Michael Penn: What The IRA Means For Oncology Innovation

Michael Penn: What The IRA Means For Oncology Innovation

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with Michael Penn [https://www.linkedin.com/in/michael-d-penn/], US Head of Reimbursement and Public Policy at Sanofi [https://www.linkedin.com/company/sanofi/], to discuss how pricing policy, the Inflation Reduction Act (IRA), small-molecule incentives, orphan drug provisions, and Most Favored Nation (MFN) proposals could shape oncology innovation, patient access, and U.S. biopharmaceutical competitiveness. Key Topics: * IRA and Oncology: Late-stage research shifts, follow-on studies, lead asset selection. * Small-Molecule Incentives: Pill penalty concerns, portfolio reassessment, biologic comparisons. * Orphan Drug Policy: Orphan Cures Act provisions, rare disease investment, post-market indication development. * Patient Access Risks: Fewer treatment options, affordability questions, unmet needs in oncology. * U.S. Competitiveness: MFN proposals, global R&D incentives, comparisons with China and Europe. Our new preprint on the IRA’s impact on late-stage R&D is available on our website [https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/] and examines declines in small-molecule oncology research and orphan oncology studies. Opinions expressed are those of the speakers. Recorded at ASCO 2026 on 5/31/26. The Vital Health Podcast is a production of Vital Transformation LLC © 2026. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

MSD Early Bird Podcast: Changing Demographics and the Case for Renewed Investment in Health

Across Europe and around the world, demographic change is reshaping our societies. Longer life expectancy, aging populations, and evolving workforce dynamics are creating both new opportunities and growing pressure on healthcare systems, economies, and public policy. Against this backdrop, health and innovation play an increasingly important role in building resilient societies and supporting healthier, more productive lives. Investing in prevention, early intervention, innovative healthcare solutions, and forward-looking health policies is becoming essential to meeting these challenges. In this Early Bird edition of the Vital Health Podcast, Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] sits with Mike Hodin [linkedin.com/in/hodin] (Global Coalition on Aging - GCOA [https://www.linkedin.com/company/global-coalition-on-aging/]; CEO) and Francesca Colombo [https://www.linkedin.com/in/francesca-colombo-a662a51/] (Organisation for Economic Co-operation and Development - OECD [linkedin.com/company/organisation-eco-cooperation-development-organisation-cooperation-developpement-eco]; Head, Health Division) to explore how strategic investment in health and innovation can help address demographic change and contribute to sustainable social and economic outcomes. They highlight the value of prevention, including adult vaccination, the importance of cardiovascular health, and the critical role of early detection, diagnosis, and timely treatment in cancer care. Opinions expressed are those of the speakers. Recorded on 6/17/26. This podcast was made with the support of Merck Sharp & Dohme [https://www.linkedin.com/company/msd-global]. The Vital Health Podcast is a production of Vital Transformation LLC [https://www.linkedin.com/company/vital-transformation/] © 2026. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

Bill Smith: How 340B Became A Hospital Profit Center

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with Bill Smith [https://www.linkedin.com/in/william-smith-phd-54628b18/] (Senior Fellow and Director, Life Sciences Initiative at The Pioneer Institute [https://www.linkedin.com/company/pioneer-institute-for-public-policy-research/]) to discuss how the 340B program has evolved from a safety net drug discount program into a major source of hospital revenue, what new research suggests about charity care and Medicaid access, and why transparency, hospital consolidation, and broader drug pricing policy are reshaping incentives across oncology and biopharma. Key Topics: * 340B Origins: Medicaid best price, safety net intent, clinic and hospital eligibility. * Hospital Arbitrage: Buy-low sell-high incentives, affluent satellite sites, oncology drug spreads. * Charity Care: Lower reported charity care, Medicaid access concerns, variation across hospital systems. * Transparency Reforms: State reporting laws, separate audited accounts, minimum charity care requirements. * Policy Collisions: Inflation Reduction Act (IRA) price controls, Most-Favored-Nation (MFN) pressure, oncology consolidation, biopharma investment risks. Opinions expressed are those of the speakers. Recorded 6/5/26. The Vital Health Podcast is a production of Vital Transformation LLC © 2026. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

Steve Potts: Policy Headwinds Are Reshaping Biotech Financing

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with Steve Potts [https://www.linkedin.com/in/steven-potts/], CEO of Breakthru Medicine [https://www.linkedin.com/company/breakthrumed/], to discuss how biotech financing, drug pricing policy, scientific infrastructure, and public trust are reshaping oncology innovation and U.S. biopharma leadership. Key Topics: * Biotech Financing: Series A funding, early-stage platform headwinds, clinical asset momentum, academic funding strain. * Small Molecule Shift: IRA incentives, NDA versus BLA timelines, oncology pipeline pullbacks, antibody drug conjugates. * Orphan Cures and EPIC Acts: Orphan Cures Act, EPIC Act, patent life concerns, investor return requirements. * Most Favored Nation (MFN) Pricing Risk: OECD reference pricing, European access delays, launch sequencing, global cost-sharing tensions. * Science Policy Threats: NIH grant oversight, peer review risks, vaccine backlash, U.S. biopharma leadership. If biotech CEOs (or an executive delegate from the CEO) are interested in taking the first step toward being a policy voice on one topic in our ecosystem, contact Steve Potts on LinkedIn [https://www.linkedin.com/in/steven-potts/]. The May 29 Office of Management and Budget sweeping regulatory change, which would shift grant funding decisions from scientists to politicians, is catastrophic for science, patients, and the biotech industry. Please read about what this proposal would do, and if you agree that it would forever tie political views to winning federal funding (and it will cut both ways), please sign this petition or others and speak out: https://fight2win.standupforscience.net/ [https://fight2win.standupforscience.net/] Opinions expressed are those of the speakers. Recorded at ASCO 2026 on 6/1/26. The Vital Health Podcast is a production of Vital Transformation LLC © 2026. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

Patrick Kelly & John Murphy: Generic Shortages and Supply Chain Risk

In this best-of edition of the Vital Health Podcast, we revisit two conversations Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] has with experts on the future of generic medicines, drug shortages, and supply chain risk in the United States. * Patrick Kelly [https://www.linkedin.com/in/patrick-kelly-08427a8/]: Chief Advocacy Officer, Healthcare Distribution Alliance [https://www.linkedin.com/company/hdma/] * John Murphy [https://www.linkedin.com/in/john-murphy-iii-9b19ab1/]: President and CEO, Association for Accessible Medicines [https://www.linkedin.com/company/accessiblemeds/] Across these conversations, they discuss how low prices, thin margins, supply chain disruption, reshoring pressure, biosimilar market dynamics, insurance design, and federal pricing policy shape access to generic and biosimilar medicines. Key Topics: * Generic Economics: Low prices, thin margins, purchaser pressure, manufacturer exits. * Shortage Drivers: Demand spikes, facility shutdowns, sterile injectables, chemotherapy disruptions. * Tariffs and Reshoring: Domestic production costs, national security concerns, tariff pass-through, contract constraints. * Biosimilar Competition: Private-label programs, vertical integration, investment uncertainty, patient access. * Policy and Insurance: IRA redesign, MFN pricing, direct-to-consumer pathways, prescription benefit reform. Opinions expressed are those of the speakers. Original podcasts published in October 2025. The Vital Health Podcast is a production of Vital Transformation LLC © 2026. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.