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BRITISH AMERICAN TOBACCO Science & Technology BRITISH AMERICAN TOBACCO Science & Technology 2015 report Foreword 1 Dr David O’Reilly, Group Scientific and R&D Director RESEARCH PRIORITIES Stewardship and next generation products 2 Dr Christopher Proctor PLANT BIOTECHNOLOGY From seed to smoke 4 Dr Kieron Edwards GOOD RESEARCH PRACTICE Good research practice — securing innovation 7 John McBrearty ANALYTICAL METHOD DEVELOPMENT Chemical characterisation of next generation Science & products 8 Dr Christopher Wright Technology POPULATION STUDIES Assessing the impact of new products 11 2015 Oscar Camacho STEWARDSHIP Leading the way in product risk assessment 14 About this Report This is a British American Tobacco p.l.c. report describing Dr Audrey Richter some of the activity of British American Tobacco Group Research & Development in the UK. References to ‘British TOBACCO HEATING PRODUCTS American Tobacco’, ‘we’, ‘us’ and ‘our’ when denoting Eliminating combustion to potentially opinion or activity refer to British American Tobacco Group Research & Development. reduce risk 16 Whilst reasonable steps have been taken to ensure that Dr Chuan Liu the information contained within this publication is correct, the authors, British American Tobacco, its agents, ELECTRONIC CIGARETTES contractors and sub-contractors give no warranty and make no representation as to its accuracy and aaccept no liability Rapid evolution presents new challenges 20 for any errors or omissions. Dr Kevin McAdam Any trademarks, service marks or logos used in this publication, and copyright in it, are the property of British PRODUCT TESTING American Tobacco. Building the evidence base 26 Also available on bat-science.com Dr Marianna Gaça QUANTIFYING RISK @BAT_Sci Improved understanding of toxicants and disease 29 Fiona Cunningham AEROSOL SCIENCE Understanding consumer product interaction 32 John McAughey Design and production JamesMcQuat.com SCIENCE ENGAGEMENT Our open approach 36 Main image photography JohnnyJGallagher.com Sarah Cooney Printing INSIDE BAT — PEOPLE hobbs.uk.com Bring your difference to BAT 40 INSIDE BAT — ENGINEERING ® MIX Focusing on practical solutions 42 Paper from responsible sources FSC® C020438 FOREWORD e have spoken for some years about the understood, and are as safe as possible. importance of tobacco harm reduc- New nicotine products should con- W tion for British American Tobacco, for tinue to increase in relevance, which our consumers and for regulators. We is why we have expanded our research believe that developing less risky tobacco efforts to focus on these emerging product and nicotine products is transforma- categories. The swift evolution of these tional in many dimensions, and know we categories and the diversity of available must take a strong lead in doing this. products means that we are constantly In 2013, we were the first international pushing the boundaries to develop more tobacco company to launch an e-cigarette, advanced mechanics and better perform- Vype, in the UK. Since then we have ing products to give our consumers what continued to innovate in the category, and they want. Our research efforts continue have since launched three new prod- to focus on understanding how the dif- ucts, Vype ePen, Vype eStick and Vype ferent product categories perform under eTank and a wide range of liquids, and various conditions and how consumers are expanding our geographic footprint. use them; the constituents of the aerosol, We are also the first tobacco company as well as the possible creation of ther- to receive, in 2014, a medicines licence mal breakdown products; and the effects for a nicotine inhalator called Voke, and on the body of inhaling the aerosol. DR DAVID O’REILLY in 2015 we launched a tobacco heating By working together with our consum- Group Scientific and product. To develop less risky choices ers, we better understand their needs and R&D Director for smokers that give them a true alter- can offer greater expertise and insight David first joined us in 1991 native choice to cigarettes will require into areas such as materials science, with a PhD in molecular strong consumer insights, tremendous formulation chemistry, and engineer- virology and he was appointed innovation, and comprehensive science ing. We must also play our part in the to the Management Board of to ensure these next generation products ongoing regulatory debate, providing BAT in 2012. He directs the company’s scientific research, do offer reduced-risk potential. We think the data to enable regulators around the which seeks to develop it is important to offer a range of prod- world to make evidence-based decisions. innovative reduced-risk products ucts, including tobacco heating prod- We have embraced and will continue along with the tools to test ucts, e-cigarettes and licenced nicotine to embrace new scientific disciplines to and substantiate their risk products because consumer needs vary. create the knowledge needed to ensure potential. He has also been the driving force behind the The next few years are incredibly the potential of this category is realised investment and growth of BAT’s important and will determine whether the as well as our intention to be a leader R&D into a forward-looking, opportunity of tobacco harm reduction in these new product categories. consumer-led, multidisciplinary becomes widely adopted. Just as we saw Through this our second Science and environment. Previously, he led with snus, some regulators have prohib- Technology Report we continue to build on our programmes in corporate social responsibility and public ited e-cigarettes, and the World Health our heritage of scientific engagement and health policy and engagement. Organisation has not been very support- transparency, and maintain our desire to ive. We are working hard to ensure that work with others to deliver the opportuni- our products are fully characterised and ties that tobacco harm reduction offer. ☐ BRITISH AMERICAN TOBACCO | SCIENCE AND TECHNOLOGY REPORT 2015 1 RESEARCH PRIORITIES STEWARDSHIP AND NEXT GENERATION PRODUCTS he risks of cigarette smoking to human chemical characterisation in a manner health are very well understood. Given that consistent with consumer use. These data T we have had a R&D unit at BAT since 1956, were all used to build our knowledge on we have decades of expertise, as well as how to apply our own stewardship stand- published research, on tobacco and tobacco ards to snus, ensuring that we minimised smoke toxicants. We have completed a risks associated with our products to every multi-year research programme, aimed at extent possible. However, as a product trying to reduce the risks associated with with potential for reducing risk, snus conventional cigarettes by using a number received little regulatory support, being of toxicant-reducing technologies. Although banned in the European Union outside this research gave some encouraging results, Sweden, and little consumer interest in the we found few differences in clinical studies markets where we tried to introduce it. between biomarkers of biological effect in More recently, we have focused on two volunteers who were switched to reduced- other potentially reduced-risk product cat- toxicant prototype cigarettes and those egories, tobacco heating products (THPs) who continued to smoke regular cigarettes. and electronic cigarettes (e-cigarettes). Through well-established principles of toxi- We also hope to add licensed medicinal cology and safety risk assessments, our prod- nicotine products, but will not discuss this uct stewardship approach, therefore, focuses category further in this report as these on ensuring that any ingredient, material, or types of products are subject to quite dif- design feature used in our products do not ferent regulatory oversight and procedures add to the inherent risk of cigarette smoking. from the THP or e-cigarette categories. The research taught us that if we hoped We were the first international tobacco to find tobacco or nicotine alternatives for company to launch an e-cigarette when cigarette smokers that might be deter- Vype was marketed in the UK in July, mined to be less risky than cigarettes, we 2013. Just as with snus, entering into a probably had to substantially reduce the new product category required an ac- toxicant emissions over and above what celerated research programme to develop DR CHRISTOPHER PROCTOR Chief Scientific Officer is possible, even with multiple toxicant- understanding of how the products work, reducing technologies, in cigarettes. what emissions they produce, and how Chris is our Chief Scientific We began with Swedish snus, given the consumers were likely to use them, so Officer and also Group Head of well-documented epidemiological data that our testing regimes could be set Scientific Product Stewardship based at R&D Southampton. accumulated in Sweden showing sole use up to be relevant to consumer use. His teams look at product to be far less risky than cigarette smok- To add to the complexity of test- safety issues and are working ing. Snus is not risk free, and, as we began ing, the e-cigarette category is much on research methodologies to developing our own products, even though broader than that of, for example, snus. substantiate the reduced-risk they complied with industry standards for We began with disposable ‘cig-a-like’ potential of next generation products. Chris regularly manufacturing and low levels of toxi- devices with simple formulations, but engages on various topics cants, such as nitrosamines, we needed to rapidly developed a range of
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