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Panel
VA, United States, 22202
OWNiT: Entrepreneurship in Nicotine and Tobacco
13:00 - 14:00

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Panel
Virginia, United States, 22202
Tobacco Science Showcase: Opening Remarks
14:15 - 14:20
Presenters talk about the interplay between the tech and the retail processes needed to implement a more sophisticated, tech & data driven YAP, and how that could impact future survey and study results.

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Virginia, United States, 22202
Breakfast
08:00 - 08:50
Sponsored by PinneyAssociates
Panel
VA, United States, 22202
A New Regulatory Landscape
09:15 - 10:20
With a new administration in place, the regulatory landscape for tobacco and nicotine products is shifting. This panel will explore the potential impact of leadership changes at HHS and the FDA, as well as what is being seen from the new administration in terms of regulatory activity. Experts will analyze what these changes could mean for product authorizations, enforcement actions and harm reduction policies.

Moderators

Speakers

  • Mary-Sumpter Lapinski

    Vice President, Head of U.S. Government Affairs, Juul Labs

  • Dr. Tom Price

    Former U.S. Secretary Of Health and Human Services and U.S. Representative GA-06 2005-2017, Health and Human Services

  • Gerry Roerty

    Secretary and Board Member of Nicotine Resource Consortium, Former General Counsel of Swedish Match North America

  • Jeff Weiss

    Former Chief Engagement Officer, NJOY

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Panel
VA, United States, 22202
Regulatory Pathway Solutions
10:35 - 11:35
As the regulatory landscape evolves, questions remain about the efficacy, transparency, and speed of product application reviews. This panel will explore the current status of application reviews, the FDA’s efforts to prioritize submissions, and how recent litigation may be shaping its review philosophy. Panelists will also discuss the agency’s evolving interpretation of “Appropriate for the Protection of Public Health” (APPH) and propose strategies to enhance the regulatory process for smoke-free products.

Moderators

Speakers

  • Guy Bentley

    Director of Consumer Freedom, Reason Foundation

  • Carl Ioos

    Senior Vice President, DRL Enterprises

  • Paige Magness

    Senior Vice President of Regulatory Affairs, Altria Client Services

  • Jeff Willett

    Vice President of Strategic Engagement, Global Action to End Smoking

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Panel
VA, United States, 22202
Smoke-Free Product Standards
11:50 - 12:50
Baseline product standards, which could take the form of voluntary consensus standards, could streamline the pathway to market for potentially reduced risk products for adults who smoke. FDA uses product standards in its regulation of pharmaceuticals and food, but they have not yet been established for regulating e-cigarettes and other non-combustible nicotine products. Could the establishment of product standards based upon the available scientific, clinical, and public health research provide regulatory and scientific clarity, and ultimately a wide variety of authorized products? Panelists will discuss how product standards might be developed in this space, and the pros and cons of such an approach

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Lunch
12:50 - 13:50
Sponsored by Tobacco Technology
Panel
VA, United States, 22202
Correcting Consumer & Health Care Provider Misperceptions
14:25 - 15:25
Health care providers, adults who smoke tobacco, and the public at large all have misperceptions about nicotine and the relative risk of non-combustible nicotine products. Misperceptions can lead to health care providers dispensing inaccurate information, motivating policy makers to pass laws that don’t improve public health, and preventing adults who smoke from switching to less harmful smoke-free products. Hear nicotine science, policy, and advocacy experts discuss long-standing misperceptions about nicotine. What misperceptions does the public believe, and where did those misperceptions come from? How can we meaningfully move the public’s understanding of nicotine and smoke-free products without inadvertently promoting use to unintended audiences (i.e., nonusers and youth)? What more can the FDA do to inform healthcare providers, people who smoke, and the public about the continuum of risk of various nicotine products? What can academic researchers do? What about manufacturers?

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VA, United States, 22202
Exploring Recent FDA Memoranda
15:45 - 16:45
In an effort to enhance transparency, FDA released a series of regulatory science policy memoranda outlining its latest thinking on toxicology assessments, excess lifetime cancer risk (ELCR) calculations, and other critical scientific evaluations in tobacco product applications. These memos provide valuable insights into the FDA’s evolving approach to reviewing PMTAs, shaping testing methodologies, and setting new regulatory expectations. Hear experts discuss these memos, exploring their impact on risk assessments, study design, and the overall PMTA process.

Moderators

Speakers

  • Dr. Jenna Guynn

    Senior Director, Scientific and Regulatory Affairs, Reynolds American

  • Dr. Matthew Holman

    Vice President and Chief Scientific and Regulatory Strategy Officer for the US, PMI

  • Dr. Don Kenkel

    Andrew Dickson White Professor, Jeb E. Brooks School of Public Policy at Cornell University

  • Dr. Charlene Liu

    President and Chief Scientist, Riskwise Solution

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Break
Virginia, United States, 22202
Breakfast
08:00 - 08:45
Sponsored by Smoker Friendly
Panel
VA, United States, 22202
The Legislative Landscape: State and Local Tobacco Policy Update
09:00 - 09:50
As state and local governments continue to shape the future of tobacco policy, industry stakeholders must stay ahead of rapidly evolving policies. This panel will provide a comprehensive update on key legislative and regulatory developments across the U.S., including proposed tax measures, flavor and product bans, and state directory bills. Experts will examine the impact and challenges of these policies on the industry and market as well as the emerging trends in enforcement and litigation.

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Being Compliant in an Illicit Market – What's the Way Forward?
10:10 - 11:10
The accelerating growth in unlawful and unregulated e-vapor and nicotine pouch products as well as emerging nicotine analogues is a significant problem that threatens the long-term success of federal tobacco regulation. This panel would include perspectives from stakeholders in the supply chain, including manufacturers, wholesalers, retailers, and consumers sharing their experiences in trying to comply with FDA regulations while competing against the huge illicit market in e-vapor products; and share learnings about other growing illicit markets, including pouches and nicotine analogues, and offer solutions at the federal and state levels.

Moderators

Speakers

  • Anna Blom

    Director, Government Relations, NACS

  • Steve Callahan

    Vice President, Enforcement and Brand Integrity, Altria Client Services

  • Ernest Legier

    Commissioner, Louisiana Office of Alcohol and Tobacco Control

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Panel
VA, United States, 22202
Post-Market Surveillance: Balancing Innovation While Guarding Against Unintended Consequences
11:30 - 12:30
This panel would discuss the role PMTA post-market authorization surveillance could play in helping get more FDA authorized smoke-free products to market while protecting against concerns about youth and non-users. Panelists could provide their perspectives on the best approach to improve public health, including the pros and cons of FDA implementing the precautionary principle vs. relying on post-market surveillance in making PMTA decisions.

Moderators

  • Dr. Jessica Zdinak

    Founder and Chief Research Officer, Applied Research and Analysis Company

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Lunch
12:30 - 13:30
Sponsored by Sanova
Panel
VA, United States, 22202
Incentivizing Investment in the "Ideal" Market
13:30 - 14:30
In the "ideal" nicotine and tobacco products market, all adult consumers would understand the relative risk of tobacco products, have access to a portfolio of regulated smoke-free products, and be provided with cessation counseling and support. And youth access and usage would be minimal to non-existent. Achieving this vision requires capital investment across all stages — from venture capital funding disruptive innovations to institutional investments in mature corporations – driving the transition toward a harm reduction market. This panel will bring together investors to discuss all these vantage points, whether investors are currently incentivized to put capital to work in the "ideal" state, and what investors are looking for to make investments into the "ideal" state.

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Panel
VA, United States, 22202
Different Seats, Same Table: Finding Common Ground & Solutions for Adults Who Smoke
14:45 - 15:55
Hear from academic research and health advocacy communities how the changing nicotine environment has influenced their policy positions. Have they encountered situations where their objectives seemed to align at least in part with those of the tobacco and nicotine industry? What can both industry and public health do to better foster engagement? What can all stakeholders do to assist the agency?

Moderators

  • Dr. Michael Cummings

    Professor of Psychiatry & Behavioral Sciences , Medical University of South Carolina

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