The NINDS Cooperative Research to Enable and Advance Translational Enterprises for Biotechnology Products and Biologics (CREATE Bio) program is dedicated to biotechnology product- and biologics-based therapies for disorders that fall under the NINDS mission.
The last NINDS CREATE Bio program announcements (PAR-17-456, PAR-17-457, PAR-18-542, and PAR-18-543) will expire in May 2021.
Applicants seeking support for the discovery and development of biotechnology products and biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) are encouraged to consider the new Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) program. See https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics for more information.
Resources and Tools
The CREATE Bio program has contracts for consultants to advise NIH staff and offer investigators assistance on an ad hoc basis. The consultants have expertise in biologic CMC development, regulatory affairs, and statistics.
Knowing therapy development is a challenging process, NINDS asked its biologic consultant contractors to generate educational guidance documents to better prepare investigators. Roadmap to IND for Protein and Peptide Therapies Cell and Gene Therapy Product Development Matrix.
List of all current (active) CREATE Bio supported projects available in the NIH RePORTER database, with associated publications.
The Translational Application Support Library contains resources to help to successfully apply to the CREATE Bio program such as videos, reference profile tables for each modality, example milestones, example target product profile table, and FAQs.
Applicants using stem cells for their therapy should check out NIH Stem Cell Information. For instance at the archive link you can find Information on a past workshop on Pluripotent Stem Cells in Translation: Preclinical Considerations.