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.
That single 50 minuet session with FDA means so much for your company and the people who (might) get your drug. Find out how to prepare for it and especially how NOT to over-prepare!