Timothy R. Coté, MD, MPH

Professor of Practice, Regulatory Affairs
Areas of Expertise
Drug Regulation, Epidemiology, Public Health Practice, Tropical Diseases, Orphan Drugs, Anatomic Pathology
Dr. Coté, a native of New Hampshire, received his undergraduate degree in premedical studies from Syracuse University in 1982 and both his MPH and his MD degrees in 1987 from the Harvard School of Public Health and the Howard University College of Medicine, respectively.  In May of 2011, he retired from 23 years of federal service at nine different positions as a US Public Health Service officer (CAPT, ret) at CDC, NIH and FDA.  He is board-certified in both Public Health and Preventive Medicine and Anatomic Pathology.  Most recently, he served for four years as the Director of FDA's Office of Orphan Products Development, where he oversaw a staff of 45 physicians, pharmacists and other professionals and a budget of $17M in implementation of the US Orphan Drug act.  Since July 1, 2011, Dr. Coté serves two half-time positions-resident Chief Medical Officer at the National Organization for Rare Disorders and Professor of Regulatory Practice at KGI.
ALS 400
Team Masters Project
The Team Masters Project (TMP) is the capstone activity for second-year Master of Bioscience (MBS) students and for Postdoctoral Professional Masters (PPM) students. It is assigned 2-course credits each semester for a total of 4 course credits and a passing grade in both semesters is required for graduation with an MBS or PPM degree.
ALS 432
Writing an Orphan Drug Designation
This course will equip students with an understanding on how to write an orphan drug designation application. The course will begin with a FDA Workshop on September 13, 2010 on how to write an orphan drug designation application. This workshop will be held at KGI and conducted by Dr. Matthew Thomas from the FDA. Students will receive further information from Dr Phillips on how to write their own orphan drug applications.
ALS 462
Introduction to US Food and Drug Law
This course will provide students with broad general competencies in regulatory affairs for all FDA-regulated product classes (drugs, biologics and devices) throughout the product lifecycle (pre-clinical development, clinical development and post marketing).

Lee E, Ferguson D, Jernigan D, Greenwald M, Cote T, Bos J, Guarner J, Zaki S, Schucat A, Beall B, et al. "Invasive group-A streptococcal infection in an allograft recipient. A case report." J.Bone Joint Surg.Am. 2007;9:2044-7

Cote T, Kelkar A, Xu K, Braun M, Phillips M, I. "Orphan products: an emerging trend in drug approvals." Nature Reviews Drug Discovery 2010;9(1):84-U11

Braun M, Farag-El-Massah S, Xu K, Cote TR. "Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years." Nature Reviews Drug Discovery 2010;9(7):519-22

Talele SS, Xu K, Pariser AR, Braun M, Farag-El-Massah S, Phillips M, I, Thompson BH, Cote TR. "Therapies for Inborn Errors of Metabolism: What Has the Orphan Drug Act Delivered?" Pediatrics 2010;126(1):101-6

McNeil D, Davis C, Jillapalli D, Targum S, Durmowicz A, Cote TR. "Duchenne Muscular Dystrophy: Drug Development and Regulatory Considerations." Muscle & Nerve 2010;41(6):740-5

Freeman SN, Burke KA, Imoisili MA, Cote TR. "The Orphan Drug Act and the Development of Stem Cell-Based Products for Rare Diseases." Cell Stem Cell 2010;7(3):283-7

Burke K, Freeman S, Imoisili M, Cote T. "The Impact of the Orphan Drug Act on the Development and Advancement of Neurological Products for Rare Diseases: A Descriptive Review." Clinical Pharmacology & Therapeutics 2010;88(4):449-53

Cote TR, Xu K, Pariser AR. "Accelerating orphan drug development". Nature Reviews Drug Discovery 2010;9(12):901-2

Timothy R. Coté

Contact Information

Timothy R. Coté, MD, MPH
Location: Building 517, Room B142
Phone: (909) 607-0171
tim_cote[at symbol]kgi.edu
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