Reflections on the 75th Tobacco Science Research Conference (TSRC)

Broughton Senior Consultant for Chemistry, Malcolm Saxton reflects on the 75^th Tobacco Science Research Conference (TSRC) and the progress made in the tobacco harm reduction space across farming, science, and engineering.

The opening symposium of the conference consisted of several talks on the history of the Tobacco Science Research Conference (TSRC) and tobacco harm reduction progress. Mike Ogden of Ogden Ology and previously of Reynold America opened with an informative, entertaining, and personal history of TSRC and its importance to the industry. This was followed by three insightful presentations covering the main pillars of tobacco harm reduction; firstly Matthew Vann of North Carolina State University on how science and farming practice have been brought together to control and reduce the formation of toxicants, and their precursors at the plant level, and the final two talks in this session, presented by Elaine Round of RAI services and Jason Flora of Altria Services respectively, showed us the past, present, and future of harm reduction for both aerosol and orally delivered nicotine. These talks showed the great progress that has already been made in the harm reduction space and the importance of bringing together multiple disciplines, including farming, sciences, and engineering to ensure the journey towards safer nicotine delivery products keeps generating effective and appealing products.

Juul labs shared several learnings and best practices around the analysis of e-cigarette aerosol and the importance of science-based decisions and justifications in relation to study design and data interpretation. A paper of particular interest was from Mark Crosswhite of Juul Labs, who presented on non-targeted analysis challenges, and best practices focusing on the importance of scientifically based rationale for any decisions made during the execution and analysis of non-targeted studies. This theme was reiterated a number of times across the conference: the importance of having strong, evidence-based justifications for how products are tested; due to the complexity and variety of products now available on the market, no one-size-fits-all solution to testing will exist, and it is, therefore, important to ensure all decisions are documented and then justified with science.

A particular highlight of the conference was the panel discussion on the FDA’s draft method validation guidance document. Melis Coraggio of the FDA presented the new process with an excellent follow-up from Juul Labs summarizing some of the industry’s concerns around the divergence of the new guidance from current International Council for Harmonization (ICH) guidelines. During the following panel discussion, Todd Cecil of the FDA was open and clear in the intentions of the FDA in producing this new guidance. The discussion was open and frank, and it was of great value to understand that the FDA was trying to set very clear expectations of what it considers a fit-for-purpose method. The challenge going forward for the industry and the FDA is to ensure that, once implemented, the new guideline can be applied in a manner consistent with current ICH guidelines and ISO requirements, but the collaborative nature of the discussion suggests that this can be achieved.