Timothy R. Coté, MD, MPH
Principal & CEO
Timothy R. Coté MD MPH is one of the leading regulatory experts in orphan drug development dedicated to assisting biotech and pharmaceutical companies through regulatory hurdles in the US and EU and specializing in helping clients obtain orphan status designation for their therapeutics.
He has worked in the field for over two decades and has acquired extensive specialized knowledge of rare diseases and orphan drugs. He is a Professor of Regulatory Practice at the Keck Graduate Institute, where he also co-directs the KGI Center for Rare Disease Therapies and co-edits the Journal of Rare Diseases and Orphan Drugs
Prior to establishing Coté Orphan Consulting, Dr. Coté served as Chief Medical Officer for the National Organization for Rare Disorders (NORD) and as the Director of the FDA’s Office of Orphan Product Development. In these positions, he advanced NORD relationships with industry, Congress, FDA and member groups and oversaw a staff of 45 and a budget of $17M in implementation of the US Orphan Drug act. Dr. Coté was instrumental in implementing the Orphan Drug Act and personally signed over 800 orphan drug designations during his time at the FDA. Before joining the FDA, Dr. Coté held positions at CDC, NIH and USDA.
Dr. Coté is also a medical doctor trained in Public Health and Anatomic Pathology, with over 70 professional publications chiefly in epidemiology, cancer, HIV/AIDS, and tuberculosis. In 2010, he was the recipient of the William J. Martin II Distinguished Achievement Award, given by the American Thoracic Society to recognize doctors that exhibit exceptional innovative spirits, outstanding leadership skills, an impressive history of public service and a passion for their patients.
He 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.