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Clinical/Medical Branch
The CMB plans, designs, and implements a comprehensive program that evaluates, in a clinical setting, investigational and marketed medications for their potential value in treating substance abuse disorders. Potential medications are studied in both inpatient and outpatient clinical settings and can be managed through all phases of clinical development (Phases 1-4). The CMB is comprised of clinicians, clinical trials specialists and a statistician. CMB staff design protocols, monitor clinical trials, analyze data, and provide consultation and collaboration to the pharmaceutical industry, academia, and other interested parties regarding projects of mutual interest, study design, and data analysis. In addition, the CMB supports research training of clinicians to expand expertise in clinical research in methods as applied to medications development. The CMB files INDs in collaboration with the Regulatory Affairs Branch.
Clinical Medical Branch Staff Contacts
Ahmed Elkashef, M.D., Chief
301-443-5055
ae8a@nih.gov
A psychiatrist with experience in mental illnesses biology, psychopharmacology, and brain imaging at NIMH, joined DPMCDA in July 1997. Oversees all phases of clinical trials for drugs of abuse, mainly opiates and stimulants. This involves protocols design, project management and neuroimaging studies.
Ann Anderson, M.P.H.
, M.D., Medical Officer
301-435-0767
aa135m@nih.gov
A family practice physician for 12 years, including some obstetrics, then 3 yrs at CDC in fetal alcohol prevention and training to investigate disease clusters and outbreaks. Monitored safety and coordinated development of multi-site trials for NIDA's Clinical Trials Network. Develops and oversees clinical trials for new pharmaceutical treatments for drugs of abuse. Monitors safety and analyzes adverse events. Joined DPMCDA in 1999.
Liza Gorgon, M.A., Clinical Trials Specialist
301-443-1138
lgorgon@nih.gov
Serves as project officer for the National Institute on Drug Abuse / Veterans Affairs Interagency Agreement as well as alternate project officer for clinical operations contracts. Manages data input for the Clinical Trials Portfolio System. Initiates, manages and monitors clinical trials with nine years of experience as a clinical research associate. Joined DPMCDA in 1991.
Barbara Herman, Ph.D., Health Scientist Administrator
301-443-9799
bh78q@nih.gov
Chairs the Compound Identification Committee (CIT) whose main function is to analyize scientific literature for suitable compounds to treat addiction. Serves as Project Officer for clinical trial sites and grants. Serves as a member of the preclinical Opiate Treatment Discovery Program. Ten previous years of experience as principal investigator in clinical pharmacology research in children with psychiatric disorders. Twenty years of academic research experience in preclinical neuropharmacology. Joined DPMCDA in 1992.
Donna Inman, B.S., Clinical Trials Specialist
301-443-1078
di13u@nih.gov
Coordinates and monitors clinical trials. Ensures budget spending compliance of these trials by analyzing, developing, and implementing tracking mechanisms, computing budget projections, and monitoring timelines. Assists the Deputy Director, DPMCDA, with projections, calculations, and reconciliation of DPMCDA budget. 14 years of budget analysis (West Los Angeles VA) and 3.5 years as a NIDA contractor. Joined DTR&D in 2000.
Roberta C. Kahn, M.D., Medical Officer
301-443-2281
rk185s@nih.gov
Specialties of anesthesiology and critical care medicine, with prior service in the Food and Drug Administration in the Division of Anesthesia, Critical Care and Addiction Drug Products. Develops and oversees clinical trials for new pharmaceutical treatments for drugs of abuse. Joined DPMCDA in 2001.
Shou-Hua Li, Ph.D., Mathematical Statistician
301-443-9811
sli1@nida.nih.gov
Oversees experimental design and statistical analyses of clinical trials. Two years of experience in the National Cancer Institute, one year in the George Washington University, and 14 years of experience in the National Institute of Dental Research. Joined DPMCDA in 1992.
Jurij Z. Mojsiak, M.S., Clinical Trials Specialist
301-443-9804
jm200p@nih.gov
Serves as project officer for clinical operations contracts and the National Institute on Drug Abuse/Veterans Affairs Interagency Agreement. Designs, initiates, directs and coordinates multi-center clinical trials. Nine years experience as a hospital-based research pharmacist and six years of experience as a clinical research coordinator and project manager (most recently with Immunomedics, Inc.). Joined DPMCDA in 1992.
Erin Iturriaga, R.N., C.C.R.C.
301 443 1061
ei21g@nih.gov
Serves as a Clinical Trials Nurse Specialist, bringing a strong background in multiple aspects of clinical research, including clinical trials management, education, and regulatory responsibilities. Eight years experience managing neuromuscular clinical trials at UT Southwest Medical Center in Dallas and the UT Health Science Center at San Antonio. Two years experience working at the National Cancer Institute as the Clinical Trials Nurse Specialist and Acting Head of the Protocol Information Office. Joined DPMCDA in 2005.
Clinical/Medical Branch (CMB)
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard
Room 4123, MSC 9551
Bethesda, Maryland 20892-9551
(301) 443-3318
(301) 443-2599 (fax)
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