NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (U44)
Post Date
July 18th 2014
Application Due Date
May 7th 2017
Funding Opportunity Number
PAR-14-289
CFDA Number(s)
93.853
Funding Instrument Type(s)
Cooperative Agreement
Funding Activity Categories
Eligibility Categories
Other Eligible Applicants include the following: Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; 3.Ф(i) SBIR and STTR.ФBe a concern which is more than 50 percent directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 percent directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR (ii) SBIR-only.ФBe a concern which is more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.ФNo single venture capital operating company, hedge fund, or private equity firm may own more than 50 percent of the concern; OR (iii) SBIR and STTR.ФBe a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with _ 121.705(b) concerning registration and proposal requirements. 4.ФHas, including its affiliates, not more than 500 employees.
Funding
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Award Range:
$None - $None
Grant Description
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.
Contact Information
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Agency
Department of Health and Human Services
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Office:
National Institutes of Health
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Agency Contact:
NIH OER Webmaster
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