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CREATE Bio Development Track: Nonclinical and Early-Phase Clinical Development for Biologics (U44 Clinical Trial Optional)
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).
- Application Due Date(s): February 20, 2018, July 18, 2018, February 13, 2019, July 18, 2019, February 13, 2020, and July 20, 2020
- AIDS Application Due Date(s): May 7, 2018; September 7, 2018; May 7, 2019; September 7, 2019; May 7, 2020; and September 7, 2020
PAR-18-543 Expiration Date September 8, 2020
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.
Application budgets are not limited but must reflect the actual needs of the proposed project.
Typical budgets for these projects will normally remain less than or equal to $1,000,000 per year in total cost for U44 Phase I and $1,500,000 per year in total cost for U44 Phase II.