BARDA Biological Animal Model Development 2017-2022

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response awarded this Master IDIQ on March 9, 2017 to establish a network of GLP laboratories for nonclinical animal studies, analytical services, and toxicology services supporting BARDA's medical countermeasures portfolio. Ordering closed on March 8, 2022 and is no longer active.

The vehicle is fully closed to new task orders. The ordering period ran for five years with 27 task orders awarded across the lifecycle. Activity front-loaded significantly: six orders in 2018, four each in 2019 and 2020, three in 2021, and one final order in March 2022. Combined potential value stands at $72.7 million with $69.9 million obligated (96% of potential).

Work contracted under the vehicle centers on development and characterization of animal models—principally nonhuman primates (rhesus and cynomolgus macaques), ferrets, and swine—to support efficacy testing of medical countermeasures against biological threats, filovirus diseases, SARS-CoV-2, Zika, and bacterial infections including ventilator-associated pneumonia. Task orders cover disease-course characterization, vaccine immunogenicity studies, therapeutic efficacy trials, and production of critical viral reagent stocks. All pricing was cost-plus-fixed-fee; most task orders ranged from roughly $750 thousand to $9.6 million.

Competition is heavily concentrated. Battelle Memorial Institute dominates with 15 of 27 orders representing $43.6 million of the $72.7 million combined potential value (60% concentration). Public Health England, Mriglobal, Lovelace Biomedical Research Institute, and IIT Research Institute split the remainder, with two orders each among them. A total of seven primes received awards. All 27 orders funded BARDA/ASPR exclusively; no other customer agencies participated.

The vehicle carried no set-aside restrictions; all awards were unrestricted competitive. The vehicle succeeded a prior BARDA Animal Model Development contract (2011–2016) and represents a closed chapter in BARDA's nonclinical services contracting architecture.

The United States Government (USG) seeks to maintain a network of GLP laboratories that will provide capability for nonclinical animal studies, analytical services, and toxicology services in support of the BARDA portfolio. 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. HHS, through AMCG and BARDA, anticipates 9-12 contract awards will be made to establish capabilities in toxicology, analytical services and nonclinical (animal) testing.