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

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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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Importance of Investigating Epigenetic Alterations for Industry and Regulators: An Appraisal of Current Efforts by the Health and Environmental Sciences Institute

Recent technological advances have led to rapid progress in the characterization of epigenetic modifications that control gene expression in a generally heritable way, and are likely involved in defining cellular phenotypes, developmental stages and disease status from one generation to the next.

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Sources of Variance in Baseline Gene Expression in the Rodent Liver

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.

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Current and Future Applications of Toxicogenomics: Results Summary of a Survey From the HESI Genomics State of Science Subcommittee

In spite of the application of toxicogenomic (TGx) data to the field of toxicology for the past 10 years, the broad implementation and full impact of TGx for chemical and drug evaluation to improve decision making within organizations and by policy makers has not been achieved.

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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

EUROTOX 2024

Copenhagen, Denmark

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

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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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                        )

                    [1] => Array
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                                    [key] => _ilsi_date
                                    [value] => 2050-01-01
                                    [compare] => <=
                                )

                            [1] => Array
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                                    [key] => _ilsi_end_date
                                    [value] => 2050-01-01
                                    [compare] => <=
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                            [relation] => AND
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                    [relation] => AND
                )

            [relation] => AND
            [meta_table] => wp_postmeta
            [meta_id_column] => post_id
            [primary_table] => wp_posts
            [primary_id_column] => ID
            [table_aliases:protected] => Array
                (
                    [0] => wp_postmeta
                    [1] => mt1
                    [2] => mt2
                )

            [clauses:protected] => Array
                (
                    [wp_postmeta] => Array
                        (
                            [key] => _ilsi_date
                            [compare] => =
                            [compare_key] => =
                            [alias] => wp_postmeta
                            [cast] => CHAR
                        )

                    [mt1] => Array
                        (
                            [key] => _ilsi_date
                            [value] => 2050-01-01
                            [compare] => <=
                            [compare_key] => =
                            [alias] => mt1
                            [cast] => CHAR
                        )

                    [mt2] => Array
                        (
                            [key] => _ilsi_end_date
                            [value] => 2050-01-01
                            [compare] => <=
                            [compare_key] => =
                            [alias] => mt2
                            [cast] => CHAR
                        )

                )

            [has_or_relation:protected] => 
        )

    [date_query] => 
    [request] => 
					SELECT SQL_CALC_FOUND_ROWS  wp_posts.ID
					FROM wp_posts  LEFT JOIN wp_term_relationships ON (wp_posts.ID = wp_term_relationships.object_id) INNER JOIN wp_postmeta ON ( wp_posts.ID = wp_postmeta.post_id )  INNER JOIN wp_postmeta AS mt1 ON ( wp_posts.ID = mt1.post_id )  INNER JOIN wp_postmeta AS mt2 ON ( wp_posts.ID = mt2.post_id )
					WHERE 1=1  AND ( 
  wp_term_relationships.term_taxonomy_id IN (143)
) AND ( 
  wp_postmeta.meta_key = '_ilsi_date' 
  AND 
  ( 
    ( mt1.meta_key = '_ilsi_date' AND mt1.meta_value <= '2050-01-01' ) 
    AND 
    ( mt2.meta_key = '_ilsi_end_date' AND mt2.meta_value <= '2050-01-01' )
  )
) AND ((wp_posts.post_type = 'event' AND (wp_posts.post_status = 'publish' OR wp_posts.post_status = 'acf-disabled')))
					GROUP BY wp_posts.ID
					ORDER BY wp_postmeta.meta_value DESC
					LIMIT 0, 6
				
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                    [post_date] => 2024-07-12 17:59:25
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                    [post_content] => 
                    [post_title] => HESI Emerging Systems Toxicology for Assessment of Risk (eSTAR) Committee 2024 Annual Meeting
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => estar-2024-annual-meeting
                    [to_ping] => 
                    [pinged] => 
                    [post_modified] => 2024-07-12 18:03:26
                    [post_modified_gmt] => 2024-07-12 18:03:26
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/event/hesi-emerging-systems-toxicology-for-assessment-of-risk-estar-committee-2023-annual-meeting-copy/
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                    [post_type] => event
                    [post_mime_type] => 
                    [comment_count] => 0
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                    [post_author] => 16
                    [post_date] => 2024-07-08 19:27:50
                    [post_date_gmt] => 2024-07-08 19:27:50
                    [post_content] => 
                    [post_title] => EUROTOX 2024
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => eurotox-2024
                    [to_ping] => 
                    [pinged] => 
                    [post_modified] => 2024-07-18 17:29:59
                    [post_modified_gmt] => 2024-07-18 17:29:59
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/?post_type=event&p=28289
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                    [post_type] => event
                    [post_mime_type] => 
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                    [post_author] => 16
                    [post_date] => 2024-06-11 17:36:13
                    [post_date_gmt] => 2024-06-11 17:36:13
                    [post_content] => 
                    [post_title] => 55th Annual Meeting of the Environmental Mutagenesis and Genomics Society (EMGS)
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => 55th-annual-meeting-of-the-environmental-mutagenesis-and-genomics-society-emgs
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                    [pinged] => 
                    [post_modified] => 2024-07-13 17:16:15
                    [post_modified_gmt] => 2024-07-13 17:16:15
                    [post_content_filtered] => 
                    [post_parent] => 0
                    [guid] => https://hesiglobal.org/?post_type=event&p=28175
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                    [post_type] => event
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            [3] => WP_Post Object
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                    [ID] => 28137
                    [post_author] => 16
                    [post_date] => 2024-05-21 14:40:29
                    [post_date_gmt] => 2024-05-21 14:40:29
                    [post_content] => 
                    [post_title] => FDA's CDER Pharmacology Toxicology Symposium
                    [post_excerpt] => 
                    [post_status] => publish
                    [comment_status] => closed
                    [ping_status] => closed
                    [post_password] => 
                    [post_name] => fdas-cder-pharmacology-toxicology-symposium
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                    [post_date_gmt] => 2024-04-11 18:29:02
                    [post_content] => 
                    [post_title] => Emerging spatial genomics and in situ sequencing technologies for carcinogenesis assessment
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                    [post_name] => emerging-spatial-genomics-and-in-situ-sequencing-technologies-for-carcinogenesis-assessment
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                    [post_date] => 2023-09-01 15:13:03
                    [post_date_gmt] => 2023-09-01 15:13:03
                    [post_content] => 
                    [post_title] => Society of Toxicology 2024 Annual Meeting
                    [post_excerpt] => 
                    [post_status] => publish
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                    [post_password] => 
                    [post_name] => society-of-toxicology-2024-annual-meeting
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                    [guid] => https://hesiglobal.org/?post_type=event&p=27244
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                    [post_type] => event
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        )

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            [post_author] => 16
            [post_date] => 2024-07-12 17:59:25
            [post_date_gmt] => 2024-07-12 17:59:25
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            [post_title] => HESI Emerging Systems Toxicology for Assessment of Risk (eSTAR) Committee 2024 Annual Meeting
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