Kimberly Schultz PhD U.S. FDA

Kimberly Schultz PhD

Kimberly Schultz PhD U.S. FDA GTB CMC Reviewer, CBER

Kimberly Schultz is a Gene Therapy Product Reviewer in the Division of Cellular and Gene Therapies at FDA’s Center for Biologics Evaluation. She is responsible for review of pre-IND, IND, and BLA submissions for gene therapy products. Kim actively participates in inter- and intra-agency working groups, meetings, and conferences focused on advancing cell and gene therapy products and has contributed to regulatory guidance documents for gene therapy products. She was a member of the BLA review team for the first approved CAR T cell therapy product (KYMRIAH). Kim joined the FDA in 2015 as a Commissioner’s Fellow to conduct a cross-study analysis of CAR T cell data. Prior to joining the FDA, she received her PhD from the University of Wisconsin and conducted postdoctoral studies at Johns Hopkins Bloomberg School of Public Health specializing in virology and immunology.