Lola A. Fashoyin-Aje, M.D., M.P.H.

Lola A. Fashoyin-Aje, M.D., M.P.H., is Senior Vice President, Head of Regulatory Oncology, Cell & Gene where she leads a team of consultants focused on consulting in these key areas of innovation and growth for Parexel. 

Dr. Fashoyin-Aje is a board-certified internist and medical oncologist with over a decade of experience at the U.S. Food and Drug Administration (FDA). She most recently served as the Director of the Office of Clinical Evaluation in the Office of Therapeutic Products at the FDA Center for Biologics Evaluation and Research (CBER). In this role, she provided clinical and scientific oversight in the clinical assessment of cellular, gene, and tissue products across all indications, supervising approximately 80 physicians and clinical pharmacologists. 

Prior to that she was Deputy Director in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Center for Drug Evaluation and Research (CDER), where she provided scientific and policy guidance and oversight to multidisciplinary teams reviewing drugs and biologics under development for the treatment of solid tumor malignancies (gastrointestinal, cutaneous, and sarcoma). Dr. Fashoyin-Aje was also an Associate Director at the FDA Oncology Center of Excellence at the FDA serving as executive lead for several scientific and policy initiatives to accelerate drug development, generate evidence in representative populations, and optimize multiregional clinical development programs, She has over a decade of experience applying the regulatory framework for the approval of products regulated in both medical product Centers at FDA, for common and rare diseases. 

Prior to joining the FDA as a clinical reviewer and then serving as a clinical team leader, Dr. Fashoyin-Aje completed her undergraduate and graduate training at Columbia University and Yale University, respectively, and received her M.D. degree from the University of Rochester School of Medicine and Dentistry. She completed her training in internal medicine and medical oncology at Johns Hopkins.