OpportunityTitle: Somatic Cell Genome Editing Program Translational Coordination and Dissemination Center (TCDC) (U24 - Clinical Trial Not Allowed)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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.
GrantorContactEmailDescription: See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
GrantorContactText: NIH OER Webmaster&lt;br/&gt;OERWebmaster03@od.nih.gov