Keith M. Wonnacott, PhD Pfizer

Dr. Keith Wonnacott has over 15 years of regulatory experience in the field of cell and gene therapies.  He currently works at Pfizer as an Executive Director of Regulatory Affairs in their Rare Diseases Unit.  At Pfizer, Dr. Wonnacott leads efforts to develop regulatory strategy and policy related to cell and gene therapy.  He is a member of the regulatory affairs committee for both ASGCT and ARM; he is on working groups related to advanced therapies with PhRMA, BIO, and EFPIA; and participates with other organizations that work on cell and gene therapy policy.  Dr. Wonnacott made the move to Pfizer after spending the previous 3 years with Novartis Pharmaceuticals.  In that role he led the team responsible for developing the CMC module for the the Kymriah (tisagenlecleucel) BLA. Prior to working at Novartis, Dr. Wonnacott was the Chief of the Cellular Therapies Branch at the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Dr. Wonnacott received his Ph.D. in Microbiology and Immunology from The Pennsylvania State University College of Medicine, Hershey, Pennsylvania in 2001.  Dr. Wonnacott completed his Bachelor's degree in microbiology at Brigham Young University, Provo, Utah in 1996.