Dr. Timothy R. Coté, MD MPH, is a renowned national regulatory expert in orphan drug regulatory affairs. He is founder and CEO at Only Orphans Cote with offices in Cambridge MA and Washington DC, leading a select team of experts in rare diseases and orphan drug regulatory affairs strategy. As former Director of the Office of Orphan Product Development (OOPD) at FDA, between 2007 – 2011, Dr. Cote led the agency’s efforts in implementing the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications. Dr. Coté received a bachelor’s degree from Syracuse University, his medical doctorate from the Howard University College of Medicine and a Master of Public Health (MPH) from the Harvard School of Public Health.

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Founder and CEO • Only Orphans Cote LLC • (June 2021- Present)
Orphan drug regulatory affairs consultancy that exclusively works with anything related to orphan products.

Founder and CEO • Silk Road Therapies LLC • (March 2018- Present).
Founded a biotech to create a new therapy for Behcet’s Disease; formulated product and conducted highly successful 41-person Phase 2 trial under FDA IND in Istanbul, Turkey; secured FDA orphan drug designation, fast track status, and conducted numerous FDA regulatory meetings

Founder and CEO • Coté Orphan, LLC • (May 2012 -June 2017).
Established sole-ownership, boutique consultancy in orphan drug regulatory affairs; Provided services in orphan product regulatory affairs for start-ups, biotech, large pharma; grew business to $7MM annual revenues, 450 clients; business acquired by IQVIA

Director • Office of Orphan Products Development, FDA•(September 2007-June 2011)
▪ Implemented the Orphan Drug Act (designed to create therapies for the estimated 8,000+ rare diseases)
▪ Led Congressional briefings on behalf of his office, administered a budget of $18M and supervised 45 professionals
▪ Formal representative of FDA in meetings with European regulatory agencies responsible for orphan drugs.
▪ Speaking engagements to multinational pharmaceutical industry, patient advocacy groups, and academic innovators
▪ Responsible for final decisions related to 1,400 applications for orphan drugs eligible for economic benefits of orphan designation
▪ Welcomed 200 new orphan drug marketing organizations
▪ Oversaw grants awards, management processes and human subject’s protection efforts
▪ Developed new initiative for the development of therapies for neglected tropical diseases.