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Artificial intelligence could transform drug discovery and biotech, but not necessarily in the ways the biggest AI predictions suggest. Where can AI actually make drug development faster and more efficient, and where does the hype collide with the realities of biology? In this episode of the Making Medicine Podcast, host John Stanford sits down with Dr. Thomas Kaiser, co-founder and Chief Scientific Officer of Avicenna Biosciences and operating partner at DCVC Bio, for a deep dive into AI, machine learning, drug discovery and the future of biotechnology. Dr. Kaiser shares how Avicenna used a focused machine-learning approach to design two clinical candidates after making just 11 compounds, compared with the hundreds or thousands of molecules traditionally needed to identify a clinical candidate. He also explains how the company has advanced its ALS program toward first-in-human trials while operating with roughly $25 million in funding. But this isn't another conversation about AI replacing scientists. Thomas explains why unreliable and irreproducible scientific data can limit AI models, why drug development still requires years of validation, and why claims that AI could deliver “100 years of biotech in the next 10 years” run into enormous scientific and financial constraints. His takeaway is simple: “Good ideas are cheap. Durable ideas are the hard part.” We explore 🔹 How AI and machine learning are actually being used in drug discovery 🔹 How Avicenna found two clinical candidates after making just 11 compounds 🔹 Why bigger datasets aren't always better for AI drug design  🔹 The reproducibility problem hiding inside scientific literature 🔹 Why AI can't eliminate the decade-long realities of drug development 🔹 The math behind claims of “100 years of biotech in 10 years” 🔹 Where AI could genuinely transform clinical candidate design 🔹 How electronic health records could unlock new drug discoveries 🔹 Why fragmented U.S. healthcare data could become a competitive disadvantage 🔹 China's growing role in global biotech and drug development 🔹 What the U.S. can learn from faster clinical trial systems abroad 🔹 The pill penalty and investment in small molecule medicines Thomas also explains where he believes AI can be transformative. When researchers understand the biology and translational pharmacology and can clearly define what a medicine needs to accomplish, AI can become a powerful tool for solving complex drug-design problems. John and Thomas examine whether fragmented U.S. health data could leave American researchers at a disadvantage to countries with centralized health records, China's growing capabilities in drug development, and how faster clinical trial systems such as Australia's could offer lessons for the United States. Ultimately, the future of AI in medicine may depend less on making bigger promises and more on understanding exactly where the technology works, where it doesn't, and how scientists can use it to develop better medicines more efficiently. Read Tom’s op-ed https://www.biospace.com/drug-development/opinion-ai-will-only-revolutionize-drug-discovery-and-development-if-we-play-to-its-strengths Join the Conversation ⬇️ Where do you think AI will have the biggest impact on drug discovery and development? Are expectations for AI in biotech moving faster than the science itself? Could fragmented healthcare data become one of America's biggest disadvantages in the global race for biotechnology innovation? Drop your thoughts in the comments below 👇 👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, policy and innovation shaping how medicines are discovered, developed and delivered to patients. 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 00:00 AI, Biotech & the Future of Drug Discovery 01:41 From Biotech Founder to Biotech Investor 05:38 Avicenna's ALS Drug & First-in-Human Trials 07:41 Building a Biotech With $25 Million  09:49 How Avicenna Uses AI Differently 11:57 11 Compounds, 2 Clinical Candidates 14:54 What the AI Drug Discovery Hype Gets Wrong 18:03 Why AI Can't Replace Drug Development 23:38 100 Years of Biotech in 10 Years? 26:07 Where AI Can Transform Drug Discovery  28:19 Is U.S. Healthcare Data a Competitive Disadvantage? 32:48 Can Foreign Health Data Work for U.S. Patients? 35:47 Japan's Biotech Investment Challenge 36:53 China and the Global Biotech Race 40:19 Speed vs. Safety in Clinical Trials  42:03 Why Australia Can Start Clinical Trials Faster 44:49 Rethinking Risk and Patient Safety 46:15 The Pill Penalty & Small Molecule Innovation DISCLAIMER: We're reporting on and discussing developments in medicine, biotechnology and healthcare policy, not making medical recommendations. For personal health questions, always consult a qualified healthcare professional.  #ArtificialIntelligence #DrugDiscovery #Biotech #DrugDevelopment #MakingMedicine

China’s biotech industry is expanding rapidly, reshaping clinical trials, drug development, licensing and the global competition for biomedical innovation. What can the United States learn from what’s happening in China? In this episode of the Making Medicine Podcast, host John Stanford sits down with Tim Scott, President & CEO of Biocom, following a biotech delegation trip to Shanghai. Tim shares his firsthand observations of China's life sciences ecosystem, including its approach to clinical trials, patient registries, drug development, biotech investment and pharmaceutical partnerships.  The conversation examines why major pharmaceutical companies are increasingly looking to China for innovation, how China's investigator-initiated trial system can accelerate development, and what the scale of China's biotech ecosystem could mean for global medicine. We explore 🔹 Why pharmaceutical companies are increasingly partnering with Chinese biotech 🔹 How China's investigator-initiated clinical trials work 🔹 Patient registries and trial-ready cohorts 🔹 Why China's biotech ecosystem is expanding so quickly 🔹 How drug development and licensing are changing globally 🔹 The role of biosecurity and scientific collaboration 🔹 NIH funding, workforce development and U.S. biotech innovation 🔹 What it takes for the United States to remain competitive in biotechnology 🔹 How AI could reshape the global biotech landscape One of the episode's central ideas comes from Tim's “playing to win” analogy. Rather than focusing only on limiting competitive threats, he argues that U.S. biotech leadership also depends on continued investment in research, clinical trials, manufacturing, workforce development and scientific innovation. The discussion also explores the tension between competition and collaboration. Tim describes China and the United States as both competitors and participants in an increasingly interconnected global life sciences ecosystem. His observations offer a firsthand look at how China's biotech capabilities are evolving and what those changes could mean for drug development worldwide. Join the Conversation⬇️ How significant is China's growing role in global biotech? What factors will determine the future of U.S. leadership in biomedical innovation? And where should the balance between international collaboration, competition and protecting sensitive biotechnology research be drawn? Drop your thoughts in the comments below👇 👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, policy and innovation shaping how medicines are discovered, developed and delivered to patients. 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 00:00 China Biotech Competition 01:00 California Life Sciences Leadership 07:45 Pharma Licensing Deals in China 13:10 China Clinical Trials & Investigator-Initiated Trials 20:00 Drug Pricing & Biotech Innovation 23:18 Inside Shanghai’s Biotech Ecosystem 25:28 China’s Biotechnology Growth Strategy 35:28 Biosecurity & U.S.-China Biotech Policy 40:20 Competing in Global Biotech 42:10 The Knicks Analogy: Playing to Win 43:20 NIH Funding & U.S. Biotech Innovation 47:35 AI, China & the Future of Biotechnology 49:58 Closing  DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #ChinaBiotech #DrugDevelopment #ClinicalTrials #biotechnology

From billion-dollar drug development bets and looming patent cliffs to drug pricing, patient access and the future of U.S. clinical trials, some of the biggest stories in biotech are connected by one question: what will they mean for the medicines patients ultimately receive? In this episode of the Making Medicine Podcast, host John Stanford breaks down the stories he’s reading and watching across biotechnology, pharmaceuticals and healthcare policy, and explains why they matter beyond the headlines. We begin with the enormous financial risk behind pharmaceutical R&D, including the fallout from a failed clinical trial following a multibillion-dollar biotech acquisition. It’s a reminder that the risk of developing a new medicine doesn’t disappear when a smaller biotech is acquired by Big Pharma. John also examines the approaching patent cliff, as major medicines lose exclusivity and pharmaceutical companies look to M&A and new pipelines for future growth. At the same time, generic drugs and biosimilars could bring lower-cost competition and expanded access for patients. Then, we turn to drug pricing and patient access. What could the latest pricing agreements mean for the proposed GLOBE and GUARD models? And why can an FDA-approved medicine still remain out of reach while insurers determine coverage and prior authorization requirements? Finally, John looks at the growing cost and complexity of conducting clinical trials in the United States, why more early-stage trials are moving overseas, and what potential regulatory reforms could mean for America's ability to compete in drug development. We explore 🔹 The high-stakes financial risk behind pharmaceutical R&D 🔹 How failed clinical trials can affect even the largest drugmakers 🔹 The patent cliff reshaping Big Pharma 🔹 M&A and the search for the next generation of medicines 🔹 GLOBE, GUARD and the changing drug pricing landscape 🔹 Why FDA approval doesn't always mean immediate patient access 🔹 Insurance coverage and prior authorization delays 🔹 Why clinical trials are increasingly moving outside the U.S. 🔹 What regulatory reform could mean for American biotech Join the Conversation ⬇️ Which issue poses the biggest challenge for the future of American medicine: the cost and risk of R&D, drug pricing, patient access or the growing difficulty of conducting clinical trials in the U.S.? What biotech or pharmaceutical story are you watching right now? Drop your thoughts in the comments below 👇 We we are reading CNBC: https://www.cnbc.com/2026/09/08/novartis-novn-del-desiran-drug-trial.html Endpoints: https://endpoints.news/mercks-top-dealmaker-signals-more-ma-as-keytrudas-patent-cliff-nears/ STAT: https://www.statnews.com/2026/09/02/trump-most-favored-nation-drug-pricing-industry-analysts-skeptical/ STAT: https://www.statnews.com/2026/08/26/pancreatic-cancer-drug-rasonque-approved/ NYT: https://www.nytimes.com/2026/09/04/opinion/clinical-trials-drugs-science.html 👍 Subscribe to the Making Medicine Podcast for more conversations about the science, business and policies shaping how medicines are discovered, developed and delivered to patients. 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 00:00 Biotech News: What We’re Reading 00:59 Novartis, Avidity & the Risk of Pharma R&D 04:05 Big Pharma’s Patent Cliff & M&A Strategy 06:49 GLOBE, GUARD & Most Favored Nation Drug Pricing 08:37 FDA Approval vs. Patient Access to Cancer Drugs 11:41 Why U.S. Clinical Trials Are Moving Overseas 14:17 Closing DISCLAIMER: We're reporting on and discussing developments in medicine, biotechnology and healthcare policy, not making medical recommendations. For personal health questions, always consult a qualified healthcare professional.  #Biotech #DrugPricing #DrugDevelopment #PatientAccess #MakingMedicine

Why does a small molecule medicine get nine years on the market before Medicare negotiation while a biologic gets 13? And what does that four-year difference mean for the medicines that do get developed? For 9/13 Day, the Making Medicine Podcast is revisiting some of our most important conversations about the pill penalty and its impact on biotech investment, drug development and patients. Under the Inflation Reduction Act, small molecule medicines become eligible for Medicare drug price setting after nine years, compared with 13 years for biologics. That difference may sound small, but investors and biotech leaders argue it can significantly change the economics of developing a new medicine. In this special episode, host John Stanford explains why some small molecule investment continues despite the pill penalty, why 13 years isn't a “magic number,” and why the later years of a medicine's life can be so important to recovering the enormous cost and risk of drug development. We also revisit conversations with investors, scientists and industry leaders who explain how the 9-versus-13-year distinction factors into real-world decisions about which technologies, companies and medicines receive investment. Plus, we look at the EPIC Act, legislation supported by Incubate that would eliminate the disparity by giving small molecule medicines and biologics the same 13-year timeline. The concern isn't parity for its own sake, the years between nine and thirteen can be some of the most commercially important in a medicine's lifecycle. Shortening that runway for biologics wouldn't fix the underlying incentive problem; it would just extend it to another class of medicines. The question isn't simply whether nine years sounds like enough. It's whether public policy is unintentionally encouraging scientists and investors to pursue one type of medicine over another, and what that could ultimately mean for patients. We explore 🔹 What the “pill penalty” actually means 🔹 Why small molecules receive nine years while biologics receive 13 🔹 Why some investors still fund small molecule medicines 🔹 Why the later years of a drug's commercial life matter 🔹 How the pill penalty can influence biotech investment decisions 🔹 Why small molecules remain important to cancer and other diseases 🔹 What Incubate's Life Science Investment Tracker is finding 🔹 Why investors say policy can influence small molecule vs. biologic development 🔹 How the EPIC Act would address the 9-versus-13-year disparity 🔹 What changing investment incentives could ultimately mean for patients Join the Conversation ⬇️ Do you think small molecule medicines and biologics should receive the same timeline before Medicare negotiation? Should policymakers consider how drug pricing policies affect investment decisions years before a medicine reaches patients? Could the 9-versus-13-year distinction change which medicines ultimately get developed? Drop your thoughts in the comments below 👇 👍 Subscribe to the Making Medicine Podcast for more conversations about the science, policy and investment shaping the future of American medicine. 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 00:00 Why Invest for 9 Years When You Can Get 13? 00:21 What Is the Pill Penalty? 03:32 How the Pill Penalty Changes Biotech Investment 07:49 Why Do Biologics Get 13 Years? 09:16 Why Years 9–13 Matter for Drug Revenue 12:22 Why Small Molecule Drugs Still Matter 19:31 9/13 Day and the EPIC Act 21:24 The Data on Declining Small Molecule Investment 24:33 How Price Controls Affect Biotech Investment 34:40 Do Investors Really Favor Biologics? 36:35 Closing DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #PillPenalty #biotech #drugdevelopment #drugpricing #MakingMedicine

A new pancreatic cancer medicine could double survival time. Its annual list price? $480,000. That number is getting lots of attention, but the economics of bringing breakthrough medicines to patients are more complex than a single price tag can convey. After more than a decade of development and billions of dollars invested, Revolution Medicines has brought a new treatment to patients with metastatic pancreatic cancer, one of the deadliest forms of cancer. Yet much of the public discourse has focused on its $480,000 annual list price. In this episode of the Making Medicine Podcast, host John Stanford examines what that price actually represents and what it can tell us about the costs, risks, and economics of medical innovation. What does it really cost to develop a breakthrough cancer medicine? How much of a drug's list price does the manufacturer actually receive? What role do insurers, rebates and payer negotiations play? And when a medicine clearly works, who should ultimately be responsible for ensuring patients can access it? John examines the economics behind the headline, including Revolution Medicines' reported billions in accumulated losses, the enormous cost and risk of oncology drug development, and the complicated insurance system standing between an approved medicine and the patients who need it. Plus, we break down a packed month of biotech and pharmaceutical policy news in Washington: new Most Favored Nation drug pricing agreements, the CMS GLOBE and GUARD models, U.S. biotech deals involving China, the fight over America's biotechnology competitiveness, and the nomination of Dr. Heidi Overton to lead the FDA. We also look ahead to the next FDA user fee agreement and what changes could mean for smaller, venture-backed biotechnology companies before closing with our FDA Approvals Roundup and the latest medicines reaching patients.   We explore 🔹 Why a new pancreatic cancer drug carries a $480,000 list price 🔹 What Revolution Medicines invested before reaching its first approval 🔹 Why drug list prices don't necessarily reflect what manufacturers receive 🔹 Insurance, rebates, and patient access 🔹 The economics and risks behind developing new cancer medicines 🔹 Most Favored Nation drug pricing and new White House agreements 🔹 CMS GLOBE and GUARD drug pricing models 🔹 U.S. biotech investment, China and national security 🔹 The nomination of Dr. Heidi Overton to lead the FDA 🔹 What the next FDA user fee agreement could mean for biotech 🔹 New FDA approvals across cancer, rare disease and other conditions Join the Conversation ⬇️ When a new medicine costs billions of dollars and more than a decade to develop, how should we determine what a fair price looks like? Should the debate over a $480,000 cancer drug focus more on the manufacturer’s list price or what patients and insurers ultimately pay? How can America make breakthrough medicines accessible to patients while still encouraging investment in the next generation of treatments? Drop your thoughts in the comments below👇 Read Incubate's comments on GLOBE and GUARDhttps://www.incubatecoalition.org/post/incubate-submits-comments-on-globe-guard-comments 👍 Subscribe to the Making Medicine Podcast for more conversations about the science, policy, investment and innovation shaping the future of American medicine. 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 00:00 Why Does a Cancer Drug Cost $480,000? 00:24 Welcome to Making Medicine 01:08 New White House Drug Pricing Deals 03:04 $20 Billion in U.S. Pharmaceutical Investment 03:55 What Drug Price Controls Could Mean for Biotech 06:15 CMS GLOBE and GUARD Explained 08:17 Congress Takes Aim at Biotech Deals With China 10:09 Is China Becoming a Biotech Superpower? 11:03 The Truth Behind the $136 Billion China Biotech Number 13:20 U.S. Biotech, China and National Security 15:36 Who Will Lead the FDA? 17:18 What's Next for FDA and Biotech? 20:00 A Breakthrough in Pancreatic Cancer 22:49 The Economics Behind Revolution Medicines 26:32 What Does the $480,000 Drug Price Really Mean? 27:51 Will Insurers Cover a Drug That Works? 30:21 Why the List Price Isn't the Whole Story 31:23 FDA Approvals Roundup 34:36 Closing DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.   #biotech #drugpricing #pancreaticcancer #pharmaceuticals #fda #MakingMedicine

🇺🇸 Artificial intelligence is reshaping biotech, drug discovery and medicine. But how much of the AI revolution is real, how much is hype, and what could it mean for the future of American medicine? In Part 6 of our How America Makes Medicine series, host John Stanford sits down with physician-scientist and venture capitalist Patrick Malone to explore how AI and machine learning could transform drug development, biotech investing and the way new medicines reach patients. Could AI agents and computational drug discovery allow a handful of people, or even one founder, to build a billion-dollar biotech company? Can better access to clinical trial and regulatory data accelerate innovation? And if AI makes drug discovery faster and cheaper, can it overcome the industry's biggest bottleneck: clinical trials? John and Patrick also examine the future of U.S. biotechnology, FDA modernization, venture capital, China's growing biotech capabilities and what America must do to remain a global leader in life sciences. Plus, John breaks down the latest biotech headlines and traces the evolution of AI in medicine, from early computer models and the Human Genome Project to AlphaFold and today's AI-driven drug discovery platforms. What happens next could reshape how America makes medicine. It’s an important conversation about the future of biotech you can’t afford to miss. We explore 🔹 What's real, and overhyped, about AI drug discovery 🔹 The rise of smaller, AI-powered biotech companies 🔹 Why clinical trials remain a critical bottleneck 🔹 The widening "Valley of Death" for biotech innovation 🔹 Clinical and regulatory data's role in the AI revolution 🔹 FDA modernization and Operation Trial Blazer 🔹 Venture capital and the future of drug development 🔹 U.S. biotechnology leadership and competition with China 🔹 What the next generation of American biotech could look like   This 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 ⬇️ How much do you think AI will change the way new medicines are discovered and developed over the next decade? Could a one-person or small-team biotech really become a billion-dollar company, or is the industry too complex for that model? What should America prioritize most to remain a global leader in biotechnology: AI and data, faster drug development, more investment, or stronger domestic capabilities? 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/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true   Timestamps 00:00  Could One Person Build a Billion-Dollar Biotech? 00:17  How America Will Make Medicine 01:36  This Week in Biotech: Headlines 03:34  The History of AI in Drug Discovery 10:08  Meet Patrick Malone: From Medicine to Venture Capital 15:07  AI Drug Discovery: What's Real and What's Hype? 17:32  The Billion-Dollar Biotech of the Future 21:51  What's Changing in Biotech Venture Capital? 23:49  Is Biotech's Valley of Death Getting Wider? 25:36  Does America Have the Data AI Needs? 29:28  Why Biotech Needs a Stronger Voice in Washington 32:30  Faster Drug Development and Operation Trial Blazer 35:04  U.S. Biotech, China and the Future of Competition 45:58  Closing DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #ArtificialIntelligence #Biotechnology #DrugDiscovery #FutureOfMedicine #MakingMedicine

🇺🇸 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 patients This 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/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps 00:00 Introduction: Venture Capital and the Drug Development Pipeline 01:36 Headlines: mRNA Cancer Vaccine and the FDA 05:15 History: How Venture Capital Became Part of Medicine 07:29 Genentech and the Birth of Venture-Backed Biotech 09:30 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 Strategy 16:00 A Day in the Life of a Biotech VC 19:15 Don't Chase the Headlines: How Investors Evaluate Biotech Data 21:30 Specialist vs. Generalist Capital in Biotech 24:51 What Happens to Medicine Without Venture Capital? 27:15 Washington's Growing Influence on Biotech Investment 30:44 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 America 39:16 Inside a $2 Billion Biotech Exit 43:46 Closing: The Day in the Life of a VC DISCLAIMER: 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 access How 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/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 Timestamps 00:00 Jeremy Levin and America's Biotech Innovation Engine 00:38 Jeremy Levin's Career in Pharmaceutical Innovation 03:04 The "String of Pearls" Strategy 05:37 The Birth of America's Biotechnology Industry 07:19 Why Patients Drive Drug Development 11:56 How Biotech Acquisitions Strengthen Drug Pipelines 16:20 Small Biotech and Larger Pharmaceutical Manufacturers 20:20 Why Small Biotech Drives Drug Innovation 21:43 Drug Pricing, Policy and Biotech Investment 28:10 How Policy Uncertainty Affects Drug Development 38:35 Biotech in the Balance: America's Innovation Advantage 40:57 NIH, FDA and America's Research Ecosystem 42:20 China and the Global Biotechnology Race 46:58 Protectionism and the Future of Innovation 49:09 How America Can Compete Through Innovation 50:44 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 development One 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/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 Timestamps 00:00 Patients Don't Care Where Medicine Comes From 00:35 Why Every Medical Breakthrough Needs an Entrepreneur 01:54 The Bayh-Dole Act and the Birth of Modern Biotech 04:40 How AskBio Was Founded 07:05 Betting on Gene Therapy Before Anyone Else 11:10 Building Biotech Companies Without Venture Capital 16:30 Why SBIR Funding Saves Medical Innovation 19:10 Is China Winning the Biotech Race? 24:20 Lower Drug Costs Through Better Innovation 26:10 AI, Gene Therapy & the Future of Drug Development 34:00 Making Gene Therapies Affordable Worldwide 39:10 When Should a Startup Partner With Big Pharma? 43:40 Lessons From Selling AskBio to Bayer 50:15 AI, Innovation & The Next Generation of Medicine DISCLAIMER: 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 innovation This 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/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 Timestamps: 00:00 Why Research Universities Matter to American Pharmaceutical Innovation 01:28 Meet Kate Hudson of the Association of American Universities 04:20 The History of America's Research Universities 08:32 Why Universities Drive Scientific Discovery 10:42 NIH Funding, NSF Grants & Basic Research Explained 14:09 Why the Free Market Alone Won't Create Medical Breakthroughs 16:05 mRNA Vaccines Took Decades of Research 18:55 The True Return on Investment in Scientific Research 21:18 Why Scientific Talent Matters More Than Ever 24:10 OMB Proposal, NIH Grants & Research Stability 29:20 Why Uncertainty Slows Drug Discovery 33:12 Technology Transfer & How Universities Create Biotech Startups 35:40 Crossing the Valley of Death in Drug Development 38:10 Bayh-Dole, China & America's Innovation Advantage 41:58 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 breakthroughs Throughout 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/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 Timestamps: 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 Manufacturing 8:53 The Biotechnology Revolution | Recombinant DNA & Genentech 11:32 Monoclonal Antibodies, HIV Therapies & Modern Biopharmaceuticals 13:15 The Human Genome Project, Precision Medicine & Gene Therapy 14:45 mRNA Vaccines | Why Medical Breakthroughs Take Decades 16:08 The Five Pillars of American Pharmaceutical Innovation 17:35 Clinical Trials, Patients & The Next 250 Years of Medicine 19:40 How America Makes Medicine | Episode 2 Preview & Subscribe DISCLAIMER: 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 Therapeutics From 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/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 Timestamps: 00:00 Why American Biotech Matters 01:35 FDA Leadership Search 03:14 FDA & China Hearings 05:13 Clinical Trial Competition 06:25 Patent Reform Explained 07:52 NIH Research Security 08:58 Why NIH Funding Matters 09:19 FDA Approvals Corner 11:32 July FDA Outlook DISCLAIMER: 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 Convention One 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/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 Tmestamps 00:00 Japan Drug Lag Explained  01:45 Japan's Biotech Growth Strategy 06:10 Drug Pricing Reform 08:24 Why Japan Misses New Medicines 11:42 Japan's Innovation Advantage 13:35 Building Japan's Startup Ecosystem 14:42 BIO International Convention 16:28 Japan's Global Investment Strategy 19:00 What's Next for Japan Biotech 22:44 Outro DISCLAIMER: 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 advantage One 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=true Timestamps 00:00 Operation Trial Blazer & US Clinical Trials 05:01 BIO 2026 and US Biotech Competitiveness 08:46 Georgia's Life Sciences Growth  12:07 Building the Next Biotech Hub 18:15 Drug Pricing and Biotech Innovation  21:29 Operation Trial Blazer Reforms 22:11 China and US Biotech Competition  26:18 Biotech Workforce Development 30:06 Why Biotech Needs Skilled Trades 33:21 Georgia Life Sciences Summit 35:42 Closing Thoughts DISCLAIMER: 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-investment Join 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/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. Time Stamps 00:00 Intro & Disclaimer 00:16 Investors Say FDA Changes Are Impacting Decisions 03:22 How We Surveyed Investors (Research Design) 07:27 Theme 1: FDA Instability & Investor Uncertainty 10:22 Investors Repricing Risk in Biotech 12:05 “Chaos Is the Only Thing” – Investor Quote 13:00 Theme 2: Pullback from Gene Therapy, Vaccines, Oncology 14:28 Theme 3: Capital Shifting Abroad (China & Competition) 17:02 Theme 4: NIH Cuts & Long-Term Innovation Risk 25:24 Key Takeaway: Regulatory Predictability Drives Investment DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #FDA #BiotechInvesting #HealthcarePolicy #DrugDevelopment #makingmedicine