The Office of the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) is seeking information on technical capabilities, data and materials from the public on current Good Laboratory Practice (cGLP) compliant research organizations that are capable of executing nonclinical animal model development studies in the areas of radiological and nuclear (Rad-Nuc) medical countermeasures (MCM).
The Department of Health and Human Services, through the BARDA, requires the establishment of animal models for the development of medical countermeasures (MCM) for Chemical, Biological, Radiological, Nuclear (CBRN); Pandemic Influenza; and Emerging Infectious Diseases (EID).
BARDA seeks information from contract research organizations with regard to their qualifications, experience and capability to conduct and manage studies related to the development of animal models in support of radiological and nuclear medical countermeasure development within BARDA’s portfolio.
Sample activities required under the envisioned contract include:
- Capability to conduct animal models studies related to the development of animal models in support of radiological and nuclear medical countermeasure development.
- Capability including throughput to perform onsite imaging analysis: in vitro and in vivo capabilities, whole body, and organ specific including vascular imaging techniques.
- Capability to perform radioisotope exposure studies using internal delivery (Plutonium, Americium, Cesium, Strontium/Yttrium, Iridium, Uranium).
- Capability to perform efficacy evaluations in various species on candidate compounds (e.g., drugs and biologics)
- Capability to conduct pilot efficacy studies for candidate MCMs using new or existing animal models or tests to establish the pathophysiology/natural history/cause of mortality of threat agents in appropriate animal species.
- Capability including throughput to analyze hematology samples: coagulation assays, Thromboelastography, CBCs with differentials (WBC, RBC, neutrophils, platelets, lymphocytes, reticulocytes, etc.), bone marrow cellularity, flow cytometry and peripheral blood smears.
BARDA intends to use responses to this RFI for planning purposes towards the possible procurement of services from Non-Clinical Contract Research Organizations (CROs).
RFI white papers are due 12:00PM ET on December 13, 2019. Please review Notice ID: RFI-75A501-19BARDARADNUC-00002 for the most current information.