Fast Track, Accelerated Approval, Breakthrough Therapy & PRVs (IN PERSON)

245 First Street,Cambridge MA 02142

21 October, 2021

Description

Regulatory Edutainment from Timothy Cote MD MPH Got an idea for a new drug for a wicked rare disease? How do you move from idea to fantasy to pharmacy? More specifically, who are those people at the FDA and how can you best engage with them without losing momentum? Timothy Cote MD MPH is the newly-arrived Entrepreneur-in-residence at the Forsyth Institute, based in Cambridge MA. He will be hosting a monthly en vivo cum en silico seminar series to discuss topics in orphan drug development with an emphasis on regulatory affairs in the US and Europe. With more than 15 years of experience in the field, Dr. Cote was previously the Director of FDA’s Office of Orphan Products Development. In that capacity he personally signed 1,400 orphan drug designation decisions and saw 140 orphan drugs go to full marketing authorization. FDA has some special perks of extraordinary value. Learn how you qualify, what they give you and how to apply.