Making Medicine

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 Reporthttps://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 Stamps00:00 Intro & Disclaimer00:17 Innovation Ecosystem Runs on Confidence00:33 FDA, Germany & Biotech Headlines Preview01:18 FDA Drug Approvals Roundup01:41 Eli Lilly’s Oral GLP-1 Approval02:16 Regeneron Gene Therapy Breakthrough03:18 Immigration Policy & Scientific Talent Concerns04:56 Germany Challenges MFN Drug Pricing05:57 Why Global Drug Pricing Could Reshape Launch Strategy06:49 Rare Disease Investment Risks07:12 Germany vs Trump MFN Policy08:08 Why Biotech Innovation Depends on ConfidenceDISCLAIMER: 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

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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps00:00 Intro and disclaimer00:17 Senator Young on China dependency risk00:33 Meet Senator Todd Young01:53 Why biotech is national security03:23 Biotech’s role in defense, materials, and Department of War04:17 Supply chain resiliency and China risk05:16 Biotech threats, food security, and countermeasures06:41 China, biotech standards, and global competition08:04 Why innovators go abroad for speed and cost08:46 FDA optimization, AI, and faster drug development12:16 Indiana’s biotech ecosystem and Eli Lilly16:32 Why small biotech and big pharma need each otherDISCLAIMER: 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

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 reporthttps://www.incubatecoalition.org/post/one-pager-complete-report-regulatory-instability-at-fda-is-reshaping-biotech-investmentJoin 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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps00:00 Intro & Disclaimer00:16  Investors Say FDA Changes Are Impacting Decisions03:22 How We Surveyed Investors (Research Design)07:27 Theme 1: FDA Instability & Investor Uncertainty10:22 Investors Repricing Risk in Biotech12:05  “Chaos Is the Only Thing” – Investor Quote13:00  Theme 2: Pullback from Gene Therapy, Vaccines, Oncology14:28  Theme 3: Capital Shifting Abroad (China & Competition)17:02 Theme 4: NIH Cuts & Long-Term Innovation Risk 25:24 Key Takeaway: Regulatory Predictability Drives InvestmentDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. #Biotech #FDA #BiotechInvesting #HealthcarePolicy #DrugDevelopment

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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps00:00 Intro + Why Biotech Policy Matters Right Now00:38 Congress Returns: RFK Jr., Drug Pricing, and Key Hearings03:29 When FDA Delays Kill Companies (Kezar Case)04:01 Replimune Collapse: From Breakthrough to Rejection05:46 The Real Risk: Can Investors Trust FDA Signals?06:51 Revolution Medicines: A Cancer Breakthrough07:49 Historic Results: First Survival Gains in Pancreatic Cancer08:22 How Biotech Actually Works (Startups → Pharma)09:56 Why Big Pharma Deals Matter for Patients10:06 Collapse vs Breakthrough: Which Future Are We Heading Toward?10:22 What Congress and FDA Need to Fix10:50 Faster Drug Development? New FDA Pathway Explained12:25 Final Take: The Stakes for U.S. Biotech LeadershipDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#Biotech #FDA #DrugDevelopment #HealthcarePolicy #BiotechInvesting

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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps0:00 Episode Introduction1:36 Section 232 Pharma Tariffs Explained2:47 Onshoring, MFN Deals, & Exemptions4:57 The Impact on Small Biotechs & VC8:17 Why Codifying MFN is Dangerous9:56 Promising FDA Budget Proposals11:32 Expedited INDs to Keep Trials in the US15:49 The Fatal Cost of FDA Delays17:52 Proposed NIH Budget Cuts & Grant Changes20:45 The Big Disconnect in Biotech PolicyDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#biotechpolicy #fda #drugdevelopment #healthcarepolicy #china #BiotechInnovation

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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps00:00 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 leadershipDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#biotech #biotechpolicy #nationalsecurity #biotechinnovation #chinabiotech

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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps0:00 Intro: Is the U.S. losing the biotech arms race?1:10 "Frogs in the Mud": Why D.C. policy misses the mark3:45 The 20-year Chinese strategic plan for biotech6:15 How IRA price controls stifle American innovation9:30 Strategic prioritization: Can the U.S. catch up?12:50 The $350B patent cliff and global market impacts16:20 Navigating the "Valley of Death" for startups20:05 Clinical trial speed: Why China is outperforming the U.S.24:30 SBIR breakthrough: New hope for early-stage funding28:10 The "Playbook for Congress" and the road to 2030DISCLAIMER: 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

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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps00:00 Episode disclaimer00:23 Japan episode introduction01:17 Why the US Japan meeting matters01:53 Japan’s drug lag problem02:47 Why Japan missed the COVID vaccine moment03:19 Live discussion from Tokyo06:36 Why BioLabs doubled down in Japan08:00 Japan’s science to startup opportunity14:00 Government alignment on biotech innovation20:23 Japan’s matching grant model25:46 Drug lag, pricing, and patient accessDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.#japanbiotech #healthcarepolicy #drugdevelopment #lifesciences #medicalinnovation

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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps0:00 Legal Disclaimer and Making Medicine Introduction1:42 Cartier Esham’s Journey to Health Policy4:08 The Mission of the Alliance for a Stronger FDA6:44 Understanding FDA Funding: User Fees vs. Appropriations7:48 Managing Operating Reserves During Government Shutdowns10:10 Navigating the 4% FDA Budget Cut and Staffing Levels15:55 Evidence-Based Assessment: 2025 CDER Drug Approvals18:01 Inside the PDUFA VIII Negotiations21:27 Establishing Financial Stability for the FDA's Future27:00 Keeping Pace with China's Biotech and Clinical Trial Growth31:05 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

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 #MedicalInnovationJoin 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 Reporthttps://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_gdNro4NTyS35w2SRxhfgz7If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTime Stamps0:00 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 gap9:02 China overtakes the U.S. in clinical trials9:30 Why China recruits trial patients faster10:11 China biotech policy advantageDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

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 conditionsDuring 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'rehere! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Rare Disease Week and disclaimer0:43 Rare disease innovation, 30 million Americans2:46 Hereditary cancer and rare genetic subtypes7:36 Prader-Willi syndrome, hyperphagia and hypothalamus11:14 First Prader-Willi FDA approval and Phase 3 pipeline12:54 FDA patient focused drug development meetings14:39 Save Rare Treatments Task Force and advocacy strategy17:20 95% lack FDA treatments and pediatric rare disease stakes21:05 Orphan Cures Act, IRA negotiation, second indications26:17 PARP inhibitors, ovarian cancer and pancreatic cancer33:01 Rare disease investment rebound after Orphan Cures Act37:36 Pediatric PRV reauthorization and faster FDA reviewDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

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 belowIf you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueLink to articleshttps://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/ Timestamps0:00 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 apply16:11 Psychedelics for depression and Alzheimer’s drug development with tau targeting26:13 State of the Union, drug pricing politics, insurance reform, and voter affordability prioritiesDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor. 

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=trueTimestamps0:00 Disclaimer: Not Medical, Financial, or Legal Advice0:42 Introduction: What Is Trump RX?0:59 How Trump RX Works as a Drug Discount Hub1:56 Trump RX vs GoodRx vs Mark Cuban’s Cost Plus Drugs3:03 Early Criticism and Generic Price Comparisons5:03 Trump RX vs Most Favored Nation (MFN) Pricing6:12 Free Market Tool or Price Control Policy?7:29 Why High Deductibles Changed the Drug Market8:22 Insurance Opacity and the Rise of Cash Markets9:34 PBMs, Gag Clauses, and Hidden Pricing Structures11:24 Why Cash Can Be Cheaper Than Insurance12:13 Final Takeaways: Reform, Transparency, and InnovationDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor

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=trueTimestamps0:00  The 1,000-pound predator and the regulatory coup0:23  Science, policy, and a destabilized ecosystem1:10  The controversial FDA town hall2:20  Skipping Congressional approval3:54  Reforming PBMs in the funding package5:10  How PBMs siphon half the cost of your medicine6:55  Why "sunlight" isn't lowering pharmacy prices yet7:54  GLOBE, GUARD, and foreign price controls8:32  Why biotech is fleeing to rival markets9:30  Shifting from price controls to insurance reform10:12  Addressing out-of-pocket costs 10:45  FDA Approvals CornerDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

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 ConversationIs 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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps0:00  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 IssueDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

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 ConversationIs 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=trueTimestamps0:00  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 innovation9:30  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 startups20:05  Clinical trial speed: Why China is outperforming the U.S.24:30  SBIR breakthrough: New hope for early-stage funding28:10  The "Playbook for Congress" and the road to 2030DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps0:00 Welcome to Making Medicine0:47 Meet the Panel: Senator Richard Burr & Commissioner Phil Hogan2:21 2026 Outlook: The Disruptive Impact of the Second Trump Admin3:51 Finding Opportunity in Policy Chaos6:06 Why Pharma Lost Its "Geopolitical Immunity" in Trade8:44 Most Favored Nation (MFN) and Global Pricing Realities10:14 Defining "MAHA" and the Future of Health Policy11:43 The Power of Direct Engagement: Bringing CEOs to the Hill15:02 The FDA in 2026: Stability vs. Disruption17:49 AI and Robotics: The New Subsectors of Medicine19:08 China, Russia, and the Protection of the Single Market25:15 2026 Predictions: Cultural Shifts and Economic Roller CoastersDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

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=oddtdtcreatorClick 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/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 Welcome and disclaimers0:17 Episode overview and JPM preview0:50 Why Incubate produces Making Medicine1:43 Why policy matters at JPM 20263:30 CMS announces new drug pricing proposals4:26 Globe Part B and Guard Part D explained5:53 Comment period and policy intent6:45 Global pricing and international context8:47 Implications for biotech innovation10:17 Listener Q&A: AI in drug development11:56 Closing thoughts and JPM logisticsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this New Year episode of the Making Medicine Podcast, we revisit a full-length conversation with U.S. Senator Thom Tillis of North Carolina, focused on the policies shaping US life sciences. The discussion explores intellectual property, drug pricing dynamics, regulatory balance, and how innovation ecosystems grow at the state and national level. The episode examines approaches to sustaining research and development while maintaining global competitiveness. It also considers the long-term implications of regulatory uncertainty and international competition.Which policy issue do you think most impacts biotech innovation today?How should decision-makers balance affordability and long-term R&D investment?What does the US need to maintain leadership in life sciences?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=trueTimestamps:0:00 Episode disclaimer 0:17 Welcome to Making Medicine and episode overview0:30 Why this conversation matters for 20261:24 Introducing Senator Thom Tillis2:16 Building a life sciences ecosystem in North Carolina3:43 Economic impact of biotech investment4:27 Tax and regulatory strategy for innovation7:52 Balancing reform and economic stability9:58 Why intellectual property matters for life sciences 12:18 Government involvement and innovation risks13:51 Drug pricing policy and unintended consequences17:05 R&D investment impacts and innovation trade-offs20:26 Global competition and China’s growing role22:55 Changing the narrative around life sciences26:52 What’s next after public service28:58 Closing reflections and future outlookDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this special holiday episode, the Making Medicine Podcast looks back at standout conversations since the show’s July relaunch, covering biotech innovation, research funding, and global competitiveness. Highlights include discussions with industry leaders on venture capital, R&D stability, manufacturing, and the importance of a connected life sciences ecosystem. The episode also revisits conversations on international competition, commercialization challenges, and how policy choices shape innovation outcomes. Together, these moments underscore why long-term investment and coordination across the value chain matter for patients and progress.Which conversation stood out most to you this year?What policy or innovation topic should we explore more deeply in 2026?How do you see global competition shaping the future of biotech?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 Show disclaimer and welcome0:23 Holiday greeting and episode overview1:00 Industry snapshot and biotech competitiveness3:36 R&D funding, NIH, and innovation stability5:36 Global competition and maintaining leadership8:23 Risks and resilience of the innovation economy8:46 Policy ideas to support US biotech14:12 Global perspectives on commercialization and pricing17:20 Integrating early innovators and large pharma21:27 Policy, pricing, and innovation trade-offs27:37 IP, R&D incentives, and unintended consequences28:23 Closing reflections and looking ahead to 2026DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this year-in-review episode, we break down key biotech investment trends from 2025, major policy developments in Congress, and what they mean for innovation and patients. The conversation covers defense-related biotech priorities, healthcare affordability challenges, PBM reform efforts, and capital access for early-stage companies. We also preview new data on venture investment, emerging therapeutic areas, and AI-enabled drug development. The episode closes with a look at recent FDA approvals that highlight real progress reaching patients. What stood out to you most in the 2025 biotech investment data?How do you see policy shaping innovation and capital formation in the year ahead?Which FDA approval gives you the most optimism for patients?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Disclaimers and welcome0:23 Year in review overview: biotech, policy, and innovation0:45 Congress wraps up the year and the FY2026 NDAA1:32 Healthcare legislation and premium pressures3:19 PBM reform efforts and legislative outlook5:39 Capital access update and the Invest Act7:32 2025 biotech investment data preview8:00 Leading therapeutic areas and rare disease trends8:41 Geographic investment highlights by state9:21 Investment by congressional district10:16 AI-enabled biotech investment trends10:46 FDA approvals corner12:31 Closing thoughts and year-end reflectionsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

This episode breaks down how Congress is turning biotechnology into a core national security priority. John Stanford explains the biggest shifts in the 2025 defense bill, why China-focused guardrails are expanding, and how new investment rules could reshape biotech funding. We also cover a new bipartisan proposal to create a government-backed investment fund, and a high-stakes battle over ACA subsidies.What NDAA change do you think will impact biotech most?Should the U.S. invest directly in emerging biotechnologies?How should policymakers balance security with scientific innovation?  If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true   Timestamps:0:00 Disclaimers & Intro0:23 NDAA Overview and Why It Matters1:54 Biotech as a Strategic National Security Capability2:54 Domestic Biomanufacturing & Supply Chain Priorities3:19 DoD Bioindustrial Base & New Biotech Office4:34 Data Standardization, AI Readiness & Security5:07 Guarding the U.S. Biotech Ecosystem from China7:09 Intelligence Community’s New Biotech Role8:00 Outbound Investment Regime Explained10:12 Implications for Investors & Biotech Leaders12:42 The Independence Investment Fund Act14:37 Why Congress Wants a Government-Backed Biotech Fund14:40 Senate Showdown on ACA Subsidies & Healthcare Costs17:36 Why Access and Innovation Are Interconnected18:17 Closing Thoughts & Call for QuestionsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode of Making Medicine, host John Stanford sits down with Senator Thom Tillis, the first sitting U.S. Senator to join the show. Tillis opens up about his relationship with President Trump, the impact of Most Favored Nation (MFN) drug pricing on U.S. innovation, and the forces shaping America’s biotech competitiveness. They discuss why predictable intellectual property and regulatory frameworks are critical for investment and how the U.S. can maintain a leading edge in life sciences. Don’t miss Tillis’s insights on why he chose not to seek reelection and what might come next for his career.This is a must-listen for anyone interested in biotech policy, life sciences innovation, or U.S. global competitiveness.What do you think about MFN-style pricing in the U.S.?How can policymakers best support biotech innovation?Which part of the life sciences ecosystem do you think needs the most attention 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/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Introduction to Making Medicine and Senator Thom Tillis1:12 Tillis joins the podcast as the first sitting Senator2:05 Early career and motivations in public service4:20 Relationship with President Trump and MFN drug pricing7:35 Potential impacts of MFN-style controls on U.S. innovation 10:10 America’s global biotech competitiveness and China13:50 Importance of IP and regulatory predictability for investment16:25 Reflections on policy successes and challenges18:40 Decision not to seek reelection 20:30 What’s next for Senator Tillis22:00 Key takeaways on biotech policy and U.S. innovation24:15 Closing thoughts and call to actionDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode of the Making Medicine Podcast, John Stanford sits down with Daphne Zohar, Founder, CEO, and Board Member of Seaport Therapeutics to explore the forces shaping today’s biotech ecosystem. Daphne shares her entrepreneurial path from PureTech to Seaport, offering a rare inside look at building companies, catalyzing innovation, and scaling breakthrough science. The conversation dives into the Massachusetts biotech flywheel, competitiveness with China, U.S. policy risks like the pill penalty and MFN, and how regulatory uncertainty ripples through capital formation and patient impact. Daphne also highlights why she’s bullish heading into 2026 and offers tactical advice for founders gearing up for JPM. What part of Daphne’s perspective resonated most with you?Which policy issue do you believe will most affect biotech innovation in 2025?What should we ask her next time she joins the show?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Welcome & Introduction1:12 Daphne Zohar’s Path into Biotech3:05 The Seaport Therapeutics Story6:10 Biotech Hangout & CEO Sisterhood8:42 Why Massachusetts Leads in Biotech10:55 The M&A Flywheel & Metsera Deal13:40 China’s Biotech Strategy & U.S. Competitiveness16:20 Pill Penalty, EPIC Act & Drug-Pricing Distortions18:55 MFN Proposals & Impact on Early-Stage Biotechs21:30 FDA Uncertainty: Regulation, Capital & Patients24:00 Positive Signals Heading Into 202626:15 JPM Outlook & Advice for FoundersDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this special Tokyo edition of the Making Medicine Podcast, John Stanford hosts a powerhouse panel of biotech investors, founders, and industry leaders to break down Japan’s emerging life-sciences boom. Together, they explore Japan’s regulatory shifts, government incentives, and rising startup momentum. This episode unpacks how Japan is positioning itself as a global hub for regenerative medicine, gene therapy, and bioeconomy innovation. Whether you're a policymaker, entrepreneur, or simply curious about global biotech trends, you'll get a front-row seat to Japan’s life sciences ecosystem, and why the rest of the world is watching.What part of Japan’s biotech ecosystem surprised you the most?Do you think global biotech companies should be paying more attention to Japan? Why or why not? Where do you see the biggest opportunity for Japan to lead in biotech?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=trueTime Stamps:0:00 Introduction: Why We’re Recording in Tokyo2:45 Japan’s Biotech Vision: From Strategy to Reality6:10 Role of Government & Public-Private Partnerships9:20 Innovation Hubs: Shared Labs & Incubators12:05 Investment Landscape: VCs, Funds & Incentives15:30 Regenerative Medicine & iPSC Development18:45 Gene & Cell Therapy Trends in Japan22:00 Regulatory Reform & Drug Approval Acceleration24:45 Global Biotech Partnerships: Japan’s Reach Abroad27:10 Challenges: From Risk-Averse Culture to Commercialization29:50 The Bioeconomy: Beyond Pharmaceuticals32:15 What’s Next: Predictions for Japan’s Biotech FutureDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

Former Sutro Biopharma CEO Bill Newell joins host John Stanford to discuss the realities of leading a biotech company through economic uncertainty, long development timelines, and a shifting policy landscape. Bill shares lessons from 16 years at the helm, raising over $1.6 billion, navigating clinical trials, and building partnerships with global pharma leaders. The episode dives deep into the challenges of price controls, intellectual property reform, and the importance of FDA consistency for innovation. A must-watch for anyone interested in how science, policy, and investment intersect to bring new medicines to life.What surprised you most about the biotech development process?How do you think policymakers should balance access and innovation?Do you agree with Bill’s stance on price controls and IP reform?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode, John Stanford breaks down the surge in U.S. biomanufacturing investments, including Virginia’s new $500B hub, and what it means for the nation’s workforce. He contrasts this expansion with the recent closure of Arena BioWorks, raising questions about the balance between onshoring and sustaining innovation. The discussion also dives into major rumors of a potential Medicare-GLP-1 deal with Eli Lilly and Novo Nordisk and explores the possible implications of new CMS demonstration projects that could impact Part B manufacturers. Finally, John reflects on the growing pressure of tax and pricing policies that could reshape the biotech landscape. Do you think the U.S. is striking the right balance between manufacturing and innovation? How might Medicare coverage of GLP-1 drugs change the healthcare system? What policy signals should Congress send to protect early-stage biotech?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true0:00 Disclaimer and introduction0:23 Welcome to the Making Medicine Podcast0:57 FDA leadership shakeup and industry uncertainty2:06 Arena BioWorks closure and policy contrasts2:32 FDA predictability and regulatory challenges3:28 Medicare and GLP-1 coverage discussion4:08 New FDA guidance on biosimilars and gene editing5:00 FDA moves to reduce biosimilar development costs5:49 Gene editing progress and regulatory flexibility6:53 Impact of pricing and revenue policies on innovation7:48 Arena BioWorks shutdown and biotech investment climate10:40 Virginia’s new manufacturing hub and workforce initiative13:14 White House drug pricing rumors and CMMI demonstration projects17:39 Closing thoughts and call for engagement DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this episode of Making Medicine, host John Stanford unpacks the Senate HELP Committee hearing on “The Future of Biotech.” From China’s accelerating investment to U.S. policy uncertainty, he explores what’s needed to protect American leadership in life sciences. The episode also covers new White House biosimilar announcements, gene therapy market challenges, and early insights from Incubate Policy Lab’s investment analysis. With over $14 billion invested in early-stage biotech this year, the conversation turns to what’s next for U.S. innovation.Do you think U.S. biotech can stay ahead of China? What policies would best support innovation? Should biosimilars have faster, simpler approvals?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 – Intro and disclaimer0:23 – Senate hearing: “The Future of Biotech” overview1:19 – China’s biotech rise and U.S. competitiveness concerns2:10 – IP protection, FDA modernization, and investment flight3:30 – NIH funding stability and bipartisan support4:00 – PBM reform and patient access challenges6:00 – John Crowley’s warning: U.S. could lose biotech leadership in 2–3 years8:00 – Incubate Policy Lab report: “Red lights in the U.S., green lights in China”10:00 – Policy solutions: pricing predictability and IP certainty12:00 – White House biosimilars announcement explained14:00 – Gene and cell therapy market struggles15:30 – AI-driven biotech investments and top-performing states17:00 – Incubate at JPM 2026 + FDA during government shutdown18:12 – Closing thoughts and audience shout-outsDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John breaks down the White House headlines, the FDA’s new wave of priority review vouchers, and September approvals, then celebrates National IP Month with guest Joshua Kresh. We dig into criteria for the new wave of CNPVs, domestic manufacturing pushes (Augmentin XR and ketamine), and why some approvals matter for patients who’ve run out of options. John also unpacks the Orphan Cures Act debate, the latest CBO chatter, and what it all means for long-term innovation. Finally, Joshua explains why IP is the backbone of biotech and flags fixes on eligibility, injunctions, and PTAB. Tell us what you think and we may feature your comment next week.What’s your take on the FDA’s new voucher selections - smart acceleration or risky subjectivity? Should Congress protect the Orphan Cures Act or revisit it in light of CBO’s estimates?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 Disclaimers0:23 Welcome & episode setup0:46 Headlines: White House update & FDA Vouhcer program1:20 FDA criteria & first recipients (overview)3:00 Domestic manufacturing: Augmentin XR & ketamine3:55 Approvals Corner: September FDA approvals4:54 Orphan Cures Act: fix, CBO score & repeal talk6:49 Tracking investor sentiment: life science & rare disease8:05 National IP Month intro8:47 Guest Joshua Kresh & IPI’s mission12:36 The big IP issues: eligibility, injunctions (RESTORE), PTAB24:49 Outro & call to actionDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John Stanford breaks down Day 15 of the federal shutdown’s impact on health agencies, major pullbacks in cell & gene therapy, and the White House’s latest MFN-style deal with AstraZeneca following Pfizer. We’re joined by Incubate’s Policy Director John Guy to explain how “BIOSECURE” found new life inside the Senate’s NDAA and what that means for biopharma. We also cover investment trends, workforce concerns, and the new DoD Biotech Management Office mandate. Stick around to the end for how all this could reshape U.S. innovation and supply chains. How will MFN-style deals affect launch strategy and U.S. pricing? Do recent exits by Novo Nordisk and Takeda change your outlook on cell & gene therapy? What’s your biggest question about BIOSECURE's due-process path and NDAA timing? DOD 1260H List: https://media.defense.gov/2025/Jan/07/2003625471/-1/-1/1/ENTITIES-IDENTIFIED-AS-CHINESE-MILITARY-COMPANIES-OPERATING-IN-THE-UNITED-STATES.PDF If you're new to the Making Medicine Podcast, we're happy you're here!Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Disclaimer0:23 Welcome & agenda0:47 Shutdown Day 15: CDC RIF confusion2:29 Court injunction + earlier HHS/FDA/NIH cuts2:49 Cell therapy pullbacks (Novo, Takeda)3:58 Investment slump in cell & gene therapy5:21 Policy clarity, China context & hope6:00 AstraZeneca White House MFN deal vs Pfizer8:07 NDAA intro & Biosecure refresher9:40 Interview: What is Biosecure? (John Guy)12:19 Biosecure 2.0 details: DOD 1260H list, OMB review & due process14:43 NDAA path, DoD Biotech Office, workforce & wrapDISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John Stanford reports from Boston - the beating heart of global biotech - with insights from investors, scientists, and executives shaping the future of life sciences. He breaks down what the government shutdown means for FDA operations, unpacks the White House–Pfizer deal, and shares key takeaways from conversations on U.S. competitiveness, biotech investment, and the next generation of talent and technology.How do you see policy uncertainty affecting biotech innovation?Are U.S. policies doing enough to keep the next generation of scientists here?What biotech breakthroughs excite you most right now?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 Disclaimer: Not medical or investment advice0:23 Welcome from Boston - biotech capital of the world1:11 Government shutdown and FDA operations2:06 What’s paused at the FDA and why it matters2:29 Understanding the White House–Pfizer deal3:19 MFN pricing, TrumpRx, and tariff waivers4:07 Pfizer’s $70B U.S. investment and industry implications4:29 Key takeaways from Boston investor meetings4:58 Policy uncertainty and its impact on biotech investment5:29 Interest rate cuts and biotech’s comeback potential6:07 The growing threat to U.S. scientific talent6:33 The “brain drain” and its implications for America’s biotech future7:22 Boston’s role in championing life sciences7:50 Exciting new biotech modalities: gene therapy, RNA, and cell engineering9:34 Policy clarity, workforce development, and scientific momentum10:20 Closing thoughts: innovation across America10:40 Outro and call to action DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

This week, John Stanford breaks down the government shutdown and its impact on FDA, NIH, and biotech innovation. He also covers the surprising lapse of the SBIR program, what it means for early-stage biotech funding, and the fierce political debate around its future. Plus, we analyze President Trump’s deal with Pfizer on “Most Favored Nation” drug pricing and his latest tariff threats.What does all this mean for the future of U.S. biotech competitiveness?How should policymakers balance affordability and innovation in drug pricing?Do you think the SBIR program will be quickly revived, or is this the start of bigger changes?What impact will tariffs and MFN drug pricing have on biotech investment?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Welcome to Making Medicine0:21 Government shutdown and biotech impact1:05 FDA furloughs and regulatory slowdowns2:00 NIH delays and research funding concerns2:40 Investor confidence during shutdowns2:57 SBIR & STTR programs expire3:22 Political stalemate in the Senate3:50 Why SBIR matters for biotech innovation4:05 Trump & Pfizer announce MFN drug pricing deal5:06 Trump RX website and drug access6:05 Market reactions and industry uncertainty6:36 Trump’s 100% pharma tariff threat7:40 Section 232 investigations on drugs and PPE7:59 Closing thoughts & audience Q&ADISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John Stanford breaks down the White House autism event, the debate over shifting SEC reports to twice-yearly, and how MFN pressure is reshaping pricing strategy - before welcoming Endpoints News’ Max Bayer for a wide-ranging Press Pass on tariffs, GLP-1s, and China’s biotech surge. We unpack what “success” might look like for the administration’s drug-pricing push, why insurers could make or break any DTC effort, and how policy whiplash is hitting rare disease developers and investors. Max shares on-the-ground reporting about China’s rapidly built “Cambridge-like” ecosystems and the risks of restricting out-licensing. We also discuss the stakes for U.S. competitiveness if Europe becomes the default partner. Stick around to the end for how we’re tracking MFN and IRA signals across company filings.Should SEC reporting shift to twice a year for biotechs, or does that cut needed transparency?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=trueFollow Max Bayer https://www.linkedin.com/in/max-bayer-20435179Timestamps:0:05 Welcome to Making Medicine0:36 Headlines: White House autism event & fallout1:34 SEC filings: quarterly to semiannual debate2:13 Press Pass: Max Bayer (Endpoints News) joins2:39 “Totality” of actions - MFN, tariffs, vaccines, China deals4:10 Investor lens: regulatory continuity & rare disease shocks6:01 MFN behavior shifts (e.g., UK pricing moves)8:39 What counts as success? GLP-1 pricing & insurer role12:11 China’s biotech surge & the out-licensing boom15:03 Policy options: restrictions vs. U.S. competitiveness (Europe risk)17:20 U.S. ecosystem headwinds: jobs, patents, visas, funding23:51 Outro, subscribe, and where to send tips for Max DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

This week, John Stanford dives into the UK’s pharmaceutical challenges, including ABPI’s warning about declining competitiveness and major companies pausing investment. We also explore the debate over direct-to-consumer drug advertising in the U.S. and how it ties into investment decisions and the pill penalty. Finally, we close with August’s FDA approvals, celebrating breakthroughs for rare diseases and cancer patients.What do you think?Can the UK become Europe’s life sciences hub by 2030?Should the U.S. rethink DTC advertising, or does it play a vital role in innovation?Which of this month’s FDA approvals excites you most? If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps: 0:00 Welcome to Making Medicine0:28 UK pharma outlook and ABPI report1:37 Weaknesses in UK drug investment2:24 Companies pausing UK investments3:08 U.S. vs UK drug access and pricing4:08 Global pressure for fair drug pricing4:33 MFN pricing concerns in the U.S.5:09 Debate over drug advertising6:09 How DTC ads affect biotech investment7:26 Connection to the pill penalty7:48 FDA Approvals Corner – August highlights8:17 Jazz Pharmaceuticals – Modeyso approval8:36 Boehringer Ingelheim – Hernexeos approval9:17 Other rare disease drug approvals10:23 Closing thoughts & FDA wins DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

In this week’s episode, John Stanford reflects on Incubate’s own holiday, September 13th (9/13), and the ongoing fight to end the pill penalty through the EPIC Act. He also covers the latest developments on tariffs, HHS hearings, FDA’s new rare disease principles, and the future of the SBIR program. We close with new research on how the IRA is affecting biotech investment.What are your thoughts on the pill penalty?Do you think FDA’s new rare disease guidance will accelerate innovation?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Welcome to Making Medicine0:32 9/13 and the pill penalty explained1:37 Incubate’s advocacy: EPIC Act and campaigns2:31 Life Science Investment Tracker: discontinued drugs & programs3:02 Trump tariffs and pharmaceutical exemptions4:06 Japan deal and Most Favored Nation strategy4:22 RFK Jr. Senate hearing on vaccines, IRA, and drug pricing5:37 The trap of list prices in policy debates5:39 FDA’s new Rare Disease Evidence Principles (RDEP)6:34 Why clarity matters for rare disease companies6:36 SBIR program renewal and uncertainty ahead7:09 NPC survey on the IRA’s impact on investment7:51 Closing thoughts & call to actionWe’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

This week, John Stanford sits down with Kendalle Burlin O’Connell (CEO & President, MassBio) to unpack the 2025 Industry Snapshot - why Massachusetts still attracts 22% of U.S. biotech VC and how advanced modalities keep the state at the cutting edge. We dig into the “flywheel” of the bioeconomy, from NIH and SBIR to FDA uncertainty, tariffs, and MFN. Kendalle lays out a unifying policy roadmap - a comprehensive competitiveness package - to keep the U.S. leading in life sciences. We also talk capital concentration, China’s rapid rise, and what it will take to avoid losing our edge in the next 2-5 years. Stick around for a candid, optimistic close on how the ecosystem rebounds.What stood out to you most from MassBio’s 2025 Snapshot?Do you agree the U.S. needs a “comprehensive competitiveness package”- and what should be in it?How are funding cuts or regulatory uncertainty affecting your team right now?If you're new to theMaking Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Intro music & welcome0:15 Guest intro: Kendalle Burlin O’Connell, MassBio CEO1:24 2025 MassBio Snapshot: why it matters now2:12 Key stats: 22% of U.S. VC & advanced modalities lead3:45 “Massachusetts works”: optimism amid a gloomy market5:03 The biotech flywheel: how uncertainty stalls the ecosystem6:59 Funding pipeline: NIH cuts, SBIR reauth, FDA/tariffs/MFN9:58 Why biotechs need big pharma; price controls’ ripple effects12:45 Capital crunch: venture down & late-stage concentration14:51 Why NIH & ARPA-H can’t be replaced by private capital16:56 The fix: a comprehensive competitiveness package19:09 China’s rise & the 2-5 year warning22:23 MA bioeconomy impact, optimism, and outro*We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”*We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”

In this week’s episode, John Stanford breaks down the latest headlines across Washington, the FDA, NIH, and industry. We cover the Trump cabinet’s tariff-drug pricing push, BARDA’s funding of vaccine research following recent pivots away from mRNA vaccines, a hopeful return of biotech IPOs, and NIH program cuts. Plus, we debut the FDA Approvals Corner celebrating new medicines reaching patients, and spotlight the looming September deadline for the SBIR and STTR programs.What do you think about tariffs being tied to drug pricing?Should Congress extend SBIR funding as-is, or rethink the program? Which FDA approval from July do you think will have the biggest impact?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=trueTimestamps:0:05 Welcome to Making Medicine0:38 Trump cabinet links tariffs & drug pricing2:24 BARDA shifts vaccine funding away from mRNA3:36 First biotech IPO in 6 months: LB Pharmaceuticals4:56 Policy headwinds in SEC filings & MassBio snapshot5:17 NIH cuts minority biomed research program5:43 Launch of FDA Approvals Corner6:25 July FDA approvals roundup7:45 Policy Spotlight: SBIR & STTR programs8:46 The Innovate Act and foreign risk concerns9:42 Extension vs. compromise for SBIR reauthorization10:27 Closing thoughts & call for comments *We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.”

This week, John Stanford sits down with Dr. Ned Sharpless - former NCI Director, Acting FDA Commissioner, and now venture capitalist at Jupiter Bio Ventures. From the challenges of biotech funding, regulatory uncertainty, and the Inflation Reduction Act to the rise of China in biotech, IP battles, and the hype around AI, Ned offers candid insights you won’t hear anywhere else.What do you think about the current funding environment in biotech?How should the U.S. respond to China’s scientific rise? 📱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=trueTimestamps:0:00 Welcome to Making Medicine0:12 Guest introduction: Dr. Ned Sharpless1:03 Launch of Jupiter Bio Ventures3:31 The tough biotech funding environment5:27 Regulatory uncertainty, IRA, and FDA challenges8:02 Leadership turmoil at FDA, NIH, and HHS 10:18 RFK Jr.’s vision and impact on health policy13:05 Morale, recruitment, and expertise at federal agencies 15:20 How NIH, FDA, and CMS work together 19:00 NIH funding freezes and Congressional outlook 23:36 FDA’s new priority review voucher program28:02 Public skepticism, politics, and FDA trust30:02 The “pill penalty,” EPIC Act, and IRA fixes34:04 Why small molecules still matter for cancer 35:40 IP protections, march-in rights, and investment risks39:20 The debate over Most Favored Nation drug pricing43:12 Direct-to-consumer pricing as a potential solution 44:38 AI in biotech-hype vs. reality46:46 China’s rise in biotech and global competition50:11 Closing thoughts and optimism for science

In this episode, John Stanford dives into the latest policy and science headlines - from Dr. Vinay Prasad’s dramatic exit and return to the FDA, to HHS’s $500M cut in mRNA research, to looming pharmaceutical tariffs. Then, we debut our new "Industry Perspectives" segment with NovaQuest Capital’s Patrick Jordan, exploring how regulatory uncertainty, populist pricing policies, and global market dynamics impact biotech innovation.What do you think about HHS’s decision to pull back on mRNA research? Could foreign reference pricing harm small biotech companies more than big pharma? And how should the FDA navigate leadership instability to keep innovation on track? 📱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

This week on the Making Medicine Podcast, John Stanford dives into the “Most Favored Nation” (MFN) pricing concept, championed by President Trump, and what it could mean for drug pricing, innovation, and patients in America. Could aligning U.S. drug prices with those abroad actually save patients money, or would it crush innovation and access? John unpacks the trade-offs of MFN, the global free-riding problem, the role of PBMs, and the rise of direct-to-patient drug models. The episode explores whether America already is the most favored nation in pharmaceuticals and what bold moves are next.What do you think: Should the U.S. demand lower prices from drug companies or protect innovation at all costs?Would a direct-to-patient model work better than today's broken system?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 The History of Most Favored Nation1:06 Trump Brings MFN Back into Focus1:22 Welcome to Making Medicine2:19 Why Drug Pricing Became the MFN Battleground3:04 Trump's Push for MFN & the Pharma Letter4:02 The Personal Story Driving Trump’s Policy5:00 The Appeal and Simplicity of MFN5:19 Industry Pushback & Potential Consequences6:02 America’s Role in Global Drug Innovation7:06 Why MFN Could Damage U.S. Biotech7:25 The Costco Analogy & Why It Fails8:20 Global Free-Riding and What Other Nations Don’t Pay9:00 The U.S. Middlemen Problem (PBMs)10:03 Global Solutions and Missed Opportunities11:01 Generics: The Hidden Strength of the U.S. System12:43 What Happens If Generics Vanish?13:14 Trump's Unclear Path Forward13:46 Direct-to-Patient Sales: A Better Path?14:42 Is the U.S. Already the Most Favored Nation?15:30 Final Thoughts on MFN & What Comes Next

In this week’s special Q&A episode, John Stanford tackles your biggest questions from around the biotech and policy world. From the growing list of drug price controls under the IRA to the newly announced 15% EU tariffs on medicines, there's a lot at stake for patients, companies, and innovation. John also breaks down the temporary NIH funding freeze, what it means for research, and why August recess matters more than you think.What impact do you think drug price controls will have on innovation?Should medicines be included in international tariff negotiations?What policies should Congress prioritize this fall?📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Tech setup and behind-the-scenes3:37 Welcome to the Making Medicine Podcast4:16 Breaking news: FDA's SBER director steps down4:58 Are we moving toward more price controls on drugs?7:47 New EU trade deal and tariffs on pharmaceuticals10:08 How the IRA continues to impact the investment environment12:31 Did the White House freeze NIH funding?15:10 What is August recess and why it matters16:53 Final thoughts and call for listener questions

In this special Press Pass episode of the Making Medicine Podcast, John Stanford welcomes Nyah Phengsitthy of Bloomberg Law to break down the latest shifts in drug pricing, FDA policy, and the unpredictable pace of the Trump administration. They explore the Medicare drug price negotiation program, new FDA leadership under Dr. Makary, and the industry’s reaction to rapidly changing executive orders. Nyah also shares her approach to filtering meaningful policy changes from political noise. Plus, they dive into how upcoming guidance may reshape the role of physicians in Part B drug distribution and what that means for innovation in medicine. How should industry leaders respond to policy announced via social media posts? Will the new FDA leadership redefine efficiency and access in drug approval? What worries you most (or excites you) about the future of drug pricing policy?📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/ https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 There's a lot going on0:36 Welcome to Making Medicine1:00 Introducing Nyah Phengsitthy and Press Pass 1:40 Top trends in drug policy under Trump2:52 Uncertainty and industry response3:57 How Nyah filters news vs. noise5:29 A changing FDA and its new direction 6:49 Stakeholder engagement and Makary’s listening tour7:51 Industry frustration over vague policy9:00 Medicare drug negotiation: Trump’s first take10:47 Fixed dose combos and Orphan Cures Act in new guidance11:50 Part B dynamics and physician involvement12:56 Listening sessions and future guidance13:19 Final thoughts and wrap-up

In this week’s episode, John Stanford breaks down the evolving story of President Trump’s aggressive tariff strategy—focusing on a potential 200% tariff on pharmaceuticals. From a historical look at Trump’s decades-long affinity for tariffs to the current Section 232 investigation into pharmaceutical imports, we explore what these actions could mean for national security, drug prices, and innovation. Could this policy lead to onshoring more drug manufacturing—or just higher prices for patients? And what exactly is “Liberation Day”? What are your thoughts on a 200% pharma tariff?Is this a smart way to strengthen domestic manufacturing—or a policy that could backfire? 📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true Timestamps:0:00 Welcome and Overview0:33 Why Tariffs? A Trump Trade Philosophy1:32 Trump’s History with Tariffs2:32 The 2025 Tariff Timeline3:59 Liberation Day and the Global Tariff Shock4:53 August 1st Deadline and Market Reaction5:27 Trump Floats 200% Pharmaceutical Tariff6:03 Section 232 Investigation Explained6:56 Incubate’s Response and Global Supply Chain Concerns7:50 National Security, APIs, and the Commerce Department8:56 Trump’s Endgame: Manufacturing Medicines at Home9:44 What the Industry Should Expect10:26 Why We’re Still in the Dark10:50 Next Week’s Preview: The Press Pass Segment

John Stanford kicks off the official relaunch of the Making Medicine Podcast with a deep dive into the "one big beautiful bill" that’s shaking up Washington. From major tax cuts to game-changing reforms like the Orphan Cures Act, this episode covers what’s in—and what’s not—in the sweeping legislation. What’s the real impact on biotech innovation, Medicaid, PBMs, and future drug pricing? John breaks it all down while teasing what’s ahead in upcoming episodes, including Trump’s proposed pharma tariffs and the evolving role of the FDA.Do you think the Orphan Cures Act goes far enough?How will these tax and policy shifts impact innovation in rare disease and biotech?📱If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Welcome to Making Medicine0:18 Podcast relaunch and weekly content1:00 One big beautiful bill becomes law1:38 Tax cuts, deficit concerns, and social program impacts2:55 How the bill affects biotech and venture capital3:26 Orphan Cures Act and rare disease investment4:20 Inflation Reduction Act reforms not included4:40 PBM cuts left out of the bill5:20 Victory on Most Favored Nations policy6:24 What “pay for” means in DC speak6:59 Industry spared from being a “pay for”7:03 What’s coming next: tariffs, NIH cuts, FDA changes7:45 Subscribe and stay updated

The path to new medicines is complex enough - policy doesn’t need to make it more difficult. But it does. In this episode, Thomas Kaiser, Co-Founder and Chief Scientific Officer Avicenna Biosciences joins the show to share how the Inflation Reduction Act is unintentionally discouraging investment in small-molecule drugs, creating the pill penalty. He explains why this matters not just to biotech founders, but to millions of patients waiting for treatments for conditions like Parkinson’s, MS, and diabetes. We also discuss:What’s at risk when chronic disease treatments are deprioritized due to poor incentivesWhy policymakers often misunderstand biotech timelines and how that disconnect can block life-saving innovation.How North Carolina’s foresight turned it into a biotech innovation hub.Read Tom’s Op-ed in BioSpace.

In this episode of The Making Medicine podcast, John Stanford sits down with Professor Fred Ledley, Director of the Center for Integration of Science and Industry at Bentley University. Professor Ledley shares his journey from medical school to biotech entrepreneurship and academia, highlighting the critical intersection of science and business. The discussion explores the evolution of gene therapy, personalized medicine, and the role of industry in driving medical innovation.Key Takeaways:The integration of science and business is essential for advancing healthcare innovations.Gene therapy and personalized medicine have evolved significantly, shaping modern treatments.Collaboration between researchers, entrepreneurs, and policymakers accelerates medical progress.

The U.S. healthcare system is a puzzle for many.To fix it, we need smarter discussions and a deeper understanding of both the industry and the policies that shape it.In this episode, host John Stanford talks to healthcare policy expert Brian Reid, Principal at Reid Strategic and author of the Cost Curve newsletter, to discuss the challenges of fixing the incentives that have led to a broken healthcare system.We also discuss:How the healthcare debate often overlooks the needs of patients, focusing instead on assigning blame to various system stakeholders.The potential consequences price controls could have on pharmaceutical innovation (particularly for small molecules and cancer treatments).Why the current healthcare environment discourages companies from investing in long-term R&D, particularly in drug types that primarily benefit the elderly.

Science should lead our policy decisions—not the other way around. In this episode, Kirsten Axelson, Senior Policy Lab Advisor at Incubate Coalition, dives deep into the power of small molecule medicines, the promise they hold for the future, and how our current policy landscape may upend their development.  This conversation focuses on Incubate Policy Lab’s most recent white paper, which sheds light on the crucial role these molecules play not only in innovative drug development, but also in ensuring equitable access to life-saving treatments. Listeners will learn: ​​The crucial role small molecules play in modern medicine, especially in treating conditions like cancer and neurological diseases.How current policy decisions, such as those in the Inflation Reduction Act, could negatively affect the development and accessibility of small molecule drugs.Why small molecule medicines contribute to equitable access to healthcare, especially for underserved populations and in global health contexts.To learn more about Kirsten’s white paper, please go to incubatecoalition.org 

As part of our inaugural CEO series, we're excited to welcome Sherine Chan, the CEO and Co-Founder of Neuroene Therapeutics.In this episode, Sherine shares her journey from academia to helming a cutting-edge biotech company. She explores the groundbreaking work her company is pioneering in targeting the powerhouses of cells: mitochondria. Sherine also dives into the influence of the Inflation Reduction Act on the development of small-molecule drugsWe also discuss: Neuroene Therapeutics' ongoing projects.The critical role of mitochondrial dysfunction in neurological conditions such as epilepsy, Parkinson's, and mitochondrial disorders.Sherine's insights for aspiring entrepreneurs and scientists.

On World IP Day, Kirsten Axelsen, Senior Advisor of the Incubate Policy Lab, joins host John Stanford to announce the newest whitepaper, delve into the myths and realities surrounding IP in the pharmaceutical industry, explore the dynamics of patent regulations, and touch on the contentious discussions around patent thickets and pharmaceutical pricing under new legislative environments like the Inflation Reduction Act.Join us as we also discuss:What to expect out of the Incubate Policy LabThe role that venture investment plays in advancing promising science and technology.The latest whitepaper that addresses misconceptions about IPThe implications of IRA policies in weakening the generics industry, potentially disrupting the balance that has historically led to affordable drug pricing post-patent expiration.