St. Jude Research
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Center for Translational Pharmacology (CTP) 

The CTP facilitates and centralizes high-quality, competitively funded peer-reviewed pharmacokinetic (PK) & pharmacodynamic (PD) research in both a clinical and preclinical setting at St. Jude.

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OVERVIEW

The CTP facilitates high-quality, competitively funded, peer-reviewed pharmacokinetic/pharmacodynamic translational research. Its key functions include:

  1. Implement translational (clinical and preclinical) trials with pharmacokinetic studies by assisting with study design, building of standard orders and laboratory test procedures, and education of nursing and other staff.
  2. Efficiently and properly collect, accession, process, and distribute pharmacokinetic samples for all trials, clinical or preclinical.
  3. Develop or implement clinical bioanalytical methods and validate their performance to ensure high-quality data, assay sensitivity, and assay specificity per FDA guidelines.
  4. Accurately analyze drug and metabolite concentrations or other relevant pharmacologic indices in clinical or preclinical biological samples.
  5. Develop and apply state-of-the-art biomedical pharmacokinetic and pharmacodynamic modeling (i.e., pharmacometrics).
Biorepository Overview
Biorepository Overview

IMPACT

The CTP resources have been and will continue to expand research horizons and funding by providing outstanding expertise in conducting pharmacokinetic and pharmacodynamic studies, developing novel biomedical models, and providing the highest quality of data while performing these studies in a cost-effective manner.

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As the PI of complex clinical trials, such as SJDAWN and SJMB12, I recognize the importance pharmacokinetic studies play in determining if the medicine is getting to our patient’s cancer in appropriate concentrations. Having the CTP, here at St Jude, means that not only do we get incredible in-house expertise to measure drug concentrations in our patients but that we also get state-of-the art sample receipt, processing, storage, and distribution whenever needed.  This is an essential resource to support our trials and, most importantly, to help improve therapy.

Dr. Giles Robinson, Associate Member

Equipment

Major instrumentation includes:

  • Waters Acquity UPLC H-Class TQD MS/MS system
  • Waters UPLC-Xevo MS/MS system
  • (3) SCIEX Triple Quad 5500 LC-MS/MS systems
  • (4) SCIEX Triple Quad 3500 LC-MS/MS systems

The CTP has access to other Pharmaceutical Sciences division equipment, including:

  • (2) SCIEX QTRAP 7500+ systems
  • SCIEX ZenoTOF 7600 system
  • API 3200 LC-MS/MS system
  • Multiple HPLCs with fluorescence, electrochemical, a UV/diode array detection,
  • Atomic absorption spectrometer 

Modeling and simulation activities use both computer workstations and the St. Jude supercomputing cloud. Pharmacometric software includes:

  • NONMEM (single & multithreaded configurations)
  • ADAPT V
  • PK-Sim 
  • MoBi
  • MonolixSuite (single & multithreaded configurations)
  • GastroPlus
  • FORTRAN
  • Matlab
  • R

Services

Members access the CTP’s clinical and preclinical services by requesting a consultation through the SRM2 portal. All clinical protocols will go through the CTP for Functions 1 and 2 (protocol implementation and sample acquisition) if they include PK/PD studies and access to analytical assay services (Functions 3 and 4). Preclinical bioanalysis is exempted from Function 3 and is performed on a fit-for-purpose basis, typically, a non-validated but rigorously qualified assay. Study design/biomedical modeling (Function 5) is via discussion between investigators and CTP.

Directors

Resources