Pharmacology Shared Resource

Matthew M. Ames, Ph.D.
Director

Mayo Clinic Cancer Center’s Pharmacology Share Resource provides clinical and preclinical pharmacologic and pharmacogenetic expertise, methodologies and support for research related to development of anticancer agents, including appropriate clinical trials. The Resource is equipped with instrumentation (most notably HPLC and LC/MS/MS) necessary to support preclinical investigations and Phase I and Phase II clinical trials of new drugs, imaging agents, and chemical compounds. The Shared Resource develops and validates bioanalytical assays for the accurate measurements of drugs and metabolites in biological samples and applies those assays to preclinical and clinical pharmacokinetic studies to assist Cancer Center investigators. The Shared Resource also develops and validates assays for determination of the role of genetic variation in patient drug response, and conducts pharmacogenetic correlative studies in clinical trials. Finally, the Shared Resource also provides a battery of pharmacologic methods for conduct of preclinical studies in support of Cancer Center investigators.

Key services provided by the Pharmacology Shared Resource include:

• Design pharmacokinetic (PK) components of clinical trials
• Develop and validate analytical methodologies (high-performance/pressure liquid chromatography, liquid chromatography-mass spectrometry, mass spectrometry, others)
• Analyze patient samples for drug/metabolite plasma, etc. concentrations
• Analyze plasma concentration-time data (compartmental, non-compartmental, population PK analysis)
• Structure determination of metabolites and elaboration of metabolic pathways
• Develop genotyping methods such as sequencing and fluorescence-based real-time polymerase chain reaction [SYBR green or TacMan]
• Validate methods (Coriell sample sets, Hardy-Weinberg, frequencies, etc.)
• Determine the presence of allelic variants in patient blood and/or tumor (including paraffin) samples
• Analyze genotyping data for genotype-phenotype correlations (in conjunction with statisticians)
• Analysis of paraffin samples

The Shared Resource provides critical pharmacologic support for early clinical trials of new agents. This in-house Resource provides services that are less expensive than outsourcing of batch samples, , and contributes to the cost-effectiveness of Mayo-based trials that contain pharmacologic components (e.g. pharmacokinetics and pharmacogeneticxs). The Resource is a critical component for the Phase I UO1 grant, and has played a major role in many clinical trials including ones sponsored by the North Central Cancer Treatment Group, Children’s Oncology Group, Mayo Clinic and industry. It is intricately connected to the Developmental Therapeutics Program as well. Preclinical studies support Cancer Center investigators in preparation for National Cancer Institute funding applications and in support of NCI-funded grants.