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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

For example, in describing how potency should be demonstrated for CGT products, the 2011 guidance simply stated that potency for gene therapy products is derived from “at least two biological activities for its potency: the ability to transfer a genetic sequence to a cell; and the biological effect of the expressed genetic sequence.”

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AI At The Frontier: Empowering Early Career Professionals In Drug Discovery

Elrig

Webinar | Ai At The Frontier: Empowering Early Career Professionals In Drug Discovery WEBINAR – ARE YOU CURIOUS ABOUT THE CUTTING-EDGE INTERSECTION OF ARTIFICIAL INTELLIGENCE AND DRUG DISCOVERY? Are you curious about the cutting-edge intersection of Artificial Intelligence and Drug Discovery?