This is a $2,014,369 fixed-price contract awarded by the Food and Drug Administration (FDA) to Georgia Tech Research Corporation (Georgia Tech) on September 28, 2022. The contract aims to evaluate and promote the use of cell- and tissue-based assays that more accurately represent human susceptibility to adverse reactions compared to animal models, and predict thresholds of toxicological concerns. This is part of the FDA's Broad Agency Announcement (BAA) focused on advancing regulatory science in nine areas of interest.
Under the contract, Georgia Tech will partner with two subcontractors - the Wisconsin Corporation for Biomedical Research and the Research Foundation for the State University of New York (RF SUNY). The subcontractors will support work related to collecting clinical samples, conducting in vitro to in vivo extrapolation and pharmacokinetic modeling. This contract does not have a set-aside designation. The contract has a period of performance through September 29, 2025.
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