Dr. Timothy R. Coté, MD MPH, is a renowned national regulatory expert in orphan drug regulatory affairs. He is founder and CEO at Only Orphans Cote with offices in Cambridge MA and Washington DC, leading a select team of experts in rare diseases and orphan drug regulatory affairs strategy. As former Director of the Office of Orphan Product Development (OOPD) at FDA, between 2007 – 2011, Dr. Cote led the agency’s efforts in implementing the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications. Dr. Coté received a bachelor’s degree from Syracuse University, his medical doctorate from the Howard University College of Medicine and a Master of Public Health (MPH) from the Harvard School of Public Health.
