Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trial Not Allowed)

The funding opportunity titled Establishing a Center for the Advancement of Substance Use Disorder Pharmacotherapeutics through Training and Preclinical Support is offered by the National Institutes of Health through the National Institute on Drug Abuse. This initiative is designed to address a critical gap in translating early-stage scientific discoveries into viable pharmacological treatments for substance use disorders. The funder’s broader mission includes advancing knowledge related to drug use, addiction, and associated health outcomes such as overdose and HIV/AIDS, while also strengthening the research workforce through training and development programs. The purpose of this funding opportunity is to create a specialized center that will provide structured education, mentorship, and technical assistance to academic researchers interested in developing pharmacotherapeutics for substance use disorders. The center is expected to support participants in understanding the full product development lifecycle, from early concept definition through feasibility validation. A central goal is to ensure that promising scientific discoveries do not stall due to lack of commercialization knowledge, technical support, or early-stage funding. The program emphasizes bridging academic research and real-world product development pathways. The scope of funding includes the establishment and operation of a multi-component center responsible for outreach, training, mentorship, and preclinical study support. Allowable uses of funds include developing training curricula, organizing workshops and networking opportunities, managing application and selection processes for program participants, and issuing subawards for early-stage preclinical studies. These subawards are intended to fund short-term experiments, typically under six months, that demonstrate the technical feasibility and commercial viability of proposed therapeutic concepts. Funds must align with NIH policies and be used to advance technologies toward clinical application. Eligibility for this opportunity is broad and includes higher education institutions, nonprofits, for-profit organizations, and various levels of government entities, including tribal and international organizations. The opportunity does not require cost sharing. However, applicants must demonstrate the organizational capacity to manage a complex, multi-core center and provide evidence of expertise in drug development, project management, and research training. Foreign organizations are eligible but cannot include foreign subawards, consistent with NIH policy restrictions. The application process requires submission through NIH-approved systems such as ASSIST or institutional system-to-system solutions. Applicants must follow detailed multi-project application instructions and include several core components, including administrative, outreach, training, and preclinical support cores. Required materials include research plans, budgets, data management plans, and supporting documentation. Applications must be submitted electronically and comply strictly with NIH formatting and submission requirements. Applications will be evaluated through a rigorous peer review process based on criteria such as significance, innovation, investigator qualifications, approach, and environment. Additional considerations include the ability of the proposed center to effectively train researchers and manage preclinical studies. The review process includes both scientific merit review and advisory council review. Successful applicants are expected to begin their projects in mid-2027, with a maximum project period of five years. The timeline for this opportunity includes an open date of August 30, 2026, and an application deadline of September 30, 2026. Applications must be submitted by 5:00 PM local time. The earliest anticipated start date for funded projects is July 2027. The opportunity is not explicitly stated as recurring, and no future cycles are guaranteed. Applicants are encouraged to begin preparation early due to the complexity of the submission process and the requirement for multiple institutional registrations and compliance steps.

Strong emphasis on demonstrating feasibility of translating research into viable pharmacotherapeutics and assembling a multidisciplinary team with product development expertise