Timothy Coté

Timothy R. Coté, MD, MPH (AKA Tim Coté), is an American doctor, expert of infectious and neoplastic disease, and a former Director of the Office of Orphan Products Development (OOPD) at the Food and Drug Administration (FDA).

Dr. Coté has worked for a number of organizations throughout his career, holding numerous positions of note.

At the Center for Disease Control and Prevention (CDC), Dr Coté acted as the Country Director for Rwanda. While stationed in Rwanda, he directed programs in HIV/AIDS, malaria and avian influenza, and was responsible for scientific and administrative leadership in patient care and research initiatives. He also oversaw the President's Emergency Plan for AIDS Relief (PEPFAR) operations in Rwanda. Under his leadership, the numbers of HIV-infected individuals receiving anti-retroviral medications from the United States rose from 20,000 to 55,000 persons.

Within the CDC Dr. Coté also held the positions of Epidemic Intelligence Officer at the Maryland Health Department. He also acted as a senior federal adviser for the CDC at the District of Columbia Health Department.

At the FDA, Dr. Coté was appointed to the role of Director of the Office of Orphan Products Development (OOPD). During his time leading the OOPD Dr. Coté was "instrumental in implementing the Orphan Drug Act" oversaw the approval of approximately 680 orphan designations. Dr. Coté also developed a much stronger relationship between the FDA and the European Medicines Agency (EMA) by harmonizing communications and standards for orphan regulations. At the time saying, "We both recognize that it's the same science, the same patients and the same companies that we're working with..." During his time as Director, Dr. Coté also sought to accelerate orphan drug development, as well as, modernize FDA systems to facilitate the approval of new therapies for individuals with rare diseases.

Prior to his role as Director of OOPD, Dr. Coté had worked as its chief of the Therapeutics and Blood Safety Branch in the Center for Biologics Evaluation and Research, office of Biostatistics and Epidemiology. A position for which he received considerable praise from former Surgeon General Richard Carmona.

After leaving the FDA, Dr. Coté served as the Chief Medical Officer for the National Organization for Rare Disorders (NORD). He also held the position of Professor of Regulatory Practice at the Keck Graduate Institute (KGI).

Currently Dr. Coté runs the regulatory affairs consulting firm Coté Orphan LLC, based in Silver Spring, MD. The firm specializes in orphan drug regulatory affairs and has worked with over 300 pharmaceutical and biotechnology companies.

Dr. Coté received his Bachelor of Arts in biology and psychology from Syracuse University.

He earned his Medical Degree from Howard University College of Medicine.

Additionally he has earned a masters in public health from the Harvard School of Public Health.

Dr. Coté is married to Dina Coté and has three children, Gabriel, Sophia, and Calvin.

Dr. Coté is a licensed pilot. He is also and avid boater and enjoys duck hunting.