Building in vivo Preclinical Assays of Circuit Engagement for Application in Therapeutic Development (R01 Clinical Trial Not Allowed)

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The overall goal of this Funding Opportunity Announcement (FOA) is to identify, in animals, in vivo neurophysiological and behavioral measures for use as assays in the early screening phase of treatment development. The FOA will support efforts to optimize and evaluate measures of neurophysiological and behavioral processes that may serve as surrogate markers of neural processes of clinical interest based on available knowledge of the neurobiology of mental illnesses. The screening assays thus developed from this FOA are expected to build upon systems neurobiology and clinical neuroscience to enhance the scientific value of preclinical animal data contributing to a therapeutic development pipeline by assessing the impact of therapeutic targets and treatment candidates on neurobiological mechanisms of clinical relevance to mental illnesses. The objectives of the FOA will be accomplished by supporting basic and translational neuroscientists who are committed to improving the efficiency and scientific value of the therapeutic development pipeline by advancing the discovery of in vivo physiological and behavioral measures reflecting circuit engagement as tools for early phase target validation and therapeutic screening for mental illness treatment development. The efforts supported by this initiative focus on measures in animals as a first step in generating translational assay measures that are adaptable across early therapeutic screens in animals to evaluation in humans. As such, this FOA may be considered a prequel to build a suite of assays that are evaluated in future projects for coherence of assay performance between the preclinical species and healthy humans (see PAR-16-065; Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3)). In summary, this FOA will support efforts to improve the tool kit of assays available for early phase testing of novel therapeutic agents by incorporating measures proximal to neural systems that impact mental h

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