Skip to main content
CORESTA Meeting, Smoke Science/Product Technology, 2023, Cancun, NAM 00

New Approach Methods (NAMs) Symposium-II: Applications in Tobacco Regulatory Sciences

LEE K.M.(1); SIMMS L.(2)
(1) Altria Client Services LLC, Richmond, VA, U.S.A.; (2) Imperial Brands PLC, Bristol, U.K.

New Approach Methods (NAMs) in toxicology refer generally to in vitro and in silico or computational methodologies that, without additional in vivo animal testing, could enable clinically relevant toxicological risk assessment.

At CORESTA SSPT2021, an introductory symposium (titled “Advancing New Alternative Methods for Tobacco Harm Reduction”) was held where regulatory and independent experts presented the latest status and case examples of utilizing NAMs to screen and even waive traditional in vivo studies in regulatory decision making.

In this follow-up Symposium, we explored specific applicability of NAMs in tobacco regulatory science and expedition of the evaluation of toxicological profiles of emerging smoke-free tobacco and nicotine products. Invited speakers presented their case examples of NAM use in early screening or support of regulatory submissions as well as challenges in wider acceptance in lieu of in vivo testing.

Key messages of the Symposium were that no single NAM can or should be expected to address all biological evidence needed to assess the toxicity profile or substantiate the reduced-risk potential of smoke-free products and that instead a tiered in vitro-based battery of predictive tools can offer clinically relevant target cellular responses as the new approach of mechanism-based toxicological assessment. The Symposium also highlighted the gaps and opportunities as well as strengths and potential of NAMs that were further explored during the panel discussion.

The Symposium is endorsed by the CORESTA Scientific Commission, the 21st Century Toxicology for Next Generation Tobacco and Nicotine Products (NGTX) Task Force, the Biomarkers (BMK) Sub-Group, and the In Vitro Toxicity Testing (IVT) Sub-Group, reflecting CORESTA’s ongoing commitment to the 3Rs (reduce, replace, and refine animal testing). Highlights of the Symposium are planned to be summarized for a peer-reviewed publication.

NAM Symposium

Programme (PDF)

Papers presented