Shared Resource 13: Pharmaco Analytical (PhASR)

PROJECT SUMMARY – PHARMACOANALYTICAL SHARED RESOURCE (PhASR) PhASR provides CCC members with expertise in pharmacokinetic (PK) and pharmacodynamic (PD) studies, including bioanalytical services to accurately quantify drugs, metabolites, and endogenous biomolecules in biological samples to support pre-clinical and clinical development of experimental cancer therapies. This support also includes experimental design, data analysis, modeling and simulation for characterizing PK/PD relationships and simulating optimal dose regimens for the advancement of anti-cancer therapies in pre-clinical and clinical development stages. PhASR was previously rated as Outstanding in the Analytical Shared Resource Group. There were no weaknesses noted, but it was recommended that PhASR plan for anticipated increases for future demand. PhASR’s Specific Aims are to: 1) develop and validate new assays to quantify drugs and metabolites in biological specimens; 2) quantify drug and metabolite levels in biological matrices, and conduct PK/PD studies for incorporation into pre-clinical and clinical decision-making; and 3) provide expertise in PK/PD study design and data interpretation to support submission of early phase 1 and 2 clinical protocols, grants, and publications. During the current 5-year funding cycle, PhASR supported 67 investigators in all five OUSCCC research programs and Nationwide Children’s Hospital, and supported 52 publications (8 with >10 impact factor) and 11 NCI grants, including 1 K22, 1 K24, 2 P01s, 2 P50s, 4 R01s, and 1 UM1. PhASR future services will address OSUCCC strategic priorities in translational genomics, immuno-oncology and cancer engineering. Given the robust OSUCCC recruitment, demand for services and new technologies will increase. The PhASR will expand its staff, instrumentation and services before capacity is reached. Recent and new technologies on order will enhance our efforts for accurate and sensitive measurements in samples of small quantity, focus on development of assays to accurately quantify immunotherapies and other biologics and increase statistical modeling services for PK/PD relationships at the cellular, tumor, organ, or whole body levels. The annual budget of the PhASR is $612,272 yet the CCSG request is $94,171. As such, the PhASR leverages extensive institutional support and seeks only 15.4% support from CCSG funds.