Administrative Core

Johns Hopkins University, Baltimore MD

Investigators

Abstract

SUMMARY Invasive fungal infections pose a formidable global challenge, particularly for immunocompromised individuals, exacerbated by the emergence of drug-resistant strains like Candida auris, Candida glabrata, and Aspergillus fumigatus. To tackle this issue, we propose establishing a Center of Excellence for Translational Research (CETR) dedicated to expediting the discovery and development of novel antifungals and a diagnostic. The establishment of an effective CETR involves developing efficient administrative structures, robust leadership plans, support infrastructure, and a pharma-style decision-making approach. We will create an integrated network of science discovery support Cores, including Pharmacology/Mycology, Animal Model, and Medicinal Chemistry Cores, staffed by experienced directors with BioPharma experience to accelerate lead compound optimization. The Administrative Core will play a crucial role in optimizing research operations and resource allocation through a lean framework that closely integrates Project Leaders and Core Directors. This centralized organization will facilitate seamless communication across multiple entities and manage all operational aspects of the Projects and Cores, ensuring efficiency and cohesion. We will provide a comprehensive support system for grant management and commercialization efforts. This includes solutions for secure data sharing and intellectual property protection, administrative systems for reporting and fiscal management, and communication protocols for collaboration and dissemination of secure and public data, as well as project reviews and updates. We will also provide support for product development, and regulatory compliance, ensuring successful initiatives. The administrative structure ensures maximal efficiency in project execution by streamlining operations and resource allocation. A robust plan led by experienced drug development experts and a world-class Scientific Advisory Board (SAB) helps guide drug candidate development and evaluate progression metrics. Pharma- style decision making with clear 'go, no-go' criteria will be used to expedite and prioritize promising candidates. External regulatory support aids in navigating requirements for pre-IND, IND-enabling and 510(k) submissions. These efforts strengthen the administrative core of the CETR-based accelerator. By leveraging the expertise of academic and industry partners and establishing a robust administrative infrastructure, we aim to combat drug- resistant fungal pathogens. This comprehensive administrative approach embodies our commitment to advancing research and translating discoveries into impactful solutions for patients.