Vital Health Podcast

In this episode, host Duane Schulthess [https://www.linkedin.com/in/duane-schulthess-66ba39b7/] sits down with Ipsita Smolinski [https://www.linkedin.com/in/ipsita-smolinski-83bb7682/], Founder and Managing Director of Capitol Street [https://capitol-street.com/] 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. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

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. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

In this Vital Health Podcast, host Duane Schulthess speaks with Jocelyn Ulrich [https://www.linkedin.com/in/jocelynulrich/], Vice President of Policy and Research at PhRMA [https://www.linkedin.com/company/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. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

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. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.

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. See omnystudio.com/listener [https://omnystudio.com/listener] for privacy information.