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.

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).

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.

Committee Resources

HESI Staff

Leadership Team

  • Brian Chorley, PhD

    US Environmental Protection Agency

  • Deidre Dalmas Wilk, PhD

    GlaxoSmithKline

Committee Events

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!

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2022 SOT Annual Meeting

San Diego, CA, USA

A number of HESI Scientific Committees will be presenting at the upcoming Society of Toxicology meeting, which will be held virtually and in person in San Diego, CA March 27-31, 2022.

Read more

HESI Sessions at EMGS 2021 Virtual Annual Meeting

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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Committee Publications

The Rat microRNA Body Atlas: Evaluation of the microRNA Content of Rat Organs Through Deep Sequencing and Characterization of Pancreas Enriched miRNAs as Biomarkers of Pancreatic Toxicity in the Rat and Dog

MicroRNAs (miRNA) are ~19-25 nucleotide long RNA molecules that fine tune gene expression through the inhibition of translation or degradation of the mRNA through incorporation into the RNA induced silencing complex (RISC). MicroRNAs are stable in the serum and plasma, are detectable in a wide variety of ...

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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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