U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of the Commissioner
  5. Office of the Chief Scientist
  6. National Center for Toxicological Research
  7. Science & Research (NCTR)
  8. NCTR Research Offices and Divisions
  9. NCTR Division of Systems Biology
  1. NCTR Research Offices and Divisions

NCTR Division of Systems Biology Also referred to as: DSB

About the Division


Address regulatory research needs, knowledge gaps, and emerging health threats in regulatory science using systems-biology approaches and innovative technologies of regulatory interests, such as (1) safety and use of medical products (i.e., drugs, biologics, and devices), (2) safety of regulated foods and supplements, (3) safety and detection of components and impurities in regulated products, and (4) develop technological standards and methods used in regulatory science.

Branches Within the Division

DSB is comprised of the immediate office and two branches:

Research Interests

  • Mechanisms of Toxicology and Susceptibility to Adverse Effects
  • Systems and Organ Toxicological Areas
  • Reproduction, Development, and Fertility 
  • Drug Addiction and Psychoactive Effects
  • Methodologies, Diagnostics, and Models for Regulatory Science Applications


  • Characterize systems biology and toxicology with state-of-the-art tools:
    • Transcriptomics, epigenomics, metabolomics, proteomics, lipidomics, and imaging
    • Human-based new alternative methodologies (NAMs) 
    • In vivo disease and pharmacodynamic models 
  • Utilize pharmacological tools — drug classes with known effects (e.g., anthracyclines, tyrosine kinase inhibitors, opioids, etc.)
  • Incorporate innovative computational and instrumental technology 
  • Integrate data with systems-biology informatics 
    • Evaluate differences in risk and toxicology related to species, tissue, sex, and sub-populations

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

    Select DSB Accomplishments in 2021

    COVID-19 Response

    • DSB — with the help of NCTR Center leadership — recruited funding for two Broad Agency Announcement (BAA) contracts that enable NCTR scientists to 1) conduct Biosafety Level 3 studies with SARS-CoV-2 viral strains at the Regional Biocontainment Laboratory at the University of Tennessee Health Science Center (USTHSC), and 2) correlate Matrix-Assisted Laser Desorption-Ionization (MALDI)-imaging mass spectrometry data from COVID-19 infections (human and animal models) with high-powered broadband coherent anti-stokes Raman scattering (BCARS) imaging technologies at Georgia Tech. Research data resulting from these BAA contracts with UTHSC and Georgia Tech are expected to make significant impacts in scientific areas related to:

      Despite the ongoing pandemic and associated limitations related to the number of on-site staff and supply deliveries, DSB scientists published 18 research articles, presented at 12 national and international scientific conferences, provided consults to and collaborated with FDA product centers, supported projects led by other NCTR research divisions, and initiated 9 studies to address COVID-19 knowledge gaps.
      • SARS-CoV-2 infection
      • Host-immune responses
      • Therapeutic combinations
      • Perinatal risks
      • Disease pathogenesis
      • Therapeutic risks
      • Variant cross-reactivity of vaccine targets
      • Potential biomarkers
    • Scientists within DSB and NCTR's Division of Bioinformatics and Biostatistics collaborated in using homology modeling computational chemistry to identify key interactions between the SARS-CoV-2 infection co-receptor angiotensin converting enzyme 2 and the full-length spike protein trimer of SARS-CoV-2 (Frontiers in Chemistry).

    Select 2021 DSB Publications

    Two DSB Researchers in the Lab

    2022 Select Research Projects

    As a result of outreach efforts, several project proposals were initiated and/or planned for development in 2022, including studies in the following topics:

    • COVID-19
    • Vaccines
    • Cannabinoids
    • Cystic fibrosis transmembrane conductance regulator (CFTR) modulators

    In addition, opportunities for new collaborations with academia and access to clinical samples, such as multisystem inflammatory syndrome in children (MIS-C) pediatric samples, were also initiated, which will complement ongoing studies and create opportunities for new projects that will contribute to the NCTR and FDA missions.

    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

    Subscribe to NCTR Research Highlights Newsletter

    Get regular FDA email updates delivered on this topic to your inbox.

    Back to Top