Dr. Larissa Lapteva is the Associate Director 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 was trained as a rheumatologist at the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), where she later conducted clinical studies in rheumatic diseases. Since joining FDA in 2006, Dr. Lapteva has held review and leadership positions in the Center for Drug Evaluation and Research and 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 NIAMS, NIH.She received her degrees of Master of Health Sciences from Duke University and Master of Business Administration from R.H. Smith School of Business.