Director: Phil Mack, Ph.D.
Video: Philip Mack, director of the Clinical and Molecular Pharmacology Shared Resource at UC Davis
Comprehensive Cancer Center, describes how the resource provides assistance to clinical trials specialists
conducting research at the Cancer Center.
The Molecular Pharmacology Shared Resource (MPSR) provides a mechanism for high-quality collection, processing and analysis of clinical specimens for pharmacokinetic and correlative studies from clinical trial patients. Additionally, this resource conducts preclinical modeling of novel anticancer agents or therapeutic combination.
This resource is primarily associated with the UC Davis Comprehensive Cancer Center's clinical trials program and works closely with the Cancer Therapeutics Program. Users of this resource are generally principal investigators (PI) of clinical trials seeking to incorporate translational and/or pharmacokinetic studies into their trial design, or generate exploratory or validational preclinical modeling for new agent development or concept proof-of-principle. The long-term objectives of this resource are to identify and validate biomarkers and molecular signatures that are predictive of response to therapy and to perform translational research with clinical impact.
A dedicated staff research associate conducts specimen processing and collection for most UC Davis clinical trials, often requiring unique preparation techniques specific to individual clinical trial protocols. The shared resource administers and maintains a secure, independent specimen database. All processed specimens are logged for tracking purposes and either prepped for shipping to outside institutions or barcoded (de-identified) and stored in aliquots onsite. All specimens are retained for sole use of the clinical trial investigation team, as stipulated by the protocol and study PI. Clinical trials specimens are not made available to investigators not associated with the clinical trial, except at the discretion and consent of the study PI.
The MPSR can provide support ranging from collection/storage of specimens to protocol development and translational study design and analysis.
NOTICE TO ALL PRINCIPAL INVESTIGATORS
This resource is funded by the UC Davis Comprehensive Cancer Center Support Grant (CCSG) awarded by the National Cancer Institute (NCI P30CA093373). Publications that have utilized facility resources, services or scientific data generated by the resource should acknowledge the resource or the assistance provided by resource staff and cite the NCI CCSG grant. The manuscript must comply with NIH Public Access Policy and therefore should be deposited in PubMed Central through the NIHMS system either through your publisher or self-upload. An electronic copy of the publication should also be sent to the resource directors.
The MPSR provides a wide variety of clinical and preclinical translational services as summarized below. Please inquire for costs.
The MPSR works to develop and implement translation/correlative study components for clinical trial protocol. The MPSR will coordinate and manage all specimen collection and processing for the trial PI.
Protocol and Study Development
- Specimen collection protocols and language
- Development of hypotheses and objectives for translational studies
- Development of novel biomarker assays
- HIPAA compliance
- Budget development
- Collection and processing of specimens
- Specimen log-in, de-identification and storage
- Provide periodic updates on specimen accrual to study PI
- Coordinate or perform specimen biomarker analysis
- DNA mutations
- RNA expression
- Plasma protein/nucleotide profiling
- Immunohistochemistry, multispectral imaging
- Data synthesis and analysis
The shared resource can develop a comprehensive analysis plan for in vitro and in vivo testing of novel agents or therapeutic combinations for discovery and proof-of-principle. Such studies can provide rationale for clinical trial development. A wide variety of molecular biology, cell culture and xenograft assays can be provided.
- Novel biomarker assay development
- Preclinical modeling
- Novel agent activity
- Synergy testing
- Target validation