Chris A. Learn leads Parexel's cell and gene therapy development, with 20+ years of clinical trial and rare disease expertise. Notably, he led teams for YONDELIS®, IMBRUVICA®, and KEYTRUDA® approvals and oversaw global trials for CAR-T assets BREYANZI® and ABECMA®. He also held roles at Brody School of Medicine and Duke University's Division of Neurosurgery. In his most recent role as Senior Director at Istari Oncology, he led strategy for gene therapy in glioblastoma

Steve spent more than 11 years at the FDA as a former Medical Officer, Team Leader, and Acting Branch Chief in the Center for Biologics Evaluation and Research’s (CBER’s) Office of Tissues and Advanced Therapies, which has recently been renamed the Office of Therapeutic Products (OTP). He has extensive experience with the review and supervision of cell and gene therapy (CGT) applications, including sponsor requests for Breakthrough Therapy and Regenerative Medicine Advanced Therapy designation. He also supervised numerous Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) and pre-IND meetings for CGTs.