FDA and Duke-Margolis Virtual Public Workshop – Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More

The U.S. Food and Drug Administration and the Duke-Margolis Center for Health Policy will convene a virtual public workshop on May 24 and 25, 2022, to present best practices and use cases for successfully bringing forward evidence generated through translational science for regulatory submissions. Stakeholders will discuss ways that translational science can contribute to drug development programs (e.g., surrogate endpoints, enrichment biomarkers, biodynamic/response biomarkers), what some of the challenges are (e.g., validating biomarkers, establishing analytic validation, obtaining biosamples) and strategies to address those challenges (e.g., public-private partnerships, collaborations between industry and academia).

Workshop Objectives:

• Present efforts from FDA, NIH, academia, patient groups, and industry to support surrogate endpoint and other biomarker identification and development for use in therapeutic development and regulatory submissions.
• Provide successful examples of using translational science in the development of therapeutics.
• Identify current challenges and opportunities in developing innovative drug development tools and applying them in therapeutic development.
• Foster interaction and discussion among the stakeholders who are developing these tools and implementing them in therapeutic development programs.

For more information and to register for the workshop, please visit the Duke-Margolis event webpage.