CORE--PHARMACOKINETICS SHARED RESOURCE

St. Jude Children'S Research Hospital, Memphis TN

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The purpose of the Pharmacokinetics Shared Resource (PSR) is to facilitate and centralize high-quality competitively funded peer-reviewed pharmacokinetic/pharmacodynamic research in both clinical and pre-clinical models at the Cancer Center. Objectives are to facilitate proper pharmacokinetic study design; the efficient and proper collection and handling of pharmacokinetic samples; the sensitive and specific analyses of those samples for anticancer drugs, their metabolites, or other relevant pharmacologic indices; and the sophisticated and parsimonious biomedical modeling of the data generated therefrom. The benefits of the PSR to the Cancer Center include: cost-efficiency, consistency in application of state-of-the-art approaches to pharmacokinetic projects, standardized operating procedures for regimented, continuous, and thoroughly documented analytical quality control, centralized sample processing and storage, consolidation of resources in a single facility, minimization of invasive collection procedures in children, and stimulation of scientific collaborations. In response to requests from Cancer Center members, in the current renewal, the capability of the PSR has been enhanced to provide pharmacokinetics research nursing expertise to all Cancer Center members. This ensures the quality of drug administration and sample collection/processing for drug doses associated with pharmacokinetic studies. Specific functions include (1) protocol implementation and maintenance (working with the investigator and CPDMO to develop standard physician's orders to ensure proper collections of clinical and laboratory data, orientation and education of clinical staff regarding pharmacokinetic studies, and ensuring proper sample collection by working with clinicians, technologists, and families, taking care to minimize venipunctures for children); (2) research sample acquisition (centralized receiving, initial processing, storage, and distribution); and (3) analytical assay implementation and ongoing quality control; biomedical modeling, study design and optimal sampling. The PSR has been used by 6 of the 7 Cancer Center programs in the last funding period. The protocol implementation and maintenance function constitutes ~ 20% of the Shared Resource budget, and its usage is demonstrated by its current support for 46 separate clinical protocols and several animal protocols, funded by 19 grant-supported investigators (20 individual grants), representing six Cancer Center programs. Extent of usage of the sample acquisition function, which constitutes ~ 35% of the Shared Resource budget, is illustrated by the monthly research sample workload received and processed by the PSR (an average of more than 800 samples per month, requiring 3197 hours or 1.6 FTE for sample acquisition alone). In the last funding period, 64% of all pharmacokinetic research samples received in the Shared Resource required specialized processing steps beyond simply centrifugation and aliquoting of samples. The analytical assay implementation and ongoing quality control, biomedical modeling, study design and optimal sampling function of the PSR constitutes ~45% of the budget; usage is illustrated by 21 current functions, with >75% of these functions benefiting more than one specific grant-funded project. To encourage usage and to avoid penalizing new projects, a chargeback is not in place. The institution provides funds for 69% of the budget, with 31% ($136,857) requested from the CCSG.