Microbicides Research Working Group (MRWG)
The need for new, effective HIV biomedical prevention strategies to stem the global HIV/AIDS epidemic is urgent. The development of these novel strategies, such as microbicides, presents complex research and development challenges and requires broad collaboration and strategic direction. The NIH Office of AIDS Research (OAR) has established the Microbicides Research Working Group (MRWG), an independent external panel of experts, to advise NIH and other government and non-governmental entities that support microbicide research and development. It is a critical time for the microbicide field, with fresh scientific opportunities and new potential classes and targets awaiting exploration and advancement. It is essential for this group to provide thoughtful consensus about basic science, translational research, and how best to proceed to bring these candidate products through the pipeline.
A number of recent activities have brought attention and focus to the field, including the NIH Microbicide Strategic Plan, the Microbicide Development Strategy sponsored by the Bill and Melinda Gates Foundation and led by the Alliance for Microbicide Development, and the Clinical Trials Working Group established by the Microbicide Donors' Committee. With those as foundation, the MRWG will serve a fresh, critical, and unique role in providing neutral strategic direction and advice regarding the microbicide pipeline, pre-clinical and clinical research programs, and overall priorities for the field. The MRWG will:
- provide critical independent expert guidance and advice to NIH and other relevant government and non-government entities supporting basic, clinical, and behavioral aspects of microbicide research
- assist in developing a comprehensive research program for expediting the discovery and development of microbicides
- serve as a bridge to better coordination and collaboration among these groups
- facilitate decision-making and minimize unnecessary or unproductive duplication
- identify and update understanding of scientific opportunities and priorities as well as gaps in discovery and development, pre-clinical testing, and clinical trials of potential microbicide products
- make recommendations concerning key scientific questions in microbicide development, including new designs and formulations, efforts to understand the mechanisms of protection, and potential new targets
- establish research standards
- recommend the highest priority science and future directions
- review protocols, ongoing programs, and progress
Structure and Administration
- The MRWG will be composed of non-government members from academia, industry, foundations, and community constituency groups with expertise in areas such as pathogenesis, immunology, microbicide development, primate research, clinical trials, biostatistics, behavioral science, women’s health issues, and international research. Ad hoc expertise may be added as necessary.
- The OAR Director will appoint the MRWG Chair. The OAR senior scientific staff responsible for microbicides will staff the MRWG and serve as its Executive Secretary. The OAR will provide administrative support to the MRWG.
- Representatives of federal government agencies (NIH, CDC, USAID, and FDA) and relevant non-governmental organizations and community constituency groups will be invited to participate.
- Topics for possible discussion/consideration may be submitted to the Executive Secretariat by any government or non-government entity supporting microbicide research and development
- The MRWG will meet approximately 3 times a year, as necessary, and some meetings will be held by teleconference. The MRWG will provide updates to the Office of AIDS Research Advisory Council (OARAC).
Ashley Haase, M.D.
University of Minnesota Medical School
Judith D. Auerbach, Ph.D.
San Francisco AIDS Foundation
Charles Carpenter, M.D.
Dr. Nomita K. Chandhiok
Indian Council of Medical Research
Janet H. Darbyshire, OBE, FRCP
Medical Research Council
Polly F. Harrison, Ph.D.
Alliance for Microbicide Development
Edward W. Hook III, M.D.
The University of Alabama at Birmingham
Christopher J. Miller, D.V.M, Ph.D.
California National Primate Research Center
Neal Nathanson, M.D.
University of Pennsylvania
Professor Helen V. Rees
Witwatersand Reproductive Health and HIV Research Unit
Renee Ridzon, M.D.
Bill and Melinda Gates Foundation
Steven G. Self, Ph.D.
Fred Hutchinson Cancer Research Center
University of Washington
Gina M. Brown, M.D.
OAR Microbicide Research Coordinator