What We Do:
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.
Staff Biographies and Research Interests:
- Shwe Gyaw, M.D., - Chief, Medical Officer
Provides medical and safety monitoring for NIDA's clinical trials. Involved in planning, design and development of clinical trial protocols and data and safety monitoring plans. Certified Physician Investigator and has worked as a principal investigator/medical director for 6 years with a global contract research organization (PAREXEL) and associate director for 2 years with Pfizer Global Research and Development. Experience in First in Man studies including various monoclonal antibodies and biologics, drug interaction studies, bioequivalent and food effect studies, thorough QT studies, methodology studies and dose titration/dose ranging studies. Board certified in Internal Medicine. Joined DTMC in 2011.
- Liza Gorgon, M.A., - Clinical Trials Specialist
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 DTMC in 1991.
- Shou-Hua Li, Ph.D., - Mathematical Statistician
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 DTMC in 1992.
- Jurij Z. Mojsiak, M.S., - Clinical Trials Specialist
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 DTMC in 1992.
- Tatiana (Tanya) Ramey, M.D., Ph.D. - Medical Officer
A psychiatrist and a physician-scientist coming to NIDA after 15-year career in the pharmaceutical industry at Eli Lilly and Pfizer. Before joining NIDA in 2014, she was an executive director and psychiatry leader at Pfizer’s neuroscience research unit (NSRU) in Cambridge, MA. Dr. Ramey received her U.S. training in psychiatry at Vanderbilt University. She was also an assistant professor of psychiatry at the Moscow State University of Medicine and Dentistry (MSUMD). Her PhD is in psychiatric genetics. Her areas of expertise are addictions, depression, anxiety disorders, cognition and psychoses. She has an extensive experience in all phases of drug development. At NIDA she provides medical and safety monitoring for clinical trials, design and development of clinical trials, scientific reviews, and is involved in other pertinent aspects of drug development.