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Timothy R Cote


Timothy R Cote

Cote Orphan LLC, USA

Biography

Timothy R Cote is a leading national Regulatory Expert in orphan drug development with 23 years of Federal Service at the FDA, NIH and CDC. He has recently served as the Director of the FDA Office of Orphan Products Development (OOPD) from 2007-2011. As an Anatomic Pathologist and Medical Epidemiologist, he has published 80 peer-reviewed articles on areas as diverse as HIV/AIDS-related malignancies, typhoid fever epidemics and the impact of bicycle helmet laws on injury statistics. He is the Founder and CEO of Cote Orphan; where he directs and trains staff to create compelling regulatory submissions that are finely tuned to each client's business strategy and to the unwritten rules within the FDA. He has received his Bachelor's degree from Syracuse University, Medical Doctorate from the Howard University College of Medicine and a Master's degree in Public Health from Harvard School of Public Health.

Abstract

Abstract : Inside track to an orphan designation

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