Kimberly Schultz

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. Kim joined the FDA in 2015 as a Commissioner’s Fellow to conduct a cross-study analysis of CAR T cell CMC 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.