Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | IIVS Workshop Series: Identification, Discussion and Recommendations for the Optimal Generation and Use of In Vitro Genotoxicity Assay Data for Tobacco and Nicotine Products
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IIVS Workshop Series: Identification, Discussion and Recommendations for the Optimal Generation and Use of In Vitro Genotoxicity Assay Data for Tobacco and Nicotine Products

October 18, 2019

The Institute for In Vitro Sciences (IIVS) is sponsoring a series of workshops to identify, discuss and develop recommendations for optimal scientific/technical approaches for utilizing in vitro assay data within and across tobacco and nicotine product categories. Workshops provide a unique opportunity for invited expert stakeholders to share experiences and to develop recommendations that may serve as a resource for developing optimal approaches and data to evaluate the toxicity of tobacco and nicotine products. It is envisioned that some of these recommendations would form the basis for the generation of guidance documents and/or serve as authoritative reference publications for optimal methodologies and data interpretation and to support regulatory submissions. Invited experts for the IIVS workshops include scientists from tobacco companies, contract research organizations, US regulatory agencies, and other in vitro assay experts with tobacco product and/or genetic toxicology experience. The format for this workshop series is primarily discussion among participants which provides an environment to tackle issues in detail. Participants are expected to actively participate by collecting relevant published and unpublished non-proprietary research information, to offer experiences and expert opinions, and to actively share with other workgroup members. While the focus will be on the widely used regulatory in vitro genetic toxicology assays, it is important to note that much of the discussion will be applicable to all in vitro assays. As a part of the workshop discussion, data gaps will be identified. Thus, in addition to recommendations based on current information, this workshop series will provide key research questions that need to be addressed by the scientific community. This will provide a useful roadmap for research that can have direct impact on the regulation of tobacco products and on protecting human health related to consumer use of tobacco products. The product of these workshops will be a series of scientific publications and meeting presentations that can be utilized by all stakeholders.

Prior to the first workshop (November 27-28, 2018) important issues for using in vitro genotoxicity assays for evaluating tobacco and nicotine products were identified. During the first workshop issues were triaged into three priority categories based on the amount of available information.