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/

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 &ldquo;Ginny&rdquo; Acha. They examine the IRA and question its promise to lower drug prices for Medicare beneficiaries, revealing how it discourages R&amp;D, reroutes venture capital, and restricts patient access.
What You&rsquo;ll Learn
<ul>
<li>Pill Penalty Breakdown: How the 9-year small-molecule vs 13-year biologic exclusivity gap reshapes R&amp;D incentives</li>
<li>Investor Exodus: The flight of early-stage venture capital and its implications for future cures</li>
<li>Access vs Cost: Why poorly designed price controls can restrict, not expand, patient access</li>
<li>Policy Fixes: From the EPIC Act to prize-based innovation rewards, proposed solutions to realign incentives</li>
<li>Global Threats: Tariff talk, reference pricing pitfalls, and reshoring risks for manufacturing and supply security</li>
</ul>
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:&nbsp;<a href="https://vitaltransformation.com/2025/04/inflation-reduction-act-two-years-on-investor-behavior-rd-impacts-proposed-solutions/" data-auth="NotApplicable" data-linkindex="0" data-ogsc="">https://vitaltransformation.com/2025/04/inflation-reduction-act-two-years-on-investor-behavior-rd-impacts-proposed-solutions/</a>

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

VT’s Grumpies Talk IRA with Virginia Acha

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on the Inflation Reduction Act (IRA) and its ripple effects across drug development, Medicare, and patient access. Over the past year, the biopharma industry and the broader healthcare system have undergone a period of rapid change as new rules surrounding drug pricing reshape how therapies are developed, financed, and delivered. In a landscape where policies are still being interpreted and adjusted, and where the long-term impact on innovation and access is far from certain, this episode serves as a year-end guide to what has changed and how to think about the road ahead.

Throughout 2025, we paired our research with a series of podcast episodes where host Duane Schulthess sat down with industry leaders. In this highlights episode, we revisit several of those conversations:
Douglas Holtz-Eakin: “Indications are going to be deeply affected by the IRA”
Steve Usdin: Tariffs, Price Controls, & Inflation Reduction Act (IRA)
VT’s Grumpies Talk IRA with Virginia Acha

Key Topics:
Pill Penalty: How the shorter negotiation window for small molecule medicines relative to biologics is changing the calculus for pursuing oral therapies in areas such as cardiovascular disease, neurodegeneration, and other chronic conditions.
Part D Redesign: Why moving more liability to plans is driving new premium and coverage tradeoffs, influencing which products stay on formularies, and raising questions about access in rural and underserved areas.
Early Stage Investment: What our data suggest about the pullback in trial starts and funding for projects most exposed to IRA mechanics, and how that is influencing company formation, licensing strategies, and pipeline mix.
PBMs, Vertical Integration, & Biosimilars: How consolidated intermediaries and payer-owned biosimilar strategies interact with IRA price setting, rebate flows, and the outlook for generic and biosimilar competition.
Patient Advocacy & Real World Impact: What older adults, cancer patients, and rare disease communities are already experiencing as coverage rules change, cost-sharing is redesigned, and uncertainty grows around long-term treatment availability.
Policy Paths Forward: Ideas from our guests for adjusting timelines, refining negotiation rules, and protecting incentives for follow-on and orphan indications while still improving affordability for patients.

Opinions expressed are those of the speakers.

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on the Inflation Reduction Act (IRA) and its ripple effects across drug development, Medicare, and patient access. Over the past year, the biopharma industry and the broader healthcare system have undergone a period of rapid change as new rules surrounding drug pricing reshape how therapies are developed, financed, and delivered. In a landscape where policies are still being interpreted and adjusted, and where the long-term impact on innovation and access is far from certain, this episode serves as a year-end guide to what has changed and how to think about the road ahead.
Throughout 2025, we paired our research with a series of podcast episodes where host Duane Schulthess sat down with industry leaders. In this highlights episode, we revisit several of those conversations:
<ul>
<li>Douglas Holtz-Eakin: &ldquo;Indications are going to be deeply affected by the IRA&rdquo;</li>
<li>Steve Usdin: Tariffs, Price Controls, &amp; Inflation Reduction Act (IRA)</li>
<li>VT&rsquo;s Grumpies Talk IRA with Virginia Acha</li>
</ul>
Key Topics:
<ul>
<li>Pill Penalty: How the shorter negotiation window for small molecule medicines relative to biologics is changing the calculus for pursuing oral therapies in areas such as cardiovascular disease, neurodegeneration, and other chronic conditions.</li>
<li>Part D Redesign: Why moving more liability to plans is driving new premium and coverage tradeoffs, influencing which products stay on formularies, and raising questions about access in rural and underserved areas.</li>
<li>Early Stage Investment: What our data suggest about the pullback in trial starts and funding for projects most exposed to IRA mechanics, and how that is influencing company formation, licensing strategies, and pipeline mix.</li>
<li>PBMs, Vertical Integration, &amp; Biosimilars: How consolidated intermediaries and payer-owned biosimilar strategies interact with IRA price setting, rebate flows, and the outlook for generic and biosimilar competition.</li>
<li>Patient Advocacy &amp; Real World Impact: What older adults, cancer patients, and rare disease communities are already experiencing as coverage rules change, cost-sharing is redesigned, and uncertainty grows around long-term treatment availability.</li>
<li>Policy Paths Forward: Ideas from our guests for adjusting timelines, refining negotiation rules, and protecting incentives for follow-on and orphan indications while still improving affordability for patients.</li>
</ul>
Opinions expressed are those of the speakers.

2025 U.S. Policy Highlights - Inflation Reduction Act (IRA) Part 1

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts in European regulation and evidence of new medicines:
Steffen Thirstrup: Chief Medical Officer at European Medicines Agency.
Richard Bergstrom: Head of Policy at IQVIA.

They compare regulatory benefit-risk decisions with HTA’s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments.

Key Topics

Regulatory Versus HTA: Benefit-risk focus, added benefit comparisons, joint clinical assessments.

Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing.

Endpoints & Outcomes: Overall survival pressure, validated biomarkers, patient experience relevance.

Real-world Evidence: Registries and randomized rollout, data quality limits, outcomes-based contracting lessons.

Adaptive Pathways & Data Space: Early joint advice, platform and sandbox tools, European Health Data Space.

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/?utm_source=chatgpt.com">Duane Schulthess</a> speaks with two experts in European regulation and evidence of new medicines:
<ul>
<li><a href="https://www.linkedin.com/in/steffen-thirstrup/">Steffen Thirstrup</a>: Chief Medical Officer at <a href="https://www.linkedin.com/company/european-medicines-agency/">European Medicines Agency</a>.</li>
<li><a href="https://www.linkedin.com/in/richard-bergstrom-62ab07198/">Richard Bergstrom</a>: Head of Policy at <a href="https://www.linkedin.com/company/iqvia/">IQVIA</a>.</li>
</ul>
They compare regulatory benefit-risk decisions with HTA&rsquo;s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments.
Key Topics 
<ul>
<li>Regulatory Versus HTA:&nbsp;Benefit-risk focus, added benefit comparisons, joint clinical assessments. </li>
<li>Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing. </li>
<li>Endpoints &amp; Outcomes:&nbsp;Overall survival pressure, validated biomarkers, patient experience relevance. </li>
<li>Real-world Evidence:&nbsp;Registries and randomized rollout, data quality limits, outcomes-based contracting lessons. </li>
<li>Adaptive Pathways &amp; Data Space: Early joint advice, platform and sandbox tools, European Health Data Space.</li>
</ul>
Opinions expressed are those of the speakers.

Steffen Thirstrup & Richard Bergstrom: Evidence, Access, and Competitiveness in Europe

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Dr. Malina Müller, Head of Health Economics at WifOR Institute, to explore the heated debate around accelerated and conditional approvals in Europe, how demographic and budget pressures shape HTA decisions, the tradeoffs between surrogate endpoints and overall survival, the challenges of using real world evidence under GDPR, and the broader pricing and competitiveness threats facing Europe’s life science ecosystem. 

Key Topics:
Accelerated Approvals: Uncertainty versus early access, conditional pathways in Europe, and costs of delayed treatment.
Health System Pressures: Aging populations, fixed-price hospital incentives, cross-country budget constraints.
Endpoints & Evidence: Surrogate versus overall survival, patient-reported outcomes, practical limits of real-world evidence in Europe.
HTA & Harmonization: Germany's strict assessments, JCA and EMA alignment, and equity gaps across member states.
Global Pricing Risks: Most Favored Nation (MFN) proposals, launch delays between the FDA and EMA, and Europe’s competitiveness versus China.

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/?utm_source=chatgpt.com">Duane Schulthess</a> speaks with <a href="https://www.linkedin.com/in/dr-malina-m%C3%BCller-190754106/?utm_source=chatgpt%2Ecom&amp;originalSubdomain=de">Dr. Malina M&uuml;ller</a>, Head of Health Economics at <a href="https://www.linkedin.com/company/wifor/">WifOR Institute</a>, to explore the heated debate around accelerated and conditional approvals in Europe, how demographic and budget pressures shape HTA decisions, the tradeoffs between surrogate endpoints and overall survival, the challenges of using real world evidence under GDPR, and the broader pricing and competitiveness threats facing Europe&rsquo;s life science ecosystem.&nbsp;
Key Topics:
<ul>
<li>Accelerated Approvals: Uncertainty versus early access, conditional pathways in Europe, and costs of delayed treatment.</li>
<li>Health System Pressures: Aging populations, fixed-price hospital incentives, cross-country budget constraints.</li>
<li>Endpoints &amp; Evidence: Surrogate versus overall survival, patient-reported outcomes, practical limits of real-world evidence in Europe.</li>
<li>HTA &amp; Harmonization: Germany's strict assessments, JCA and EMA alignment, and equity gaps across member states.</li>
<li>Global Pricing Risks: Most Favored Nation (MFN) proposals, launch delays between the FDA and EMA, and Europe&rsquo;s competitiveness versus China.</li>
</ul>
Opinions expressed are those of the speakers.

VT’s Grumpies Talk IRA with Virginia Acha

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