Juli Tomaino, M.D., M.S., is a pediatric gastroenterologist with over 13 years of experience within FDA’s Center for Drug Evaluation and Research (CDER). She served as Deputy Director of the Division of Gastroenterology in CDER’s Office of New Drugs for more than five years, after serving as a lead medical officer and clinical reviewer. In these roles, she provided scientific, clinical, and technical direction for the review and evaluation of drug development programs for gastrointestinal conditions.
During her tenure at FDA, Dr. Tomaino led multidisciplinary review teams on programs involving complex regulatory and scientific considerations and contributed to efforts to refine the review approach for Fast Track and Breakthrough Therapy Designation requests. A recognized authority on gastrointestinal diseases, as well as clinical trial design and endpoint selection, she also contributed to the development of several guidance documents. She additionally served as Deputy Director of the Division of Clinical Trial Quality within CDER’s Office of Medical Policy, where she led a multidisciplinary team developing and guiding policy initiatives to promote trial quality and data integrity in support of regulatory decision-making.
She is board-certified in Pediatrics and Pediatric Gastroenterology, completed her fellowship at Mount Sinai Medical Center and residency at the Children’s Hospital at Montefiore, Albert Einstein College of Medicine, New York. She holds a Master of Science in clinical research from Icahn School of Medicine at Mount Sinai and an M.D. from Drexel University College of Medicine.