OpportunityTitle: IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, 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: This funding opportunity announcement (FOA) is part of a suite of FOAs of the NIH Common Fund Somatic Cell Genome Editing (SCGE) Phase II Program. The goal of this U19 FOA is to support team-based research Projects to accelerate further optimization and development of genome editing-based therapeutic leads towards IND-enabling studies and an IND (Investigational New Drug) application submission to the U.S. Food and Drug Administration (FDA). The proposed leads should demonstrate strong biological rationale and in vitro and/or in vivo proof of concept (POC) data generated in model system(s) each defined by the targeted cell or tissue type to establish a genome editing therapeutic approach that is potentially adaptable to target different pathogenic variants in the same cell or tissue types.
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