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NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 - Clinical Trial Optional)

ID: PAR-18-542 • Type: Posted
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Description

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with 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 this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

Overview

Category of Funding
Health
Funding Instruments
Cooperative Agreement
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 12/20/17 the National Institutes of Health posted grant opportunity PAR-18-542 for NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 - Clinical Trial Optional). The grant will be issued under grant program 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.

Timing

Posted Date
Dec. 20, 2017, 12:00 a.m. EST
Closing Date
May 7, 2021, 12:00 a.m. EDT Past Due
Last Updated
April 28, 2020, 12:23 p.m. EDT
Version
2
Archive Date
June 6, 2021

Eligibility

Eligible Applicants
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
Special district governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
County governments
State governments
City or township governments
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
For profit organizations other than small businesses
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
Additional Info
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.

Award Sizing

Ceiling
$1,500,000
Floor
Not Listed
Estimated Program Funding
Not Provided
Estimated Number of Grants
Not Listed

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster
Contact Phone
(301) 496-3405

Documents

Posted documents for PAR-18-542

Grant Awards

Grants awarded through PAR-18-542

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