Garvey Associates, Inc.

Background Information

Thomas Q. Garvey III, MD

Dr. Garvey has been designing and analyzing clinical trials and programs of clinical trials for drugs, biologics, and medical diagnostics since founding Garvey Associates, Inc. (GAI) in 1981. Dr. Garvey received his B.A. from Harvard College, his M.D. from New York University, and his training in internal medicine at Roosevelt Hospital in New York City and Georgetown University Hospital in Washington, DC. He spent 3 years as a Research Fellow in the Laboratory of Biochemistry in the National Cancer Institute and received his training in Gastroenterology at the Massachusetts General Hospital in Boston.

After completion of his training in Gastroenterology, Dr. Garvey returned to the National Institutes of Health in the Digestive Diseases Branch of the National Institute of Diabetes, Digestive and Kidney Diseases. He became a guest investigator there and at Georgetown University School of Medicine when he joined the Food and Drug Administration, where he served for 5 years as Supervisory Medical Officer in the Division of Cardio-Renal Drug Products (HFD-110). He left FDA in 1981 to start Garvey Associates, Inc. Until December, 2010, he also maintained a small practice of Internal Medicine and Gastroenterology.

Dr. Garvey has been involved in the development and composition of many New Drug Applications (NDAs) and Investigational New Drug (IND) Exemption submissions for gastroenterologic (e.g., histamine H2 inhibitors, proton pump blockers, bile acids, antidiarrheals, laxatives, drugs for inflammatory bowel disease and irritable bowel syndrome, over-the-counter [OTC] drugs for heartburn and other indications), cardiovascular (e.g., antihypertensives, antiarrhythmics, inotropes), endocrinologic (e.g., hypolipidemics, oral hypoglycemics), oncologic (e.g., cytolytics, growth factor antagonists), neurologic (e.g., drugs for attention deficit hyperactivity disorder [ADHD], migraine headaches, sleep disorders, schizophrenia and bipolar disorders) urologic (e.g., drugs for "overactive bladder"), respiratory, pain, imaging agents and other classes of drugs and diagnostics. He has up-to-date, practical, in-depth, working knowledge of FDA's Center for Drug Evaluation and Research (CDER) requirements, procedures, philosophy and personnel, and considerable experience with FDA's Center for Biologics Evaluation and Research (CBER), and with the Center for Devices and Radiological Health (CDRH).

Dr. Garvey is frequently asked to assess safety data for drugs in development and for approved drugs and often assists in developing labeling for new drugs and in modifying labeling for approved drugs. He has a special interest in and long experience with drug-related hepatotoxicity. He is in regular contact with most of the drug reviewing divisions at FDA's Center for Drug Evaluation and Research (CDER) and has worked with many of the divisions in the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH). Current projects for GAI include NDA development programs for drugs for sleep disorders, diabetic retinopathy, and dental analgesia; and for several OTC analgesic and gastrointestinal drugs.

E-mail: Thomas Q. Garvey III, MD

Curriculum Vitae