Archives: Agenda

• Leveraging microfluidics to replace the wick and coil
• Using silicon chip manufacturing techniques to make the quantum chip
• Quantum vape performance relative to market leading vapes

• Implications of recent changes at CTP and how they may shape regulatory priorities
• The outlook on enforcement against illicit e-vapor and nicotine pouch products
• Improving the PMTA process to accelerate authorization of smoke-free products
• Assessing the regulatory impact of recent court rulings on product authorizations

Moderator: Agustin Rodriquez, Partner, Troutman Pepper Locke

Panelists

Lillian Ortega, Owner & Chief Regulatory Strategist, WOW Solutions LLC

And Former Director, Division of Enforcement and Manufacturing (Center for Tobacco Products), FDA

Azim Chowdhury, Partner, Keller and Heckman

Guy Bentley, Director of Consumer Freedom, Reason Foundation

• An introduction covering why DVCR? DVCR’s capabilities, facilities and investment
• Individual risk assessment, clinical work on nicotine exposure, abuse liability and biomarkers
• Performance of candidate products in the real world, risk comprehension, TPPI and actual use studies

• Many factors impede optimal dialogue between private and public THR researchers. This limits progress in ending smoking
• The results of a 10-year review of public and private THR research will be presented. Major differences are outlined suggesting we need greater engagement not less
• The outcomes of a recent meeting held under the Chatham House Rule suggests a desire to engage exists from leading industry and academic players
• I will discuss opportunities to make faster progress and provide recent examples of how this is underway

• Carbon footprints – what are they?
• Nicotine’s production chain: tobacco and synthetic
• How the footprints are calculated, data sources, key sensitivities
• Tobacco-based nicotine’s footprint – about 3-4 times higher than synthetic nicotine’s

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 40 minutes, and delegates may attend up to 2 roundtables.

Roundtable 1: Enforcement and Illicit Products – State of the Union Update and Moving Forward

Angela Ho-Chen, Managing Counsel – Regulatory, Reynolds American

Roundtable 2: Navigating Non-Clinical: Strategic Insights and Considerations for Nicotine Pouch Testing

HPHC: Testing Considerations

• The selection of an appropriate HPHC test list should be guided by a thorough understanding of the product’s constituent sources (e.g., plant-based or synthetic) and relevant chemical properties. Consideration should also be given to compounds that would only be present due to combustion or pyrolysis mechanisms.

Stability Studies: Optimize Your Study Duration and Testing Intervals

• Testing intervals and overall study duration should be determined based not only on the product’s intended shelf life but also on an assessment of inherent risks associated with its composition (e.g., susceptibility to microbial growth). Leveraging existing knowledge can help optimize study design and ensure robust stability assessments.

Extractables & Leachables: Identify and Mitigate Material-Related Risks

• Evaluating extractables and leachables is critical to ensuring the safety and quality of pouch materials and packaging. Identifying potential impurities or contaminants that could migrate into the product allows manufacturers to proactively mitigate risks and maintain product integrity.

Dissolution Testing Applications: How to Strengthen Your Regulatory Strategy

• Nicotine release profiles derived from dissolution testing can be influenced by various product-specific factors, including pH modifiers, particle size, and pouch material. Comparing these release profiles across tobacco products can provide valuable insights into whether a new product may present different public health considerations.

Valerie Schwartz, Regulatory Affairs Manager, Accorto Regulatory Solutions