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.

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…