IITRI was one of 7 organizations chosen as a member of a Nonclinical Studies Network created by BARDA to aid in the successful development of medical countermeasures for biological threats. Nonclinical studies supporting treatments for biological threats is especially important since the efficacy of products cannot typically be verified in humans before use in clinical studies due to ethical concerns. The FDA Animal Rule allows the use of new drug products (including vaccines) for potentially lethal biologic threats based on appropriate animal studies that establish that the drug is reasonably likely to produce clinical benefit in humans. Animal Rule studies are conducted at IITRI in our GLP-compliant, BSL-2 or BSL-3 facilities to comply with FDA requirements.