Administrative Core

行政核心

• 批准号: 10589586
• 负责人: DAVID B. WEINER
• 金额: $ 72.69万
• 依托单位: WISTAR INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-08 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10589586
• 关键词: Adjuvant; Animals; Antigens; Attention; Clinical Trials; Communication; DNA; Data Reporting; Ensure; Feedback; Financial Support; Funding; Goals; HIV; HIV Vaccine Trials Network; Human Resources; Industry; Intellectual Property; Leadership; Mission; Monitor; Office of Administrative Management; Outcome; Performance; Plasmids; Primates; Production; Program Reviews; Progress Reports; Publications; Reporting; Research; Resources; Sampling; Schedule; Site; Time; United States National Institutes of Health; Update; Work; Writing; conflict resolution; experience; meetings; member; open data; product development; programs; synthetic construct; video chat; working group

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.

摘要：行政核心 用于HIV的合成DNA启动和佐剂Env免疫原 该IPCAVD将在动物中从概念到向下选择开发2种质粒产品 支持GMP生产，并协助HVTN提交HVTN临床IND 试验将在该计划的第五年开始。行政核心负责全面 提供行政管理和监督以确保计划绩效 目标得以实现。将通过对行政管理人员进行积极的方案管理来取得成果。 和财政支持，项目监测和报告，研究合规监督，团队 通信/会议的组织和便利、资源管理、冲突 解决方案，知识产权管理，支持样品配送。在这些函数中， AC将负责整个计划的执行，人员支持，样品 团队之间的分配/协调，并指导NHP动物研究。管理员 核心将与NIH/DAIDS和HVTN合作-组装一个恒星SAB进行年度审查， 建议节目。将与DAIDS一起审查SAB会议指导结果， 需要进行必要的方案调整，以保持方案目标的正常进行。的 管理核心将提供关于DAIDS计划审查和正式审查进展的年度书面报告。 反馈AC将安排两周一次的项目团队视频会议，以讨论开放数据， 时间线审查，每月与NIH/DAIDS和项目PI通话，邀请HVTN参与 并为HVTN提供季度更新。行政核心将协调国家卫生政策研究 项目和Bioqual指定NHP场地之间的活动，特别注意 NHP研究提供了产品进步和HVTN试验信息。到 促进这一使命的核心嵌入一个经验丰富的行业项目经理与显着 DNA产品开发经验，在这些活动的核心（史密斯博士- Inovio项目 3)以促进灵长类动物的工作Bioqual和服务于国家安全委员会。帕特尔博士将主持IPCAVD NHP工作组，包括韦纳博士，库尔普博士，肖博士，贝茨博士，史密斯博士和博士。 法拉利每季度审查和促进该计划下的整合NHP研究。 扎伊迪先生将作会议记录，并分发给各位成员。行政核心将 还促进与团队完成的工作的出版物，并在 小组会议到DAIDS。韦纳是PI的管理核心，其管理是 由Kulp博士协助。此外，帕特尔博士将成为解决冲突委员会的一部分。