Making Medicine

Incubate Coalition
  • 5.0 (15)
  • Health & Fitness
  • Updated Semiweekly

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. 1d ago

    Rep. Scott Peters on the Pill Penalty, PBMs, China & America’s Biotech Future

    China and biotech competition. Drug pricing reform. The FDA. PBMs. America’s innovation economy. This week on the Making Medicine Podcast, John Stanford sits down with Rep. Scott Peters to discuss the future of American biotech innovation, the importance of ending the “pill penalty,” and why China’s rapid rise in biotechnology is becoming a major strategic concern for the United States. Representing one of the country’s leading biotech hubs in San Diego, Congressman Peters explains why policies tied to the Inflation Reduction Act and investment incentives directly impact whether innovative medicines get funded, developed, and brought to patients. The conversation also explores the future of PBM reform, rare disease investment, FDA modernization, the workforce and scientific talent, supply chain security, and what policymakers must do to keep America competitive in biotech and life sciences innovation. This episode covers: 🔹 Why San Diego became a biotech powerhouse 🔹 The “pill penalty” and the EPIC Act 🔹 How the IRA changed biotech investment incentives 🔹 Why rare disease investment rebounded after the ORPHAN Cures Act 🔹 China’s growing role in global biotech innovation 🔹 FDA modernization and regulatory competitiveness 🔹 Immigration, talent, and scientific leadership 🔹 PBM reform and healthcare affordability 🔹 Why diagnostics and genomics may transform healthcare 🔹 The importance of bipartisan problem-solving in healthcare policy At the center of the discussion is one core issue: competitiveness. Congressman Peters argues that America’s advantage in biotech depends on stable investment incentives, strong scientific institutions, private-sector innovation, and policies that continue attracting talent and capital into the United States. Check out more from Incubate Coalition: https://www.incubatecoalition.org/ Join the Conversation ⬇️ Do you think the United States is doing enough to stay competitive with China in biotech innovation? Should Congress further reform the IRA to encourage more biotech investment and drug development? What matters most for the future of American healthcare innovation: FDA modernization, PBM reform, or stronger investment incentives? Let us know your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true 👍 Like and subscribe for more 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 00:17 Why China Is Catching Up in Biotech 00:31 Meet Congressman Scott Peters 01:28 Why San Diego Became a Biotech Hub 03:24 The Role of NIH & Research Institutions 05:02 Venture Capital & Biotech Growth 07:06 The “Pill Penalty” Explained  08:05 The IRA & Medicare Drug Negotiation 09:25 Why Investment Incentives Matter 11:11 How Small Molecule Investment Was Affected 12:20 Political Risks of Supporting Biotech 15:17 Why Independence Still Matters in Congress 21:26 Rare Disease Investment & Orphan Cures Act 24:00 China’s Rise in Biotech Innovation 25:27 FDA Challenges & Global Competition 27:19 Immigration, Talent & Scientific Leadership 30:25 PBM Reform & Healthcare Costs 33:19 Diagnostics, Genomics & Preventive Medicine 34:19 Why Congress Needs Better Biotech Education 36:35 Closing Thoughts DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #fda #biotech #drugpricing #china #pbm #healthcarepolicy #innovation

    37 min

  2. May 21

    The FDA Decoded: Roles, Responsibilities & What They Mean for Drug Development

    What does the FDA actually look like on the inside — and why does its structure matter for drug approvals, rare disease therapies, and biotech investment? This week on the Making Medicine Podcast, host John Stanford is joined by Jef Akst, senior editor at BioSpace, to break down the FDA's key divisions, what each one is responsible for, and how they shape the drug development landscape. Jef walks through the roles of CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) — what each center oversees, how they differ, and why their review processes matter to biotech companies navigating approval timelines. The episode also explains how FDA advisory committees work, what authority they hold, and how their recommendations influence regulatory outcomes. The conversation then expands to the broader policy environment shaping biotech today — including CMS marketplace rule changes that affect patient cost exposure, Section 232 pharmaceutical tariff procedures, Most Favored Nation pricing, and the Orphan Cures Act. The episode closes with data from the INCUBATE Coalition's biotech investment tracker, examining how IRA policy and regulatory uncertainty are influencing capital allocation across the life sciences sector. Check out the full report from Manatt Health https://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investment Check out INCUBATE'S biotech investment tracker https://lifesciencetracker.com/ Join the Conversation ⬇️ Do you think FDA leadership turnover is creating too much uncertainty for biotech companies and investors? Should the FDA rely more heavily on advisory committees and outside scientific experts during periods of instability? How should policymakers balance lower healthcare premiums with the risk of higher out-of-pocket costs for patients? Let us know your thoughts in the comments below 👇 If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:  X: https://x.com/MakingMedPod Instagram: https://www.instagram.com/makingmedicinepod/ TikTok: https://www.tiktok.com/@makingmedicinepodcast?lang=en LinkedIn: https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true 👍 Like, follow, and subscribe for more conversations on FDA policy, biotech innovation, healthcare regulation, drug pricing, rare disease development, and life sciences investment. Time Stamps 00:00 Intro & Disclaimer 00:17 FDA Instability & Biotech Uncertainty 00:39 Meet BioSpace’s Jef Akst 01:51 FDA, HHS & RFK Jr. Influence 04:13 What CDER Does 05:55 Drug Delays & FDA Inconsistency 07:23 What CBER Does 10:33 Office of Therapeutic Products Turnover 13:08 FDA Commissioner’s Role Explained 15:17 Advisory Committees & Expert Panels 18:00 CMS ACA Rule Changes 19:24 Pharma Tariffs & MFN Pricing 21:06 Senator Bill Cassidy’s Primary Loss 22:50 New Biotech Investment Tracker Data 24:41 Rare Disease Investment Trends 25:17 Closing Thoughts DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #FDA #Biotech #HealthcarePolicy #DrugDevelopment #RareDisease #CMS #Pharma #LifeSciences #MFN #MakingMedicine

    26 min

  3. May 14

    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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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
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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
    79
  • Rating
    Clean
  • Copyright
    © Copyright Making Medicine Duality
  • Show Website
    Making Medicine

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