Ahead of his presentation at this June's ENDS conference, we spoke to Ian Fearon, Director of Tobacco Research at Celerion, about clinical studies on ENDS products, the public perception of ENDS products, the lack of firm regulatory guidance and more.
Q1. You will be presenting on ‘Clinical studies on ENDS products - past, present and future’ this June, could you give us a sneak peek of what you will be sharing?
Studies on human subjects are critical to our understanding of the potential health impacts of switching from smoking cigarettes to using ENDS products. In my presentation, I will present a broad overview of the studies that have been performed to date by both academic and industrial research groups. I will use case studies of research studies to highlight where things can be improved, particularly focussing on the global standards applicable to ENDS clinical studies. I will end by summarising where we are now, and where we need to be in the future, in order to realise whether ENDS possess harm reduction potential for smokers who switch to using them.
Q2. What do you think are the most significant future opportunities in this industry over the next 12-24 months?
Critical to the industry is the public perception of ENDS products and their impacts on health. What I see as a real opportunity is to perform and publicise data from studies examining changes in markers of health in smokers switching to using ENDS products. Currently, smokers are being dissuaded from switching by poor-quality data from sub-standard studies and by addressing this, smokers could be better convinced of the harm reduction potential of ENDS, leading to a greater uptake and, therefore, a greater impact on public health.
Q3. What do you see as the biggest stumbling blocks for the industry at the moment?
The lack of firm regulatory guidance is perhaps hampering the ability of companies to address regulatory scientific needs. While European regulatory submissions do not necessarily require clinical data, in the US companies will have to submit dossiers to FDA to either retain products on the market or to launch new products. While some companies have their own view on the scientific requirements, others remain in limbo while they await stronger guidance. Without this, many companies are unlikely to begin clinical product testing due to the high degree of risk involved in doing so without great instruction on the regulatory requirements.
Q4. Why do you feel it is important for people to attend ENDS 2018?
For me, this conference is the only forum in Europe which brings together product developers and manufacturers, testing companies, regulatory experts and public health advocates into a single event. Attendees will gain a broad perspective as to what is happening in the industry and where it is heading in the coming years.
Q5. What are you most looking forward to at ENDS 2018?
Hearing about the latest research and regulatory trends in the industry, both formally during the presentations and informally.
Ian will be presenting as part of the Driving Confidence & Trust in ENDS - Investing in Science, Long-Term Studies, Standardisation & Industry Collaboration session at ENDS this June. Other speakers in the session include Altria Client Services, CORESTA, Totally Wicked/IBVTA, Imperial Brands and more.
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