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  1. NCTR Research Offices and Divisions

NCTR Division of Systems Biology Also referred to as: DSB

NCTR Division of Systems Biology Word Cloud

Division Director: William B. Mattes, Ph.D., DABT

Meet the Principal Investigators — Systems Biology

Overview of FDA's Perinatal Health Center of Excellence: Development and Validation of Predictive Systems
Presented by Amy Inselman, Ph.D.

Watch the Recorded Presentation

About the Division

The division focuses on the development and evaluation of new technologies and the identification of new biomarkers (disease indicators) to support the FDA's mission. The division's mission is to address problems of food, drug, and medical-product safety using systems biology approaches and innovative technology: 

    Biomarkers of Doxorubicin-Induced Heart Injury

    NCTR scientists developed and used a mouse model of DOX-induced heart injury to identify two proteins (NOTCH1 and vWF) that were elevated in plasma prior to the release of cardiac-specific injury marker, troponin T, in plasma and development of pathology in the heart. Increased level of both proteins was mitigated when toxic effects of DOX were diminished in the heart in mice that received a cardioprotective drug, dexrazoxane, suggesting these proteins as candidate early markers of DOX cardiotoxicity. These early protein markers of DOX-induced heart injury with potential applications in the clinic for monitoring and/or predicting cardiotoxicity induced by DOX will help design more effective treatment regimens. These results have been published in Toxicology and Applied Pharmacology.

    Development of a Mouse Testis Organ System

    The potential for medicines to have adverse effects on male reproductive capacity remains a concern in drug development. While animal tests have been useful, faster methods would be desirable. At the meeting titled “FutureTox IV Progress to Maturity: Predictive Developmental and Reproductive Toxicology for Healthy Children,” scientists from NCTR and CDER presented results of a new in vitro assay where a mouse testis organ system is used to examine the toxicity of chemicals. Further results have been published in Birth Defects Research.

    2019 Select Accomplishments

    • An Integrated Analysis of Metabolites, Peptides, and Inflammation Biomarkers for Assessment of Preanalytical Variability of Human Plasma. Publication in Journal of Proteome Research.
    • Use Cases, Best Practice and Reporting Standards for Metabolomics in Regulatory Toxicology. Nature Communications.
    • Evaluation of the Performance of Lipidyzer Platform and Its Application in the Lipidomics Analysis in Mouse Heart and Liver. Publication in Journal of Proteome Research.
    • Candidate Early Predictive Plasma Protein Markers of Doxorubicin-Induced Chronic Cardiotoxicity in B6C3F1 Mice. Publication in Toxicology and Applied Pharmacology.
    • Testicular Function in Cultured Postnatal Mouse Testis Fragments is Similar To That of Animals During the First wave of Spermatogenesis. Publication in Birth Defects Research.
    • Determined the Sensitivity of CD-1 and CF-1 Mouse Strains to Morphine and Methadone and Whether Exposure During Gestation Leads to the Development of Neural Tube Defects.
    • Investigated the Effects of Opioid Exposure on Neural Precursor Differentiation Using a Human Induced-Pluripotent Stem Cell Model.

    2020 Select Research Projects

    • Investigation of the Mechanistic Aspects of Sex-Based Differences in Susceptibility to Doxorubicin-Induced Cardiac Toxicity in Mice
    • Predict Tyrosine Kinase Inhibitor (TKI) -Induced Cardiotoxicity Using Induced Pluripotent Stem Cell-Derived Cardiomyocytes
    • Verification of Novel Predictive Biomarkers of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients
    • SpecID for Organic Chemical Characterization
    • Evaluation of an In Vitro Mouse Testis Organ Culture System for Assessing Testicular Toxicity

    Resources for You

    Contact Us

    Contact Point
    National Center for Toxicological Research
    Food and Drug Administration
    3900 NCTR Rd
    Jefferson, AR 72079
    Hours Available
    (870) 543-7121
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