NINDS CREATE Bio Optimization Track for Biologics (U01)

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This Funding Opportunity Announcement (FOA) supports the optimization of potential therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene and cell therapies) for disorders identified under the NINDS mission. This track supports the further characterization and optimization of therapeutic lead(s) that showed promise as a potential therapeutic agent as evidenced by convincing animal proof-of-concept studies. Therefore, at the end of this funding period, successful projects will have delivered and optimized therapeutic candidate with demonstrated bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and should be eligible for entry into the CREATE Bio Development track. The CREATE Bio Development track is a later stage program focused on the development of optimized therapeutic candidates through Investigational New Drug (IND)-enabling studies and submission of an IND package to the Food and Drug Administration (FDA).

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