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

    FDA Leadership After Marty Makary: What Biotech Needs Next

    FDA instability. AI in clinical trials. China overtaking the United States in biotech development. Following news that Marty Makary has stepped down as FDA commissioner, questions around regulatory stability, scientific leadership, and the future of biotech innovation are back in focus. This week on the Making Medicine Podcast, John Stanford examines what the FDA needs most during periods of leadership transition: scientific credibility, regulatory expertise, and a stable, predictable process for developing new medicines. Recorded before the latest leadership announcement, this episode focuses less on personalities and more on the broader institutional questions shaping the future of drug development, clinical trials, AI-enabled regulation, rare disease research, and America’s global competitiveness in biotech. This episode covers:   This episode covers: 🔹 What Marty Makary’s departure could mean for the FDA 🔹 Why FDA stability matters for biotech investment 🔹 The qualities that define effective FDA leadership 🔹 AI, clinical trials, and the future of drug development 🔹 FDA modernization and new approach methodologies 🔹 Rare disease development and regulatory predictability 🔹 Why global biotech competition is accelerating 🔹 How FDA credibility impacts patients, investors, and innovation At the center of the conversation is one core issue: confidence. Confidence that the FDA remains a science-driven institution capable of supporting innovation while ensuring drugs are safe and effective for American patients. Because uncertainty at the agency doesn’t just affect markets — it affects clinical timelines, capital allocation, and ultimately whether treatments reach patients. Join the Conversation ⬇️ Do you think the FDA is becoming less predictable? Should AI play a larger role in clinical trials? Can America maintain its leadership in biotech innovation? Let us know your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you'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 https://www.tiktok.com/@makingmedicinepodcast?lang=en 👍 Like and subscribe for more conversations on FDA policy, biotech investing, healthcare innovation, drug development, gene therapy, AI in medicine, and the future of biotechnology. Timestamps 00:00 Intro & Disclaimer 00:33 Why FDA Leadership Matters 01:00 FDA Leadership Shakeup Explained 01:50 Why FDA Stability Impacts Biotech 02:14 The Cost Of Regulatory Uncertainty 02:59 The Three Qualities Of A Strong FDA Commissioner 03:51 Why Regulatory Experience Matters 04:40 AI & The Future Of Clinical Trials 05:47 America’s Healthcare Data Problem 06:17 Why The FDA Must Lead On AI 06:41 The Limits Of FDA Authority 07:07 Why Investors Need Predictability 07:33 FDA Modernization & Innovation 07:55 Why This Matters For Patients 08:21 Rare Disease Patients & FDA Stability 08:41 Passage Bio’s FDA Setback 09:27 China Surpasses The U.S. In Drug Trials 10:09 What The Industry Wants From The FDA 10:32 Why Stable Regulation Matters DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #FDA #Biotech #AI #ClinicalTrials #HealthcarePolicy #RareDisease #GeneTherapy #DrugDevelopment #China #MakingMedicine

    11 min

  2. MAY 7

    FDA Approvals Corner, Immigration Warnings & Germany's MFN Complication | Making Medicine Headlines

    Gene therapy breakthroughs. The first oral GLP-1 pill. A troubling signal for scientific talent. And a German pricing move that could quietly reshape global drug development. This week on the Making Medicine podcast, John Stanford breaks down four stories shaping the future of life sciences and biotech investment. From the FDA's landmark approval of Regeneron's gene therapy for genetic hearing loss to new survey data showing immigration policy is already influencing where top researchers choose to build their careers — the pressure on the innovation ecosystem is building from multiple directions at once. This episode covers: 🔹 FDA Approvals Corner: Eli Lilly's Foundayo (first oral small-molecule GLP-1 for weight management), Regeneron's Otarmeni (gene therapy for genetic hearing loss), and Merck's Idvynso (once-daily HIV treatment). 🔹 Immigration policy and what a new STAT News survey says about the research pipeline. 🔹 Germany's drug discount proposal and why it complicates the U.S. Most Favored Nation pricing strategy. At the center of all these conversations is one critical question: can the United States maintain the confidence, in its regulators, its talent pipeline, and its pricing environment, that keeps the biomedical innovation engine running? Check out the full STAT News Report https://www.statnews.com/2026/05/04/trump-immigration-policy-stat-survey-measures-science-impact/ Join the Conversation ⬇️ Do you think the FDA is becoming less predictable? Should the US rethink its MFN drug pricing strategy? Can America maintain its leadership in biotech innovation? Let us know your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true 👍 Like and subscribe for more conversations on FDA policy, biotech investment, drug pricing, healthcare innovation, China competition, and national security. Time Stamps 00:00 Intro & Disclaimer 00:17 Innovation Ecosystem Runs on Confidence 00:33 FDA, Germany & Biotech Headlines Preview 01:18 FDA Drug Approvals Roundup 01:41 Eli Lilly’s Oral GLP-1 Approval 02:16 Regeneron Gene Therapy Breakthrough 03:18 Immigration Policy & Scientific Talent Concerns 04:56 Germany Challenges MFN Drug Pricing 05:57 Why Global Drug Pricing Could Reshape Launch Strategy 06:49 Rare Disease Investment Risks 07:12 Germany vs Trump MFN Policy 08:08 Why Biotech Innovation Depends on Confidence DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #fda #biotech #drugpricing #glp1 #healthcarepolicy #mfn #germany #regeneron #EliLilly #MakingMedicine

    9 min

  3. APR 30

    Senator Todd Young on China, FDA Reform, and Why Biotech Is National Security

    Biotech is no longer just about medicine. It is now a frontline issue in national security, global competition, and economic independence. In this episode of the Making Medicine Podcast, Senator Todd Young joins us to break down the growing risks of relying on China for critical biotech inputs, why FDA speed and regulatory clarity matter more than ever, and how the US can stay competitive in a rapidly shifting global landscape. From supply chain vulnerabilities to AI-driven drug development, this conversation explores the intersection of policy, innovation, and national defense. Senator Young also shares insights on drug pricing, biotech investment, and why strengthening the full ecosystem from startups to large manufacturers is critical for long-term US leadership. If the US fails to act, the consequences go far beyond healthcare. They shape who leads the next century of innovation. At stake is not just faster cures, but whether America remains the global leader in biotech or falls behind. Join the Conversation ⬇️ Should the US decouple biotech supply chains from China? Can the FDA move faster without sacrificing safety? What policy change would most strengthen US biotech leadership? Drop your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Time Stamps 00:00 Intro and disclaimer 00:17 Senator Young on China dependency risk 00:33 Meet Senator Todd Young 01:53 Why biotech is national security 03:23 Biotech’s role in defense, materials, and Department of War 04:17 Supply chain resiliency and China risk 05:16 Biotech threats, food security, and countermeasures 06:41 China, biotech standards, and global competition 08:04 Why innovators go abroad for speed and cost 08:46 FDA optimization, AI, and faster drug development 12:16 Indiana’s biotech ecosystem and Eli Lilly 16:32 Why small biotech and big pharma need each other DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #biotech #FDA #China #nationalsecurity #pharma #healthpolicy #innovation #senatortoddyoung

    26 min

  4. APR 23

    FDA Instability Is Changing Biotech Investment—What Investors Are Saying

    FDA instability is reshaping biotech investment decisions in real time. Investors are recalibrating risk, pulling back, and even shifting capital abroad. In this episode of the Making Medicine Podcast, John Stanford is joined by Rachel Sher of Manatt Health to unpack new original research conducted with investors across the biotech ecosystem. The goal was simple: move beyond speculation and understand whether recent leadership changes, staffing cuts, and policy uncertainty at FDA are actually shaping investor behavior. What emerged is a clear signal. Across venture capital, public equity, private equity, and industry investors, the vast majority said recent changes at FDA have altered how they think about risk, capital allocation, and the attractiveness of U.S.-based drug development. This conversation walks through the four major themes that surfaced in the research: growing concern about regulatory instability, reduced appetite for certain product categories like gene therapy and vaccines, increasing attention to China and other international markets, and broader concern that instability across agencies like NIH and FDA could weaken the long-term innovation pipeline. At the center of it all is one core issue: regulatory predictability. When investors lose confidence in consistency, policy clarity, and institutional knowledge, the consequences extend far beyond individual companies. They affect portfolios, research priorities, and where innovation happens next. This episode also highlights something important. Even with all these concerns, investors still want to back innovation in the United States. The question is whether policymakers and regulators can restore the stability and trust that made the U.S. the global leader in biotech in the first place. Watch for a grounded conversation on what investors are really saying, what it means for the biotech ecosystem, and why FDA predictability matters more than ever. Check out the full report https://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investment Join the Conversation ⬇️ Do you think FDA instability is already changing the future of biotech investment?  Are investors right to look abroad when U.S. regulatory signals become less predictable? What matters more right now: speed, stability, or scientific consistency? Drop your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Time Stamps 00:00 Intro & Disclaimer 00:16  Investors Say FDA Changes Are Impacting Decisions 03:22 How We Surveyed Investors (Research Design) 07:27 Theme 1: FDA Instability & Investor Uncertainty 10:22 Investors Repricing Risk in Biotech 12:05  “Chaos Is the Only Thing” – Investor Quote 13:00  Theme 2: Pullback from Gene Therapy, Vaccines, Oncology 14:28  Theme 3: Capital Shifting Abroad (China & Competition) 17:02 Theme 4: NIH Cuts & Long-Term Innovation Risk  25:24 Key Takeaway: Regulatory Predictability Drives Investment DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.  #Biotech #FDA #BiotechInvesting #HealthcarePolicy #DrugDevelopment

    28 min

  5. APR 16

    FDA Signals Are Breaking Biotech | Collapse, Breakthrough, and What Congress Does Next

    FDA signals are starting to break down, and biotech is feeling it. One company is collapsing while another is breaking through. As lawmakers return to Washington for a packed schedule of healthcare hearings, the conversation will be shaped by what’s happening inside the biotech ecosystem right now, both the breakthroughs and the breakdowns. In this episode of Making Medicine, we connect the dots between what’s unfolding on Capitol Hill and what companies are experiencing on the ground. We start with the policy backdrop: multiple hearings across the House and Senate, including appearances by HHS Secretary RFK Jr. and a renewed focus on drug pricing, FDA oversight, and the future of biomedical innovation. Then we turn to two stories that highlight what’s at stake. On one side is Replimune, a biotech facing layoffs and a collapsing market response after repeated FDA rejections and what leadership described as inconsistent communication and a slow-moving regulatory process. On the other is Revolution Medicines, whose pancreatic cancer drug is delivering unprecedented clinical results and offering real hope to patients, a powerful example of what the innovation ecosystem looks like when it works. Together, these stories raise a critical question: Can companies and investors still rely on FDA signals? Because when those signals become unpredictable, capital pulls back, risk tolerance shrinks, and fewer breakthrough therapies get funded. We also explore how early-stage investors rely on regulatory clarity, how large pharma acquisitions are helping fuel the biotech ecosystem, and why Congress plays a critical role in shaping what comes next. The takeaway is simple: Biotech doesn’t succeed or fail in isolation. Policy, regulation, and capital all move together. Join the Conversation ⬇️ Are we creating a system that rewards safe, incremental drugs over true breakthroughs? If FDA decisions feel unpredictable, does capital move elsewhere, or does innovation slow down entirely? Drop your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Time Stamps 00:00 Intro + Why Biotech Policy Matters Right Now 00:38 Congress Returns: RFK Jr., Drug Pricing, and Key Hearings 03:29 When FDA Delays Kill Companies (Kezar Case) 04:01 Replimune Collapse: From Breakthrough to Rejection 05:46 The Real Risk: Can Investors Trust FDA Signals? 06:51 Revolution Medicines: A Cancer Breakthrough 07:49 Historic Results: First Survival Gains in Pancreatic Cancer 08:22 How Biotech Actually Works (Startups → Pharma) 09:56 Why Big Pharma Deals Matter for Patients 10:06 Collapse vs Breakthrough: Which Future Are We Heading Toward? 10:22 What Congress and FDA Need to Fix 10:50 Faster Drug Development? New FDA Pathway Explained 12:25 Final Take: The Stakes for U.S. Biotech Leadership DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #FDA #DrugDevelopment #HealthcarePolicy #BiotechInvesting

    14 min

  6. APR 9

    Tariffs, MFN & FDA Delays: Why Biotech Is at Risk

    Tariffs, MFN pricing, and FDA delays are colliding, and small biotech is paying the price. One company already collapsed. More could follow. In this episode, we break down how Section 232 pharmaceutical tariffs, the push to codify Most Favored Nation (MFN) pricing, and new proposals in the FDA budget are reshaping biotech in real time. The stakes are high. These policies don’t just exist on paper, they directly impact where drugs are developed, how capital flows, and whether small biotech companies survive. We explore how tariffs could strain supply chains and smaller companies, how MFN could change global pricing and investment behavior, and how a proposed expedited IND pathway could help keep early-stage drug development in the United States. But the biggest signal comes from a real-world example: Kezar Life Sciences, a biotech that shut down after FDA delays disrupted its timeline and investor support. This episode makes one thing clear: policy is now one of the biggest drivers of innovation or failure in biotech. When the system works, it accelerates breakthroughs. When it doesn’t, it pushes capital, companies, and science elsewhere. Join the Conversation ⬇️ Are U.S. biotech policies slowing down the industry more than global competitors like China? If a company shuts down because of regulatory delays, is that a policy failure or just the cost of doing business? Would you accept higher risk in early drug development if it meant faster innovation and more breakthroughs? Drop your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Time Stamps 0:00 Episode Introduction 1:36 Section 232 Pharma Tariffs Explained 2:47 Onshoring, MFN Deals, & Exemptions 4:57 The Impact on Small Biotechs & VC 8:17 Why Codifying MFN is Dangerous 9:56 Promising FDA Budget Proposals 11:32 Expedited INDs to Keep Trials in the US 15:49 The Fatal Cost of FDA Delays 17:52 Proposed NIH Budget Cuts & Grant Changes 20:45 The Big Disconnect in Biotech Policy DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #biotechpolicy #fda #drugdevelopment #healthcarepolicy #china #BiotechInnovation

    24 min

  7. APR 2

    The China Biotech Threat Is Already Here | John Gutierrez on Capitol Hill, Drug Pricing & FDA

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

    24 min

  8. MAR 26

    Biotech, National Security, and Global Competition | Dr. Rozo (NSCEB) | JPM Re-Air

    In this special re-air of the Making Medicine Podcast, we revisit a timely conversation with Dr. Michelle Rozo of the National Security Commission on Emerging Biotechnology NSCEB, originally recorded live at JPM 2026. We are re-airing this episode in recognition of a recent roundtable hosted on Capitol Hill by the Incubate Coalition and NSCEB, where these same themes took center stage. As policymakers, investors, and industry leaders increasingly focus on the intersection of biotechnology and national security, this discussion offers critical context on how global competition and U.S. policy choices are shaping the future of innovation. Filmed live at JPM, host John Stanford sits down with leaders operating at the ground level, what one panelist calls the “frogs in the mud”, to unpack how capital flows, regulatory signals, and long-term strategy are evolving in real time. Rather than framing innovation as a zero-sum global rivalry, the conversation highlights a more complex reality. The U.S. remains deeply connected to global science, but risks falling behind if domestic policies create friction for innovation. The takeaway is clear. Maintaining U.S. leadership in biotech is not guaranteed. It requires a policy environment that supports discovery, development, and scale while recognizing the growing national security implications of the life sciences. Join the Conversation ⬇️ Do you think the U.S. is treating biotech as a national security priority yet? Drop your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  https://x.com/MakingMedPod https://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Time Stamps 0:00 Intro: Is the U.S. losing the biotech arms race? 1:10 "Frogs in the Mud": Why D.C. policy misses the mark 3:45 The 20-year Chinese strategic plan for biotech 6:15 How IRA price controls stifle American innovation 9:30 Strategic prioritization: Can the U.S. catch up? 12:50 The $350B patent cliff and global market impacts 16:20 Navigating the "Valley of Death" for startups 20:05 Clinical trial speed: Why China is outperforming the U.S. 24:30 SBIR breakthrough: New hope for early-stage funding 28:10 The "Playbook for Congress" and the road to 2030 DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #NationalSecurity #NSCEB #LifeSciences #HealthcareInnovation #BiotechPolicy #Innovation #JPM2026

    30 min
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Trailer

Ratings & Reviews

5
out of 5
15 Ratings

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
    77
  • Rating
    Clean
  • Copyright
    © Copyright Making Medicine Duality
  • Show Website
    Making Medicine

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