Vital Health Podcast

Latest Episodes:

Bettina Ryll, Kjetil Taskén & Anni Lepland: PRIME-ROSE & EU Joint Action Oct 15, 2025

Show notes

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.

See omnystudio.com/listener for privacy information.

John Murphy: Generics, Biosimilars, and U.S. Policy Oct 08, 2025

Show notes

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.

See omnystudio.com/listener for privacy information.

Patrick Kelly: Inside the Generic Supply Chain Squeeze Oct 01, 2025

Show notes

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.

See omnystudio.com/listener for privacy information.

Lieven Annemans & Andreas Charalambous: Moving the Needle in EU Cancer Care Sep 03, 2025

Show notes

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.

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Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks Aug 27, 2025

Show notes

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.

See omnystudio.com/listener for privacy information.

Best-of Edition: Pernille Weiss & Niklas Blomberg on EU Pharma Policy Aug 21, 2025

Show notes

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.

See omnystudio.com/listener for privacy information.

Henry Skinner: Fixing the Antibiotics Market & Confronting AMR Aug 13, 2025

Show notes

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.

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Best-of Edition: Peter Kolchinsky & John LaMattina on the IRA Aug 06, 2025

Show notes

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.

See omnystudio.com/listener for privacy information.

Barbara McAneny, Rafael Fonseca, and Steve Potts: Protecting Patients Amid the IRA Jul 30, 2025

Show notes

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.

See omnystudio.com/listener for privacy information.

Sam Rasty, Steve Potts, and Joe Hammang: Policies, Patients, and the Biotech Narrative Jul 17, 2025

Show notes

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.

See omnystudio.com/listener for privacy information.

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