The Duke Funding Alert newsletter, published every Monday, provides information on all new and updated grants and fellowships added to the database during the prior week. This listserv is restricted to members of the Duke community.
CREATE Bio Development Track: Nonclinical and Early-Phase Clinical Development for Biologics (U01 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-18-542 Expiration Date September 8, 2020
Application budgets are not limited but must reflect the actual needs of the proposed project.
Applications should rarely exceed $1,000,000 in direct costs per year unless during the optional clinical trial phase in which up to $1,500,000 in direct costs per year may be justified.