Keith Wonnacott

Keith Wonnacott, Ph.D. joined LEXEO Therapeutics as Vice President of Regulatory Affairs in Q4 2021. Prior to joining LEXEO, Dr. Wonnacott was an Executive Director of Regulatory Affairs at Pfizer where he had responsibility for gene therapies within the Rare Disease Business Unit. He provided guidance on regulatory strategy and led regulatory policy for the gene therapy portfolio, which included advancing 3 late-stage programs into phase 3 clinical trials. Dr. Wonnacott also worked at Novartis where he was a Director of regulatory CMC and led the development of Module 3 for the Kymriah BLA, which became the first gene therapy product to receive FDA approval in 2017. Dr. Wonnacott also held roles of increasing responsibility at FDA at the start of his career. He spent 15 years in the Division of Cell and Gene Therapies at FDA, the last 10 of which were as Chief of the Cellular Therapies Branch. He is a respected leader in the field, speaker, and published author, and is currently serving as the Chair of the Regulatory Affairs Committee for the American Society of Gene and Cell Therapy. Dr. Wonnacott received his Ph.D. from the Pennsylvania State University and his undergraduate degree from Brigham Young University.