Internationally experienced neuropsychopharmacologist. Special expertise in psychotherapeutic drug development, including preclinical (pharmacology, pharmacokinetics, toxicology), clinical (trial design, implementation, monitoring) and regulatory (IND/NDA preparation and submission to FDA). Current research emphasis is the neuropharmacology, clinical application, and interaction potential of novel compounds, nutritional supplements (especially omega-3 essential fatty acids), and botanicals for their potential use in the prevention and treatment of mental disorders. Initiated the NIH controlled clinical trials for hypericum in major depression and for ginkgo in dementia. 

Education:

B.S. 1969 Central State University, Edmond, Oklahoma, 1965-1969. Chemistry/Biology major

Ph.D. 1975 University of North Carolina at Chapel Hill, Department of Pharmacology, 1971-1975. Pharmacology major, Neurobiology minor. Member Sigma Xi. Predoctoral Research Associate - George Breese, Ph.D., advisor. Thesis: Investigations into the mechanism of reduction of ethanol-induced sleep by thyrotropin-releasing hormone (TRH)

Postdoctoral 1976 Swedish Medical Research Council Fellow: 1975-1976, University of Göteborg, Department of Pharmacology, Göteborg, Sweden. Arvid Carlsson, M.D., director (Nobel Prize for Physiology & Medicine, Oct. 2000). Research: Investigations into the involvement of central GABAergic systems with ethanol and psychostimulant-induced locomotor activity

Professional Experience:

U.S. Food and Drug Administration (FDA),Silver Spring, Maryland   1/03-present : Review Pharmacologist/Toxicologist - Center for Drug Evaluation and Research, Division of Anesthesia, Analgesia & Rheumatology Products, 10903 New Hampshire Ave., Bldg 22, Room 3134, Silver Spring, MD 20993-0002, Tel: 301/796-1194; Fax: 301/796-9723; E-mail: Jerry.Cott@fda.hhs.gov;  Review pharmacology and toxicology sections of new drug applications.  Liaison to FTC (Federal Trade Commission) regarding medical claims of supplement manufacturers.  CoChair, CDER Botanicals Subcommittee.  Visiting lecturer, Tai Sophia Institute, Laurel, Maryland.

Psychopharmacology Consulting Services, College Park, Maryland 6/00-1/03 Research Pharmacologist: Scientific advisor to the health professions.  Interface with variety of healthcare professionals on issues related to mental health, herb-drug interactions, etc.  Provide CME training to physicians, psychiatrists, pharmacists, psychologists, and nurses.  

National Institute of Mental Health, Rockville, Maryland 3/91-5/00 –Chief, Adult Psychopharmacology Research Program (10/97-6/00); Chief, Pharmacologic Treatment Research Program (8/93-9/97); Chief, Psychotherapeutic Drug Discovery & Development Program (3/91-8/93). Development and administration of these new programs to promote research and development of novel treatments (especially natural products) for potential use as psychotherapeutic medications or adjuncts by means of extramural research grants, contracts, and workshops. Conceived and published NIMH Program Announcement PA-92-15: Psychotherapeutic Drug Discovery and Development Program. Conceived and received approval and funding for the September, 1998 NIH international workshop: "Omega-3 Essential Fatty Acids and Psychiatric Disorders" and three original NIMH clinical trial contracts: "Hypericum in the Treatment of Major Depression," the NIMH "Systematic Treatment Effectiveness Program (STEP) for Bipolar Disorder" and "Verapamil in the Treatment of Females with Bipolar Disorder."

Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut 10/88-3/91 –  Senior Principal Scientist: Supervision of the Toxicology Department's Safety Assessment Program. Responsibilities included review and evaluation of all preclinical reports from in-licensed drugs; product development from a preclinical regulatory/safety evaluation perspective; strategic planning; report generation for the preclinical sections of the IND/NDA; project team representation; Medical/Regulatory liaison and safety/risk assessments of all externally acquired drug candidates; contracting of supplemental toxicity testing performed to support product registration; supervision of the Research Data Center staff and activities.

Bristol-Myers Company, Wallingford, Connecticut 1984-1988  Senior Research Scientist/Project Leader - Responsible for the clinical development of a novel CNS drug from early Phase I to early Phase III; coordination of project team activities (toxicology, production, formulation, packaging, etc.). Initiated setup of first remote data entry trial at Bristol-Myers/Ct. Initiated use of in-house computer graphics capability. Initiated development of slow-release formulations for gepirone/buspirone. Successfully promoted the investigation of two compounds for a new indication, leading to 3 patents.

U.S. Food & Drug Administration, Rockville, Maryland 1980-1984 – Review Pharmacologist - Reviewed pharmacology, toxicology and clinical portions of INDs and NDAs for approval of clinical trials with investigational psychotherapeutic drugs.

Astra Pharmaceutical Company, Södertälje, Sweden 1978-1980 – Research Pharmacologist: Responsible for preclinical evaluation of behavioral interactions between investigational antidepressants and CNS depressants. Later worked in clinical research and liaised with marketing division. Identified early warning signs of clinical toxicity potential for zimelidine. Demonstrated an unsuspected mechanism for potentially toxic interaction of antidepressants with ethanol.

University of Ibadan, Department of Pharmacology, Ibadan, Nigeria 1976-1978 – Lecturer I - Taught CNS portion of pharmacology curriculum for schools of Medicine, Dentistry and Pharmacology. Responsible for graduate student supervision and research. Developed graduate pharmacology curriculum.