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CORESTA Meeting, Smoke Science/Product Technology, 2021, Online, NAM 00

Advancing new alternative methods for tobacco harm reduction

LEE K.M.(1); BELL S.(2)
(1) Altria Client Services LLC, Richmond, VA, U.S.A.; (2) Integrated Laboratory Systems (ILS), Morrisville, NC, U.S.A.

New approach methodologies (NAMs) represent in vitro and in silico or computational methodologies, an emerging set of chemical safety assessment tools without needing additional in vivo animal testing. This virtual Symposium introduced the current status of NAMs and their potential to support the evaluation of potentially reduced-risk tobacco products in support of tobacco harm reduction. Significant progress has been made toward the reduction, refinement, and replacement (3R) of animal studies for pharmaceutical and environmental toxicity assessment through the adoption of NAMs. At the same time, NAMs acceptance beyond screening and prioritization, including regulatory decision making, remains challenging. At this Symposium, external experts from regulatory agencies and research organizations shared insights on the current status, strengths, and opportunities in application of NAMs using case examples from safety assessments of chemicals and consumer products. Following the presentations, the panel were available to answer questions from the Symposium participants and discussed opportunities and challenges in applying NAMs for toxicological assessment of tobacco and novel nicotine products.

The Symposium intended to foster scientific engagement between CORESTA members (endorsed by the In vitro Toxicity Testing Sub-Group, Biomarker Sub-Group, and 21st Century Toxicology for Next Generation Tobacco and Nicotine Products Task Force) and the external NAMs community, in order to facilitate together the utility of NAMs in support of evidence-based tobacco regulatory science. Highlights of the symposium were submitted for peer-review publication and published in the Toxics Journal in December 2022.

NAM Symposium

Programme (PDF)

Papers presented

Peer-Reviewed Publication

Advancing New Approach Methodologies (NAMs) for Tobacco Harm Reduction: Synopsis from the 2021 CORESTA SSPT—NAMs Symposium
Toxics 2022, 10(12), 760