BARDA Biological Animal Model and MCM Development   9

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), seeks appropriate facilities that are adequate and available to support establishing new or existing nonclinical models, and/or supportive reagents and assays for the development of medical countermeasures (MCMs) against biological threats, influenza and emerging infectious diseases, and for regulatory acceptance in the U.S. It is anticipated that fixed-price and cost reimbursement type task orders under the IDIQ contract will be issued to carry out nonclinical services.

Biological Nonclinical Studies Network (NSN) of laboratories capabilities must provide expertise, capacity, and program management across three capability areas:

Capability Area 1: Animal Model Development and MCM Testing (Biological Agents)

Capability Area 2: Analytical Method Development, Qualification, Validation, and Testing

Capability Area 3:) Safety and Toxicity Testing

The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the Biomedical Advanced Research and Development Authority (BARDA) to support development and acquisition of medical countermeasures (MCMs) to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza (PI), and emerging infectious diseases (EID). These MCMs include vaccines, therapeutics, diagnostics, and medical devices. Additionally, BARDA is entrusted to foster innovation of technologies that enable better manufacturing, testing, and utilization of these medical countermeasures.

The development of animal models is a key element in the successful development of MCMs for biological threats, particularly since efficacy of products directed against most of these threats cannot be verified using clinical studies. The United States Government (USG) therefore seeks appropriate facilities that are adequate and available to support establishing new or existing nonclinical models, and/or supportive reagents and assays for the development of medical countermeasures (MCMs) against biological threats, influenza and emerging infectious diseases, and for regulatory acceptance in the U.S. It is anticipated that fixed-price and cost reimbursement type task orders under the IDIQ contract will be issued to carry out nonclinical services.

In 2002 and 2015, the FDA amended its regulations for drugs and biologics to permit approval or licensure of MCMs based on substantial evidence of effectiveness in animals when adequate and well-controlled efficacy studies in humans cannot be conducted because it would be unethical to expose healthy human volunteers to lethal or disabling toxic CBRN substances. This change in the regulations (21 CFR 314.600 for drugs and 21 CFR 601.90 for biologics), commonly referred to as the Animal Rule, made the design and conduct of adequate efficacy studies in appropriate animal models of paramount regulatory importance, since the inference of efficacy in humans necessary for drug approval or licensure is based solely on efficacy data derived in animals. Demonstration of the safety of the medical countermeasure (drug or biologic) is done in normal, healthy adult humans and in some cases safety in a related pathology particularly if the drug or biologic is already approved for the related pathology.