eSTAR

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.

TGx-DDI Project receives FDA Funding

The HESI eSTAR committee is proud to announce that it was awarded a $250,000 USD grant (U01) as part of the USFDA’s Biomarker Qualification Program in June 2022. This funding will be partnered with Committee resources to support a four-site ring trial generating additional data on the TGx-DDI (TGx = toxicogenomics; DDI = DNA damage inducing) biomarker. The TgX-DDI biomarker is currently under review by the FDA as part of the FDA Biomarker Qualification program. Pending the results of this final study, the marker is anticipated to gain FDA approval for optional use as added weight of evidence in the assessment of genotoxicity. The marker has the potential to improve upon the low specificity of in vitro chromosome damage assays used in current testing and to aid drug development by providing mechanistic insights into transcriptional changes occurring in genes involved in key DNA damage pathways.

Cell Painting and Error Corrected Sequencing Call for Stakeholders

The Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee is exploring two new projects, one relating to cell painting for safety assessment and the other exploring the use of error corrected sequencing to predict tumorigenicity from non-genotoxic carcinogens. Both groups are looking for additional stakeholders.

Interested in finding out more? Please contact Saddef Haq (shaq@hesiglobal.org)

Working Groups

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

    This group is exploring the use of transcriptomic point of departure for chemical risk assessment. A state of the science manuscript is in preparation.

  • 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

    The HESI eSTAR committee is proud to announce that it was awarded a $250,000 USD grant (U01) as part of the USFDA’s Biomarker Qualification Program in June 2022. This funding will be partnered with Committee resources to support a four-site ring trial generating additional data on the TGx-DDI (TGx = toxicogenomics; DDI = DNA damage inducing) biomarker. The TgX-DDI biomarker is currently under review by the FDA as part of the FDA Biomarker Qualification program. Pending the results of this final study, the marker is anticipated to gain FDA approval for optional use as added weight of evidence in the assessment of genotoxicity. The marker has the potential to improve upon the low specificity of in vitro chromosome damage assays used in current testing and to aid drug development by providing mechanistic insights into transcriptional changes occurring in genes involved in key DNA damage pathways.

    Learn more about the use of the TGx-DDI transcriptomic biomarker for the genotoxicity assessment of data-poor chemicals here (poster presented at the 2021 EMGS Virtual Annual Meeting by Anne-Marie Fortin, University of Ottawa).

HESI Staff

Leadership Team

  • Brian Chorley, PhD

    US Environmental Protection Agency

  • Deidre Dalmas Wilk, PhD

    GlaxoSmithKline

Committee Events

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HESI at ICEM2022

August 27, 2022 – September 1, 2022

Ottawa, Canada

HESI will be attending the 13th International Conference on Environmental Mutagens. Meet us there!

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HESI Sessions at EMGS 2021 Virtual Annual Meeting

September 15, 2021 – September 25, 2021

Virtual annual meeting, hosted by the Environmental Mutagenesis and Genomics Society (EMGS)

The Botanical Safety Consortium (BSC), Genetic Toxicology Technical Committee (GTTC), and Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee will present their work at the Environmental Mutagenesis and Genomics Society (EMGS) 2021 Virtual Annual Meeting on September 15-25, 2021.

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Journey of Biomarkers: From Discovery to Qualification

February 11, 2021

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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Laboratory Variability Does Not Preclude Identification of Biological Functions Impacted by Hydroxyurea

Environmental and Molecular Mutagenesis, 2005

Müller A, Boitier E, Hu T, Carr GJ, Le Fèvre AC, Marchandeau JP, ...

The multi-lab International Life Sciences Institute (ILSI) project on the application of genomics to risk assessment offered the unique opportunity to investigate the influence of variability within and between laboratories on identifying biologically relevant gene expression changes.

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