Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed)

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There is a lack of early translational funding and technical support for new product developers to move beyond the idea stage and into the product development space. Establishing a technical development center (or centers) will assist researchers developing new digital therapeutics for SUD. These centers will provide idea developers with technical development support to prepare the PI for future funding applications (e.g. Phase I SBIR, other NIH research grants, Blueprint Neurotherapeutics or Blueprint MedTech, etc.). The technical development assistance will include support from experts in the idea to product translation activities including the following: target product profile development clinical need assessment project plan development with timeline and milestones prototype development proof-of-concept study design preliminary safety assessments assistance in understanding current and future regulatory requirements