NEW DATE: December 12, 2025 – Hop on Zoom to hear from medical professionals in the Duchenne space on the clinical trial process for individuals and families impacted by Duchenne muscular dystrophy and rare diseases. Jett Foundation’s Community Webinars are free to join and we encourage all to ask questions.
From Molecule to Market: Understanding the Clinical Trial Journey
December 12, 2025 | 1pm ET | Zoom Webinar
Keith Wonnacott, PhD is Vice President of Regulatory Affairs at Lexeo Therapeutics, a small biotech focused on genetic therapies for various indications. Dr. Wonnacott has spent his entire career of more than 2 decades working in cell and gene therapy. He is a respected leader in the field, serving on many trade association and society committees. He currently is a co-chair of the Alliance for Regenerative Medicine’s Regulatory Advisory Group and recently completed a term as the Chair of the Regulatory Affairs Committee for the American Society of Gene and Cell Therapy. Dr. Wonnacott has spoken and published extensively on topics related to the regulation of cell and gene therapies. Â
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 13 years in the Division of Cell and Gene Therapies at FDA, the last 10 of which were as Chief of the Cellular Therapies Branch. Dr. Wonnacott received his PhD from the Pennsylvania State University and his undergraduate degree from Brigham Young University.Â
Dr. Dan Levy has extensive experience in the clinical development of treatments for rare disease, primarily at Pfizer Inc. At Pfizer, he led strategic planning and clinical trial conduct of gene therapy treatments and actively participated in consortia across industry, academics, and regulatory bodies. His work included leading their gene therapy program for Duchenne muscular dystrophy Dr. Levy is now serving as a consultant to companies that are making medicines for rare diseases.
Before joining Pfizer, he was a faculty member at the University of Chicago in the Section of Nephrology. He has published original research in nephrology, neurosciences, and gene therapy. Dr. Levy received a Ph.D. in Physiology and an M.D. from the University of Pennsylvania. He completed a medical residency at the Hospital of the University of Pennsylvania and a renal fellowship at Yale.
Dr. Han Phan is a pediatric neurologist and sleep specialist who is highly passionate about clinical trials in neuromuscular diseases, specifically Duchenne Muscular Dystrophy and Spinal Muscular Atrophy. She is a member of the Pediatric Advisory Board at the FDA and a guest researcher at the CDC Newborn Screening Branch. She served as an Associate Professor at the University of Alabama, and co director of MDA clinic. At the Rare Disease Research center, she is the principal investigator overseeing ongoing studies in neuromuscular patients.
