NextGen 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
  • Miami, USA
  • Ticketed

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

2024 Agenda

  • 19 Jun 2024
  • 20 Jun 2024
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7:30 AM

Registration and Refreshments

8:50 AM

Chair’s opening remarks

Speakers

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

9 AM

Opening keynote: FDA regulation update

  • PMTA applications update
  • Update on the ban on menthol
  • Upcoming rulemaking: flavored vapes, flavored disposable vapes, very low nicotine cigarettes (VLNCs), salt nicotine pouches
  • Are any of the products currently on the market likely to get banned in the near future?
  • How the FDA is responding to serious youth-vaping concerns

Speakers

Todd Cecil
Deputy Director for Regulatory Management, FDA

9:50 AM

The Tobacco Control Act 15 Years Later: Is the Center for Tobacco Products Achieving the Act’s Goals?

  • The TCA was a landmark event that for the first time, established a comprehensive regulatory system with the goal of reducing tobacco-related death and disease as the proper framework for regulation
  • As we approach the 15th anniversary of the TCA’s enactment—and the inception of FDA’s Center for Tobacco Products—it’s time to reflect on what’s working well at the Center and where there are potential opportunities for improvement
  • Regulations and Guidance: Do stakeholders have clarity on the Center’s current thinking, expectations, and requirements?
  • Timely, Clear, and Consistent Application Review: Is the current application process fostering innovation and promoting tobacco harm reduction?
  • Compliance and Enforcement: Has the Center established a coherent compliance framework for responsible industry members that has resulted in a well-regulated marketplace?
  • Communication and Education: Has the Center provided clear, science-based, and relevant communications to public health and adult smokers on the continuum of risk and the misperceptions of nicotine?

Speakers

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

10:20 AM

Novel Approaches to Understanding Human Behavior in Next Generation Products

  • Understanding behavior change through a person-centered approach (observational oriented modeling)
  • Unlocking the motivations for consumer behavior
  • The importance of incorporating cultural competency in product development and global market launch

Speakers

Dr. Jessica Zdinak
Chief Research Officer and Owner, ARAC

10:50 AM

Morning Refreshments & Networking

11:20 AM

Next generation nicotine: the global regulatory challenge

  • How do global regulatory approaches vary between countries and categories?
  • Does the motivation for regulation boil down to one key issue?
  • What responsibilities do the industry have, and how are they discharging these
  • responsibilities?
  • Does the lack of enforcement remove incentives for industry responsibility?
  • What next for global nicotine regulation?

Speakers

Tobias Baude
Director of Corporate Affairs for NGP, Imperial Brands

11:50 AM

Insights into youth access prevention

  • Active and Passive Youth Access Prevention
  • Considering Youth Access Prevention in product development
  • Accelerating path to market with compliance focused strategies

Speakers

Chris Allen
Chief Executive Officer, Broughton

12:20 PM

Overview of FDA enforcement tools & actions

  • Brief overview of the regulation of tobacco products
  • Enforcement discretion & priorities
  • Compliance & enforcement tools
  • Recent enforcement actions by the agency
  • Pending lawsuits

Speakers

LieAnn T. Van-Tull
Associate Washington, DC, Keller and Heckman

12:50 PM

Lunch & Networking

Sponsored by AmeriNic

1:50 PM

NJOY ACE: Advancing Harm Reduction for Adults who Smoke

  • The science and evidence demonstrating APPH
  • The role of flavors in transitioning to smoke-free products

Speakers

Dr. Kate Vergara
Senior Principal Scientist, Altria Client Services

2:20 PM

Ploom System: The Harm Reduction Opportunity for Heated Tobacco in the U.S.

Speakers

Jason Hong
MD, Senior Principal Scientist, Altria Client Services

2:40 PM

Analyzing key market data and trends – understanding consumer behavior

  • What is driving consumers to switch from cigarettes to nicotine alternatives
  • Analyzing consumer preferences – what flavors appeal the most
  • Understanding the path taken by consumers who have switched to pouches

Speakers

Gavin O’Dowd
CEO, Haypp Group

3:10 PM

Afternoon Refreshments and Networking

3:40 PM

Panel Discussion: What the flavor restrictions mean for the future of nicotine delivery?

  • Identifying growth opportunities outside of the US
  • Key regulatory developments and considerations
  • Consumer trends and preferences in key international markets
  • EU Regulation – The EU has banned flavored heated tobacco, how will pouches be regulated in the future?
  • Smoking cessation by using nicotine alternatives

Speakers

Gavin O’Dowd
CEO, Haypp Group
Zoe Walker-Cleave
Head of Corporate Affairs Next Generation Products, Imperial Brands

4:10 PM

Tax Man Update: Challenging State Tobacco and Vape Tax Issues and Refunds

  • Recap of Successful State Tobacco Tax Refunds & Savings
  • Common State Tax Audit Pitfalls
  • Future Vape & Tobacco Refund Opportunities
  • State Licensing Issues

Speakers

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

4:25 PM

Chairman’s closing remarks

Speakers

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

4:30 PM

Drinks reception

6 PM

End of day one

8 AM

Registration and networking

8:50 AM

Chairman’s opening remarks

Speakers

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

9 AM

Interview: A Discussion with the Office of Science

1)         Recent Actions

  • Review Actions (MGO,MDO, Deficiency Letters, RTA, RTF, Flavored ENDS, Etc.)

2)         Additional resources/ Transparency

  • Memo posting
  • Searchable Products Database
  • Public meeting
  • Further discussion of APPH

3)         Questions FDA would like some feedback on

  • What do you need to hear from us?
  • What scientific guidance do you need the most?
  • How do you want to engage with us?

 

Speakers

Todd Cecil
Deputy Director for Regulatory Management, FDA

9:40 AM

Up in Smoke? Protecting and Enforcing Your Brand in Emerging Regulated Industries for Vaping Products and Other “Illegal Use” Gray Areas

Speakers

Carrie A. Shufflebarger
Partner, Thompson Hine

10:10 AM

Panel Discussion: Age verification e-cigarettes

  • Understanding the importance of identity and age verification
  • What is involved in using an age-verification app
  • Unlocking devices using a Bluetooth connection
  • Ensuring compliance with FDA rules and regulations

 

Speakers

Michael Wang
CEO, Ispire
Ed Carmines
Chief Scientific Officer, Chemular
Thomas Chen
Co-Founder, Berify
Jason Carignan
Chief Commercial Officer, Chemular

10:40 AM

Morning Refreshments and Networking

11:10 AM

Speaker Hosted Roundtables

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: Opportunities for Stronger, More Effective, and Streamlined Enforcement

Stronger Enforcement

  • How can CTP leverage its existing enforcement toolkit to strengthen its enforcement?
  • What’s the role of Civil Money Penalties, and should they be enhanced?
  • How can CTP improve enforcement up the supply chain, including at the ports?

More Effective Enforcement

  • How can CTP implement more effective enforcement?
  • Are there learnings from other Centers, e.g., infant formula, heparin, that CTP could leverage?
  • Can AI play a role in post inspections to effectively verify products entering the ports?

Streamlined Enforcement

  • How can CTP streamline its enforcement activities to be more agile?
  • Is direct seizure authority possible for CBP?
  • Are there other improvements that would allow CTP to minimize the time between warning letter and enforcement or judicial action, e.g., seizures, injunctions, or civil monetary penalties?

Hosted by: Angela Ho-Chen, Managing Counsel – Regulatory, Reynolds American

 

ROUNDTABLE 2: Non-Internet Connected Youth Access Prevention Technology to Nicotine Products

Youth Access Prevention Technologies are critical for nicotine products to mitigate risks to minors and assist transitioning adult smokers. While many suitable technologies assist, industry proposals have focused on Bluetooth LE solutions. Yet critics have pointed out issues related to data privacy of user information and usability issues for adult smokers. This round table reviews the current public discourse around youth access and discusses alternative solutions to Bluetooth.

 

  • Sources of youth access and adult smoker demographics
  • Technological solutions to solve the problem of youth access while not overburdening smokers
  • Unique challenges to Bluetooth and internet-connected solutions in the nicotine industry
  • Apple store ban on nicotine apps causes usability issues for adult smokers and barrier to trial
  • Data privacy concerns for collected user data on company apps
  • Propensity of adult smokers to adopt technology may dramatically impact switching rates to ENDS
  • Access prevention technologies tailored to continuum of product appeal (tobacco vs flavors)
  • Emerging field of youth access solutions to disposable ENDS and oral nicotine products

HOSTS:

Martin Steinbauer, Co-founder, SMOOD

Speakers

Angela Ho-Chen
Managing Counsel – Regulatory, Reynolds American
Martin Steinbauer
Co-founder, SMOOD LLC

12:30 PM

Lunch and networking

1:30 PM

Case study: Introducing ‘Breakers’ – A first-of-its-kind product

  • ‘Breakers’ - a redesigned nicotine experience
  • Product innovation and design - a breakthrough in pouch technology
  • Understanding how 'Breakers' meets consumer needs
  • Developing products that serve as satisfying and less harmful alternatives to smoking and vaping
  • Delivering on LUCY's mission to reduce tobacco-related harm to users

Speakers

David Renteln
Co-Founder And CEO, Lucy Goods

2 PM

Panel discussion: Key developments in the cannabis and hemp markets

  • Review of states that have increased legal access to cannabis and hemp products
  • States that are likely to be allowed to sell Hemp/Cannabis/CBD products in the future
  • Innovation in delta 8 products
  • The growth of cannabis vaping
  • Update on vaping CBD
  • Outlook for the category over the next 3-5 years
  • What’s going to be the next big thing in the cannabis/hemp category?

 

Speakers

Yan Cuie
VP Encapsulation/Application, Blue California
Joe Smith
Partner, Thompson Hine
Travis Priddy
CEO, 369 Hemp, Inc.

2:40 PM

Afternoon refreshments and networking

3:10 PM

Panel discussion: Industry innovations – new products on the market

  • Heated tobacco alternatives
  • Nicotine gums and edibles
  • Update on synthetic nicotine
  • Environmentally friendly nicotine products

Speakers

Martin Steinbauer
Co-founder, SMOOD LLC
Samy Hamdouche
Co-founder and COO, Lucy Goods Inc.
Jeff Connell
CEO, Innevape
Lorenzo De Plano
Chief Strategy Officer, Turning Point Brands

3:40 PM

Market Insights and Trends in the Novel Nicotine Industry

  • A global overview and regulatory outlook
  • Updates on the continued rise of disposables – emerging trends and what the future holds
  • Discuss recent US vape store survey to uncover key industry behaviors from retailers
  • Analyze consumer data to understand usage patterns, preferences, and trends in the US
  • Examine growth and market dynamics of nicotine pouches and heated tobacco products

Speakers

Jonathan Darnell
Market Analyst, ECigIntelligence

4:10 PM

Chairman’s closing remarks

4:15 PM

End of conference

2024 Speakers

Select a speaker to learn more

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Todd Cecil
Deputy Director for Regulatory Management, FDA

Todd is the Deputy Director of Regulatory Management in the Office of Science of CTP.  Todd joined CTP in 2015 and has served in many roles within the Office of Science from a chemistry reviewer, through several leadership roles.  He has also served in the Technical Project Lead role for SE, EX, and PMTA programs.  He currently provides leadership for the SE and EX pathways and serves in the PMTA clearance review for the center.

Prior to joining FDA, Todd spent over 23 years at the United States Pharmacopeia (USP), where he served as the Vice-president of Compendial Science.

He received his BS in Chemistry from the University of Iowa and Ph.D. in Analytical Chemistry from Virginia Commonwealth University

Session Details:

Opening keynote: FDA regulation update

2024-06-19, 9:00 AM

Session Details:

Interview: A Discussion with the Office of Science

2024-06-20, 9:00 AM

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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:

The Tobacco Control Act 15 Years Later: Is the Center for Tobacco Products Achieving the Act’s Goals?

2024-06-19, 9:50 AM

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Angela Ho-Chen
Managing Counsel – Regulatory, Reynolds American

Angela Ho-Chen currently serves as Managing Counsel – Regulatory for RAI Services Company (Reynolds American, Inc.).

Angela’s career has spanned nearly 20 years in the medical device and tobacco regulatory arenas. She served as Division Regulatory Counsel and Regulatory Counsel at FDA’s Center for Tobacco Products (CTP) for over seven years, where she was one of the founding members of the Office of Compliance and Enforcement. Prior to her time at CTP, Angela served as a Consumer Product Safety Officer at FDA’s Center for Devices and Radiological Health. Following her time at FDA, she transitioned into the legal and regulatory departments at Altria Client Services and Juul Labs. Before joining Reynolds, Angela consulted at FDA Regulatory and Legal Services, a firm she founded following her time at Juul.

Angela has extensive cross-functional regulatory and legal leadership and project management experience. Her legal and regulatory review portfolio includes premarket and postmarket regulatory submissions strategy and execution, gap analyses, marketing and labeling reviews, inspection/audit readiness, compliance analyses, and enforcement mitigation in medical devices and tobacco. She has assisted clients with interpreting the Food, Drug, and Cosmetic Act, the Family Smoking Prevention and Tobacco Control Act, and their implementing regulations.

Angela received her BA from Emory University, her MPH in Cancer Epidemiology and Biostatistics and MPA from the University of Miami, and her JD from American University.

 

Session Details:

Speaker Hosted Roundtables

2024-06-20, 11:10 AM

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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:

Next generation nicotine: the global regulatory challenge

2024-06-19, 11:20 AM

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Zoe Walker-Cleave
Head of Corporate Affairs Next Generation Products, Imperial Brands

My role is the global Head of Corporate Affairs for Next Generation Products at Imperial Brands. I have 12 years in the business including Group Corporate Affairs, Head of Government Affairs in UK market, Head of Policy for Fontem. Previously, I started my career in Westminster,UK with 10 years of experience across public affairs, consultancy and the civil service.

My passions are my family, politics, and the environment.

Session Details:

Panel Discussion: What the flavor restrictions mean for the future of nicotine delivery?

2024-06-19, 3:40 PM

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Jason Hong
MD, Senior Principal Scientist, Altria Client Services

Session Details:

Ploom System: The Harm Reduction Opportunity for Heated Tobacco in the U.S.

2024-06-19, 2:20 PM

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Dr. Kate Vergara
Senior Principal Scientist, Altria Client Services

Kate Vergara, Ph.D., M.P.H is a Sr. Principal Scientist, Regulatory Affairs for Altria Client Services in Richmond, VA. In this role she serves as Science Lead for NJOY Products, developing and guiding scientific strategies to support tobacco harm reduction.

Prior to joining Altria, Dr. Vergara, was Vice President Health Impact at NJOY, LLC leading individual and population health studies for the NJOY ENDS PMTAs submitted to the FDA (Marketing Granted Orders issued for NJOY ACE April 2022 and NJOY DAILY June 2022).

Before her four years at NJOY, Dr. Vergara dedicated almost 20 years to addressing public health infectious disease burdens in vulnerable populations in emerging economy settings, including tuberculosis and intestinal parasites (Peru), and vaccine preventable diseases in high-risk counties in Africa (Angola, Nigeria, Ethiopia, Kenya, South Sudan, Somalia, and Sierra Leone) and India. She passionately supports growing a more diverse public health workforce, launching the flagship course Public Health Concepts in Epidemiology in 2019 at Baylor University’s Master of Public Health program, one of the most diverse student and faculty MPH programs in the US. Dr. Vergara continues to serve as an adjunct faculty as well as the course lead developing course content and overseeing all faculty teaching the course.

She has authored several peer-reviewed scientific publications and has presented on numerous public health research topics domestically and internationally.

Board experience includes the American Public Health Association SA Executive Board Treasurer from 2014-2016. And, after receiving a Fulbright to Peru 2003-04, Dr. Vergara continues to engage with the US State Department Fulbright Program serving as a Board Member for the Fulbright Association Chicago Chapter since 2021. Dr. Vergara has been an active volunteer with the US Medical Reserve Corps since 2020 and a member of the Chicago Triathlon Club since 2015.

Executive and Continuing Professional Education (ongoing) Harvard T.H. Chan School of Public Health, Boston, Massachusetts

Ph.D., Public Health, University of Illinois at Chicago, Chicago, Illinois

M.P.H., Community Health Sciences, University of Illinois at Chicago, Chicago, Illinois

B.S., Education, New York University, New York, New York

Session Details:

NJOY ACE: Advancing Harm Reduction for Adults who Smoke

2024-06-19, 1:50 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: Industry innovations – new products on the market

2024-06-20, 3:10 PM

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Lorenzo De Plano
Chief Strategy Officer, Turning Point Brands

Lorenzo De Plano was a founder of Solace Technologies in 2015.  Solace Technologies was a pioneer of open system nicotine salt based products.  In July of 2019, Lorenzo De Plano sold Solace Technologies, LLC to Turning Point Brands (NYSE: TPB) for $15.25m.  Lorenzo De Plano is now the senior director of the Turning Point Brands new ventures division, which specializes in the development, launch and marketing of new active ingredients products.

Session Details:

Panel discussion: Industry innovations – new products on the market

2024-06-20, 3:10 PM

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Martin Steinbauer
Co-founder, SMOOD LLC

Martin Steinbauer is the Chief Engineer and co-founder of SMOOD, where he focuses on youth access prevention technologies and sustainability solutions for ENDS. SMOOD has grown into a global business built on sustainability, advanced chemistry, IoT-enabled devices, and consumer centricity. Prior to SMOOD, Martin was an investment analyst at BlackRock in New York City. Martin graduated from Harvard University with a degree in Applied Mathematics.

Session Details:

Speaker Hosted Roundtables

2024-06-20, 11:10 AM

Session Details:

Panel discussion: Industry innovations – new products on the market

2024-06-20, 3:10 PM

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David Renteln
Co-Founder And CEO, Lucy Goods

Session Details:

Case study: Introducing ‘Breakers’ – A first-of-its-kind product

2024-06-20, 1:30 PM

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Jeff Connell
CEO, Innevape

I am a true entrepreneur and your classic visionary in every sense. A musician from the age of 5, at the tender age of 18 I signed my first record deal and became a professional musician. My band Baddax had multiple releases in the 1990’s with minor success, and toured throughout the country. I then spent the next few years as a professional screenwriter with 2 scripts optioned, as well as ghostwriting for other scripts. I have owned multiple businesses throughout my career, ranging from construction to sales/marketing, and of course, the entertainment industry. I made the switch to vaping in 2007 and stared perfecting the craft of making the ultimate eliquids. I founded Innevape Eliquids in 2012 with the singular mission of changing people’s lives for the better, the way vaping has changed mine.

Session Details:

Panel discussion: Industry innovations – new products on the market

2024-06-20, 3:10 PM

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Dr. Jessica Zdinak
Chief Research Officer and Owner, 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:

Novel Approaches to Understanding Human Behavior in Next Generation Products

2024-06-19, 10:20 AM

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Carrie A. Shufflebarger
Partner, Thompson Hine

Carrie focuses her practice on intellectual property counseling, prosecution and enforcement, with an emphasis on intellectual property litigation. She has represented clients in disputes in federal trial and appellate courts, before the Trademark Trial and Appeal Board, and before the International Trade Commission. Carrie represents clients of various sizes, ranging from individuals and startups to Fortune 500 companies, which span a broad range of industries, including apparel, medical devices, pharmaceuticals, school and office supplies, agricultural equipment, and various service sector industries.

Session Details:

Up in Smoke? Protecting and Enforcing Your Brand in Emerging Regulated Industries for Vaping Products and Other “Illegal Use” Gray Areas

2024-06-20, 9:40 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: Key developments in the cannabis and hemp markets

2024-06-20, 2:00 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:

Panel Discussion: What the flavor restrictions mean for the future of nicotine delivery?

2024-06-19, 3:40 PM

Session Details:

Analyzing key market data and trends – understanding consumer behavior

2024-06-19, 2:40 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:

Insights into youth access prevention

2024-06-19, 11:50 AM

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Yan Cuie
VP Encapsulation/Application, Blue California

Dr. Cuie Yan holds four degrees including a Ph. D. in Polymer Chemistry & Physics. She has been working on encapsulation/application of active ingredients and taste modulators for 26+ years, with DSM, PepsiCo and AB-InBev prior to Blue California, with a focus on leading teams launching marketing winning food, nutrient and pharma products, with $100 + million profit creation. Meanwhile, she has authored 36 articles in peer reviewed scientific journals including 2 book chapters, along with 10 patents.

Session Details:

Panel discussion: Key developments in the cannabis and hemp markets

2024-06-20, 2:00 PM

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Travis Priddy
CEO, 369 Hemp, Inc.

Travis Priddy is the founder and CEO of 369 Hemp, a startup hemp cigarette company located in Ridgeway, SC’s Opportunity Zone. Travis is a seasoned entrepreneur; in 2017 he sold his previous cannabis startup, GreenRock Botanicals, Inc., of California, to a well known publicly traded company. In 2014, after a 12 year career at Philip Morris International managing multiple international cigarette markets for the tobacco giant, Travis started his first company, Rock Vapor Technologies, Inc, which designed and manufactured electronic cigarettes in Austin, TX and San Clemente, California. Travis currently resides in Greenville, SC with his wife and 3 sons. When he is not working on his new manufacturing project with the 369 Hemp team, he can be found on the sidelines or in the dugout at one of his son’s (many) games as coach or enthusiastic supporter

Session Details:

Panel discussion: Key developments in the cannabis and hemp markets

2024-06-20, 2:00 PM

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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:

Chair’s opening remarks

2024-06-19, 8:50 AM

Session Details:

Chairman’s opening remarks

2024-06-20, 8:50 AM

Session Details:

Chairman’s closing remarks

2024-06-19, 4:25 PM

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LieAnn T. Van-Tull
Associate Washington, DC, Keller and Heckman

LieAnn Van-Tull practices food and drug law with an emphasis on food and drug packaging regulation and tobacco and e-vapor regulation. She advises domestic and foreign clients regarding compliance with global food and drug packaging requirements.

LieAnn assists companies in obtaining food contact clearances for their products in the United States (U.S.), Canada, China, South America, as well as the European Union (EU) and its individual Member States. She also provides guidance to clients on ways to establish a suitable regulatory status for products for which explicit premarket approval is not necessary.

In addition, LieAnn advises foreign and domestic clients on tobacco and e-vapor regulation by providing state and federal legislative counsel to tobacco and e-vapor suppliers, retailers, distributors, and manufacturers. She also counsels clients on approaches to establishing clearances for tobacco products marketed in the U.S.

Prior to joining Keller and Heckman, LieAnn served as regulatory counsel for the U.S. Food and Drug Administration (FDA), where she was a member of the lead counsel team on enforcement actions against companies that produce electronic nicotine delivery systems (ENDS). She also developed policies and programs involving matters affecting the regulation of the tobacco industry. Her experience at FDA allows LieAnn to assist Keller and Heckman partners in sorting through the complex and ever-changing e-vapor and tobacco regulations and explain them clearly and effectively to clients.

(Admitted to practice in Maryland only. Practice limited to matters before the FDA and matters ancillary thereto.)

 

Representative Matters

Provided regulatory guidance regarding food contact legislation across multiple jurisdictions for multinational food packaging companies

Advised clients regarding tobacco and e-vapor regulation as it relates to the Family Smoking Prevention and Tobacco Control Act

Counseled clients on securing a suitable regulatory status for food contact materials marketed in the U.S. and EU

 

Memberships

American Bar Association (ABA)

Washington Bar Association (WBA), Committee Member, 2018 – 2019 Term; Membership Chair, 2019 – 2020 Term; Secretary, 2021 – 2022 Term; President-Elect, 2022 – 2023 Term; President, 2023 – 2024 Term

 

Awards

National Conference of Bar Presidents (NCBP) Diversity Scholar, 2023 – 2024

National Bar Association (NBA) 40 Under 40 Nation's Best Advocates, 2023

 

Education

University of Maryland Baltimore County, B.S., 2006

University of Maryland, College Park, M.S., 2013

University of Baltimore School of Law, J.D., 2014

George Washington University Law School, L.L.M., 2018

Session Details:

Overview of FDA enforcement tools & actions

2024-06-19, 12:20 PM

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Jonathan Darnell
Market Analyst, ECigIntelligence

Jonathan has a BA in Economics from Western Kentucky University (USA) and a Master’s in International Economics from Universitat Rovira i Virgili (Spain). He has analyst and insight experience across several industries such as automotive, alcohol, and nuts and dried fruits. He also serves as an adjunct professor within the Economics Department at Universitat Rovira i Virgili for the International Markets Master Degree.

Session Details:

Market Insights and Trends in the Novel Nicotine Industry

2024-06-20, 3:40 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:

Tax Man Update: Challenging State Tobacco and Vape Tax Issues and Refunds

2024-06-19, 4:10 PM

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Michael Wang
CEO, Ispire

Michael Wang was promoted to the role of Co-Chief Executive Officer (CEO) on August 7, 2023. Mr. Wang had previously served as our Chief Financial Officer since August 2020. Mr. Wang is an experienced CEO, COO and President for a number of companies. From September 2018 through August 2020, he was the President, COO and then Co-CEO of The Pharm/Sunday Goods (located in California and Arizona), a vertically integrated leader in the cannabis cultivation, processing, manufacturing, distribution, wholesale, and retail industry. Mr. Wang served as President and COO of Onestop Commerce from 2013 to 2015 and as CEO from 2015 to 2018. Onestop Commerce managed all aspects of omni-channel-commerce for over 100 of the world’s top lifestyle brands and retailers. From 2005 through 2012, he was the Chief Operating and Fulfillment Officer and an investor in Zazzle, a world leader in online customization and personalization service. He started his leadership career in 1992 at Honeywell. Mr. Wang received Bachelor of Science and Master of Science degrees in Aerospace Engineering in 1983 and 1985 respectively, from the Beijing University of Aeronautics & Astronautics. In 1987, he received a Master of Science degree in Systems Engineering from Oakland University located in Rochester, Michigan. In 1992, Mr. Wang received an MBA in Finance and General Management from the University of Chicago’s Booth School of Business.

Session Details:

Panel Discussion: Age verification e-cigarettes

2024-06-20, 10:10 AM

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Ed Carmines
Chief Scientific Officer, Chemular

Ed Carmines PhD brings over a three decades of experience in regulatory and compliance solutions within the tobacco and nicotine industry. He is a proven leader with the ability to merge science and business.  He has extensive experience with the Center for Tobacco Products at the FDA. He has a proven track record with Premarket Tobacco Applications, Modified Risk Tobacco Applications, Substantial Equivalence, and Exemptions Requests. He is known for his detailed knowledge of the technical aspects of all types of e-cigarettes, oral tobacco, tobacco leaf free oral products, cigars, Heat Not Burn products and cigarettes as well as the regulatory requirements for product authorization. He is known for his ability to understand complex scientific problems and to develop business relevant solutions.

During his tenure at Altria, Ed was initially responsible for the safety of cigarettes worldwide.  He played a pivotal role in designing and executing a program to test the safety of ingredients and materials used in the manufacture of cigarettes. He was intimately involved in the development of new reduced risk products including the original Heat Not Burn product, Accord. This product was the precursor to IQOS. At the end of Ed’s career at Altria, he was responsible for innovation. His team was involved in finding and evaluating new technology and products. After retiring from Altria, Ed was employed by Reynolds. His role there was shepherding product safety review of novel and oral products. He was involved in the early development of the VUSE e-cigarette.

Ed has been a consultant to the tobacco industry for over 20 years. He single handedly designed the program, executed the studies, and wrote the PMTA and MRTP applications for VLN reduced nicotine cigarettes (over 20 million pages of documents). The PMTA was authorized in 2019 and the MRTP in 2021. This is the only cigarette ever to receive market authorization. He joined Chemular in 2019 as the Chief Scientific Officer. Ed directs all aspects of the scientific studies involved in PMTA and MRTP applications. During his tenure with Chemular, Ed has directed the work on over 1000 PMTAs on all types of ENDS, smokeless tobacco, modern oral products, and novel products.

Session Details:

Panel Discussion: Age verification e-cigarettes

2024-06-20, 10:10 AM

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Jason Carignan
Chief Commercial Officer, Chemular

Jason Carignan serves as Chief Commercial Officer at Chemular, Inc, and its affiliated companies, where he spearheads overall business strategy, revenue enhancement, strategic partnerships, and intellectual property management. Formerly, he was President of the Phillips & King and Tobacco Plus Expo (TPE) divisions of Kretek International. He also founded and served as President of Dryft Sciences, which was acquired by British American Tobacco in late-2020. Earlier in his career, Jason founded and led Vapur, an outdoor recreation brand focused on ultra-portable hydration products and Tonic, a leading SoCal-based brand management consultancy.

Throughout his career, Mr. Carignan has helped champion growth and win markets for B2C and B2B companies across diverse industries including consumer products, premium tobacco, alcoholic beverages, outdoor products, manufacturing, technology, hospitality, financial services, wellness and healthcare. With pioneering vision, he has lead start-ups and middle-market companies manage ground-up business unit development, go-to-market strategies, marketing strategy, customer experience optimization, brand management, design management, digital modernization, mergers and acquisitions and public deal transactions.

Session Details:

Panel Discussion: Age verification e-cigarettes

2024-06-20, 10:10 AM

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Thomas Chen
Co-Founder, Berify

Thomas M. Chen is the co-founder and Chief Technology Officer (CTO) of Berify, a leader in

blockchain-based authentication solutions that seamlessly bridge the physical and digital worlds.

Prior to his role at Berify, Thomas founded TrinityTech in 2012, a global systems integrator (SI)

and managed service provider (MSP). TrinityTech is renowned for assisting organizations in

achieving regulatory compliance and frameworks from DO/ISO/IEC, particularly within the

military, aerospace, automotive, healthcare, and medical verticals. Under Thomas’s leadership,

TrinityTech significantly expanded its global presence and consistently achieved revenue growth

exceeding 70% year over year.

From 1996 to 2011, Thomas held various executive positions at Parasoft Corporation, a leading

company in automated software testing and application security solutions. His strategic

contributions were instrumental in growing the startup to over $60 million in annual recurring

revenue (ARR). During his tenure at Parasoft, he served as the President and Chairman of the

Board for Parasoft Asia, overseeing operations across the Asia-Pacific (APAC) region.

Additionally, he held roles such as Senior Vice President of Development Tools and Senior Vice

President of Sales and Support.

Currently, Thomas serves as the Chairman of the Board for TrinityTech. He also holds board

position at Crosscheck Networks, a leader in API testing solutions; Forum Systems, a leading

provider of API Security Gateway solutions, securing 10B+ transactions daily with 100%

success deployments spanning across United States Treasury, Blue Cross Blue Shield, Federal

Aviation Administration and more; and Visure Solutions, a leader in requirement management

and application lifecycle management (ALM) tools, ensuring compliance for 1000+ highly

regulated organizations.

Thomas holds a Bachelor of Science degree in Electrical Engineering from Loyola Marymount

University (LMU) and an MBA from the Marshall School of Business at the University of

Southern California (USC). An innovator in his field, Thomas has been awarded seven patents in

blockchain technology, natural language processing (NLP), and artificial intelligence (AI).

Session Details:

Panel Discussion: Age verification e-cigarettes

2024-06-20, 10:10 AM

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