Dr. Larissa Lapteva is the Associate Director for Clinical and Nonclinical Regulation in the Division of Clinical Evaluation, Pharmacology, and Toxicology, in the Office of Tissues and Advanced Therapies in the Center for Biologics Evaluation and Research at FDA. Dr. Lapteva is a physician with long-standing experience in clinical research with novel drugs and biological products. Prior to her work at FDA, Dr. Lapteva served as a lead clinical investigator in clinical trials conducted at the National Institutes of Health (NIH). Since joining FDA in 2006, Dr. Lapteva has held review and leadership positions in the Office of New Drugs and Office of Generic Drugs in the Center for Drug Evaluation and Research and in the Center for Biologics Evaluation and Research and provided scientific and regulatory advice for clinical development programs with investigational products across different therapeutic areas. Dr. Lapteva is a practicing clinician and serves as faculty at the National Institute of Arthritis, Musculoskeletal, and Skin Diseases, NIH, advancing the teaching mission of the Institute for the next generation of physician-scientists. Dr. Lapteva received her degrees of Master of Health Sciences from Duke University and Master of Business Administration from R.H. Smith School of Business.