CORE-012: PHARMACOANALYTICAL SHARED RESOURCE (PhASR) PROJECT SUMMARY / ABSTRACT The Ohio State University Comprehensive Cancer Center (OSUCCC) Pharmacoanalytical Shared Resource (PhASR) provides critical support to OSUCCC's robust drug development efforts, highlighted by a robust clinical trials program that has increased therapeutic accruals by 51% during the prior grant period and notable because the OSUCCC is one of only five institutions with both an NCI clinical trials UM1 Phase I grant and N01 Phase II contract. PhASR's Specific Aims are: 1) development and validation of new assays to quantify drugs and metabolites in biological specimens; 2) quantify drug and metabolite levels in biological matrices, and conduct pharmacokinetic (PK) and pharmacodynamic (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 clinical protocols, grants, and publications. PhASR is directed by Dr. Mitchell Phelps (LR) and the Senior Faculty Advisor is Dr. Michael Grever (LR). Located within the Biomedical Research Tower, PhASR is accessible to most OSUCCC cancer researchers, and is directly across from the new James Cancer Hospital. Outstanding institutional support is provided by the OSUCCC, College of Pharmacy, and Center for Clinical and Translational Science. Major equipment in PhASR includes 5 LC-MS systems ideally suited for drug quantification and metabolite identification, namely a quadrupole-time-of-flight, an ion trap, and three triple-quadrupole mass spectrometers, supported by ultra-high pressure liquid chromatography systems and automated sample processing for high throughput analysis. The Dionex RSLCnano/TSQ Quantiva mass spectrometer is the most advanced on the market. During the prior grant period, PhASR provided services to 50 OSUCCC members, representing all 5 programs, and developed more than 120 assays. It has provided 14,416 hours of services as well as assays for 2024 samples during the prior grant period. PhASR has contributed to over 79 publications (7 with an impact factor >10), contributed data for 41 grant applications and has supported 53 clinical trials. In the future, the PhASR will enhance its support for the OSUCCC Drug Development Institute (DDI), and increase both its pharmacodynamic and modeling services, and recruit additional faculty in pharmaceutics. The annual budget is $744,732, yet the CCSG request is $77,729. The PhASR leverages extensive institutional support and seeks only 10.4% support from CCSG funds. The Pharmacoanalytical Shared Resource is part of the Analytics Grouping.
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