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:
- Finds new translational biomarkers that
- Improve detection of unsafe drugs and other FDA-regulated products and
- Improve the identification of disease onset and its progression to enable faster and more effective medical intervention.
- Investigates usefulness of cell-culture models to examine various types of toxicity.
- Facilitates reducing or replacing animals FDA-regulated products safety testing.
- Develops and evaluates innovative methods that
- Detect unsafe products,
- Advance the identification of infectious disease, and
- Enhance disease-detection procedures.
- 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
Select DSB Accomplishments in 2021
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
Technology and Methods
2022 Select Research Projects
Technology and Methods
As a result of outreach efforts, several project proposals were initiated and/or planned for development in 2022, including studies in the following topics:
- 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
- DSB Fact Sheet
- NCTR Grand Rounds: "Overview of FDA's Perinatal Health Center of Excellence: Development and Validation of Predictive Systems" (Presentation recorded in Adobe Connection on July 13, 2019)
- Perinatal Health Center of Excellence (PHCE)
- Annual Report
- Meet the Principal Investigators
- MitoChip: An NCTR-Developed Mitochondrial Research Tool
- About the National Center for Toxicological Research
- National Center for Toxicological Research
Food and Drug Administration
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