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NINDS CREATE Bio Optimization Track for Biologics (U01)
This Funding Opportunity Announcement (FOA) supports the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene and cell therapies) for disorders identified under the NINDS mission.
This track supports the further characterization and optimization of therapeutic lead(s) that showed promise as a potential therapeutic agent as evidenced by convincing animal proof-of-concept studies.
Therefore, at the end of this funding period, successful projects will have delivered and optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track.
The CREATE Bio Development track is a later stage program focused on the development of optimized therapeutic candidates through Investigational New Drug (IND)-enabling studies and submission of an IND package to the Food and Drug Administration (FDA).
This track supports the further characterization and optimization of therapeutic lead(s) that showed promise as a potential therapeutic agent as evidenced by convincing animal proof-of-concept studies.
Therefore, at the end of this funding period, successful projects will have delivered and optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track.
The CREATE Bio Development track is a later stage program focused on the development of optimized therapeutic candidates through Investigational New Drug (IND)-enabling studies and submission of an IND package to the Food and Drug Administration (FDA).
Related Programs
Extramural Research Programs in the Neurosciences and Neurological Disorders
Department of Health and Human ServicesWho's Eligible
Relevant Nonprofit Program Categories
Obtain Full Opportunity Text:
http://grants.nih.gov/grants/guide/pa-files/PAR-17-456.html
Additional Information of Eligibility:
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.
Full Opportunity Web Address:
Contact:
Agency Email Description:
Agency Email:
FBOWebmaster@OD.NIH.GOV
Date Posted:
2017-08-14
Application Due Date:
2020-09-07
Archive Date:
2020-10-13
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