Steven P. Pakes

Division of Comparative Medicine

University of Texas Southwestern Medical Center

Dallas, Texas

We all know that there have been significant advances in the various genomic projects. The number of genetically engineered animals is increasing exponentially, as other speakers have said. There has been a virtual explosion of these animals' development, not only to study gene function but also to serve as animal models for human disease. Then there is the important element of harmonization, also mentioned earlier, and especially the standardization of inbred and outbred stocks for biomedical research, drug development, and testing. With regard to mice, there has been an attempt to talk about strain standardization, the preservation of these important strains, and, certainly, genetic and microbiological monitoring and standardizations of these important animal stocks.

The primary purpose of the first cooperative agreement between the United States and Japan was to focus on laboratory animal quality and to exchange knowledge on technologies for identifying the presence or absence of pathogens of animals (primarily laboratory rodents) and methodologies to genetically define those animals. During the last few years, programs to address animal models and genetic preservation of important animal stocks have been conducted. This US/Japan interaction has tried to remain true to its original aim of focusing on the quality of laboratory animals and their definition, and I believe that today's meeting has served to revitalize that notion.

Issues related to laboratory animal quality are more important today than ever before because of the necessity, as the speakers have said, of focusing on the issues emanating from the explosion of genetically engineered stocks. Issues of microbiological quality become even more important because the presence of pathogens may significantly complicate phenotypic expression and may misrepresent those research data. Other factors that further illuminate the importance of microbiological and genetic definition are the global exchange of animals from country to country and laboratory to laboratory and the need to compare testing results for new pharmaceutical products between countries and even between sites in different countries within the same company.

Our current cooperative agreement should continue to be a forum to identify major issues and concerns that deal with the expanding need and importance of defined laboratory animals for biomedical research, drug development, and testing and to work toward agreed-upon approaches to defining and monitoring those animals. The issues that come out of this cooperative program hopefully will stimulate other bodies to address the same topics in more detail than is possible for us in one day, once a year. I am referring primarily to the NIH and its constituents, the CIEA as well as funding agencies and pharmaceutical companies in Japan, funding agencies and pharmaceutical companies in the United States, ILAR, ICLAS, and other national and international groups.

Tatsuji Nomura

Director, Central Institute for Experimental Animals

Kawasaki, Japan

In Japan, we view laboratory animal science as an integrative science that encompasses various disciplines including veterinary science, medicine, pharmacology, drug discovery, and animal experimentation technology. Laboratory animal science is viewed as one part of the infrastructure of biomedical research that aids in the quest to promote the health and welfare of humans and animals. Laboratory animals are indispensable to basic research in nearly all facets of the biosciences. Laboratory animals are also required as living scales for drug development and safety testing of those drugs.

The progress of laboratory animal science requires global leadership and partnership. Historically, several laboratory animal centers were established around the world at about the same time, during the 1950s. These centers had the common goal of modernizing laboratory animal science by improving the quality of laboratory animals, thereby improving research and testing that required animals. Until that time, most stocks of laboratory animals were overtly or covertly infected with various pathogens, and the genetic quality of animals was not widely appreciated. As a result, the interpretation of research results was often complicated. Unfortunately, many of these centers began closing in the mid-1970s. First the center in the United Kingdom closed, followed by those in France and Germany. Although not a center, the Veterinary Resources Branch of the Division of Research Services in NIH also closed. As an exception to this trend, ILAR (established in 1952) did not close and is of course still very active.