Lola A. Fashoyin-Aje, MD, MPH, is a medical oncologist and serves as the Director of the Office of Clinical Evaluation in the Center for Biologic Evaluation and Research (CBER) Office of Therapeutic Products. In this role, Dr. Fashoyin-Aje oversees the clinical experts in CBER responsible for regulating cellular and gene therapies, including genetically modified cellular therapies, tissue-engineered products, plasma protein therapeutics across all indications. These clinical staff also review selected medical device and xenotransplantation studies. Prior to joining CBER, Dr. Fashoyin-Aje served as Deputy Director in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Center for Drug Evaluation and Research- Food and Drug Administration (FDA). In that role, she provided clinical, scientific, and regulatory policy guidance and oversight to multidisciplinary teams reviewing drugs and biologics under development for the treatment of solid tumor malignancies. Dr. Fashoyin-Aje was also an Associate Director at the FDA Oncology Center of Excellence at the FDA, where she led initiatives to address clinical and regulatory science and policy issues impacting oncology drug development. She has been at FDA for over a decade, joining as a clinical reviewer and serving as a clinical team leader. Prior to joining the FDA, 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 postgraduate training in internal medicine and medical oncology at Johns Hopkins.