This FOA provides support using the SBIR cooperative agreement mechanisms for the development, regulatory qualification and commercialization of alternative approaches methods (NAMs) that specifically utilizes the neuromuscular junction Tissue Chips (TC) platforms that will replace the LD50 assay (mouse lethality bioassay (MLB) as a potency assay for botulinum toxin.
The NIH NCATS and FDA are partners in this FOA and will collaborate and coordinate efforts with award recipients. The goal of this collaboration is to establish the Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) as a Drug Development Tool (DDT). A main objective for this funding opportunity would be to position BoT PATCh as an alternative test method that can be utilized as a stand-alone replacement for MLB. As a cooperative agreement, small business concerns (SBCs) will be expected to work with NIH and FDA staff to develop and implement the final validation plan for the proposed alternative test method.