Vital Health Podcast Steffen Thirstrup & Richard Bergstrom: Evidence, Access, and Competitiveness in Europe
Dec 11, 2025
34:38
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.
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