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2026 State of Real-World Evidence Policy

Event • 07/21/26

2026 State of Real-World Evidence Policy

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Cross-Cutting Themes

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Duke-Margolis Spotlight

Advancing Biomarker Use in Regulatory Review: Evidence, Engagement, and Ecosystem Opportunities

 

Duke-Margolis convened a public workshop to inform a preliminary policy roadmap to improve the use of biomarkers and surrogate endpoints in regulatory decision-making for individual product submissions. The workshop sessions focus on biomarker-supported accelerated approvals and rare disease contexts, while considering lessons that may apply to broader therapeutic areas. Discussions highlight sponsors’ real-world experiences developing biomarker evidence, challenges related to analytical and clinical validation, and opportunities to strengthen FDA engagement and review transparency.

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