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.
Companion FOAs:
RFA-RM-22-014 , U01 Research Project (Cooperative Agreements)
RFA-RM-22-015 , U19 Research Program (Cooperative Agreement)
RFA-RM-22-016 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
Deadlines:
Letter of Intent Due Date(s): June 17, 2022
Application Due Date: July 19, 2022
RFA-RM-22-017 Expiration Date July 20, 2022
