Dr. Heather Lombardi has served as Director of the Office of Cellular Therapy and Human Tissue within CBER’s Office of Therapeutic Products since April 2023. Previously, Dr. Lombardi served as the Director, Division of Cellular and Gene Therapies within CBER’s Office of Tissues and Advanced Therapies. Prior to her tenure at CBER, Dr. Lombardi was Director, Division of Animal Bioengineering and Cellular Therapies at the FDA’s Center for Veterinary Medicine (CVM). Dr. Lombardi has expertise in the review of CMC information for innovative products such as proteins, peptides, and cell and gene therapy products for both animals and humans. Dr. Lombardi holds a PhD in biological chemistry from the University of Pennsylvania and a BS in chemistry (biochemistry track) from UNC Chapel Hill.