Vital Health Podcast

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.

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.

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.

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.

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.

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on the Inflation Reduction Act (IRA) and its ripple effects across drug development, Medicare, and patient access. Over the past year, the biopharma industry and the broader healthcare system have undergone a period of rapid change as new rules surrounding drug pricing reshape how therapies are developed, financed, and delivered. In a landscape where policies are still being interpreted and adjusted, and where the long-term impact on innovation and access is far from certain, this episode serves as a year-end guide to what has changed and how to think about the road ahead. Throughout 2025, we paired our research with a series of podcast episodes where host Duane Schulthess sat down with industry leaders. In this highlights episode, we revisit several of those conversations: Donna Cryer: Advocacy, Drug Incentives & Research Crisis Barbara McAneny, Rafael Fonseca, and Steve Potts: Protecting Patients Amid the IRA Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks Key Topics: Pill Penalty: How the shorter negotiation window for small molecule medicines relative to biologics is changing the calculus for pursuing oral therapies in areas such as cardiovascular disease, neurodegeneration, and other chronic conditions. Part D Redesign: Why moving more liability to plans is driving new premium and coverage tradeoffs, influencing which products stay on formularies, and raising questions about access in rural and underserved areas. Early Stage Investment: What our data suggest about the pullback in trial starts and funding for projects most exposed to IRA mechanics, and how that is influencing company formation, licensing strategies, and pipeline mix. PBMs, Vertical Integration, & Biosimilars: How consolidated intermediaries and payer-owned biosimilar strategies interact with IRA price setting, rebate flows, and the outlook for generic and biosimilar competition. Patient Advocacy & Real World Impact: What older adults, cancer patients, and rare disease communities are already experiencing as coverage rules change, cost-sharing is redesigned, and uncertainty grows around long-term treatment availability. Policy Paths Forward: Ideas from our guests for adjusting timelines, refining negotiation rules, and protecting incentives for follow-on and orphan indications while still improving affordability for patients. Opinions expressed are those of the speakers.

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on Most Favored Nation (MFN) drug pricing and its knock-on effects for jobs, state budgets, and the generic supply chain. Over the past year, proposals to link U.S. prices to those in other countries have collided with inflation pressures, tariff debates, and reshoring efforts, creating new uncertainty for manufacturers, payers, and policymakers. In an environment where expectations about future returns are shifting, and the rules of the game are still being defined, this episode is designed as a year-end guide to what MFN-style policies could mean in practice and how to think about the tradeoffs. Throughout 2025, we our research on MFN-style reference pricing with a series of podcast episodes where host Duane Schulthess sat down with leaders across the generic, distribution, and policy landscape. In this highlights episode, we revisit several of those conversations: Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks Patrick Kelly: Inside the Generic Supply Chain Squeeze John Murphy: Generics, Biosimilars, and U.S. Policy VT’s Grumpies (Harry Bowen, Joe Hammang) Talk MFN Key Topics: MFN Mechanics Explained: How tying U.S. prices to the lowest GDP-adjusted price in a reference basket translates into steep cuts for top-spend medicines in Medicare Parts B and D and shapes expectations across commercial and Medicaid contracts. Jobs, Earnings, & State Budgets: What our modeling suggests about potential impacts on employment, earnings, and tax revenue under MFN-style reference pricing, and how those effects concentrate in R&D-intensive regions and manufacturing hubs. Spillovers Into Medicaid, 340B, & ASP: Why MFN in Medicare does not stay in Medicare, how Medicaid best price and 340B ceilings pull discounts across programs, and what lower ASP add-ons could mean for hospital and community oncology margins. Generics, Shortages, & Tariffs: How razor-thin margins for sterile injectables and generic manufacturers interact with purchaser consolidation, tariff shocks, and price referencing, raising the risk of exits, inventory write-downs, and persistent shortages. Global Competition & Offshoring: How aggressive reference pricing can accelerate shifts in trials, licensing, and high-value manufacturing to countries that offer more predictable returns, and what that implies for long-run U.S. competitiveness. Alternatives To MFN: Ideas from our guests on value-based approaches, targeted incentives, and other tools that can improve affordability without hollowing out domestic capacity, innovation, and resilience in the generic and biosimilar supply chain. Opinions expressed are those of the speakers.

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on the Inflation Reduction Act (IRA) and its ripple effects across drug development, Medicare, and patient access. Over the past year, the biopharma industry and the broader healthcare system have undergone a period of rapid change as new rules surrounding drug pricing reshape how therapies are developed, financed, and delivered. In a landscape where policies are still being interpreted and adjusted, and where the long-term impact on innovation and access is far from certain, this episode serves as a year-end guide to what has changed and how to think about the road ahead. Throughout 2025, we paired our research with a series of podcast episodes where host Duane Schulthess sat down with industry leaders. In this highlights episode, we revisit several of those conversations: Douglas Holtz-Eakin: “Indications are going to be deeply affected by the IRA” Steve Usdin: Tariffs, Price Controls, & Inflation Reduction Act (IRA) VT’s Grumpies Talk IRA with Virginia Acha Key Topics: Pill Penalty: How the shorter negotiation window for small molecule medicines relative to biologics is changing the calculus for pursuing oral therapies in areas such as cardiovascular disease, neurodegeneration, and other chronic conditions. Part D Redesign: Why moving more liability to plans is driving new premium and coverage tradeoffs, influencing which products stay on formularies, and raising questions about access in rural and underserved areas. Early Stage Investment: What our data suggest about the pullback in trial starts and funding for projects most exposed to IRA mechanics, and how that is influencing company formation, licensing strategies, and pipeline mix. PBMs, Vertical Integration, & Biosimilars: How consolidated intermediaries and payer-owned biosimilar strategies interact with IRA price setting, rebate flows, and the outlook for generic and biosimilar competition. Patient Advocacy & Real World Impact: What older adults, cancer patients, and rare disease communities are already experiencing as coverage rules change, cost-sharing is redesigned, and uncertainty grows around long-term treatment availability. Policy Paths Forward: Ideas from our guests for adjusting timelines, refining negotiation rules, and protecting incentives for follow-on and orphan indications while still improving affordability for patients. Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts in European regulation and evidence of new medicines: Steffen Thirstrup: Chief Medical Officer at European Medicines Agency. Richard Bergstrom: Head of Policy at IQVIA. They compare regulatory benefit-risk decisions with HTA’s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments. Key Topics Regulatory Versus HTA: Benefit-risk focus, added benefit comparisons, joint clinical assessments. Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing. Endpoints & Outcomes: Overall survival pressure, validated biomarkers, patient experience relevance. Real-world Evidence: Registries and randomized rollout, data quality limits, outcomes-based contracting lessons. Adaptive Pathways & Data Space: Early joint advice, platform and sandbox tools, European Health Data Space. Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Dr. Malina Müller, Head of Health Economics at WifOR Institute, to explore the heated debate around accelerated and conditional approvals in Europe, how demographic and budget pressures shape HTA decisions, the tradeoffs between surrogate endpoints and overall survival, the challenges of using real world evidence under GDPR, and the broader pricing and competitiveness threats facing Europe’s life science ecosystem.  Key Topics: Accelerated Approvals: Uncertainty versus early access, conditional pathways in Europe, and costs of delayed treatment. Health System Pressures: Aging populations, fixed-price hospital incentives, cross-country budget constraints. Endpoints & Evidence: Surrogate versus overall survival, patient-reported outcomes, practical limits of real-world evidence in Europe. HTA & Harmonization: Germany's strict assessments, JCA and EMA alignment, and equity gaps across member states. Global Pricing Risks: Most Favored Nation (MFN) proposals, launch delays between the FDA and EMA, and Europe’s competitiveness versus China. Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host Duane Schulthess sits down with two Vital Transformation colleagues to explore key trends in drug pricing and macroeconomic policy: Joe Hammang: US Business Director at Vital Transformation. Harry Bowen: Consulting Economist at Vital Transformation. They unpack the Trump administration’s “Most Favored Nation” approach as applied to Medicaid, contrast it with past Medicare proposals, and discuss modeled employment, tax, and GDP impacts. The conversation explores why effects would differ by company and therapy area, the EU’s move toward streamlined compulsory licensing, the knock-on risks for premiums and investment, the fragility of the generics market, and how global competition - including China’s growing clinical footprint - could reshape innovation incentives. Key Topics: MFN Basics: What is MFN?, Medicaid focus versus Medicare, price-leveling concept. Modeled Impacts: Jobs and GDP effects, tax revenue losses, insurance premium pressure. Uneven Company Effects: Medicaid-heavy portfolios, orphan and rare disease exposure, negotiation dynamics. EU Signals: Compulsory licensing push, UK pricing realities, risks of spillover to U.S. policy. Innovation and Competition: Biologics cost structure, generic market fragility, and China’s rising clinical pipeline. Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with three leaders advancing precision cancer medicine implementation in Europe: Bettina Ryll: Stockholm School of Economics, Institute for Research; Founder, Melanoma Patient Network Europe. Kjetil Taskén: Head of the Institute for Cancer Research, Oslo University Hospital; Professor, University of Oslo; Coordinator, PRIME-ROSE. Anni Lepland: Head of Personalized Medicine in Oncology, Estonian Cancer Network. They explore how Europe’s new Joint Action can accelerate equitable precision oncology, what PRIME-ROSE has learned from aggregating data across national pragmatic trials, and why a distributed, bottom-up model with strong patient involvement and industry collaboration is key to scaling access and evidence generation across member states. Key Topics: EU Joint Action: Governmental collaboration, precision prevention, diagnosis, and treatment, precision follow-up. PRIME-ROSE Collaboration: Data sharing agreements, aggregated cohorts, common biomarker definitions, and monthly alignment. Patient Need First: Options after standard care, access to molecular profiling, pragmatic protocols, and learning from each case. Widening Country Gaps: Workforce shortages, national coordination, digital tools, and equitable access to innovative drugs. Industry and Access: Single point of entry for drugs, managed entry agreements, off-label registries, and scaling trials across Europe. Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with John Murphy, President and CEO of the Association for Accessible Medicines (AAM), to discuss how U.S. purchasing dynamics and thin margins drive shortages, the evolving biosimilar landscape amid insurer vertical integration, the Inflation Reduction Act (IRA)’s ripple effects on plan risk and rebates, Most Favored Nation (MFN) policy proposals, and what it will take to reshore capacity while preserving competition and patient access. Key Topics: Generic Pricing Pressures: Purchaser consolidation, sterile injectables, margin squeeze, and exits. Drug Shortage Economics: Quality investments, underpriced redundancy, lessons from saline disruptions. Biosimilar Market Dynamics: Private-label payer programs, rebate tactics, chilling pipeline investment. Inflation Reduction Act (IRA) and Coverage: Part D risk shift to plans, negotiation uncertainty, and Medicare access delays. Tariffs and Reshoring: API onshoring realities, carve-outs to avoid shortages, resilient capacity building. Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Patrick Kelly, Chief Advocacy Officer at the Healthcare Distribution Alliance, to discuss why generic markets face razor-thin margins and concentration risk, what is driving recent drug shortages, how tariffs and reshoring could affect costs, potential ripple effects from Most Favored Nation pricing, and the rise of direct-to-consumer pathways and traceability across the supply chain. Key Topics: Generic Market Pressures: Race-to-the-bottom pricing, manufacturer exits, concentration risks. Shortage Drivers: Telemedicine demand spikes for controlled substances, facility shutdowns, and sterile injectable constraints. Tariffs and Reshoring: Section 232 outlook, potential India duties, pass-through pressures to patients. MFN Pricing Impacts: Inventory devaluation risk, price-depreciation clauses, manufacturer responses. DTC and Traceability: Direct-to-consumer models, pharmacy and provider roles, DSCSA unit-level safety. Opinions expressed are those of the speakers.

In this Vital Health Podcast, host Duane Schulthess speaks with two leading European voices on oncology and health economics: Andreas Charalambous: Chair of Nursing at Cyprus University and Executive Board Member at MASCC, former President of the European Cancer Organization, Director of the Research Center for Oncology and Palliative Care at eOncoRise Lieven Annemans: Professor of Health Economics at Ghent University, past President of ISPOR Together, they unpack why the EU’s Beating Cancer Plan and Cancer Mission remain only partially implemented and what it will take to turn commitments into action. Key Topics Centralized vs. National Action: Why Europe still needs coordinated cancer strategies alongside national execution, and how fragmentation drives inertia. Costs, Rarity, and Value: The economics of small patient populations, return on investment, and why rare cancers demand inclusion in national plans. Prevention & Early Detection: How shifting budgets from treatment to prevention and screening offers long-term impact but little short-term political payoff. Equity & Access: Unequal survival rates between and within EU member states, limited medicine availability in countries like Greece, and the role of patient engagement. Data & Accountability: Calls for plan-do-check-act cycles, stronger measurement, and better digital health training for Europe’s cancer workforce. Financing & Long-Term Policy: Whether EU-level financing instruments should support health infrastructure, and why tackling social and commercial determinants could reshape outcomes over decades. This episode offers a candid look at the complexity of cancer policy in Europe, exploring prevention, financing, innovation, and political realities that will define cancer care over the next decade. Opinions expressed are those of the speakers, not the institutions listed. Podcast created with the support of Merck Sharp & Dohme. Recorded July 2025.

Kirsten Axelsen is an economist specializing in Medicare reimbursement, payer negotiations, and innovative reimbursement contracts. She’s a fellow of the Aspen Institute and a visiting scholar with the American Enterprise Institute. She joins host Duane Schulthess to unpack bipartisan pressure on drug prices, the Part D redesign’s rapid shift of catastrophic costs to plans, and the resulting premium versus coverage tradeoffs and PDP exits. Axelson explains why forecasting IRA impacts is uncertain, how nine versus thirteen-year timelines tilt incentives toward biologics, and why price controls can weaken both generic entry and biosimilar uptake. The discussion explores MFN-style ideas and trade uncertainties, vertical integration around biosimilars, and practical fixes from EPIC-like timelines to building a faster, more connected U.S. clinical-trial ecosystem with better participant support. Politics & Incentives: Trump MFN attempts, bipartisan pressure on high drug prices, and insurer dynamics versus the pace of biomedical innovation. Part D Redesign: The rapid shift of catastrophic costs to plans, premium versus coverage tradeoffs, PDP exits, and access challenges in rural areas. Modeling & Consequences: Limits of CBO forecasts, uncertainty bands, design choices around price controls, and risks to post-market and follow-on research. Competition Levers: Small molecule disincentives, low biosimilar uptake on formularies, generic entry pressures under price controls, and plan behavior. Policy Paths: EPIC-style timeline fixes, negotiation mechanics, MFN and trade uncertainties, and making U.S. clinical trials faster, more connected, and participant-friendly. Recorded on July 28, 2025. Opinions expressed are those of the speakers.

In this "Best-of" edition of the Vital Health Podcast, Duane Schulthess revisits two listener favorites on the future of medicines in Europe. First, former MEP Pernille Weiss explains how the European Parliament reshaped the EU’s General Pharmaceutical Legislation (GPL) to better support innovation while respecting member state control over pricing and reimbursement. Then, Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), outlines how Europe’s largest public-private partnership is convening pharma, medtech, regulators, HTAs, payers, and patients to solve pre-competitive hurdles from real-world data to digital endpoints. Key Topics Parliament Process: How Parliament shaped the General Pharmaceutical Legislation (GPL) and why it rejected incentives tied to launches in all 27 member states. Innovation and Access: Avoiding rock-bottom pricing that causes shortages and using quality-of-life outcomes in pricing and reimbursement decisions. EU vs National Roles: Where joint procurement helps, and where member-state control over pricing and reimbursement should prevail to reflect health system differences. From IMI to IHI: Evolution from the Innovative Medicines Initiative (IMI) to the Innovative Health Initiative (IHI), a cross-sector platform convening pharma, medical devices, diagnostics, imaging, regulators, health technology assessment (HTA) bodies, payers, clinicians, and patients to solve pre-competitive evidence needs such as real-world data and digital endpoints. Data and Regulation: Working within the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the Artificial Intelligence (AI) Act using federated access, shared standards, and a regulatory sandbox to pilot novel technologies. SME Pathways: How small and medium-sized enterprises (SMEs) join funded consortia via brokering events, with current examples in lung cancer real-world data and cardiovascular prevention and care. Originally broadcast Sep 4, 2024 (Weiss) and Jul 3, 2024 (Blomberg). Edited and compiled Aug 2025. Opinions expressed are those of the speakers.

In this Vital Health Podcast, host Duane Schulthess - joined by Joe Hammang, Vital Transformation's US Business Director - speaks with Henry Skinner (CEO, AMR Action Fund), about the escalating threat of antimicrobial resistance (AMR) and what it will take to rebuild a viable antibiotics pipeline. The conversation follows the full story - from bedside to boardroom - covering why short-course, stewardship-constrained antibiotics are undervalued, how cancer patients shoulder disproportionate risk, and which practical incentives can bring capital and talent back into the field. Henry Skinner also details how the AMR Action Fund is investing roughly $1B in clinical-stage biotech while emphasizing that policy, diagnostics, and prevention must move in lockstep. Key Topics The Antibiotics Market Problem: Short treatment durations, "break-glass" stewardship, and decade-long, high-cost development create a public-goods gap that markets alone will not solve. Oncology & Sepsis Under AMR: Cancer patients face higher rates of infection and drug-resistant infection, undermining gains from modern cancer care. Diagnostics Economics: Cultures and advanced molecular tests are underused due to cost and turnaround time, even though delays drive longer ICU stays and higher system costs. Rebuilding R&D: Big-pharma retreat, brain drain, and investor opportunity costs demand durable pull incentives to attract capital and expertise back to antibiotics. Prevention: Vaccination and prudent antibiotic use can reduce morbidity, resistance, and cost when the system properly values these tools. Recorded July 1, 2025. Opinions expressed are those of the speakers.

In this “Best of” edition, host Duane Schulthess revisits two landmark conversations on the long-term impact of the Inflation Reduction Act (IRA) on the biopharmaceutical industry. First, Peter Kolchinsky (Managing Partner, RA Capital Management; Steering Committee Member, No Patient Left Behind), explains why nine-year negotiation timelines for small molecules undermine early-stage R&D and how extending biologics to 13 years still falls short of the “social contract” Congress originally intended. Then, John LaMattina (former President of Pfizer Global R&D; Senior Partner, PureTech Health) discusses how real-world IRA pricing is reshaping pipelines, discovery priorities, and venture capital strategies. Key Topics: IRA negotiation timelines and their effect on R&D decisions Differential price-setting mechanisms: nine years for small molecules vs. 13 years for biologics Patient access challenges under out-of-pocket caps and the case for insurance reform The march-in rights debate and its (limited) practical impact Shifts in VC focus and logical portfolio rebalancing Read our research on the impacts of the IRA: https://vitaltransformation.com/2025/04/inflation-reduction-act-two-years-on-investor-behavior-rd-impacts-proposed-solutions/ Originally broadcast Jan 17, 2024 and Mar 27, 2024. Edited and compiled Aug 2025. Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host Duane Schulthess convenes three leading voices from the 2025 BIO International Convention - prominent physicians, innovators, and advocates shaping the future of drug development in the wake of the Inflation Reduction Act (IRA). Throughout this conversation, they examine policy impacts, clinical ramifications, and patient access challenges: Barbara McAneny: Former American Medical Association President; Co‑Chair, ONCare Alliance; CEO, New Mexico Oncology Hematology Consultants, Ltd. Rafael Fonseca: Chief Innovation Officer & Getz Family Professor of Cancer, Mayo Clinic in Arizona Steve Potts: Chair, Drug Development Council, ICAN (International Cancer Advocacy Network) Key Topics: Pipeline Modality Shifts: Early‑stage developers are retooling small molecule programs into biologics, or abandoning follow‑on indications altogether to sidestep the IRA’s nine‑year exclusivity pill penalty. Clinical Trial Ecosystem: Independent and academic centers alike are seeing fewer small molecule trials, threatening orphan drug expansions and revenue streams that underwrite care. Oncology Practice Economics: Cuts to drug margins will jeopardize community practices, forcing difficult choices between patient treatment and financial survival. Patient Affordability & Copays: The cap on out‑of‑pocket oral drug costs versus the hidden burden of high copays and co‑insurance - and why eliminating them could raise premiums only modestly. PBM & Insurer Vertical Integration: Payers acquiring manufacturers and ownership of formularies are steering patients toward the highest‑rebate products at the expense of clinical judgment. Broader Systemic Ripples: From congested ERs due to unmanaged side effects to rural access collapse, plus the missed opportunity to cut PBM take‑rates instead of hampering innovation. Policy Fix Imperatives: Proposals include recalibrating exclusivity durations (extend small molecule to 13 years), automating rebate flows to CMS, and overhauling PBM incentives. This discussion covers the interplay between drug-pricing reform and the future of care, highlighting unintended consequences and pragmatic solutions. It’s essential listening for policymakers, payers, industry leaders, patient advocates, and every stakeholder invested in sustaining medical innovation and ensuring equitable patient access. Opinions expressed are those of the speakers, not the companies listed. Recorded on June 16, 2025.

In this episode, Duane Schulthess is joined by Sam Rasty, Chief Business Officer at Sensorium Therapeutics, Steve Potts, Chair of the Drug Development Council at the International Cancer Advocacy Network, and Joe Hammang, neuroscientist and US Business Director at Vital Transformation, to discuss how U.S. health policy is reshaping neuroscience innovation, investment priorities, and patient access. Key Topics: - Investment and R&D Strategy Shifts: Explore how the Inflation Reduction Act’s pricing controls and Medicare negotiations change venture capital allocation and steer neuroscience pipelines. - Patient Advocacy and Access Barriers: Guests discuss how formulary rules, generic-first requirements, and uneven advocacy across diseases affect drug adoption and innovation incentives. - Neuroscience Development Hurdles: The discussion highlights how social stigma around psychiatric conditions, fragmented orphan-disease incentives, and small-molecule exclusivity gaps slow CNS drug progress. - Legislative Fix Imperatives: Contributors outline proposed solutions such as the EPIC Act and expanded orphan-designation policies aimed at restoring balanced incentives for novel therapies. - Ecosystem Collaboration: The conversation covers the essential partnership between NIH funding, biotech startups, and pharmaceutical companies in advancing drugs from discovery to patients. This episode examines the policy, economic, and social factors influencing neuroscience drug discovery and the importance of communicating biotech’s value. It also highlights the need to improve the biotech narrative so that policymakers and the public understand its contributions. It is essential listening for industry leaders, investors, policymakers, and patient advocates seeking insight into innovation challenges and solutions.

In this episode, host Duane Schulthess sits down with Ipsita Smolinski, Founder and Managing Director of Capitol Street and faculty at Georgetown University and Johns Hopkins Carey Business School. They unpack the Inflation Reduction Act’s drug-pricing mechanisms, assess economic projections against emerging industry data, and discuss how changing R&D incentives, trade policy complexities, and regulatory uncertainty are reshaping the biopharmaceutical landscape. Key Topics: Data-Driven Strategy: A look at how economic modeling and real-world data underpin policy recommendations for biopharma legislation and health policy. IRA Drug-Pricing Mechanisms: Exploration of CPI-U–based inflationary rebates, the Part D overhaul with a $2,000 out-of-pocket cap, and the phased rollout of Medicare negotiations in 2026. Forecasts Versus Impact: Examination of the CBO’s initial estimate of two drugs every ten years compared to later indications of a far greater effect on individual companies. R&D Incentive Shifts: Analysis of the nine-year exclusivity for small molecules versus thirteen years for biologics and its influence on venture capital flows. Trade, Tariffs, and Regulation: Discussion of EPIC Act prospects, most favored nation pricing proposals, tariff implementation challenges, China’s expanding trial footprint, and the call for clearer FDA and NIH guidance. This episode illuminates how the IRA, economic forecasts, and global policy dynamics are influencing drug pricing, innovation incentives, and supply chains. It’s essential listening for policymakers, industry leaders, investors, and anyone invested in the future of healthcare economics and biopharma strategy.

In this Vital Health Podcast episode, host Duane Schulthess sits down with Steve Potts, biopharma entrepreneur and chair of the Drug Development Council (ICAN), and Robert Coughlin, Managing Director of Life Sciences at Jones Lang LaSalle, to explore how recent policy changes are reshaping the future of drug development. They unpack the unintended consequences of exclusivity gaps, discuss legislative fixes, and examine the broader impact on patients, investors, and regional biotech clusters. Key Topics: - Pill Penalty Explained: How nine-year data exclusivity for small molecules versus 13 years for biologics discourages investment in affordable therapies for older adults.   - EPIC Act Solutions: A bipartisan proposal to extend small-molecule exclusivity to 13 years and rebalance research and development incentives.   - Orphan Drug Incentives: Proposed reforms that would allow multiple exclusivity periods per drug to drive rare disease innovation.   - Patient Advocacy Role: Strategies for empowering patients and disease foundations to influence policy and protect future therapies.   - Biotech Ecosystem Impact: The effect of policy shifts on venture capital flows, lab space demand, and the health of regional innovation hubs. This episode highlights the critical link between policy design and the pace of medical innovation and why targeted legislative adjustments are essential to sustain future cures. It is a must-listen for policymakers, industry leaders, patient advocates, and anyone interested in the intersection of health policy and drug development. Recorded on May 30th, 2025.

In this Vital Health Podcast, host Duane Schulthess speaks with Jocelyn Ulrich, Vice President of Policy and Research at PhRMA, to discuss the far-reaching implications of current U.S. drug pricing and reimbursement policies. With a unique journey from opera stages to Senate testimony, Ulrich brings both strategic acumen and firsthand experience in navigating complex policy terrain. The conversation explores PBM consolidation, the fallout from the Inflation Reduction Act, vertical integration in biosimilars, and looming tariff threats - all through the lens of innovation, patient access, and economic resilience. Key Topics PBM Consolidation Concerns: Three PBMs now control 80% of U.S. prescriptions, raising red flags over patient steering, inflated costs, and limited access. IRA's Small-Molecule Penalty: The Inflation Reduction Act's nine-year price-setting for pills versus thirteen for biologics is shrinking investment in elderly-targeted therapies. Vertical Integration in Biosimilars: Insurers and PBMs are now owning biosimilars and pharmacies, limiting patient options and delaying uptake of lower-cost treatments. Tariff Risks and U.S. Manufacturing: Proposed pharmaceutical tariffs could undermine domestic production despite the sector’s significant economic footprint and current exemptions. Rebuilding Innovation Incentives: From the EPIC Act to patient-first rebate reform, industry stakeholders are pushing for legislative fixes that sustain R&D and reduce care disparities. This episode unpacks how policy shifts are reshaping biopharma’s incentive structures, investment flows, and ultimately, patient outcomes. Essential listening for policymakers, investors, and health economists seeking clarity on U.S. pharmaceutical policy and its global ripple effects.

In this episode of the Vital Health Podcast, host Duane Schulthess sits down with Jenni Nordborg, Director of International Affairs at The Swedish Association of the Pharmaceutical Industry (LIF), to explore how national and European policies intersect to shape life sciences innovation. They discuss Sweden’s holistic governance model, the strategic framing of healthcare spending as an investment, and the challenges of aligning regional autonomy with EU‑wide regulatory frameworks. Key Topics: - National Strategy Spotlight: Sweden’s comprehensive life sciences strategy underscores government priorities and creates cross‑ministerial governance for innovation.   - Regional Autonomy Dynamics: Balancing national directives with regional healthcare mandates enables tailored implementation and closer patient engagement.   - Funding as Investment: Reframing healthcare budgets as long‑term investments is illustrated by Sweden’s hepatitis C program and emerging prevention initiatives.   - Governance and Collaboration: The Office for Life Sciences and public‑private partnerships align industry, academia, and policymakers for cohesive action.   - EU Policy Intersection: Navigating Europe’s complex regulatory landscape - from data protection periods to strategic autonomy - reveals opportunities to accelerate R&D and access. This episode uncovers the strategic mechanisms behind Sweden’s success in life sciences and offers a roadmap for harmonizing national and EU policies to boost innovation and patient access. It’s essential listening for policymakers, industry leaders, and healthcare stakeholders seeking practical guidance on aligning governance, funding, and regulation for sustainable pharmaceutical advancements.

In this episode of the Vital Health Podcast, host Duane Schulthess sits down with patient advocate and Global Liver Institute founder Donna Cryer. They trace her journey from Harvard and the DOJ prosecutor’s office to becoming a liver transplant recipient and a leading voice in healthcare policy. Donna shares insights on orphan drug incentives, the Inflation Reduction Act’s impact on research, the politicization of mRNA innovation, and the current crisis in NIH funding. Key Topics: - Patient Advocacy Evolution: Donna reflects on her transition from DOJ prosecutor to founding the Global Liver Institute and amplifying patient voices in healthcare policy. - Rare Disease Incentive Gaps: An examination of the orphan drug exclusivity landscape and its impact on treatment pipelines for ultra‑rare conditions. - Inflation Reduction Act Fallout: Insights into how Medicare price controls under the IRA are reshaping research priorities and patient access for older and rare disease populations. - mRNA Platform Politics: A discussion on the politicization of mRNA vaccines and the threat this poses to future cancer and therapeutic innovations. - NIH Funding Emergency: A look at the dramatic NIH budget cuts, stalled clinical trials, and the broader implications for biomedical research. Throughout this episode, Donna Cryer and Duane Schulthess unpack the challenges and potential solutions shaping patient‑driven policy, drug innovation, and research funding – insights critical for anyone invested in the future of healthcare. Patient advocates, healthcare policymakers, and industry leaders will find this discussion indispensable for navigating the complexities of innovation incentives and research ecosystems.

In this special Grumpies episode, host Duane Schulthess, CEO of Vital Transformation, is joined by neuroscientist and US Business Director Joe Hammang, consulting economist Dr. Harry Bowen, and MSD Associate VP of Science and Regulatory Policy Virginia “Ginny” Acha. They examine the IRA and question its promise to lower drug prices for Medicare beneficiaries, revealing how it discourages R&D, reroutes venture capital, and restricts patient access. What You’ll Learn Pill Penalty Breakdown: How the 9-year small-molecule vs 13-year biologic exclusivity gap reshapes R&D incentives Investor Exodus: The flight of early-stage venture capital and its implications for future cures Access vs Cost: Why poorly designed price controls can restrict, not expand, patient access Policy Fixes: From the EPIC Act to prize-based innovation rewards, proposed solutions to realign incentives Global Threats: Tariff talk, reference pricing pitfalls, and reshoring risks for manufacturing and supply security This episode is essential for policymakers, industry leaders, and anyone invested in the future of medicine. Download our free IRA impact report at the link below: https://vitaltransformation.com/2025/04/inflation-reduction-act-two-years-on-investor-behavior-rd-impacts-proposed-solutions/

In this episode, host Duane Schulthess sits down with Steve Usdin, Senior Washington Editor at BioCentury Publications since 1993 and one of the most cited experts on FDA regulation, Medicare policy and the political forces driving biopharma innovation, to explore the major forces reshaping U.S. life sciences: looming Section 232 tariff probes, the unintended “small-molecule penalty” baked into the Inflation Reduction Act, deep NIH/FDA budget cuts, post-COVID science skepticism, and China’s surge in clinical filings, and what these policy shifts mean for innovation, patient access and America’s competitive edge. Recorded April 8th, 2025 Key Topics: Tariffs & Trade Policy: Section 232 investigations threaten pharma-specific levies that drive up interest rates, deter capital raises, and expose domestic and allied supply chains to greater disruption. Inflation Reduction Act (IRA) Impacts: A nine-year exclusivity window for small molecules versus thirteen for biologics creates a “pill penalty,” chilling R&D in age-related and chronic disease; debates around the EPIC Act and expanded orphan-drug carve-outs aim to recalibrate incentives. Regulatory Uncertainty: Arbitrary NIH and FDA budget cuts, coupled with an HHS leadership shake-up, are stalling translational science, jeopardizing advanced biomanufacturing efforts, and eroding long-term policy stability. Science & Public Trust: COVID-era vaccine mandates and missteps have fueled anti-science sentiment and mRNA platform skepticism, complicating future therapeutic innovation and public-health communication. Global Competition & Talent: China’s record number of IND filings, restrictive H-1B visa policies, and repatriation of PhD talent threaten U.S. biotech preeminence unless immigration and research-funding policies pivot to attract and retain innovators.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two key voices driving the PRIME-ROSE initiative: Gro Live Fagereng, Project Manager of the EU-project PRIME-ROSE and Coordinator of Precision Cancer Medicine at Oslo University Hospital, and Henk van der Pol, Ph.D. Candidate at Leiden University Medical Center. They explain the DRUP (Drug Rediscovery Protocol) trial approach, which repurposes existing oncology drugs for new off-label uses, and discuss how this can widen treatment options for patients with rare or underserved tumor types. They also describe the complexities of consolidating small patient cohorts across multiple sites and countries, shedding light on how data models like OMOP help standardize clinical information. Listeners will learn about the unique challenges of data harmonization and the importance of building robust evidence in real-world settings. Gro Live and Henk share how PRIME-ROSE is helping healthcare systems coordinate more efficiently, reduce barriers to cutting-edge treatments, and ultimately improve patient outcomes. Tune in for a closer look at how forward-thinking collaborations and adaptive trial designs are reshaping the landscape of precision oncology in Europe.

Join host Duane Schulthess on the Vital Health Podcast as he explores the groundbreaking Prime Rose Project, an initiative redefining the use of off-label drugs in oncology. Featuring insights from Dr. Hans Gelderblom, Chair of Medical Oncology at Leiden University Medical Center, and Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, a member of the Dutch National Payers Evaluation Committee, this episode delves into the challenges and opportunities of drug rediscovery protocols. Learn how this innovative approach balances accessibility, affordability, and evidence-based treatments, transforming the landscape of personalized medicine across Europe.

In this Vital Health Podcast, John Stanford, Executive Director of Incubate, discusses the impact of the Inflation Reduction Act (IRA) on venture capital investments in life sciences. Stanford emphasizes that the IRA's price control mechanisms have led to significant shifts in funding, particularly away from small-molecule drug development, creating what is described as the "small molecule penalty." Key points include: Venture Capital's Role and Challenges: Venture capital is critical in translating basic research into medicines. The Inflation Reduction Act has disrupted this ecosystem, discouraging investment in certain drugs due to anticipated lower returns under price control regimes. Data from the Life Science Tracker: Stanford highlights the Life Science Tracker findings, showing 36 research programs and 21 specific drug developments discontinued since the IRA's passage. Notably, investments are markedly shifted from small molecules to biologics. Economic and Patient Impact: The IRA has led to reduced innovation in critical areas like oncology and rare diseases. Treatments for diseases like ovarian cancer and blindness have been deprioritized. Stanford argues that the act inadvertently penalizes older patients, the demographic it was designed to benefit, by disincentivizing drugs for age-related diseases. Proposed Solutions: The EPIC Act, a bipartisan effort supported by Incubate, aims to address the disparities by giving small molecules the same 13-year exclusivity period as biologics. Fixing the incentives for drug development, including addressing multiple indication penalties, is crucial to fostering innovation. Critique of Government Assessments: Stanford critiques the Congressional Budget Office (CBO) for its reliance on limited data sources and narrow time horizons, which fail to capture the long-term impacts of the IRA. In conclusion, Stanford stresses the need for legislative adjustments to mitigate the IRA's unintended consequences on drug innovation and patient care. For more insights, listeners are directed to the Life Science Tracker at lifesciencetracker.com.

In this insightful episode of the Vital Health Podcast, we dive deep into the economic and societal benefits of investing in healthcare. Our esteemed guests, Professor Herwig Ostermann, Executive Director, Austrian National Public Health Institute, Professor Dennis A. Ostwald, CEO, WifOR Institute and Professor at Steinbeis School of International Business and Entrepreneurship (SIBE), and Massimo Bordignon, Professor of Public Economics at the Catholic University of Milan and member of the European Fiscal Board, EU Commission, share their expertise on how improved budgeting models and investment metrics can lead to healthier societies and economic growth.  Join us as we explore how smart investments in healthcare can drive economic growth and create healthier, more productive societies. Don’t miss this episode packed with valuable insights and practical recommendations.  Listen now and be part of the conversation on building a well-being economy through strategic health investments. Key Highlights: Well-being Economy: Professor Ostwald emphasizes the concept of a well-being economy, where health investments are seen not as costs but as crucial investments in the prosperity of countries. He highlights that 12% of Germany’s GDP is related to health investments, showcasing the significant economic impact. Budget Allocation: Professor Ostermann discusses the complexities of health budget allocation in Austria, stressing the need for a holistic approach that integrates various policy areas to maximize the benefits of health investments. EU Perspective: Professor Bordignon talks about the European Union’s new economic framework, which allows for multi-year budgeting, enabling more strategic investments in healthcare. He underscores the importance of seeing health spending as an investment rather than a cost. Prevention and Long-term Planning: The speakers agree on the necessity of shifting from a reactive to a proactive approach in healthcare. Investing in prevention and early diagnostics, particularly for diseases like cardiovascular conditions, can yield substantial long-term benefits. European Health Union: The discussion also touches on the potential of a European Health Union to streamline healthcare investments and policies across member states, enhancing overall efficiency and effectiveness.

Join us at the Gastein Health Conference for an insightful conversation on Europe's healthcare challenges and innovations! Host Duane Schulthess sits down with experts like Josep Figueras, the Founder and Director of the European Observatory on Health Systems and Policy, Francesca Colombo, the Head of the OECD Health Division, and Annemiek Verkamman, the Managing Director of HollandBIO, to tackle the EU's pressing healthcare issues. From aging populations and non-communicable diseases to data-driven health innovations, they explore how policy, technology, and cross-border collaboration can enhance Europe's healthcare resilience. Tune in for a deep dive into the future of health in Europe!

In this episode of the Vital Health podcast, host Duane Schulthess sits down with Steve Potts, a seasoned entrepreneur and CEO of SLAM BioTherapeutics. They dive deep into the challenges and opportunities in biotech, exploring how recent legislative changes, like the IRA, are reshaping the industry. Steve shares insights on the shift from small molecules to biologics, the funding landscape, and the critical role of American innovation in drug development. Tune in to hear about the state of biotech in the U.S., the future of drug discovery, and what it takes to succeed in this evolving field.

In the latest episode of the Vital Health podcast, we delve into the future of healthcare with Blythe Adamson from Flatiron Health. Learn how Flatiron is at the forefront of transforming drug discovery through real-world data—using insights from everyday clinical practices to drive innovation and improve patient outcomes.Blythe shares fascinating insights on the role of AI in healthcare, stating, "The integration of AI into our data processes isn't just about speed; it's about uncovering patterns and insights that were previously invisible." She also discusses the unique challenges of navigating health data regulations across different countries and how Flatiron is overcoming these hurdles to make a global impact. This episode is packed with valuable perspectives for anyone interested in biotech, data science, or the evolving landscape of healthcare.

In the latest episode of the Vital Health podcast, we engage in a thought-provoking discussion with Hans Sauer, Deputy General Counsel for Intellectual Property at the Biotechnology Innovation Organization (BIO), and Gwen O'Loughlin, a seasoned health data researcher. Together, they unpack the complexities of intellectual property (IP) in the rapidly evolving biotech landscape. Hans and Gwen share insights into the current challenges facing the industry, particularly in the wake of new patent eligibility standards. "The crux of innovation in biotech is not just discovery, but ensuring those discoveries are protected and can reach the market," says Sauer, emphasizing the critical role of IP in fostering continued advancement. The conversation also touches on the impact of recent court rulings on biotech patents and what these changes mean for future innovation. Gwen adds, "Understanding these legal nuances is key for anyone in biotech—it’s about protecting your work and driving the industry forward." This episode is a must-listen for anyone involved in biotech, law, or IP management, offering a deep dive into how legal frameworks shape the future of biotechnology.

In this episode of the Vital Health podcast, we dive deep into the world of genomic data and its transformative impact on healthcare. Join host Duane Schulthess as he sits down with Judsen Schneider, CTO of Nashville Biosciences, and Curt Allen, VP of Sales, to explore the origins and growth of Nashville Biosciences. Discover how this pioneering company, in collaboration with Vanderbilt University, is leveraging vast amounts of clinical data to drive innovation in drug development and treatment strategies. Learn about the unique healthcare ecosystem in Nashville, the challenges of coastal bias, and the significant role of data diversity in their success. The discussion also touches on the evolving landscape of AI in healthcare, the global reach of their data, and what the future holds for genomic discovery. Whether you're a healthcare professional, biotech enthusiast, or just curious about the future of medicine, this episode is packed with insights you won't want to miss! Don't forget to like, comment, and subscribe for more episodes of the Vital Health podcast!

In this Vital Health Podcast, Duane Schulthess speaks to Pernille Weiss, a former Member of the European Parliament and the Rapporteur of the European Parliament’s revision of the EU's General Pharmaceutical Legislation (GPL). The GPL proposes many profound changes to the regulatory structures of the EU’s pharmaceutical sector, and MEP Weiss sat at the centre of the European Parliament’s revision which rolled-back many of the European Commissions’ suggested cuts to regulatory data protection. Pernille Weiss is a qualified Nurse, and the CEO of the healthcare consultancy Archimed. Vital Transformation’s analysis of the EU GPL's impact on the pharmaceutical ecosystem can be accessed here.

Join us at the International 2024 BIO conference as host Duane Schulthess sits down with Virginia Amann, CEO of the Entente Network. Discover how Virginia has led her firm to become a global leader in strategic communications, crisis management, and behavior science. They discussed the firm's mission to secure positive outcomes for clients, the importance of social capital, and the evolving landscape of health communications. Learn about the latest industry challenges, the impact of COVID-19 on public trust, and innovative strategies for effective advocacy and engagement. Don't miss this in-depth conversation filled with valuable insights for anyone interested in the biotech and life sciences sectors!

With the continuing pressure placed upon the US biopharma sector from Washington DC, how is the California biopharma ecosystem, arguably the leading hub for innovative biotech worldwide, responding?  In this Vital Health Podcast, we speak with Joseph Panetta to discuss this issue.  Joe is the President & CEO of Biocom California, an organization representing over 1,800 members working in California's life sciences sector to break down barriers to doing business and advocate for innovation.  As the head of Biocom California since 1999, Joe is regarded as a thought leader in biotech and life sciences globally.

In this Vital Health Podcast, recorded live at the 2024 Bio International Conference, host Duane Schulthess sits down with Niklas Blomberg, the Executive Director of the EU Innovative Health Initiative (IHI). Together, they delve into the transformative journey from the Innovative Medicines Initiative to the broader, more inclusive Innovative Health Initiative. Niklas shares his perspectives on fostering collaboration between pharmaceuticals, medical technologies, and diagnostics while elaborating on the challenges and strategies for integrating diverse sectors in healthcare research. Discover how IHI is breaking down silos and creating a collaborative platform that brings together regulators, industry players, and patient organizations. Nicholas also touches on the importance of comprehensive public healthcare systems, the role of SMEs in innovation, and the exciting projects on the horizon, including those addressing regulatory science and digital health. Whether you are interested in public-private partnerships, healthcare innovation, or the future of medical research in Europe, this episode will provide valuable insights and forward-thinking ideas. It’s an engaging discussion with one of the leading voices in global health research.

Congressman Michael Burgess is the Chair of the House Rules Committee and one of only 20 M.D.s currently serving in Congress. Before his election to the House of Representatives in 2002 for the 26th District in Texas, Congressman Burgess was a practicing physician in obstetrics and gynecology. In this Vital Health podcast, Congressman Burgess outlines the historical background of the need for the Medicare prescription drug benefit passed in 2003, the risks posed to seniors and U.S. healthcare more broadly due to the Inflation Reduction Act, and the Government’s potential use of march-in rights.

Trials@Home is a €39 million, pan-European public private partnership of the EU’s Innovative Medicines Initiative, focused on defining the best practices to conduct decentralised clinical trials (DCTs). In this Vital Health Podcast, Duane Schulthess speaks with Kim Hawkins, Global Head of Clinical Project Operations at Sanofi, and the Co-Project Lead of the Trials@Home consortium. Kim outlines how Trials@Home is applying new innovative approaches to DCTs to evaluate different operational models of DCTs in RADIAL, the project’s pan-European proof of concept study. As well, Kim Hawkins describes how one core mission of the project is placing patient choices and opinions at the centre of decision making and implementation.

Douglas Holtz-Eakin was formerly a professor of economics at Syracuse University and served as the director of the Congressional Budget Office from 2003 – 2005. He was the chief economic policy adviser to Senator John McCain's 2008 presidential campaign and is currently president of the American Action Forum, a highly respected think tank in Washington, DC. While heading the CBO, Douglas played a pivotal role in designing and implementing the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, aka the Medicare Part D prescription drug benefit. Given his experience, in this podcast, we reflect upon how that legislation led to the rapid expansion of the U.S. innovative biopharma sector and the material risks posed by the Inflation Reduction Act.

John LaMattina was President of Pfizer Global Research and Development and ran an international team of over 13,000 scientists and professionals. He has authored several books, including the highly acclaimed Pharma and Profits – Balancing Innovation, Medicine, and Drug Prices. He is also a senior partner at PureTech Health and a contributor to Forbes. Last year, when John was a guest on the Vital Health Podcast, the potential impacts of the Inflation Reduction Act (IRA) were still theoretical. But one year on, the Centers for Medicare and Medicaid Services (CMS) released their prices for drug negotiations, and the impacts of the IRA have now become real. John discusses how the IRA will impact the development of critically needed new therapies and provides his insights into the Biden Administration’s recent threats to use march-in rights to confiscate intellectual property as a way to control the price of drugs. 

This podcast features Kate Hudson, the Associate Vice President and Counsel for Policy at the Association of American Universities, and Joseph P. Allen, the Executive Director of the Bayh-Dole Coalition. They discuss the unintended consequences that the Biden Administration’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act is having on small companies and VCs inside and outside of the biopharmaceutical sector.  As well, they detail how well-funded advocacy groups had promoted the use of march-in rights as an effective tool for price controls, and were mistaken in this belief. Kate and Joe also describe a new strategy being pressure tested in DC, promoting the expansion of the application of march-in rights to IP created by the private sector.

On December 8, 2023, The Biden Administration under the National Institute of Standards and Technology (“NIST”) released a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights in the Bayh-Dole Act. VT’s Grumpy Old Men are back to discuss what this means to R&D. Vital Transformation released our report, March-in rights under the Bayh-Dole Act & NIH contributions to pharmaceutical patents one week before the Biden Administration released its guidance. We found that of the 363 novel therapies we’ve investigated over the last ten years, only 5 had mechanism of action and composition of matter patents where all had government interest statements. 

With a six million EUR funding grant from the European Commission, the PRIME-ROSE project will implement, across Europe, a series of prospective, non-randomized clinical trials known as DRUP trials. DRUP trials started in the Netherlands and have successfully increased inclusion rates to offer additional lines of treatment to patients. On this Vital Health Podcast, Duane Schulthess speaks to PRIME-ROSE’s Project Coordinator, Kjetil Tasken of the University of Oslo’s Institute for Cancer, and PRIME-ROSE’s Work Package Lead of Social Innovation, Bettina Ryll of the Stockholm School of Economics Institute for Research. They outline how the project will develop and build upon the DRUP trial model. For more information about the project, contact PRIME-ROSE via email at kjetil.tasken@medisin.uio.no.

In this Vital Health Podcast, Duane Schulthess speaks with Peter Kolchinsky, Managing Partner at RA Capital Management. Peter has authored several critically acclaimed books, including The Great American Drug Deal and The Entrepreneur’s Guide to a Biotech Startup. Peter also serves as the Director of No Patient Left Behind, a non-profit organization. Peter outlines that not only are IRA’s provisions negotiating small molecules after 9 years a huge challenge, but the continuation of ratcheting up of increasingly hostile regulatory proposals is having a demonstrably negative impact on biopharma investments and innovations. 

Christian Schneider is the Chief Medical Officer of Biopharma Excellence, and was formerly the Chief Scientific Officer at the UK’s MHRA. He was the Medical Head for Licensing at the Danish Medicines Agency, and a member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. In this podcast, we discuss the continuing challenges to Europe’s Biopharma competitiveness, and how an improved regulatory environment could be a benefit. Christian also highlights both the risks and opportunities of the EU’s proposed revision of the general pharmaceutical legislation. This podcast was supported by The European Federation of Pharmaceutical Industries and Associations (EFPIA) and has been recorded in collaboration with PharmaLex GmbH.  It is not meant to serve as legal advice and may contain certain marketing statements. PharmaLex and its parent, Cencora, Inc. strongly encourage listeners to review all available information and to rely on their own experience and expertise in making decisions with regard to the information discussed today. 00:00:01 Introduction  00:01:05 What's your day like as a regulator?  00:09:48 Patient access to novel and effective treatments and patient engagement with the EMA.  00:11:40 Availability of data and clinical trials.  00:14:12 Clinical Trials Regulation.  00:15:19 Europe's loss of competitiveness and its role as an innovator.  00:16:36 The importance of Scientific Advice.  00:17:28 Revision of the EU Pharmaceutical legislation: Fostering innovation and streamlining the regulatory process.  00:20:32 Europe losing ground vis-à-vis the USA: Regulatory assessment.  00:27:37 The use of drug-device combinations.  00:32:30 Reimbursement and pricing decisions and criteria for (High) Unmet Medical Needs.  00:41:02 Revising EU Pharmaceutical legislation and creating a future-proof framework for clinical trials and R&D investments.  00:44:15 Ability of Member States to access all medicines.  00:46:27 Recommendations to the European Commission and the EMA on the EU Pharmaceutical package.