2017 Agenda

Smithers Rapra is pleased to announce the ENDS US 2017 Agenda:

Day 1: Tuesday, December 5th

Registration & Exhibit Hall Open

  1. Registration and Exhibit Hall Opens

  2. Opening Remarks

    Lucia Regan | Conference Producer, Smithers Rapra

Session I: Regulations US Compliance and Perspectives for E-Cigarettes

The FDA recently released news on a long term plan for lower nicotine levels in tobacco products including ENDS and E-Cigs. You will have the opportunity to hear from the FDA Director of CTP and regulatory specialists in this segment.

  1. Keynote: Update on Regulatory Landscape– FDA’s Comprehensive Approach to Regulation

    Mitch Zeller, J.D. | Director, Center for Tobacco Products of FDA

    The U.S. FDA recently announced its new "comprehensive regulatory plan to shift trajectory of tobacco-related disease, death" that refocuses the Agency's implementation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Rule. FDA's new strategy aims to strike an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes. While the FDA has indicated that its long-term plan, among other things, is to potentially lower nicotine in cigarettes to non-addictive levels.  It also made major changes to its compliance policy for recently "deemed" tobacco products that immediately impacts manufacturers of e-vapor, e-liquid, cigars, hookah, and pipe tobacco products.  FDA Center for Tobacco Product Director Mitch Zeller will discuss FDA’s new comprehensive regulatory plan and the importance of various stakeholders working together. 

  2. Labeling in the US, Ingredients Listing, and PMTA Guidelines with the FDA for E-cigs and ENDS Products

    Azim Chowdhury | Partner of Keller and Heckman LLP

    Azim Chowdhury, Partner at Keller & Heckman LLP, will review the Tobacco Control Act requirements, deadlines and challenges that apply to e-cigarettes and vapor products, including: product registration, ingredient listing, health document submissions, labeling regulations, and Premarket Tobacco Application requirements.

  3. Finding Balance in ENDS Regulation

    David Graham | Chief Impact Officer of NJOY

    This presentation will explore how ENDS regulation has multiple options ranging from idealistic to simplistic, and how the right balance needs to be struck to allow continued innovation in the interests of public health.

  4. Networking & Coffee Break

Session II: Regulations and Impact in Market Growth

This session will be focusing on the way regulations impact the growth possibilities of the e-cigarettes industry in the market. It will also discuss the perspectives on managing current compliance, challenges and best practices. 

  1. Progress in the Current Nicotine Market, Responsible Regulation of Harms Reduction, and Recent US Developments

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

    This talk focuses attention on reviewing the latest developments in the regulatory landscape and the interest in working on harm reduction, specifically what does it mean for the industry and how to work together to provide safer products.

  2. Panel: What are Tobacco Manufacturers Doing and How can they Support Harm Reduction?

    Dr. Ian M. Fearon | Principal Scientist and Head of Clinical Research of British American Tobacco

    Large, multinational tobacco companies have invested heavily in developing e-cigarettes, as well as in fundamental research supporting the harm reduction potential of this technology. This panel session will examine the motives behind tobacco industry research and seek to explore whether their involvement is beneficial or detrimental to the category and the to the vaping industry as a whole.

    Panelists:

    • James Murphy | Head of Biological Science | British American Tobacco
    • Willie McKinney | Vice President Regulatory Sciences | Altria Client Services LLC
    • Ian Jones | Reduced-Risk Products Vice President | JTI
    • Christopher Russel | Senior Research Fellow | Centre for Substance Use Research

     

  3. Impact of Regulations on Manufacturers and Retailers

    Brittani Cushman | Vice President of External Affairs of Turning Point Brands, Inc.

    This presentation will continue the discussion on how regulations could impact the ENDS industry and the distribution chain of products. In the coming years, companies and retailers will have to put their products under rigorous scrutiny given the newly proposed regulations and protocols they must comply with. It will be an interesting trajectory to follow because there is no doubt that E-Cigarettes and ENDS products are gaining space in the current market.

  4. Lunch Break & Networking

Session III: New Developments and Public Health Implications

E-Cigarettes are not new in the industry but in recent years have gained notoriety for the capacity of technological development and research that open new possibilities and alternatives. Electronic Delivery Systems have emerged as an online leader in popularity among smoking alternatives in the U.S. and Canada. This session will evaluate health and legal implications. It will also review the historic landscape and current situation of e-cigarettes.

  1. Tobacco Harm Reduction in an FDA Regulated Environment

    Jose Luis Murillo | Vice President​ Regulatory Affairs of Altria Client Services LLC

    This session will emphasize the importance of tobacco harm reduction for public health, and discuss  tobacco harm reduction in light of the FDA's newly announced plan to regulate tobacco and nicotine. Joe will also highlight work that remains to be done and talk about Altria's efforts to advance a harm-reduction strategy.

  2. Panel: ENDS and Electronic Non-Nicotine Delivery Systems (ENNDS) as Alternative for Tobacco Cessation

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

    We have the opportunity to hear the science behind the polemic statement that promotes the use of electronic nicotine delivery systems and Non nicotine delivery systems as an effective and less harmful alternative to traditional tobacco and nicotine use. The panel will discuss what recent studies have been done and their findings.

    Panelists:

    • David Graham | Chief Impact Officer | NJOY
    • Christopher Russell | Senior Research Fellow | Center for Substance Use Research (CSUR)
    • Gregory Conley | President | American Vaping Association
  3. Innovation in ENDS and E-Cigarettes Products

    John Bellinger | Co-Owner of Evolv

    Product innovation drives towards increasing safety and health concerns from the manufactures to the consumer, guided by regulatory frame in an attempt to create a better product with a lower risk for the end consumer.

  4. Networking & Coffee Break

Session IV: Testing Process and Toxicological Studies for ENDS and E-Cigs

With the open dissemination in social network of information we are seeing new small producers of e-cigarettes as well as accessory producers participating in the market. These growths show the need for more information and follow-up to the right protocols that will guarantee public safety in the products for the final consumer.

  1. Testing Components and Parts, E-liquid Tobacco, Liquid Nicotine, Flavors and Aromas

    Dr. Daniel Norwood | Executive Partner of SCIO Analytical & Senior Consultant at Smithers Rapra

    This talk will review the process of approval and testing that new components and parts have to follow in order to be commercialized in the market. More than 460 different e-cigarettes brands are currently on the market such as: e-cigs, vapes, vape pens, etc.

  2. Understanding Extractables and Leachables Testing for ENDS Products

    Charles Ducker, Ph.D. | Principal Chemist/Group Leader of Eurofins Medical Device Testing

    Eurofins is a worldwide leader in the analytical testing of new devices and will share their experience in navigating the regulatory water with these new nicotine delivery systems. The FDA extended their regulatory authority in 2016 to include all ENDS. Their current draft guidance for ENDS, published in May of 2016, indicates the need for extractables and leachables (E&L) data. Since the route of administration is through inhalation, ENDS are considered high risk based on the FDA’s E&L risk matrix. In order to satisfy the safety concerns of the regulatory agencies, manufacturers must perform an E&L evaluation to demonstrate that the device will not introduce harmful chemicals due to the storage and use of the product. Since the FDA has not offered guidance specific to the setup of E&L studies for ENDS, it is necessary to design a relevant study based on the intended use. A typical E&L study would include a reflux extraction coupled with a simulation study to look at real time storage and use conditions. This would be followed by a two pronged stability studies where both the liquid drug product and the vapor it produces would be tested on the shelf life of the product.

  3. Toxicological Studies and In Silico Models for E-Cigarettes and ENDS Products

    Glenn J. Myatt, Ph.D. | Chief Scientific Officer of Leadscope

    • Review of considerations in identifying toxicological data
    • Outline of in silico toxicology methodologies to fill data gaps
    • Description of on-going efforts to provide guidance for the assessment of hazard using in silico models and toxicological data
  4. Closing Remarks from the Moderator

  5. Evening Reception

Day 2: Wednesday, December 6th

Welcome and Opening Remarks

  1. Exhibit Hall Opens

Session V: Case Studies and Data Acquirement

This session is dedicated to presenting different case studies from pharmaceuticals and manufacturers to analyze diverse points of view, closing the conversation with a Q&A session for sharing experiences and ideas.

  1. Morning Keynote: Global Market Overview for the E-Cigarettes Industry

    Tim Phillips | Managing Director of ECigIntelligence

    • How has the global e-cig market reacted since the EU's TPD has been implemented and the deadline for the Deeming Regulations has been pushed back?
    • What is happening elsewhere in the world, in emerging markets?
    • What impact is the tobacco industry's launch of heat-not-burn products having on the e-cigarette sector?
    • What are the policy changes we can expect over the next few years, and how will that impact the market?
    • What else can we expect in this sector for the future, both in terms of product development and distribution?
  2. Pre-Clinical Studies on ENDS and ECIGs Products: Framework and Experimental Findings

    Co-presented by Amy Madl and Autumn Bernal of Cardno ChemRisk

    • Companies submitting Premarket Tobacco Applications must demonstrate that new tobacco products are appropriate for the protection of public health
    • Human health risk assessment is a critical method for evaluating impacts on human health
    • This presentation will address important aspects of non-clinical study design for the application of conducting human health risk assessments of e-cigarette users
    • Case examples will be used to illustrate how product testing, toxicological evaluations, toxicity tests, and consumer use patterns are used in a risk assessment framework to assess impact on human health
  3. Clinical Trials Meta-Analysis, Data Acquisition and Interpretation

    Dr. Ian M. Fearon | Principal Scientist and Head of Clinical Research of British American Tobacco

    Dr. Fearon will be presenting the process for data acquisition in clinical studies for e-cigarettes and ENDS. His experience involves GCP compliant human studies examining the effects of novel nicotine and tobacco products and biological effects. 

  4. Post-Clinical Studies on ENDS Products and ENDS Consumers

    Christopher Russell | Senior Research Fellow, Behavioural Studies of Tobacco and Nicotine Use of Centre for Substance Use Research (CSUR)

    This talk will complete the block on case studies, specifically focusing on the investigation and findings done on post-consumer experiences. When a clinical study for E-Cigarettes is required what are the important topics to take into account health wise and what are the findings.

  5. Networking & Coffee Break

Session VI: Advancement in Electronic Device Technology

We will bring presentations on the media impact, scientific advancements in research and innovations with the intention to take a panoramic view and discuss next steps in the Electronic Nicotine Delivery Systems and E-Cigarettes field.

  1. Smoking Out the Facts

    Chris Howard | Vice President, General Counsel and Chief Compliance Officer of E-Alternative Solutions, LLC

    This talk will cover how regulatory restrictions and media make it difficult for consumers to obtain accurate information about ENDS risks and benefits. Today we have all kinds of information in our hands as we grow more conscious about what we use and consume. Health information is fundamental for a product to get into the market, but what happens when the information is not available or the regulatory framework is not clear? This topic is very important since misjudgement and fear takes over the consumer perception and affects the industry in negative ways. 

  2. Novel Products and New Regulation Demand New Testing Methods

    Linda Crumpler | Business Development Director of Cerulean

    In the ENDS market the pace of new product development has been striking and regulation has followed this explosion of new products. Increasingly data on composition, construction, emissions and the consequences of these emissions has to be submitted to allow continued sales. The conflict presented by this fast evolving market landscape is that information requirements are separated from the methods of generating raw test data. It is clear that new methods of testing need to be developed. These can be informed by burnt down tobacco testing but should not slavishly follow the same methods if a more appropriate method can be developed for the ENDS industry. Two novel methods of testing are discussed.  The first one that casts a new spotlight on in vitro exposure testing that is designed around ENDS products.  The second method offers the prospect of real time chemical analysis of ENDS vapors. The key issue of validity of results and instrumental artifacts are discussed in depth as is where these new ideas can take us for the future when HNB products are considered. 

  3. Closing Panel: Future, Innovations and Next Steps

    Dr. Daniel Norwood and Members of the Advisory Board

    After a journey of extensive information, exchange of knowledge, studies and ideas, everyone will gather together to see what comes next and the future outlook for ENDS and E-Cigarettes.