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. 1D AGO

    Regulatory Risk: How FDA Instability Is Threatening America's Biotech Investment Edge

    The FDA is being asked to keep pace with today's rapid scientific advancements amid ongoing resource constraints. In this episode, we unpack why regulatory predictability and *stability* matters more than ever for the future of America's medical innovation ecosystem. Regulatory uncertainty is reshaping where biotech capital flows. In this episode of the Making Medicine podcast, John Stanford sits down with Cartier Esham of Esham Strategies and Executive Director of the Alliance for a Stronger FDA to examine how budget pressures and workforce challenges at the FDA are affecting investors, innovators, and the companies betting on U.S. regulatory predictability. As scientific complexity accelerates, questions are mounting about whether the agency has the capacity needed to meet its growing responsibilities. For biotech investors, uncertainty around review timelines and approval pathways can quickly influence where capital is deployed – and whether the U.S. remains the preferred marketing for early- stage innovation. Meanwhile, the FDA, industry, and other stakeholders are looking towards the next reauthorization of the Prescription Drug User Fee Act (PDUFA) program. These five- year user fee agreements are more than just a funding mechanism; they are a key pillar of the predictable, science-based regulatory framework that underpins biotech investment. When that framework is in doubt, review timelines stretch, approval certainty erodes, and risk calculations for early-stage investment changes. The global context raises the states. While the U.S. continues to lead in clinical trial activity, other countries like China are investing aggressively to narrow the gap. A strong, well-functioning FDA is not just a domestic priority: it is a signal to global capital that the U.S. remains committed to regulatory excellence and innovation leadership. Join the Conversation ⬇️ Is FDA instability already showing up in your investment decisions or deal timelines? As China scales its clinical trial infrastructure, how long can the U.S. afford regulatory uncertainty? 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 Legal Disclaimer and Making Medicine Introduction 1:42 Cartier Esham’s Journey to Health Policy 4:08 The Mission of the Alliance for a Stronger FDA 6:44 Understanding FDA Funding: User Fees vs. Appropriations 7:48 Managing Operating Reserves During Government Shutdowns 10:10 Navigating the 4% FDA Budget Cut and Staffing Levels 15:55 Evidence-Based Assessment: 2025 CDER Drug Approvals 18:01 Inside the PDUFA VIII Negotiations 21:27 Establishing Financial Stability for the FDA's Future 27:00 Keeping Pace with China's Biotech and Clinical Trial Growth 31:05 Tracking Global Clinical Trial Starts as a Barometer for Success   DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.  #BiotechPolicy #FDAResources #PDUFA #MakingMedicine #ChinaCompetition #HealthcareInnovation

    32 min

  2. MAR 5

    China Just Passed the U.S. in Drug Clinical Trials

    China has now overtaken the United States in new drug clinical trials. At the same time regulatory uncertainty and funding lapses are raising new questions about the future of the American biotech leadership. In this episode of the Making Medicine Podcast, host John Stanford examines three developments shaping the future of the biotechnology ecosystem. First, the Senate passed a bipartisan agreement to reauthorize the Small Business Innovation Research and Small Business Technology Transfer programs. These programs have long served as a launchpad for biotech startups and early-stage medical innovation across the United States. The reauthorization comes after the first lapse in the program’s 44-year history, which paused billions in potential research funding for months. Restarting SBIR is a major development for small biotech companies developing new therapies. Recent regulatory decisions and declining approval numbers are raising new questions among investors and researchers about the stability of the regulatory environment. Finally, new global data shows China has now overtaken the United States in new drug clinical trials. Faster recruitment, national biotechnology policy incentives, and streamlined regulatory review are helping China accelerate its clinical research ecosystem. The United States has been the global leader in biomedical innovation for decades. Maintaining that leadership will require strong research funding, regulatory clarity, and policies that continue to support innovation and investment. #BiotechInnovation #HealthcarePolicy #ClinicalTrials #DrugDevelopment #MedicalInnovation Join the Conversation ⬇️ Do you think the United States can maintain its leadership in biomedical innovation? What policies are most important for supporting biotech startups and early-stage research? How should regulators balance speed and safety when approving new medicines? Drop your thoughts in the comments below 👇 Link to WSJ Report https://www.wsj.com/tech/biotech/maha-is-bringing-chaos-to-biotech-investment-beyond-just-vaccines-fbb82c6b?gaa_at=eafs&gaa_n=AWEtsqek_Ljd3Z49rusYI-f_MECgRKwStXEjR6_pP7SqdkNhBeyB-fywedtgZKvdRLg%3D&gaa_ts=69a8660d&gaa_sig=FMTHTFVHKAw_gdNro4NTyS35w2SRxhfgz7 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 Biotech policy and innovation overview  1:05 SBIR reauthorization passes the Senate  2:45 Why SBIR matters for biotech startups  4:40 The five month SBIR funding lapse  5:23 FDA accelerated approval pathway explained  6:10 Accelerated approvals drop in 2025  7:30 Regulatory uncertainty and biotech investment  8:26 Rare disease treatment gap 9:02 China overtakes the U.S. in clinical trials 9:30 Why China recruits trial patients faster 10:11 China biotech policy advantage DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

    12 min

  3. FEB 26

    Why 95% of Rare Diseases Still Have No Treatment

    About 90–95% of rare diseases still lack an FDA-approved treatment, underscoring the urgency for continued innovation on behalf of the estimated 30 million Americans — and families — affected by these conditions During Rare Disease Week, this special episode of the Making Medicine podcast focuses on the patients, caregivers, and policy choices shaping the future of rare disease research. Host John Stanford is joined by Lisa Schlager (FORCE), Elaine Towle (Prader-Willi Syndrome Association), and Josh Trent (Save Rare Treatments Task Force) for a thoughtful discussion on the scientific, financial, and regulatory realities of developing therapies for small patient populations. The conversation explores how federal incentives, reimbursement frameworks, and regulatory clarity can influence whether promising treatments move forward, as well as the broader ripple effects rare diseases have on families and support networks. The panel also reflects on ongoing policy discussions, including proposals such as Most Favored Nation (MFN) drug pricing, and how stakeholders are evaluating their potential impact on future innovation. Progress in rare diseases depends on sustained collaboration among patients, advocates, researchers, investors, and policymakers. This episode highlights both the scale of unmet need and the growing momentum to deliver new treatments and hope to millions of Americans. Do you believe the Orphan Cures Act went far enough to protect rare disease research? Should the Pediatric Priority Review Voucher program be made permanent? What rare disease policy reform should Congress address next? 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: 0:00 Rare Disease Week and disclaimer 0:43 Rare disease innovation, 30 million Americans 2:46 Hereditary cancer and rare genetic subtypes 7:36 Prader-Willi syndrome, hyperphagia and hypothalamus 11:14 First Prader-Willi FDA approval and Phase 3 pipeline 12:54 FDA patient focused drug development meetings 14:39 Save Rare Treatments Task Force and advocacy strategy 17:20 95% lack FDA treatments and pediatric rare disease stakes 21:05 Orphan Cures Act, IRA negotiation, second indications 26:17 PARP inhibitors, ovarian cancer and pancreatic cancer 33:01 Rare disease investment rebound after Orphan Cures Act 37:36 Pediatric PRV reauthorization and faster FDA review DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

    47 min

  4. FEB 19

    FDA Chaos and Foreign Price Controls Are Collapsing American Innovation

    FDA reversals and price controls are handing biotech dominance to China. We expose the national security crisis in drug development. The FDA is facing a crisis of confidence that threatens the stability of the entire US biopharmaceutical industry. In this episode, John Stanford is joined by Jef Akst, Managing Editor at BioSpace, to expose how recent "regulatory reversals" and inconsistent decision-making are rendering major vaccine and therapeutic programs "uninvestable". We analyze the shocking "Moderna gate" incident, where the FDA issued a "refuse to file" letter for an mRNA flu vaccine only to reverse course days later, a chaotic move that sent stock prices flying and disrupted timelines for the entire vaccine sector. Beyond the FDA, a new national security threat is emerging in the form of "Most Favored Nation" (MFN) pricing proposals. We unveil data from the Incubate MFN Tracker, which catalogs how these European-style price controls are now being flagged in quarterly SEC filings (10-Ks and 10-Qs) as material risks to business operations. Companies large and small are warning that MFN policies will compress expected returns and force a reprioritization away from riskier, high-impact R&D. This creates a vacuum that allows adversaries like China to further develop their own pipelines and grow a stronger foothold in the global market. This episode also covers the shifting center of gravity in clinical research. While 58% of industry professionals still choose the US as the best place to start a career, 27% now look to Asia-Pacific, while only 9% choose Europe—a stark warning of what happens when regions adopt restrictive pricing policies. We discuss Senator Bill Cassidy’s new "Patient and Families First" white paper, which proposes solutions like an Australia-style pilot for faster Phase 1 trials and updated pathways for digital health and AI tools. Finally, we look ahead to the State of the Union, where polling reveals that only 2% of Americans believe Congress should prioritize lowering drug costs, with the vast majority focused on grocery and insurance affordability instead. Join the Conversation  Does the current FDA instability make you worry about the future of new medicines reaching patients? Do you believe importing foreign price controls is worth the risk of losing American biotech leadership to China? Should Congress focus on insurance reform instead of drug price caps to help with affordability? 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 Link to articles https://endpoints.news/pharma-is-done-negotiating-as-trump-pushes-to-codify-deals/ https://www.biospace.com/business/opinion-2026-could-mark-a-turning-point-for-american-innovation https://endpoints.news/even-europeans-dont-see-a-future-in-euro-biopharma-anymore/  Timestamps 0:00 Making Medicine disclaimer, no medical advice and no investment advice  0:42 Making Medicine Press Pass with BioSpace Managing Editor Jeff Akst  1:16 What BioSpace covers, biotech news, drug development, VC funding, FDA approvals  3:42 Is the FDA functioning properly, transparency and communication problems  4:17 FDA reversals and the Moderna mRNA flu vaccine refuse to file letter  6:19 Ripple effects, Moderna stock, vaccine timelines, and mRNA platform investment risk  8:37 FDA shifting to stricter approvals, risk benefit changes, and trial design uncertainty  10:35 Drug development timelines, regulatory instability, and investor confidence  12:17 Inside FDA culture, leadership turnover, layoffs, and decision making uncertainty  12:50 National priority vouchers, review delays, and why companies hesitate to apply 16:11 Psychedelics for depression and Alzheimer’s drug development with tau targeting 26:13 State of the Union, drug pricing politics, insurance reform, and voter affordability priorities DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

    29 min

  5. FEB 12

    TrumpRx Explained: Cash Markets, MFN, and What This Moment Means for Drug Pricing

    TrumpRx has quickly become part of the broader drug pricing conversation, not as a new insurance program or pharmacy, but as a government website highlighting direct-to-patient cash pricing options for certain brand-name medicines. In this episode of the Making Medicine Podcast, host John Stanford walks through what TrumpRx is, what it isn’t, and why it’s generating attention right now. Rather than setting prices or replacing insurance, the platform points patients toward manufacturer-listed cash prices for select innovative drugs, bringing another pathway to medicine outside traditional insurance channels. The episode also steps back to examine the larger shift this represents. Cash markets for prescription drugs have been growing in visibility, from coupon platforms like GoodRx to cost-plus pharmacy models like Mark Cuban Cost Plus Drugs. TrumpRx enters that landscape from a different angle, one tied, at least rhetorically, to “Most Favored Nation” policy discussions and broader debates about international price comparisons. We discuss early reactions and critiques, including questions about whether some listed products are actually the lowest available option, particularly when lower-cost generics exist. That tension underscores a bigger point: patients often have to shop around, and the system remains opaque enough that even policymakers, manufacturers, and payers frame pricing differently. More broadly, this moment reflects a structural reality in American healthcare. High deductibles, rebate dynamics, and insurance design can make paying cash cheaper than using coverage, a counterintuitive outcome that continues to fuel debate. Finally, we touch on how pricing policy conversations intersect with innovation. Short-term affordability tools, cash-market visibility, and long-term price regulation debates are often discussed together, but they have different implications for investment, drug development, and patient access over time. TrumpRx may or may not be transformative. But it is a visible signal of where the drug pricing conversation is headed: toward transparency, toward cash markets, and toward renewed debate over how the U.S. balances cost, competition, and innovation. Join the Conversation ⬇️ Is Trump RX a meaningful transparency tool or just a temporary fix for a broken insurance system? Do you find it cheaper to pay cash for prescriptions rather than using your insurance copay? Do you believe price controls will help affordability or hurt the development of new cures?  Like and Subscribe on YouTube ▶️ 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 0:00 Disclaimer: Not Medical, Financial, or Legal Advice 0:42 Introduction: What Is Trump RX? 0:59 How Trump RX Works as a Drug Discount Hub 1:56 Trump RX vs GoodRx vs Mark Cuban’s Cost Plus Drugs 3:03 Early Criticism and Generic Price Comparisons 5:03 Trump RX vs Most Favored Nation (MFN) Pricing 6:12 Free Market Tool or Price Control Policy? 7:29 Why High Deductibles Changed the Drug Market 8:22 Insurance Opacity and the Rise of Cash Markets 9:34 PBMs, Gag Clauses, and Hidden Pricing Structures 11:24 Why Cash Can Be Cheaper Than Insurance 12:13 Final Takeaways: Reform, Transparency, and Innovation DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor

    14 min

  6. FEB 5

    Speed, Scrutiny, and Spending: How Washington Is Reshaping the Future of Medicine

    Washington is navigating a period of significant change in health policy, with implications for how new medicines are developed, reviewed, and paid for. In this episode of Making Medicine, we take a closer look at several recent developments shaping the life sciences landscape. We discuss the FDA’s new priority review voucher pilot and the debate around how the agency can balance speed, scientific rigor, and public trust as it works to accelerate patient access to therapies. We also break down new reforms aimed at increasing transparency in Medicare Part D and reining in pharmacy benefit manager (PBM) practices, exploring what these changes could mean for patients, payers, and innovators across the system. Finally, we examine emerging international reference pricing proposals, including the GLOBE and GUARD concepts, and the broader conversation about how the U.S. can maintain its leadership in biomedical innovation while addressing affordability and global competition. If you care about the future of medical innovation, and the policy decisions shaping it, this episode offers context, clarity, and a balanced look at what’s ahead. Link to article: https://www.washingtonpost.com/opinions/2026/02/03/vaccine-development-moderna-rfk-china-drug-prices/ Join the Conversation ⬇️ Do you believe the government has become the biggest obstacle to the next American cure? Will the U.S. lose its status as the world leader in medical breakthroughs by 2030? Is the FDA's new 'National Priority' pilot a necessary evolution for 21st-century medicine, or is it a dangerous bypass of the scientific checks and balances that protect us all? 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 0:00  The 1,000-pound predator and the regulatory coup 0:23  Science, policy, and a destabilized ecosystem 1:10  The controversial FDA town hall 2:20  Skipping Congressional approval 3:54  Reforming PBMs in the funding package 5:10  How PBMs siphon half the cost of your medicine 6:55  Why "sunlight" isn't lowering pharmacy prices yet 7:54  GLOBE, GUARD, and foreign price controls 8:32  Why biotech is fleeing to rival markets 9:30  Shifting from price controls to insurance reform 10:12  Addressing out-of-pocket costs  10:45  FDA Approvals Corner DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

    11 min

  7. JAN 29

    Live From JPM 2026: Is This the End of American Biotech Leadership?

    The race is being won by someone else. While the headlines focus on the prestige of JPM 2026, a much quieter and more dangerous shift is happening behind the scenes. In this special edition of The Making Medicine Podcast, John Stanford sits down with Terzel Vasquez of STAT Brand Studio to discuss why the American biotech engine is beginning to stall. Stanford argues that capital flows like water, and right now, poorly designed Washington policies are acting like boulders in the stream, forcing vital investment away from life-saving small molecules and rare disease research. The conversation pulls back the curtain on a massive cognitive dissonance in modern policy. By attacking the end of the value chain, specifically the large manufacturers who bring drugs to the finish line, lawmakers are inadvertently starving the early-stage startups they claim to protect. From the Pill Penalty to the looming shadow of China’s bio-dominance, this episode explores why biotech has officially moved from a healthcare issue to a critical national security prerogative.  Join the Conversation Is U.S. biotech leadership still a "national security priority," or have we already ceded the lead? If “unintended consequences" force a choice between a $100,000 injectable biologic and a $200 oral pill that never gets funded, who actually wins? Is Washington "fixing" the price of medicine, or just distracting us from a broken insurance system? 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 0:00  Policy Warning & Headlines  0:23  JPM 2026: Incubate Briefing  0:36  Capital Flight: Policy Barriers  1:24  The IRA "Pill Penalty"  2:22  Rare Disease Funding Gap  2:32  The $1 Billion Fix  3:18  The Innovation Relay Race  4:24  The Movie Studio Paradox  5:28  China’s "Green Light" Strategy  6:58  Biotech: National Security Asset  9:20  The $3 Billion Drug Cost  10:18  Insurance Breakdown & Access  11:36  Fixing the Root Issue DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

    12 min

  8. JAN 22

    How Global Competition and U.S. Policy Choices Are Reshaping Biotech | Live at JPM 2026 (Part 2)

    Is the U.S. at risk of losing its edge in biotech innovation? Filmed live at JPM 2026, host John Stanford sits down with industry leaders who are deep in the work,what one panelist calls the “frogs in the mud”, to unpack how long-term global strategies, shifting capital flows, and U.S. policy decisions are reshaping the biotech landscape. Rather than framing innovation as an all-or-nothing rivalry, the conversation focuses on a harder truth: the U.S. cannot isolate itself from global science, but it can fall behind if domestic policies make innovation harder at home. While Washington often debates from 30,000 feet, this panel dives into the operational realities founders and investors face every day, from the implications of the National Security Commission’s recommendations, to the looming $350B patent cliff, to the “Valley of Death” threatening early-stage companies. We also examine how pricing uncertainty under the IRA, regulatory friction, and capital constraints intersect, and highlight a recent breakthrough in SBIR funding that offers a glimpse of what pro-innovation policy can look like when it’s done right.  The takeaway is clear: safeguarding U.S. biotech leadership isn’t about cutting science off at the knees or cutting off collaboration, it’s about championing policies that keep America the best place in the world to discover, develop, and scale new medicines. Watch to understand the real, ground-level forces shaping the future of biotech, and what policymakers need to get right next. Join the Conversation Is the U.S. still the global center of gravity for biotech innovation, or are we relying too heavily on past momentum? What poses the greater long-term risk to patients: short-term cost controls, or policies that reduce where and how new medicines get developed? In the biotech “Valley of Death,” what matters more for survival: access to capital, or regulatory speed and predictability? 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 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.

    30 min
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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
    68
  • Rating
    Clean
  • Copyright
    © Copyright Making Medicine Duality
  • Show Website
    Making Medicine

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