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Agenda

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Session I: Market Updates + Current Trends
The US vape market: disposables, new nicotine alternatives, and changing trends in a post-PMTA landscape
Following the deadline for submission for PMTA in the US in September 2020, the market has altered as some companies have pulled out of the market or paused innovation while waiting for marketing approval from the FDA while others have filled perceived gaps in the sector. This presentation will look at the product mix of those applications which form the over 6m PMTA submissions currently being reviewed by the FDA and what this suggests about the future of the post-regulated market. In addition, it will look at trends which are in part caused by the regulatory uncertainty, from the growth of disposables and smaller pod devices, to the changing flavour preferences in response to increasing restrictions being imposed on flavoured products. It will also look at new alternatives to nicotine products such as heated tobacco, nicotine pouches and the cross-over with cannabis, and the impact this has on the vape market in the US.
 
Tim Phillips | Managing Director, ECigIntelligence
PANEL: Global ENDS Market Discussion
Panelists:
  • David Ettinger – Partner, Keller & Heckman
  • Eric Gu – Associate, Keller & Heckman
  • Tim Phillips - Managing Director, EcigIntelligence
  • Greg Conley – President, American Vaping Association
Description
This panel will dive into a global discussion regarding the current ENDS Market – with special focus on the following markets:
  • United States
  • United Kingdom
  • UAE
  • China
  • Australia
  • Japan
  • South Korea
The panelists will present different perspectives regarding challenges, regulations, and opportunities moving forward within the industry.
 
Networking Break
Session II: Understanding the Regulatory Landscape
What You Should Know About FDA Regulation of E-Cigarettes
During the one-year period of September 9, 2020-2021, FDA took final action on over 6 million PMTAs for e-cigarettes.  Final actions included refuse to accept (RTA), refuse to file (RTF), and marketing denial order (MDO).  These actions provide insights into how FDA evaluates PMTAs for e-cigarettes.  It is important to understand what information is needed for a PMTA to be accepted and filed so that it can enter scientific review.  Once in scientific review, FDA focuses on whether marketing of an e-cigarette is appropriate for the protection of public health (APPH).  There are many factors that FDA weighs in evaluating an e‑cigarette PMTA to determine whether it is APPH or not.  Critically, FDA weighs the potential benefit of an e-cigarette to move smokers down the continuum of risk against the potential risk of an e-cigarette leading to youth use.  This presentation will discuss how FDA approaches our review of e-cigarette PMTAs.
 
Matt Holman | Director, Office of Science, FDA
Lunch Break
Session III: Premarket Tobacco Applications: A Helpful Guide
The FDA gifted you a PMTA deficiency letter … what now?
So You Got your PMTA. What Do You Do Next?
Following the submission deadline for PMTAs in September 2020, a number of manufacturers have their PMTA submissions under FDA review.  While FDA have been overwhelmed with the sheer volume of PMTAs submitted, a number of manufacturers can expect their decision letters in the latter quarter of 2021.  In these letters, FDA will outline their requirements for ongoing reporting of numerous factors and in particular, manufacturers will be expected to continually assure FDA that their ENDS product is APPH.  Without this reassurance, FDA can and likely will repeal the marketing order.  FDA have made it clear in previous PMTA marketing orders that they expect behavioral survey data as a means of continuously demonstrating that an ENDS product is APPH; this presentation will outline what type of survey data FDA will expect and also how manufacturers need to act well in advance of their marketing order to design their surveys and have them ready for implementation once a marketing order is granted. The presentation will further provide a high-level overview of how to design and implement behavioral surveys to maximise chances of continued marketing of an ENDS product.
Ian Fearon – Director, Whatif Consulting
 
Ian Fearon | Director, Whatif Consulting
Don’t Reinvent the Wheel: How to Expand Your Product Portfolio the Smart Way
Additional Presenter:
Evan Richardson – Director, Regulatory Services, Synchrogenix


Following the receipt of a Marketing Order for their initial Electronic Nicotine Delivery Systems (ENDS) products, stakeholders will turn their attention towards the expansion of their product portfolios. Minimizing the costs – in time and money – to obtain a Marketing Order for these subsequent products will be a primary focus. Ultimately, stakeholders may find their testing, reporting, and Premarket Tobacco Product Application (PMTA) submission strategies evolve as their portfolios grow.
In this presentation, regulatory experts from Synchrogenix will discuss strategies to obtain PMTAs for similar products by leveraging the existing body of data to support the next round of PMTA submissions. Examples include the benefits of Tobacco Product Master Files (TPMFs), supplemental PMTAs, and bridging strategies. The usefulness of a forward-thinking and submission-focused approach in terms of study design, document preparation, and electronic Tobacco Technical Document (eTTD) structure will also be discussed.
Vivienne Tedesco-Ciavarra | Regulatory Services Manager, Synchrogenix
Session IV: ENDS + Efficacy
Panel: A Breakdown of the Flavor Ban + The Challenges that it Brings
Panelists:
  • Eric Heyer – Partner, Thompson Hine
  • Patricia Kovacevic, General Counsel and Chief Compliance Officer Consultant, Independent
  • Chris Russell – Director of Russell Burnett Research and Consultancy Ltd
  • Mark Anton – President, What A Smoke, LLC
  • Greg Conley – President, American Vaping Association
This panel will discuss the Flavor Ban in the US and what it means for the future. A discussion about youth use, adult consumers, challenges in getting behind in technology and other areas from the rest of the world.
Closing Remarks
Session V: Tobacco Harm Reduction – Diverging Perspectives
Presentation to Come!
PANEL: ENDs + Public Health Coming Together
Panelists:
  • Ray Niaura – Interim Chair of the Department of Epidemiology – Professor of Social and Behavior Sciences, New York University
  • Charles Gardner – President, INNCO
Networking Break
Session VI: The Future of ENDs
Presentation to Come
Synthetic Nicotine – How FDA Could Regulate This Growing Segment of the Vape Industry
PANEL: A Look into the Future Landscape
Panelists
  • Peter Beckett – Co-Founder and Director of Strategy, Vaping.com
  • Monica Schick – Senior Consultant, North Guide Solutions
  • Amanda Wheeler – President, American Vapor Manufacturers Association
  • Ian Fearon – Director, Whatif Consulting
  • Chris Allen - Chief Scientific Officer, Broughton Nicotine Services
Description:
  • Discuss new products, technology, and the expansion of the market landscape
  • Potential opportunities and growth as we move the market further
  • Expand on challenges within the market, i.e. flavor ban, regulations, etc.
  • Bring to the forefront any big conversations or discussions that were seen within the workshop
Closing Remarks and Farewell