Patricia I. Kovacevic | General Counsel and Chief Compliance Officer of Nicopure Labs LLC
Mary Yates | Nurse Consultant – Health Promotion & Wellbeing of South London and Maudsley NHS Foundation Trust
John Dunne | Managing Director of E-Liquid Brands UK and Board Member of UK Vaping Industry Association (UKVIA)
Gal Cohen | Senior Director, Scientific Affairs, of JUUL Labs
Beryl Keeley | Advertising Standards and Outreach Unit Manager of Medicines and Healthcare products Regulatory Agency (MHRA)
Tim Phillips | Managing Director of ECigIntelligence
Chris Allen | Managing Director of Broughton Laboratories
2 presentations and joint Q&A from British American Tobacco and Japan Tobacco International
Both speakers will present their perspective before a join Q&A session:
Next-generation products: A science and regulation update
James Murphy, Head of Biosciences, British American Tobacco
How do you determine reduced risk? What do we know today?
Ramunas Macius, JTI Reduced-Risk Products Corporate Development Vice President, Japan Tobacco International
Tanvir Walele | Director - Scientific Affairs of Fontem Ventures
When the National Academies of Sciences released "Toxicity Testing in 21st Century (TT21C): A Vision and a Strategy" a new toxicological paradigm was created moving away from the idea of animal tests, focusing on the use of human cell systems that assess the disruption of key cellular pathways that can subsequently lead to disease.
The use of Integrated Approaches to Testing and Assessments (IATA) that integrate classical toxicology with high throughput (HT), high content (HC) and omics approaches can be applied for the assessment of ENDS to determine subtle biological responses at the cellular and molecular level.
This presentation will discuss the various methods currently being developed and utilized in our risk assessment process and will highlight some of the data generated to date for e-cigarettes.
Richard Young | Principal Toxicologist and Managing Director of bibra toxicology advice and consulting
Emissions testing is a regulatory requirement (e.g. as part of your TPD notification) and a fundamental aspect of ensuring the safety of your ENDS product to the consumer. Notably, such analytical assessment has routinely identified low levels of certain (non-added) organic compounds, often generated during heating and emitted, including low molecular-weight aldehydes (e.g. formaldehyde). Other compounds (e.g. e-liquid impurities and leachables from the device) are also analytically identified on occasion (including glycols and metals). As such, these emissions may include a number of highly toxic compounds. It is essential that these are adequately analysed and toxicologically evaluated, for example as part of a robust human health risk assessment. This presentation will discuss the key aspects to consider when emissions testing (from a toxicologists perspective), the challenges, variability and uncertainties to consider, the standard risk assessment approach to assessment of these compounds (including the derivation of tolerable inhalation levels), and the challenges (and pitfalls) faced by the human health risk assessor. A couple of case studies will be included in the presentation.
Scott Fletcher | Director of Analytical Services of Hall Analytical
What role do the common flavour classes play in the generation of carbonyls, VOCs and nicotine dose in both the aerosol and e-liquid at low power, high PG, and high power, high VG, under typical usage conditions and lifetimes?
Shaun Wedgewood | Technical Director of EL-Science
Antonin Cohen | CEO of Harmony
CBD e-liquids for vaporizers and electronic cigarettes are an excellent product for cannabis and tobacco smokers. Thousands of shops are already distributing CBD e-liquids in Europe. During this presentation, Antonin Cohen, CEO of Harmony, will explain the most important challenges and opportunities for the CBD e-liquid industry from a legal, economic and consumer angle.
Liam Humberstone | Technical Director at Totally Wicked of Product Design & Engineering at Independent British Vape Trade Association (IBVTA)
Judy E. Gibson | Secretary General (CEO) of INNCO (International Network of Nicotine Consumer Organisations)
Matthew Moden | Managing Director of Liberty Flights
Umberto Roccatti | President of PUFF STORE Group
Neil McCallum | CEO of JAC Vapour Ltd
David McLaughlin | Director, Business Development of Elucid8
Chaired by: Ian Jones | Vice President Reduced-Risk Products of Japan Tobacco International
Willie McKinney | Vice President Regulatory Sciences of Altria Client Services
Collaborations between industry scientists and the broader scientific community are common but tobacco industry collaboration with public health scientists presents unique opportunities and challenges. Most notably, the history of the tobacco industry may sometimes negatively impact effective scientific engagement efforts.
Regardless of potential barriers, several new forums are facilitating productive communications between academic harm reduction enthusiasts, pessimists, public health and the tobacco industry. These forums serve to diminish barriers such as a lack of trust.
Is the common goal of tobacco harm reduction sufficient to overcome a history of mistrust of research funded or conducted by tobacco product manufacturers?
Ian Fearon | Director of Tobacco Research of Celerion
Human clinical studies are vital for our understanding of the potential health impacts of the use of Electronic Nicotine Delivery Systems. In this presentation, Dr. Fearon will outline current knowledge concerning ENDS and health and give a critical appraisal of the literature in this area. He will further discuss regulatory requirements for the generation and submission of clinical study data on ENDS, and how future studies have the potential to better elucidate the health impacts of ENDS use compared to smoking conventional cigarettes.
Eduardo Berea | Member of the Board of CORESTA
Since the first e-cigarette, tremendous product changes have occurred. Contradictory regulations have appeared. Numerous studies were conducted by experts in favour or disfavour of vaping. Lacking the necessary knowledge, mass media made headlines that ended into controversy, misleading opinion and bringing confusion. The new industry invented by small independent companies focussed on business, quality, safety, innovation, but science was not in their scope. Now, with regulations, science is a necessary step. Larger organisations have now joined the game, inventing alternative products to complement the offer to smokers willing to change. They brought scientific information based on research and experience. However, single source science may be challenged, due to bias and conflicts of interest. Collaborative work involving independent, in-house or government labs, including competitive organisations, is the natural way to develop proper science and common methods and standards. CORESTA, a non-profit scientific platform, will discuss its involvement in studies leading to international agreed recommended methods for the benefit of the whole industry of next generation products.
Dr Andrea Vansickel | Manager Consumer & Marketplace Insights of Altria Client Services
Flavour options may play a critical role in moving adult smokers toward potentially modified risk products. In an actual use study, we demonstrated that a variety of flavour options facilitates adoption of ENDS among adult smokers. To characterize e-vapour use behaviour, its influence on other tobacco use behaviour, and the potential role of flavour variety on behavioural outcomes, we conducted an 8-week, 2-phase, at-home use study. This presentation will discuss the methods, results and conclusions from this study.
Dr. Lorraine Rusch | President of High Point Clinical Trials Center
Discussion featuring IBVTA, Nicoventures and Imperial Brands
Short presentations followed by a discussion between the experts.
Product standards have many stakeholders beyond the consumer, of which two often have rather opposing needs. Regulators need established standards to assure quality, safety and efficacy of products, but contrastingly producers and importers of products sometimes find that such standards impede product innovation and slow down routes to market. The vape industry, particularly in terms of device standards, has been particularly challenged by regulations that came into force very early in the lifetime of an emerging sector. This presentation talks to those challenges, and the approaches used in the creation of BSI PAS 54115 and CEN TC437 to generate meaningful and appropriate standards.
Liam Humberstone, Technical Director, Totally Wicked; Product Design and Engineering, Independent British Vape Trade Association (IBVTA)
Dr. Sudhanshu Patwardhan, Senior International Engagement Manager, British American Tobacco / Nicoventures
Olivia Hibbert, Scientific Regulatory Engagement Manager, Imperial Brands PLC