2018 ENDS US Agenda

Smithers Rapra is pleased to announce the ENDS US 2018 Agenda:

Pre Conference Workshop

Assessing the Safety of ENDS in a Regulatory and Product Stewardship Framework

  1. ENDS Product Stewardship: It’s Not Just About Regulatory Compliance

    Amy Madl, Ph.D., DABT

    In today’s world, consumers expect products to meet their personal needs and be safe for human health and the environment.  Additionally, product liability is not confined to regulatory compliance.  Thus, development and use of products throughout its entire life-cycle must be examined in the context of industry best practices and the current state-of-the-science to assure products are not only innovative but also safe for the marketplace. 

    This speaker will introduce concepts of a product stewardship program and implications for the ENDS industry.

  2. The ‘Nuts and Bolts’ of the PMTA and Beyond

    Elise De Gandiaga, B.S.

    Although the PMTA guidance has yet to be finalized, the time for ENDS and e-liquid companies to develop their PMTA research plans and strategies is now; this is especially imperative, given the recent FDA enforcement activities and potential threat of moving up the PMTA deadline. 

    This speaker will address all the various components of the PMTA and illustrate how an integrated research approach is essential for evaluating impacts on public health.

  3. ENDS Safety by Design: Role of Hazard Screening

    Autumn Bernal, Ph.D.

    It has been estimated that 9 million adults in the US regularly use ENDS.  Understanding the health impacts of these products is complicated by constantly evolving device technology. Hazard screening, toxicology assays, and human health risk assessment are important tools to leverage in the product design phase so that public health risks of the final product are minimized. 

    This speaker will illustrate how a risk assessment framework and toxicology-based decision process can aide in designing safer products for the marketplace.

  4. Networking Break

  5. Integration of Nonclinical and Clinical Research and Public Health

    Stacey Benson, Ph.D.

    To receive pre-market approval of tobacco products by FDA, a company must demonstrate through their PMTA that the product is protective of public health.  Nonclinical and clinical research to support a PMTA application requires an integrative approach to understand how ENDS emissions and consumer use patterns translate human health risks or benefits in comparison to other tobacco products. 

    This speaker will discuss ways in which product testing, toxicity assays, and human clinical studies can/should be integrated and bridged to characterize the impacts of ENDS products on human health.

  6. Stewardship and Sustainability in a Global Market: Lessons Learned from the Tire Industry

    Marisa Kreider, Ph.D., DABT

    The tire industry makes one product…tires.  Without a proactive, prospective approach to understanding the human and environmental health impacts of tires throughout its entire life-cycle, the sustainability of this industry could be at risk.  For more than a decade, the tire industry has taken an industry-wide stewardship approach to preemptive health research and transparent risk communication. 

    This speaker will address the tire industry’s global product stewardship approach and provide corollaries (and perhaps lessons learned) to the ENDS industry.

  7. Q&A Roundtable

Day 1 | December 6

Registration & Welcome

  1. Registration & Exhibit Hall Open

  2. Welcome & Opening Remarks

Session I: Regulations and Evolving Policy- Making Considerations

In the opening session of our conference, leading industry experts explore varied approaches and key considerations for ENDS regulations. Discuss the FDA’s latest updates concerning flavors and E-Liquids, and the most current state taxation initiatives.

 

Moderator: Scott Ballin, JD, Health Policy Consultant and Former VP and Legislative Counsel

  1. Keynote | U.S. E-Vapor Policy and Regulation: A Road Map to Getting it Right

    Larry Flick | Executive Director of American E-Liquid Manufacturing Standards Association (AEMSA)

    • Effective industry-led youth uptake prevention
    • Continuum of Risk-based proportionate regulation
    • Industry-led product standards development and government-led enforcement
    • A certification-of-standards-compliance path to market that fosters innovation
    • Public and industry-sponsored education targeted to educating adult smokers how to transition to vaping
    • Continued non-biased research on vaping as a tobacco harm reduction technology
  2. Updates on Flavor Compliance and Enforcement Efforts

    Azim Chowdhury | Partner of Keller and Heckman LLP

    • What is a “kid-appealing” flavor?
    • FDA’s Advance Notice of Proposed Rulemaking on Flavors in Tobacco Products- what’s next?
    • FDA Enforcement Warning Letters to E-Liquid Companies
  3. Legislative Updates on Electronic Cigarette and Vapor Product Taxation

    Paul Blair | Director of Strategic of Initiatives of Americans for Tax Reform (ATR)

    • Local/State Excise Tax Models
    • Proposition 56 in California
    • How are taxes paid and by whom?
    • Tax trends moving forward?
  4. Panel Discussion: Key Considerations for ENDS Regulations

    Panelists to Include:

    Alex Clark, Executive Director, The Consumer Advocates for Smoke-free Alternatives Association (CASAA)

    Greg Conley, President, American Vaping Association

    David Graham, Chief Impact Officer, NJOY

    Larry Flick,   Executive Director,   American E-Liquid Manufacturing Standards Association (AEMSA)

  5. Networking & Coffee Break

Session II: Economic Viability and Commercial Responsibility

The ENDS market is evolving but the competitive landscape faces many financial opportunities and challenges, including policy changes, taxation revisions, barriers for entry, sustainable profitability, internal supply chain controls, and rapid market shifts. This session will delve into an analysis of current and future financial trends in the tobacco and emerging cannabis sector and the short and long term effect on disruptive innovations, while sharing strategies to help adapt and meet stakeholder’s expectations.

 

Moderator: Tim Philips, Managing Director, E-Cig Intelligence

  1. Discussion of Current Tobacco Trends and the Emerging Cannabis Sector

    Vivien Azer | Managing Director of Cowen

    • FDA & ENDS
    • Youth consumption trends- ENDS vs. combustion
    • JUUL – who is the core consumer
    • Global RRPs- views from global tobacco
  2. Managing Supply Chain Responsibly

    Crystal Wersching | Sr. Director of the Procurement Center of Excellence of Altria

    A focused approach on how to develop and execute supply chain corporate responsibility strategies. How to re-assess annually to account for changes in your business and stakeholder expectations.

    • Develop diverse supplier base
    • Communicate expectations
    • Assess supplier performance
    • Engage with stakeholders
  3. Financial Panel: Economic Viability of ENDS Market and Critical Considerations for Growth

    What does the long term performance landscape and profit margin sustainability look like in this space?

    Are there current tax advantages for ENDS industry and future profitability levels in reference to federal excise taxes and sales tax revenue? How will this impact the future shift for smokers down the continuum of potential reduced risk?

    Growth opportunities and barriers for innovation in expanding and new markets


    Panelists Include: 

    Tim Phillips, Managing Director, E-Cig Intelligence

    Bonnie Herzog, Managing Director of Tobacco Goods, Wells Fargo

    Pamela Kaufman, Vice President, Morgan Stanley Research

  4. Networking Lunch

Session III: Examination of Practical Applications for Going to Market

Join us as we take a scientific journey through technological knowledge and research discoveries, and how they translate from clinical practice to further help improve the health and quality of public health. These developed scientific components help with an overall understanding of how to best navigate the compliance testing, product ingredient quality control, evaluations for toxicology, product stewardship and product routes for going to market.

 

Moderator: Sarah Cooney, Head of Scientific Collaboration and Communication, British America Tobacco

  1. What Should You Already Be Testing for Complete Compliance

    Amy Madl | Senior Principal Health Scientist of Cardno ChemRisk

    • Product ingredients and testing – Understanding your product from the ingredient supplier to the consumer
    • Screening hazards and minimizing health risks – Evaluating chemical toxicology and consumer exposures in anticipated and worst-case conditions
    • ENDS in the context of the continuum of risk – Testing strategies to evaluate ENDS compared to other tobacco products
  2. Stewardship assessment of e-liquid ingredients and U.S. regulatory considerations

    Ryan Potts, PhD, DABT | Vice President, Scientific & Regulatory Affairs of RAI Services Company

    Key components of a pre-market stewardship assessment program for e-liquid ingredients

    • Chemical/biological testing considerations for ENDS products
    • Perspectives on U.S. FDA review of ingredients in tobacco products
  3. Systems Toxicology Assessment of E-Vapors

    Nikolai V. Ivanov, PhD | Director Biomarker & Biosensor Research | Philip Morris International R&D

    Abstract Coming Soon!

  4. Reference e-liquid, flavors and reproducibility

    Jeffrey Kim, D.D.S., Ph.D. | Project Leader of American Dental Association Volpe Research Center

    There are significant quality variations among consumer e-liquid products. It is difficult to keep up with vast array of products and the rapid changes in e-cigarette technology.

    When used appropriately, the reference e-liquids can serve as a reliable control in research experiments and during manufacturing processes.

  5. The United Kingdom: Consumer and Medicinal Product Routes for ENDS

    Dr. Ian M. Fearon | Senior Director Clinical and Regulatory Affairs EMEA of JUUL Labs

    Update on EU rules for notifying novel ENDS products

    • Registering a novel product in the UK
    • UK environment for ENDS as a licensed medicinal product
  6. Networking & Coffee Break

Session IV: How to Understand the Vapor and Flavor Puzzle

Interpreting the vapor and flavor outlook and its dynamic relationship with nicotine can be challenging. In this session we will discuss clinical studies and the lessons learned about flavors in relation to smoking cessation, toxicological effects, preferences, impact of flavors, and help to create well informed dialogue of current ANPRM comments.

 

Moderator: Azim Chowdhury, Partner, Keller & Heckman

  1. The Science of Flavors: The Evidence in Response to FDA’s Flavors ANPRM

    Eric Heyer | Partner of Thompson Hine LLP

    Discussion of the role flavors play in ENDS products and cessation demands

    • “Gateway Theory” and the current research on youth initiation related to flavors
    • Toxicological Effects of ENDS Flavorings
  2. ENDS Flavors: Their Role in Initial Liking at Trial, Preference Formation and Switching

    Dr Andrea Vansickel | Manager Consumer & Marketplace Insights of Altria Client Services

    Flavor options may play a critical role in moving adult smokers toward potentially reduced harm tobacco products. To characterize e-vapor use behavior, its influence on other tobacco use behavior, and the potential role of flavor variety on behavioral outcomes, we conducted an 8-week, 2-phase, at-home use study. We demonstrated that a variety of flavor options facilitated adoption of e-vapor among adult cigarette smokers. This presentation will discuss the methods, results and conclusions from this study. We will discuss findings in light of the existing literature on the role of e-vapor flavor options in adult cigarette smokers’ transitions to exclusive e-vapor use.

  3. Vapor and Flavor Panel: Opportunities and Threats in the Vaping Industry

    Discussion based around trends and how to evaluate flavor strengths & their role in smoking cessation.

    • What ANPRM comments help map the outcomes relative to other initiatives?
    • Clinical evidence relative to outcomes
    • Impact of local ban on flavors in SF, CA?

    Panelists Include:

    Chris Allen,    Managing Director, Broughton Laboratories

    Doug Copeland, Executive VP of Corporate Development, High Point Clinical Trials Center

    Janet Aho, VP, Regulatory Affairs & Product Safety, Flavors, MANE, Inc.

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

  4. Closing Remarks - Day 1

  5. Evening Welcome Reception

Day 2 | December 7

Registration & Welcome

  1. Exhibit Hall Opens

  2. Welcome and Opening Remarks

Session V: Public Safety Concerns and Societal Implications

Conflicting views among the prohibition and harm reduction camps has public safety at the forefront of debate concerning compliance and regulation standards. How to find the balance between maximizing the potential for e-cigarettes and appropriate regulation? A comprehensive review of how large scale studies can potentially aid in pattern of use pure data points and safety concerns leading to harm reduction outcomes.

 

Moderator: Ian Fearon, Senior Director Clinical and Regulatory Affairs EMEA, JUUL Labs

  1. Day 2 Keynote | Rates of Smoking Cessation and Magnitudes of Reduction in Cigarette Consumption Among New Adult E-commerce and Retail Purchasers of JUUL Vapor Products in the United States - Findings From Retrospective and Prospective Observational Studies

    Christopher Russell Ph.D. | Deputy Director of Centre for Substance Use Research (CSUR)

    This presentation will detail:

    • The rate and speed at which new e-commerce and retail purchasers of a JUUL quit smoking completely.
    • How smoking quit rates vary by individuals' use of JUUL pods in tobacco flavors (e.g. Virginia Tobacco) versus characterizing flavors (e.g. Mint, Mango).
    • Factors that increase and decrease a smokers' likelihood of switching completely to a JUUL.
    • The impact of long-term JUUL use on U.S. cigarette volumes.
  2. Fact or fiction? The Importance of communicating sound science on nicotine delivery products

    Sarah Cooney | Head of Scientific Collaboration and Communication of British American Tobacco

    • Why are so many consumers confused about next generation products and whether theyare less risky than cigarettes?
    • This talk looks at where the confusion arises, and what can be done to ensure that consumers and regulators have access to good quality research
    • Importance of high quality science on next generation products, by both industry and independent researchers
  3. Don’t Make Me Warn You Again – How do I comply with this new FDA agreement?

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

    FDA’s November 15 Announcement seems to be a new standard in product regulation – regulation by agreement and compliance policy.  The presentation will address:

    • What is, and isn’t, in the November 15 Announcement.
    • FDA’s authorities and how the Agency is attempting to maneuver around them.
    • Questions, issues raised and the impact of FDA’s “flavor ban” at most retail shops.
    • On-line sales, age verification and compliance.
    • Marketing to kids – what we think the FDA is attempting to address and how to get ahead of the curve.
  4. Networking & Coffee Break

Session VI: Health Risk Assessments and Behavioral Testing Strategies

Examination of the scientific framework and top line methodology strategies used to assess potential health risks and create clean population studies with sensitive populations to avoid pitfalls, ethical and moral issues.

 

Moderator: Patricia Kovacevic, General Counselor and Chief Compliance Officer Consultant, Independent

  1. Assessing User Behavior and Risk Perceptions: A Case Study from Philip Morris International

    Erica Spies, PhD | Senior Scientist of Philip Morris R&D Biomedical

    • An overview of existing behavioral frameworks that propose explanations of and factor associated with the use of tobacco and nicotine products, including the Host Agent Vector Environment (HAVE Framework).
    • A summary of the Tobacco Regulatory Research Collections from the PhenX Toolkit
    • The application of U.S. Food and Drug Administration’s “Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims” to the development of measurement instruments within Philip Morris International’s Assessment of Behavioral OUtcomes related to Tobacco and nicotine products (ABOUT) Toolbox
    • A synopsis of the empirical results illustrating the use of the ABOUT-Perceived Risk instrument to assess the public health impact of IQOS® in pre-market and post-market settings.
  2. Assessing Potential Health Risks from ENDS Delivery Systems

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

    • Defining potential risks to ENDS users from delivery systems
    • A possible risk assessment process
    • Laboratory assessment of ENDS delivery systems
    • The ENDS delivery system supply chain
  3. Strategies and Sensitivities for Data Collection Among Youth Populations

    David Wourms | Senior Research Scientist of Battelle Memorial Institute

    This presentation will focus on the ins and outs of collecting data among youth populations, under the age of 18. Discussion areas will include obtaining participant assent and parent/guardian consent, meaningful and sensitive data collection modes, methods and approaches and strategies for handling participant recruitment. Ethical and moral considerations for working with this vulnerable population are also a critical part of working with youth that will be covered during this talk.

  4. Networking Lunch

Session VII: Disruptive Technologies and Looking to the Future:

What could the future look like for the unfolding ENDS story? Product innovation drives toward increasing safety and health outcomes from the manufacturers to the consumer, within an evolving regulatory backdrop. How will scientific advancements in research and key legislation help to support innovations within polarizing societal views and the next steps in the ENDS industry.

 

Moderator: Willie McKinney, VP Regulatory Sciences, Altria Services LLC

  1. Innovation and Trends In Next Generation Products

    Chris Morrison | Science Officer | BAT

    How BAT and RAI have partnered to bring innovations for adult smokers, applying smoker product-technology insights

  2. Innovations in the Vapor Space

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

    With FDA regulation hindering the release of new innovations in the tobacco-based vapor space, we explore what other alternatives exist or are coming to market and how those products might be regulated.

    Overview – New Products

    • Why innovation is hindered in the tobacco-based vapor industry • Hemp • CBD • Alternatives

    Regulation

    • CBD - Farm Bill / state-by-state • Canada (nutraceuticals)

    Market

    • CBD • Vaporizing alternatives

  3. CBD and Cannabis - What are the risks?

    Christopher Van Gundy | Partner of Keller and Keckman LLP

    Legal Status of CBD and Cannabis:

    • DEA, Controlled Substances Act & State Laws
    • FDA Regulation of CBD in E-Liquids
    • California Emergency Cannabis Regulations
  4. Wise Regulation Is the Key to the Vaping Industry

    Patricia I. Kovacevic | Consultant of Independent Consultant

    • Latest most relevant FDA developments
    • Update on litigation against FDA
    • Regulatory Predictions for 2019-2020
  5. Closing Remarks