Soligenix, Inc. announced the appointment of Timothy R. Coté, M.D., M.P.H. to its Board of Directors. Dr. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Centers for Disease Control (CDC), Dr. Coté served as the Director of the FDA Office of Orphan Products Development (OOPD) from September 2007 to May 2011.

In this role, he implemented the U.S. Orphan Drug Act and personally signed decisions on more than 1,400 orphan drug designation applications. After leaving FDA, Dr. Coté founded Cote Orphan (with a consultancy of 450 clients), where he served as Chief Executive Officer (CEO) until its sale in 2017 to IQVIA for $20 million. He is currently CEO of Only Orphans Cote LLC, a regulatory affairs consulting firm leveraging his expertise and commitment to delivering drugs for rare diseases.

He also serves as the CEO of Silk Road Therapeutics, a privately held rare disease company from which Soligenix recently acquired an exclusive option to purchase a novel topical formulation of Pentoxifylline (PTX), a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient's suffering from Behçet's Disease. Dr. Coté received his bachelor's degree from Syracuse University, a medical doctorate from the Howard University College of Medicine and a master's degree in Public Health from Harvard School of Public Health. An anatomic pathologist and medical epidemiologist, he has published 80 peer-reviewed articles on areas as diverse as HIV/AIDS-related malignancies, typhoid fever epidemics, and the impact of bicycle helmet laws on injury statistics.