Former FDA Official Tim Coté Joins KGI Faculty
A former high-level official with the U.S. Food and Drug Administration (FDA) will join Keck Graduate Institute's (KGI) faculty in July, bringing extensive knowledge and experience in clinical regulatory affairs.
Dr. Tim Coté, former director of the FDA's Office of Orphan Products Development, will split his time between teaching at KGI and serving as chief medical officer for the National Organization for Rare Disorders (NORD).
"I was attracted to KGI because it is one of the only academic institutions active in the orphan drug sphere," said Coté, who recently retired after 22 years with the federal government, including eight years at the FDA.
Coté is no stranger to KGI, having worked on special workshops with the Center for Rare Disease Therapies, which is dedicated to promoting the development of orphan drug therapies that target rare diseases affecting nearly 30 million Americans or approximately 1 out of 10 people.
"This is really a big advance for KGI in terms of capability and visibility, adding someone like Tim who has such extensive and recent experience at the FDA," said KGI President Sheldon M. Schuster, PhD, who also serves on the NORD Board of Directors. "His appointment brings not only awareness from outside KGI but also brings a level of experience that's going to be available for our students that nothing else can match."
Coté began his association with the Center for Rare Disease Therapies four years ago when he and his staff started conducting a series of workshops for students on how to write an orphan drug designation application.
What started out as an academic exercise for KGI students led to a series of two-day workshops in which FDA officials met with pharmaceutical and biotech companies, academics and patient advocates and walked them through the orphan product application process step-by-step. The first industry workshop, held at KGI in February 2010, resulted in 18 applications being filed.
The workshops, designed to simplify and demystify the orphan designation application process, were a historic step for the FDA and reflected Coté's desire to interact with academia and develop partnerships to benefit people with rare diseases. It was the first time that the FDA had sent so many people outside Washington, DC, to assist companies and individuals in preparing orphan drug designation applications.
Ian Phillips, PhD, KGI's Norris Professor of Applied Life Sciences and director of the Center for Rare Disease Therapies, said, "Dr. Tim Coté is highly respected in the rare disease community and brings enormous stature, experience and connections in the orphan drug and FDA regulation fields. With his reputation, teaching ability and knowledge, I look forward to working with Tim to elevate the Center for Rare Disease Therapies to a higher level."
By Elaine Regus