Innovative technologies to transform antibiotic discovery. Administrative Core

摘要 我们建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) - 将提供 1) 针对未满足的临床前抗生素候选药物 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 (CRE)； 2）新药- 未来的治疗方法（除了该奖项将提供的治疗方法之外）可以在发现平台上进行 得到开发。 CITADel 独特的药物发现和开发方法基于紧密的联盟 - 在整个药物发现和开发过程中——学术研究人员、工业合作伙伴之间， 临床医生和监管专家——从所有科学努力的一开始就如此。 我们将建立一个行政核心来管理和监督四个高度集成和 CITADel 的协同研究项目。职责包括为所有研究项目提供支持 关于行政可交付成果，除了监测所有研究项目的时间表和可交付成果外， 组织计划会议和 NIAID 实地考察，提供监管指导 所有研究项目都确保将开发的疗法成功转化为临床，创造 治疗剂的商业化策略，协调项目内的沟通以及与 NIAID，以及识别和解决项目效率低下的问题。 行政核心还将建立和协调 1) 两个校内指导的活动 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； 2) 校外 科学监督委员会 – 由科学咨询委员会和 NIAID 组成 – 将提供 对 CITADel 及其项目的外部指导和支持。 行政核心将在 Deborah Hung（CITADel 总监）的领导下成立 和行政核心），以及 Laura Kiessling（CITADel 副主任和 行政核心）和 Helen Boucher（行政核心监管总监）。 ！

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). !