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

    This project is developing transcriptomic-based biomarkers that will be predictive of particular molecular initiating events leading to rat liver tumors. The group has also launched an experimental study in wildtype & knockout rats for molecular initiating events.

  • Cell Painting - Oasis Consortium

    This Consortium has initiated the design and implementation of a pioneering experimental study to advance integration of in vitro ‘omics approaches (Cell Painting, transcriptomics, and proteomics) into safety evaluation. The Massachusetts Life Sciences Center (MLSC) grant has been awarded to our nonprofit partner, the Broad Institute, at $1,000,000! Matched with contributions from our 16 industry partners, we expect a total project budget of approximately $4.2 million.

  • Error Corrected Sequencing

    This group is exploring the use of error corrected sequencing to identify non-genotoxic tumorigenic agents in rodents. An inventory of samples from members was compiled that can be used to measure cancer driver genes. A pilot study has been completed comparing study designs to detect clonal expansion.

  • miRNA Biomarkers Project

    This team designed a study looking at the effect of different nephrotoxicants on multiple miRNAs using an in vitro model for proximal tubule cells. They also conducted a multi-site experimental program on the use of exosomal miRNAs expressed in response to renal toxicants; manuscript published in 2024.

  • TGx-DDI Project

    This group was awarded a $250,000 USD grant (U01) as part of the US FDA’s Biomarker Qualification Program in 2022. This funding was partnered with Committee resources to support a four-site ring trial generating additional data on the TGx-DDI biomarker. Submission package is being prepared for qualification and the group is exploring other opportunities such as the OECD Test Guideline process.

    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.

  • Past Working Groups

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

Committee Publications

Filter

Methodological Considerations for Measuring Biofluid-Based MicroRNA Biomarkers

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 ...

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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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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

FDA’s CDER Pharmacology Toxicology Symposium

Webinar, Global

On May 13, 2024, several esteemed members from HESI’s Genetic Toxicology Technical Committee (GTTC) and Emerging Systems Toxicology for the Assessment of Risk Committee (eSTAR) delivered insightful presentations at the FDA's CDER Pharmacology Toxicology Symposium. This event, organized by the Education Subcommittee, ...

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EUROTOX 2024

Copenhagen, Denmark

Members of the HESI DART, eSTAR and GTTC Committees will be in attendance at EUROTOX 2024 taking place September 8-11 in Copenhagen.

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Using ‘Omics for in vitro toxicology and drug discovery

HESI OASIS Consortium Members Presenting, eSTAR Committee

Join HESI OASIS Consortium members David Rouquie (Bayer) and Jessica Ewald (Broad Institute) for an exciting installment of the DyNAMic Discussions webinar series, where experts share their experiences in overcoming barriers to applying New Approach Methodologies (NAMs) in their fields. This seminar series offers candid ...

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2025 Toxicology Forum Winter Meeting

Raleigh, North Carolina, US

The HESI eSTAR Committee is chairing a session titled "Omics to facilitate more accurate translation from non-clinical models to human health".

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                    [post_title] => 55th Annual Meeting of the Environmental Mutagenesis and Genomics Society (EMGS)
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                    [post_title] => HESI Emerging Systems Toxicology for Assessment of Risk (eSTAR) Committee 2024 Annual Meeting
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