2018 Agenda

Below is the exciting 2018 agenda. 

 

Tuesday 5 June

ROLE OF ENDS TO IMPROVE HEALTH OUTCOMES FOR NICOTINE USERS

  1. Registration and welcome refreshments

  2. Chair's opening remarks

    Patricia I. Kovacevic | General Counsel and Chief Compliance Officer of Nicopure Labs LLC

  3. Update from the All Party Parliamentary Group on E-Cigarettes - addressing public policy questions and regulatory response to e-cigarettes

    Mark Pawsey MP | Chair of the All-Party Parliamentary Group on E-Cigarettes of Member of Parliament for Rugby

  4. Bringing data and science to life: the role of e-cigarettes in supporting people with mental health problems to stop smoking

    Mary Yates | Nurse Consultant – Health Promotion & Wellbeing of South London and Maudsley NHS Foundation Trust

  5. Industry viewpoint

    John Dunne | Managing Director of E-Liquid Brands UK and Board Member of UK Vaping Industry Association (UKVIA)

  6. Summary of scientific progress in the US

    Gal Cohen | Head of Scientific Affairs of JUUL Labs

  7. Networking refreshment break

REGULATORY ROUND UP: HOW HAVE TWO YEARS OF REGULATION HELPED OR HINDERED HARM REDUCTION?

  1. Update on the e-cigarette notification scheme and MHRA priorities for 2018/19

    Beryl Keeley | Advertising Standards and Outreach Unit Manager of Medicines and Healthcare products Regulatory Agency (MHRA)

    • Review of notification information - MHRA findings and submission problems to avoid
    • Ensuring effective regulation - working with Trading Standards and Joint Action with other EU member states
    • The medicines licensing system - supporting the Tobacco Control Delivery Plan
  2. Summary of TPD interpretation and the impacts to the markets across Europe

    Tim Phillips | Managing Director of ECigIntelligence

    • Overview of the regulatory environment across the EU
    • Impact of TPD on markets across the EU
    • Tax policy across the EU, and the future of tax in the sector
    • Comparisons of a regulated market such as the EU with other international markets across the world
    • Future scenarios for the sector
  3. Adding value to ENDS via the Medicinal Product route

    Chris Allen | Managing Director of Broughton Laboratories

    • History of TPD and Marketing Authorisation Application (MAA)
    • Understanding the MHRA and MAA Process
    • Will an MAA change public perception to product safety?
  4. Dual perspective: The intersection of science and regulation

    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

    •  ENDS regulatory update and case studies on ban reversals
    • BAT science gathered on vapour and THP
    • Population assessments: polar views on the health benefits of ENDS
    • What’s missing in the published science of NGPs?

    James Murphy, Head of Biosciences, British American Tobacco

     

    How do you determine reduced risk? What do we know today?

    • How are regulations adapting (introduction of new reduced risk regulations in Europe)

    Ian Jones, Vice President, Reduced-Risk Products, Japan Tobacco International

  5. Networking lunch

CHARACTERISATION, ANALYTICS AND TESTING – BEST PRACTICE STEWARDSHIP

  1. Overview of in-vitro methods used to assess ENDS based on "Toxicity Testing in 21st Century" principles

    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.

  2. Toxicological assessment of emissions from e-cigarette devices and e-liquids

    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.

  3. Do the different classes of flavours have an impact on electronic cigarette emissions?

    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?

  4. Networking refreshment break

  5. Explanation of Health Criteria Values (HCVs) and why they are an essential element in product development

    Shaun Wedgewood | Technical Director of EL-Science

    • Potential long term harm from ecigarettes - a statistical overview
    • Presenting some statistical data showing the extent of the problem, having tested over 1,000 eliquid samples from companies around the world
    • A pre-emptive approach to the toxicology
    • External bodies continue to perform research into the safety of cigarettes, it is vital that the industry embrace the toxicology and adapt before further damaging studies are published
    • Why a unified approach is best
    • Legislation falls short, it’s much better for industry to set their own operating standard as a whole
  6. Best-practice E&L Testing

  7. Chair's closing remarks

  8. Networking drinks reception

Wednesday 6 June

HUMAN FACTORS AND MARKET REALITIES FOR ENDS PRODUCTS

  1. Morning refreshments

  2. Chair's opening remarks

    Liam Humberstone | Technical Director at Totally Wicked of Product Design & Engineering at Independent British Vape Trade Association (IBVTA)

  3. Consumer view - update of the current situation affecting vaping consumers globally with particular emphasis in Europe

    Judy E. Gibson | Secretary General (CEO) of INNCO (International Network of Nicotine Consumer Organisations)

  4. What does the consumer want? What is driving e-cigarette take up? What are the advertising challenges?

    Matthew Moden | Managing Director of Liberty Flights

  5. Innovative design and manufacture for the UK market and beyond

    Neil McCallum | CEO of JAC Vapour Ltd

    • Building confidence in your manufacturing supply chain
    • Latest design trends, taking into account human factors and customer feedback
    • Battery design and safety 
  6. The perfect e-cigarette: product design, functionality and customer demand

    David McLaughlin | Director, Business Development of Elucid8

    • The world as we know it:
      • market facts;
      • the perfect customer
    • Case study - is the USB effect universal?
    • Meeting customer needs:
      • how give them exactly what they want
      • the functionality triangle
    • The challenges of success - regulatory dreamscape
  7. Networking refreshment break

DRIVING CONFIDENCE AND TRUST IN ENDS – INVESTING IN SCIENCE, LONG-TERM STUDIES, STANDARDISATION AND INDUSTRY COLLABORATION

Chaired by: Ian Jones | Vice President Reduced-Risk Products of Japan Tobacco International

  1. Industry engagement with the scientific community

    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?

  2. Clinical studies on ENDS products – past, present and future

    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.

  3. Providing unbiased scientific information through international collaboration

    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.

  4. Networking lunch

  5. The role of choice in trial, preference formation and adoption for ENDS

    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.

  6. Spirometry as an effective tool for screening eligibility in e-cigarette clinical trials

    Dr. Lorraine Rusch | President of High Point Clinical Trials Center

    • Spirometry is the preferred tool for pulmonary function assessment to assess validity of e-cig’s harm reduction potential
    • Screening was performed on subjects considered for two clinical trials
    • Over a dozen subjects screen failed due to airway disease, which might have altered study conclusions
    • 5% of subjects undergoing spirometry during screening for two trials were detected with COPD.
    • Spirometry is a useful test to eliminate inappropriate subjects from participating in clinical trials, avoiding potential bias
  7. Snapshot panel: Establishing meaningful product standards in a developing technological landscape

    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.

    Speakers include:

    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

  8. Chair's closing remarks and close of ENDS 2018