Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional) | PAR 23 087

Opportunity Information: Apply for PAR 23 087

Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional), PAR-23-087, is a National Institutes of Health (NIH) funding opportunity that aims to strengthen the bridge between preclinical research and clinical testing for mental health treatments. The central focus is on neurophysiological measures, meaning quantifiable signals of nervous system function, that could be shaped into practical assays for treatment development. In plain terms, the program is looking for measures that can be used reliably to test whether a potential therapy is doing something meaningful to the brain or related biological systems, and to do so in ways that make results more comparable across species and across stages of the development pipeline.

The FOA supports projects that optimize and evaluate neurophysiological measures tied to processes disrupted within individual mental disorders or shared across multiple mental disorders. A defining feature is that the work must be carried out in both healthy humans and at least one other species that is relevant to how therapies are typically developed (for example, an animal species used in preclinical screening). That cross-species requirement is meant to address a long-standing problem in psychiatric treatment development: findings that look promising in animals often fail to translate when therapies reach human testing. By pushing applicants to examine whether the same measure behaves similarly across humans and another species, the initiative tries to identify which measures are genuinely comparable and which ones diverge in ways that should caution against over-interpreting animal results.

The supported studies are described as initial proof-of-concept efforts. That means the program is not simply asking for broad exploratory work, but for targeted early-stage studies that can demonstrate whether a candidate neurophysiological measure can function as a preclinical assay for evaluating drug and device interventions and their biological targets. A successful project would help determine whether a measure is sensitive, reliable, and practical enough to be used in the screening and optimization of new therapeutic candidates, including interventions that affect specific neural circuits or physiological pathways. At the same time, the FOA explicitly values negative or differentiating information: data that show certain measures do not align between animal models and humans are still useful because they create a more defensible basis for limiting speculative extrapolations and refining which preclinical findings should be taken forward.

The practical end goal is to improve the efficiency and credibility of the therapeutic development process for mental disorders. By identifying where measures are coherent across the preclinical-to-clinical pipeline, researchers can make better decisions about which candidates to advance, how to interpret early signals of target engagement, and how to design clinical evaluations that are more likely to succeed. By also documenting inconsistencies, the program aims to reduce wasted effort on measures that cannot realistically serve as translational assays, which can ultimately speed the arrival of more effective treatments.

From an administrative standpoint, this is a discretionary NIH opportunity using a cooperative agreement mechanism, indicating substantial NIH involvement during the project, and it uses the UG3/UH3 phased structure with clinical trials being optional. The activity category is Health (CFDA 93.242). Eligible applicants are broad and include many types of U.S. government entities (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized tribal governments, and tribal organizations that are not federally recognized. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, and for-profit organizations (other than small businesses) and small businesses may also apply. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). The posting lists an original closing date of 2025-06-20 and a creation date of 2023-01-13. The award ceiling and expected number of awards are not specified in the provided listing.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2023-01-13.
• Applicants must submit their applications by 2025-06-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 23 087

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