episode setup0:46 Headlines: White House update & FDA Vouhcer program1:20 FDA criteria & first recipients (overview)3:00 Domestic manufacturing: Augmentin XR & ketamine3:55 Approvals Corner: September FDA approvals4:54 Orphan Cures Act: fix, CBO score & repeal talk6:49 Tracking investor sentiment: life science & rare disease8:05 National IP Month intro8:47 Guest Joshua Kresh & IPI’s mission12:36 The big IP issues: eligibility, injunctions (RESTORE), PTAB24:49 Outro & call to actionDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John Stanford breaks down Day 15 of the federal shutdown’s impact on health agencies, major pullbacks in cell & gene therapy, and the White House’s latest MFN-style deal with AstraZeneca following Pfizer. We’re joined by Incubate’s Policy Director John Guy to explain how “BIOSECURE” found new life inside the Senate’s NDAA and what that means for biopharma. We also cover investment trends, workforce concerns, and the new DoD Biotech Management Office mandate. Stick around to the end for how all this could reshape U.S. innovation and supply chains. How will MFN-style deals affect launch strategy and U.S. pricing? Do recent exits by Novo Nordisk and Takeda change your outlook on cell & gene therapy? What’s your biggest question about BIOSECURE's due-process path and NDAA timing? DOD 1260H List: https://media.defense.gov/2025/Jan/07/2003625471/-1/-1/1/ENTITIES-IDENTIFIED-AS-CHINESE-MILITARY-COMPANIES-OPERATING-IN-THE-UNITED-STATES.PDF If you're new to the Making Medicine Podcast, we're happy you're here!Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Disclaimer0:23 Welcome & agenda0:47 Shutdown Day 15: CDC RIF confusion2:29 Court injunction + earlier HHS/FDA/NIH cuts2:49 Cell therapy pullbacks (Novo, Takeda)3:58 Investment slump in cell & gene therapy5:21 Policy clarity, China context & hope6:00 AstraZeneca White House MFN deal vs Pfizer8:07 NDAA intro & Biosecure refresher9:40 Interview: What is Biosecure? (John Guy)12:19 Biosecure 2.0 details: DOD 1260H list, OMB review & due process14:43 NDAA path, DoD Biotech Office, workforce & wrapDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John Stanford reports from Boston - the beating heart of global biotech - with insights from investors, scientists, and executives shaping the future of life sciences. He breaks down what the government shutdown means for FDA operations, unpacks the White House–Pfizer deal, and shares key takeaways from conversations on U.S. competitiveness, biotech investment, and the next generation of talent and technology.How do you see policy uncertainty affecting biotech innovation?Are U.S. policies doing enough to keep the next generation of scientists here?What biotech breakthroughs excite you most right now?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 Disclaimer: Not medical or investment advice0:23 Welcome from Boston - biotech capital of the world1:11 Government shutdown and FDA operations2:06 What’s paused at the FDA and why it matters2:29 Understanding the White House–Pfizer deal3:19 MFN pricing, TrumpRx, and tariff waivers4:07 Pfizer’s $70B U.S. investment and industry implications4:29 Key takeaways from Boston investor meetings4:58 Policy uncertainty and its impact on biotech investment5:29 Interest rate cuts and biotech’s comeback potential6:07 The growing threat to U.S. scientific talent6:33 The “brain drain” and its implications for America’s biotech future7:22 Boston’s role in championing life sciences7:50 Exciting new biotech modalities: gene therapy, RNA, and cell engineering9:34 Policy clarity, workforce development, and scientific momentum10:20 Closing thoughts: innovation across America10:40 Outro and call to action DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

This week, John Stanford breaks down the government shutdown and its impact on FDA, NIH, and biotech innovation. He also covers the surprising lapse of the SBIR program, what it means for early-stage biotech funding, and the fierce political debate around its future. Plus, we analyze President Trump’s deal with Pfizer on “Most Favored Nation” drug pricing and his latest tariff threats.What does all this mean for the future of U.S. biotech competitiveness?How should policymakers balance affordability and innovation in drug pricing?Do you think the SBIR program will be quickly revived, or is this the start of bigger changes?What impact will tariffs and MFN drug pricing have on biotech investment?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Welcome to Making Medicine0:21 Government shutdown and biotech impact1:05 FDA furloughs and regulatory slowdowns2:00 NIH delays and research funding concerns2:40 Investor confidence during shutdowns2:57 SBIR & STTR programs expire3:22 Political stalemate in the Senate3:50 Why SBIR matters for biotech innovation4:05 Trump & Pfizer announce MFN drug pricing deal5:06 Trump RX website and drug access6:05 Market reactions and industry uncertainty6:36 Trump’s 100% pharma tariff threat7:40 Section 232 investigations on drugs and PPE7:59 Closing thoughts & audience Q&ADISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John Stanford breaks down the White House autism event, the debate over shifting SEC reports to twice-yearly, and how MFN pressure is reshaping pricing strategy - before welcoming Endpoints News’ Max Bayer for a wide-ranging Press Pass on tariffs, GLP-1s, and China’s biotech surge. We unpack what “success” might look like for the administration’s drug-pricing push, why insurers could make or break any DTC effort, and how policy whiplash is hitting rare disease developers and investors. Max shares on-the-ground reporting about China’s rapidly built “Cambridge-like” ecosystems and the risks of restricting out-licensing. We also discuss the stakes for U.S. competitiveness if Europe becomes the default partner. Stick around to the end for how we’re tracking MFN and IRA signals across company filings.Should SEC reporting shift to twice a year for biotechs, or does that cut needed transparency?If you're new to the Making Medicine Podcast, we're happy you're here!Follow us for more:https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueFollow Max Bayer https://www.linkedin.com/in/max-bayer-20435179Timestamps:0:05 Welcome to Making Medicine0:36 Headlines: White House autism event & fallout1:34 SEC filings: quarterly to semiannual debate2:13 Press Pass: Max Bayer (Endpoints News) joins2:39 “Totality” of actions - MFN, tariffs, vaccines, China deals4:10 Investor lens: regulatory continuity & rare disease shocks6:01 MFN behavior shifts (e.g., UK pricing moves)8:39 What counts as success? GLP-1 pricing & insurer role12:11 China’s biotech surge & the out-licensing boom15:03 Policy options: restrictions vs. U.S. competitiveness (Europe risk)17:20 U.S. ecosystem headwinds: jobs, patents, visas, funding23:51 Outro, subscribe, and where to send tips for Max DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

This week, John Stanford dives into the UK’s pharmaceutical challenges, including ABPI’s warning about declining competitiveness and major companies pausing investment. We also explore the debate over direct-to-consumer drug advertising in the U.S. and how it ties into investment decisions and the pill penalty. Finally, we close with August’s FDA approvals, celebrating breakthroughs for rare diseases and cancer patients.What do you think?Can the UK become Europe’s life sciences hub by 2030?Should the U.S. rethink DTC advertising, or does it play a vital role in innovation?Which of this month’s FDA approvals excites you most? If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps: 0:00 Welcome to Making Medicine0:28 UK pharma outlook and ABPI report1:37 Weaknesses in UK drug investment2:24 Companies pausing UK investments3:08 U.S. vs UK drug access and pricing4:08 Global pressure for fair drug pricing4:33 MFN pricing concerns in the U.S.5:09 Debate over drug advertising6:09 How DTC ads affect biotech investment7:26 Connection to the pill penalty7:48 FDA Approvals Corner – August highlights8:17 Jazz Pharmaceuticals – Modeyso approval8:36 Boehringer Ingelheim – Hernexeos approval9:17 Other rare disease drug approvals10:23 Closing thoughts & FDA wins DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John Stanford reflects on Incubate’s own holiday, September 13th (9/13), and the ongoing fight to end the pill penalty through the EPIC Act. He also covers the latest developments on tariffs, HHS hearings, FDA’s new rare disease principles, and the future of the SBIR program. We close with new research on how the IRA is affecting biotech investment.What are your thoughts on the pill penalty?Do you think FDA’s new rare disease guidance will accelerate innovation?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Welcome to Making Medicine0:32 9/13 and the pill penalty explained1:37 Incubate’s advocacy: EPIC Act and campaigns2:31 Life Science Investment Tracker: discontinued drugs & programs3:02 Trump tariffs and pharmaceutical exemptions4:06 Japan deal and Most Favored Nation strategy4:22 RFK Jr. Senate hearing on vaccines, IRA, and drug pricing5:37 The trap of list prices in policy debates5:39 FDA’s new Rare Disease Evidence Principles (RDEP)6:34 Why clarity matters for rare disease companies6:36 SBIR program renewal and uncertainty ahead7:09 NPC survey on the IRA’s impact on investment7:51 Closing thoughts & call to actionWe’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.