Clinical Pharmacology Shared Resource

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Clinical Pharmacology Shared Resource – Project Summary Established as a University of Kansas Cancer Center (KUCC) developing shared resource in 2012 and selected as an established shared resource in 2015, the Clinical Pharmacology Shared Resource (CPSR) is led by Gregory Reed, PhD. This shared resource has three functional components. 1. Correlative Laboratories - directed by LaToya Berry. The Correlative Laboratories provide GXP-compliant acquisition, processing and storage or shipping of clinical research samples. Following either a sponsor's protocol or CPSR protocols, the staff efficiently and precisely prepares samples from blood (whole blood, serum, plasma or specific blood cell fractions), urine and saliva or processes tissue samples, and then stores or transfers those samples for analysis. The Correlative Laboratories are located near patient treatment areas at the KU Clinical Research Center (KU CRC), Westwood (The University of Kansas Health System's outpatient clinical facility) and at The University of Kansas Health System's main campus. The Correlative Laboratories also provide scientific and technical support to the community oncology sites and Midwest Cancer Alliance (MCA) sites to assist them in sample acquisition, processing and shipping. 2. Bioanalytical Laboratory - led by Reed. Located at the KU CRC, this GLP-compliant facility prepares biological fluids, cells or tissue samples, and analyzes them for concentrations of drugs, drug metabolites and other small molecule biomarkers. Analyses are performed on two UPLC-tandem quadrupole mass spectrometers, with a combined sample throughput of over 30,000 samples per year. 3. Pharmacokinetics/Pharmacodynamics (PK/PD) Unit – also directed by Reed. Reed performs calculations and modeling using the Phoenix/WinNonlin® software to define and interpret the kinetics of drugs and their actions. In addition to these study-specific activities, the staff of the CPSR also play a major role in educating future physicians and researchers, as well as nurses and study coordinators currently involved in cancer clinical trials, on the theory and practice of clinical pharmacology and on how those applications of clinical pharmacology result in more powerful and informative results from clinical trials.