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

    Workshop Speakers | Amy Madl, Ph.D., DABT and Autumn Bernal, Ph.D., of Cardno ChemRisk

    Product stewardship is the understanding, controlling and communicating of a product’s health and safety throughout its life cycle.  Whether or not ENDS companies anticipate submitting a PMTA in 2022, having a solid product stewardship program is important for sustaining product innovation and marketplace.  In other industry sectors, product stewardship programs have evolved beyond product safety and regulatory compliance to corporate responsibility and sustainable product innovation. 

    This half-day workshop will focus on the research strategies and testing methods available to evaluate the safety of ENDS products in the context of the Pre-Market Tobacco Application (PMTA), as well as in the framework of best practices for product stewardship. 


    Participants of the workshop will learn more about:

    • The basic components of a product stewardship program
    • Best practices of product stewardship executed by other industry sectors
    • Strategies to integrate and bridge non-clinical and clinical ENDS research for the PMTA across products -including different e-liquid flavors
    • Screening approaches to identify products for PMTA submission
    • Information that is needed up and down the supply chain to support safety and regulatory compliance
    • Study design considerations to leverage clinical and non-clinical testing for a human health risk assessment

    * You cannot participate in the workshop without registering for ENDS US 2018 2-Day Conference *

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 Address - Coming Soon!

    Stay Tuned - More details coming soon!

  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

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

  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 Outperform

    • 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. Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products

    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:

    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. Opening Key Note: Promise of E-Cigarettes. Do they help people switch?

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

    Stay Tuned! More details coming soon!

  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 – Complying with FDA Warning Statement Requirements

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

    • Reviewing existing FDA regulations and guidance on warning statement requirements
    • Identifying gaps in FDA regulations and guidance on warning statements
    • Run-of-the-mill warning statements– the easy calls
    • Solutions for the “not so easy calls” – warning statements on different electronic and socialmedia, point-of-sale advertising and other “non-traditional” advertising
  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 | General Counselor and Chief Compliance Officer Consultant of Independent Consultant

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