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.

Working Groups

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

    This Working Group has compiled a broad membership of experts across sectors and chemical classes to write a recently accepted manuscript on the state of the science on the use and potential applications of transcriptomic PODs. Future work will include discussion of bioinformatic methods to derive transcriptomic PODs.

  • Carcinogenomics Project

    A manuscript was accepted describing the group’s strategy to create transcriptomic biomarkers for particular pathways leading to rat tumors. Current work is to derive and refine the biomarkers. There is also planned experimental work to see gene expression difference in wild type and knock out rats in response to reference compounds.

  • miRNA Biomarkers Project

    Designed and launched a multi-site experimental program on the use of exosomal miRNAs expressed in response to renal toxicants.

  • 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).

  • FFPE Project

    A manuscript on DNA de-modification analysis of clinical tumor samples was accepted; the project will sunset after an educational webinar.

  • Cell Painting - Oasis Consortium

    This newly formed group is planning a proof of concept study to see if Cell Painting data (with or without transcriptomic data) can be predictive of existing rat liver data.

  • Error Corrected Sequencing

    This newly formed group is exploring the use of error corrected sequencing to detect clonal expansion of non-genotoxic carcinogens.

Committee Publications

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 ...

Read more

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 ...

Read more

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Committee Resources

HESI Staff

Leadership Team

  • Brian Chorley, PhD

    US Environmental Protection Agency

  • Deidre Dalmas Wilk, PhD

    GlaxoSmithKline

  • Scott Auerbach, PhD

    National Institute of Environmental Health Sciences

Committee Events

Society of Toxicology Meeting 2023

Nashville, TN, USA

A number of HESI committees will have presentations and posters at the Society of Toxicology Meeting in Nashville, TN.

Read more

eSTAR Committee Annual Meeting 2022

eSTAR Committee Annual Meeting, Virtual

The goals of the eSTAR Annual Meeting will be to communicate updates from the various working groups and listen to talks from leading experts in systems toxicology. On the second day we will have two concurrent half-day sessions for our newest projects, Error Correcting Sequencing and Cell Painting. The entire meeting is free and ...

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HESI at ICEM2022

Ottawa, Canada

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

Read more

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