Administrative Core

行政核心

• 批准号: 10513914
• 负责人: David S Perlin
• 金额: $ 755.88万
• 依托单位: HACKENSACK UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-16 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10513914
• 关键词: 2019-nCoV; Academia; Address; Agreement; Antiviral Agents; Biotechnology; Businesses; Decision Making; Development; Ensure; Fostering; Goals; Health; Healthcare Systems; Individual; Industry; Institution; Intellectual Property; Investigational Drugs; Lead; Leadership; Licensing; Logistics; Mediation; Medicine; Mentors; Meridians; National Institute of Allergy and Infectious Disease; New Jersey; Online Systems; Outcome; Output; Performance; Pharmaceutical Chemistry; Pharmacology; Press Releases; Process; Progress Reports; Publications; Reporting; Research; Research Project Grants; Resource Allocation; Resources; Rice; Rights; Risk; Schedule; Secure; Site Visit; Structure; Time; Travel; United States National Institutes of Health; Virus; antiviral drug development; base; conflict resolution; data sharing; design; drug development; drug discovery; experience; industry partner; innovation; material transfer agreement; meetings; member; metropolitan; organizational structure; pandemic disease; pre-clinical; preclinical development; programs; success; virology

The MAVDA Administrative Core (MAC) will be established as an integrated, priority-setting consortium involving the Program Directors (PDs), a Business Director (BD), an internal MAVDA Leadership Team (MLT), and a Scientific Advisory Board (SAB) with programmatic involvement from NIAID to enhance potential product outcome in the form of antivirals against SAR-CoV-2 and other viruses with pandemic potential. The management function is designed to provide administrative support that facilitates the success of individual projects, promotes effective integration and allocation of support functions and resources, and stimulates scientific exchange between MAVDA members, thus ensuring that the overall program achieves its objectives. The MAC will be overseen by co-PDs, Dr. David S. Perlin and Dr. Charles M. Rice, who will be supported by an experienced BD and appropriate support staff to coordinate and manage all administrative functions. To best advance MAVDA's objectives, the MAC will coordinate regular meetings of Project Leaders, Pharma/Biotech Partners, Core Directors, and SAB members. The meetings are designed to advance compounds through the discovery matrix enabling timely and objective ‘Go/No Go’ decision making. A secure web-based platform will be used to foster interactions between Projects and Cores. The MAC will facilitate an annual review meeting with the SAB, and a reverse site visit at NIAID. It will produce and submit the annual progress report to the NIH, and it will coordinate research publications, meeting presentations, reports and press releases. MAVDA is designed to encourage partnering among academia and industry, specifically Pharma and Biotech companies, and has protections in place to protect the intellectual property of participating organizations. There is universal confidentiality between projects and cores, with data shared as required to advance compounds and at no risk to the project team. As MAVDA retains no IP rights, all IP rights reside in the host institutions or per agreements with industry partners. The MAC will execute the following Specific Aims: 1) establish a highly efficient management structure that supplies essential oversight and guidance for Project Leaders and Core Directors, effectively integrates the Scientific Advisory Board as strategic advisors in the discovery process, and promotes scientific exchange; 2) maximize allocation of resources and prioritize compound development by establishing critical metrics for ‘Go/No Go’ decision making and resource allocations by supporting close interactions of Project Leaders and Core Directors and scheduling regular reviews; 3) annually assess project performance and prepare interim and year-end reports; 4) solicit and manage Developmental and Mentored Research Projects; 5) coordinate publications, presentations of results, and press releases from these studies and develop a managerial plan for conflict resolution and other operational issues; and 6) establish an internal organizational structure that addresses logistics for material transfer agreements, intellectual property filings, licensing opportunities, and negotiations.

MAVDA行政核心（MAC）将被确定为一个集成的优先设定联盟 涉及计划董事（PDS），商业总监（BD），内部MAVDA领导团队（MLT）， 以及一个科学顾问委员会（SAB），从NIAID提高潜在产品的程序化参与 针对SAR-COV-2和其他具有大流行潜力的抗病毒药形式的结果。这 管理功能旨在提供行政支持，以促进个人的成功 项目，促进支持功能和资源的有效整合和分配，并刺激 MAVDA成员之间的科学交流，从而确保了整体计划实现其目标。 Mac将由Co-PDS，David S. Perlin博士和Charles M. Rice博士监督 经验丰富的BD和适当的支持人员来协调和管理所有行政职能。最好 Advance Mavda的目标，Mac将协调项目负责人，Pharma/Biotech的定期会议 合作伙伴，核心董事和SAB成员。会议旨在通过 Discovery Matrix启用及时，客观的“ Go/No Go”决策。一个安全的基于Web的平台将 用于促进项目与核心之间的互动。 Mac将最喜欢与 SAB，并在Niaid进行反向访问。它将为NIH生产并提交年度进度报告，并将其提交 它将协调研究出版物，符合演讲，报告和新闻稿。 Mavda是设计的 鼓励在学术界和行业中合作，特别是药房和生物技术公司，并 保护参与组织的知识产权的适当措施。有通用 项目与核心之间的机密性，并根据需要的数据共享，以推进化合物，没有风险 向项目团队。由于MAVDA没有任何IP权利，因此所有IP权利都存在于主机机构或每个协议中 与行业合作伙伴。 Mac将执行以下特定目的：1）建立高效 为项目负责人和核心董事提供必要的监督和指导的管理结构， 有效地将科学顾问委员会纳入发现过程中的战略顾问，并促进 科学交流； 2）通过建立资源最大化资源分配并优先考虑复合开发 通过支持紧密互动的“ GO/NO GO”决策和资源分配的关键指标 项目负责人和核心主管以及安排定期审查； 3）年度评估项目绩效和 准备临时和年终报告； 4）征求并管理发展和指导的研究项目； 5）协调出版物，结果的介绍以及这些研究的新闻稿并开发了 解决冲突和其他操作问题的管理计划； 6）建立内部组织 解决物流转移协议，知识产权申报，许可的结构 机会和谈判。