Defining Regulatory Expectations For Non-Invasive Endpoint Qualification To Improve Development Confidence, Enable Accelerated Pathways & Support Broader Clinical Adoption

• Defining regulatory expectations for non-invasive endpoint qualification to improve development confidence, enabling clearer validation strategies and accelerating clinical progression
• Aligning biomarker evidence packages with evolving regulatory frameworks to strengthen endpoint acceptance, improving approval readiness and reducing development uncertainty
• Establishing clinically meaningful non-invasive endpoints to support broader adoption across trials, improving scalability and future patient accessibility
• Leveraging public-private partnerships to generate the shared data, expertise, and regulatory science needed to advance qualification efforts that no single organization could achieve alone

Speakers:

Patricia Grebenstein

Scientific Researcher & Project Manager

Foundation for the National Institutes of Health