Government-issue animal models

EVERETT, Wash.—SNBL USA Ltd., a wholly owned subsidiary of Japan’s Shin Nippon Biomedical Laboratories Ltd. (SNBL), announced recently that it had been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Service.

This “indefinite delivery indefinite quantity” (IDIQ) contract, with anticipated issuance of fixed-price and cost reimbursement-type task orders, was issued to support the development of chemical, radiological and nuclear (CRN) countermeasures, enabling participating nonclinical laboratories to assist in the animal model development of medical countermeasures and/or supportive reagents and assays for regulatory acceptance in the United States.

The IDIQ contract is estimated at $20 million per year for five years by SNBL’s vice president of business development and marketing, Mark Crane. SNBL had never worked with BARDA before, and this deal was three years in the making.

“BARDA funds programs such as research on acute radiation syndrome (ARS) that no one wants to do,” Crane observes. Animal models will be set up so drugs that are tested can be determined to be effective. Crane notes that destruction of the immune system is one of several sub-syndromes that characterize ARS.

“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 Dr. Koichiro Fukuzaki, CEO of SNBL USA, in an official statement. “We are confident that our fully licensed facilities, good laboratory practice (GLP) experience and knowledgeable scientific leadership will be a unique scientific resource for BARDA’s programs and research initiatives.”

The creation of animal models is a key element in the successful development of medical countermeasures for CRN threats, particularly since efficacy of products directed against most of these threats cannot be verified in human clinical studies for ethical and other reasons. Dr. Ronald Manning, SNBL USA senior director for model development, comments: “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.”

One potential treatment may be Neupogen (filgrastim), a man-made form of a protein that stimulates the growth of white blood cells in the body. Neupogen is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy or by other conditions, and it may be useful in battling ARS.

“SNBL USA has aligned the resources necessary to extend our scope of services,” the company website states. “By utilizing our nonhuman primate, minipig and mouse experience and proficiency, SNBL USA is in a unique position to perform ARS studies, from demonstration of efficacy in representative animal models to pivotal GLP nonclinical studies under the FDA’s Animal Rule.”

The FDA's so-called animal rule was authorized by Congress in 2002, shortly after the 9/11 terrorist attacks, and applies to development and testing of drugs and biologicals to reduce or prevent serious and potentially life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological or nuclear), where human efficacy trials are not feasible or ethical.

SNBL USA is dedicated to the development and expansion of its ARS program in support of ongoing initiatives that relate to research, development and licensure of medical countermeasures aimed at national preparedness. As part of this effort, the company actively participates in local and national meetings and seminars and interacts with divisions of the U.S. government (i.e., the FDA, NIH, DOD and CDC) to develop and sustain collaborative interactions between industry and regulatory agencies.