“Dr. Coté is the leading national regulatory expert in orphan drug development. With 22 years of Federal service at the FDA, NIH, and CDC, Dr. Coté most recently served as the Director of the FDA Office of Orphan Products Development (OODP) from Sept 2007 — May 2011. Dr. Coté was instrumental in implementing the Orphan Drug Act and personally signed over 800 orphan drug designations in his time at the Agency.
Currently, Dr. Coté runs a consulting firm in addition to being the Professor of Regulatory Practice at the Keck Graduate Institute in Claremont, California and co editor of two journals focused on rare diseases (with Dr. M. Ian Phillips).
Cote Orphan Consulting helps companies understand FDA operations as they affect their company and provide advice regarding strategic planning and execution in regulatory affairs for orphan drugs.
In this exclusive interview with Rare Disease Report, Dr. Cote explained the reasons why orphan drugs are currently being well studied and marketed in the United States.
For more information about his consulting firm, visit coteorphan.com (Source: Rare Disease Report)