Core A will be responsible for providing administrative and biostatistics support for the overall program. 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 clinical efforts and direct the efforts toward enhancing the clinical outcome. Dr. C. June is Principal Investigator for the Core, and he will be responsible for coordination of scientific direction and will preserve time-lines essential to productivity to assure overall clinical progress of the IPCP. Dr. G. Binder will coordinate clinical operations and is responsible for interactions with private sector partners. She will also oversee all budgetary interactions with investigators. Mrs. Veloso will coordinate regulatory correspondence with federal and local authorities. Core A will provide comprehensive biostatistics support for the basic science projects and for the design and implementation of the clinical trials. Therefore, the specific aims are: ? Specific aim 1. To coordinate the interactions among scientists, private sector partners and NIH personnel regarding efficient implementation of proposed plans and projects. ? Specific aim 2. To oversee all budgetary matters, including monitoring of monthly expenses and preparation of non-competitive renewal applications. ? Specific aim 3. To maintain final records of the pre-clinical and clinical documents required by FDA and coordinate all applications/continuations to meet requirements of other regulatory agencies and committees. ? Specific aim 4. To provide statistical support for projects and the clinical trials, bioinformatics support for Project 2, and to implement the plans to promote data sharing for all projects and cores.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI082628-05
Application #
8460556
Study Section
Special Emphasis Panel (ZAI1-CCH-A)
Project Start
Project End
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
5
Fiscal Year
2013
Total Cost
$95,757
Indirect Cost
$34,677
Name
University of Pennsylvania
Department
Type
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
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Richardson, Max W; Guo, Lili; Xin, Frances et al. (2014) Stabilized human TRIM5? protects human T cells from HIV-1 infection. Mol Ther 22:1084-95
Maier, Dawn A; Brennan, Andrea L; Jiang, Shuguang et al. (2013) Efficient clinical scale gene modification via zinc finger nuclease-targeted disruption of the HIV co-receptor CCR5. Hum Gene Ther 24:245-58
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Wilen, Craig B; Wang, Jianbin; Tilton, John C et al. (2011) Engineering HIV-resistant human CD4+ T cells with CXCR4-specific zinc-finger nucleases. PLoS Pathog 7:e1002020
Cannon, Paula; June, Carl (2011) Chemokine receptor 5 knockout strategies. Curr Opin HIV AIDS 6:74-9
Francica, Joseph R; Varela-Rohena, Angel; Medvec, Andrew et al. (2010) Steric shielding of surface epitopes and impaired immune recognition induced by the ebola virus glycoprotein. PLoS Pathog 6:e1001098
Mukherjee, Rithun; Plesa, Gabriela; Sherrill-Mix, Scott et al. (2010) HIV sequence variation associated with env antisense adoptive T-cell therapy in the hNSG mouse model. Mol Ther 18:803-11
June, Carl H; Blazar, Bruce R; Riley, James L (2009) Engineering lymphocyte subsets: tools, trials and tribulations. Nat Rev Immunol 9:704-16

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