Break

Virginia, United States, 22202

Breakfast

08:00 - 08:50

Sponsored by PinneyAssociates

Break

Welcome

09:00 - 09:15

Speakers

• Christopher B. Greer

  Chief Executive Officer, Nicotine Resource Consortium

• John "Jack" Marshall

  NRC Board Chair & Senior Director, Regulatory Affairs, Altria Client Services

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

• Stacy Ehrlich

  Partner, Kleinfeld Kaplan and Becker LLP

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

Watch Replay

Break

Networking Coffee Break

10:20 - 10:35

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

• Beth Oliva

  Partner, Fox Rothschild

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

Watch Replay

Break

Networking Coffee Break

11:35 - 11:50

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

Moderators

• Rachael Schmidt

  Senior Consultant, ALINC

Speakers

• Dr. Preston Campbell

  Managing Partner, Sapphire Sciences

• Dave Dobbins

  Principal Consultant, Dobbins Consulting

• Dr. Amy Madl

  President, Senior Principal Health Scientist, Valeo Sciences

• Dr. Rob Stevens

  Director, Scientific & Regulatory Affairs, HP Submissions, Reynolds American

Watch Replay

Break

Lunch

12:50 - 13:50

Sponsored by Tobacco Technology

Keynote

VA, United States, 22202

Zyn TPL Overview

13:50 - 14:10

Moderators

• Dr. Brian Erkkila

  Director of Regulatory Science, Swedish Match

Watch Replay

Keynote

VA, United States, 22202

Prevalence and Perceptions of Commercial Tobacco & Nicotine Products Across the Continuum of Risk

14:10 - 14:25

This presentation will provide a high level overview of the prevalence of product use among youth and adults across the continuum of risk, followed by perceptions of products among consumers and health care providers.

Moderators

• Dr. Cristine Delnevo

  Director, Rutgers Institute for Nicotine & Tobacco Studies

Watch Replay

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?

Moderators

• Joe Gitchell

  CEO, PinneyAssociates

Speakers

• Dr. Cristine Delnevo

  Director, Rutgers Institute for Nicotine & Tobacco Studies

• Cliff Douglas

  President and CEO, Global Action to End Smoking

• Kim "Skip" Murray

  Consumer Advocate, Skip's Corner

Watch Replay

Break

Networking Coffee Break

15:25 - 15:45

Panel

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

• Sarah Marking

  Co-Founder and Chief Strategy Officer, Sanova

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

Watch Replay

Break

Closing & Special Programing

16:45 - 17:00

Moderators

• Christopher B. Greer

  Chief Executive Officer, Nicotine Resource Consortium

Break

Networking Reception & Dinner

17:30 - 20:00

Sponsored by Sapphire Sciences

Break

Virginia, United States, 22202

Breakfast

08:00 - 08:45

Sponsored by Smoker Friendly

Panel

Welcome

08:45 - 08:50

Moderators

• Christopher B. Greer

  Chief Executive Officer, Nicotine Resource Consortium

• John "Jack" Marshall

  NRC Board Chair & Senior Director, Regulatory Affairs, Altria Client Services

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.

Moderators

• Agustin Rodriguez

  Partner, Troutman Pepper Locke

Speakers

• Tim Andrews

  Director of Consumer Issues, Americans for Tax Reform

• Jennifer Cunningham

  Regional Diector, State Government Affairs, Juul Labs

• Scott Pearce

  President, Cigar Association of America

• David Spross

  Executive Director, National Association of Tobacco Outlets

• Lindsey Stroud

  Creator and Manager , Tobacco Harm Reduction 101

Watch Replay

Break

Networking Coffee Break

09:50 - 10:10

Panel

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

• Lillian Ortega

  Owner and Chief Regulatory Strategist, WOW Solutions

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

Watch Replay

Break

Networking Coffee Break

11:10 - 11:30

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

Speakers

• Bryan Haynes

  Partner, Troutman Pepper Locke

• Gavin O’Dowd

  CEO, Haypp Group

• Brad Seipel

  Executive Vice President and Group Director, M/A/R/C Research

• Dr. Brindusa Taranu

  Head of Global Product Safety Surveillance, Philip Morris International

• Dr. David Utley

  President and CEO, Pivot Health Technologies

Watch Replay

Break

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.

Moderators

• Stefanie Miller

  Vice President of External Affairs , Juul Labs Inc

Speakers

• Owen Bennett

  VP of Strategic Finance, Plxsur

• Natasha Collins

  CEO and Founder, Live Willow Capital

• Catharine Dockery

  Founder and General Partner, Vice Ventures

• Ryan Selby

  Serial Entrepreneur

Watch Replay

Break

Networking Coffee Break

14:30 - 14:45

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

Speakers

• Scott Ballin

  Independent Health Policy Consultant

• Dr. Michael Eriksen

  Founding Dean School of Public Health, Georgia State University

• Dr. Dale Mantey

  Assistant Professor, University of Texas School of Public Health

Watch Replay

Break

Closing Remarks

15:55 - 16:00

Moderators

• Christopher B. Greer

  Chief Executive Officer, Nicotine Resource Consortium