Analytical Pharmacology

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PROJECT SUMMARY/ABSTRACT The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Analytical Pharmacology Shared Resource (APSR) has offered state-of-the-art and cost-effective analytical chemistry and clinical pharmacology services to Members continuously since its inception in 1985. The APSR provides instrumentation and facilities in a 1,750 ft2 laboratory on the first floor of the SKCCC Bunting-Blaustein Cancer Research Building. The specific aims of APSR are to: 1) provide expertise in clinical trial and preclinical study design, with a focus on critical pharmacological endpoints; 2) provide state-of-the-art, Good Laboratory Practice-quality, cost-effective services to quantitate anticancer drugs and metabolites or biomarkers in biological fluids; and 3) provide exposure-response analysis and interpretation, with the long-term vision of providing decision tools for drug development in both the preclinical and clinical settings. The APSR houses four ultra-performance liquid chromatography instruments with one UV/Vis detector, three triple-stage quadruple mass spectrometers, one QTrap system with ion trap capabilities for more intricate drug metabolism studies, and one ion mobility spectrometer. The APSR analyzes ~3,600 samples/year, develops ~15 new methods involving ~30 analytes per year and serves 29 faculty members across six of the CCSG Programs (plus nonprogrammatically aligned), with the majority of the users having peer-reviewed funding. The APSR remains a critical component across the translational spectrum, providing services in analytical method development (two manuscripts), drug discovery (three manuscripts), preclinical studies (16 manuscripts), clinical trials (18 manuscripts), exposure- response analyses (five manuscripts) and three other manuscripts. The APSR has participated in the submission of 57 cancer-focused grants over five years (across all CCSG Programs); played a major role in the successful applications for the Johns Hopkins Early Therapeutics Clinical Trials Network (UM1), AIDS Malignancy Consortium (UM1) and Chesapeake-Ohio Pharmacokinetics Core for the ETCTN (U24); and serves as a second laboratory for the Adult Brain Tumor Consortium (UM1). The requested CCSG funding will support personnel who provide consultative services related to assay development, protocol design and data interpretation, and ensure that instrumentation is suitably maintained and utilized efficiently. SKCCC Managed Shared Resource Reporting Period: January 1, 2020 to December 31, 2020