In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Harry Bowen, Economics Research Partner at Vital Transformation, about their newly published study on the Inflation Reduction Act (IRA) and late-stage drug research, including additional uses of medicines after their first FDA approval.

They explain why separating small molecules from biologics and examining the mix of research across disease areas can reveal patterns hidden in aggregate results. The conversation also covers policy expectations, venture capital, global biopharma competition, and the economic trade-offs involved in tariffs and domestic manufacturing.

Key Topics:
- Late-Stage Cancer Research: Follow-on studies, lead indication approvals, orphan oncology research.
- Research Portfolio Choices: Small molecules and biologics, disease categories, study counts and research proportions.
- Policy Expectations: Decisions before enactment, uncertainty, earlier venture capital and angel investment findings.
- Global Biopharma Competition: Research locations, European and U.S. experience, Chinese-origin assets and licensing.
- Trade Policy Costs: Generic manufacturing, proposed tariffs, export restrictions, and opportunity cost.

Resources Discussed & Further Reading:
- The Inflation Reduction Act’s Modeled Impacts upon Late-Stage R&D (Vital Transformation, 2026): https://link.springer.com/article/10.1007/s43441-026-01061-4
- The Price Control Debate: Protecting Patient Access and Future Innovation (Sanofi, 2026): https://www.sanofi.us/en/sanofi-today/social-impact/the-price-control-debate-protecting-patient-access-and-future-innovation
- The Inflation Reduction Act’s Impact Upon Early-Stage Venture Capital Investments (Vital Transformation, 2025): https://link.springer.com/article/10.1007/s43441-025-00773-3
- CBO’s Model of Drug Development: Ongoing Updates (Congressional Budget Office, 2025): https://www.cbo.gov/system/files/2025-04/61231-Drug-Development-Model.pdf
- The Historical Impact of Price Controls on the Biopharma Industry (Vital Transformation, 2021): https://vitaltransformation.com/2021/11/the-historical-impact-of-price-controls-on-the-biopharma-industry/
- China Is Increasing Its Share of Global Drug Development (Goldman Sachs, 2025): https://www.goldmansachs.com/insights/articles/china-is-increasing-its-share-of-global-drug-development

Opinions expressed are those of the speakers.

#VitalHealthPodcast #IRA #OncologyResearch #DrugDevelopment

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/harry-p-bowen-10761b31/">Harry Bowen</a>, Economics Research Partner at <a href="https://vitaltransformation.com/">Vital Transformation</a>, about their newly published study on the Inflation Reduction Act (IRA) and late-stage drug research, including additional uses of medicines after their first FDA approval.
They explain why separating small molecules from biologics and examining the mix of research across disease areas can reveal patterns hidden in aggregate results. The conversation also covers policy expectations, venture capital, global biopharma competition, and the economic trade-offs involved in tariffs and domestic manufacturing.
Key Topics: - Late-Stage Cancer Research: Follow-on studies, lead indication approvals, orphan oncology research. - Research Portfolio Choices: Small molecules and biologics, disease categories, study counts and research proportions. - Policy Expectations: Decisions before enactment, uncertainty, earlier venture capital and angel investment findings. - Global Biopharma Competition: Research locations, European and U.S. experience, Chinese-origin assets and licensing. - Trade Policy Costs: Generic manufacturing, proposed tariffs, export restrictions, and opportunity cost.
Resources Discussed &amp; Further Reading: - The Inflation Reduction Act&rsquo;s Modeled Impacts upon Late-Stage R&amp;D (Vital Transformation, 2026): <a href="https://link.springer.com/article/10.1007/s43441-026-01061-4">https://link.springer.com/article/10.1007/s43441-026-01061-4</a> - The Price Control Debate: Protecting Patient Access and Future Innovation (Sanofi, 2026): <a href="https://www.sanofi.us/en/sanofi-today/social-impact/the-price-control-debate-protecting-patient-access-and-future-innovation">https://www.sanofi.us/en/sanofi-today/social-impact/the-price-control-debate-protecting-patient-access-and-future-innovation</a> - The Inflation Reduction Act&rsquo;s Impact Upon Early-Stage Venture Capital Investments (Vital Transformation, 2025): <a href="https://link.springer.com/article/10.1007/s43441-025-00773-3">https://link.springer.com/article/10.1007/s43441-025-00773-3</a> - CBO&rsquo;s Model of Drug Development: Ongoing Updates (Congressional Budget Office, 2025): <a href="https://www.cbo.gov/system/files/2025-04/61231-Drug-Development-Model.pdf">https://www.cbo.gov/system/files/2025-04/61231-Drug-Development-Model.pdf</a> - The Historical Impact of Price Controls on the Biopharma Industry (Vital Transformation, 2021): <a href="https://vitaltransformation.com/2021/11/the-historical-impact-of-price-controls-on-the-biopharma-industry/">https://vitaltransformation.com/2021/11/the-historical-impact-of-price-controls-on-the-biopharma-industry/</a> - China Is Increasing Its Share of Global Drug Development (Goldman Sachs, 2025): <a href="https://www.goldmansachs.com/insights/articles/china-is-increasing-its-share-of-global-drug-development">https://www.goldmansachs.com/insights/articles/china-is-increasing-its-share-of-global-drug-development</a>
Opinions expressed are those of the speakers.
#VitalHealthPodcast #IRA #OncologyResearch #DrugDevelopment

The IRA Promised Lower Drug Prices. Why Did It Cut Follow-On Cancer Research?

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Eric Lindquist, biotech entrepreneur and former Chief Business and Commercial Officer at Celcuity, about the 2021 deal to license gedatolisib from Pfizer.

Drawing on Lindquist’s experience with the transaction, they explore portfolio fit, the responsibilities of advancing a medicine, and how funding, pricing policy, and international competition shape drug development and patient access.

Key Topics:
Drug Licensing: The Pfizer-Celcuity agreement, portfolio fit, development responsibilities.
Pricing Policy: Inflation Reduction Act incentives, Most Favored Nation proposals, international launch decisions.
Global Investment: Venture capital in Europe and the U.S., China’s role in drug licensing, clinical development costs.
Venture Philanthropy: Funding gaps, Lindquist’s plans for a new fund, companies outside traditional investment mandates.
AI in Trials: Uses of digital pathology, patient identification, confirmatory testing.

Resources Discussed & Further Reading:
Original Gedatolisib Licensing Announcement (Celcuity, April 2021; PDF page 26): https://ir.celcuity.com/static-files/3a24eb9e-2798-43e3-bcab-660f1dc11a54#page=26
Gedatolisib Fact Sheet (Pfizer, May 2018; historical development background): https://cdn.pfizer.com/pfizercom/news/asco/Gedatolisib_Fact_Sheet_25MAY2018.pdf
FDA Approval of Revtorpyk (Gedatolisib) (Celcuity, July 2026): https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-fda-approval-revtorpyktm-gedatolisib
The Inflation Reduction Act’s Impact Upon Late-Stage R&D (Vital Transformation preprint, 2026): https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/
EU General Pharmaceutical Legislation & Clawbacks (Vital Transformation, 2024; European investment research): https://vitaltransformation.com/2024/03/the-eu-general-pharmaceutical-legislation-clawbacks-calculated-impacts-both-designed-and-unintended/
The Impact of MFN on Oncology and Hematology Treatments (Vital Transformation preprint, 2026; related modeling): https://vitaltransformation.com/2026/02/preprint-new-research-the-impact-of-mfn-on-oncology-and-hematology-treatments/
China’s Growing Share of Drug Development (Goldman Sachs, December 2025; related background): https://www.goldmansachs.com/insights/articles/china-is-increasing-its-share-of-global-drug-development
European Bofanglutide Licensing Agreement (Gan & Lee and Menarini, September 2026): https://www.menarini.com/en-us/news/news-detail/gan-lee-and-menarini-group-partner-to-advance-bofanglutide-in-europe.html

Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/eric-lindquist-mba-7608172/details/education/?locale=en-US">Eric Lindquist</a>, biotech entrepreneur and former Chief Business and Commercial Officer at Celcuity, about the 2021 deal to license gedatolisib from Pfizer.
Drawing on Lindquist&rsquo;s experience with the transaction, they explore portfolio fit, the responsibilities of advancing a medicine, and how funding, pricing policy, and international competition shape drug development and patient access.
Key Topics:
<ul>
<li>Drug Licensing: The Pfizer-Celcuity agreement, portfolio fit, development responsibilities.</li>
<li>Pricing Policy: Inflation Reduction Act incentives, Most Favored Nation proposals, international launch decisions.</li>
<li>Global Investment: Venture capital in Europe and the U.S., China&rsquo;s role in drug licensing, clinical development costs.</li>
<li>Venture Philanthropy: Funding gaps, Lindquist&rsquo;s plans for a new fund, companies outside traditional investment mandates.</li>
<li>AI in Trials: Uses of digital pathology, patient identification, confirmatory testing.</li>
</ul>
Resources Discussed &amp; Further Reading:
<ul>
<li>Original Gedatolisib Licensing Announcement (Celcuity, April 2021; PDF page 26): <a href="https://ir.celcuity.com/static-files/3a24eb9e-2798-43e3-bcab-660f1dc11a54#page=26">https://ir.celcuity.com/static-files/3a24eb9e-2798-43e3-bcab-660f1dc11a54#page=26</a></li>
<li>Gedatolisib Fact Sheet (Pfizer, May 2018; historical development background): <a href="https://cdn.pfizer.com/pfizercom/news/asco/Gedatolisib_Fact_Sheet_25MAY2018.pdf">https://cdn.pfizer.com/pfizercom/news/asco/Gedatolisib_Fact_Sheet_25MAY2018.pdf</a></li>
<li>FDA Approval of Revtorpyk (Gedatolisib) (Celcuity, July 2026): <a href="https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-fda-approval-revtorpyktm-gedatolisib">https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-fda-approval-revtorpyktm-gedatolisib</a></li>
<li>The Inflation Reduction Act&rsquo;s Impact Upon Late-Stage R&amp;D (Vital Transformation preprint, 2026): <a href="https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/">https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/</a></li>
<li>EU General Pharmaceutical Legislation &amp; Clawbacks (Vital Transformation, 2024; European investment research): <a href="https://vitaltransformation.com/2024/03/the-eu-general-pharmaceutical-legislation-clawbacks-calculated-impacts-both-designed-and-unintended/">https://vitaltransformation.com/2024/03/the-eu-general-pharmaceutical-legislation-clawbacks-calculated-impacts-both-designed-and-unintended/</a></li>
<li>The Impact of MFN on Oncology and Hematology Treatments (Vital Transformation preprint, 2026; related modeling): <a href="https://vitaltransformation.com/2026/02/preprint-new-research-the-impact-of-mfn-on-oncology-and-hematology-treatments/">https://vitaltransformation.com/2026/02/preprint-new-research-the-impact-of-mfn-on-oncology-and-hematology-treatments/</a></li>
<li>China&rsquo;s Growing Share of Drug Development (Goldman Sachs, December 2025; related background): <a href="https://www.goldmansachs.com/insights/articles/china-is-increasing-its-share-of-global-drug-development">https://www.goldmansachs.com/insights/articles/china-is-increasing-its-share-of-global-drug-development</a></li>
<li>European Bofanglutide Licensing Agreement (Gan &amp; Lee and Menarini, September 2026): <a href="https://www.menarini.com/en-us/news/news-detail/gan-lee-and-menarini-group-partner-to-advance-bofanglutide-in-europe.html">https://www.menarini.com/en-us/news/news-detail/gan-lee-and-menarini-group-partner-to-advance-bofanglutide-in-europe.html</a></li>
</ul>
Opinions expressed are those of the speakers.

Eric Lindquist: Why Did Pfizer License a Promising Cancer Drug to Celcuity?

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Harry Bowen, Economic Research Partner at Vital Transformation, about Most-Favored-Nation (MFN) drug pricing and the lessons they draw from Europe's experience with price controls. They discuss how pricing rules, revenue uncertainty, and regulatory choices influence market access and the geography of pharmaceutical innovation.

Key Topics:
MFN Pricing Incentives: International reference pricing, launch decisions, links between U.S. and European markets.
European Approval Trade-offs: Centralized review, national decision-making, consistency and time to market.
Investment and Uncertainty: Expected returns, late-stage financing, retrospective clawbacks and revenue planning.
Global Innovation Competition: Mobile research investment, changing capabilities, Europe's experience and China's role.
Policy and Evidence: Historical comparisons, incentives and unintended effects, distinguishing policy explanations from broader economic change.

Resources Discussed:
The historical impact of price controls on the biopharma industry (Schulthess & Bowen, 2021): https://vitaltransformation.com/2021/11/the-historical-impact-of-price-controls-on-the-biopharma-industry/
Pharmaceutical regulation in Europe and its impact on corporate R&D (Eger & Mahlich, 2014): https://link.springer.com/article/10.1186/s13561-014-0023-5
The EU General Pharmaceutical Legislation & Clawbacks: Calculated impacts - both designed and unintended (Schulthess et al., 2024): https://vitaltransformation.com/2024/03/the-eu-general-pharmaceutical-legislation-clawbacks-calculated-impacts-both-designed-and-unintended/
Savings from Most-Favored-Nation Drug Pricing Policy (White House, 2026): https://www.whitehouse.gov/research/2026/05/savings-from-most-favored-nation-drug-pricing-policy/
The Inflation Reduction Act’s Impact Upon Late-Stage R&D (Bowen et al., 2026): https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/
EIRA 2026 conference information: https://eirainitiative.org/events/

Opinions expressed are those of the speakers. Discussion recorded on 9/19/26.

#VitalHealthPodcast #MFN #DrugPricing

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/harry-p-bowen-10761b31/?isSelfProfile=false">Harry Bowen</a>, Economic Research Partner at Vital Transformation, about Most-Favored-Nation (MFN) drug pricing and the lessons they draw from Europe's experience with price controls. They discuss how pricing rules, revenue uncertainty, and regulatory choices influence market access and the geography of pharmaceutical innovation.
Key Topics:
<ul>
<li>MFN Pricing Incentives: International reference pricing, launch decisions, links between U.S. and European markets.</li>
<li>European Approval Trade-offs: Centralized review, national decision-making, consistency and time to market.</li>
<li>Investment and Uncertainty: Expected returns, late-stage financing, retrospective clawbacks and revenue planning.</li>
<li>Global Innovation Competition: Mobile research investment, changing capabilities, Europe's experience and China's role.</li>
<li>Policy and Evidence: Historical comparisons, incentives and unintended effects, distinguishing policy explanations from broader economic change.</li>
</ul>
Resources Discussed:
<ul>
<li>The historical impact of price controls on the biopharma industry (Schulthess &amp; Bowen, 2021):&nbsp;<a href="https://vitaltransformation.com/2021/11/the-historical-impact-of-price-controls-on-the-biopharma-industry/">https://vitaltransformation.com/2021/11/the-historical-impact-of-price-controls-on-the-biopharma-industry/</a></li>
<li>Pharmaceutical regulation in Europe and its impact on corporate R&amp;D (Eger &amp; Mahlich, 2014): <a href="https://link.springer.com/article/10.1186/s13561-014-0023-5">https://link.springer.com/article/10.1186/s13561-014-0023-5</a></li>
<li>The EU General Pharmaceutical Legislation &amp; Clawbacks: Calculated impacts - both designed and unintended (Schulthess et al., 2024): <a href="https://vitaltransformation.com/2024/03/the-eu-general-pharmaceutical-legislation-clawbacks-calculated-impacts-both-designed-and-unintended/">https://vitaltransformation.com/2024/03/the-eu-general-pharmaceutical-legislation-clawbacks-calculated-impacts-both-designed-and-unintended/</a></li>
<li>Savings from Most-Favored-Nation Drug Pricing Policy (White House, 2026): <a href="https://www.whitehouse.gov/research/2026/05/savings-from-most-favored-nation-drug-pricing-policy/">https://www.whitehouse.gov/research/2026/05/savings-from-most-favored-nation-drug-pricing-policy/</a></li>
<li>The Inflation Reduction Act&rsquo;s Impact Upon Late-Stage R&amp;D (Bowen et al., 2026):&nbsp;<a href="https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/">https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/</a></li>
<li>EIRA 2026 conference information:&nbsp;<a href="https://eirainitiative.org/events/">https://eirainitiative.org/events/</a></li>
</ul>
Opinions expressed are those of the speakers. Discussion recorded on 9/19/26.
#VitalHealthPodcast #MFN #DrugPricing

VT Discusses MFN and Price Controls

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Michael Penn, US Head of Reimbursement and Public Policy at Sanofi, to discuss how pricing policy, the Inflation Reduction Act (IRA), small-molecule incentives, orphan drug provisions, and Most Favored Nation (MFN) proposals could shape oncology innovation, patient access, and U.S. biopharmaceutical competitiveness.

Key Topics:
IRA and Oncology: Late-stage research shifts, follow-on studies, lead asset selection.
Small-Molecule Incentives: Pill penalty concerns, portfolio reassessment, biologic comparisons.
Orphan Drug Policy: Orphan Cures Act provisions, rare disease investment, post-market indication development.
Patient Access Risks: Fewer treatment options, affordability questions, unmet needs in oncology.
U.S. Competitiveness: MFN proposals, global R&D incentives, comparisons with China and Europe.

Our new preprint on the IRA’s impact on late-stage R&D is available on our website and examines declines in small-molecule oncology research and orphan oncology studies.

Opinions expressed are those of the speakers. Recorded at ASCO 2026 on 5/31/26. The Vital Health Podcast is a production of Vital Transformation LLC © 2026.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/michael-d-penn/">Michael Penn</a>, US Head of Reimbursement and Public Policy at <a href="https://www.linkedin.com/company/sanofi/">Sanofi</a>, to discuss how pricing policy, the Inflation Reduction Act (IRA), small-molecule incentives, orphan drug provisions, and Most Favored Nation (MFN) proposals could shape oncology innovation, patient access, and U.S. biopharmaceutical competitiveness.
Key Topics:
<ul>
<li>IRA and Oncology: Late-stage research shifts, follow-on studies, lead asset selection.</li>
<li>Small-Molecule Incentives: Pill penalty concerns, portfolio reassessment, biologic comparisons.</li>
<li>Orphan Drug Policy: Orphan Cures Act provisions, rare disease investment, post-market indication development.</li>
<li>Patient Access Risks: Fewer treatment options, affordability questions, unmet needs in oncology.</li>
<li>U.S. Competitiveness: MFN proposals, global R&amp;D incentives, comparisons with China and Europe.</li>
</ul>
Our new preprint on the IRA&rsquo;s impact on late-stage R&amp;D is available on <a href="https://vitaltransformation.com/2026/05/preprint-new-research-the-inflation-reduction-acts-impact-upon-late-stage-rd/">our website</a> and examines declines in small-molecule oncology research and orphan oncology studies.
Opinions expressed are those of the speakers. Recorded at ASCO 2026 on 5/31/26. The Vital Health Podcast is a production of Vital Transformation LLC &copy; 2026.

Michael Penn: What The IRA Means For Oncology Innovation

Across Europe and around the world, demographic change is reshaping our societies. Longer life expectancy, aging populations, and evolving workforce dynamics are creating both new opportunities and growing pressure on healthcare systems, economies, and public policy.

Against this backdrop, health and innovation play an increasingly important role in building resilient societies and supporting healthier, more productive lives. Investing in prevention, early intervention, innovative healthcare solutions, and forward-looking health policies is becoming essential to meeting these challenges.

In this Early Bird edition of the Vital Health Podcast, Duane Schulthess sits with Mike Hodin (Global Coalition on Aging - GCOA; CEO) and Francesca Colombo (Organisation for Economic Co-operation and Development - OECD; Head, Health Division) to explore how strategic investment in health and innovation can help address demographic change and contribute to sustainable social and economic outcomes. They highlight the value of prevention, including adult vaccination, the importance of cardiovascular health, and the critical role of early detection, diagnosis, and timely treatment in cancer care.

Opinions expressed are those of the speakers. Recorded on 6/17/26. This podcast was made with the support of Merck Sharp & Dohme. The Vital Health Podcast is a production of Vital Transformation LLC © 2026.

Across Europe and around the world, demographic change is reshaping our societies. Longer life expectancy, aging populations, and evolving workforce dynamics are creating both new opportunities and growing pressure on healthcare systems, economies, and public policy.
Against this backdrop, health and innovation play an increasingly important role in building resilient societies and supporting healthier, more productive lives. Investing in prevention, early intervention, innovative healthcare solutions, and forward-looking health policies is becoming essential to meeting these challenges.
In this Early Bird edition of the Vital Health Podcast, <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> sits with <a href="linkedin.com/in/hodin">Mike Hodin</a> (<a href="https://www.linkedin.com/company/global-coalition-on-aging/">Global Coalition on Aging - GCOA</a>; CEO) and <a href="https://www.linkedin.com/in/francesca-colombo-a662a51/">Francesca Colombo</a> (<a href="linkedin.com/company/organisation-eco-cooperation-development-organisation-cooperation-developpement-eco">Organisation for Economic Co-operation and Development - OECD</a>; Head, Health Division) to explore how strategic investment in health and innovation can help address demographic change and contribute to sustainable social and economic outcomes. They highlight the value of prevention, including adult vaccination, the importance of cardiovascular health, and the critical role of early detection, diagnosis, and timely treatment in cancer care.
Opinions expressed are those of the speakers. Recorded on 6/17/26. This podcast was made with the support of <a href="https://www.linkedin.com/company/msd-global">Merck Sharp &amp; Dohme</a>. The Vital Health Podcast is a production of <a href="https://www.linkedin.com/company/vital-transformation/">Vital Transformation LLC</a> &copy; 2026.

MSD Early Bird Podcast: Changing Demographics and the Case for Renewed Investment in Health

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Bill Smith (Senior Fellow and Director, Life Sciences Initiative at The Pioneer Institute) to discuss how the 340B program has evolved from a safety net drug discount program into a major source of hospital revenue, what new research suggests about charity care and Medicaid access, and why transparency, hospital consolidation, and broader drug pricing policy are reshaping incentives across oncology and biopharma.

Key Topics:
340B Origins: Medicaid best price, safety net intent, clinic and hospital eligibility.
Hospital Arbitrage: Buy-low sell-high incentives, affluent satellite sites, oncology drug spreads.
Charity Care: Lower reported charity care, Medicaid access concerns, variation across hospital systems.
Transparency Reforms: State reporting laws, separate audited accounts, minimum charity care requirements.
Policy Collisions: Inflation Reduction Act (IRA) price controls, Most-Favored-Nation (MFN) pressure, oncology consolidation, biopharma investment risks.

Opinions expressed are those of the speakers. Recorded 6/5/26. The Vital Health Podcast is a production of Vital Transformation LLC © 2026.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/william-smith-phd-54628b18/">Bill&nbsp;Smith</a> (Senior Fellow and Director, Life Sciences Initiative at <a href="https://www.linkedin.com/company/pioneer-institute-for-public-policy-research/">The Pioneer Institute</a>) to discuss how the 340B program has evolved from a safety net drug discount program into a major source of hospital revenue, what new research suggests about charity care and Medicaid access, and why transparency, hospital consolidation, and broader drug pricing policy are reshaping incentives across oncology and biopharma.
Key Topics:
<ul data-start="982" data-end="1512">
<li data-start="982" data-end="1074" data-section-id="1peq6hi">340B Origins: Medicaid best price, safety net intent, clinic and hospital eligibility.</li>
<li data-start="1075" data-end="1179" data-section-id="crugk7">Hospital Arbitrage: Buy-low sell-high incentives, affluent satellite sites, oncology drug spreads.</li>
<li data-start="1180" data-end="1289" data-section-id="1md5czd">Charity Care: Lower reported charity care, Medicaid access concerns, variation across hospital systems.</li>
<li data-start="1290" data-end="1401" data-section-id="1mugpb2">Transparency Reforms: State reporting laws, separate audited accounts, minimum charity care requirements.</li>
<li data-start="1402" data-end="1512" data-section-id="1e21uam">Policy Collisions: Inflation Reduction Act (IRA) price controls, Most-Favored-Nation (MFN) pressure, oncology consolidation, biopharma investment risks.</li>
</ul>
Opinions expressed are those of the speakers. Recorded 6/5/26. The Vital Health Podcast is a production of Vital Transformation LLC &copy; 2026.

Bill Smith: How 340B Became A Hospital Profit Center

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Steve Potts, CEO of Breakthru Medicine, to discuss how biotech financing, drug pricing policy, scientific infrastructure, and public trust are reshaping oncology innovation and U.S. biopharma leadership.

Key Topics:
Biotech Financing: Series A funding, early-stage platform headwinds, clinical asset momentum, academic funding strain.
Small Molecule Shift: IRA incentives, NDA versus BLA timelines, oncology pipeline pullbacks, antibody drug conjugates.
Orphan Cures and EPIC Acts: Orphan Cures Act, EPIC Act, patent life concerns, investor return requirements.
Most Favored Nation (MFN) Pricing Risk: OECD reference pricing, European access delays, launch sequencing, global cost-sharing tensions.
Science Policy Threats: NIH grant oversight, peer review risks, vaccine backlash, U.S. biopharma leadership.

If biotech CEOs (or an executive delegate from the CEO) are interested in taking the first step toward being a policy voice on one topic in our ecosystem, contact Steve Potts on LinkedIn.

The May 29 Office of Management and Budget sweeping regulatory change, which would shift grant funding decisions from scientists to politicians, is catastrophic for science, patients, and the biotech industry. Please read about what this proposal would do, and if you agree that it would forever tie political views to winning federal funding (and it will cut both ways), please sign this petition or others and speak out: https://fight2win.standupforscience.net/

Opinions expressed are those of the speakers. Recorded at ASCO 2026 on 6/1/26. The Vital Health Podcast is a production of Vital Transformation LLC © 2026.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/steven-potts/">Steve Potts</a>, CEO of <a href="https://www.linkedin.com/company/breakthrumed/">Breakthru Medicine</a>, to discuss how biotech financing, drug pricing policy, scientific infrastructure, and public trust are reshaping oncology innovation and U.S. biopharma leadership.
Key Topics:
<ul data-start="324" data-end="922">
<li data-start="324" data-end="448" data-section-id="p0uqsi">Biotech Financing: Series A funding, early-stage platform headwinds, clinical asset momentum, academic funding strain.</li>
<li data-start="449" data-end="573" data-section-id="k7qssb">Small Molecule Shift: IRA incentives, NDA versus BLA timelines, oncology pipeline pullbacks, antibody drug conjugates.</li>
<li data-start="574" data-end="686" data-section-id="1ma6irf">Orphan Cures and EPIC Acts: Orphan Cures Act, EPIC Act, patent life concerns, investor return requirements.</li>
<li data-start="687" data-end="807" data-section-id="11b70pc">Most Favored Nation (MFN) Pricing Risk: OECD reference pricing, European access delays, launch sequencing, global cost-sharing tensions.</li>
<li data-start="808" data-end="922" data-section-id="1x0h8b">Science Policy Threats: NIH grant oversight, peer review risks, vaccine backlash, U.S. biopharma leadership.</li>
</ul>
If biotech CEOs (or an executive delegate from the CEO) are interested in taking the first step toward being a policy voice on one topic in our ecosystem, contact&nbsp;<a href="https://www.linkedin.com/in/steven-potts/">Steve Potts on LinkedIn</a>.
The May 29 Office of Management and Budget sweeping regulatory change, which would shift grant funding decisions from scientists to politicians, is catastrophic for science, patients, and the biotech industry. Please read about what this proposal would do, and if you agree that it would forever tie political views to winning federal funding (and it will cut both ways), please sign this petition or others and speak out: <a href="https://fight2win.standupforscience.net/">https://fight2win.standupforscience.net/</a>
Opinions expressed are those of the speakers. Recorded at ASCO 2026 on 6/1/26. The Vital Health Podcast is a production of Vital Transformation LLC &copy; 2026.

Steve Potts: Policy Headwinds Are Reshaping Biotech Financing

In this best-of edition of the Vital Health Podcast, we revisit two conversations Duane Schulthess has with experts on the future of generic medicines, drug shortages, and supply chain risk in the United States.
Patrick Kelly: Chief Advocacy Officer, Healthcare Distribution Alliance
John Murphy: President and CEO, Association for Accessible Medicines

Across these conversations, they discuss how low prices, thin margins, supply chain disruption, reshoring pressure, biosimilar market dynamics, insurance design, and federal pricing policy shape access to generic and biosimilar medicines.

Key Topics:
Generic Economics: Low prices, thin margins, purchaser pressure, manufacturer exits.
Shortage Drivers: Demand spikes, facility shutdowns, sterile injectables, chemotherapy disruptions.
Tariffs and Reshoring: Domestic production costs, national security concerns, tariff pass-through, contract constraints.
Biosimilar Competition: Private-label programs, vertical integration, investment uncertainty, patient access.
Policy and Insurance: IRA redesign, MFN pricing, direct-to-consumer pathways, prescription benefit reform.

Opinions expressed are those of the speakers. Original podcasts published in October 2025. The Vital Health Podcast is a production of Vital Transformation LLC © 2026.

In this best-of edition of the Vital Health Podcast, we revisit two conversations <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> has with experts on the future of generic medicines, drug shortages, and supply chain risk in the United States.
<ul data-start="348" data-end="502">
<li data-section-id="mlchlg" data-start="348" data-end="426"><a href="https://www.linkedin.com/in/patrick-kelly-08427a8/">Patrick Kelly</a>: Chief Advocacy Officer, <a href="https://www.linkedin.com/company/hdma/">Healthcare Distribution Alliance</a></li>
<li data-section-id="wnfwxb" data-start="427" data-end="502"><a href="https://www.linkedin.com/in/john-murphy-iii-9b19ab1/">John Murphy</a>: President and CEO, <a href="https://www.linkedin.com/company/accessiblemeds/">Association for Accessible Medicines</a></li>
</ul>
Across these conversations, they discuss how low prices, thin margins, supply chain disruption, reshoring pressure, biosimilar market dynamics, insurance design, and federal pricing policy shape access to generic and biosimilar medicines.
Key Topics:
<ul data-start="760" data-end="1312">
<li data-section-id="1l363d" data-start="760" data-end="850">Generic Economics: Low prices, thin margins, purchaser pressure, manufacturer exits.</li>
<li data-section-id="j2s9a5" data-start="851" data-end="956">Shortage Drivers: Demand spikes, facility shutdowns, sterile injectables, chemotherapy disruptions.</li>
<li data-section-id="1gqfuvg" data-start="957" data-end="1083">Tariffs and Reshoring: Domestic production costs, national security concerns, tariff pass-through, contract constraints.</li>
<li data-section-id="1n5vcwb" data-start="1084" data-end="1199">Biosimilar Competition: Private-label programs, vertical integration, investment uncertainty, patient access.</li>
<li data-section-id="1jlakpo" data-start="1200" data-end="1312">Policy and Insurance: IRA redesign, MFN pricing, direct-to-consumer pathways, prescription benefit reform.</li>
</ul>
Opinions expressed are those of the speakers. Original podcasts published in October 2025. The Vital Health Podcast is a production of Vital Transformation LLC &copy; 2026.

Patrick Kelly & John Murphy: Generic Shortages and Supply Chain Risk

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Christopher Locher, Chief Executive Officer at Versatope Therapeutics, about the current landscape for vaccine manufacturers and innovators. Their conversation covers vaccine platform development, financing challenges for infectious disease companies, policy and regulatory uncertainty, the public health implications of changes to childhood immunization schedules, and the steps needed to rebuild trust in vaccination.

Key Topics:

Vaccine Platform Innovation: Nanoparticle technology, universal influenza vaccine development, multispecific targeting, infectious disease, and oncology applications.

Financing Challenges: Venture capital headwinds, NIH support, clinical development costs, grant cancellations, and startup survival pressures.

Policy Uncertainty: Changes to childhood immunization schedules, liability debates, academic licensing concerns, royalty proposals, and the biotech investment climate.

Public Health Risks: Vaccine access, childhood disease vulnerability, antimicrobial resistance, influenza complications, and consequences of fragmented immunization policy.

Trust Rebuilding: COVID backlash, transparency concerns, anti-science sentiment, provider-patient communication, rebuilding confidence in vaccines.

Opinions expressed are those of the speakers.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/christopher-locher-biotech/">Christopher Locher</a>, Chief Executive Officer at <a href="https://www.linkedin.com/company/versatope/">Versatope Therapeutics</a>, about the current landscape for vaccine manufacturers and innovators. Their conversation covers vaccine platform development, financing challenges for infectious disease companies, policy and regulatory uncertainty, the public health implications of changes to childhood immunization schedules, and the steps needed to rebuild trust in vaccination.
Key Topics: 
<ul>
<li>Vaccine Platform Innovation: Nanoparticle technology, universal influenza vaccine development, multispecific targeting, infectious disease, and oncology applications. </li>
<li>Financing Challenges:&nbsp;Venture capital headwinds, NIH support, clinical development costs, grant cancellations, and startup survival pressures. </li>
<li>Policy Uncertainty: Changes to childhood immunization schedules, liability debates, academic licensing concerns, royalty proposals, and the biotech investment climate. </li>
<li>Public Health Risks: Vaccine access, childhood disease vulnerability, antimicrobial resistance, influenza complications, and consequences of fragmented immunization policy. </li>
<li>Trust Rebuilding:&nbsp;COVID backlash, transparency concerns, anti-science sentiment, provider-patient communication, rebuilding confidence in vaccines.</li>
</ul>
Opinions expressed are those of the speakers.

Christopher Locher: Why Vaccine Innovation Matters More Than Ever

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Melanie Whittington, Managing Director and Head of the Leerink Center for Pharmacoeconomics and Senior Fellow at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center.

They examine how health economic modeling can more accurately reflect real-world market dynamics, the rising pressure behind IRA and MFN drug pricing, the risks to oncology innovation, the limits of conventional cost-effectiveness frameworks, plus the role of transparency and clearer communication of long-term value in sustaining a healthy innovation ecosystem.

Key Topics
Market Modeling: Hypothetical models versus real-world pricing dynamics, patent cliffs.
Pricing Policy: IRA, MFN, market-based pricing scrutiny, communicating why prices are "worth it".
Innovation Incentives: Private capital risk, oncology small molecules, policy-driven pipeline shifts.
Value Framework Limits: QALY concerns, rule-versus-tool debates, GRACE, broader treatment impacts.
Transparency and Outlook: Net price opacity, PBM negotiations, generics and biosimilars, the next innovation cycle.

Opinions expressed are those of the speakers. The Leerink Center for Pharmacoeconomics is a division of MEDACorp.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/melanie-whittington/">Melanie Whittington</a>, Managing Director and Head of the Leerink Center for Pharmacoeconomics and Senior Fellow at the <a href="https://www.linkedin.com/company/cevr/">Center for the Evaluation of Value and Risk in Health at Tufts Medical Center</a>.
They examine how health economic modeling can more accurately reflect real-world market dynamics, the rising pressure behind IRA and MFN drug pricing, the risks to oncology innovation, the limits of conventional cost-effectiveness frameworks, plus the role of transparency and clearer communication of long-term value in sustaining a healthy innovation ecosystem.
Key Topics
<ul>
<li>Market Modeling: Hypothetical models versus real-world pricing dynamics, patent cliffs.</li>
<li>Pricing Policy: IRA, MFN, market-based pricing scrutiny, communicating why prices are "worth it".</li>
<li>Innovation Incentives: Private capital risk, oncology small molecules, policy-driven pipeline shifts.</li>
<li>Value Framework Limits: QALY concerns, rule-versus-tool debates, GRACE, broader treatment impacts.</li>
<li>Transparency and Outlook: Net price opacity, PBM negotiations, generics and biosimilars, the next innovation cycle.</li>
</ul>
Opinions expressed are those of the speakers. The Leerink Center for Pharmacoeconomics is a division of MEDACorp.

Melanie Whittington: Why Are Drugs So Expensive?

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess, Managing Director of Vital Tran…

Vital Health Podcast

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