The Administrative Core (AC) will be responsible for managing, coordinating, and supervising all TBRU activities. The TBRU AC will be directed by a Leadership Team that includes the dual Pis of this application (Henry M. Blumberg, MD at Emory and Joel D. Ernst, MD at NYU) and Rafi Ahmed, PhD (Director, Emory Vaccine Center) who will serve as TBRU Scientific Advisor. These 3 AC Program Directors (PDs) have substantial experience and expertise in immunology, clinical/translational research, and scientific program management. They will provide leadership to support scientific investigation into the immunology of latent TB infection and facilitate communication among investigators, research projects and cores to ensure there is translation and back translation between human subjects studies and animal studies that will utilize a non-human primate TB model. The AC includes a Data Management Center (DMC) under the direction of Dr. Lance Waller (Chair, Emory Department of Biostatistics and Bioinformatics) that will be responsible for collection, storage, quality control, and evaluation of all study data and will provide biostatistical and bioinformatics support to TBRU investigators at all of the collaborating sites. The DMC will collaborate with the Aeras on the implementation of an integrated data management system for tracking of TBRU specimens from both human subjects and non-human primates (NHP) across research projects. The AC will provide effective coordination and communication across projects and cores at collaborating institutions;fiscal management and regulatory requirement oversight;and as part of evaluation activities will monitor progress and assess the degree to which TBRU goals are being met. The PDs will receive input from our Internal Advisory Committee and a Steering Committee as well as NIAID and the External Advisory Group;they will implement changes based on progress or lack of progress achieved and based on scientific discoveries which warrant that new strategies be implemented and new pathways pursued. The AC will also facilitate involvement in collaborative research opportunities across the NIAID TBRU network, leveraging our unique resources including clinical sites, a NHP model for TB, and investigators with expertise in TB immunology
Tuberculosis (TB) is an enormous global public health problem but the mechanisms associated with control of TB infection or progression to active TB are poorly understood. The Administrative Core of this TBRU application will be responsible for managing, coordinating, and supervising all TBRU activities that are focused on enhancing our understanding of the immunology of latent TB infection and control of TB.