Dynamic and Adaptable Infrastructure for Drug Development and Outreach to Aid the Research Community in Advancing Medication Repurposing and Repositioning Efforts for Substance Use Disorders (SUDs) (U54 - Clinical Trials Not Allowed)

This grant opportunity aims to establish and operate a dynamic and adaptable drug development infrastructure to support the research community in advancing medication repurposing and repositioning efforts for Substance Use Disorders (SUDs). The proposed infrastructure will provide comprehensive services to academic and biotech researchers, including Target Product Profiles creation, Freedom-to-Operate analysis, intellectual property consultations, regulatory guidance, and technical pipeline support. The goal is to strengthen and expand the SUD drug development pipeline by accelerating the evaluation and validation of repurposed and repositioned drugs. Key aspects of this opportunity include: • The infrastructure will serve as a hub to support researchers at all stages of product development. • The services offered will include assistance in creating Target Product Profiles, Freedom-to-Operate analysis, intellectual property consultations, regulatory guidance, and technical pipeline support. • The infrastructure will engage in outreach efforts to connect with the research community, solicit proposals, and implement processes to evaluate, select, and advance high-quality projects. • Collaborative investigations combining expertise in in silico discovery, target validation, preclinical development, clinical protocol development, regulatory affairs, and intellectual property management will be encouraged.