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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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.

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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/

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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.

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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.

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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.

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