SETAC North America
November 2, 2026 – November 5, 2026
Montreal, Canada
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.
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.
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.
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.
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.
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).
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.
FFPE Project: A manuscript on DNA de-modification analysis of clinical tumor samples was accepted; the project will sunset after an educational webinar.
National Institute of Environmental Health Sciences
Syngenta
November 2, 2026 – November 5, 2026
Montreal, Canada
November 5, 2026 – November 6, 2026
Online, HESI Global eSTAR Committee
Please join us for the eSTAR Annual Meeting to review the current portfolio of projects and get updates on new trends in systems toxicology for decision making.
October 12, 2026 – October 14, 2026
Online, Virtual
September 6, 2026 – September 10, 2026
Edinburgh, Scotland
Multiple HESI Global Committees attending.
Toxicological Sciences, 2022
This call-to-action paper published in Toxicological Sciences describes a multi-sector collaboration seeking to accelerate the evaluation of biomarker tools in carcinogenicity studies which will facilitate the transition from current heavy reliance on conventional 2-year rodent ...
Regulatory Toxicology and Pharmacology, 2019
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 ...
Toxicological Sciences, 2022
Here, a logic framework is proposed to explore the feasibility and future development of transcriptomic methods to refine and replace the current apical endpoint-based regulatory toxicity testing paradigm.
Environmental Health Perspectives, 2004
On the surface, transcript profiling using microarrays seems to offer a way of looking at the global response of the cell to perturbation, with a focus on changes in gene expression.
Toxicological Sciences, 2025
This comprehensive review, from HESI's Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee, explores the use of transcriptomic points of departure (tPODs) to enhance toxicological safety assessment.
Cell Systems, 2026
A HESI Global OASIS Consortium study shows how Cell Painting boosts cytotoxicity detection and mode-of-action discovery in human hepatocytes.
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:
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-8403
740 15th Street NW, Suite 600
Washington, DC 20005
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