6:30pm

Welcome Reception - Join us for the welcome reception to connect with peers and make new connections in an informal atmosphere.

9:15 - 10:15

Keynote Address: CTP Director Mitch Zeller

10:15 - 11:00

Framing FDA's New Harm Reduction Policy: Bill McGrath, Partner at Potomac Law  and Dr. Teodoro Forcht Dagi of Queens University Belfast & Harvard University set the context by framing the overall policy agenda put forth by FDA-CTP from two contexts: where it fits into the process of US rule-making and as an overarching social and regulatory science policy structure.

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11:15 - 12:30

Product Standards: Moderated by Thomas Lindegaard, Senior Vice President of Scientific and Regulatory Affairs at Scandinavian Tobacco Group Lane Ltd - This wide ranging discussion spotlights key aspects of the future nicotine product standard that stakeholders are considering for ANPR comments with a focus on Europe’s T/N/CO reduction, where addiction fits into nicotine policy, a consideration of sensory aspects and a wrap-up covering overall nicotine/harm reduction within a historical context.

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• Eduardo Berea International Sales Manager, Alternative Ingredients
• Michiel Reerink Global Regulatory Strategy Vice President, Japan Tobacco International
• James Vail Director of Communications, 22^nd Century Group

12:30 - 1:45

TMA's 103rd Annual Meeting & Conference Luncheon

Sponsored by

2:00 - 3:30

Using the Triple Continua to Make Sense of FDA’s Comprehensive Nicotine Regulatory Framework: Moderated by Joe Gitchell, President of PinneyAssociates - The product standard ANPRMs are the potential building blocks of a sea change in CTP’s approach to tobacco and nicotine regulation. Building on the groundwork of the previous panel, this discussion utilizes the three-axis (Toxicity, Addictiveness, and Appeal) model described by Abrams et al to shape a discussion about what such rulemaking and other policies or actions should be implemented to achieve agreed-upon goals as quickly as possible.

• Allison Glasser Assistant Research Scientist, NYU College of Global Public Health Download PDF
• Patricia Kovacevic General Counsel and Chief Compliance Officer, Nicopure Labs
• Kathleen Stratton Scholar National Academies of Sciences, Engineering and Medicine
• Jeffrey Willett Vice President, Truth Initiative Schroeder Institute

3:45 - 5:00

Cigar & Pipe Regulation: Crafting a Reasonable Regulatory Approach: Moderated by Barry Schaevitz, Partner at Fox Rothschild - One of the early moving parts of FDA's policy is to re-examine the premium cigar exemption and investigate flavors in all tobacco and nicotine products. This discussion with industry category leaders from the cigar and pipe worlds takes an in-depth look at thorny issues like differential regulation by category, the latest studies examining the issue and potential solutions going forward.

• Mike Copperman Federal Regulatory and Legislative Director, Cigar Rights of America
• Jeremy McKenna President, Sutliff Tobacco
• Joe Murillo Vice President Regulatory Affairs, Altria Client Services
  

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• Noah Steinsapir General Counsel, Kretek International

7:00 - 10:00

Cocktail Reception and Dinner

8:30 - 8:45

TMA Welcome

8:45 - 9:30

Keynote Address: Dr. Matt Holman, Director of the CTP Office of Science

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9:30 - 10:45

Clarity of Vision: Constructing a Better Product Authorization System: Moderated by Darshan Kulkarni, Vice President, Regulatory Policy and Strategy at Synchrogenix - With all the attention on the recent ANPR announcements, it’s important to focus on getting and keeping products on the market. As Commissioner Gottlieb noted, the premarket authorization process is key to this effort. Consultants and laboratories on the leading edge of premarket submissions will examine trends and issues in the current submission pathways and use this insight to pivot us toward a conversation on constructive improvements necessary to make the process better.

• Gene Gillman Lab Director, Enthalpy Analytical
• Matthew Holman Director of the CTP Office of Science
• Mark Perry Commercial Business Manager, Battelle

11:00 - 12:00

Clarity of Vision: Constructing a Better Product Authorization System: Moderated by Evan Richardson Director of Regulatory Services at Synchrogenix  - Building on the wider perspective of the first panel, manufacturers will provide their take on the process now and what’s necessary for the emerging policy goals to ensure products get or stay in-market.

• Brittani Cushman Vice President External Affairs, Turning Point Brands

• Thomas Lindegaard Senior Vice President, Scandinavian Tobacco Group Download PDF

• Mike Ogden Senior Vice President, Scientific & Regulatory Affairs, RAI Services Company

12:00 - 1:00

Lunch - sponsored by

1:00 - 3:15

Nicotine Dialogue: Spotlight On the Start and End of the Line: Moderated by Jim Solyst, Vice President, Federal Regulatory Affairs at Swedish Match N.A. - A lot of the focus in the nicotine dialogue is on manufacturers, regulators, policy and the population. This discussion shines the light on the very start and end of the supply chain and groups that aren’t usually part of discussions. Hear about their positions, what support they have and need and what steps they’re taking to adapt to the new realities posed by the nicotine dialogue going on within tobacco and nicotine.

The discussion begins with representatives of the grower communities and where leaf supply fits into the wider nicotine dialogue.

Terry Gallagher, President of Smoker Friendly International hosts a discussion on the complexities of the nicotine dialogue faced at the other end of the supply chain where it’s most complex. What retailers and wholesalers think and what are the communication pitfalls in dealing with their customers within the context of the nicotine dialogue.

John Anderson W. Curtis Draper Tobacconist, Owner

Graham Boyd Executive Vice President, Tobacco Growers Association of NC

Mark Davenport TCSC/Smoker Friendly, Director OTP

Tim Greene Division President, Core-Mark International

Hampton Henton Board Member, Council For Burley Tobacco Growers

Wayne Jones Senior Vice President Sales Operations, Fontem Ventures

Graham Purdy Turning Point Brands, President, New Ventures

Daniel Trope Director of Federal Government Affairs, IPCPR

James Xu Chief Executive Officer, AVAIL Vapor