Kimberly Schultz is currently the Chief of Gene Therapy Branch 4 in the Office of Gene Therapies which is part of the Office of Therapeutic Products at FDA’s Center for Biologics Evaluation. She oversees the product review for pre-IND, IND, and BLA submissions for gene therapy products. Kim also contributes to regulatory guidance documents for gene therapy products.
Kim joined the FDA in 2015 as a Commissioner’s Fellow to conduct a cross-study analysis of CAR T cell CMC data and then transitioned to a full time reviewer. 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.
