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It is becoming increasingly apparent that the genetic toxicology community should move away from qualitative hazard-based approaches to quantitative risk-based methodologies to facilitate data interpretation in the context of informing human risk. Given that genetic toxicologists employ a number of different in vitro as well as in vivo test systems, it is imperative that approaches for comparing the dose-metrics across the test systems be standardized so that a point of departure (POD) or no-observed-genotoxic-effect-level (NOGEL) derived in one test system can be extrapolated or compared to another and eventually from experimental models to humans.
This workshop is organized by the HESI Genetic Toxicology Technical Committee (GTTC), formerly known as the IVGT. It will bring together experts in the fields of genetic and general toxicology, risk assessment, and computational biology representing industry, academia, and government to address and make recommendations on a path forward on this topic, including the identification of any key data gaps in our knowledge that require further research. While the focus of this workshop is on genetic toxicology studies, the key learnings from this effort will have a much broader impact across various toxicology disciplines.
Introduction: Towards a New Paradigm in Genetic Toxicology: From Qualitative to Quantitative Approaches, Bhaskar Gollapudi, Exponent, USA
Plenary Lecture I: PK and PD Tools for DNA-Damage Pathways: Modeling Dose Metrics and DNA-Repair Processes, Mel Andersen, The Hamner Institutes, USA
IWGT Workgroup Recommendations for Quantitative Assessment of Dose-Response in Genetic Toxicology, George Johnson, Swansea University, UK
A Toolbox to Estimate Point-of-Departure Metrics in Genetic Toxicology, Paul White, Health Canada, Canada
Biological Processes Driving the Response to Low Doses, George Johnson, Swansea University, UK
Application of the TT21C Strategy to Safety Assessment for DNA Damaging Compounds Using Quercetin as a Case Study, Rebecca Clewell, The Hamner Institutes, USA [presentation not available]
Qualitative and Quantitative Approaches on the Threshold of Genotoxic Carcinogens, Shoji Fukushima, Japan Bioassay Research Center, Japan
Benchmark Dose for Genetox and Cancer Endpoints and Correlating between Systems, Wout Slob, RIVM, Netherlands
Update on IGG Work of In Vitro Risk Assessment, Ann Doherty, AstraZeneca, UK
Plenary Lecture II: Level of Concern for Genotoxic Carcinogens at Human Relevant Exposure, Alan Boobis, Imperial College London, UK [presentation not available]
Integration of Dosimetry and Exposure into In Vitro High-Throughput Screening, Amin Rostami-Hodjegan, The University of Manchester, UK
Computational Tools and Models to Facilitate In Vitro to In Vivo Exposure Extrapolation – Lessons from the Drug Development World, Oscar Della Pasqua, University College London, UK
Reverse PB/PK Dosimetry for Extrapolation of Biomonitoring, George Loizou, Health and Safety Laboratory, UK
Can In Vivo PoD Estimates for Genotoxicity Inform Carcinogenic Potency? Lya Soeteman-Hernandez, RIVM, Netherlands
The Use of Dose Response Data for Risk Assessment, Diane Benford, Food Standards Agency, UK
The COSMOS Project: Developing in Silico Models to Support in Vitro Approaches to Ultimately Predict in Vivo Toxicity, Mark Cronin, Liverpool John Moores University, UK
CAAT Perspectives on In Vitro to In Vivo Extrapolations, Thomas Hartung, Johns Hopkins University, USA
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