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管理核心(MAC)将被建立为一个综合的、确定优先事项的联合体 项目总监(PD)、业务总监(BD)、内部MAVDA领导团队(MLT)、 和一个科学咨询委员会(SAB)，由NIAID参与计划，以增强潜在的产品 以抗SARS-CoV-2病毒和其他具有大流行潜力的病毒的形式取得的结果。这个 管理职能旨在提供行政支持，促进个人的成功 项目，促进有效整合和分配支助职能和资源，并刺激 在MAVDA成员之间进行科学交流，从而确保整个计划实现其目标。 互委会将由共同民主党监督，大卫·S·佩林博士和查尔斯·M·赖斯博士将由 有经验的业务部和适当的支持人员来协调和管理所有行政职能。做到最好 为了推进MAVDA的目标，MAC将协调制药/生物技术项目负责人的定期会议 合作伙伴、核心董事和SAB成员。这些会议旨在推动化合物通过 发现矩阵，支持及时、客观地进行/不进行决策。安全的基于Web的平台将 用于促进项目和核心之间的互动。互委会将协助召开年度审查会议 SAB，以及NIAID的反向现场访问。它将编制并向国家卫生研究院提交年度进展报告，以及 它将协调研究出版物、会议陈述、报告和新闻稿。MAVDA被设计成 鼓励学术界和产业界，特别是制药和生物技术公司之间的合作，并已 保护参与组织的知识产权的保护措施到位。有普遍性的 项目和核心之间的机密性，根据需要共享数据以推进化合物，并且没有风险 给项目团队。由于MAVDA不保留知识产权，所有知识产权都驻留在主办机构或根据协议 与行业合作伙伴合作。MAC将执行以下具体目标：1)建立高效的 为项目负责人和核心主管提供必要监督和指导的管理结构； 有效地将科学咨询委员会作为战略顾问纳入发现进程，并促进 科学交流；2)最大限度地配置资源，优先发展复合发展 通过支持以下方面的密切交互，制定和分配资源的关键指标： 项目负责人和核心总监并安排定期评审；3)每年评估项目绩效和 准备中期和年终报告；4)征集和管理发展研究项目和指导研究项目； 5)协调这些研究的出版物、结果陈述和新闻稿，并制定 解决冲突和其他业务问题的管理计划；以及6)建立内部组织 解决材料转让协议、知识产权申请、许可的物流问题的结构 机遇和谈判。