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.

    Homepage

     

  • 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 Resources

TGx-DDI Biomarker for DNA Damage Classification

Recent Highlights

The HESI Emerging Systems Toxicology Committee (eSTAR) is pleased to recognize Kati Vennemen, PhD candidate at the University of Kansas Medical Center, for her valuable contributions to the Carcinogenomics Working Group.

Supported in part by eSTAR, Kati is advancing gene expression signatures to improve cancer bioassay interpretation and reduce animal use, critical goals in modern toxicology.

The HESI Emerging Systems Toxicology Committee (eSTAR) is pleased to recognize Dr. James Alper Alcaraz, postdoctoral fellow at the University of Ottawa, for his invaluable contributions to the Error Corrected Sequencing Working Group.

Supported in part by eSTAR and the Genetic Toxicology Technical Committee (GTTC), James has led method development and data analysis for using error corrected sequencing methods to advance the use omics in decision making for carcinogenesis assessment.

 

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.


View TGx-DDI Key Publications & Accomplishments

HESI Staff

Leadership Team

  • Scott Auerbach, PhD

    National Institute of Environmental Health Sciences

  • John Rooney, PhD

    Syngenta

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Committee Publications

Filter

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

BMC Genomics, 2016

Smith A, Calley J, Mathur S, Qian HR, Wu H, Farmen M, Caiment F, ...

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 ...

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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Sources of Variance in Baseline Gene Expression in the Rodent Liver

Mutation Research/Genetic Toxicology and Environmental Mutagenesis, 2012

Corton JC, Bushel PR, Fostel J, Raegan BO
  • HESI - Health and Environmental Sciences Institute

The use of gene expression profiling in both clinical and laboratory settings would be enhanced by better characterization of variation due to individual, environmental, and technical factors.

Read more

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Center for Translational Sciences

The Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee is part of the Center for Translational Sciences. This HESI Center serves as a focal point for staff to share strategic approaches, scientific developments, management best practices and innovations with other related HESI committees.

Other Committees in the Center for Translational Sciences are:

For questions about the Center contact:

Contact Us

Health and Environmental Sciences Institute (HESI)

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