Timothy Cote

About Timothy Cote

Dr. Timothy R. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the FDA, NIH, and CDC, Dr. Coté recently served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept 2007 – May 2011. In this role he implemented the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications. An anatomic pathologist and medical epidemiologist, he has published 80 peer-reviewed articles on areas as diverse as HIV/AIDS-related malignancies, typhoid fever epidemics, and the impact of bicycle helmet laws on injury statistics. Dr. Coté is founder and CEO at Cote Orphan; he directs and trains staff to create compelling regulatory submissions that are finely tuned to each client\'s businessDr. Coté received a bachelor\'s degree from Syracuse University, a medical doctorate from the Howard University College of Medicine and a master\'s degree in Public Health from Harvard School of Public Health.

Experience

1. CEO

   Only Orphans Cote Llc

   Jun 2021 — Present

Education

• Harvard T.H. Chan School of Public Health

  Master of Public Health (MPH), Tropical Public Health

  1984 — 1985

Skills

• Pharmaceutical Industry
• Fda
• Life Sciences
• Biotechnology
• Orphan Drugs
• Regulatory Affairs
• Lifesciences
• Research
• Oncology
• Vaccines
• Infectious Diseases
• Laboratory
• Drug Development
• Cancer
• Biopharmaceuticals
• Hospitals
• Market Access
• Public Health
• Clinical Trials
• Strategic Planning
• Regulatory Submissions
• Data Analysis
• Healthcare
• Clinical Development
• U.s. Food and Drug Administration (Fda)
• Biostatistics
• Medicine
• Epidemiology
• Medical Devices
• Clinical Research