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Accelerating Drug Discovery Through Repurposing

DrugBank

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. Key techniques include high-throughput screening (HTS), cell-based assays, and animal models.

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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input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