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中文摘要
翻译
摘要:管理核心 IPCAVD合成DNA推出并辅以针对HIV的环境免疫原 这项IPCAVD将在动物体内开发出从概念到下选择的两种质粒产品 支持GMP的生产,并协助HVTN提交针对HVTN临床的IND 试验将在该计划的第5年启动。行政核心负责整体 计划绩效提供行政治理和监督,以确保计划 目标实现了。将通过行政管理的积极计划管理实现成果 和财务支持、项目监测和报告、研究合规监督、团队 通信/会议的组织和促进、资源管理、冲突 解析、知识产权管理、支持样品分发。在这些函数中, AC将负责整个计划的绩效、人员支持、样本 在团队之间进行分配/协调,并指导NHP动物研究。《管理员》 CORE将与NIH/DAIDS和HVTN合作-组装一份出色的SAB,供年度审查 对该计划提出建议。将与DAIDS一起审查SAB会议指导结果,以 实施必要的方案调整,使方案目标保持在正轨上。这个 管理核心将提供关于DAIDS计划审查和正式进展的年度书面报告 反馈。咨询委员会将安排两周一次的项目团队视频电话会议,以进行公开数据讨论和 时间线回顾,每月与NIH/DAIDS和PIS计划通话,邀请HVTN参与 并提供HVTN的季度更新。行政核心将协调国家惠普研究 项目与Bioqual指定的NHP场地之间的活动,并给予特别关注 提供给NHP研究,这些研究是为了产品进步和HVTN试验信息。至 促进这一使命的核心嵌入了一位经验丰富的行业项目经理 DNA产品开发经验,是这些活动的核心(Smith-Inovio博士项目 3)促进灵长类工作Bioqual并为NSC服务。帕特尔博士将担任IPCAVD主席 NHP工作组包括Weiner博士、Kulp博士、Shaw博士、Betts博士、Smith博士和Dr. 法拉利每季度审查并促进NHP在这一计划下的整合研究。 扎伊迪先生将记录会议纪要并分发给成员。行政核心意志 还促进发布与团队完成的工作和报告数据演示文稿,网址为 DAIDS团队的会议。韦纳博士是管理核心的PI,其管理是 在库尔普医生的协助下。此外,帕特尔博士还将成为冲突解决委员会的成员。
英文摘要
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.
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会议论文
2023 International Society for Vaccines (ISV) Annual Congress, October 22-25, Lausanne, Switzerland
Administrative Core
  • 批准号:
    10328139
  • 项目类别:
  • 资助金额:
    $27.52万
  • 财政年份:
    2022
  • 负责人:
    DAVID B. WEINER
  • 依托单位:
Rapid, single-dose coronavirus vaccines via DNA-launched nanoparticles and genetic adjuvants for durable anti-coronavirus immunity
  • 批准号:
    10328141
  • 项目类别:
  • 资助金额:
    $110.71万
  • 财政年份:
    2022
  • 负责人:
    DAVID B. WEINER
  • 依托单位:
Synthetic DNA-launched and adjuvanted Env immunogens for HIV
  • 批准号:
    10589585
  • 项目类别:
  • 资助金额:
    $449.79万
  • 财政年份:
    2022
  • 负责人:
    DAVID B. WEINER
  • 依托单位:
海外基金