Core A will be responsible for providing administrative and biostatistics support for the overall program project. The Core will interact with Program management at NIAID and with the external Scientific Advisory Panel, coordinating meetings and progress reports. Budget reports and annual reports to NIH and FDA will be coordinated by Core A. It will also serve to amalgamate the investigators, their experimental findings and their ideas, evaluation of preclinical and clinical efforts to focus efforts on enhancing the clinical outcome. The administrative functions will be accomplished using a structure in which the Core Leader, Dr. Riley, is advised by an Executive Committee of Project and Core Leaders with input from the Scientific Advisory Committee. Dr. Carl June will serve as the regulatory sponsor for the clinical trial described in Project 1 will coordinate clinical operations and is responsible for interactions with private sector partners. The finances of the U19 will be organized by Mr. Mark Sudell who will meet monthly with the U19 PI and each Project and Core Leader. Dr. Shaw will provide comprehensive biostatistics support for the scientific project and core, and for the design and implementation of the clinical trial. Therefore, the specific aims are: SA1: To coordinate the interactions among scientists, private sector partners, and NIH personnel regarding efficient implementation of proposed plans and projects. SA2: To oversee all budgetary matters, including monitoring of monthly expenses and preparation of non-competitive renewal applications. SA3: To maintain records of the pre-clinical and clinical documents required by FDA and coordinate all applications/continuations to meet requirements regulatory agencies and committees. SA4: To provide statistical support for projects and the clinical trials, bioinformatics support for Project 1, and to implement the plans to promote data sharing for all projects and cores.
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