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; 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 IPCAVD合成DNA发射并为HIV辅助ENV免疫剂 此IPCAVD将开发2种质粒产品，从概念到动物的选择 支持GMP生产并协助HVTN提交HVTN临床 试验将在该计划的第五年开始。行政核心总体负责 计划绩效提供行政治理和监督以确保计划 实现目标。成果将通过主动的管理计划管理来实现 以及财务支持，项目监控和报告，研究合规性监督，团队 沟通/会议组织和促进，资源管理，冲突 解决方案，知识产权管理，支持样本分布。在这些功能中， AC将负责总体计划绩效，人员支持，样本 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 - 组装出色的SAB，以供年度审查 建议程序。 SAB会议指导结果将通过daids进行审查 必须实施必要的程序调整，以使程序目标逐步稳步。这 Admin Core将提供有关DAIDS计划审查进度和正式进度的年度书面报告 反馈。 AC将安排每两周一次的项目团队视频呼吁进行开放数据讨论，并 时间线审查，每月与NIH/daids和计划PI的电话，邀请HVTN参与 并为HVTN提供季度更新。行政核心将协调NHP研究 项目与Bioqual指定的NHP网站之间的活动，特别关注 提供了用于产品发展和HVTN试验信息的NHP研究。到 促进这项任务核心使一位经验丰富的行业项目经理拥有重要的 DNA产品开发经验，以这些活动的核心（Smith- Inovio Project 3）促进灵长类动物的生物验菌并在NSC上服务。帕特尔博士将主持ipcavd NHP工作组，包括Weiner博士，Kulp博士，Shaw博士，Betts博士，Smith博士和博士 法拉利每季度根据该计划进行审查和促进NHP研究。 Zaidi先生将拿出会议记录并分发给成员。行政核心将 还促进了与团队一起完成的工作的出版物，并在 团队的会议与妻子的会议。 Weiner博士是管理员的PI，其管理是 由Kulp博士协助。此外，帕特尔博士将成为冲突解决委员会的一部分。