Core A: Administrative & Regulatory

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PROJECT SUMMARY: CORE A The Overall Program objectives are ambitious and complex: to iteratively, rationally, and expeditiously select a safe and effective combination antiretroviral (ARV) non-vaccine biomedical prevention (nBP) candidate through in vitro, in vivo, and clinical testing, and to establish the capability to manufacture this candidate for future clinical studies. The IPCP-MBP investigators are deeply committed to the development of topical nBP candidates and delivery systems to prevent the sexual transmission of HIV. To meet these goals, the Program must be run by a strong Administrative & Regulatory Core (Core A). The Overall Program PI, Project Leads, and key personnel have significant administrative and regulatory experience, which they bring to successfully complete this project. Success of this IPCP-MBP will rely on Core A to provide scientific, regulatory, and administrative leadership in coordinating the five Scientific Projects, one Scientific Core, and the multiple investigators and sites that make up this IPCP-MBP. Core A will have the primary goals of efficiently facilitating interactions, providing a reliable infrastructure for fiscal management of the Program, providing on-going communications with NIH and the Project Officer as well as the Scientific Advisory Panel (SAP) approved by NIH. It will provide focus for efficient leadership of the overall project by facilitating communication between the Executive Committee (EC) and Steering Committee (SC) members, project investigators, and staff. Core A will also monitor data acquisition and sharing, and coordinate and monitor the exchange of materials and samples between the Projects and Cores, so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones. The regulatory aspect of Core A will coordinate with and support the administrative and scientific staff involved in gaining IACUC, IRB, PSRC, and IND approvals required in Projects. It will ensure data from the Exploratory Clinical Trial is properly managed and analyzed and that all GMP and GLP requirements for manufacture and testing in Core B and Project 5 are satisfied and documented.