Somatic Cell Genome Editing Program Translational Coordination and Dissemination Center (TCDC) (U24 - Clinical Trial Not Allowed)

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Deadline: Jul 19, 2022

Grant amount: Unspecified amount

Fields of work: Human Genome & Genetics

Applicant type: Government Entity, Indigenous Group, Nonprofit

Funding uses: Research

Location of project: Anywhere in the world

Location of residency: United States

Overview:

The purpose of this FOA is to support the establishment of a Translational Coordination and Dissemination Center (TCDC) for the NIH Somatic Cell Genome Editing (SCGE) Consortium. In its second phase (FY2023-2027), the SCGE program will accelerate the development of genome-editing therapeutic agents by: facilitating IND-enabling studies; establishing pathways to regulatory approval; and disseminating successful strategies for initiating first in human clinical trials. In addition to this TCDC, the Consortium will include three components (development of technology/assays that support IND-submissions, optimize genome editing-based therapeutic leads for safety and efficacy and conduct platform clinical trials using genome editing technologies in 1 disease) which together will accelerate the optimization of promising clinical candidates toward IND filings and future first in human clinical trials. The TCDC is expected to lead consortium-wide activities that facilitate intra-consortium collaborations and that support broad dissemination strategies for regulatory submission. The TCDC will develop a publicly available online platform for data collection and dissemination of consortium-wide activities including stewardship and preservation of data generated by SCGE in Phase I.

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This page was last reviewed April 20, 2022 and last updated April 20, 2022