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.
The CMB also includes the MCB grant portfolio.
The MCB plans, develops and administers a national and international program of research on medical/clinical/health consequences associated with drugs of abuse (licit [alcohol, tobacco, prescription medications] and illicit [amphetamines, cocaine, inhalants, marijuana, and others]) and their nexus to co-occurring viral and bacterial infections including HIV, hepatitis [B, C, D], tuberculosis, STIs, and others in humans (special studies in women, minorities, children and adolescents and underserved populations. Research may include, but not limited to, studies of the impact of drug addiction on medical/health conditions and the spread of infectious diseases and other conditions that might impact on all physiological or biochemical systems including role of nutrition in drug addiction and infectious diseases; morbidity, co-morbidity and mortality associated with drug use/abuse and/or infections; pathogenesis of drug abuse-associated HIV/AIDS and other co-occurring or opportunistic infectious diseases; medical intervention research concerning consequences of drug use/abuse and infections; pharmacokinetic and pharmacodynamic interactions between drugs of abuse and antiretroviral drugs; interactions between virus, host, and other factors in vulnerability and resistance to infection; pharmacological, physiological, genetic, and clinical factors in progression of infectious diseases in drug users/abusers; and promotes and supports research training and career development programs in the area of clinical/medical consequences.
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.
- Guifang Lao, M.D., Ph.D., - Health Scientist Administrator/Program Officer
Dr. Lao is responsible for developing innovative research programs of HIV clinical research, justice system and training clinical research. Dr. Lao received an MD and MS in Biochemistry from China, a Ph.D. in Microbiology/Biochemistry from Cornell University, and postdoctoral training at NINDS/NIH. She also worked in biotech and pharmaceutical companies and in the Department of Radiology at the NIH Clinical Center. Over the past 25+ years, her research interests have been in the areas of clinical medicine, clinical molecular biology, immunology, neuroscience, protein chemistry, and non-invasive techniques of assessing medical consequences. She has several publications in Neuron, Neuroscience, Molecular and Cell Biology, Biochemistry, and Medicine.
- Raul N. Mandler, MD; FAAN; FANA, Senior Medical Officer
Raul N. Mandler, M.D. is Senior Medical Officer in the Medical Consequences Branch. Prior to joining DTMC, Raul served as Senior Medical Officer in the CCTN , uninterruptedly for the past 12 years Raul was instrumental in developing clinical trials for the diagnosis and prevention of HIV and Hep-C in drug abuse populations. These projects culminated in several publications in high impact journals, including JAMA, JAIDS, Addiction, JAMA Int. Med, etc. Results of those studies have helped to shape national policy and intervention programs for HIV and co-morbidities in people with drug abuse.
Raul is a Board-Certified neurologist, graduated with highest honors from the University of Buenos Aires, interned at the Rambam Medical Center in Haifa, Israel, did his neurology residency and fellowship at the Cleveland Clinic and was a Clinical Associate at NINDS. Prior to joining NIDA, he served as Associate Professor of Neurology and Neurosciences at the University of New Mexico, Visiting Professor at UC Davis, and Professor of Neurology and Neurosciences at The George Washington University. He received the King Faisal International Travel Fellowship Award from The Cleveland Clinic and The Teacher of the Year Award of the Department of Medicine of George Washington University. Raul is a long-standing fellow of the American Academy of Neurology and the American Neurological Association.
Following the exemplary tenure of Dr. Jag Khalsa who retired after more than three decades of exemplary leadership, Raul continues working on the DTMC’s portfolio of studies on medical consequences of drug abuse, including HIV, HCV, and other infections. He is also a member of research teams in DTMC and supports the Division’s work on medical safety and human subjects protection issues in grants and contracts.
- Jurij Z. Mojsiak, M.S., - Pharmacologist
Serves as Project Officer for clinical operations and SBIR contracts with early phase clinical trials component. Expertise in protocol development, clinical trial design, data management, and coordination of clinical trials. Prior to joining DTMC in 1992, spent 6 years in pharmaceutical/biotech industries in project management of clinical trials, and nine years as a hospital-based research pharmacist. Currently serves as executive secretary of NIDA’s Data Safety and Monitoring Board.
- Liza Zeinert, 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.