Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee

Mission Statement

The mission of HESI’s Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee is to develop and deliver innovative systems toxicology approaches for risk assessment. The committee aims to catalyze adoption of new translational and predictive tools that guide decision-making based on mechanistic understanding of toxicological response.

Working Groups

  • Use of Transcriptomic Point of Departure (POD) for Chemical Risk Assessments

    This newly launched project has compiled a broad membership in its first year, was a featured topic at a June 2020 USEPA Science Advisory Panel meeting on next-generation approaches, and was accepted as a 2021 SOT Workshop. A manuscript and a potential data collection activity are in progress.

  • Carcinogenomics Project

    Three active working groups have compiled, curated, and begun analysis of transcriptomic, toxicologic, and pathologic data to identify short-term transcriptional signatures. These signatures will inform molecular mechanisms underlying pathogenesis of histologic risk factors of neoplasia observed in 90-day studies or chronic 6-month rat toxicology studies and that will inform the value/need to conduct a 2-year rat carcinogenicity study. Novel data housing/analysis partnerships were formed with the NIEHS Chemical Effects in Biological Systems (CEBS) data repository and Lhasa.

  • miRNA Biomarkers Project

    An miRNA best practices manuscript was submitted in August 2020. A second paper on renal miRNA biomarkers will be submitted by October 2020. A new experimental and/ or methodology project to reduce hurdles to the use of miRNAs for translational safety assessment and in biological discovery efforts is in development.

  • TgX-DDI Project

    Multiple revisions of the Qualification Plan for the TgX-DDI biomarker were submitted to FDA during 2020, including an added multi-site validation study design per the FDA. The plan is under FDA review; if accepted, experimental work and full qualification will proceed in 2021.

  • FFPE Project

    Multiple revisions of the Qualification Plan for the TgX-DDI biomarker were submitted to FDA during 2020, including an added multi-site validation study design per the FDA. The plan is under FDA review; if accepted, experimental work and full qualification will proceed in 2021.

HESI Staff

Leadership Team

  • Alison Harrill, PhD

    National Institute of Environmental Health Sciences, National Toxicology Program

  • Kamin Johnson, PhD

    Corteva Agriscience

  • Brian Chorley, PhD

    US Environmental Protection Agency

Committee Events

Journey of Biomarkers: From Discovery to Qualification

Webinar, hosted by HESI and the American Association of Pharmaceutical Scientists (AAPS)

Noninvasive monitoring of nephrotoxicity is challenging. Kidney toxicity is currently monitored by plasma/serum markers, e.g., blood urea nitrogen, and serum creatinine, and urinary markers, such as urinary volume, specific gravity, or osmolality, protein, fractional electrolyte excretion, or sediment examination). ...

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Committee Publications

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Urinary miRNA Biomarkers of Drug-Induced Kidney Injury and Their Site Specificity Within the Nephron

Drug-induced kidney injury (DIKI) is a major concern in both drug development and clinical practice. There is an unmet need for biomarkers of glomerular damage and more distal renal injury in the loop of Henle and the collecting duct (CD). A cross-laboratory program to identify and characterize urinary microRNA (miRNA) patterns ...

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A Cross-Sector Call to Improve Carcinogenicity Risk Assessment Through Use of Genomic Methodologies

Robust genomic approaches are now available to realize improvements in efficiencies and translational relevance of cancer risk assessments for drugs and chemicals. The authors propose a path for implementation of innovative cancer risk assessment including incorporating genomic signatures to assess mechanistic relevance ...

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TGx-DDI, A Transcriptomic Biomarker for Genotoxicity Hazard Assessment of Pharmaceuticals and Environmental Chemicals

Genotoxicity testing is an essential component of the safety assessment paradigm required by regulatory agencies world-wide for analysis of drug candidates, and environmental and industrial chemicals. Current genotoxicity testing batteries feature a high incidence of irrelevant positive findings – particularly for in ...

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RATEmiRs: The Rat Atlas of Tissue-Specific and Enriched miRNAs Database

MicroRNAs (miRNAs) regulate gene expression and have been targeted as indicators of environmental/toxicologic stressors. Using the data from our deep sequencing of miRNAs in an extensive sampling of rat tissues, we developed a database called RATEmiRs for the Rat Atlas of Tissue-specific and Enriched miRNAs to allow users to ...

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Demodifying RNA for Transcriptomic Analyses of Archival Formalin-Fixed Paraffin-Embedded Samples

Archival formalin-fixed paraffin-embedded (FFPE) tissue samples offer a vast but largely untapped resource for genomic research. The primary technical issues limiting use of FFPE samples are RNA yield and quality. In this study, we evaluated methods to demodify RNA highly fragmented and crosslinked by formalin fixation. ...

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Development and Validation of a High-Throughput Transcriptomic Biomarker to Address 21st Century Genetic Toxicology Needs

Interpretation of positive genotoxicity findings using the current in vitro testing battery is a major challenge to industry and regulatory agencies. These tests, especially mammalian cell assays, have high sensitivity but suffer from low specificity, leading to high rates of irrelevant positive findings (i.e., positive ...

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