In this "Best-of" edition of the Vital Health Podcast, Duane Schulthess revisits two listener favorites on the future of medicines in Europe. First, former MEP Pernille Weiss explains how the European Parliament reshaped the EU’s General Pharmaceutical Legislation (GPL) to better support innovation while respecting member state control over pricing and reimbursement. Then, Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), outlines how Europe’s largest public-private partnership is convening pharma, medtech, regulators, HTAs, payers, and patients to solve pre-competitive hurdles from real-world data to digital endpoints.

Key Topics
Parliament Process: How Parliament shaped the General Pharmaceutical Legislation (GPL) and why it rejected incentives tied to launches in all 27 member states.
Innovation and Access: Avoiding rock-bottom pricing that causes shortages and using quality-of-life outcomes in pricing and reimbursement decisions.
EU vs National Roles: Where joint procurement helps, and where member-state control over pricing and reimbursement should prevail to reflect health system differences.
From IMI to IHI: Evolution from the Innovative Medicines Initiative (IMI) to the Innovative Health Initiative (IHI), a cross-sector platform convening pharma, medical devices, diagnostics, imaging, regulators, health technology assessment (HTA) bodies, payers, clinicians, and patients to solve pre-competitive evidence needs such as real-world data and digital endpoints.
Data and Regulation: Working within the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the Artificial Intelligence (AI) Act using federated access, shared standards, and a regulatory sandbox to pilot novel technologies.
SME Pathways: How small and medium-sized enterprises (SMEs) join funded consortia via brokering events, with current examples in lung cancer real-world data and cardiovascular prevention and care.

Originally broadcast Sep 4, 2024 (Weiss) and Jul 3, 2024 (Blomberg). Edited and compiled Aug 2025. Opinions expressed are those of the speakers.

In this "Best-of" edition of the Vital Health Podcast,&nbsp;<a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> revisits two listener favorites on the future of medicines in Europe. First, former MEP <a href="https://www.linkedin.com/in/pernille-weiss/?originalSubdomain=dk">Pernille Weiss</a> explains how the <a href="https://www.linkedin.com/company/european-parliament/?originalSubdomain=be">European Parliament</a> reshaped the EU&rsquo;s General Pharmaceutical Legislation (GPL) to better support innovation while respecting member state control over pricing and reimbursement. Then, <a href="https://www.linkedin.com/in/niklas-blomberg-a711167/?originalSubdomain=be">Niklas Blomberg</a>, Executive Director of the <a href="https://www.linkedin.com/company/innovative-health-initiative/">Innovative Health Initiative (IHI)</a>, outlines how Europe&rsquo;s largest public-private partnership is convening pharma, medtech, regulators, HTAs, payers, and patients to solve pre-competitive hurdles from real-world data to digital endpoints.
Key Topics
<ul>
<li>Parliament Process: How Parliament shaped the General Pharmaceutical Legislation (GPL) and why it rejected incentives tied to launches in all 27 member states.</li>
<li>Innovation and Access: Avoiding rock-bottom pricing that causes shortages and using quality-of-life outcomes in pricing and reimbursement decisions.</li>
<li>EU vs National Roles: Where joint procurement helps, and where member-state control over pricing and reimbursement should prevail to reflect health system differences.</li>
<li>From IMI to IHI: Evolution from the Innovative Medicines Initiative (IMI) to the Innovative Health Initiative (IHI), a cross-sector platform convening pharma, medical devices, diagnostics, imaging, regulators, health technology assessment (HTA) bodies, payers, clinicians, and patients to solve pre-competitive evidence needs such as real-world data and digital endpoints.</li>
<li>Data and Regulation: Working within the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the Artificial Intelligence (AI) Act using federated access, shared standards, and a regulatory sandbox to pilot novel technologies.</li>
<li>SME Pathways: How small and medium-sized enterprises (SMEs) join funded consortia via brokering events, with current examples in lung cancer real-world data and cardiovascular prevention and care.</li>
</ul>
Originally broadcast Sep 4, 2024 (Weiss) and Jul 3, 2024 (Blomberg). Edited and compiled Aug 2025. Opinions expressed are those of the speakers.

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

Best-of Edition: Pernille Weiss & Niklas Blomberg on EU Pharma Policy

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Tim Scott, President & CEO of Biocom California, a biopharma executive with more than two decades of experience, including spinning out companies from UC San Diego and leading firms acquired by BioMarin and Novartis, to discuss how California’s life sciences ecosystem became a global innovation engine, why the state’s research and venture networks matter, and how policy headwinds such as the Inflation Reduction Act (IRA) and Most Favored Nation (MFN) reference pricing reshape investment, rare disease development, and competition with Europe and China.

Key Topics:


Biocom Origins: Municipal policy roots, industry advocacy, ecosystem evolution across California.


Innovation Network: University and research density, regional clusters, talent, and collaboration effects.


Capital Pathway: NIH and NSF support, SBIR and STTR bridges, venture appetite, and liquidity.


MFN and IRA: Pill penalty incentives, orphan exemption stakes, Medicare exposure, and VC pullback.


Next-Gen Development: AI-enabled discovery, faster trial enrollment, digital twins, and regulator openness.

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/tim-scott-501631/">Tim Scott</a>, President &amp; CEO of&nbsp;<a href="https://www.linkedin.com/company/biocom-california/">Biocom California</a>, a biopharma executive with more than two decades of experience, including spinning out companies from UC San Diego and leading firms acquired by BioMarin and Novartis, to discuss how California&rsquo;s life sciences ecosystem became a global innovation engine, why the state&rsquo;s research and venture networks matter, and how policy headwinds such as the Inflation Reduction Act (IRA) and Most Favored Nation (MFN) reference pricing reshape investment, rare disease development, and competition with Europe and China.
Key Topics:
<ul data-start="642" data-end="1173">
<li data-start="642" data-end="745">
Biocom Origins: Municipal policy roots, industry advocacy, ecosystem evolution across California.
</li>
<li data-start="746" data-end="857">
Innovation Network: University and research density, regional clusters, talent, and collaboration effects.
</li>
<li data-start="858" data-end="956">
Capital Pathway: NIH and NSF support, SBIR and STTR bridges, venture appetite, and liquidity.
</li>
<li data-start="957" data-end="1060">
MFN and IRA: Pill penalty incentives, orphan exemption stakes, Medicare exposure, and VC pullback.
</li>
<li data-start="1061" data-end="1173">
Next-Gen Development: AI-enabled discovery, faster trial enrollment, digital twins, and regulator openness.
</li>
</ul>
Opinions expressed are those of the speakers.

Tim Scott: MFN Pricing, Venture Risk, and the Future of California Biotech

In this episode of the Vital Health Podcast, host Duane Schulthess examines how NIH-funded research fits into the U.S. innovation and IP ecosystem, and why today’s political rhetoric about “government-developed drugs” often misses how commercialization actually happens. Featuring expert perspectives on NIH technology transfer and drug IP from:


Mark Rohrbaugh: Former Director of Technology Transfer and Innovation Policy at the National Institutes of Health (NIH), IP Consultant at Vital Transformation


Gwen O’Loughlin: Research Partner at Vital Transformation

They discuss how the Bayh-Dole Act shaped university tech transfer, what government interest statements do - and do not - tell you about a drug’s origins, why “march-in rights” were designed as a development backstop rather than a pricing tool, and how proposals to redirect royalties or restrict NIH-industry collaboration could disrupt the pipeline that turns early science into real-world therapies.

Key Topics:


NIH’s Role in the Innovation Pipeline: How NIH funding de-risks foundational science, how industry and universities translate it, and why “NIH developed all drugs” is a misleading simplification.


Government Interest Statements: What the statement signals, why it is inconsistently surfaced across patents, and what large-scale reviews suggest about how often it appears in drug-related patent portfolios.


March-In Rights and Policy Misuse: The original purpose (anti-shelving and public health needs), how petitions are evaluated in practice, and why pricing-based efforts have not succeeded.


Mechanisms Supporting Translation: Why CRADAs and licensing structures matter for bringing technologies to market and for enabling NIH research with proprietary industry tools.


Forward Outlook: How royalty diversion or restricting partnerships could weaken incentives and capacity, and why the guests anticipate near-term disruption with longer-term consequences.

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> examines how NIH-funded research fits into the U.S. innovation and IP ecosystem, and why today&rsquo;s political rhetoric about &ldquo;government-developed drugs&rdquo; often misses how commercialization actually happens. Featuring expert perspectives on NIH technology transfer and drug IP from:
<ul data-start="273" data-end="455">
<li data-start="273" data-end="396">
<a href="https://www.linkedin.com/in/mark-l-rohrbaugh-9462a57/">Mark Rohrbaugh</a>: Former Director of Technology Transfer and Innovation Policy at the <a href="https://www.linkedin.com/company/national-institutes-of-health/">National Institutes of Health (NIH)</a>, IP Consultant at <a href="https://www.linkedin.com/company/vital-transformation/">Vital Transformation</a>
</li>
<li data-start="397" data-end="455">
<a href="https://www.linkedin.com/in/gwen-o-loughlin-8792003a9/">Gwen O&rsquo;Loughlin</a>: Research Partner&nbsp;at <a href="https://www.linkedin.com/company/vital-transformation/">Vital Transformation</a>
</li>
</ul>
They discuss how the Bayh-Dole Act shaped university tech transfer, what government interest statements do - and do not - tell you about a drug&rsquo;s origins, why &ldquo;march-in rights&rdquo; were designed as a development backstop rather than a pricing tool, and how proposals to redirect royalties or restrict NIH-industry collaboration could disrupt the pipeline that turns early science into real-world therapies.
Key Topics:
<ul data-start="872" data-end="1917">
<li data-start="872" data-end="1071">
NIH&rsquo;s Role in the Innovation Pipeline: How NIH funding de-risks foundational science, how industry and universities translate it, and why &ldquo;NIH developed all drugs&rdquo; is a misleading simplification.
</li>
<li data-start="1072" data-end="1303">
Government Interest Statements: What the statement signals, why it is inconsistently surfaced across patents, and what large-scale reviews suggest about how often it appears in drug-related patent portfolios.
</li>
<li data-start="1304" data-end="1495">
March-In Rights and Policy Misuse: The original purpose (anti-shelving and public health needs), how petitions are evaluated in practice, and why pricing-based efforts have not succeeded.
</li>
<li data-start="1496" data-end="1694">
Mechanisms Supporting Translation: Why CRADAs and licensing structures matter for bringing technologies to market and for enabling NIH research with proprietary industry tools.
</li>
<li data-start="1695" data-end="1917">
Forward Outlook: How royalty diversion or restricting partnerships could weaken incentives and capacity, and why the guests anticipate near-term disruption with longer-term consequences.
</li>
</ul>
Opinions expressed are those of the speakers.

Mark Rohrbaugh & Gwen O’Loughlin: Drug Patents, March-In Rights, and NIH Technology Transfer

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland:


Oriana Ciani:Associate Professor of Practice at SDA Bocconi School of Management


Denis Lacombe: Director General at EORTC

They discuss why accelerated pathways are used in oncology, what becomes feasible and risky when patient populations are small, how surrogate endpoints such as progression-free survival can differ from overall survival and quality of life, and why post-authorization evidence generation and treatment optimization shape whether early access translates into sustained patient benefit.

Key Topics:


Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology.


Rare Trial Design: Small populations, randomization feasibility, comparator constraints.


Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates.


HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects.


Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier.

Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp & Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

In this episode of the Vital Health Podcast, host <a href="https://www.linkedin.com/in/duane-schulthess-66ba39b7/">Duane Schulthess</a> speaks with two experts on evidence standards for early oncology access at ISPOR Europe 2025 in Glasgow, Scotland:
<ul data-start="9398" data-end="9526">
<li data-start="9398" data-end="9482">
<a href="https://www.linkedin.com/in/oriana-ciani-bb029a8/?originalSubdomain=it">Oriana Ciani:</a> Associate Professor of Practice at <a href="https://www.linkedin.com/school/sda-bocconi-school-of-management/">SDA Bocconi School of Management</a>
</li>
<li data-start="9483" data-end="9526">
<a href="https://www.linkedin.com/in/denislacombe/?originalSubdomain=be">Denis Lacombe:</a> Director General at <a href="https://www.linkedin.com/company/eortc/">EORTC</a>
</li>
</ul>
They discuss why accelerated pathways are used in oncology, what becomes feasible and risky when patient populations are small, how surrogate endpoints such as progression-free survival can differ from overall survival and quality of life, and why post-authorization evidence generation and treatment optimization shape whether early access translates into sustained patient benefit.
Key Topics:
<ul data-start="9929" data-end="10469">
<li data-start="9929" data-end="10028">
Accelerated Approvals: Unmet need concepts, regulatory pathways, and access pressure in oncology.
</li>
<li data-start="10029" data-end="10123">
Rare Trial Design: Small populations, randomization feasibility, comparator constraints.
</li>
<li data-start="10124" data-end="10240">
Surrogate Endpoints: Progression-free survival, early-stage endpoints, evidence needed to validate surrogates.
</li>
<li data-start="10241" data-end="10343">
HTA Variation: Differing national standards, uncertainty handling, reimbursement timing effects.
</li>
<li data-start="10344" data-end="10469">
Treatment Optimization: Post-authorization evidence gaps, dose and duration questions, aligning evidence needs earlier.
</li>
</ul>
Opinions expressed are those of the speakers.&nbsp;This podcast was supported by Merck Sharp &amp; Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

Best-of Edition: Pernille Weiss & Niklas Blomberg on EU Pharma Policy

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