Agenda & Speakers Slides

Day 1: Agenda & Speaker Slides
Day 2: Agenda & Speakers Slides
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Friday, October 25

8:30 – 8:55 AM 

Registration and Continental Breakfast

8:55 – 9:00 AM 

FDLI Welcome and Announcements
Steven Leslie, Assistant Director, Educational Programs, Food and Drug Law Institute

9:00 – 9:45 AM 

A Conversation with David A. Kessler on the Future of Youth e-Cigarette Use and Regulation
David A. Kessler,
 Chairman, Board of Directors, Center for Science in the Public Interest, and former FDA Commissioner
Discussion with Amy Comstock Rick, President & CEO, Food and Drug Law Institute

9:45 – 10:30 AM

FDA recently finalized its “Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS)” guidance. FDA also issued a marketing order for a non-combustible tobacco product, IQOS, in accordance with the guidance. In this session, panelists will engage in a detailed discussion of both the finalized guidance and the marketing order.

Priscilla Callahan-Lyon, Deputy Director, Division of Individual Health Science, FDA – CTP
Mark Greenwold, Senior Consultant, Campaign for Tobacco-Free Kids
Jim Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Moderated by Scott Ballin, Tobacco and Health Policy Consultant

10:30 – 10:45 AM

Networking and Refreshment Break

10:45 – 11:30 AM 

Building off the previous session, panelists will discuss the future of PMTAs in light of recent developments.  The discussion will focus on the particular challenges faced by ENDS manufacturers as well as the public health perspective on the PMTA process.

Katherine Ciambrone, Executive Vice President, Legal, Regulatory, and External Affairs, Fontem Ventures
Eric N. Lindblom, Director for Tobacco Control and Food and Drug Law, O’Neil Institute for National and Global Health Law, Georgetown Law
Beth G. Oliva, Partner, Fox Rothschild LLP
Moderated by Scott Ballin, Tobacco and Health Policy Consultant

11:30 AM– 12:15 PM

The Tobacco Control Act (TCA) establishes a novel population impact standard for reviewing applications for new products and health claims. In this session, panelists will discuss computational modeling of tobacco product impacts on public health, various types of modeling systems used for nicotine products, and what factors should be considered or included when utilizing these models to support an application.

Ryan Black, Associate Fellow, Regulatory Sciences, Altria Client Services LLC
David Levy, Professor, Lombardi Comprehensive Cancer Center, Georgetown University Global Health Initiative
Moderated by Saul Shiffman, Professor of Psychology, University of Pittsburgh and Senior Scientific Advisor, Pinney Associates, Inc.

12:15 – 1:15 PM 

Luncheon with Table Top Discussions

1:15 – 1:30 PM 

Transition

1:30 – 2:00 PM 

The session will feature an overview of the key elements of FDA’s proposed rule for substantial equivalence, as well as a question and answer session.

Barry S. Schaevitz, Partner, Fox Rothschild LLP

2:00 – 3:00 PM 

Currently, if a tobacco or nicotine product is modified or altered after a PMTA is submitted, a new PMTA would need to be submitted for the altered product. This results in substantial costs to manufacturers and restricts the number of reduced risk products in the marketplace by hindering innovation. In this session, panelists will discuss post-application product modifications in light of FDA’s proposed rule for PMTAs, as well as potential alternatives and their respective benefits and drawbacks.

Matt Holman, Director, Office of Science, CTP, FDA
Patricia Miller, Senior Director, Premarket Tobacco Applications, Altria Client Services LLC
Moderated by Elizabeth Oestreich, Vice President, Regulatory Compliance, Greenleaf Health

3:00 – 4:00 PM 

From cigarettes to cigars to chewable tobacco to e-cigarettes, flavored tobacco and nicotine products are widely available…for now. This session will feature a comprehensive discussion of flavors, including why manufacturers use flavors, responsible marketing of flavored products, how flavors fold into public health goals, and FDA guidance on and enforcement discretion of flavored products.

Tony Abboud, Executive Director, Vapor Technology Association
Aruni Bhatnagar, Chair, School of Medicine, University of Louisville and co-Director, American Heart Association Tobacco Center for Regulatory Science
Moderated by Seth A. Mailhot, Partner, Husch Blackwell LLP

4:00 PM

Conference Adjournment