Timothy R. Coté

Timothy R. Coté has been a director since May 2023. Dr. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the FDA, NIH, and CDC, Dr. Coté served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept 2007 – May 2011. In this role he implemented the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications. After leaving FDA, Dr. Coté founded Cote Orphan (with a consultancy of 450 clients), where he served as CEO until its sale in 2017 to IQVIA for $20m. 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.

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.