HESI will be attending the 13th International Conference on Environmental Mutagens. Meet us there!
HESI at ICEM2022
August 27, 2022 – September 1, 2022
Ottawa, 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.
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.
The Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee is exploring two new projects, one relating to cell painting for safety assessment and the other exploring the use of error corrected sequencing to predict tumorigenicity from non-genotoxic carcinogens. Both groups are looking for additional stakeholders.
Interested in finding out more? Please contact Saddef Haq (shaq@hesiglobal.org)
This group is exploring the use of transcriptomic point of departure for chemical risk assessment. A state of the science manuscript is in preparation.
Three active working groups have compiled, curated, and begun analysis of transcriptomic, toxicologic, and pathologic data to identify short-term transcriptional signatures. These signatures will inform molecular mechanisms underlying pathogenesis of histologic risk factors of neoplasia observed in 90-day studies or chronic 6-month rat toxicology studies and that will inform the value/need to conduct a 2-year rat carcinogenicity study. Novel data housing/analysis partnerships were formed with the NIEHS Chemical Effects in Biological Systems (CEBS) data repository and Lhasa.
An miRNA best practices manuscript was submitted in August 2020. A second paper on renal miRNA biomarkers will be submitted by October 2020. A new experimental and/ or methodology project to reduce hurdles to the use of miRNAs for translational safety assessment and in biological discovery efforts is in development.
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).
US Environmental Protection Agency
GlaxoSmithKline
August 27, 2022 – September 1, 2022
Ottawa, Canada
HESI will be attending the 13th International Conference on Environmental Mutagens. Meet us there!
May 10, 2022
HESI eSTAR Committee, Webinar
During this webinar hosted by HESI's Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee, Dr. Subham Dasgupta will be presenting on the project titled, Phenotypically Anchored mRNA & miRNA Expression Profiling in Zebrafish Reveals Flame Retardant Chemical Toxicity Networks.
February 17, 2022
eSTAR Committee, Virtual
The eSTAR Committee hosted a webinar on February 17th, 2022 entitled “Tox-GAN: An AI Approach Alternative to Animal Studies – a Case Study with Toxicogenomics” presented by Dr. Weida Tong from the US FDA’s National Center for Toxicology Research.
September 15, 2021 – September 25, 2021
Virtual annual meeting, hosted by the Environmental Mutagenesis and Genomics Society (EMGS)
The Botanical Safety Consortium (BSC), Genetic Toxicology Technical Committee (GTTC), and Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee will present their work at the Environmental Mutagenesis and Genomics Society (EMGS) 2021 Virtual Annual Meeting on September 15-25, 2021.
February 11, 2021
Webinar, hosted by HESI and the American Association of Pharmaceutical Scientists (AAPS)
Noninvasive monitoring of nephrotoxicity is challenging. Kidney toxicity is currently monitored by plasma/serum markers, e.g., blood urea nitrogen, and serum creatinine, and urinary markers, such as urinary volume, specific gravity, or osmolality, protein, fractional electrolyte excretion, or sediment examination). ...
May 25, 2017 – May 26, 2017
Montreal, Canada
This is a 2-day workshop co-organized by the Health and Environmental Sciences Institute, Health Canada, and McGill University to address current and potential applications of genomics in cancer risk assessment.
Environmental Health Perspectives, 2004
In 1999 the membership of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) formed a multisector consortium to address challenges associated with the integration of genomics data into risk assessment (Pennie et al. 2004).
Environmental Health Perspectives, 2004
A significant limitation to the analytical accuracy and precision of dual-labeled spotted cDNA microarrays is the signal error due to dye bias.
Environmental Health Perspectives, 2004
Within the International Life Sciences Institute Committee on Genomics, a working group was formed to focus on the application of microarray technology to preclinical assessments of drug-induced nephrotoxicity.
Environmental Health Perspectives, 2004
DNA microarrays and related tools offer promise for identification of pathways involved in toxic responses to xenobiotics.
Environmental Health Perspectives, 2004
Several studies using microarrays have shown that changes in gene expression provide information about the mechanism of toxicity induced by xenobiotic agents.
Environmental and Molecular Mutagenesis, 2005
The multi-lab International Life Sciences Institute (ILSI) project on the application of genomics to risk assessment offered the unique opportunity to investigate the influence of variability within and between laboratories on identifying biologically relevant gene expression changes.
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859
740 15th Street NW, Suite 600
Washington, DC 20005
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