Center for accelerated development of drug candidates targeting high threat bacterial infections

SUMMARY In the face of a global crisis of antimicrobial resistance (AMR) in bacterial infections, the imperative for effective new treatments is urgent. Our vision for the Center of Excellence in Translational Research (CETR) is to establish a top-tier drug accelerator dedicated to advancing antibiotic development, focusing primarily on combating high- threat multidrug-resistant bacteria. Drawing on expertise from leading drug developers within the academic (CDI, Rutgers) and pharmaceutical/biopharmaceutical sectors (Merck, Prokaryotics), this CETR aims to drive forward advanced antibacterial small molecule inhibitor programs, positioning them as preclinical development candidates for multiple IND submissions. The Administrative Core plays a pivotal role in optimizing research operations and resource allocation, closely aligning with Project Leaders and Core Directors. This centralized structure fosters seamless communication, overseeing all operational aspects to ensure efficiency and cohesion. Our comprehensive support system encompasses grant management, secure data sharing, intellectual property protection, internal and external reporting, conflict and fiscal management, collaboration communications, and data dissemination aiming to maximize project execution efficiency. Synergy among projects is cultivated by leveraging diverse chemistries toward shared pathogens or molecular targets, complemented by the Center’s collaborative ecosystem that fosters accelerated drug discovery. Guided by a robust plan crafted by experienced drug development experts and a world-class Scientific Advisory Board (SAB), we will navigate drug candidate development, employing pharma-style decision-making with clear 'go, no-go' criteria to expedite and prioritize the most promising candidates. Building on past CETR successes and existing partnerships, the program will support the development of novel chemical classes, conducting comprehensive preclinical IND-enabling studies, ensuring regulatory compliance, promoting data sharing, and fostering capacity building. Additionally, commercial partners and external regulatory support will aid in navigating IND submission requirements. Through a robust administrative infrastructure and a seasoned management team, our CETR is optimally positioned to achieve its drug development objectives resulting in critical new therapies addressing the pressing issue of multidrug-resistant bacterial infections, thus safeguarding public health globally.