Pharmacokinetics Shared Resources Core

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PROJECT SUMMARY/ABSTRACT— Pharmacokinetics Shared Resource The Pharmacokinetic Shared Resource (PKSR) is an SJCCC-managed shared resource with the overarching goal of enabling more effective and safer anticancer drug use in children. We accomplish this goal by facilitating high-quality, competitively-funded, peer-reviewed pharmacokinetic (PK) and pharmacodynamic (PD) research by SJCCC investigators working in clinical trials and preclinical cancer models. PKSR collaborates with SJCCC investigators to integrate the highest-quality PK/PD studies into SJCCC preclinical research and Phase I, Phase II, and Phase III clinical trials via the centralized research infrastructure provided by the core. The PKSR also supports education and improvement of research efforts at other institutions by offering PK/PD modeling workshops and a publicly-available, highly-accessed online resource to simulate plasma concentrations of methotrexate in children. The impact of the PKSR on the cancer research in all 5 Programs is evidenced by the high level of collaborative publications and key scientific contributions in high-impact journals such as Journal of Clinical Oncology (n=12), Blood (n=11), Nature Genetics (n=4), and Cancer Cell (n=3). During the last funding period, 139 SJCCC publications from January 2013–December 2017 used the PKSR, representing 38 (27%) interprogrammatic and 96 (69%) intraprogrammatic collaborations. These included publications from all 5 Programs: CCSP (n=6), DBSTP (n=35), HMP (n=86), CBP (n=13), and NBTP (n=51). During the index year (FY2017), 67% of all investigators using the PKSR were SJCCC members (56/83). The PKSR is directed by Dr. Mary Relling (HMP), who is Chair of the Pharmaceutical Sciences Department and has more than 32 years of experience in pediatric cancer PK, PD, and pharmacogenomic research. Dr. Kristine Crews is the co-director of the PKSR, serving in this role since 2005. She has more than 20 years of experience in the areas of clinical pharmacology, PK, and pharmacogenetics. Together, they supervise a staff of technologists, biomedical modelers, coordinators, and research nurses who are fully integrated into the clinical research and pharmaceutical sciences enterprise to ensure that all SJCCC clinical PK/PD research is consistently supported. Goals for the next period include continuing to support SJCCC PK/PD research to advance the translational development of anticancer agents for children. Services will be modified, as needed, to accommodate new assay technologies and modeling approaches and to align with the evolving needs of the SJCCC Programs. The PKSR will also continue to collaborate with SJCCC investigators on the implementation and support of clinical protocols involving PK/PD studies. The PKSR anticipates implementing 12 new protocols and supporting 90 individual projects or protocols each year in the next project period. Lastly, the PKSR will maintain state-of-the art analytical facilities and bring online new assay technologies and modeling approaches to align with the evolving needs of the SJCCC Programs.