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
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