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

National Institutes of Health

The goal of this initiative is to identify neurophysiological measures as potential assays for treatment development research. The Funding Opportunity Announcement (FOA) will support efforts to optimize and evaluate pharmacodynamic (PD) measures of neurophysiological processes that are disrupted within or across mental disorders in both healthy humans and in another species relevant to the therapeutic development pipeline. The initiative will support initial proof of concept studies aimed at identifying measures for potential development as preclinical assays for evaluating potential new drug and device therapies and their targets. Data may also reveal assay measures where performance is dissimilar between preclinical animal species and humans, thus establishing a firm basis for limiting speculative extrapolations of preclinical animal findings to humans. The ultimate goal of this FOA is to improve the efficiency of the therapeutic development process by identifying congruent measures as well as inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates.

The objectives of the FOA will be accomplished by supporting partnerships among basic and translational neuroscientists who are committed to advancing the discovery of in vivo physiological measures as tools for target validation and therapeutic development. Groups will be tasked with developing and optimizing in vivo assays of brain processes in both animals and in healthy humans. Groups will evaluate assay performance across both species in response to pharmacologic manipulations. In this way, projects will reveal the potential of specific assays to translate from animals to humans, suggesting assays for further development as tools in the treatment development pipeline.

Deadlines:

Letter of Intent Due Date(s): 30 days prior to application due date
Application Due Date(s): Feb 21, 2023; June 21, 2023; Oct 21, 2023; Feb 21, 2024; June 21, 2024; Oct 21, 2024; Feb 21, 2025; June 20, 2025

PAR-23-087 Expiration Date June 21, 2025