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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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.

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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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

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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!

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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.

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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.

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