Vital Health Podcast

VT's Grumpies and Lady Discuss the U.S. Biotech Policy Landscape

Read our MFN preprint: https://vitaltransformation.com/2026/02/preprint-new-research-the-impact-of-mfn-on-oncology-and-hematology-treatments/ [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 [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with two Vital Transformation [https://www.linkedin.com/company/vital-transformation/] colleagues on biopharma pricing policy, market access, and innovation risk: * Gwen O'Loughlin [https://www.linkedin.com/in/gwen-o-loughlin-8792003a9/]: Research Partner at Vital Transformation [https://www.linkedin.com/company/vital-transformation/] * Harry Bowen [https://www.linkedin.com/in/harry-p-bowen-10761b31/]: Consulting Economist at Vital Transformation [https://www.linkedin.com/company/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 [https://omnystudio.com/listener] for privacy information.

Tim Scott: MFN Pricing, Venture Risk, and the Future of California Biotech

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with Tim Scott [https://www.linkedin.com/in/tim-scott-501631/], President & CEO of Biocom California [https://www.linkedin.com/company/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 [https://omnystudio.com/listener] for privacy information.

Mark Rohrbaugh & Gwen O’Loughlin: Drug Patents, March-In Rights, and NIH Technology Transfer

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] 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 [https://www.linkedin.com/in/mark-l-rohrbaugh-9462a57/]: Former Director of Technology Transfer and Innovation Policy at the National Institutes of Health (NIH) [https://www.linkedin.com/company/national-institutes-of-health/], IP Consultant at Vital Transformation [https://www.linkedin.com/company/vital-transformation/] * Gwen O’Loughlin [https://www.linkedin.com/in/gwen-o-loughlin-8792003a9/]: Research Partner at Vital Transformation [https://www.linkedin.com/company/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 [https://omnystudio.com/listener] for privacy information.

Oriana Ciani & Denis Lacombe: Overall Survival and Surrogate Endpoints in Early Oncology Approvals

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland: * Oriana Ciani: [https://www.linkedin.com/in/oriana-ciani-bb029a8/?originalSubdomain=it] Associate Professor of Practice at SDA Bocconi School of Management [https://www.linkedin.com/school/sda-bocconi-school-of-management/] * Denis Lacombe: [https://www.linkedin.com/in/denislacombe/?originalSubdomain=be] Director General at EORTC [https://www.linkedin.com/company/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 [https://omnystudio.com/listener] for privacy information.

Anja Schiel & Nicholas Hedberg: Accelerated Approvals, Evidence Gaps, and Reimbursement Risk

In this episode of the Vital Health Podcast, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] speaks with two experts on reimbursement-facing evidence questions for accelerated oncology approvals at ISPOR Europe 2025 in Glasgow, Scotland: * Anja Schiel: [https://www.linkedin.com/in/anjaschiel/?originalSubdomain=no] Senior Advisor, Norwegian Medical Products Agency [https://www.linkedin.com/company/direktoratetformedisinskeprodukter/] * Niklas Hedberg: [https://www.linkedin.com/in/niklas-hedberg-3947231/] Chief Pharmacist at The Dental and Pharmaceutical Benefits Agency (TLV) [https://www.linkedin.com/company/tlv-the-dental-and-pharmaceutical-benefits-agency/] 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 [https://omnystudio.com/listener] for privacy information.