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What’s moving in biotech policy right now? In this Headlines episode of Making Medicine, host John Stanford runs through the month’s top stories shaping how medicines are discovered, developed, and delivered in America. Leading the headlines is the Faster Clinical Trials Act, a new bipartisan proposal to modernize clinical trials, reduce regulatory delays, and speed up drug development. From there, John covers how Most Favored Nation (MFN) drug pricing is changing launch strategies in Europe, the latest on the COINS Act, why Japan is rethinking its approach to drug pricing, and what October’s investment numbers say about the state of American innovation.  This month’s headlines: 🔹 COINS Act: Where China investment restrictions meet U.S. biotech competitiveness. 🔹 Faster Clinical Trials Act: Five proposed reforms to expand trial access, streamline FDA processes, and support innovation. 🔹 MFN Drug Pricing: Companies reconsider their European launch strategies. 🔹 Japan’s Pricing Reforms: Encouraging signals for innovation and patient access. 🔹 FDA Approvals Corner: Two new treatments approved in October. 🔹 Biotech Venture Capital: About $1.14 billion invested across 50 early-stage deals. 🔹 London Preview: Making Medicine heads to the Jefferies London Healthcare Conference. Taken together, these stories point to one question: can the U.S. remain the best place in the world for new medicines? Watch the full episode for a quick, clear rundown of the policy and market news you need to know this month. Timestamps 00:00 Cold Open: Why Faster Clinical Trials Matter 00:30 Introduction: This Week in Biotech Policy 01:19 Election 2026: What's Next for Biotech? 02:22 Faster Clinical Trials Act: Bipartisan FDA Reform 03:28 Five Proposed Clinical Trial Reforms 05:55 How Faster Trials Could Strengthen Biotech Investment 07:09 MFN Drug Pricing and Global Drug Launches 08:06 Roche and Novartis: Rethinking European Markets 09:20 How MFN Could Impact U.S. Innovation 10:30 COINS Act, China, and Global Competition 11:29 Japan's Drug Pricing Reforms 12:51 FDA Approvals Corner 14:07 October Biotech Investment: $1.14 Billion 15:21 Jefferies London Healthcare Conference 16:19 Closing: The Future of American Biotech Join the Conversation ⬇️ Should Congress prioritize modernizing clinical trials to accelerate drug development and help American patients access new treatments faster? Could Most Favored Nation (MFN) drug pricing policies discourage pharmaceutical companies from launching new medicines in Europe and ultimately weaken U.S. biotech innovation? Can the United States remain the global leader in biotechnology while restricting investment in China and facing growing pressure on drug pricing and research funding? Drop your thoughts in the comments below 👇 👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, investment, and policy shaping the future of 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 DISCLAIMER: This podcast discusses biotechnology, pharmaceutical policy, and healthcare innovation for informational purposes. It does not provide medical advice. Consult a qualified healthcare professional for personal medical questions #FasterClinicalTrialsAct #FDAModernization #MakingMedicine #COINSAct #Biotech #Innovation

Could Treasury’s proposed COINS Act rule make it harder for American patients to get promising new medicines? The proposed regulations would restrict a broad range of transactions with Chinese companies. That could change how U.S. biotech companies partner, invest, and bring new therapies to American patients. But how far does the rule actually reach? In this Making Medicine Press Pass episode, host John Stanford welcomes Max Bayer, Senior Reporter at Endpoints News, to break down Treasury’s proposed COINS Act rule and what it could mean for drug development in the United States. Max shares insights from his reporting and his conversations with Treasury officials. That includes why the rule’s broad language leaves that far from settled for co-development partnerships, joint ventures, and other collaborations. We explore: 🔹 What the proposed rule means for U.S. biotech partnerships and investment involving China. 🔹 Why licensing remains at risk under the rule’s current language. 🔹 How the rule could give China more control over how medicines are developed and who gets access. 🔹 Treasury’s own acknowledgment of potential risks to U.S. public health and American companies. 🔹 Why biotech is not AI or semiconductors: in drug discovery, the promising science U.S. companies want often originates in China. 🔹 How U.S. leadership is holding up, with record U.S. biotech M&A and rising phase 1 trial activity at home. 🔹What policymakers can do instead: target real security risks, make U.S. clinical trials faster and cheaper, and hold China accountable on market access and IP. The question for policymakers: Can the United States address real national security concerns without slowing the medicines American patients are waiting for? Watch the full conversation for an in-depth look at the COINS Act, U.S.-China biotech competition, and the choices that will decide whether America stays the best place in the world to discover, develop, and manufacture new medicines. Timestamps 00:00 Cold Open: Max Bayer Reacts to COINS Act Rules 00:46 Introduction: Treasury’s Proposed China Biotech Restrictions 01:30 FDA Reform and Other Policy Headlines 02:18 Meet Max Bayer of Endpoints News 03:06 Why China Biotech Became a Major Washington Story 04:39 COINS Act and BINSA: Competing Policy Approaches 07:50 Breaking Down Treasury’s Proposed Regulations 08:23 First Reaction: How Tough Are the Biotech Rules? 09:56 Are Pharmaceutical Licensing Deals Exempt? 10:39 What Treasury Told Max About Licensing 12:23 Could Licensing Continue While Collaboration Slows? 15:23 Co-Development and the Future of Biotech Partnerships 18:29 Treasury Acknowledges Potential Public Health Risks 21:38 Regulatory Uncertainty and Investor Decisions 25:20 National Security vs. Medical Innovation 28:22 How Washington Interprets China Biotech Deals 29:11 The $120 Billion Biobucks Debate 33:31 China’s Strategy and International Competition 35:05 Could Europe and Japan Benefit? 39:33 Europe, MFN Pricing, and Global Drug Access 43:46 Could the World Develop Separate Drug Pipelines? 45:28 The Next Generation of Chinese Medicines 46:12 Patient Access and the Ethics of Restrictions 48:50 Can the U.S. Accelerate Its Own Innovation? 51:24 Does America Still Lead in Biotech? 53:00 Closing Thoughts with Max Bayer 53:34 Subscribe to Making Medicine Join the Conversation ⬇️ Should the U.S. restrict biotech investment in China if it could limit Americans' access to new medicines? Do the proposed COINS Act regulations strike the right balance between national security and American biotech innovation? Should pharmaceutical licensing agreements remain exempt from COINS Act restrictions, even when they involve co-development with Chinese companies? Drop your thoughts in the comments below 👇 👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, investment, and policy shaping the future of 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 DISCLAIMER: This podcast discusses biotechnology, pharmaceutical policy, and healthcare innovation for informational purposes. It does not provide medical advice. Consult a qualified healthcare professional for personal medical questions. COINSAct #ChinaBiotech #MakingMedicine #Biotech #DrugDevelopment

Are American biotech companies really sending $120 billion to China? And could restricting U.S. investment weaken America's position in the global biotech industry? As Washington debates biotechnology investment restrictions and national security, Making Medicine host John Stanford examines five common claims shaping the conversation about China, pharmaceutical innovation, and American competitiveness. From the economics of biotech licensing agreements to the role of American venture capital, this episode explores what the headlines may be missing, and why the distinction between announced deal values and actual investment matters.  We explore 🔹 The $120 billion question: Why announced biotech licensing deals don't necessarily represent money actually paid to Chinese companies. 🔹 American innovation: How U.S. biotech companies can develop medicines originally discovered overseas. 🔹 China's biotech ambitions: Why restricting American investment may not stop China's pharmaceutical industry from growing. 🔹 National security: The importance of distinguishing legitimate security threats from investments in therapeutic drug development. 🔹 Winning the biotech race: Why FDA modernization, research funding, intellectual property protection, and venture capital are central to America's competitiveness. Featuring examples involving Summit Therapeutics and Candid Therapeutics, Stanford examines how international partnerships can influence drug development, economic value, and patient access. The central question: Can America strengthen its biotech leadership by restricting China, or should it focus on making the United States the best place in the world to develop new medicines? Timestamps 10:53 Understanding the $120 Billion Headline 11:20 How Biotech Licensing Deals Work 13:35 Myth 2: American Investment Must Stay in America 14:29 U.S. Biotech and Chinese Drug Discoveries 17:29 Myth 3: Cutting Off Investment Will Stop China 18:20 China's Long-Term Biotech Strategy 22:07 Myth 4: Every Biotech Investment Is a Security Risk 23:21 Candid Therapeutics Case Study 26:23 Myth 5: Restricting China Is the Best Strategy 27:11 Strengthening American Biotech 29:22 The Five Myths: Final Takeaways Join the Conversation ⬇️ Should the U.S. restrict investment in Chinese biotech, or prioritize stronger domestic innovation policies? How should policymakers distinguish national security risks from legitimate pharmaceutical partnerships? Can international biotech collaboration strengthen American companies while improving patient access to new medicines? Drop your thoughts in the comments below 👇  👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, investment, and policy shaping the future of 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 DISCLAIMER: This podcast discusses biotechnology, pharmaceutical policy, and healthcare innovation for informational purposes. It does not provide medical advice. Consult a qualified healthcare professional for personal medical questions. #ChinaBiotech #Biotechnology #BiotechInvestment #DrugDevelopment #MakingMedicine ​

Japan has many of the ingredients of a world-class biotechnology ecosystem: leading scientific research, Nobel Prize-winning discoveries, and growing investment. Yet many innovative medicines reach Japanese patients later than in other markets, and some never launch at all. So what explains the gap? In this special Tokyo episode of the Making Medicine Podcast, host John Stanford is joined by Michael Gutbrod, Principal at Santé Ventures, and Marian Nakada, former Vice President of Venture Investments at Johnson & Johnson Development Innovation, for a conversation about Japan’s innovation paradox. Following a week of meetings with Japanese policymakers, biotech executives, and investors, the group explores a key question: how can a country with so many advantages in science and innovation still struggle to attract investment, accelerate commercialization, and ensure timely patient access to new medicines? The discussion examines the strengths that position Japan for success, including government support for biotechnology, growing venture activity, leading academic research, and emerging startup ecosystems. At the same time, John, Michael, and Marian discuss the policies and incentives in Japan that shape investment decisions, product launches, and the future development of innovative medicines. The group discusses whether Japan can fully realize its ambitions as a global biotechnology leader while addressing longstanding challenges around drug pricing. Along the way, the guests share insights from their meetings across Tokyo and discuss the opportunities ahead for Japan's life sciences sector. The conversation also explores: 🔹 Japan's growing biotechnology and life sciences investment opportunities 🔹 AMED funding and support for early-stage biotech startups 🔹 The challenges of translating academic research into commercial medicines 🔹 Why accepting failure matters in biotech entrepreneurship 🔹 Collaboration between universities, startups, investors, and pharmaceutical companies 🔹 Drug pricing and delayed access to innovative medicines 🔹 The relationship between pharmaceutical launches and future R&D investment 🔹 Artificial intelligence, healthcare data, and patient awareness 🔹 Regenerative medicine, radiopharmaceuticals, and emerging technologies 🔹 How companies such as Typewriter Therapeutics could help shape Japan's biotech future The guests also share their experiences meeting Japanese government officials and discuss the opportunities for Japan to build a more connected, internationally competitive biotechnology ecosystem. Join the Conversation ⬇️ Can Japan turn its scientific strengths into a thriving biotech startup economy? What needs to change to accelerate patient access to innovative medicines? Drop your thoughts in the comments below 👇 👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, investment, and policy shaping the future of 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 Japan's Emerging Biotech Ecosystem 01:10 Inside BioLabs Tokyo 02:54 Why Investors Are Looking at Japan 03:44 Government Funding and AMED 06:39 Japan's Scientific Strengths 07:25 Cultural Challenges for Biotech Startups 10:13 Collaboration, Risk, and Innovation 13:31 Meetings With Japanese Policymakers 14:51 Drug Pricing and Economic Pressures 17:08 Japan's Drug Lag and Patient Access 18:14 How Drug Pricing Affects Biotech Investment 20:27 The Pharma Talent and Innovation Ecosystem 22:14 Policy Predictability and Investment 24:31 U.S. Drug Pricing Policy and Japan 26:18 Japan's Political Culture and the Orchid Index 29:33 Funding Future Pharmaceutical Innovation 31:16 Patient Awareness and Access to Medicines 33:19 AI and Healthcare Information 35:20 The Economic Value of Innovative Medicines 37:13 Healthcare Data and AI Opportunities 38:38 Radiopharmaceuticals and Nuclear Medicine 40:06 Japan's Next Generation of Entrepreneurs 42:23 Typewriter Therapeutics and Startup Success 45:11 A Wish for Japan's Biotech Future 47:50 Final Thoughts DISCLAIMER: This podcast discusses biotechnology, pharmaceutical policy, and healthcare innovation for informational purposes. It does not provide medical advice. Consult a qualified healthcare professional for personal medical questions. #JapanBiotech #Biotechnology #DrugDevelopment #LifeSciences #MakingMedicine

Ohio is emerging as a major U.S. life sciences hub, with growing investment in biotech, gene therapy, biomanufacturing and pharmaceutical innovation. But what does it take to build a competitive biotech ecosystem outside traditional hubs like Boston and San Francisco? In this episode of the Making Medicine Podcast, host John Stanford sits down with Eddie Pauline, President & CEO of Ohio Life Sciences, to explore how Ohio is building its biotech ecosystem—and how decisions involving research funding, drug pricing and federal policy could shape what happens next. Eddie explains how research from institutions including The Ohio State University, Cleveland Clinic, Cincinnati Children’s and Nationwide Children’s Hospital is helping fuel the state's growth. Nationwide Children’s alone has been involved in roughly 10% of FDA-approved gene therapies, according to Eddie, helping attract additional gene therapy companies and investment to Ohio. The conversation also examines how Ohio is working to turn world-class research into companies that start, grow and stay in the state, including targeted investment, innovation districts and a planned $40 million life sciences training center designed to strengthen the workforce pipeline. We explore 🔹 Why Ohio is becoming a major U.S. biotech hub 🔹 Gene therapy and Ohio’s innovation ecosystem 🔹 NIH and SBIR/STTR funding 🔹 Building and retaining biotech companies 🔹 GLOBE, MFN drug pricing and biotech investment 🔹 China’s growing biotechnology ambitions 🔹 U.S.-China competition in life sciences 🔹 Biomanufacturing and workforce development 🔹 What comes next for Ohio biotech John also breaks down the newly finalized GLOBE drug pricing model, including its international pricing benchmark, reduced scope and what MFN-style pricing could mean for early-stage biotech investment. Later, Eddie discusses Ohio's engagement with the National Security Commission on Emerging Biotechnology and competition with China. His message is clear: China’s investment and ambition in biotechnology are real, and the United States cannot take its leadership for granted. Join the Conversation ⬇️ Can states like Ohio become the next major centers of American biotechnology? What will determine whether biotech companies build and remain in emerging life sciences hubs? And what must the U.S. do to remain competitive as China expands its biotechnology capabilities?  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 America’s Emerging Biotech Hubs 01:40 GLOBE Drug Pricing & MFN Policy 06:06 Meet Eddie Pauline 10:04 Why Ohio Is Becoming a Biotech Hub 12:32 Gene Therapy & Ohio Innovation 15:22 NIH Funding & Life Sciences Policy 18:07 Building & Funding Ohio Biotech 20:22 Investing in Ohio Life Sciences 22:04 Drug Pricing & Biotech Investment 26:06 U.S.-China Biotech Competition 29:03 Ohio’s Biotech & Biomanufacturing Future  32:56 Closing DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #LifeSciences #GeneTherapy #Biotechnology #Ohio

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 in 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