Novel Assays to Address Translational Gaps in Treatment Development (UH2/UH3)

Submission Date: April 3, 2015

The overall goal of this initiative is to identify, optimize, and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders and which can be assessed in animals and humans. The goal is to support further development of these measures as assays for evaluating potential new drug and device therapies and their targets. Data will also reveal assay measures where the performance between preclinical species and humans is dissimilar, thus establishing a firm basis for limiting speculative extrapolations of preclinical findings. Ultimately, the goal of this FOA is to improve the efficiency of the therapeutic development process by addressing inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates and thereby hasten the development of more effective treatments for mental disorders. The objectives of the FOA will be accomplished by supporting partnerships among basic and translational neuroscientists who are committed to advancing the discovery of physiological measures as tools for target validation and therapeutic development. Groups will be tasked with building a target-engagement-linked-to-functional-brain-effect suite of assays with potential to translate from animals to humans and thus serve as a basis for selecting preclinical treatment candidates for further development and clinical testing. Towards this goal, the FOA will support development, optimization and evaluation of brain based assays in both preclinical species and in healthy humans and the evaluation of assay performance in response to carefully selected chemical, physiological, or behavioral manipulations.

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