Brian Stultz

Brian Stultz is the Chief of Gene Therapy Branch 3 located in the Office of Gene Therapy CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research. Brian has over 20 years of experience with cell and gene therapy CMC review including expertise in plasmids, peptides, mRNA, genome editing, microbial vector, and AAV based products. He received a Master of Science with training in Biochemistry and Molecular Biology from the University of Virginia. Brian joined the FDA in 2000 working in the lab of Dr. Hursh publishing multiple papers on the regulation of the TGF-β signaling pathway and identifying critical quality attributes of MSCs. In addition to lab research, he participated in reviewing gene therapy CMC and eventually transitioned to full time review of gene therapy products. In 2023 he took on the role of branch chief in the new super office of therapeutic products.