Administrative Core

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Summary: Administrative Core IPCAVD Synthetic DNA launched and Adjuvanted Env immunogens for HIV This IPCAVD will develop 2 plasmid products from concept to down selection in animals support GMP production and assist the HVTN with IND submission for an HVTN clinical trial to be initiated in year 5 of the program. The Administrative Core is responsible for overall program performance providing administrative governance and oversight to ensure Program goals are met. Outcomes will be achieved through active program management of administrative and financial support, project monitoring and reporting, research compliance oversight, team communications/meetings organization and facilitation, resource management, conflict resolution, intellectual property management, support sample distribution. In these functions, the AC will be responsible for overall program performance, personnel support, sample distribution/coordination among the team, and for guiding the NHP animal studies. The Admin Core will work with NIH/DAIDS and the HVTN - assembling a stellar SAB for yearly review to advise the program. The SAB meeting guidance outcomes will be reviewed with DAIDS for necessary programmatic adjustments to be implemented to keep the program goals on track. The Admin Core will provide yearly written reports on progress for DAIDS program review and formal feedback. The AC will arrange biweekly Project team Video calls for open data discussion and time line review, monthly calls with NIH/DAIDS and the program PIs, inviting HVTN participation and provide a quarterly update for HVTN. The Administrative Core will coordinate the NHP studies activities between the Projects and the designated NHP site at Bioqual, with special attention given to the NHP studies that are for product advancement and HVTN trial information. To facilitate this mission the core imbeds an experienced industry project manager with significant DNA product development experience, in the core for these activities (Dr. Smith - Inovio Project 3) to facilitate the primate work Bioqual and serve on the NSC. Dr. Patel will chair the IPCAVD NHP working group which includes Dr. Weiner, Dr. Kulp, Dr. Shaw, Dr. Betts, Dr. Smith, and Dr. Ferrari on a quarterly basis to review and facilitate the integration NHP studies under this program. Minutes will be taken by Mr. Zaidi and distributed to the members. The Administrative core will also facilitate publications of work accomplished with the team and report data presentations at meetings of the team to DAIDS. Dr. Weiner is PI of the Admin Core, and its administration is assisted by Dr. Kulp. In addition, Dr. Patel will form part of the conflict resolution committee.