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.

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.

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

Breaking Barriers: The Prime Rose Project and Off-Label Drug Innovations

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.

Breaking Barriers: The Prime Rose Project and Off-Label Drug Innovations

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