NINDS CREATE Bio Development Track: Preclinical Development for Bio...

By National Institutes of Health
Government Grant





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). Cooperative Agreement


  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others

Thanks to the funder for their generosity.