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Clinical Molecular Pharm

$152,393P30FY2014CANIH

University Of California At Davis, Davis CA

Investigators

Linked publications, trials & patents

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Abstract

The CMPSR continues to provide a resource for high quality collection and analysis of pharmacokinetic specimens. However, the CMPSR has greatly expanded to include collection, processing and analysis of clinical specimens for translational/correlative and pharmacodynamic studies associated with the Center's clinical trials program. Additional objectives of the CMPSR are to: 1) Provide a resource for high-quality collection, processing and analysis of clinical specimens for pharmacokinetic and correlative studies; 2) Develop translational components for investigator-initiated clinical trials; and 3) Identify and validate biomarkers and molecular signatures that are predictive of response to therapy and investigate drug activity, pharmacodynamic responses and mechanisms of acquired or innate resistance. Further, the CMPSR provides UC Davis clinical investigators a comprehensive resource for clinical trial protocol development, including standardized and/or trial-specific language for specimen collection, and development of correlative study scientific components. It also provides services for preclinical modeling and biologic investigations of novel agents and therapeutic combinations that can serve as rationale for study development. Resource personnel work closely with the CTSU and clinical trial investigators to incorporate comprehensive and meaningful correlative and pharmacokinetic components into each trial. Users of the CMPSR are primarily UC Davis Cancer Center clinical investigators developing clinical trials. The CMPSR involvement in a clinical trial may range from the collection and shipping of UCD patient blood specimens enrolled on a cooperative group study, to broader roles including development and implementation of specialized specimen collection procedures and novel assays, comprehensive molecular correlative analysis of trial specimens and preclinical in vitro or in vivo modeling to generate drug mechanism hypotheses that can be tested in the clinic. These efforts often include significant CMPSR input during trial protocol development. The CMPSR also services as a bridge between clinical investigators with other Shared Resources.

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