Charles Gorodetzky, MD, PhD

After obtaining his BS at M.I.T. in 1958, Dr. Gorodetzky earned his MD at Boston University School of Medicine (1962) and a PhD in Pharmacology from the University of Kentucky Medical Center (1975). He served for 21 years as a USPHS Officer in the intramural NIH research program at the NIDA (formerly NIMH) Addiction Research Center in Lexington, KY; and he was the last Director of that facility (from 1981-84). His major research interests were the clinical pharmacology and metabolism of drugs of abuse, with extensive work in the development and clinical application of urine screening methodology. He served on the FDA’s Drug Abuse Advisory Committee from 1978-83. He entered the pharmaceutical industry in 1984, and has worked for the next 21 years in Clinical Development primarily of CNS drugs. He has held positions as Section Head at Burroughs Wellcome, Executive Director at Ciba Geigy, Medical Director at Cygnus Therapeutic Systems, and Vice President at Hoechst Marion Roussel (and Marion Merrill Dow), serving as Global Head of CNS Development, Head of Clinical Research North America and North American Medical Advisor. He joined Quintiles as a Vice President in Jan. 1999 and held the positions of Deputy Department Head and Head, Neurology Team; and Central Region Medical Director, Department of Medical and Scientific Services, QAMR until his retirement in 2005. He served on the NIDA Medications Development Initial Review Group (NIDA-E, then NIDA-L) from 1996-2003 and is a frequent consultant to NIDA. He is a member of many scientific societies and is particularly active in the College on Problems of Drug Dependence (CPDD), in which he is a Charter Fellow. He has served 2 elected terms on the Board and has chaired the Rules Committee since 1978.

Dr. Gorodetzky has had extensive experience in development, conduct and management of Phase I-IV clinical trials, preparation of INDs and NDAs, and preparation and presentation to FDA Advisory Committees and the CPMP (Oral Explanation). His clinical trial experience includes epilepsy; smoking cessation (gum and transdermals); abuse liability; substance abuse treatment (including opiates, alcohol, cocaine and methamphetamine); antipsychotics; antidepressants; anti-stroke medications; Alzheimer’s drugs; anti-tuberculosis drugs; and hormone replacement (transdermals). Since March 2005 he has been actively engaged as a Consultant in Pharmaceutical Medicine and is currently Medical Monitor on major trials in treatment of opioid withdrawal and treatment of the neurological illness Lambert Eaton Myesthenic Syndrome (LEMS).