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Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective

FDA discusses the preclinical program to inform early clinical development for cell and gene therapy (CGT) products; including considerations for relevant animal models, assessments for proof-of-concept, safety, biodistribution to support first-in-human studies, and pathways of early communication with FDA and CBER. Presenter: Ying Huang, Ph.D., Pharmacology/Toxicology Reviewer, Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissues and Advanced Therapies (OTAT), CBER Learn more at: https://www.fda.gov/drugs/news-events... --------------------  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.   Upcoming Training - https://www.fda.gov/cdersbia    SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance     SBIA Training Resources - https://www.fda.gov/cderbsbialearn   Twitter -   / fda_drug_info     Email - [email protected]   Phone - (301) 796-6707 I (866) 405-5367