National Institutes of Health

Description

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.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

NIH OER Webmaster<br/>OERWebmaster03@od.nih.gov
OERWebmaster03@od.nih.gov