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02688 NIAID TOPICAL MICROBICIDE STRATEGIC PLAN: DISCOVERY, DEVELOPMENT AND EVALUATION Black, Roberta*; The long-term goal of the NIAID is to identify safe, effective and acceptable microbicides to prevent HIV/AIDS and other sexually transmitted infections. A five-year strategic plan has been implemented following approval by a Blue Ribbon Panel of extramural scientific experts. The objective of the plan is to support the near-term goal of establishing proof-of-clinical efficacy for at least one microbicide candidate. The plan is configured to simultaneously address, through integrated basic and applied programs and workshops, the scientific challenges that span basic, preclinical, clinical, and behavioral research while providing targeted support to advance the development of priority products of public health import. Preclinical development resources have been established to help address needs in the key areas of in vitro screening, in vivo safety and efficacy testing, chemical synthesis, formulation development, and clinical product manufacture. Project management and regulatory documentation capabilities will be added, upon availability of funds. To assure efficient use of NIAID resources, priorities have been set at specific junctures in the development process. Well-defined in vitro and in vivo criteria serve as the basis for advancement of the most promising candidates into Phase I trials. In addition, considerations for progression of the highest priority candidates into effectiveness trials will be discussed. Roberta Black, PhD |
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