Patricia Grebenstein

Step away from the slide decks and join informal, peer-led discussion groups. Share experiences, debate novel methodologies, and benchmark strategies with your peers in an intimate, high-value networking environment.

• Defining regulatory expectations for non-invasive endpoint qualification provide greater clarity around evidence requirements, enabling more efficient biomarker and drug development
• Building fit-for-purpose evidence packages that align with evolving regulatory frameworks and support acceptance of non-invasive endpoints across multiple contexts of use
• Establishing clinically meaningful endpoints that can improve trial efficiency, reduce reliance on invasive procedures, and expand patient access to innovation

• 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