CREATE Bio Development Track: Nonclinical and Early-Phase Clinical Development for Biologics (U01 Clinical Trial Optional)

Funding Agency:
National Institutes of Health

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).

Companion FOAs:

PAR-17-456U01 Research Project – Cooperative Agreement ,

PAR-17-457U44 Small Business Innovation Research (SBIR) Cooperative, Agreement-Phase II and Fast Track,

PAR-18-543U44 Small Business Innovation Research (SBIR) Cooperative, Agreement-Fast Track  


  • 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

Agency Website

Amount Description

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.     

Funding Type





Engineering and Physical Sciences
Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

February 13, 2020