Next Generation Nicotine Delivery USA 2021
Virtual Event | 11:55 AM BST | 6:55 AM EDT
9th June 2021
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Next Generation Nicotine Delivery USA 2021
DAY 1|9th June 2021
11:50 am Setting the Scene - the significance of the role of the global Framework Convention on Tobacco Control (FCTC Treaty) in shaping global nicotine regulation.
- Understanding the various players participating on the international health policy stage – the role of the World Health Organisation, the FCTC COP, and others.
- How best to use the policy hooks in the FCTC to shape national nicotine policy, drive tobacco harm reduction and establish risk proportionate regulation.
- Alternatives to smoking – protecting the human rights of those who wish to have access to and information about less harmful nicotine options.
- The role of domestic judiciaries in promoting compliance with treaty obligations and protecting treaty-based private rights.
- Comparisons and differences between the Framework Convention on Climate Change and other industries impacted by international regulatory policy.

Jeannie Cameron
Vice President - International Engagement
Juul Labs
12:30 pm What ENDS companies should be considering when developing new products and how trends in global regulations could impact such decisions.
- Considerations for new products – understanding the consumer and the competition
- Understanding the product – demonstrating its characteristics and harm reduction potential
- Current and emerging regulations – applicability of MAA and sustainability of PMTA.

Paul Hardman
Head of Scientific Affairs
Broughton Nicotine Services
1:00 pm Tobacco Reset? A look into the future of the New Nico Industry: 2021 and Beyond –
- FDA & the Future of Flavors given recent FDA announcements that it will seek to ban menthol cigarettes and flavored cigars, and the likelihood of Congressional action
- PMTA Application Process Update: What does the industry look like post application and what will this mean in terms of product accessibility and choice?
- Emerging Trends in the Nicotine Industry including disposable ENDS and Synthetic Nicotine

Tony Abboud
Executive Director
Vapor Technology Association
1:30 pm Morning refreshments and networking
1:40 pm Extractables & Leachables - What are they and why are they important to the world of vaping?
- What are Extractables and Leachables?
- Why are the regulators interested in them?
- What does an Extractables and Leachables assessment involve?
- How is the regulatory landscape around Extractables and Leachables likely to evolve with respect to current and future vaping products?

Shane Smith
Managing Director
ExtLe Solutions Ltd
2:10 pm FDA Update and Communications Surrounding Comparative Risk of Nicotine Products
- Latest FDA developments over the past 9 months
- Role of governments in accurately communicating comparative risk of nicotine products
- Government action and its impact on consumer behaviour

Patricia I. Kovacevic
Founder and Principal, Regulation Strategy & General Counsel
Andina Gold Corp
2:40 pm Remote Regulatory Assessments for Vapor Product Manufacturers in PMTA Review: What to Expect and How to Prepare
- Setting the Foundation: The 3 C’s of cGMPs
- Building Quality into the Manufacturing Process – Impact on PMTAs
- FDA Inspections
- Remote Regulatory Assessments (RRAs): How to prepare and what to expect

Neelam Gill
Associate
Keller and Heckman Partners
3:10 pm Scientific studies for Regulatory submissions: An update on Vapour and Modern Oral science
- Part (1) Scientific assessment approach
- Part (2): Focus on Vapour – Overview of Vapour studies and data
- Part (3): Focus on Modern Oral – Overview of Modern oral studies and data

Sarah Baxter-Wright
Senior Director Clinical Studies
RAI Services Company
3:40 pm OPEN DISCUSSION: Sink or Swim: What does the future of Nicotine hold? do post PMTA in the nicotine landscape?
- Where is the category today?
- What does the category need to do to stay relevant and competitive?
- Innovation in liquids and technology
- Future of vaping in the Nicotine category and beyond like caffeine, THC, CBD and nutraceuticals

Ray Story
United Tobacco Vapor Group, Founder/CEO; UTVG Europe B.V.; TVECA, Founder/CEO; TVECA Europe, Founder. Founder QMOS Next generation Technology.
TVECA
4:10 pm Lunch and networking
4:20 pm Through the Eyes of the New – Age Nicotine User: The evolution of the pouch, e-tobacco and nicotine landscape
- Gaining an understanding of what smokers and non-smokers alike are looking for in nico products to better cater to market needs
- Understanding the role of the wide variety of products in the market to identify how these can complement existing nicotine and e-tobacco formats
- Looking at the growth of pouch tobacco and e-cigarette use to understand who these appeal to and how to better leverage the market
- Exploring current innovations to better predict emerging trends and declines
- Discussing possibilities of undoing the stigmas surrounding e-cigarettes to rebuild consumer confidence in the market

Tim Phillips
Managing Director
ECigIntelligence
4:50 pm Premarket Assessment of Perceptions and Intentions to Use the RELX Infinity ENDS and RELX PRO E-Liquid Pods Among Adult Tobacco Users and Non-Users in the United States
• RELX Infinity ENDS
• RELX PRO e-liquid pods
• Adults’ risk perceptions and use intentions
• PMTA quantitative assessment
• Potential population health impact

Christopher Russell
Director
Russell Burnett Research and Consultancy Limited
5:20 pm A look into the Future : Next Gen Nico & Oral Products
- Analysing the smokeless and smoke free tobacco market to predict the direction of the industry
- Questioning the role in regulations across the whole nicotine portfolio and how this effects the product to market process
- Transitioning from traditional tobaccos to next-gen nicotine formats effectively to promoto harm reduction and cater to consumer choice
- Onboarding tobacco users to the smokeless product range to cater to smokers’ needs by way of an effective harm reduction strategy

Tryggve Ljung
Vice President of Scientific Affairs
Swedish Match

Brian Erkkila
Director of Regulatory Science
Swedish Match
5:50 pm Marketing Approval for Next Generation Nicotine Products: Is It Politics or Evidence that Will Determine the Outcome
- This presentation will focus upon the contested space that is the regulation of next generation nicotine products -electronic nicotine delivery systems.
- Now in the latter stages of the Pre-Market Tobacco Application process- what does this mean for ENDS companies.
- The need to begin planning for Post Market Surveillance
- The need to begin planning for the loss of products.
- The importance of ensuring that there is up to date evidence with which to challenge the basis upon which PMTA decisions have been made where there is at least a prima-facie case that those decisions have been politically influenced.
- The importance of behavioral data on the impact of reduced availability of ENDS devices within the U.S. market- what happens to those vapers that are using devices and liquids withdrawn from the U.S. market?
- The need to recognise that not all devices are equal in their impact and the need to identify which devices are most impactful with which groups of smokers.
- The Big Vape U.S. study what is it? what will it tell us? when will it start? who will it report to?

Neil McKeganey
Director
Centre for Substance Use Research
6:20 pm Coffee Break and networking
6:25 pm PANEL Navigating the Waves To & From the Vaping and Smoking Industry
- How has the tobacco and e-tobacco industry been affected by the pandemic?
- Compete or Collaborate? How can we navigate the fragmentation of product choice? Is there opportunity to work together to impulse sales cross-category?
- Do we really understand the drivers that make the consumer opt for nico & nico-alternative products?
- Where is the market headed considering being hit with new e-cig regulations and delivery challenges?
- How can we overturn the skeptical attitudes from consumers surrounding certain formats and address concerns that are holding the market back?
- How can we honour consumer choice and listen to their needs?

Tim Phillips
Managing Director
ECigIntelligence

Tony Abboud
Executive Director
Vapor Technology Association

Jeannie Cameron
Vice President - International Engagement
Juul Labs

Elaine Round
Vice President, Scientific & Regulatory Affairs
RAI Services Company

Patricia I. Kovacevic
Founder and Principal, Regulation Strategy & General Counsel
Andina Gold Corp
7:15 pm The Emerging Synthetic Nicotine Market
- Products – Manufacturers and Product Offerings
- Markets – USA, Korea, Europe
- Opportunities – Vape, Nicotine Pouch, HNB, Non-Tobacco Alternatives

Ron Tully
Founder
Next Generation Labs
7:45 pm PANEL DISCUSSION The synthetic nicotine loophole: Regulatory issues and technical challenges associated with testing
PANEL DISCUSSION
The synthetic nicotine loophole: Regulatory issues and technical challenges associated with testing
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Bonnie Coffa
Business Development Manager
Enthalpy Analytical, LLC

Elizabeth Sprowl
Regulatory Compliance Manager
Pyxus International, LLC

Stanley Gilliland III
Practice Lead for Materials Science
Consilium Sciences, LLC

Kevin Burd
CEO
Houtz Ltd
8:15 pm So, you’ve got your PMTA. What next?
- What data behavioural data FDA will expect to receive on an ongoing basis?
- How to design and implement behavioral studies to support continued APPH status
- Outline the opportunities and pitfalls of post-market behavioral studies
- Describe how alliances can protect company resources

Ian Fearon
Director
whatIF? Consulting
8:45 pm Close of Conference
SPONSORSHIP ENQUIRIES
Next Generation Nicotine Delivery USA offers multiple sponsorship opportunities, including thought leadership, exhibition space and networking packages. If you like to hear more, contact our commercial team at the address below
Francesco Magli
T: +44 (0) 207 936 6728
E: francesco.magli@arena-international.com
SPEAKER OPPORTUNITIES
The program for Next Generation Nicotine Delivery USA is available upon request. If you would like to get involved, please contact:
Amy Avanzato
Conference Producer
T: +44 (0) 207 9366 605
E: amy.avanzato@arena-international.com