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 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.

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

Vital Health Podcast

In 1 playlist(s)

Vital Health Podcast

Social links

Follow podcast

Recent clips