Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trial Not Allowed)
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The National Institute on Drug Abuse (NIDA) is seeking to establish a Specialized Center through a U54 cooperative agreement to advance the development of pharmacotherapeutics for substance use disorders (SUD). The primary objective of the Center is to educate and mentor academic researchers in formal product development while providing technical and financial support to advance promising preclinical concepts. The Center will operate through four primary functional areas: an Administrative Core, an Outreach and Networking Core to recruit researchers and mentors, a Drug Development Training and Education Core to deliver a customized curriculum on the drug development process, and a Preclinical Study Support Core to manage sub-awards for initial experiments. NIDA intends to commit 3 million dollars to fund one award in Fiscal Year 2027. Applications will be evaluated based on scientific and technical merit through the NIH peer review system, with a focus on the collective expertise of the investigative team and the potential for the project to exert a sustained influence on the research field. Eligible applicants include for-profit organizations, including small businesses, and other institutional entities with the capacity to support such a center. Awardees must comply with NIH guidelines for preclinical studies, federal regulations for the protection of human research participants, and specific cybersecurity incident reporting requirements, including notifying HHS agencies within 48 hours of a discovery.
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Full Description
The National Institute on Drug Abuse (NIDA) seeks to advance its mission by establishing a Center that educates and supports researchers in formal product development for new substance use disorder (SUD) pharmacotherapeutics. The Center will also help advance the best concepts through initial experiments via technical and financial support. Previous NIDA-supported initiatives in early translational research have shown that drug addiction researchers are eager to acquire formal product development skills and access technical expertise and support. Prospective applicants are encouraged to: develop plans for a product development curriculum to be taught to SUD researchers, outline outreach and networking initiatives to engage the research community and recruit researchers' concepts for development within the Center, and describe the infrastructure support that may be provided for initial experiments.
Applications are not being solicited at this time. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive applications. Investigators with expertise in the areas of drug discovery and development and institutional capacities to support such a Center are encouraged to begin to consider applying for this NOFO.Grant authorities that allow NIH to forecast this opportunity are as follows Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200].
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