vations. CRITIQUE ComponentScore OVERALL CENTER SCORE175 RESOURCES AND ENVIRONMENT131Resources131Improvement and Modernization132 ADMINISTRATION AND CENTER OPERATIONS Program Direction: Director's Office143Administrative Services246Business Services187Environmental Health &Radiation Safety351Facilities &Property133Information Technology &Engineering351Research Library139 Animal Services: Division of Animal Resources199Administration Unit181Operations Unit181Behavioral Services Unit134Veterinary Services Unit199Pathology Services Unit232Tissue Distribution Program179Surgery Services Unit200Clinical Medicine Unit180 Core Science Services: Research Support Cores Assisted Reproductive Technology / Embryonic Stem Cell Support Core171Endocrine Technology Support Core150Imaging &Morphology Support Core190Immunology Support Core170Magnetic Resonance Imaging Support Core160Molecular &Cellular Biology Support Core152Virology &Serology Support Core225 Research Plans/Scientific Components Working Groups Biology of Aging151Metabolic Disease160Stem Cells &Developmental Biology151 Collaborative Research Unit154 SCIENTIFIC DIVISIONS AND PROGRAM AREAS Division of Neuroscience129Division of Pathobiology &Immunology160Division of Reproductive Sciences150 Special Resource Programs Primate Genetics Program143Collaborative Genetics Resource Unit125Colony Demographics &Informatics Unit187Biostatistics Unit167Aging NHP Resource (NIA-supported colony)170Obese NHP Resource 162 Pilot Project Program240Deriving Oocytes from Embryonic Stem Cells 221Ex Vivo Analysis of Primate Islet Function244Evaluation of Normal and Ectopic Implantation in Primates with Contrast Enhanced Ultrasound281Determination of Immune Correlates of Protection for Chikungunya Virus Infections245 Resource-Related Research Program Characterization of a Novel Non-Human Primate Inflammatory Bowel Disease Model328 Overall Center Critique: The ONPRC has made significant progress in the past five years by supporting world-class science. The Center has provided specialized animal and research resources to investigators who are Core scientists at the Center, and to collaborative scientists at the host institution or outside of OHSU. The progress is evident in an exemplary publication record in peer-reviewed forums, in investigators'consistent success in obtaining research support (an 8% annual increase is noted), and in the number and quality of collaborative scientific ventures. Specialized resources of particular interest include the Aging Non-Human Primates Resource and the Obese Non-Human Primate Resource. The ONPRC has a number of strengths, including the outstanding quality of science in the three research divisions. Research is viewed as cutting-edge and highly productive, especially in the Neuroscience Division. Center NHPs are managed in state-of-the-art facilities, and their well being is supported with a very strong program attending to behavioral needs. The health status of the animals is exceptional. There has been recent attention given to expanding veterinary care as evidenced by the recruitment of three bright, energetic veterinarians who have strong support from the Center Director;this is seen as a major strength. The planned integration of a newly-recruited veterinarian into the Reproductive Sciences Division, and the plan for veterinary teams to specialize in support of each of the scientific divisions and of the Collaborative Research Unit, are commendable ideas. However, while improvements in the veterinary care program are seen as positive developments, the additional presence of senior boarded professionals would provide important support for the programs, including primate veterinary training programs. Collaborative and coordinated interactions with other, especially west coast, NPRCs are strengths, as is the developing genetics program. The ONPRC is making strides in addressing current needs for NHPs by using creative methods for accessing/swapping animals with other Centers, through improvements in the coordination and sharing of animal use, and with incorporation of non-invasive imaging techniques. Over the course of a decade of leadership changes and the retirement of senior scientists, the ONPRC has experienced major personnel shifts, including the recent selection of a new P51 Principal Investigator and a new Center Director;additional changes have resulted in modification of the areas of responsibility of several Associate Directors. Appointment of the new ONPRC Director has brought about a focus on formalizing the previously functional, although informal, management processes. This formalization is occurring through the use of working groups and the concept of specialized resources as focal points that cross traditional departmental and campus boundaries. The new Center Administration is seen as having great potential. However, as experienced senior scientists depart and retire, the expanded utilization of external advisors for program evaluations and to assist with the recruitment of mid-level scientists would augment internal evaluation processes. There has been a renewed focus on the use of NHP resources because of recent changes in the field of HIV research. The stated goal of improving the efficiency of animal use and of increasing access is commendable, although there is some concern that the ONPRC is not planning to increase the size of the NHP resource along with the improvements in utilization. Infrastructure limitations appear to be the reason for this. The recent recruitment of additional veterinarians, along with plans to create specialized units to support each of the research divisions and the CRU are welcome developments after an extended period of understaffing. Animal sharing within the ONPRC and OHSU seem to be occurring, and the CRU will need be become more involved at advertising this possibility to outside users. The current effort to share and circulate cells, tissues, and animal samples is viewed as a strength, but improvements in documenting these uses would be helpful. It is important to formulate a master plan to develop and enhance Center capabilities, and the lack of such a plan is the basis for several observed weaknesses at the ONPRC. An important component of this plan will be to evaluate inadequate computational services. The tracking of charges for services, of publications and grant outcomes for research projects, of adverse outcomes resulting from animal procedures and surgeries, and of animal health problems could be improved by a process utilizing state-of-the-art computer capture of information and direct user access. The incorporation of plans for the capture of veterinary data was enthusiastically endorsed during the site visit, however, a master plan will be needed to respond fully to computational deficiencies, for software and hardware issues, and for incorporation of state-of-the-technologies. The initiation of a strategic planning process is seen as critical by the Center Director, and these activities will begin within the next several months. The relationship between the ONPRC and the host institution has been evolving as the ONPRC and OHSU organizations continue to merge. Benefits to the Center include assistance for the recruitment of scientists, with joint appointments and support shared between OHSU departments and ONPRC research divisions. The recruitment of two new jointly supported and appointed faculty is a strength. Concerns about the likelihood of fiscal challenges within OHSU impacting the ONPRC were addressed at the site visit by OHSU President and ONPRC Principal Investigator Joseph E. Robertson, Ph.D. Dr. Robertson said that he ONPRC will be protected from adverse cuts, which is welcome recognition of the importance of the ONPRC to the future of OHSU. Despite these positive developments, OHSU needs to demonstrate support for the new Director with ongoing commitment to facility development and through the creation of responsive administrative structures that allow for direct reporting to the Director of critical program elements. Serious weaknesses were noted during the site visit with respect to Environmental Health and Radiation Safety (EHRS) at the ONPRC. There is concern about the number of NHP-human incidents;the level of incidents could indicate haphazard handling of animals, inadequate tranquilization, lack of use of high quality PPE, poor training, risk-taking behavior by employees, poor engineering/cage design, or other causes. Enhanced enforcement of laboratory safety practices and the implementation of needed improvements would be facilitated by a stronger EHRS staff presence at the Center and by direct reporting of EHRS staff to the Director's Office, rather than to the OHSU Director of Environmental Health and Safety. Because of the weaknesses identified with respect to this situation, recruitment of biosafety experts to review the program and allocation of a full-time nurse or certified safety officer to the Center are recommended. There are concerns about adverse interactions resulting from the future development of adjacent lands that have served as buffer zones. These issues will be addressed by the use of fencing and augmented security arrangements. The risk of animal rights terrorist attacks on the ONPRC continue, and will be a focus of OHSU security arrangements for the Center. Dr. Conn has been transferred to direct the Research Advocacy Office at OHSU, and will focus continued attention on ONPRC security issues. Communications have been enhanced through the use of electronic newsletters, cross-campus meetings, focus groups, and improvements in the ONPRC website. These communications are critical to the development of the Center as a national resource. Additional innovations, such as projects to develop colony modeling and the acquisition of a dedicated MRI facility for NHPs are also reported, and have a high potential for improving development and utilization of NHP resources. Lastly, the ongoing involvement of the Center with international training programs and the recruitment of under-represented minority students and post-doctorial fellows are considered to be strengths. These efforts could be further enhanced by using under-represented minority scientist supplements to the P51, R01, and other grant mechanisms to increase the recruitment of Hispanic, African-American, Asian-American, and Native American investigators. I. RESOURCES AND ENVIRONMENT Overall Resources and Environment Critique: The ONPRC Resources and Environment component is well organized, is critical to the Center mission, and supports the OHSU mission effectively. The component is effective in assisting the Center to meet the major goals of providing a regional and national resource for NHP research, with experienced professionals available to assist in the conduct of interdisciplinary biomedical research. Resources and Environment Overall Scientific/Technical Evaluation: 131 Resources Component Critique: The ONPRC is located as a free standing institute on approximately 250 acres and employs approximately 310 people, 80 of whom are doctoral-level scientists or veterinarians. The ONPRC is an Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accredited institute and adheres to all PHS policies and USDA regulatory guidelines. The Center has several different species of primates, with the rhesus macaque specific pathogen free (SPF) resource the most important for Center endeavors. The ONPRC NHP census totals about 4,200 animals, in addition to the 40,000 rodents on related breeding and research projects. The map of the West Campus shows locations of various buildings and animal resources are in a logical orientation with each other, and with easy access from the main Center entrance. Resources important to the Center mission include research laboratories for Core scientists and investigators, and laboratory and support space for seven support Cores including Assisted Reproductive Technology (ART) and Embryonic Stem Cells, Endocrine Technology, Imaging and Morphology, Immunology, Magnetic Resonance Imaging, Molecular and Cellular Biology, and Virology and Serology. There is a mass spectrophotometer room and a tissue distribution area;a Research Library;a bioengineering laboratory that supplies specialized technological laboratories;animal housing and support space for NHPs;an Animal Services Building that contains biosafety containment facilities;first-rate outdoor NHP housing with 32 units holding up to 45 groups of animals;a holding area for an expanded Indian origin SPF rhesus colony;and a computerized animal record system and charge back account service system that tracks all animal records, including documentation of psychological well-being, SPF status, and pedigree analysis. The ONPRC consists of administration buildings, research buildings, eight main indoor animal housing areas and a number of structures for Center support functions. The facilities contain 221,000 sq. ft. of usable indoor space, 74,000 sq. ft. dedicated to laboratory space and 21,000 sq. ft. assigned as office space. Indoor animal housing encompasses 56,000 sq. ft., with the remaining space containing service areas, mechanical rooms, etc. In addition, there are 32 sheltered housing units providing nearly 40,000 sq. ft of animal housing space and seven outdoor NHP corrals, covering a total of 324,000 sq. ft. Resources Scientific/Technical Evaluation: 131 Improvement and Modernization Component Critique: This is an outstanding component that has the means, personnel, and experience to anticipate, purchase, and store replacement equipment. The Facilities Group is critical for the routine maintenance of infrastructure, buildings, security, major equipment, and the daily operation of power plants. Requested equipment is prioritized and appropriately justified. Priority is determined by Advisory Committee consensus and input from personnel. The schedule of completed improvement and modernization projects reflects significant and appropriate expenditure of funds. Funds for improvement and modernization are intended to upgrade the physical plant and replace obsolete resources and research equipment. Items are requested on a per year basis by Core scientists, associated staff, and the Division of Animal Resources (DAR). The list appears to be comprehensive and addresses long-term needs of the Center facilities and the resources thought to be needed for improvement and modernization. Items are been prioritized on the charting tables that give a comprehensive overview and projection of needed Center alterations, renovations, and equipment over the next five years. During the site visit, reviewers noted biosafety hoods made of wood. Although they were certified, wooden hoods are difficult to sanitize and should be slated for replacement with modern equipment. Comprehensive maintenance plans for the Center are accomplished by two methods. First, the ongoing status of equipment is recorded in a Computerized Maintenance Management System (CMMS);and second, industry standards are used to predict when replacement components are required. This is an effective way to determine obsolescence for the purposes of appliance and major parts replacement and timely repairs. This sophisticated computerized process is used in direct combination with staff observation and input on needed maintenance, repairs, or replacements. The combination the two methods can accurately predict and help to assemble a comprehensive plan for maintaining campus infrastructure and building components, and, through documentation, assists in verifying that maintenance gets done. This process is used for administration and research buildings;the physical plant;indoor and outdoor NHP holding areas;corrals;and general facility upgrades including roofs, heating, ventilation, and air conditioning (HVAC) systems, water heaters, cages and racks, freezers, cage washers, surface maintenance, and seismic upgrades of various structures and support equipment, including surgery and research equipment. Improvement and Modernization Scientific/Technical Evaluation: 132 Budget: Recommend support at the requested level. II. ADMINISTRATION AND CENTER OPERATIONS Program Direction: Director's Office
The funds requested will provide support for the research infrastructure required to conduct the most advanced biomedical research using NHPs as models of human health and disease, and to meet the needs of new emerging areas of research in which the NHP model is critical, including increased biodefense and HIV vaccine research, as well as translational research initiatives that are highly interdisciplinary in nature.
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