Timothy R. Coté is an American doctor, expert of infectious and neoplastic disease,[1] and a former director of the Office of Orphan Products Development (OOPD) at the Food and Drug Administration (FDA).
Timothy R. Coté | |
|---|---|
 | |
| Director of the Office of Orphan Products Development | |
| In office September 2007 – June 2011 | |
| Preceded by | Marlene Haffner |
| Succeeded by | Gayatri R. Rao |
Professional career
editCoté has worked for a number of organizations throughout his career, holding numerous positions of note.
At the Centers for Disease Control and Prevention (CDC), Coté acted as the Country Director for Rwanda. While stationed in Rwanda, he directed programs in HIV/AIDS, malaria and avian influenza, and was responsible for scientific and administrative leadership in patient care and research initiatives. He also oversaw the President's Emergency Plan for AIDS Relief (PEPFAR) operations in Rwanda. Under his leadership, the numbers of HIV-infected individuals receiving anti-retroviral medications from the United States rose from 20,000 to 55,000 persons.[2]
Within the CDC, Coté also held the positions of Epidemic Intelligence Officer at the Maryland Health Department. He also acted as a senior federal adviser for the CDC at the District of Columbia Health Department.[2]
At the FDA, Coté was appointed to the role of Director of the Office of Orphan Products Development (OOPD). During his time leading the OOPD, Coté was "instrumental in implementing the Orphan Drug Act"[3] oversaw the approval of approximately 680 orphan designations.[4] Coté also developed a much stronger relationship between the FDA and the European Medicines Agency (EMA) by harmonizing communications and standards for orphan regulations. At the time saying, "We both recognize that it's the same science, the same patients and the same companies that we're working with..."[5] During his time as Director, Coté also sought to accelerate orphan drug development,[6] as well as, modernize FDA systems to facilitate the approval of new therapies for individuals with rare diseases.[7]
Prior to his role as Director of OOPD, Coté had worked as its chief of the Therapeutics and Blood Safety Branch in the Center for Biologics Evaluation and Research, office of Biostatistics and Epidemiology.[8] A position for which he received considerable praise from former Surgeon General Richard Carmona.[9]
After leaving the FDA, Coté served as the Chief Medical Officer for the National Organization for Rare Disorders (NORD).[10] He also held the position of Professor of Regulatory Practice at the Keck Graduate Institute (KGI).[3][11]
Coté ran a regulatory affairs consulting firm Coté Orphan LLC, based in Silver Spring, MD. The firm specializes in orphan drug regulatory affairs and has worked with over 300 pharmaceutical and biotechnology companies.[12] Cote Orphan has a score of 1.8 on Glassdoor and numerous employee reviews specifically referring to Cote.[13]
On June 2, 2017 Cote Orphan was purchased by QuintilesIMS[14] subsequently Cote separated from the company and now refers to himself as an independent entrepreneur.[15]
Education
editCoté received his Bachelor of Arts in biology and psychology from Syracuse University.[2] He earned his Medical Degree from Howard University College of Medicine.[1] Additionally he has earned a masters in public health from the Harvard School of Public Health.[2]
Personal life
editCoté is married to Dina Coté and has three children, Gabriel, Sophia, and Calvin. Coté is a licensed pilot.[citation needed]
References
edit- ^ a b "Archived copy" (PDF). csdd.tufts.edu. Archived from the original (PDF) on 11 June 2010. Retrieved 17 January 2022.
{{cite web}}: CS1 maint: archived copy as title (link) - ^ a b c d Commissioner, Office of the. "2007 - FDA Appoints Coté to Head Orphan Products Development Office". Food and Drug Administration.
- ^ a b "Former FDA Official Tim Cote JoinsEmmaus Medical Inc as Regulatory Advisor".
- ^ "Search Orphan Drug Designations and Approvals".
- ^ Torres, Christian (1 March 2010). "Rare opportunities appear on the horizon to treat rare diseases". Nat Med. 16 (3): 241. doi:10.1038/nm0310-241. PMID 20208483. S2CID 1332461.
- ^ Coté, Timothy R.; Xu, Kui; Pariser, Anne R. (1 December 2010). "Accelerating orphan drug development". Nat Rev Drug Discov. 9 (12): 901–902. doi:10.1038/nrd3340. PMID 21119719. S2CID 43668080.
- ^ Xu, Kui; Coté, Timothy R. (1 July 2011). "Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases". Brief Bioinform. 12 (4): 341–345. doi:10.1093/bib/bbr006. PMID 21357612 – via bib.oxfordjournals.org.
- ^ "Cote named as FDA director of orphan product development". Archived from the original on 2016-08-13. Retrieved 2016-06-23.
- ^ "Meeting Our Nation's Important Public Health Challenges: Transformation of the Public Health Service Commissioned Corps, Testimony Before the Committee on Government Reform, October 30, 2003". Archived from the original on August 28, 2016. Retrieved June 23, 2016.
- ^ "#PhRMA12 Conversations: Dr. Tim Cote - PhRMA".
- ^ "Since July 2011, Timothy Cote MD MPH has served half the time as the Chief Medical Officer for the National Organization for Rare Disorders (NORD) and the other half as Professor of Regulatory Practice for the Keck Graduate Institute (KGI) in Claremont, California. Prior to these appointments he was Director of FDA's Office of Orphan Products Development for four years. - Image - Pharmaceutical Technology".
- ^ "Home". Archived from the original on 2016-07-06. Retrieved 2016-06-23.
- ^ "Coté Orphan Consulting Reviews".
- ^ "Coté Orphan, a QuintilesIMS company". LinkedIn.
- ^ "Timothy Cote - Independent Entrepreneur - Self Employed | LinkedIn".