The University of Wisconsin-Madison was awarded a $353,326 firm fixed price definitive contract by the Department of Health and Human Services Food and Drug Administration to develop modernized susceptibility guidance for oral cephalosporin antimicrobial agents using pharmacometric approaches. This award responds to the FDA's FY22 Broad Agency Announcement for Advanced Research and Development of Regulatory Science, which sought proposals to advance regulatory science in nine areas of interest through the development of new tools, standards, and approaches supporting safety, efficacy, and quality evaluations of FDA-regulated products. Specifically, this contract will improve susceptibility test interpretive criteria for older oral cephalosporin agents increasingly recommended for treatment of severe bacterial infections, through contemporary characterization of minimum inhibitory concentration distributions for guideline-recommended agents against Escherichia coli and Staphylococcus aureus, pharmacokinetic/pharmacodynamic modeling of these agents using a mouse thigh infection model, and integration of PK-PD relationships with human exposure simulations to identify candidate interpretive criteria. The Institute for Clinical Pharmacodynamics was listed as a major subcontractor on this award. Work will be conducted in Silver Spring, Maryland with no set-aside designation.
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