Innovative technologies to transform antibiotic discovery. Administrative Core

改变抗生素发现的创新技术。

• 批准号: 10670185
• 负责人: DEBORAH T HUNG
• 金额: $ 32.89万
• 依托单位: BROAD INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-07 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10670185
• 关键词: Acinetobacter baumannii; Advisory Committees; Antibiotics; Award; Clinic; Clinical; Communication; Complex; Development; Discipline; Drug resistance; Ensure; Extramural Activities; Future; Goals; Individual; Industrialization; Klebsiella pneumoniae; Leadership; Monitor; National Institute of Allergy and Infectious Disease; Nature; Process; Pseudomonas aeruginosa; Research Personnel; Research Project Grants; Resources; Site Visit; Therapeutic; Therapeutic Agents; Translations; United States National Institutes of Health; Work; antimicrobial; candidate selection; clinical development; commercialization; drug development; drug discovery; innovation; innovative technologies; meetings; novel therapeutics; pathogen; pre-clinical; programs; synergism; timeline

ABSTRACT The goal of our proposal is to establish an interdisciplinary center - Center for Innovation to Transform Antibiotic Discovery (CITADel) - that will deliver 1) pre-clinical antimicrobial candidates that target the unmet therapeutic needs of the most clinically important drug-resistant Gram-negative pathogens today – Pseudomonas aeruginosa, Acinetobacter baumannii and Klebsiella pneumoniae (CREs); and 2) novel drug- discovery platforms upon which future therapeutics - beyond those that will be delivered from this award - can be developed. CITADel's unique approach to drug discovery and development is grounded in a close alliance - throughout the drug discovery and development process - between academic investigators, industrial partners, clinicians, and regulatory experts – from the very outset of all scientific efforts. We will establish an Administrative Core that will manage and oversee the four highly integrated and synergistic research projects of CITADel. Responsibilities include providing support to all research projects on administrative deliverables, monitoring the timelines and deliverables of all research projects, in addition to those of the Center, organizing programmatic meetings and NIAID site visits, providing regulatory guidance to all research projects to ensure successful translation of the developed therapeutics into the clinic, creating commercialization strategies for therapeutic agents, coordinating communication within the program and with NIAID, and identifying and resolving program inefficiencies. The Administrative Core will also establish and coordinate the activities of 1) two Intramural Steering Committees – the Scientific Steering Committee and the Clinical Development Steering Committee – which collectively provide scientific, clinical and regulatory guidance to the research projects; and 2) an Extramural Scientific Oversight Committee – composed of a Scientific Advisory Committee and NIAID – which will provide and external guidance and support to CITADel and its projects. The Administrative Core will be established under the leadership of Deborah Hung (Director of CITADel and the Administrative Core), and the co-leadership of Laura Kiessling (Associate Director of CITADel and the Administrative Core) and Helen Boucher (Regulatory Director of the Administrative Core). !

摘要 我们提议的目标是建立一个跨学科中心--创新转型中心 抗生素发现(Citadel)-它将提供1)针对未获治疗的患者的临床前抗菌药候选药物 当今临床上最重要的耐药革兰氏阴性病原体的治疗需求- 铜绿假单胞菌、鲍曼不动杆菌和肺炎克雷伯菌(Cres)； 发现平台，未来的治疗方法--除了本奖项将提供的治疗方法--可以 被开发出来。Citadel在药物发现和开发方面的独特方法建立在密切的联盟基础上- 在整个药物发现和开发过程中-学术研究人员、工业合作伙伴、 临床医生和监管专家-从所有科学工作的一开始。 我们将建立一个行政核心，管理和监督四个高度整合和 Citadel的协同研究项目。职责包括为所有研究项目提供支持 关于行政交付成果，监测所有研究项目的时间表和交付成果，此外 组织方案会议和NIAID现场访问，为以下方面提供监管指导 所有研究项目，以确保成功地将开发的疗法转化为临床，创造 治疗药物的商业化战略，协调计划内和与 NIAID，以及识别和解决程序低效。 行政核心还将建立和协调1)两个内部指导的活动 委员会-科学指导委员会和临床开发指导委员会- 共同为研究项目提供科学、临床和监管指导；以及2)校外 科学监督委员会--由一个科学咨询委员会和NIAID组成--它将提供 以及对城堡及其项目的外部指导和支持。 行政核心将在Deborah Hung(城堡主任)的领导下建立 和行政核心)，以及Laura Kiessling(Citadel和 行政核心)和海伦·鲍彻(行政核心监管主任)。 好了！