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.

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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.

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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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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.

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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.

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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.

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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.

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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.

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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.

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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.

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