Timothy R. Coté

Founder & CEO

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Dr. Timothy R. 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 recently 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. A Board Certified 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. Dr. Coté is founder and CEO at Cote Orphan; he directs and trains staff to create compelling regulatory submissions that are finely tuned to each client’s business strategy and to the unwritten rules within the FDA.

Dr. Coté received a 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.