NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (UH2/UH3)

 

This Funding Opportunity Announcement (FOA) is dedicated to the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission. An identified candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to the CREATE Bio Development Track. The FOA supports Investigational New Drug (IND)-enabling studies for the candidate and early-phase clinical trials. At the end of the funding period, a successful project should have an IND application submitted to the U.S. Food and Drug Administration (FDA), at a minimum. The program supports early-phase clinical trials, although these are not required.

General information about this opportunity
Last Known Status
Active
Program Number
PAR-14-288
Federal Agency/Office
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Cooperative Agreement
Who is eligible to apply/benefit from this assistance?
Applicant 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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.
What is the process for applying and being award this assistance?
Deadlines
05/07/2017
Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements.
Who do I contact about this opportunity?
Headquarters Office
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV
Website Address
http://grants.nih.gov/grants/guide/pa-files/PAR-14-288.html
E-mail Address
FBOWebmaster@OD.NIH.GOV
Financial Information
Obligations
$0.00

 


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