Notice of Intent to Publish a Funding Opportunity Announcement for Somatic Cell Genome Editing Translational Coordination and Dissemination Center (U24, Clinical Trial Not Allowed)

The Somatic Cell Genome Editing (SCGE) program from the NIH Common Fund intends to issue Funding Opportunity Announcements (FOAs) for the second phase (FY2023-2027) of the program. In Phase 2 the SCGE program will accelerate the development of genome editing therapeutic agents by: facilitating Investigational New Drug (IND) application enabling studies; establishing pathways to regulatory approval; and disseminating successful strategies for initiating first in human clinical trials. SCGE Phase 2 will include four FOAs; 1) an initiative for the development of technology/assays that support IND-submissions, 2) another for optimizing genome editing-based therapeutic leads for safety and efficacy, 3) a platform clinical trials initiative using genome editing therapeutics for more than one disease, 4) and a Translational Coordination and Dissemination Center (TCDC). Together these initiatives will comprise a consortium that will accelerate the optimization of promising clinical candidates toward IND filings and first in human clinical trials. This Notice is being provided to allow potential TCDC applicants sufficient time to develop responsive projects. The FOA is expected to be published in Spring 2022 with expected application due dates in Summer 2022. Details are provided below.
Categories: Health.