Innovative technologies to transform antibiotic discovery. Administrative Core

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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). !