Director: Phil Mack, Ph.D.
The Molecular Pharmacology Shared Resource (MPSR) was created to support the extensive clinical and preclinical oncology research performed at the UC Davis Comprehensive Cancer Center. Through preclinical modeling of novel therapies, high quality specimen collection and banking, predictive and pharmacodynamic specimen analysis and protocol development, the MPSR is designed to augment clinical investigations by advancing understanding of tumor biology and therapeutic activity at a molecular level.
Services provided include (1) collection, processing, and storage of research specimens for clinical trials, (2) molecular correlative and pharmacodynamic studies of specimens from patients on clinical trials, (3) identification and evaluation of biomarkers of treatment benefit or resistance, and (4) molecular characterization and hypothesis-testing of drug activity using in vivo or in vitro modeling. The goal of the MPSR is to provide a centralized, cost-effective and user-friendly service for biospecimen processing, storage and analysis for members of the cancer center research community. The MPSR is completely integrated with the Clinical Trials Support Unit such that specimen collection is conducted automatically and efficiently following the guidelines specified in each unique protocol. In addition, we also assist clinical investigators in protocol development to ensure that the potential of each research study is maximized.
Patient specimens that are collected by the MPSR are processed according to the specified protocol in our on-site lab located on the first floor of the cancer center. Specimens that are intended for off-site analysis are shipped according to International Air Transport Association (IATA) regulations. Specimens that are designated for analysis by UC Davis researchers are bar-coded for de-identification and stored at -80°C until the research is conducted, in accordance with HIPAA privacy guidelines.
- Study consultation to develop correlative research components and determine specimen collection regimen
- Specimen collection, fractionation, bar-coding, transport, tracking, and de-identification (when required by institutional review board (IRB) or requested by the principal investigator)
- Specialized preservation techniques such as collecting cell fractions.
- Extraction of DNA and/or RNA from specimens
- Detection of mutations, quantification of RNA expression levels, and analysis of protein expression of activity
- Specialized assays and novel assay development (IHC, mutational analyses, polymorphisms, ELISAs, etc., with quality controls)
- Honest-broker system to re-match research results with patient data to prepare results for statistical analysis
- Pre-clinical modeling to support clinical trial concepts and LOIs
- Preparation of progress reports on collection and analysis
- Collaboration in manuscript preparation
The MPSR laboratories are equipped to facilitate, coordinate and/or conduct correlative studies associated with clinical trials. MPSR faculty and staff will work with each investigator to develop a correlative analysis plan best suited to each individual study, including coordinating with outside researchers, development of novel assays, specialized collection techniques and all level of specimen handling. All of our specimens are assigned an alpha-numeric code which is printed and barcoded onto each aliquot. Specimen and aliquot data are maintained using Dataworks Development's Freezerworks Unlimited, a caBIG-compliant laboratory information management system for security and efficient tracking of specimen information.
It is the expressed policy of the MPSR to collect and disseminate specimens ONLY AS DIRECTED BY EACH TRIAL SPONSOR AND PRINCIPAL INVESTIGATOR. Specimens from your trial will never be made available to any other researchers without the expressed permission of the study leader, and all policies and practices of the sponsoring agent will be rigidly adhered to. Upon request by the principal investigator, specimens are made available to a designated researcher, usually within 24 hours. Specimens can be provided in any manner, for instance in de-identified single aliquots or fully identified complete specimens. When using our collection services, it is not necessary to use our analysis services. In short, specimens collected on a clinical trial belong solely to the trial sponsor and/or principal investigator and will be preserved for their exclusive use.