BARDA, the Biomedical Advanced Research and Development Authority within the US Government’s Office of the Assistant Secretary for Preparedness and Response, granted the Indefinite Delivery Indefinite Quantity agreement. The contract requires SNBL to develop animal models to support R&D into chemical, radiological, and nuclear (CRN) countermeasures and supportive reagents and assays for regulatory acceptance by the FDA.
The financials of the contract, which includes fixed-price and cost reimbursement orders, are unknown.
Animal Rule: an ethical solution
Medical countermeasures for CRN threats are an unusual area of research because drug products in this area are not allowed to be tested on humans. Ronald Manning, SNBL USA senior director for model development, said this makes the quality of countermeasure animal models paramount:
“It is most important that the animal models we develop translate to people; a lot of work remains to be done in this area. SNBL USA is committed to the successful development of well-characterized animal models.”
Under the FDA’s Animal Rule, passed as a result of bioterrorism concerns following the September 11th attacks, the agency may license drugs for CRN countermeasures without data from clinical trials where it would be unethical or impossible to test the products on humans.
SNBL USA, a wholly-owned subsidiary of the Japanese contract research organization Shin Nippon Biomedical Laboratories, is headquarted in Everett, Washington and specializes in pre-clinical toxicology models. Its Acute Radiation Syndrome (ARS) programme includes countermeasure evaluation resources, including exploratory animal efficacy studies and pivotal pre-clinical studies under the FDA’s Animal Rule in rodents, mini-pigs and non-human primates.
“SNBL USA is honored to work with BARDA on this contract, which reflects the government’s commitment to enhancing collaborative partnerships to achieve a state of readiness for public health emergencies,” said Koichiro Fukuzaki, SNBL USA CEO. “We are confident that our fully-licenced facilities, Good Laboratory Practice (GLP) experience, and knowledgeable scientific leadership will be a unique scientific resource for BARDA’s programs and research initiatives.”