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Summary of Presentations 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, pharma- cology, 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 devel- opment and safety testing of those drugs. LABORATORY ANIMAL SCIENCE: 1950s TO 1990s 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 ani- mals. 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. 92
TATSUJI NOMURA 93 The institutions that closed were not able to sustain the support bases that initiated them. For laboratory animal science, their closure was a global setback. As a result, less attention was paid to the microbiological and genetic quality of labo- ratory animals, and the quality of animal research has remained compromised. Medical researchers realize the importance of using high-quality laboratory animals. They have started making demands on laboratory animal scientists to produce high-quality animals and to maintain them in that state. The result has been a renewed impetus to improve laboratory animal quality worldwide. Centers that have not heeded expectations have not survived. Had those centers followed the precepts of their founders, many would undoubtedly still be in existence today. Because such centers have ceased to exist, it has been difficult to continue progress in improving laboratory animal quality globally. Moreover, it has become very difficult to establish long-term uniform strategies to improve labo- ratory animal quality. This problem has been complicated by the advent of genetically engineered rodents produced by molecular biologists and geneticists who are seeking assistance from laboratory animal scientists in defining their animals and maintaining them free of pathogens. Laboratory animal scientists are responsible for helping to establish animal models for human diseases. They require the input of medical doctors to assist in validating animals. Often such expertise and input are not available or sought, resulting in models that are poorly characterized for the human disease they were intended to study. GENETICALLY ENGINEERED ANIMALS Animals created to study human disease are different from animals with a human gene integrated into the genome. Human disease models are used to clarify the etiology, prevention, and treatment of diseases. Laboratory animal scientists should be involved in this domain, especially in the standardization of these animals. We have developed nude mice, severe combined immuno- deficiency disorders (SCID) mice, and several other models from spontaneous mutants that were established as standardized laboratory animals and validated as human disease models. Animals with integrated human genes are used by molecular geneticists to clarify the functions of introduced genes. Human genes or gene products are isolated and inserted to form transgenic animals. Such animal models are used only for molecular genetics. To develop these transgenic mice as human disease models, the process applied to spontaneous mutants is used. To explain this difference from another perspective, molecular geneticists create genetically engineered animals to use as models for their research. How- ever, subsequent use of these animals as human disease models requires stan- dardization, with an established supply system and quality standards. The useful- ness and limitations must also be validated before the animal becomes a model.
94 MICROBIAL AND PHENOTYPIC DEFINITION OF RATS AND MICE It should be emphasized that molecular biologists are users or consumers in the same way as is the pharmaceutical industry. They are not involved in laboratory animal science. CONCLUSION The immediate future promises to be the golden age of international labora- tory animal science. We must have opinion leaders who are aware of the need both for high-quality animals for biomedical research and drug discovery and for meeting the new challenges presented by the diversification of genetically engi- neered rodents.