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

  • 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.

  • 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.

  • FFPE Project

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

  • 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).

  • 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.

Recent Highlights

 

HESI OASIS Consortium receives $1.2 million USD grant

The OASIS Consortium, a working group within HESI’s Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee, received $1.2 million from the Massachusetts Life Sciences Center Bytes to Bytes Awards. These funds, supplemented with $2.5 from industry, will support laboratory work at the Broad Institute of Harvard and MIT to investigate Cell Painting, transcriptomics, and proteomics for decision making in toxicology. These funds also support two postdocs positions at the Broad Institute. This 3-year project will explore approximately 1600 compounds across 3 cell types, organoids, and microphysiological systems.

Read the full press release here.

 

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 Publications

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Methodological Considerations for Measuring Biofluid-Based MicroRNA Biomarkers

Critical Reviews in Toxicology, 2021

Chorley BN, Atabakhsh E, Doran G, Gautier JC, ...

MicroRNAs (miRNAs) are small non-coding RNA that regulate the expression of messenger RNA and are implicated in almost all cellular processes. Importantly, miRNAs can be released extracellularly and are stable in these matrices where they may serve as indicators of organ or cell-specific toxicity, disease, and biological ...

Read more

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

Toxicological Sciences, 2020

Chorley BN, Ellinger-Ziegelbauer H, Tackett M, Simutis FJ, ...

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 ...

Read more

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

Regulatory Toxicology and Pharmacology, 2019

Yauk CL, Harrill AH, Ellinger-Ziegelbauer H, van der Laan JW, ...

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

Frontiers in Big Data, 2019

Li HH, Yauk C, Chen R, Hyduke DR, Williams A, Frötschl R, ...

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

BMC Genomics, 2018

Bushel PR, Caiment F, Wu H, O'Lone R, Day F, Calley J, Smith A, ...
  • HESI - Health and Environmental Sciences Institute

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

Toxicological Sciences, 2017

Wehmas LC, Wood CE, Gagne R, Williams A, Yauk C, Gosink MM, ...

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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Committee Resources

HESI Staff

Leadership Team

  • Deidre Dalmas Wilk, PhD

    GlaxoSmithKline

  • Scott Auerbach, PhD

    National Institute of Environmental Health Sciences

  • John Rooney, PhD

    Syngenta

Committee Events

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Genomics in Cancer Risk Assessment

August 27, 2009 – August 28, 2009

Venice, Italy

This workshop was  co-organized by the carcinoGENOMICS Program, ECVAM, HESI Application of Genomics to Mechanism-based Risk Assessment Technical Committee, and the Netherlands Genomics Initiative.

Read more

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                    [post_title] => Genomics Applications in Safety Studies Workshop
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                    [post_title] => HESI Presentations at the 49th Congress of the European Societies of Toxicology
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