Centralized administration is critical for efficient project management, coordination, and execution. Core A (Administrative Core) will provide all the logistic, scientific, managerial, and financial oversight to facilitate and to coordinate the studies described in this IPCAVD program. The Administrative Core will ensure that the preclinical studies (Project 1), clinical studies (Project 2), manufacturing and regulatory activities (Project 3), and immune monitoring core services (Core B) adhere to the timelines and deliverables described in those sections of this IPCAVD program. The Administrative Core will organize weekly conference calls and regular in-person meetings among the investigators, interface with collaborators and clinical sites, maintain regulatory approvals for all preclinical and clinical studies, provide fiscal and logistic oversight, manage subcontracts, and coordinate meetings with the Scientific Advisory Board and DAIDS Program Officials. This detailed administration and management structure will ensure that all the studies remain focused on the overall objective of advancing the clinical development of our novel Ad26/MVA and Ad26/Protein HI V-1 vaccines. ' To accomplish these goals, we propose the following four Specific Aims: 1. To coordinate communications, interactions, and operations among investigators, projects, and cores to facilitate the overall progress and goals of this IPCAVD program; 2. To ensure and to maintain regulatory compliance for all preclinical and clinical studies; 3. To provide detailed financial oversight and management;and 4. To coordinate meetings with the Scientific Advisory Board and DAIDS Program Officials.
Core A will provide cohesive scientific management, financial oversight, and regulatory support for the proposed studies and will coordinate interactions among the investigators, collaborators, advisors, clinical trials networks, clinical sites, and regulatory agencies. This detailed administration and management structure will ensure that all the studies remain focused on the overall objective of advancing the clinical development of our HIV-1 vaccine candidates.
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