Andrea Leonard-Segal

In July 2020, Andrea Leonard-Segal, M.D., F.A.C.R, joined Olatec’s Drug Development Team as an advisor on strategies in connection with clinical and regulatory drug development programs for the Company and in July 2021 joined the Scientific Advisory Board. Dr. Segal has been the President and CEO of Andrea Leonard-Segal, MD Consulting, LLC since February 2013, in which she provides consultative services to pharmaceutical companies on nonprescription and prescription drug programs, serves on data safety monitoring boards and other advisory boards. Previously, Dr. Segal spent 15 years at Food and Drug Administration (FDA) in positions of increasing authority, of which almost eight years were as the Director of the Division of Nonprescription Clinical Evaluation. She was instrumental in overseeing the development of many successful over-the-counter (OTC) switch projects, overseeing and participating in the development of several Guidance for Industry publications, working on many OTC drug monograph rulemaking projects and providing leadership and direct oversight to a multidisciplinary staff of clinicians, social scientists, pharmacologists and regulatory project managers. Dr. Segal worked collaboratively on OTC development programs with each of the Prescription Review Divisions within The Office of New Drugs, except for the Office of Oncology Drug products. Consequently, she has provided oversight in trial design spanning a broad variety of different medical topics in both prescription and OTC regulatory paradigms. In addition, she worked on many FDA committees focused on policy development and organized and ran meetings of the Nonprescription Drug Advisory Committee for FDA. Dr. Segal is a board-certified internist and rheumatologist and Associate Clinical Professor of Medicine at the George Washington University School of Medicine and Health Sciences. Prior to her years at FDA, she was in the Division of Rheumatology at the Washington VA Medical Center which was part of the Georgetown University Division of Rheumatology. In her capacity as an attending physician, she saw patients, taught Georgetown University rheumatology fellows, and engaged in clinical research including as an investigator in clinical pharmaceutical trials, and reviewed protocols for the hospital Institutional Review Board. She continues to see patients and teach medical students and residents at the GWU Center for Integrative Medicine. Dr. Segal is a graduate of the University of Michigan and graduated with distinction from the George Washington School of Medicine and Health Sciences where she was elected to the Alpha Omega Alpha Honorary Medical Society.