Biography
Biography: Timothy R Cote
Abstract
All too often, creators of new therapies for people with rare diseases will expend vast resources on drug discovery, manufacturing, clinical key opinion leaders and of course raising money but ignore regulatory affairs, assuming that will just itself somehow work out. In this presentation, Dr. Cote, previous Director of the FDA orphan drug office, will discuss the intricacies of the orphan drug designation in the US and in Europe, preparing for a winning pre-IND meeting, crafting clinical trials that make sense to regulators, special incentives like breakthrough therapy designation, the pediatric rare disease designation and the PRIME program will also be demystified.
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