APPENDIX D COMPARATIVE MEDICAL SCIENTISTS' REPORT

(Gail H. Cassell, Thomas P. Clarkson, Linda C. Cork, James G. Fox, Robert O. Jacoby, Denny Liggitt, J. Russell Lindsey, Daniel H. Ringler and John D. Strandberg)

The Comparative Medicine Biotechnology Network would be composed of Comparative Medicine Biotechnology Resources (CMBR's). They would be established at academic institutions with demonstrated excellence in comparative medicine. Each CMBR would provide a specific portfolio of critical technologies and resources that would be accessible to the local, regional and national scientific community. They would also feature specialized services that would contribute to a national network of expertise on animal biology and disease. For example, a given CMBR may have special expertise in molecular diagnostics or genetic engineering or experimental surgery. Establishment of these resources through centralized programmatic planning at NIH would take specialized capabilities and regional needs into account in making awards.

Institutions where biomedical research on animals is conducted under the aegis of public or private nonprofit organizations or governmental agencies would be eligible for support. Grantees would normally be expected to have an affiliation with a school of medicine, but other institutions of higher learning such as schools of veterinary medicine or biotechnology could also apply for support. The animal resource serving the applicant institution would need to be fully accredited by the American Association for Assessment and Accreditation of Laboratory Animal Care International and, when appropriate, registered with the United States Department of Agriculture.

The consortium of CMBRs constituting the Network would serve as institutional, regional, and national resources for critical technologies, services and facilities. These resources would include: 1) animal biotechnology; 2) special animal care facilities; 3) diagnostic services; 4) training in comparative medicine research and technology; 5) information and advice on animal-based research, animal biology, animal health and related issues. The Network would be accessible to investigators and trainees in clinical and basic sciences, both at institutions hosting CMBRs as well as at institutions where expertise or facilities are not available. Use of the Network would emphasize proximate access to facilities or biotechnology services, but would also encourage remote access through a telemedicine network; a feature that should be especially attractive for ensuring the health and quality of research animals. The Network would also encourage collaborative interdisciplinary research among investigational groups and with primary CMBR scientists. Primary scientists would be specialists in key disciplines of comparative medicine and would facilitate research and development supported through individual CMBRs. Financial support for the scientific staff, facilities and equipment would be provided, in part, through federal grants, with the remainder obtained from fees for service.

The 5 primary cores of a comprehensive CMBR (biotechnology, facilities, diagnostics, informatics and training) would be managed by an administrative core that would include a scientific advisory board. A given CMBR would have to provide at least 3 of these cores and demonstrate their value to the host institutions and as regional or national resources. A central advisory or planning group empowered by the NIH may also be desirable to help ensure complementarity, thoroughness, quality and efficiency among individual CMBRs. Each core within a given CMBR would, however, develop, validate and provide a defined menu of services, facilities and/or training in support of cutting-edge animal-based research. It also would emphasize flexibility and responsiveness. Coordination among cores in a given CMBR and among complementary cores with the Network would be fundamental for a user friendly environment and to foster comprehensive services. For example, a molecular geneticist who wishes to examine the effects of a newly identified gene in an animal model, but has only tangential experience with animals, could request a "package" of services including gene-targeting, in vivo phenotyping,



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Biomedical Models and Resources: Current Needs and Future Opportunities APPENDIX D COMPARATIVE MEDICAL SCIENTISTS' REPORT (Gail H. Cassell, Thomas P. Clarkson, Linda C. Cork, James G. Fox, Robert O. Jacoby, Denny Liggitt, J. Russell Lindsey, Daniel H. Ringler and John D. Strandberg) The Comparative Medicine Biotechnology Network would be composed of Comparative Medicine Biotechnology Resources (CMBR's). They would be established at academic institutions with demonstrated excellence in comparative medicine. Each CMBR would provide a specific portfolio of critical technologies and resources that would be accessible to the local, regional and national scientific community. They would also feature specialized services that would contribute to a national network of expertise on animal biology and disease. For example, a given CMBR may have special expertise in molecular diagnostics or genetic engineering or experimental surgery. Establishment of these resources through centralized programmatic planning at NIH would take specialized capabilities and regional needs into account in making awards. Institutions where biomedical research on animals is conducted under the aegis of public or private nonprofit organizations or governmental agencies would be eligible for support. Grantees would normally be expected to have an affiliation with a school of medicine, but other institutions of higher learning such as schools of veterinary medicine or biotechnology could also apply for support. The animal resource serving the applicant institution would need to be fully accredited by the American Association for Assessment and Accreditation of Laboratory Animal Care International and, when appropriate, registered with the United States Department of Agriculture. The consortium of CMBRs constituting the Network would serve as institutional, regional, and national resources for critical technologies, services and facilities. These resources would include: 1) animal biotechnology; 2) special animal care facilities; 3) diagnostic services; 4) training in comparative medicine research and technology; 5) information and advice on animal-based research, animal biology, animal health and related issues. The Network would be accessible to investigators and trainees in clinical and basic sciences, both at institutions hosting CMBRs as well as at institutions where expertise or facilities are not available. Use of the Network would emphasize proximate access to facilities or biotechnology services, but would also encourage remote access through a telemedicine network; a feature that should be especially attractive for ensuring the health and quality of research animals. The Network would also encourage collaborative interdisciplinary research among investigational groups and with primary CMBR scientists. Primary scientists would be specialists in key disciplines of comparative medicine and would facilitate research and development supported through individual CMBRs. Financial support for the scientific staff, facilities and equipment would be provided, in part, through federal grants, with the remainder obtained from fees for service. The 5 primary cores of a comprehensive CMBR (biotechnology, facilities, diagnostics, informatics and training) would be managed by an administrative core that would include a scientific advisory board. A given CMBR would have to provide at least 3 of these cores and demonstrate their value to the host institutions and as regional or national resources. A central advisory or planning group empowered by the NIH may also be desirable to help ensure complementarity, thoroughness, quality and efficiency among individual CMBRs. Each core within a given CMBR would, however, develop, validate and provide a defined menu of services, facilities and/or training in support of cutting-edge animal-based research. It also would emphasize flexibility and responsiveness. Coordination among cores in a given CMBR and among complementary cores with the Network would be fundamental for a user friendly environment and to foster comprehensive services. For example, a molecular geneticist who wishes to examine the effects of a newly identified gene in an animal model, but has only tangential experience with animals, could request a "package" of services including gene-targeting, in vivo phenotyping,

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Biomedical Models and Resources: Current Needs and Future Opportunities animal breeding and embryo cryopreservation. Alternatively, a small research institution wishing to establish a resource for genetically engineered animals would have, on request, telemedicine access to expertise in facility design, normative biology, health monitoring, diagnostic laboratory protocols and related disciplines. Results and advice on animal health issues such as diagnostic microbiology and pathology would also be available through the telemedicine network. A. Biotechnology Biotechnology cores would offer critical, cutting-edge services and advice pertaining to transgenesis; gene-targeting; embryo and sperm cryopreservation; applied immunology including hybridoma production and animal immunization; tissue analysis including special techniques such as molecular hybridization in situ, and biochemical analysis; functional analyses in neurobehavior and other disciplines; advanced imaging; advanced experimental surgery; bioengineering and laboratory diagnostics including molecular diagnostics. B. Specialized Facilities These cores would provide special housing and husbandry such as biohazard containment, gnotobiotic facilities, tissue, cell line and reagent banks, diet kitchens, surgical facilities, bioengineering workshops and telemonitoring facilities. C. Diagnostics These cores would provide expertise in testing and reagent development, including molecular diagnostics, to ensure the quality of research animals and to minimize interference and interruption from infection and disease. They would detect and analyze conditions that may distort animal-based research and provide guidance for the elimination and prevention of these conditions. They also would interface with the biotechnology core(s) to develop, improve and validate testing methods, and with specialized facilities to provide testing reagents to qualified clients such as animal resource directors. D. Informatics These cores would provide consultation on issues concerning animal experimentation ranging from research planning to animal health to biotechnology. The cores would link their expertise for "real time" responses through a national telemedicine network under a common web-site.

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Biomedical Models and Resources: Current Needs and Future Opportunities E. Training These cores would provide advanced training in animal-based research, animal biotechnology and diagnostic laboratory methods for aspiring or for established scientists who want to improve their ability to use animals in research. Training would emphasize bench experience, but also would include an outreach program using telemedicine seminars and short-courses coordinated among the CMBRs. Visiting scientists could train for variable periods. Full-time extended training of up to 3 years would be geared to aspiring comparative medical scientists. Each trainee would choose a mentor at the host institution, who may be a primary scientist in the respective CMBR. Full-time training would develop independent scientists with a primary interest in comparative aspects of animal biology and disease. Training programs for technical staff would also be encouraged. F. Administration These cores would provide overall leadership for a CMBR. Each CMBR would have a director. The CMBR directors would interact regularly to ensure that the national Network provides complementary and comprehensive services. Each core in a given CMBR would be directed by a senior primary scientist. Each CMBR would also have a scientific advisory committee consisting of senior scientists drawn from the host institutions and from other institutions in the region. They would overview the direction and quality of CMBR services and facilities. The director also would have an administrative staff for routine services and to provide informatics support. G. Personnel Principal Investigator (unsalaried) The Principal Investigator would be a senior official of the institution such as a Dean or Provost. This individual would be responsible to the funding agency for the overall administration and operation of the CMBR. Program Director (salaried) The Program Director (PD) would be a leading comparative medical scientist with extensive research and administrative experience and a senior full-time faculty member at the host institution. The PD would have an established record of peer-reviewed research productivity and training experience. Although it would be desirable for the PD to hold a PIship on an NIH grant or other peer-reviewed external funding at the time of the application, the individual's overall academic and administrative record would be paramount in judging his/her qualifications for leadership. The PD should be familiar with all of the services provided by the CMBR, a working knowledge of all technologies would not be essential. Core Directors (salaried) Each Core Director (CD) would be a senior full-time scientist at the host institution. He/she would demonstrate a thorough working knowledge of the services provided under his/her core. The CD would supervise the core's technical staff and any additional faculty, such as those who would contribute to training or to providing specific technologies.

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Biomedical Models and Resources: Current Needs and Future Opportunities H. Facilities Institutions would have to demonstrate the availability of facilities essential to their CMBR plan. Renovations, equipment and other improvements to existing facilities could be requested. Funds to help develop new facilities would be considered depending on individual circumstances and justification. For example, expansion of a gene targeting facility to include cryopreservation facilities. Optimally, cores with overlapping missions or with the need for common services such as tissue culture hoods, would be physically proximate. Such an arrangement would also facilitate cross-training and cross-coverage among staff. However, a dispersed configuration would be considered, provided that strategies for functional efficiency are demonstrated."