CLINICAL PHARMACOLOGY SHARED RESOURCE (CPSR): ABSTRACT The first aim of The University of Kansas Cancer Center (KUCC) is to “Leverage unique assets to transform research discoveries from the laboratory and the clinic to drive new anticancer therapeutic development”. The Clinical Pharmacology Shared Resource (CPSR) provides critical technical and scientific support in clinical pharmacology that is absolutely required to achieve this aim. The overarching goal of the CPSR is to provide support to all KUCC investigators and their research teams throughout the lifecycle of a hypothesis-driven investigator-initiated clinical trial (IIT), from early development of trial concept through publication and follow-on grant application. The CPSR provides guidance to our investigators at no cost in dose, analyte and matrix selection, design of sampling schemes, pharmacodynamic endpoints, preparation of clinical trial protocols and data analysis plans, preparation of study-specific laboratory manuals, as well as PK and PK/PD data analysis and reporting. Once activated, the CPSR provides GXP-compliant sample acquisition, processing, short-term storage, and transfer of samples to study-defined sites for analysis. The CPSR provides validated and SOP-driven analysis of trial samples for identification and quantification of drugs, metabolites, and biomarkers using LC-MS/MS, biochemical, and immunochemical methods. Drug and biomarker data, whether generated in the CPSR or from other laboratories, then are used for parametric and nonparametric PK data analysis, PK/PD modeling, and population pharmacokinetics. In response to the needs of our investigators as well as growth in the KUCC research portfolio over the current funding period, we have and will continue to expand our range of available technologies and services required. Based on project demands for greater quantitative sensitivity, structural elucidation of drug metabolites, and for quantification of therapeutic and biomarker proteins, the CPSR is acquiring new LC-MS/MS instrumentation and expanding its capabilities in immunochemical methods. The CPSR works extensively with KUCC members through the IIT Steering Committee as well as the Disease Working Groups to identify opportunities to incorporate clinical pharmacology objectives into clinical trials. The CPSR not only provides direct scientific and technical support for the design, but also enhances productivity and quality of clinical research by educating all members of the research team on the goals of clinical pharmacology and the interactions between team members to achieve these goals. In short, the goal of the CPSR is to provide guidance and technical support to KUCC transdisciplinary teams across research programs to ensure that our IITs evaluate new cancer therapeutic and prevention agents in patients, optimize the utilization of existing anticancer agents, identify new cancer therapeutic and prevention indications for FDA-approved non-cancer drugs, ...