The Chesapeake-Ohio Pharmacokinetics Core for The ETCTN

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The Chesapeake-Ohio Pharmacokinetics Core (ChOP-KC) will provide state-of-the-art and efficient bioanalytical service, design and integration of clinical pharmacology studies into clinical protocol development, sample analysis, and data interpretation to the Experimental Therapeutics Clinical Trials Network (ETCTN). The ChOP-KC consists of the Johns Hopkins University Analytical Pharmacology Core, The Ohio State University Pharmacoanalytical Shared Resource, and the University of Maryland Center for Translational Medicine. The ChOP-KC was formed to maximize expertise, infrastructure, and capabilities and to ensure adequate capacity to achieve the goal of providing world-class bioanalytical and clinical pharmacology support to the ETCTN, including analysis of up to approximately 7,500 pharmacokinetic (PK) specimens per year. We have assembled an interactive team of highly collaborative clinical and translational pharmacologists (Drs. Michelle Rudek (mPI), Sharyn Baker (mPI), Mitch Phelps and Alex Sparreboom), pharmacometricians (Drs. Phelps and Joga Gobburu), and statistician (Dr. Gary Rosner) that have a solid foundation in anticancer drug development. We will utilize our extensive pharmacology experience to support the ETCTN with study design, assay development, generation, analysis, and interpretation of high-quality data to enhance efficient evaluation and development of novel cancer therapies and to positively impact the clinical care of cancer patients. The ChOP-KC is experienced in providing clinical pharmacology and drug development support during the conduct of early phase clinical trials and has an extensive track-record of collaboration within various NCI Cooperative Agreements funded entities, including the ETCTN (UM1CA186691 and UM1CA186712) and associated Project Teams, AIDS Malignancy Consortium (UM1CA121947), and the Adult Brain Tumor Consortium (UM1CA137443), in addition to supporting investigator-initiated trials and non-clinical cancer drug development at their respective institutions and nationally. Specific Aims are: 1) To provide state-of-the-art, Good Laboratory Practice (GLP)-quality evaluations to quantitate anticancer drugs and metabolites in biological fluids; 2) To contribute collaboratively and actively in the NCI ETCTN by providing clinical pharmacology expertise to develop clinical trial protocols; and 3) To provide pharmacokinetic/pharmacodynamic data analysis and interpretation to support decision-making for safe and efficient clinical drug development. The ChOP-KC looks forward to applying their collective expertise to benefit ETCTN clinical trials and accelerate experimental therapeutic agent development.