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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  • Agenda
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Featured Speakers

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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

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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.

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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.

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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.

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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.

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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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    Sponsors Include

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    Company Information

    Reynolds American Inc., the BAT Group’s U.S. subsidiary, and its operating companies are leading the transformation of the tobacco and nicotine industry. Our purpose is to create A Better Tomorrow™ by Building a Smokeless world. Our strategic aim is to migrate smokers from cigarettes to smokeless alternatives and become a predominantly smokeless business by 2035.

    Company Website

    To learn more, please visit our website - www.reynoldsamerican.com

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    Company Information

    At Accorto Regulatory Solutions, we specialize in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market through the development of bespoke, cost-effective solutions across a range of FDA regulated industries.

    Company Website

    To learn more, please visit our website - www.accortoreg.com

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    Company Information

    Inter Scientific is an independent, accredited contract research organization specializing in regulatory product testing and compliance for customers in regulated markets. Inter Scientific’s areas of expertise include nicotine-containing products, medical devices, pharmaceuticals, cosmetic products, and novel foods. With over a decade of expertise, we empower your business to navigate complex regulations confidently.

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    Company Information

    At Altria, our Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We are Moving Beyond Smoking™, leading the way in moving adult smokers away from cigarettes by taking action to transition millions to potentially less harmful choices – believing it is a substantial opportunity for adult tobacco consumers, our businesses and society.

    Altria has a leading portfolio of tobacco products for U.S. tobacco consumers age 21+. In combustibles, we own Philip Morris USA, the maker of Marlboro cigarettes and John Middleton, manufacturer of Black & Mild cigars. Our smoke-free portfolio includes ownership of U.S. Smokeless Tobacco Company, the maker of Copenhagen and Skoal, Helix Innovations, the maker of on! oral nicotine pouches and NJOY, maker of NJOY ACE, currently the only pod-based e-vapor product with market authorization from the Food and Drug Administration. Additionally, we have a majority-owned joint venture with JT Group, Horizon Innovations, for the U.S. marketing and commercialization of heated tobacco stick products.

    Company Website

    To learn more, please visit our website - www.altria.com

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    Company Information

    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.

    LEARN MORE > www.ARACscience.com

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    Company Information

    Broughton is a Contract Research Organisation (CRO) with over 10 years’ experience delivering analytical, scientific and regulatory services for the ENDS industry. Our team of scientists, toxicologists and regulatory experts are generating data and managing client projects in areas including US PMTA strategy and delivery, EU TPD submissions and Medicinal Product strategy and applications. Our 20,000ft2 CRO facility in the UK incorporates several specialist laboratories equipped with the latest aerosol collection instruments, high-spec analytical equipment and fully validated data management systems.

    Company Website

    To learn more, please visit our website - http://www.broughton-group.com

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    Dr. Vince Clinical Research (DVCR) is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and therapeutic areas such as neuroscience, substance abuse, pain, tobacco harm reduction, infectious diseases and many others. CRO services include project management, data management, biostatistics, statistical programming, PK/PD analysis, medical writing, monitoring, site feasibility and management for multi-site trials.

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    IKE is setting the standard for product security and safety through advanced biometric device pairing, blockchain data protection and integrated BLE technology. Our next generation platform and world-class partnerships deliver a robust, reliable solution for age-verification and authentication across product categories using a single, easy-to-use mobile app.

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    Company Information

    Imperial Brands, a FTSE 100 company headquartered in the UK, is a global consumer-led tobacco business. Aligned with our purpose to forge a path to a healthier future for moments of relaxation and pleasure, we are committed to building a targeted range of potentially less harmful alternatives to traditional tobacco products.

    Company Website

    To learn more, please visit our website - www.imperialbrandsplc.com

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    Company Information

    Keller and Heckman is the premier law firm servicing the global regulatory, public policy, and litigation needs for the Tobacco and E-Vapor industry. Our decades of comprehensive and extensive experience dealing with the regulation of food, supplements, drugs, and medical devices before regulatory agencies such as the U.S. Food and Drug Administration (FDA), as well as international regulatory authorities, uniquely positions us to guide companies through the myriad of federal, state and international requirements for tobacco, nicotine and related products (including cannabis, hemp and CBD). We advise businesses on all levels of the tobacco, e-vapor, and vaping supply chain, including ingredient and component suppliers, finished product manufacturers, distributors, wholesalers, and retailers.

    Company Website

    To learn more, please visit our website - https://www.khlaw.com/

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    Company Information

    McKinney Specialty Labs draws upon decades of experience testing nicotine and other aerosolized products to generate reliable quality data that is accepted by regulators. We utilize robust and validated analytical methods and offer testing solutions that exceed the diverse needs of our clients.

    Company Website

    To learn more, please visit our website - www.mckinneyrsa.com

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    Company Information

    The lawyers at Thompson Hine LLP successfully litigated the very first federal vaping case against the FDA and have more than ten years of experience advising and representing clients in the vaping, CBD, and cannabis industries on all facets of their business, including federal and state regulatory compliance, pre-market tobacco applications, product labeling and advertising, intellectual property rights and disputes, supply and distribution contracts, and consumer safety issues.  Thompson Hine is a full-service business law firm with approximately 400 lawyers in 8 offices and was ranked number 1 in the category “Most innovative North American law firms: New working models” by The Financial Times.

     

    Company Website

    To learn more, please visit our website - www.thompsonhine.com

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    AgeChecker.Net is the leading provider in online age verification for age-restricted industries. Our system is designed to prevent underage sales and comply with federal, state and local regulations.

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    Company Information

    The Law Office of Moffa, Sutton, & Donnini, PA, focuses primarily on state and local taxes, including Florida sales tax, tobacco tax and motor fuel taxes. We have defended businesses against state agencies, including the Florida Department of Revenue, since 1991. Our firm has offices in Fort Lauderdale, Tampa, and Tallahassee.

    Company Website

    To learn more, please visit our website - https://www.floridasalestax.com/

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    Riskwise Solution, founded by Dr. Charlene Liu, is a leading regulatory consulting firm specializing in tobacco harm reduction products. With over a decade of technical and management experience in some of the largest tobacco and ENDS companies, combined with two decades of prior environmental consulting experience, Dr. Liu pioneered quantitative risk assessment (QRA) methodologies for PMTA and SE submissions. Her efforts significantly influenced the FDA’s 2024 adoption of QRA as a regulatory framework for evaluating toxicological risk in ENDS PMTA to inform APPH decisions.

    Riskwise supports clients in navigating the evolving U.S. regulatory landscape, offering services in regulatory strategy, product development, specification, and manufacturing, chemical characterization, toxicology, and risk assessment to bring innovative ENDS, nicotine pouch, and heated tobacco products to market.

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    Company Information

    Zanoprima is a manufacturer of S-nicotine. The company has developed a novel enzymatic process for the production utilizing “green chemistry”, yielding a significant carbon emission reduction and other ESG benefits when compared to plant extraction. These processes are subject to granted patents in over 40 countries. Zanoprima supports manufacturers in regulatory submissions, through a Drug Master File (DMF) and Tobacco Product Master File (TPMF) on file with the US Food and Drug Administration. Further, Zanoprima has developed improved reduced risk nicotine products using this high purity S-nicotine, including next generation Nicotine Replacement Therapies, with patents granted for novel vaping and oral products.

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    Sanova provides comprehensive regulatory, scientific, and litigation consulting services for regulated tobacco products. We offer full-service PMTA, MRTPA, SE, TPMF, and TPSAC support, and cost-sharing programs for literature reviews, ingredient assessments, and nationally representative survey analytics. Our experts have extensive FDA CTP experience and a strong history of delivering results.

    Company Website

    To learn more, please visit our website - www.sanova.co

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      Why attend?

      Building on previous success the event brings together key business leaders from the FDA, ENDS and tobacco industry across the US market along with solution providers. The two-day conference will provide valuable insights into the biggest challenges and opportunities in the sector.

      Keep up-to-date with the latest developments, challenges, and breakthroughs in nicotine research and public health through keynote presentations, panel discussions, roundtable discussions and dynamic networking sessions.

      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

      Testimonials

      Agenda

      • 4 Jun 2025
      • 5 Jun 2025
      Expand All

      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

      Opening Keynote: Developing Policies And Strategies To Best Guide The Nation Toward A Healthier Future

      • Proposed rules: Limiting the level of nicotine in products
      • Research findings: Reduced nicotine content cigarettes do not lead smokers to compensate for lower nicotine by smoking more
      • Encouraging individuals to quit or switch to less harmful products
      • FDA’s Population Heal Model: the model estimates that by the year 2060, the product standard would result in 1.8 million tobacco-related deaths averted, rising to 4.3 million deaths averted by the end of the century

      Speakers

      Todd Cecil
      Deputy Director for Regulatory Management, FDA

      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

      Dealing With Regulatory Challenges

      • Getting your product on the market
      • Managing the application process and post-market reporting requirements
      • Understanding the role of Risk Assessments for FDA Regulatory Submissions

      Senior representative, Accorto

      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

      Senior representative, Altria Client Services

      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: Age Verification Technology For Electronic Nicotine Delivery Systems

      • Technology that can prevent youth access while expanding adult market access to flavored PMTA-authorized products
      • Blockchain-based age-gating solution
      • How age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage

      Senior representative, IKE Tech

      2 PM

      New Age Verification Technology Could Help Solve Youth Appeal

      • Use of e-cigarettes has become more prominent as a smoking cessation tool
      • Dealing with bans on disposable vaping devices
      • Age-gating options that are available to manufacturers and how it can help bring products to market quicker
      • Reviewing the potential for reusable, pod-based systems

      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

      Senior representatives, 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

      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

      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

      7:15 AM

      Registration and networking

      8:30 AM

      Chairman’s opening remarks

      Speakers

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

      8:40 AM

      Keynote: FDA Interview: A Discussion With The Office Of Science

      • Recent Actions
      • Additional resources/ Transparency
      • Questions FDA would like some feedback on

      Speakers

      Todd Cecil
      Deputy Director for Regulatory Management, FDA

      9:10 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

      9:25 AM

      Case Study: Dr. Vince Clinical Research

      Dr Neil Sherwood, Manager, Tobacco Harm Reduction Research

      Claudia Kanitscheider, Associate Director, Behavioural Science

      George Hardie, Executive Director, Tobacco Harm Reduction

      10:15 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

      10:55 AM

      Spotlight: Towards A Clean Nicotine Future

      Introducing Zanoprima’s SyNic, the world’s first synthetic, high chemical purity (typically 99.9%) synthetic (S) -nicotine that is neither derived from any part of the tobacco plant nor from a synthetic racemic mixture of S- and R-Nicotine.

      Senior representative, Zanoprima

      11:10 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: Accorto Regulatory/Inter Scientific

       

      Roundtables 3 and 4: Available for sponsorship

      1 PM

      Lunch and networking

      1:50 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

      2:30 PM

      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

      3 PM

      Industry Case Study

      3:30 PM

      Afternoon refreshments

      3:50 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

      4:05 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

      4:40 PM

      Chairman’s closing remarks

      Speakers

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

      4:45 PM

      End of conference

      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: Developing Policies And Strategies To Best Guide The Nation Toward A Healthier Future

      2025-06-04, 8:40 AM

      Session Details:

      Keynote: FDA Interview: A Discussion With The Office Of Science

      2025-06-05, 8:40 AM

      View In Agenda
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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, 8:30 AM

      Session Details:

      Chairman’s closing remarks

      2025-06-05, 4:40 PM

      View In Agenda

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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:

      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:

      New Age Verification Technology Could Help Solve Youth Appeal

      2025-06-04, 2:00 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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      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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      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, 3:50 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: How Can Industry Work Together To Improve Positive Messaging For Nicotine Products

      2025-06-05, 4:05 PM

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