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Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (R01 Clinical Trial Not Allowed)

May 2021 Council

Lead Division/Office

KUH, DEM, DDN

Point(s) of Contact

Anna B. Sadusky, Ph.D.; Bonnie Burgess-Beusse, Ph.D.; Yan Li, Ph.D.; Daniel Gossett, Ph.D.

Executive Summary

Although our understanding of biology and disease continues to increase, there are still numerous failures to advance efficacious and safe therapeutics, leaving significant unmet medical needs. The NIDDK has established a presence in therapeutics translation and, through this initiative, created a route for innovative R01 applications to be solicited and appropriately reviewed. This has resulted in 41 R01 awards from FY2014-FY2020. Without continuation of this initiative, the review venue for this effort cannot be maintained. Given the success of the program, the NIDDK proposes to continue this initiative with a focus on novelty, innovation, and advancing therapeutics where there is clear clinical need.