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. VOR 5 TAGEN

    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.

  2. 26. MÄRZ

    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.

  3. 19. MÄRZ

    Solving Japan's Drug Lag: Why PM Takaichi Must Agree to a Fair U.S. Pricing Deal

    With Japanese Prime Minister Sanae Takaichi meeting President Trump this week, we are re-airing our special episode from Tokyo. We explore why the U.S. delegation must prioritize a fair pricing agreement that ensures Japan pays its fair share while giving patients access to life-saving cures. As the US and Japan put renewed focus on their partnership in science and the life sciences, we are revisiting a special episode of the Making Medicine podcast recorded on the ground in Tokyo late last year to mark this critical geopolitical moment. This week's summit presents a rare win-win opportunity if the U.S. delegation focuses on securing a fair commercial pricing agreement. For years, arcane and arbitrary pricing schemes have limited the value Japan is willing to pay for medical breakthroughs. By pushing Japan to pay its "fair share" for innovation, U.S. leaders can help solve the severe drug lag that leaves 70 percent of new American medicines unavailable to Japanese patients. A modernized pricing agreement wouldn't just protect early-stage biopharma investments; it would give Japan's aging population access to the breakthroughs they desperately need. During this international panel, John Stanford sat down with a premier group of global investors to discuss the path forward. He was joined by Shaan Gandhi of Pfizer, Patrick Jordan of NovaQuest Capital Management, Heather Berger of Forge Life Sciences, and Johannes Freuhauf of Biolabs. The group explored how the Japanese government is systematically addressing structural challenges through unified agency alignment from the MHLW and METI. A major highlight of the conversation was a remarkably forward-looking program that offers a two-to-one non-dilutive matching grant for accredited international venture capital investments. The panel also discussed the rapid expansion of vital infrastructure, celebrating the announcement of a second Biolabs incubator facility opening in Tokyo in mid-2026. However, the investors agreed that early-stage funding must be paired with a predictable commercial pricing environment. To ensure sustainable global investment, Prime Minister Takaichi's administration must commit to valuing innovation across the entire value chain, allowing for the successful exits and capital recycling that fuel the next generation of medicines. Join the Conversation ⬇️ What policy changes would most effectively help Japan reduce its drug lag? Do you believe government matching grants are the most effective way to accelerate early-stage biotech ecosystems? Can Japan build a globally competitive biotech sector without a modernized pricing agreement? 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 Episode disclaimer 00:23 Japan episode introduction 01:17 Why the US Japan meeting matters 01:53 Japan’s drug lag problem 02:47 Why Japan missed the COVID vaccine moment 03:19 Live discussion from Tokyo 06:36 Why BioLabs doubled down in Japan 08:00 Japan’s science to startup opportunity 14:00 Government alignment on biotech innovation 20:23 Japan’s matching grant model 25:46 Drug lag, pricing, and patient access DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #japanbiotech #healthcarepolicy #drugdevelopment #lifesciences #medicalinnovation

    43 Min.

  4. 12. MÄRZ

    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.

  5. 5. MÄRZ

    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.

  6. 26. FEB.

    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.

  7. 19. FEB.

    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.

  8. 12. FEB.

    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.
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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.

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  • Erstellt von
    Incubate Coalition
  • Jahre aktiv
    2021 - 2026
  • Folgen
    71
  • Bewertung
    Unbedenklich
  • Copyright
    © Copyright Making Medicine Duality
  • Sendungswebsite
    Making Medicine

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