Clinical Pharmacology (CP)

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Project Summary/Abstract: Clinical Pharmacology (CP) The Clinical Pharmacology (CP) Shared Resource is now in its 19th year of operation and primarily functions to support Norris Cotton Cancer Center (NCCC) investigators in the design, performance, data analysis, and interpretation of pharmacology objectives in preclinical (in vivo and ex-vivo), clinical, chemoprevention, and epidemiological studies, at lowest cost and highest value as possible. The major CPSR services are in 4 domains: (1) Central processing for biological fluids and tissues (e.g., cells, tumor tissue, plasma, saliva, urine, DNA) obtained as part of approved clinical and epidemiological protocols; services that include, but are not limited to, sample logging, processing (including processing peripheral blood mononuclear cells), aliquoting, storage and sample distribution when necessary; (2a) Development of novel analyte assays (when such assays are only available as research methods) using either high performance liquid chromatography (HPLC) with ultra-violet (UV) and/or fluorescence detection, or increasingly liquid-chromatography mass spectrometry (LC-MS/MS) methodology; (2b) Performance of analyte-concentration measurements in biological fluids and tissues for preclinical and clinical oncology studies using these validated bioanalytical assays; (3a) Expert consultation regarding study design and pharmacokinetic and pharmacodynamic hypothesis-development and testing in preclinical and clinical cancer studies; (3b) Pharmacokinetic (PK) and pharmacodynamic (PD) data analysis and PK-PD modeling from pre-clinical and clinical studies; and (4) Research pharmacy services for cancer therapeutic clinical studies with both commercially available drugs and drugs under an investigational new drug application (IND). CP is directed by Dr. Lionel D. Lewis, who has established expertise in the clinical performance, the pharmacokinetics, and the pharmacodynamics of early phase clinical studies of investigational oncology drug/drug combinations. Other staff include a junior faculty pharmacologist with bioanalytical and molecular pharmacology expertise, a research assistant-lab manager with biorepository and bioanalytical expertise, and a research pharmacist with expertise in oncologic and investigational drug pharmacy. During the period 12/01/2012 to 11/30/2013, members of the Molecular Therapeutics (MT) program were the most common and frequent users of CP services, representing 60% of use. However, CP provided important services to other NCCC program members. Cancer Epidemiology (CE) members represented 8.5% of users, Cancer Mechanisms (CM) members represented 8.5% of users, and Immunology & Cancer Immunotherapy (ICI) program members represented 17% of users.