Join us at the Gastein Health Conference for an insightful conversation on Europe's healthcare challenges and innovations! Host Duane Schulthess sits down with experts like Josep Figueras, the Founder and Director of the European Observatory on Health Systems and Policy, Francesca Colombo, the Head of the OECD Health Division, and Annemiek Verkamman, the Managing Director of HollandBIO, to tackle the EU's pressing healthcare issues. From aging populations and non-communicable diseases to data-driven health innovations, they explore how policy, technology, and cross-border collaboration can enhance Europe's healthcare resilience. Tune in for a deep dive into the future of health in Europe!

Join us at the Gastein Health Conference for an insightful conversation on Europe's healthcare challenges and innovations! Host Duane Schulthess sits down with experts like Josep Figueras, the Founder and Director of the European Observatory on Health Systems and Policy, Francesca Colombo, the Head of the OECD Health Division, and Annemiek Verkamman, the Managing Director of HollandBIO, to tackle the EU's pressing healthcare issues. From aging populations and non-communicable diseases to data-driven health innovations, they explore how policy, technology, and cross-border collaboration can enhance Europe's healthcare resilience. Tune in for a deep dive into the future of health in 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

Addressing Europe's Health Challenges: Innovation, Prevention, and Policy

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.

Oriana Ciani & Denis Lacombe: Overall Survival and Surrogate Endpoints in Early Oncology Approvals

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts on reimbursement-facing evidence questions for accelerated oncology approvals at ISPOR Europe 2025 in Glasgow, Scotland:


Anja Schiel:Senior Advisor, Norwegian Medical Products Agency


Niklas Hedberg: Chief Pharmacist at The Dental and Pharmaceutical Benefits Agency (TLV)

They unpack why results that are strong inside a clinical trial can be harder to apply to real-world national populations, how decision-makers weigh patient-relevant outcomes and uncertainty at the time of access decisions, and what risk management can look like when early approvals require follow-up evidence and potential reassessment.

Key Topics:


Trial Generalizability: Selection in trials, real-world populations, and health system variation.


Reimbursement Evidence: Patient-relevant outcomes, absolute versus comparative benefit, small-sample challenges.


Conditional Approval: Evidence at authorization, reassessment expectations, withdrawal, and restriction risk.


Risk Tradeoffs: Approving too early versus delaying access, urgency in progressive disease, and equity constraints.


Adaptive Follow-up: Real-world evidence plans, managed entry approaches, learning while treating.

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 reimbursement-facing evidence questions for accelerated oncology approvals at ISPOR Europe 2025 in Glasgow, Scotland:
<ul data-start="5108" data-end="5337">
<li data-start="5108" data-end="5246">
<a href="https://www.linkedin.com/in/anjaschiel/?originalSubdomain=no">Anja Schiel:</a> Senior Advisor, <a href="https://www.linkedin.com/company/direktoratetformedisinskeprodukter/">Norwegian Medical Products Agency</a>
</li>
<li data-start="5247" data-end="5337">
<a href="https://www.linkedin.com/in/niklas-hedberg-3947231/">Niklas Hedberg:</a> Chief Pharmacist at <a href="https://www.linkedin.com/company/tlv-the-dental-and-pharmaceutical-benefits-agency/">The Dental and Pharmaceutical Benefits Agency (TLV)</a>
</li>
</ul>
They unpack why results that are strong inside a clinical trial can be harder to apply to real-world national populations, how decision-makers weigh patient-relevant outcomes and uncertainty at the time of access decisions, and what risk management can look like when early approvals require follow-up evidence and potential reassessment.
Key Topics:
<ul data-start="5695" data-end="6250">
<li data-start="5695" data-end="5794">
Trial Generalizability: Selection in trials, real-world populations, and health system variation.
</li>
<li data-start="5795" data-end="5913">
Reimbursement Evidence: Patient-relevant outcomes, absolute versus comparative benefit, small-sample challenges.
</li>
<li data-start="5914" data-end="6028">
Conditional Approval: Evidence at authorization, reassessment expectations, withdrawal, and restriction risk.
</li>
<li data-start="6029" data-end="6146">
Risk Tradeoffs: Approving too early versus delaying access, urgency in progressive disease, and equity constraints.
</li>
<li data-start="6147" data-end="6250">
Adaptive Follow-up: Real-world evidence plans, managed entry approaches, learning while treating.
</li>
</ul>
Opinions expressed are those of the speakers. This podcast was supported by Merck Sharp &amp; Dohme as part of the APACE project, in collaboration with GlaxoSmithKline and AstraZeneca.

Addressing Europe's Health Challenges: Innovation, Prevention, and Policy

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