Episodes

  • Why 95% of Rare Diseases Still Have No Treatment

    Why 95% of Rare Diseases Still Have No Treatment
    Feb 26 2026
    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?

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    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.
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    47 mins
  • FDA Chaos and Foreign Price Controls Are Collapsing American Innovation

    FDA Chaos and Foreign Price Controls Are Collapsing American Innovation
    Feb 19 2026
    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

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    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.
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    29 mins
  • TrumpRx Explained: Cash Markets, MFN, and What This Moment Means for Drug Pricing

    TrumpRx Explained: Cash Markets, MFN, and What This Moment Means for Drug Pricing
    Feb 12 2026
    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
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    14 mins
  • Speed, Scrutiny, and Spending: How Washington Is Reshaping the Future of Medicine

    Speed, Scrutiny, and Spending: How Washington Is Reshaping the Future of Medicine
    Feb 5 2026
    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.
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    11 mins
  • Live From JPM 2026: Is This the End of American Biotech Leadership?

    Live From JPM 2026: Is This the End of American Biotech Leadership?
    Jan 29 2026
    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?

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

    How Global Competition and U.S. Policy Choices Are Reshaping Biotech | Live at JPM 2026 (Part 2)
    Jan 22 2026
    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.
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    30 mins
  • Innovation at a Crossroads | Live at JPM 2026 (Part 1)

    Innovation at a Crossroads | Live at JPM 2026 (Part 1)
    Jan 15 2026
    Filmed live at the JPMorgan Healthcare Conference 2026, this episode of the Making Medicine Podcast examines how global power shifts are reshaping the pharmaceutical industry. This Part 1 conversation features host John Stanford with former Senator Richard Burr and EU Commissioner Phil Hogan as they discuss whether the pharmaceutical industry is losing its long-held “geopolitical immunity.” As thousands of leaders gather in San Francisco for the year’s biggest healthcare event, the discussion offers a roadmap for navigating the shift from business as usual to a new era of geopolitical scrutiny.

    What do you think is the biggest "opportunity in the chaos" for biotech in 2026?
    Do you believe the FDA will become more or less predictable under the current administration?
    How should global pharma companies prepare for the rise of "MAHA" and lifestyle-focused health policy?

    If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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    Timestamps
    0:00 Welcome to Making Medicine
    0:47 Meet the Panel: Senator Richard Burr & Commissioner Phil Hogan
    2:21 2026 Outlook: The Disruptive Impact of the Second Trump Admin
    3:51 Finding Opportunity in Policy Chaos
    6:06 Why Pharma Lost Its "Geopolitical Immunity" in Trade
    8:44 Most Favored Nation (MFN) and Global Pricing Realities
    10:14 Defining "MAHA" and the Future of Health Policy
    11:43 The Power of Direct Engagement: Bringing CEOs to the Hill
    15:02 The FDA in 2026: Stability vs. Disruption
    17:49 AI and Robotics: The New Subsectors of Medicine
    19:08 China, Russia, and the Protection of the Single Market
    25:15 2026 Predictions: Cultural Shifts and Economic Roller Coasters

    DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
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    30 mins
  • CMS Drug Pricing Proposals and What JPM 2026 Signals

    CMS Drug Pricing Proposals and What JPM 2026 Signals
    Jan 8 2026
    In this episode of the Making Medicine Podcast, John Stanford previews new CMS drug pricing proposals and explains how they could shape biotech investment and innovation. The conversation looks ahead to the JPMorgan Healthcare Conference, where policy, capital formation, and global competition are expected to drive discussion. The episode breaks down the Globe and Guard Medicare models, their potential impact on R&D, and what founders and investors are watching next. It also explores how pricing uncertainty can influence early-stage biotech and global competitiveness. Finally, the listener Q&A highlights where AI is gaining traction across therapeutic areas.

    Join us in San Francisco:
    https://www.eventbrite.com/e/innovation-at-a-crossroadsbiopharma-policy-in-an-era-of-global-competition-tickets-1965538834565?aff=oddtdtcreator

    Click here to be featured in an Incubate short:
    https://calendly.com/grace-incubatecoalition/incubate-shorts-jpm-2026?month=2026-01

    What should innovators and investors watch most closely as these proposals move forward?
    How might policy signals from JPM influence biotech decision-making in 2026?
    Where do you see the biggest opportunities for AI in medicine right now?

    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/
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    Timestamps:
    0:00 Welcome and disclaimers
    0:17 Episode overview and JPM preview
    0:50 Why Incubate produces Making Medicine
    1:43 Why policy matters at JPM 2026
    3:30 CMS announces new drug pricing proposals
    4:26 Globe Part B and Guard Part D explained
    5:53 Comment period and policy intent
    6:45 Global pricing and international context
    8:47 Implications for biotech innovation
    10:17 Listener Q&A: AI in drug development
    11:56 Closing thoughts and JPM logistics

    DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
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    12 mins