Advertise on podcast: Vital Health Podcast

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Eric Lindquist, biotech entrepreneur and former Chief Business and Commercial Officer at Celcuity, about the 2021 deal to license gedatolisib from Pfizer. Drawing on Lindquist’s experience with the transaction, they explore portfolio fit, the responsibilities of advancing a medicine, and how funding, pricing policy, and international competition shape drug development and patient access. Key Topics: Drug Licensing: The Pfizer-Celcuity agreement, portfolio fit, development responsibilities. Pricing Policy: Inflation Reduction Act incentives, Most Favored Nation proposals, international launch decisions. Global Investment: Venture capital in Europe and the U.S., China’s role in drug licensing, clinical development costs. Venture Philanthropy: Funding gaps, Lindquist’s plans for a new fund, companies outside traditional investment mandates. AI in Trials: Uses of digital pathology, patient identification, confirmatory testing. Resources Discussed & Further Reading: Original Gedatolisib Licensing Announcement (Celcuity, April 2021; PDF page 26): https://ir.celcuity.com/static-files/3a24eb9e-2798-43e3-bcab-660f1dc11a54#page=26 Gedatolisib Fact Sheet (Pfizer, May 2018; historical development background): https://cdn.pfizer.com/pfizercom/news/asco/Gedatolisib_Fact_Sheet_25MAY2018.pdf FDA Approval of Revtorpyk (Gedatolisib) (Celcuity, July 2026): https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-fda-approval-revtorpyktm-gedatolisib The Inflation Reduction Act’s Impact Upon Late-Stage R&D (Vital Transformation preprint, 2026): https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/ EU General Pharmaceutical Legislation & Clawbacks (Vital Transformation, 2024; European investment research): https://vitaltransformation.com/2024/03/the-eu-general-pharmaceutical-legislation-clawbacks-calculated-impacts-both-designed-and-unintended/ The Impact of MFN on Oncology and Hematology Treatments (Vital Transformation preprint, 2026; related modeling): https://vitaltransformation.com/2026/02/preprint-new-research-the-impact-of-mfn-on-oncology-and-hematology-treatments/ China’s Growing Share of Drug Development (Goldman Sachs, December 2025; related background): https://www.goldmansachs.com/insights/articles/china-is-increasing-its-share-of-global-drug-development European Bofanglutide Licensing Agreement (Gan & Lee and Menarini, September 2026): https://www.menarini.com/en-us/news/news-detail/gan-lee-and-menarini-group-partner-to-advance-bofanglutide-in-europe.html Opinions expressed are those of the speakers. See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Harry Bowen, Economic Research Partner at Vital Transformation, about Most-Favored-Nation (MFN) drug pricing and the lessons they draw from Europe's experience with price controls. They discuss how pricing rules, revenue uncertainty, and regulatory choices influence market access and the geography of pharmaceutical innovation. Key Topics: MFN Pricing Incentives: International reference pricing, launch decisions, links between U.S. and European markets. European Approval Trade-offs: Centralized review, national decision-making, consistency and time to market. Investment and Uncertainty: Expected returns, late-stage financing, retrospective clawbacks and revenue planning. Global Innovation Competition: Mobile research investment, changing capabilities, Europe's experience and China's role. Policy and Evidence: Historical comparisons, incentives and unintended effects, distinguishing policy explanations from broader economic change. Resources Discussed: The historical impact of price controls on the biopharma industry (Schulthess & Bowen, 2021): https://vitaltransformation.com/2021/11/the-historical-impact-of-price-controls-on-the-biopharma-industry/ Pharmaceutical regulation in Europe and its impact on corporate R&D (Eger & Mahlich, 2014): https://link.springer.com/article/10.1186/s13561-014-0023-5 The EU General Pharmaceutical Legislation & Clawbacks: Calculated impacts - both designed and unintended (Schulthess et al., 2024): https://vitaltransformation.com/2024/03/the-eu-general-pharmaceutical-legislation-clawbacks-calculated-impacts-both-designed-and-unintended/ Savings from Most-Favored-Nation Drug Pricing Policy (White House, 2026): https://www.whitehouse.gov/research/2026/05/savings-from-most-favored-nation-drug-pricing-policy/ The Inflation Reduction Act’s Impact Upon Late-Stage R&D (Bowen et al., 2026): https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/ EIRA 2026 conference information: https://eirainitiative.org/events/ Opinions expressed are those of the speakers. Discussion recorded on 9/19/26. #VitalHealthPodcast #MFN #DrugPricing See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Michael Penn, US Head of Reimbursement and Public Policy at 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 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 for privacy information.

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 sits with Mike Hodin (Global Coalition on Aging - GCOA; CEO) and Francesca Colombo (Organisation for Economic Co-operation and Development - OECD; 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. The Vital Health Podcast is a production of Vital Transformation LLC © 2026. See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Bill Smith (Senior Fellow and Director, Life Sciences Initiative at The Pioneer Institute) 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 for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Steve Potts, CEO of Breakthru Medicine, 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. 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/ 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 for privacy information.

In this best-of edition of the Vital Health Podcast, we revisit two conversations Duane Schulthess has with experts on the future of generic medicines, drug shortages, and supply chain risk in the United States. Patrick Kelly: Chief Advocacy Officer, Healthcare Distribution Alliance John Murphy: President and CEO, Association for Accessible Medicines 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 for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Christopher Locher, Chief Executive Officer at Versatope Therapeutics, about the current landscape for vaccine manufacturers and innovators. Their conversation covers vaccine platform development, financing challenges for infectious disease companies, policy and regulatory uncertainty, the public health implications of changes to childhood immunization schedules, and the steps needed to rebuild trust in vaccination. Key Topics: Vaccine Platform Innovation: Nanoparticle technology, universal influenza vaccine development, multispecific targeting, infectious disease, and oncology applications. Financing Challenges: Venture capital headwinds, NIH support, clinical development costs, grant cancellations, and startup survival pressures. Policy Uncertainty: Changes to childhood immunization schedules, liability debates, academic licensing concerns, royalty proposals, and the biotech investment climate. Public Health Risks: Vaccine access, childhood disease vulnerability, antimicrobial resistance, influenza complications, and consequences of fragmented immunization policy. Trust Rebuilding: COVID backlash, transparency concerns, anti-science sentiment, provider-patient communication, rebuilding confidence in vaccines. Opinions expressed are those of the speakers. See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Melanie Whittington, Managing Director and Head of the Leerink Center for Pharmacoeconomics and Senior Fellow at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center. They examine how health economic modeling can more accurately reflect real-world market dynamics, the rising pressure behind IRA and MFN drug pricing, the risks to oncology innovation, the limits of conventional cost-effectiveness frameworks, plus the role of transparency and clearer communication of long-term value in sustaining a healthy innovation ecosystem. Key Topics Market Modeling: Hypothetical models versus real-world pricing dynamics, patent cliffs. Pricing Policy: IRA, MFN, market-based pricing scrutiny, communicating why prices are "worth it". Innovation Incentives: Private capital risk, oncology small molecules, policy-driven pipeline shifts. Value Framework Limits: QALY concerns, rule-versus-tool debates, GRACE, broader treatment impacts. Transparency and Outlook: Net price opacity, PBM negotiations, generics and biosimilars, the next innovation cycle. Opinions expressed are those of the speakers. The Leerink Center for Pharmacoeconomics is a division of MEDACorp. See omnystudio.com/listener for privacy information.

Read our MFN preprint: https://vitaltransformation.com/2026/02/preprint-new-research-the-impact-of-mfn-on-oncology-and-hematology-treatments/ In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two Vital Transformation colleagues on biopharma pricing policy, market access, and innovation risk: Gwen O'Loughlin: Research Partner at Vital Transformation Harry Bowen: Consulting Economist at Vital Transformation They discuss what our new MFN pricing modeling suggests about drug viability, how IRA incentives appear to be reshaping oncology and orphan drug development, why Medicare Advantage and commercial coverage can create administrative friction and delays compared with traditional Medicare, how 340B opacity and consolidation affect the value chain, and what these pressures could mean for insurance premiums, investment, and future innovation. Key Topics: MFN Modeling: Net present value analysis, benchmark-country pricing, launch viability, and market uncertainty. Effects of IRA on Trials: Oncology pullback, small-molecule exposure, orphan drug pressure, and suspended trials. Coverage Friction: Medicare Advantage burden, prior authorization delays, formulary shifts, and referral slowdowns. 340B Transparency: Vertical integration, hospital consolidation, opaque pricing flows, and revenue pressure. Innovation Outlook: Premium increases, global competition, intellectual property risk, and future access concerns. Opinions expressed are those of the speakers. See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Tim Scott, President & CEO of Biocom California, a biopharma executive with more than two decades of experience, including spinning out companies from UC San Diego and leading firms acquired by BioMarin and Novartis, to discuss how California’s life sciences ecosystem became a global innovation engine, why the state’s research and venture networks matter, and how policy headwinds such as the Inflation Reduction Act (IRA) and Most Favored Nation (MFN) reference pricing reshape investment, rare disease development, and competition with Europe and China. Key Topics: Biocom Origins: Municipal policy roots, industry advocacy, ecosystem evolution across California. Innovation Network: University and research density, regional clusters, talent, and collaboration effects. Capital Pathway: NIH and NSF support, SBIR and STTR bridges, venture appetite, and liquidity. MFN and IRA: Pill penalty incentives, orphan exemption stakes, Medicare exposure, and VC pullback. Next-Gen Development: AI-enabled discovery, faster trial enrollment, digital twins, and regulator openness. Opinions expressed are those of the speakers. See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess examines how NIH-funded research fits into the U.S. innovation and IP ecosystem, and why today’s political rhetoric about “government-developed drugs” often misses how commercialization actually happens. Featuring expert perspectives on NIH technology transfer and drug IP from: Mark Rohrbaugh: Former Director of Technology Transfer and Innovation Policy at the National Institutes of Health (NIH), IP Consultant at Vital Transformation Gwen O’Loughlin: Research Partner at Vital Transformation They discuss how the Bayh-Dole Act shaped university tech transfer, what government interest statements do - and do not - tell you about a drug’s origins, why “march-in rights” were designed as a development backstop rather than a pricing tool, and how proposals to redirect royalties or restrict NIH-industry collaboration could disrupt the pipeline that turns early science into real-world therapies. Key Topics: NIH’s Role in the Innovation Pipeline: How NIH funding de-risks foundational science, how industry and universities translate it, and why “NIH developed all drugs” is a misleading simplification. Government Interest Statements: What the statement signals, why it is inconsistently surfaced across patents, and what large-scale reviews suggest about how often it appears in drug-related patent portfolios. March-In Rights and Policy Misuse: The original purpose (anti-shelving and public health needs), how petitions are evaluated in practice, and why pricing-based efforts have not succeeded. Mechanisms Supporting Translation: Why CRADAs and licensing structures matter for bringing technologies to market and for enabling NIH research with proprietary industry tools. Forward Outlook: How royalty diversion or restricting partnerships could weaken incentives and capacity, and why the guests anticipate near-term disruption with longer-term consequences. Opinions expressed are those of the speakers. See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland: Oriana Ciani: Associate Professor of Practice at SDA Bocconi School of Management Denis Lacombe: Director General at EORTC They discuss why accelerated pathways are used in oncology, what becomes feasible and risky when patient populations are small, how surrogate endpoints such as progression-free survival can differ from overall survival and quality of life, and why post-authorization evidence generation and treatment optimization shape whether early access translates into sustained patient benefit. Key Topics: Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology. Rare Trial Design: Small populations, randomization feasibility, comparator constraints. Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates. HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects. Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier. Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca. See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on reimbursement-facing evidence questions for accelerated oncology approvals at ISPOR Europe 2025 in Glasgow, Scotland: Anja Schiel: Senior Advisor, Norwegian Medical Products Agency Niklas Hedberg: Chief Pharmacist at The Dental and Pharmaceutical Benefits Agency (TLV) They unpack why results that are strong inside a clinical trial can be harder to apply to real-world national populations, how decision-makers weigh patient-relevant outcomes and uncertainty at the time of access decisions, and what risk management can look like when early approvals require follow-up evidence and potential reassessment. Key Topics: Trial Generalizability: Selection in trials, real-world populations, and health system variation. Reimbursement Evidence: Patient-relevant outcomes, absolute versus comparative benefit, small-sample challenges. Conditional Approval: Evidence at authorization, reassessment expectations, withdrawal, and restriction risk. Risk Tradeoffs: Approving too early versus delaying access, urgency in progressive disease, and equity constraints. Adaptive Follow-up: Real-world evidence plans, managed entry approaches, learning while treating. Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca. See omnystudio.com/listener for privacy information.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with three experts on accelerated patient access to cancer medicines at ISPOR Europe 2025 in Glasgow, Scotland: Martina Garau: Director at Office of Health Economics Bettina Ryll: Founder at MPNEurope Kathleen Grieve: Director - European Public Policy, Access, Pricing and Affordability Lead at MSD Europe They explore why accelerated access matters when evidence is still emerging, how the APACE framework proposes a structured path from eligibility through reassessment, what it could take to reduce fragmentation across national HTA and reimbursement processes, and why pragmatic pilots and agreed data expectations are central to learning while treating. Key Topics: Accelerated Access: Urgency in life-threatening cancer, uneven uptake across countries, and patient time sensitivity. APACE Framework: Eligibility screening, initial assessment, temporary reimbursement, reassessment, and exit decisions. National Alignment: EU-level assessment versus country decisions, shared principles, local implementation limits. Evidence Uncertainty: Early evidence tradeoffs, real-world data needs, and affordability pressure under uncertainty. Getting Started: Pilot use cases, coalition of the willing, dynamic evidence expectations over time. Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca. See omnystudio.com/listener for privacy information.