Nonclinical Development Network
The Pandemic and All-Hazards Preparedness Act of 2006 specified that among the duties of advanced research, development, and procurement of qualified medical countermeasures was the design and development of tests or models, including animal models, for such testing.
The development of animal models is a key element in the successful development of medical countermeasures for CBRN, influenza, and emerging infectious agents. The efficacy of products against most of these threats could never be verified using traditional clinical studies. In 2002, the FDA amended its regulations for drugs and biologics to permit approval or licensure of medical countermeasures 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 agents, and relevant field efficacy trials in humans are not feasible. This change in the regulations 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 is based on efficacy data derived in animals.
In May 2011, BARDA awarded multiple contracts to establish the Nonclinical Development Network and facilitate development and qualification of animal models in support of the chemical, biological, radiological and nuclear countermeasures in BARDA's portfolio. The goals of the program are:
- Development of models that meet the requirements to ensure regulatory compiance in support of BARDA's portfolio
- Reduction of project timelines and duplicative studies
- Testing and evaluation of already established products for potential use as MCMs (repurposing)
- Participation from and consultation with external partner AMIC members (NIAID, DoD, FDA) within the PHEMCE organization to maximize productivity and efficiency of the program
- A reasonably well-understood pathophysiological mechanism of the toxicity of the substance (agent) and its prevention/reduction by the test product
- The effect is demonstrated in one or more animal species expected to react with a response predictive of humans
- An animal study outcome that is clearly related to the desired benefit in humans
- Data on pharmacokinetics/dynamics of the product in animals and humans that allows selection of effective doses in humans
- Allow for the testing and evaluation of candidate medical countermeasures
- Use optimized/validated assays to monitor response and bridge data to humans
The animal studies program is a component of BARDA's core services and is available to all of the operational teams within BARDA - CBRN, Influenza and Emerging Infectious Diseases. Areas of focus thus far, include animal model development for Burkholderia psudomallei, Burkholderia mallei Francisella tularemia, hematopoietic acute radiation syndrome, and cyanide ingestion.
Animal Model Network contract awardee map (PDF - 163KB)