Emmaus Medical, a specialty pharmaceutical and regenerative medicine company, has appointed Timothy Cote, M.D., MPH, former director of the Office of Orphan Product Development of the FDA, as its regulatory advisor. Cote will advise Emmaus on the regulatory pathway for the company's sickle cell disease treatment.
Cote is a national regulatory expert in orphan drug development. As a part of 22 years of federal service at the FDA, National Institutes of Health (NIH) and Centers for Disease Control (CDC), he served as the director of the FDA Office of Orphan Products Development (OODP) from 2007 to 2011. The OODP is the FDA's primary interface with companies seeking orphan designation for drug and device products or seeking guidance in navigating FDA processes in reviewing orphan products. He was instrumental in implementing the Orphan Drug Act and personally signed more than 800 orphan drug designations in his time at the Agency.
Cote also has served as senior federal advisor to the director, D.C. Department of Health; branch chief, therapeutics and blood safety, FDA Center for Biologics Evaluation and Research (CBER); and medical director, cancer statistics branch, National Cancer Institute. In 2011 he was the CMO for the National Organization for Rare Disorders (NORD). Currently, he is the professor of regulatory practice at the Keck Graduate Institute in Claremont, Calif., and principal of Cote Orphan Consulting.