7th Annual Next Generation Nicotine Delivery USA

Join key business leaders from the FDA, ENDS and tobacco industry across the US market to explore actionable strategies to facilitate legal compliance and commercial success.

4 - 5

June

2025
  • Hyatt Regency Miami
  • Ticketed
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Why attend?

WHAT TO EXPECT FOR 2025?

The leading event to connect the nicotine industry to drive a strong future in tobacco and nicotine derived products by aligning strategic priorities to achieve new heights in consumer reach and profitability.

150+

Attendees

15+

Exhibitors

80%

Attendees at Director+ level

150+

Attendees

15+

Exhibitors

80%

Attendees at Director+ level

Agenda

  • 4 Jun 2025
  • 5 Jun 2025
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7:30 AM

Registration and Refreshments

8:30 AM

Chair’s opening remarks

Speakers

Willie McKinney
Ph.D. Founder & CEO, McKinney Regulatory Science Advisors, LLC

8:40 AM

Keynote: What FDA cuts could mean for the future of next generation nicotine?

  • Implications of the sweeping cuts at the FDA Center for Tobacco Products (CTP)
  • The FDA had rejected 99% of the more than 27 million applications it had received without providing detailed product standards. What can we expect from the new leaders at the FDA?
  • The future of e-cigarettes and flavored vaping
  • Can we expect to see increased enforcement against illegal Chinese vapes?
  • Will the new FDA publicly state that vaping and other non-combustible nicotine products are much safer than smoking?
  • How will Trump’s tariffs affect the tobacco industry?

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

John O'Brien, Vice President and Assistant General Counsel - Regulatory, Reynolds American

Azim Chowdhury, Partner, Keller and Heckman

Guy Bentley, Director of Consumer Freedom, Reason Foundation

Senior representative, Altria

 

Speakers

Agustin Rodriquez
Partner, Troutman Pepper Locke
John O’Brien
Vice President and Assistant General Counsel - Regulatory, Reynolds American
Azim Chowdhury
Partner
Guy Bentley
Director of Consumer Freedom, Reason Foundation

9:30 AM

Regulatory Compliance And Opportunities For Improvement

  • Challenges of introducing new-to-market tobacco products
  • Our commitment to both offering adult tobacco and vapor consumers choices as well as underage access prevention
  • Pre-Market Tobacco Product Application (PMTA) submissions

Speakers

John O’Brien
Vice President and Assistant General Counsel - Regulatory, Reynolds American

10 AM

Navigating the Regulatory Landscape of ENDS and Nicotine Pouches in the U.S.

  • Strategic Considerations for PMTA (Premarket Tobacco Product Application)
  • Successfully Submitting Your PMTA
  • Managing the Application Process and Post-Market Reporting
  • The Role of Risk Assessments in FDA Regulatory Submissions

 

Speakers

Dr. Vince Angelico
Chief Science Officer, Accorto Regulatory Solutions

10:30 AM

Morning Refreshments & Networking

11 AM

Pathways To Getting Products Authorized

  • Introducing innovative new products for the modern consumer
  • Protecting U.S.-developed innovations against those who seek to import copycat products
  • Enforcement of illegal products to protect and improve industry and trade practices

 

Speakers

Sonny Sisodiya
Regulatory Science Integration Director, JTI (Japan Tobacco International)
Joshua Karelitz
PhD, Principal Scientist II, Altria

11:30 AM

Bridging the Gap between PMTA Module 5 & 6 Regulatory Expectations and Business Objectives

  • Understanding FDA CTP's Guidance in 2025 and beyond
  • Risk: Benefit ratio of human behavior
  • Importance of Product Development and early-stage market considerations

 

Speakers

Dr. Jessica Zdinak
Founder & Chief Research Officer, Applied Research and Analysis Company (ARAC)

12 PM

Next Generation Products (NGP)

  • Innovation and new product launches
  • Consumer trends in key markets
  • Vaping and heated tobacco - meeting consumer preferences and needs in Europe

Speakers

Tobias Baude
Director of Corporate Affairs for NGP, Imperial Brands

12:30 PM

Lunch & Networking

Sponsored by AmeriNic

1:30 PM

Innovation Insights: Leveraging Technology to End Youth Vaping for Electronic Nicotine Delivery Systems

  • The Persistent Challenge of Youth Vaping: Despite progress in the US, youth vaping remains a critical issue for regulators, public health, and the global ENDS industry
  • Regulatory Effectiveness and Access Control Gap: Existing regulatory strategies, while showing some positive effects, have failed to effectively restrict product access for minors, instead producing unintended category consequences for wider users
  • Point-of-Use Age Verification as a Targeted Solution: Continuous age verification at the point of use offers a direct solution to prevent youth access while simultaneously expanding adult market access, particularly for flavored ENDS products
  • Setting New Industry Benchmarks for Secure Access: Using cutting-edge technologies like biometric verification, blockchain security, and Bluetooth Low Energy (BLE), the industry can establish robust security standards to ensure ENDS access is restricted to authorized adults

 

Speakers

John Patterson
President, IKE Tech

2 PM

Postmarket Under the Microscope: A Global Look at Regulatory Expectations for Nicotine Products

  • What global regulators are learning from the market: quality concerns, GMP expectations, and the rise of enforcement activity
  • The US PMTA lifecycle: What happens after authorization — and how to manage change effectively
  • Strategies for building postmarket compliance into your product development from the start
  • When things go wrong: dealing with adverse events and meeting FDA’s 15-day reporting expectations

 

Speakers

Chris Allen
Chief Executive Officer, Broughton

2:30 PM

Panel Discussion: Navigate The Legal And Policy Challenges In The Evolving Tobacco And Nicotine Industry

  • Industry update: Changes in law and upcoming regulatory deadlines
  • Judicial opinions that may impact your business
  • Update on federal and state tobacco regulatory matters
  • The latest in premarket tobacco product applications (PMTAs)
  • Recent enforcement actions and investigations by state regulators

 

Speakers

Bryan Haynes
Partner, Troutman Pepper Locke
Agustin Rodriquez
Partner, Troutman Pepper Locke

3:10 PM

Impact of Supreme Court Cases and ENDS Litigation Update

  • Wages and White Lion and R.J. Reynolds Supreme Court cases
  • State of New York enforcement action
  • MDO challenges

 

Speakers

Eric P. Gotting
Partner, Washington, DC, Keller and Heckman LLP

3:40 PM

Afternoon refreshments and networking

4:10 PM

Spotlight: FDA’s Current Approach to Toxicological Risk Evaluation to Inform APPH: A Nonclinical Case Study of Breeze Pro Disposable ENDS

In 2024, the FDA released two key scientific memoranda that shifted their approach to evaluating toxicological risk in ENDS PMTA from a mixture-based to a component-based framework, focusing on individual constituents and their cancer risk profiles. These memoranda established Quantitative Risk Assessment (QRA) as the cornerstone of toxicological risk evaluation in ENDS PMTAs, informing regulatory decisions on whether products are APPH. This presentation will explore the implications of the FDA's new perspective, discuss strategies for navigating the evolving PMTA regulatory landscape, and use Breeze Pro ENDS chemistry, toxicology, and QRA as a case study.

Speakers

Dr. Charlene Liu, Sc.D.
President and Chief Scientist, Riskwise Solution LLC.

4:25 PM

Panel discussion: Harm Reduction – Key Developments Globally

  • Regulation and harm reduction in key markets
  • How are key markets responding to illicit products
  • How are international policies and regulations affecting US regulations and vice versa
  • The Tobacco and Vapes Bill: Implications of the U.K Generation Ban

-Will other nations follow suit?

  • Implications of recent US Regulations under the New Administration: Withdrawal of plan to ban menthol cigarettes in the United States

Panelists

Tobias Baude, Director of Corporate Affairs for NGP, Imperial Brands

Dr. Jessica Zdinak, Founder & Chief Research Officer, Applied Research and Analysis Company (ARAC)

Senior representative, Sanova

Gavin O’Dowd, CEO, Haypp Group

Joe Smith, Partner, Thompson Hine

Speakers

Dr. Jessica Zdinak
Founder & Chief Research Officer, Applied Research and Analysis Company (ARAC)
Tobias Baude
Director of Corporate Affairs for NGP, Imperial Brands
Gavin O’Dowd
CEO, Haypp Group
Joe Smith
Partner, Thompson Hine

5:05 PM

Case study: Project insights and best practice at McKinney Regulatory Science Advisors

Senior representative, McKinney Regulatory Science Advisors

5:35 PM

How MyCheckr age assurance technology can protect your staff and business

  • Assisted age check success in the UK & European tobacco / vaping market
  • How AI can help to deter purchase attempts with fake IDs
  • Privacy assured – no data stored

Speakers

Dr Andrew O’Brien
Biometrics Product Manager, Innovative Technology

6:05 PM

Shark Tank: Innovation in Products and Services

A highlight of the 2025 programme, a selection of companies will be invited to pitch their innovations to the industry. The companies will be carefully vetted to ensure they are recognized leaders with cutting-edge products and services. Delegates will benefit from learning about recent innovations at the forefront of the industry. A carefully curated cross section of products and services will be presented at the 2025 Shark Tank presentations.

Each company will provide a 2-minute elevator pitch to showcase their innovations.

PRIZE DRAW: The audience will vote to pick their first and second choice innovations of the year.

The conference will host a wonderful drinks reception immediately after the Shark Tank where the featured companies will host an exhibition stand. Delegates can further discover the products and services that have been showcased and their unique features.

Featured Companies Presenting Innovation

Sanova

Dr Andrew O’Brien, Biometrics Product Manager, Innovative Technology

Age Checker

Gavin O’Dowd, CEO, Haypp Group

Speakers

Dr Andrew O’Brien
Biometrics Product Manager, Innovative Technology
Gavin O’Dowd
CEO, Haypp Group

6:30 PM

Chairman’s closing remarks

Speakers

Willie McKinney
Ph.D. Founder & CEO, McKinney Regulatory Science Advisors, LLC

6:40 PM

Drinks reception hosted by Innovative Technology

Speakers

Dr Andrew O’Brien
Biometrics Product Manager, Innovative Technology

8 PM

End of Day One

7:30 AM

Registration and networking

8:40 AM

Chairman’s opening remarks

Speakers

Willie McKinney
Ph.D. Founder & CEO, McKinney Regulatory Science Advisors, LLC

8:50 AM

Keynote: Bridging The Divide Between Public And Private Tobacco Harm Reduction Researchers

• 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

Speakers

Derek Yach
Member, Global Health Strategies LLC

9:30 AM

Spotlight: How Effective Are Age Checking Technologies

  • Have age checking technologies succeeded in identifying legal aged consumers?
  • How have consumers responded to age checking technologies?
  • How have age checking technologies affected sales?

Senior representative, Age Checker

9:45 AM

Case Study: Dr. Vince Clinical Research

Speakers

George Hardie
Executive Director, Tobacco Harm Reduction, Dr. Vince Clinical Research
Dr Neil Sherwood
Manager, Tobacco Harm Reduction Research, Dr. Vince Clinical Research
Claudia Kanitscheider
Associate Director, Behavioural Science, Dr. Vince Clinical Research

10:15 AM

Spotlight: Synthetic nicotine’s carbon footprint is far lower than that of tobacco-derived nicotine

  • 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

 

 

Speakers

Eric Johnson
Managing Director, Atlantic Consulting

10:30 AM

Key Legal Developments: Tobacco Alternatives And Nicotine Products

  • Regulatory compliance: Key considerations for industry
  • Best practice regulatory compliance for e-cigarette industry, ENDS device and e-liquid manufacturers
  • Update on state flavor bans and marketing restrictions
  • Developing and implementing effective risk mitigation strategies
  • Reserving and protecting their intellectual property rights

Speakers

Joe Smith
Partner, Thompson Hine

11 AM

Morning refreshments, networking and prize draw

Delegates will enter a prize draw to be in with a chance to win one of three prizes.

11:40 AM

Speaker Hosted Roundtables

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: 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

Speakers

Valerie Schwartz
Regulatory Affairs Manager, Accorto Regulatory Solutions

1 PM

Lunch and networking

1:50 PM

Industry Case Study

2:20 PM

Update: Florida’s State And Local Tax Law

  • Dealing with challenging state tobacco and vape tax issues and refunds
  • Recent success stories: From initial audit notice through litigation, civil and criminal cases
  • Best practice when dealing with an audit

Speakers

Jerry Donnini
Shareholder, Law Offices of Moffa, Sutton, & Donnini, P.A. & Founder of Tobacco Tax Refund, Inc

2:35 PM

Panel Discussion: Key Developments in The Cannabis Market

  • Recent developments in the cannabis, cannabidiol (CBD) and hemp industries
  • New innovative products that have recently entered the market
  • Understanding key regulations and compliance requirements
  • Update on the uptake of cannabis and CBD vaping

3:10 PM

Afternoon refreshments

3:30 PM

Panel Discussion: How Can Industry Work Together To Improve Positive Messaging For Nicotine Products

  • Using industry research and data to communicate positive messaging
  • The key roles academia and science labs play in collecting data and demonstrating harm reduction
  • Working effectively with the FDA to ensure harm reduction

Speakers

Samy Hamdouche
Co-founder and COO, Lucy Goods Inc.
Joe Smith
Partner, Thompson Hine
Derek Yach
Member, Global Health Strategies LLC

4 PM

Chairman’s closing remarks

Speakers

Willie McKinney
Ph.D. Founder & CEO, McKinney Regulatory Science Advisors, LLC

4:10 PM

End of conference

Speakers

Select a speaker to learn more

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Willie McKinney
Ph.D. Founder & CEO, McKinney Regulatory Science Advisors, LLC

A tobacco industry regulatory executive and inhalation toxicologist who’s spent more than two decades conducting research and developing product and regulatory strategies that bring better products to market.

Session Details:

Chairman’s closing remarks

2025-06-04, 6:30 PM

Session Details:

Chair’s opening remarks

2025-06-04, 8:30 AM

Session Details:

Chairman’s opening remarks

2025-06-05, 8:40 AM

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Chairman’s closing remarks

2025-06-05, 4:00 PM

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John O’Brien
Vice President and Assistant General Counsel - Regulatory, Reynolds American

John O’Brien serves as Vice President and Assistant General Counsel – Regulatory for RAI Services Company, where he counsels Reynolds American Inc.’s operating companies on a wide range of regulatory-related matters.

Prior to joining Reynolds in 2018, John spent over a decade in private practice, where he counseled some of the largest consumer packaged goods companies on a wide range of FDA, USDA, and FTC regulatory matters, including enforcement actions, civil litigation, investigations, inspections, product recalls, claims substantiation, labeling, and compliance.

He earned his BM from Northwestern University and earned his MM and JD degrees from the University of Illinois at Urbana-Champaign.

Session Details:

Keynote: What FDA cuts could mean for the future of next generation nicotine?

2025-06-04, 8:40 AM

Session Details:

Regulatory Compliance And Opportunities For Improvement

2025-06-04, 9:30 AM

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Dr. Jessica Zdinak
Founder & Chief Research Officer, Applied Research and Analysis Company (ARAC)

Dr. Jessica Zdinak is an Eastern Shore of Virginia native who received a B.S. in Psychology from Christopher Newport University, and a M.S. and Ph.D. in Experimental Psychology & Statistics from Oklahoma State University. Dr. Zdinak has dedicated 20 years working as a behavioral scientist in a variety of settings, including academic, federal government, public health, and industry, and now serves as Chief Research Officer of a leading U.S. based Contract Research Organization, ARAC. 

Her team services both U.S. and International clients in their product development and consumer research supporting innovation and “next generation” products, with a focused expertise on the regulatory sciences for U.S. applications including: ITPs, PMTAs, MRTPAs, SEs, 510(k), and Breakthrough Designations. 

The ARAC firm specializes in providing boutique-level personalized research services, combining their expertise in psychology, statistics, and behavior change, with a focus on the consumer, and the role of the regulator. Their triangular approach has proven successful across a variety of studies, including label development and comprehension, human factors/usability, clinical behavioral studies, specifically randomized experimental trials, TPPI, and post-market surveillance systems.

Session Details:

Bridging the Gap between PMTA Module 5 & 6 Regulatory Expectations and Business Objectives

2025-06-04, 11:30 AM

Session Details:

Panel discussion: Harm Reduction – Key Developments Globally

2025-06-04, 4:25 PM

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Tobias Baude
Director of Corporate Affairs for NGP, Imperial Brands

As the Director of Corporate Affairs for Next Generation Products Tobias leads Imperial Brands‘ global NGP policy. He is a member of Imperials global NGP leadership team.

Tobias expertise is in public affairs, regulations and compliance. He has previously held leadership positions in travel  retail & duty free, corporate affairs and global supply chain.

Session Details:

Panel discussion: Harm Reduction – Key Developments Globally

2025-06-04, 4:25 PM

Session Details:

Next Generation Products (NGP)

2025-06-04, 12:00 PM

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Chris Allen
Chief Executive Officer, Broughton

Chris co-founded Broughton in 2006, having worked previously within global blue-chip pharmaceutical companies and Contract Research Organisations within the medicinal product and medical device sectors.

  • Over 25 years’ experience in Analytical and Regulatory Science focussing on inhaled and solid dose pharmaceuticals, medical devices, and nicotine products
  • Extensive experience with global regulatory agencies, including US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA)
  • Oversees the overall direction of the organisation, ensuring that Broughton’s mission is achieved
  • Has a passion for developing Broughton’s services and team members to help accelerate life-enhancing products to market

Chris Allen is the Chief Executive Officer at Broughton. Since obtaining a Bachelor of Science degree in Chemistry and a subsequent Post Graduate Certificate in Analytical Science, he has gained over 25 years of analytical and regulatory experience working in global medical device and pharmaceutical companies and leading CROs. Chris started his career working on both Medical Devices and Pharmaceutical products within Smith+Nephew. Subsequently, Chris moved into inhaled medicines, supporting blue-chip pharmaceutical companies’ drug product registration programs within Melbourn Intertek.

Before co-founding Broughton, Chris moved into a leadership role with Sciantec (Cawood), successfully overseeing its entry into the Veterinary Medicines market, supporting global Marketing Authorizations and site inspections.

Chris co-founded Broughton Laboratories in 2006, with Paul Moran, overseeing its first and successful MHRA Good Manufacturing Practice (GMP) inspection within the first three months. With a focus on supporting Marketing Authorizations and Post Marketing activities within the pharmaceutical sector, Broughton played a pivotal role in obtaining the first UK Medicinal License for an electronic cigarette, a project that started in 2010.

Chris took this combined experience of Pharmaceuticals and Nicotine to expand Broughton’s services to support the development and registration of Reduced-Risk Tobacco Products, including Electronic Nicotine Delivery Systems (ENDS). Rapid growth within this area resulted in the expansion to a second site, and a multi-million-pound (GBP) investment into a custom-built facility, leading-edge analytical equipment and expansion of the team and service offerings. Chris has overseen multiple product applications for Medicinal Marketing Authorization Applications (MAA), EU Tobacco Products Directive (TPD), US Premarket Tobacco Product Application (PMTA) and other global markets. Chris has become well established as a recognized subject matter expert in the science and regulation of pharmaceuticals, medical devices and reduced risk nicotine products.

As Chief Executive Officer of Broughton, Chris’ passion lies in developing the Broughton Team and associated services to deliver life-enhancing products to market for their clients.

Session Details:

Postmarket Under the Microscope: A Global Look at Regulatory Expectations for Nicotine Products

2025-06-04, 2:00 PM

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Sonny Sisodiya
Regulatory Science Integration Director, JTI (Japan Tobacco International)

Session Details:

Pathways To Getting Products Authorized

2025-06-04, 11:00 AM

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Joshua Karelitz
PhD, Principal Scientist II, Altria

Session Details:

Pathways To Getting Products Authorized

2025-06-04, 11:00 AM

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Derek Yach
MBChB MPH,

Derek Yach is a global public health leader with deep experience based on years of work for WHO, leading corporations including PepsiCo, investment funds, academia (as Professor of Global Health at Yale), and not-for-profit organizations such as the Rockefeller and Smoke Free Foundations. His focus in these diverse settings has been to lead initiatives with impact on chronic diseases and their risks, and on mental health. Looking forward, he believes that governments, industry and investors need to give far greater focus to the health of adults as the pandemic recedes if we are to build more resilient and productive populations. He has focused on ways to implement harm reduction strategies within the context of substance abuse, tobacco control and food and nutrition policy. He has degrees in medicine and public health.

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Guy Bentley
Director of Consumer Freedom, Reason Foundation

Session Details:

Keynote: What FDA cuts could mean for the future of next generation nicotine?

2025-06-04, 8:40 AM

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John Patterson
President, IKE Tech

John Patterson is President of IKE Tech, a leading provider of identity verification (IDV), biometric authentication, and tokenization technology across a range of everyday consumer products.  A passionate champion of Tobacco Harm Reduction, John has spent the last decade leading programs for some of the biggest brands in vapour technology including NJOY, JUUL and Aspire. As current Head of IKE Tech LLC, he is steering the organisation's focus on solving some of the biggest industry challenges by utilizing innovative solutions to address youth access and illicit products.

Session Details:

Innovation Insights: Leveraging Technology to End Youth Vaping for Electronic Nicotine Delivery Systems

2025-06-04, 1:30 PM

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Eric Gotting
Partner, Keller and Heckman LLP

Eric Gotting represents Keller and Heckman’s clients in litigation and related matters, specializing in complex civil and appellate matters, internal investigations, and regulatory compliance. With an extensive background in environmental and FDA law, he has expanded his practice over the years to cover many of Keller and Heckman’s industry sectors and regulatory areas, including tobacco and e-vapor. Eric is a former Am Law 50 litigation partner and U.S. Department of Justice, Civil Division, Trial Attorney. Eric’s practice spans a broad range of legal issues, including administrative and constitutional law, agency enforcement actions, toxic torts, product liability, general business litigation, and regulatory advice. He works with a diverse set of industries, including chemicals, plastics, pesticides, fuels and pipelines, food and packaging, consumer goods, telecommunications, and e-cigarettes. As a litigator, Eric has tried cases to verdict and argued appeals before federal and state courts across the country. His experience includes class actions, mass tort litigation, AAA arbitrations, and agency proceedings. Eric has also litigated challenges to federal and state statutes, regulations, and orders, including PMTA marketing denial orders. He has particular expertise involving the Administrative Procedure Act (APA), the Dormant Commerce Clause, the First Amendment, the Due Process Clause, and federal preemption. He has also filed amicus briefs in litigation involving regulatory issues facing a variety of industry sectors, including on behalf of the e-vapor industry.

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Dr. Charlene Liu, Sc.D.
President and Chief Scientist, Riskwise Solution LLC.

Dr. Charlene Liu is a renowned expert in regulatory strategy development and nonclinical studies for tobacco harm reduction products. She brings nearly a decade of leadership experience in toxicology and risk assessment at R.J. Reynolds, JUUL Labs, and RELX International. With nearly 20 years of prior experience in human health risk assessment at Environmental Protection Agency Superfund sites, Dr. Liu was a pioneer in applying quantitative risk assessment (QRA) to evaluate the relative health risks of tobacco harm reduction products over a decade ago. She has successfully developed and applied QRA methodologies for PMTAs and substantial equivalence filings. Her work has influenced the FDA to adopt QRA as a key component in evaluating toxicological risk in ENDS PMTA for regulatory decisions on APPH.
In 2023, Dr. Liu founded Riskwise Solution, a consulting firm providing expertise in nonclinical science, including chemical characterization, stability, toxicology, and risk assessment, to help clients navigate the evolving PMTA regulatory landscape.

Session Details:

Spotlight: FDA’s Current Approach to Toxicological Risk Evaluation to Inform APPH: A Nonclinical Case Study of Breeze Pro Disposable ENDS

2025-06-04, 4:10 PM

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Gavin O’Dowd
CEO, Haypp Group

CEO, Chief  Executive Officer

At Haypp Group since September 2017.

Education and work experience:
A chartered management accountant who trained in Accenture and PwC. Has spent 11 years in the nicotine industry, at BAT, in Group Corporate Finance, CFO Iberian and General Manager for Sweden and Norway.

Session Details:

Shark Tank: Innovation in Products and Services

2025-06-04, 6:05 PM

Session Details:

Panel discussion: Harm Reduction – Key Developments Globally

2025-06-04, 4:25 PM

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Dr Andrew O’Brien
Biometrics Product Manager, Innovative Technology

Andrew gained his PhD in physics in 2008.  Since then he has been involved in numerous start-ups commercialising and bringing to market innovative technical solutions.  He joined Innovative Technology in 2019 where he heads up their Biometrics Division developing age and identity verification technology ICU Lite, MyCheckr and MyCheckrMini. These devices are now widely used across tobacco, retail and gaming to help control underage access to age restricted products and services. 

Session Details:

Shark Tank: Innovation in Products and Services

2025-06-04, 6:05 PM

Session Details:

Drinks reception hosted by Innovative Technology

2025-06-04, 6:40 PM

Session Details:

How MyCheckr age assurance technology can protect your staff and business

2025-06-04, 5:35 PM

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Jerry Donnini
Shareholder, Law Offices of Moffa, Sutton, & Donnini, P.A. & Founder of Tobacco Tax Refund, Inc

Gerald "Jerry" Donnini II is a shareholder of the Law Offices of Moffa, Sutton, & Donnini, P.A. He is also president and founder of Tobacco Tax Refund, Inc, which focuses on state tax and licensing issues in the tobacco and vape industry.  Mr. Donnini concentrates in the area of state tax and licensing matters, with a heavy emphasis on the tobacco, convenience store and petroleum industries. He has represented and handled millions of dollars in tobacco and vape tax refunds and assessments for distributors and retailers nationwide.

Session Details:

Update: Florida’s State And Local Tax Law

2025-06-05, 2:20 PM

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Samy Hamdouche
Co-founder and COO, Lucy Goods Inc.

Samy Hamdouche is a co-founder and Chief Operating Officer at Lucy. Prior to Lucy, he helped to build a number of companies in the biopharmaceuticals industry, including Avidity Biosciences and Kura Oncology. He is a scientist by training, and received his Ph.D. in biochemistry and molecular biophysics from Caltech.

David Renteln is a co-founder and Chief Executive Officer at Lucy. He started Lucy during his attempt to quit smoking, when he first became aware of what is now called the continuum of risk, and the public health potential of reduced harm products. Prior to Lucy, he was a co-founder and Chief Marketing Officer at Soylent, a nutrition and food technology company.

Session Details:

Panel Discussion: How Can Industry Work Together To Improve Positive Messaging For Nicotine Products

2025-06-05, 3:30 PM

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Eric Johnson
Managing Director, Atlantic Consulting

Session Details:

Spotlight: Synthetic nicotine’s carbon footprint is far lower than that of tobacco-derived nicotine

2025-06-05, 10:15 AM

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George Hardie
Executive Director, Tobacco Harm Reduction, Dr. Vince Clinical Research

Session Details:

Case Study: Dr. Vince Clinical Research

2025-06-05, 9:45 AM

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Dr Neil Sherwood
Manager, Tobacco Harm Reduction Research, Dr. Vince Clinical Research

Session Details:

Case Study: Dr. Vince Clinical Research

2025-06-05, 9:45 AM

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Claudia Kanitscheider
Associate Director, Behavioural Science, Dr. Vince Clinical Research

Session Details:

Case Study: Dr. Vince Clinical Research

2025-06-05, 9:45 AM

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Joe Smith
Partner, Thompson Hine

Joe Smith, a partner in the firm’s Washington D.C. office, is a member of the Business Litigation group and co-leads the Cannabis practice. Joe focuses his practice on litigation and regulatory compliance with a particular bend toward the cannabis and hemp industries and related industries. Joe is considered one of the cannabis industry’s most knowledgeable lawyers on federal and state regulatory compliance, including compliance with the expanded PACT Act and related state licensure and tax requirements. Joe regularly counsels clients in the cannabis industry and ancillary businesses on federal and state regulations affecting marijuana, hemp, CBD and other cannabis-related products and services. Joe also currently serves as vice-chair of the State Regulations Committee of the National Cannabis Industry Association. Additionally, as an experienced litigator, Joe represents cannabis and non-cannabis clients in state and federal court in a broad range of commercial and civil matters.

Session Details:

Panel Discussion: How Can Industry Work Together To Improve Positive Messaging For Nicotine Products

2025-06-05, 3:30 PM

Session Details:

Panel discussion: Harm Reduction – Key Developments Globally

2025-06-04, 4:25 PM

Session Details:

Key Legal Developments: Tobacco Alternatives And Nicotine Products

2025-06-05, 10:30 AM

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Agustin Rodriquez
Partner, Troutman Pepper Locke

Agustin Rodriguez is a seasoned business partner at Troutman Pepper Locke with extensive experience in guiding clients through complex regulatory landscapes in industries such as tobacco, cannabis, and gambling. As a partner in the firm's Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and its Tobacco + Nicotine and Cannabis law practices, he provides strategic counsel on complex regulatory compliance issues, including licensing, taxation, marketing, and advertising.

Before joining the firm, Agustin served as Vice President and Associate General Counsel at Altria Group, Inc., where he managed compliance, corporate governance, litigation, and transactional matters globally. Fluent in Spanish and proficient in Portuguese, Agustin has developed compliance programs across Europe, Latin America, Asia, and Africa, addressing risks related to antitrust, anticorruption, the FCPA, and corporate social responsibility.

Session Details:

Panel Discussion: Navigate The Legal And Policy Challenges In The Evolving Tobacco And Nicotine Industry

2025-06-04, 2:30 PM

Session Details:

Keynote: What FDA cuts could mean for the future of next generation nicotine?

2025-06-04, 8:40 AM

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Bryan Haynes
Partner, Troutman Pepper Locke

Bryan Haynes is an experienced attorney at Troutman Pepper Locke, specializing in regulatory compliance and enforcement within the tobacco industry. As a key member of the firm's Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and head of the Tobacco + Nicotine practice, he adeptly assists clients in navigating complex regulatory landscapes. Bryan's expertise spans FDA requirements, tobacco taxation, and administrative disputes. He has been instrumental in advising on the Family Smoking Prevention and Tobacco Control Act and the FDA's deeming rule. A skilled litigator, Bryan has successfully represented clients in state and federal courts, ensuring compliance and mitigating risks aligned with business objectives. His comprehensive knowledge and strategic approach make him an invaluable asset to tobacco manufacturers, distributors, retailers, and suppliers.

Session Details:

Panel Discussion: Navigate The Legal And Policy Challenges In The Evolving Tobacco And Nicotine Industry

2025-06-04, 2:30 PM

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Azim Chowdhury
Partner

Azim Chowdhury, a partner with the law firm of Keller and Heckman LLP, counsels domestic and foreign corporations on U.S. Food and Drug Administration (FDA) and international regulatory compliance matters and on tobacco and e-vapor product regulation.

Mr. Chowdhury advises corporations in establishing clearances for food and drug additives in the U.S., Canada, and European Union, with an emphasis on indirect additives used in drug and food-contact materials. He has expertise in the tobacco and e-vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act and spearheads the FDA Tobacco and Electronic Cigarette practice at Keller and Heckman LLP. 

Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance. He represents clients on tobacco, e-cigarette and e-liquid matters before the FDA and the Consumer Product Safety Commission (CPSC). He is also a frequent contributor to the Food and Drug Law Institute (FDLI) Update Magazine, has served on the Editorial Advisory Board of the Food and Drug Law Journal, and edited and co-authored FDLI’s recent publications, Tobacco Regulation and Compliance: An Essential Resource and FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer. Mr. Chowdhury is a frequent speaker and author.

Session Details:

Keynote: What FDA cuts could mean for the future of next generation nicotine?

2025-06-04, 8:40 AM

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Dr. Vince Angelico
Chief Science Officer, Accorto Regulatory Solutions

Dr. Vincent Angelico is a co-founder of Accorto Regulatory Solutions and serves as its Chief Science Officer. In this role, Vince spends most of his time working with clients to formulate cost effective and successful regulatory strategies that meet client and FDA expectations.  Prior to joining Accorto, Vince was a senior executive at Blackbriar Regulatory Services, where he provided scientific and regulatory consulting to several alternative nicotine products companies and developed the regulatory strategy for Avail Vapor LLC, which ultimately submitted some of the few pre-market applications that the FDA did not reject in this constantly changing newly regulated market.  Vince developed his professional career working in the in the pharmaceutical industry, starting out as research and development chemist at Merck & Co Pharmaceuticals.  While at Merck, Vince helped develop products in the new drug pipeline and moved through the ranks to become a product development team leader.  His work led to regulatory filings on the notable cholesterol regulating drug ZOCOR™ (simvastatin).  Vince later worked for the German based pharmaceutical company Boehringer Ingelheim (BI), where he was assigned to their active ingredient manufacturing site in Petersburg Virginia.  Vince served in several different leadership roles for BI before ultimately becoming the Director of Manufacturing Operations in 2012.  Vince holds a BS in Chemistry from Virginia Commonwealth University and a Ph.D. in Analytical Chemistry from the University of Arizona.

Session Details:

Navigating the Regulatory Landscape of ENDS and Nicotine Pouches in the U.S.

2025-06-04, 10:00 AM

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Valerie Schwartz
Regulatory Affairs Manager, Accorto Regulatory Solutions

Session Details:

Speaker Hosted Roundtables

2025-06-05, 11:40 AM

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