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SUMMARY:FDA and Duke-Margolis Virtual Public Workshop – Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More
DESCRIPTION: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).\nWorkshop Objectives:\n\nPresent 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.\nProvide successful examples of using translational science in the development of therapeutics.\nIdentify current challenges and opportunities in developing innovative drug development tools and applying them in therapeutic development.\nFoster interaction and discussion among the stakeholders who are developing these tools and implementing them in therapeutic development programs.\n\nFor more information and to register for the workshop, please visit the Duke-Margolis event webpage.\n
URL:https://www.cac2.org/cac2c-events/fda-and-duke-margolis-virtual-public-workshop-translational-science-in-drug-development-surrogate-endpoints-biomarkers-and-more/
CATEGORIES:Community Event,Professional Meeting,Virtual Event
LOCATION:Silver Springs, MD 20993
ATTACH;FMTTYPE=image/png:https://www.cac2.org/wp-content/uploads/2025/06/Virtual-Program.png
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