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Microbial and Phenotypic Definition of Rats and Mice: Proceedings of the 1998 US/Japan Conference (1999)
Institute for Laboratory Animal Research (ILAR)

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Summary of Presentations

Steven P. Pakes

Division of Comparative Medicine

University of Texas Southwestern Medical Center

Dallas, Texas

Current Status of Laboratory Animal Science

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.

Revitalization of Original Focus

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.

 Page
90
Front Matter (R1-R10)
Opening Remarks (Ota) (1-2)
Opening Remarks (Vaitukaitis) (3-4)
The Need for Defined Rats and Mice in Biomedical Research: Problems, Issues, and the Current State of Affairs (Nomura) (5-6)
The Need for Defined Rats and Mice in Biomedical Research: Problems, Issues, and the Current State of Affairs (Tamaoki) (7-11)
The Biological Integrity of Laboratory Rodents (12-14)
Quality Testing System for SPF Animals in Japan and Problems in the Management of Such Systems (15-23)
Definition of Microbiological Status of Rats and Mice/ The Need for Methods of Defining Flora/ International Standards for Terminology (24-27)
Development of Rodent Pathogen Profiles and Adequacy of Detection Technology (28-38)
Current Status of Pathogen Status in Mice and Rats (39-43)
Genetic Background and Phenotypes in Animal Models of Human Diseases (44-47)
Genetic and Phenotypic Definition of Laboratory Mice and Rats/ What Constitutes an Acceptable Genetic-Phenotypic Definition (Katoh) (48-57)
Phenotype Assessment Requires More Than a Casual Observation (58-62)
Genetic and Phenotypic Definition of Laboratory Mice and Rats/ What Constitutes an Acceptable Genetic-Phenotypic Definition (Davisson) (63-70)
Genetic and Phenotypic Definition of Laboratory Mice and Rats/ What Constitutes an Acceptable Genetic-Phenotypic Definition (DeGeorge) (71-75)
CIEA/NCRR/NIH Genetic and Microbiological Monitoring of Mouse and Rat Resources: Directions for the Future (Nomura) (76-77)
CIEA/NCRR/NIH Genetic and Microbiological Monitoring of Mouse and Rat Resources: Directions for the Future (West) (78-82)
Closing Comments/ Summary of Presentations (83-89)
Summary of Presentations (Pakes) (90-91)
Summary of Presentations (Nomura) (92-94)
Appendix A: US/Japan Meeting Agenda (95-97)
Appendix B: Meeting Participants (98-100)

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OCR for page 90
Summary of Presentations Steven P. Pakes Division of Comparative Medicine University of Texas Southwestern Medical Center Dallas, Texas Current Status of Laboratory Animal Science 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. Revitalization of Original Focus 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.

OCR for page 91
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. Future Cooperation 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.

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pharmaceutical companies