Tobacco and Nicotine Products Regulatory Science Symposium

October 23, 2024   Washington, DC   In-Person & Virtual Event

Agenda

Subject to Change
All Times Are Eastern Standard Time

Wednesday, October 23

9:00–9:45 AM   
Registration and Breakfast 

9:45–10:00 AM  
FDLI Welcome
Christine M. Simmon, President & CEO, FDLI
J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP

10:00–11:00 AM 
Are We There Yet? Risk/Benefit Assessment of an Appropriate for the Protection of the Public Health (APPH) Determination: NJOY Case Study
Presenters: Ed Largo, Associate Fellow, Regulatory Sciences, Altria Client Services LLC and Kate Vergara, Senior Principal Scientist, Regulatory Affairs, Altria Client Services LLC
Discussant: Kenneth Michael Cummings, Professor, Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina
Moderator: Jim Solyst, Principal, JMS Scientific Engagement

11:00–11:20 AM  
Discussion and Networking Break

11:20 AM–12:20 PM 
End-to-End Review of an Electronic Nicotine Delivery System Product Premarket Tobacco Application Science Package: Vuse Case Study
Presenter: Jenna Guynn, Senior Director, Scientific and Regulatory Affairs, RAI Services Company (Reynolds American Inc.)
Moderator and Discussant: Jasjit S. Ahluwalia, Professor, Behavioral and Social Sciences and Professor, Medicine, Brown University School of Public Health and Warren Alpert Medical School

12:20–1:20 PM  
Luncheon

1:20–2:20 PM 
Conceptualizing Population Health Impact Modeling as a Framework for Assessing APPH
Presenter: Nathan M. Holt, Principal Scientist, Biostatistician, Juul Labs
Discussant: David Levy, Professor, Lombardi Comprehensive Cancer Center, Georgetown University
Moderator: Nathan A. Beaton, Associate, Latham & Watkins LLP

2:20–2:40 PM  
Discussion and Networking Break

2:40–3:40 PM 
Derivation of Excess Lifetime Cancer Risk for Non-Combustible Nicotine Products
Presenter: Ramez Labib, Principal Toxicologist, Consilium Sciences
Discussant: Todd Cecil, Deputy Director for Regulatory Management, Office of Science, CTP, FDA
Moderator: Kiri Stauch, Behavioral Scientist, Applied Research and Analysis Company LLC (ARAC)

3:40–4:00 PM  
Discussion and Networking Break

4:00–5:00 PM 
Following the Science–or Lack Thereof–on Tobacco Use Later in Life: Implications for Tobacco Regulatory Policy
Presenter: Bethea (Annie) Kleykamp, Assistant Professor, University of Maryland School of Medicine and Director of Research and Evaluation, Maryland Addiction Consultation Service (MACS)
Discussant: Nikki L. Nollen, Professor, Population Health, University of Kansas School of Medicine and Co-Leader, Cancer Prevention and Control Program, University of Kansas Cancer Center
Moderator: Mohamadi Sarkar, Fellow, Scientific Strategy & Advocacy, Regulatory Affairs, Altria Client Services LLC

5:00–6:00 PM
Networking Reception (In-Person Attendees Only)