BARDA Chem and RadNuc Animal Model 2015-2020

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response awarded this Master IDIQ on September 30, 2015, to establish Good Laboratory Practice animal models for testing medical countermeasures against chemical, radiological, and nuclear agents; the ordering period closed on September 30, 2020, and the vehicle is no longer active.

The vehicle is closed to new orders and past pursuit. The last task order was awarded in September 2021, nearly five years ago. Of the $82.7 million combined potential value across 18 awards, $66.6 million (81%) has been obligated. Most task orders have completion dates in 2022 or earlier, with only a handful extending into 2025 and 2026. New work would require a fresh vehicle or amendment.

Work focuses on animal model development and validation for chemical, radiological, and nuclear threat agents. Task orders span murine, rabbit, minipig, and guinea pig models testing efficacy of medical countermeasures against chlorine gas, sarin, potassium cyanide, sulfur mustard, synthetic opioids, and acute radiation syndrome. Orders include both model development and pharmacodynamic screening of candidate therapeutics. Most task orders carry Cost Plus Fixed Fee or Cost No Fee pricing structures typical of research and development work.

Competition is concentrated among academic institutions and research organizations. University of Maryland, Baltimore leads by potential value at $30 million across four orders, followed by Battelle Memorial Institute at $25.9 million across five orders. University of Illinois, Lovelace Biomedical and Environmental Research Institute, and Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek TNO complete the awardee base. These five firms account for 94% of task-order count and 96% of combined potential value. All 18 awards are unrestricted (no set-aside designations).

The sole customer is ASPR, which placed all 18 orders. Ordering velocity peaked at 10 awards in 2016, then declined to two to three per year through 2018, with minimal activity in 2020 and 2021. Typical task-order ceilings range from roughly $2 million to $11.8 million, with a single outlier at $6.6 million.

The United States Government (USG) seeks appropriate Good Laboratory Practice (GLP) laboratories that are adequate and available to establish new or existing animal tests and/or models for the development of CRN MCMs. In these models, the challenge dose generally should be the same as that which produces the human disease or condition and the pathophysiological mechanism of its toxicity should be reasonably well-understood and mimic the human disease/condition as closely as possible. When these models are used to test the efficacy of potential MCMs for CRN agents, the mechanism of action of the countermeasure will need to establish the utility of the animal model as a surrogate for humans. BARDA anticipates that contracts awarded from this RFP will serve to facilitate the animal model development of medical countermeasures and/or supportive reagents and assays for regulatory acceptance in the U.S.