Making Medicine

Incubate Coalition

There's a scientific breakthrough in your medicine cabinet. But how did it get there? At a time when medicines are helping us all live longer and healthier lives, this podcast will explore where these taken-for-granted miracles come from, how many of them almost never happened, where the life science ecosystem is taking us next, and most importantly, what it means for patients. From chance meetings that led to new ideas, to risky investments that never pay off, hear from the people behind today's and tomorrow's treatments, vaccines, technologies, devices, and yes, cures. In this golden age of health discovery and innovation fueled by record breaking investment in the life sciences, we'll bring guests who really understand what it means to be Making Medicine.

  1. 5d ago

    Inside the COINS Act: How Treasury’s China Rule Could Reshape Drug Development

    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

  2. Oct 22

    Myths vs. Facts: China, Biotech, and National Security

    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 ​

  3. Oct 15

    Biotech Boom, Drug Lag: Japan's Innovation Paradox

    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

  4. Oct 8

    Ohio’s Biotech Boom: Gene Therapy, Investment & the Race with China

    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

  5. Oct 1

    AI in Drug Discovery: What Works, What’s Hype & What Comes Next

    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

  6. Sep 24

    China’s Biotech Rise: Clinical Trials, Drug Development & U.S. Competition

    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

  7. Sep 17

    Biotech’s Biggest Stories: Drug Pricing, Access & R&D

    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

  8. Sep 10

    9 Years vs. 13: The Problem With the Pill Penalty

    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

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About

There's a scientific breakthrough in your medicine cabinet. But how did it get there? At a time when medicines are helping us all live longer and healthier lives, this podcast will explore where these taken-for-granted miracles come from, how many of them almost never happened, where the life science ecosystem is taking us next, and most importantly, what it means for patients. From chance meetings that led to new ideas, to risky investments that never pay off, hear from the people behind today's and tomorrow's treatments, vaccines, technologies, devices, and yes, cures. In this golden age of health discovery and innovation fueled by record breaking investment in the life sciences, we'll bring guests who really understand what it means to be Making Medicine.

Information

  • Creator
    Incubate Coalition
  • Years Active
    2021 - 2026
  • Episodes
    101
  • Rating
    Clean
  • Copyright
    © Copyright Making Medicine Duality
  • Show Website
    Making Medicine

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