Timothy R. Coté , MD, MPH
Coté Orphan - Principal & CEO
Dr. Timothy R. Coté is a leading national regulatory expert in orphan drug development. With 22 years of Federal service at the FDA, NIH, and CDC, Dr. Coté most recently served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept 2007 – May 2011. He was instrumental in implementing the Orphan Drug Act and was the authorizing signator to over 800 orphan drug designations in his time at the Agency.
COTÉ CURRICULUM BY TIM COTÉ
• Essentials of Orphan Drug Designation
• Pediatric/Tropical Rare Disease Priority Review Voucher (PRV)
• Breakthrough Therapies for Orphans
• Special Tenderness Offered to Orphans by the FDA Review Divisions
WHO SHOULD ATTEND
Coté Orphan Boot Camp: London will include key players of the regulatory affairs industry. Attendees will learn first-hand how orphan drugs are managed with special deference by regulatory agencies such as the FDA and EMA. This one-day seminar is a unique and free opportunity to hear from the former head of the FDA orphanage just how things are viewed from the inside.