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Progress Towards an OECD Reporting Framework for Transcriptomics and Metabolomics in Regulatory Toxicology

Joshua Harrill 1 Mark Viant 2 Carole Yauk 3 Magdalini Sachana 4 Timothy Gant 5 Scott Auerbach 6 Richard Beger 7 Mounir Bouhifd 8 Jason O’brien 9 Lyle Burgoon 10 Florian Caiment 9 Donatella Carpi 11 Tao Chen 7 Brian Chorley 1 John Colbourne 2 Raffaella Corvi 11 Laurent Debrauwer 12, 13 Claire O’donovan 14 Timothy.M.D. Ebbels 15 Drew Ekman 1 Frank Faulhammer 16 Laura Gribaldo 11 Gina Hilton 17 Stephanie Jones 9 Aniko Kende 17 Thomas Lawson Sofia Leite 11 Pim E.G. Leonards 18 Mirjam Luijten 19 Alberto Martin 8 Laura Moussa 20 Serge Rudaz 21 Oliver Schmitz 22 Tomasz Sobanski Volker Strauss Monica Vaccari Vikrant Vijay 7 Ralf J.M. Weber 2 Antony Williams 23 Andrew Williams Russell Thomas 24 Maurice Whelan 11
Abstract : Omics methodologies are widely used in toxicological research to understand modes and mechanisms of toxicity. Increasingly, these methodologies are being applied to questions of regulatory interest such as molecular point-of-departure derivation and chemical grouping/read-across. Despite its value, widespread regulatory acceptance of omics data has not yet occurred. Barriers to the routine application of omics data in regulatory decision making have been: 1) lack of transparency for data processing methods used to convert raw data into an interpretable list of observations; and 2) lack of standardization in reporting to ensure that omics data, associated metadata and the methodologies used to generate results are available for review by stakeholders, including regulators. Thus, in 2017, the Organisation for Economic Co-operation and Development (OECD) Extended Advisory Group on Molecular Screening and Toxicogenomics (EAGMST) launched a project to develop guidance for the reporting of omics data aimed at fostering further regulatory use. Here, we report on the ongoing development of the first formal reporting framework describing the processing and analysis of both transcriptomic and metabolomic data for regulatory toxicology. We introduce the modular structure, content, harmonization and strategy for trialling this reporting framework prior to its publication by the OECD.
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Submitted on : Tuesday, August 3, 2021 - 3:23:17 PM
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Joshua Harrill, Mark Viant, Carole Yauk, Magdalini Sachana, Timothy Gant, et al.. Progress Towards an OECD Reporting Framework for Transcriptomics and Metabolomics in Regulatory Toxicology. Regulatory Toxicology and Pharmacology, Elsevier, 2021, ⟨10.1016/j.yrtph.2021.105020⟩. ⟨hal-03313213⟩



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