Structure and Divisions

Division of Translational Research

Division of Translational Research will focus on late stage pre-clinical research and the initial translation from bench to human studies. This is most analogous to Phase I studies in FDA terminology. This component will draw extensively on the UW General Clinical Research Center, and be headed by Dr. Nora Disis, Associate Professor of Medical Oncology. Dr. Danny Shen, Chair of the Department of Pharmacy, will be Co-Director.

DNA Sequence and Gene Analysis Center

Provides high-quality, automated DNA sequencing technology; equipped with automated DNA sequencers including a ABI 377 capable of sequencing 96 samples within a few hours as well as a 3100 Avant High throughput DNA sequencer based on capillary technology. In addition to automated DNA sequencing, the Center also supports genotype analysis of drug metabolizing enzymes and drug transporters. Genotype analysis of pharmacological receptors will be available. (Edward Kelly, PhD, Director)

The Center for Expression Arrays

Provides access to cDNA and Affymetrix microarrays as well as imaging and bioinformatics support for array-based experiments. The range of services spans the development and analysis of custom arrays to Affymetrix chip processing and scanning. The center offers face-to-face and online tutorials such as "Clustering 101", "Challenges in Creating Expression Databases", and "Experimental Design & Other Issues in Microarray Studies". (Roger Bumgarner, PhD, Microbiology, Director)

Clinical Nutrition Research Unit

Supports nutrition-based research. A Laboratory Core provides access to nutritional assays, a Clinical Research Core provides expertise and support personnel to conduct outpatient clinical studies in nutrition and biostatistical analysis, the Body Composition/Energy Expenditure Core provides methods for measuring body composition and metabolic expenditure in humans and small animals, as well as consultation and guidance in choosing methods, and the Nutrient Gene Core provides expertise in mouse genetics to aid in the identification of new genes and disease etiology. (Alan Chait, MD, Endocrinology and Metabolism, Director)

Analytical Assay Development

Support includes identification and quantification of endogenous compounds, as well as drug and metabolite concentrations. Provides complete assay development services, including mini-and full assay validation; routine drug analyses, and customized synthesis services including stable isotope inclusion. Other support includes human and animal pharmacokinetic and pharmacodynamic studies, analyte quantification and biotransformation/disposition. (Evan Kharasch MD, Anesthesiology, Director)

Mass Spectrometry Center/Proteomics Facility

Provides training and access to state-of-the-art instrumentation for detection, identification, and quantification of materials in biomedical and biopharmaceutical research. The UW has made a substantial investment in a proteomics unit with this Center, providing state-of-the-art peptide and protein identification. A major interest is development of proteomics applications in clinical research. Other typical projects are the identification and structural elucidation of natural and synthetic products and quantification of drugs and their biotransformation products in invitro and in vivo studies of drug metabolism and drug-drug interactions. (William Howald, Director)

Cell Analysis Facility

Supports flow cytometric and confocal instrumentation. Facility includes a large teaching component; consultation in experimental design, technical assistance, distribution of raw data files over a network, provision of methods for archival storage, data analysis away from the acquisition computers, interpretation of results, facilities for the preparation and production of presentation graphics, as well as flow cytometry and confocal microscopy courses.(Michele Black, Director)

Molecular Imaging Center

Offers specialized imaging services, research design, and consultation using an array of molecular imaging, PET and MR techniques. The center supports both human and rodent imaging. Resources include instrumentation and expertise for experimental design. (Janet Eary MD, Medicine, Director)

Population Kinetics Resource Facility

Promotes application of integrated systems modeling in biomedical research by providing expertise in experimental design, model development and testing, education, and new mathematical/statistical methods for incorporation in state-of-the-art software tools.(Paolo Vicini, PhD, Director)

UW Gene and Cell Therapy Core Laboratory

Supports clinical trials that require the genetic modification and/or ex vivo manipulation of patient tissues under current Good Manufacturing Practice conditions. A central feature of the laboratory is that it is located on the UW GCRC, facilitating the transfer of patient samples between the clinic and the laboratory. The staff of the laboratory assists investigators in preclinical stages of developing a cell or gene therapy by developing SOP, performing the pre-clinical runs that would add to an IND , and assist in filing of the IND itself. (Anthony Blau MD, Director)

FHCRC Biologics Production Facility

Provides support for the production and purification of antibodies and other cell culture-derived protein products and plasmid DNA, in amounts ranging from milligrams to grams. The facility is designed to produce both clinical grade products, intended for intravenous administration in humans, and non-clinical grade products for use in research models. As with the UW GMP facility, the staff of the laboratory assists investigators in the preclinical stages of development of a cell or gene therapy by developing SOP, performing the pre-clinical runs that would add to an IND , and assist in filing the IND. General Clinical Research Center

The GCRC is a focal point for translational research with studies ranging from novel transplant protocols to infusional agents delivered into the CSF. The GCRC provides research nursing care, biostatistical, informatics, and research compliance support. (Nora Disis MD)

Investigational Drug Services

Assists investigators in carrying out clinical drug studies and using investigational medications. Services offered by the IDS are: preparing and dispensing investigational drugs per study protocols and federal guidelines, protocol review and development, maintaining blinding and randomization records, maintaining drug accountability and dispensing records, procuring and storing investigational drug supplies, patient monitoring, patient education, and 24-hour availability of study medications and drug information through the inpatient pharmacies.(Sheree Miller, PharmD, Dir.)

Transgenic Animal Support Core Laboratory

Supports the development and use of transgenic and knock-out animals. Services and resources provided include the generation of transgenic and gene-targeted mice, frozen stocks of certain mouse ES cell lines, maintenance of transgenic mice or re-generation of previously created strains from other laboratories, and consultation such as designing the carrier for the gene, selection of appropriate mouse strains, etc. (Warren C. Ladiges, DVM, Professor of Comparative Medicine, Director)

The Washington National Primate Research Center

One of eight NIH-supported National Primate Research Centers in the US . Provides specialized resources for nonhuman primate research applicable to the solution of human health problems as well as training programs for scientists, staff and students regarding safety, biohazards, and proper care and use of nonhuman primates in research. (William Morton PhD,VMD, Comparative Medicine, Dir)