National Cooperative Drug/Device Discovery/Development Groups (U01 Clinical Trial Optional)

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The purpose of this initiative is to: accelerate innovative drug and device discovery; develop pharmacologic and neuromodulatory tools for basic and clinical research on mental health, substance use disorders (SUDs) or alcohol addiction; develop and validate tools (pharmacologic or neurostimulation) in support of experimental therapeutic studies of innovative new candidates for mental disorders; and support early stage human studies to rapidly assess the safety, tolerability, and pharmacodynamics of promising drug candidates/devices and new indications for novel Investigational New Drug (IND)-ready agents or Pre-Market Approval (PMA)-ready devices for the treatment of mental disorders, SUDs or alcohol addiction. This FOA encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders or SUDs or alcohol addiction, and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged.

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