The Clinical Pharmacodynamics - Biomarkers Program analyzes and creates guidance, standards, and references for assays, including nondiagnostic clinical assays, in support of National Cancer Institute research efforts.

Preclinical assays as resources 

Our preclinical assays are tools for contextualizing the measurements made by related clinical assays and their underlying scientific bases. They are critical for advancing the most promising experimental therapies and making relevant measurements that inform researchers’ drug development decisions.

Validating assay performance 

Our group's National Clinical Target Validation Laboratory is a clinical pharmacodynamics validation and testing center that works with investigators to validate and evaluate the performance of pharmacodynamics assays. Our team analyzes patient-derived clinical specimens, especially those from first-in-human drug studies.

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Measuring T-cell activation in peripheral blood 

Our group’s Pharmacodynamic Assay Development and Implementation Section supported a project to develop an assay to measure the activation of CD4+ and CD8+ T cells in peripheral blood. Clinical trials subsequently demonstrated the assay’s utility and clinical readiness. The assay, known as TCAP-1, assesses how certain drugs affect the phosphorylation status of T-cell receptor–related protein in peripheral blood immune cells.

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Our Work

Pharmacodynamic Assay Development and Implementation Section 

Our team designs, develops, validates, and transfers assays. We support preclinical drug development for various clinical trials and provide support for the NCI Experimental Therapeutics (NExT) Program.

Our section includes the Immuno-oncology Pharmacodynamics Flow Cytometry Team, which focuses on designing and developing flow cytometry assays to support NCI clinical trials.

National Clinical Target Validation Laboratory 

Our laboratory is a clinical pharmacodynamic biomarker validation and testing center and is a key component of the Clinical Pharmacodynamics - Biomarkers Program. 

Our team works closely with clinicians and investigators in the Preclinical Assay Development and Implementation Section and at NCI to validate pharmacodynamic assay performance and provide laboratory support for clinical trials sponsored by the NCI Division of Cancer Treatment and Diagnosis, especially first-in-human drug studies, by analyzing patient specimens.

We focus on quantitative immunofluorescence assays (IFAs), circulating tumor cell (CTC) biomarker assays, and multiplexed immunoassays (IAs).

Phase I/II Pharmacokinetic/Pharmacodynamic Support Laboratory 

We provide biospecimen collection and processing core support in accordance with clinical protocols for the Early Clinical Trials Development Program. Our laboratory processes specimens for pharmacokinetic/pharmacodynamic components of clinical trials sponsored by NCI's Cancer Therapy Evaluation Program