Administrative Core

行政核心

• 批准号: 10359712
• 负责人: Colleen B Jonsson
• 金额: $ 16.59万
• 依托单位: UNIVERSITY OF TENNESSEE HEALTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-06 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10359712
• 关键词: Achievement; Advisory Committees; Alphavirus; Animals; Award; Back; Canis familiaris; Charge; Chemistry; Collaborations; Communication; Communities; Consult; Consultations; Data; Development Plans; Documentation; Drug Kinetics; Ensure; Evaluation; Foundations; Funding; Future; Health Sciences; Holly; IACUC; In Vitro; Information Dissemination; Infrastructure; Intellectual Property; Investigational New Drug Application; Laboratories; Lead; Leadership; Maximum Tolerated Dose; Modeling; Monitor; National Institute of Allergy and Infectious Disease; Outcome; Pilot Projects; Publishing; Rattus; Research; Research Project Grants; Resources; Safety; Schedule; Secure; Site; Small Business Innovation Research Grant; Technology Transfer; Tennessee; Testing; Therapeutic; Time; Toxicokinetics; United States National Institutes of Health; Universities; Validation; Wisconsin; Work; commercialization; efficacy study; in vivo; lead candidate; meetings; member; nonhuman primate; novel; pre-clinical; product development; programs; safety study

Project Summary The overall objective of the Administration (Admin) Core efforts is to provide a robust and dynamic infrastructure for the Center of Excellence for Encephalitic Alphavirus Therapeutics that enables consistent and notable progress through the milestones. Led by the Program Director, Dr. Jonsson (UTHSC, University of Tennessee Health Science Center), the Core will be the main interface between the Scientific Advisory Committee (SAC), the Research Project PIs, and NIAID. To support the achievement of the aims and milestones of the Center, Dr. Jonsson will be supported by Jayne McKinnie (Admin Core Associate) to: (1) ensure coordination and dissemination of information across the research projects, (2) coordinate results required for filing intellectual property, (3) publish results of disclosed leads and provide novel resources to the scientific community, (4) coordinate input into the refinement of the product development plan outlined in the Overall section with our University partners and SAC, (4) attract commercial partners for future SBIR or similar proposal efforts, and (5) administratively support the Center in collaboration with our regulatory consultants to prepare for our meetings with the FDA at the end of year 3 and at the start of year 5. Specific aims of the Admin Core will be to: Aim 1. Organize, manage, and document Center communications and findings; Aim 2. Manage and ensure fiscal responsibility and regulatory compliance; and Aim 3. Manage lead prioritization and documentation, the refinement of the Product Development Plan and a path to Commercialization.

项目摘要 核心工作的总体目标是提供一个强有力和充满活力的 脑炎甲病毒治疗卓越中心的基础设施， 通过里程碑取得一致且显着的进展。由项目主任Jonsson博士领导 （UTHSC，田纳西大学健康科学中心），核心将是 科学咨询委员会（SAC），研究项目PI和NIAID。支持 为了实现中心的目标和里程碑，Jayne McKinnie将支持Jonsson博士 （行政核心助理）：（1）确保整个研究的协调和信息传播 项目，（2）协调知识产权备案所需的结果，（3）公布披露线索的结果 并为科学界提供新的资源，（4）协调对改进 与我们的大学合作伙伴和SAC一起制定总体部分中概述的产品开发计划，（4）吸引 为未来SBIR或类似提案工作提供商业合作伙伴，以及（5）在行政上支持中心 与我们的监管顾问合作，为年底与FDA的会议做准备 3、年初5。管理核心的具体目标将是：目标1。组织、管理和 文件中心的通信和调查结果;目标2.管理和确保财务责任， 合规;目标3。管理潜在客户优先级排序和文档， 产品开发计划和商业化途径。