(Clinical Shared Resources) Clinical Pharmacology

The overall objective of the Clinical Pharmacology Shared Resource is to advance clinical cancer research by providing clinical pharmacology services to Masonic Cancer Center (MCC) members. This objective is closely aligned with the goal ofthe MCC to translate research findings into safe and highly effective cancer treatments. In the last Cancer Center Support Grant renewal, the Clinical Pharmacology Shared Resource was supported as a developing shared resource. In this application, it is included as a full shared resource. The Shared Resource provides 1) drug analysis services and 2) consulting services for pharmacokinetics, pharmacodynamics, and pharmacogenetics. The Clinical Pharmacology Shared Resource was established in 2008 as a developing shared resource using resources contained in the existing Clinical Pharmacology Analytical Laboratory, which was formed in 2003 in the College of Pharmacy. Personnel in the Shared Resource develop assays to measure drug and metabolite concentrations using HPLC, GC-MS, and LC-MS/MS and validate them to ensure accurate measurement across broad ranges of concentrations. The Shared Resource processes, stores, and ships samples for local and national pharmacology studies. The faculty also provide consulting services to support the design, conduct, and analysis of clinical pharmacology studies and conduct pharmacokinetic, pharmacodynamic, and pharmacogenetic analyses. These services are highly cost efficient because most clinical investigators cannot afford to purchase the expensive analytical equipment needed for drug analysis, may not have laboratory staff trained in assay development and validation, and in some cases may not have laboratories that can process and store blood samples for analysis of drugs in pharmacokinetic or pharmacodynamics studies. In addition, most clinical investigators do not have the expertise to conduct pharmacokinetic analyses. Therefore, the Clinical Pharmacology Shared Resource is providing important, accessible, and value-added services to MCC members. Under the leadership of Pamala Jacobson, PharmD, and Mark Kirstein, PharmD, the Shared Resource has consulted on and supported more than 25 studies and has developed assays to detect more than a dozen cancer drugs and their metabolites. The leaders have extensive research experience in clinical pharmacology, with expertise in stem cell transplantation and solid tumors. Day-to-day operations ofthe analytical laboratory are overseen by Mr. Jim Fisher, who has 28 years of analytical experience and has managed the laboratory since 2003. Within the past 2 years, an external advisory board was established, new staff were hired to improve the timeliness of sample analysis and assay development, and new instruments were purchased. As a result, use and recognition ofthe Clinical Pharmacology Shared Resource have increased among MCC members.