Next Generation Nicotine Delivery USA 2023

The leading event connecting the Nicotine industry for strategic growth and unrivalled networking - FREE TO ATTEND FOR MANUFACTURERS AND RETAILERS

28 - 29

June

2023
  • Hilton Miami Airport Blue Lagoon
  • Ticketed

Why attend?

WHAT IS NEW FOR 2023?

150+

Attendees

15+

Exhibitors

80%

Attendees at Director+ level

150+

Attendees

15+

Exhibitors

80%

Attendees at Director+ level

Agenda

  • 28 Jun 2023
  • 29 Jun 2023
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8 AM

Registration and Refreshments

8:50 AM

Chair’s opening remarks

Speakers

9 AM

FDA process updates and things you need to know for new applications

• Leveraging long-awaited FDA feedback on submissions to be successful in reapplying
• What is the tangible value of an MRTPA without healthcare provider outreach?
• Strategies in post-market surveillance activities
• Looking backwards to look forwards: Retrospective look at FDA tobacco and nicotine regulations

Speakers

9:30 AM

Session reserved for sponsorship

10 AM

Current regulatory landscape and views from in-house counsel

• Need for more compliance and enforcement and increased clarity about what products can be lawfully sold
• Potential impact and changes at CTP in response to the Reagan-Udall Foundation’s Report
• Upcoming rulemaking (e.g., menthol, VLNC)

Speakers

10:30 AM

Session reserved for sponsorship

11 AM

Morning Refreshments & Networking

11:30 AM

Addressing the contradictions of FDA and US regulatory policy on tobacco and nicotine

  • Are FDA’s response to serious criticisms of Reagan-Udall Foundation sufficient or appropriate?
  • Are current US regulatory approaches injurious to, rather than protective of, public health?
  • What is the role of science in driving FDA regulation and decisions on PMTAs?
  • What are potential policy and regulatory solutions to the apparent contradictions in science and US/FDA approaches to harm reduction?

Speakers

12 PM

FDA PMTA Deficiency Letters – Are you prepared?

  • Where are we now – insight into the FDA PMTA review process
  • Defining your strategy – the art of good preparation
  • PMTA modules where deficiencies are most common
  • Finding the right partner for a successful response

Speakers

12:30 PM

Panel Discussion: What’s happening in the rest of the world?

  • Identifying opportunities for overseas growth
  • Comparing and contrasting approaches from around the globe
  • Global influences on the US nicotine market
  • Worldwide outlook on the burden of tobacco

Chair: Robert Burton, Group Scientific and Regulatory Director, Plxsur
Panel: Jeff Connell, CEO, Innevape Eliquids
Michael Saxon, Chief Executive Officer and Board Director, TAAT
Tim Phillips, Managing Director, EcigIntelligence
Chris Allen, Chief Executive Officer, Broughton

Speakers

1 PM

Lunch & Networking

2 PM

Youth vaping “Epidemic”

  • Finding the balance; addressing youth marketing while ensuring vaping maintains its harm reduction status
  • Potential regulations to deal with youth vaping
  • Function of disposables or marketing; understanding is the key to prevent future negligence
  • Urging companies to review their marketing to make sure it is responsible
  • Understanding the difference between observations of facts and actual problems with solutions

Speakers

2:20 PM

Getting into the minds and hearts of the consumer: how to use behavioral science from product development to product applications

  • Do you know who your target consumer is and what they want?
  • What (and who) are the key roadblocks to switching adult smokers?
  • Are you designing your key Perception and Behavior PMTA studies to effectively address FDA’s needs and concerns?
  • How can the social and behavioral sciences “save” flavors?

Speakers

2:50 PM

Role of innovation to protect consumer

  • ENDS industry made remarkable progress switching millions of adult smokers to potentially reduced-risk products
  • Despite all the challenges and mainly what Middle Eastern markets are facing, such as harsh fiscal, non-balanced regulation, illicit rage, and others, the ENDS industry is growing
  • A key issue we are facing today, beyond switching adult smokers, is targeting the WRONG group of consumers, such as non-smokers, ex-smokers, and minors, who are being attracted to many wrong innovations.
  • Industry needs to work together to find a solution to protect the WRONG group of consumers from accessing the category by exploring innovations and programs to protect the WRONG group of consumers from getting attracted to these products and making it difficult to have access to such products

Speakers

3:10 PM

Full Court Press: Vapor Litigation Update

  • Flavor Bans
  • FDA Refuse-to-Accept (RTA) and Refuse-to-File (RTF) Orders
  • Recent FDA Enforcement Actions and Consent Decrees
  • Challenges to FDA Marketing Denial Orders (MDOs)

Speakers

3:40 PM

Afternoon Refreshments and Networking

4:10 PM

Why isn’t synthetic nicotine doing as well as predicted?

  • Why are countless synthetic nicotine products being rejected by the FDA?
  • What have been the implications on business as FDA closes regulatory loophole?
  • Fostering a positive approach and benefiting from the opportunities the new regulations bring

Speakers

4:30 PM

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

  • Looking outward: can Australia’s prescription-only model for vaping products be viable in the US?
  • Will the prohibition of menthol be detrimental to the progress the alternative nicotine delivery industry has made in helping smokers quit or will it serve the opposite effect?
  • Would total flavor prohibition be beneficial for tobacco control?

Chair: Tony Abboud, Executive Director, Vapor Technology Association and President, Strategic Government Solutions

Panel: Samy Hamdouche, Cofounder and COO, Lucy Goods Inc.
Saadiq Daya, CEO, VanGo Vapes
Bonnie Herzog, Managing Director, Goldman Sachs

Speakers

5 PM

Nicotine Addiction: Politics, The Media, Regulation, and Science

  • Managing addiction using the risk continuum versus the unrealistic objective of cessation.
  • Traditional Tobacco versus Newly Deemed less harmful products - who should have greater access to the marketplace?
  • The Media, Special Interest Groups and Politicians driven misperceptions of the relative harm reduction of newly deemed products.
  • The CTP has failed in its implementation of a predictable path to market for safer nicotine delivery products while allowing hundreds of grandfathered product types to get to market via the substantial equivalence pathway. Why?

Speakers

5:15 PM

Live Long Vapor – Our 10-year journey from a small Florida business to a worldwide brand

Speakers

5:35 PM

Chair’s Summary and Close of Day 1

5:45 PM

Drinks Reception

7:50 AM

Registration and refreshments

8:20 AM

Chair’s Opening Remarks

8:30 AM

Revolutionizing Innovation: The Harm Reduction Opportunity of Modern Oral Nicotine Pouches

  • Role of modern oral nicotine pouches in tobacco harm reduction
  • Flavors as a motivator to switch for adults who smoke
  • The importance of a marketplace of FDA-authorized smoke-free products that satisfy adults who smoke

Speakers

9 AM

Why harm reduction nicotine is the only investible category for the future of nicotine delivery

  • Tackling current controversies surrounding harm reduction nicotine
  • Maximizing ESG potential of harm reduction nicotine
  • Delving deeper into the anti-vaping trajectory in USA
  • Sharing insight on investing in early-stage nicotine companies

Speakers

9:30 AM

Roundtables

Roundtable 1:
Hosted by David DeJean, Head of Sales and Business Development, Systech International
Creating an industry-FDA collaboration to prevent illicit products, reduce youth use, and protect brands and consumers

Roundtable 2:
Hosted by Peter Joza, Chief Scientific Adviser, Labstat and Shelly Blackwell, Senior Director for Dietary Supplement and Tobacco Services, EAS Consulting Group
Heated Tobacco and Modern Oral Products – Tobacco Product Manufacturing Practice (TPMP) Readiness and Premarket Tobacco Product Application (PMTA) Testing Challenges

Roundtable 3:
Hosted by Allison Boughner, VP, American Vapor Manufacturers Organization
How to keep up with changing consumer behavior

Roundtable 4:

Hosted by Jake Hilldrup, Technical Director and Ethan Sill, Smoke Lab Manager, Enthalpy Specialty Labs

NTA Analysis of Sweeteners and Other Flavoring Compounds in ENDS and Oral Products

 

Speakers

10:30 AM

Morning Refreshments and Networking

11 AM

Reducing the risks of inauthentic nicotine products

The global popularity of tobacco and the massive profits generated by cigarettes and other nicotine products attracts highly motivated counterfeiters. Fakes can have catastrophic consequences for producers ranging from harmful effects on consumers and an increased risk of lawsuits, to lost revenue, poor brand loyalty, and the scrutiny that results from lower tax proceeds.

  • Learn why the nicotine delivery market needs more sophisticated anti-counterfeiting solutions
  • Hear about how a major global tobacco producer is leveraging digital watermarks to secure the authenticity of its products
  • Understand what you can learn from pharmaceutical brands and central banks that use the same technologies to protect their integrity

Speakers

11:15 AM

Navigating the FDA PMTA landscape from a device engineering perspective for next generation product submissions

• The PMTA pathway involving electronic devices according to the Final Rule

• The PMTA Final Rule requirements for components, device design, specifications, and parameters

• Product Design, Functionality, Testing, and Analysis of electronic devices for a PMTA

Speakers

11:45 AM

Challenging the tax man: an update on state tobacco and vape tax issues and refunds

  • Recap of successful state tobacco tax refunds and savings
  • Common state tax audit pitfalls
  • Future vape and tobacco refund opportunities
  • State licensing issues

Speakers

12 PM

FIRESIDE CHAT Unlocking the potential of herbal tobacco amidst regulatory changes to flavors

  • Herbal tobacco as a catalyst for the whole sector to start moving again since slow FDA product approvals
  • Critical appraisal of clinical trials assessing heated tobacco products: Latest scientific findings on the impact on public health
  • Capitalizing off the growing popularity preparing for new era of herbal tobacco products
  • Has the herbal tobacco industry overcome the necessary regulatory hurdles to be a sustainable solution to end smoking?

Speakers

12:20 PM

Lunch and Networking

1:20 PM

Using consumer insights to understand future opportunities

  • The claims, ingredients and flavours driving consumer engagement.
  • Understanding and leveraging ethics and ethical decision making
  • Identifying how the younger consumer (21-30) makes decision today.

 

Speakers

1:40 PM

The conscious smoker in the modern world: growing hemp to grow business

  • Getting excited for the future of hemp
  • Managing the accelerating change in smokers’ habits
  • Capitalizing on opportunities in the untapped hemp market
  • What the hemp boom means for the legalization of cannabis?

Speakers

2 PM

Session reserved for sponsorship

2:30 PM

Panel discussion: Where is the cannabis industry headed?

  • Hear about latest regulatory updates on CBD, Delta-8, and hemp-derived products
  • Assessing the marketability of cannabis products and how it will affect the nicotine industry
  • Dispelling doubts and concerns of unreceptive consumers
  • Delving deeper into implications of legalizing cannabis and reducing access to black market

Chair: Mark Dempsey, Global Consulting Director, Global Data
Panel: Travis Priddy, CEO, 369 Hemp, Inc.
Dr Cuie Yan, VP Encapsulation/Application, Blue California
Eric Heyer, Partner – Business Litigation and Regulatory, Thompson Hine
Joe Smith, Partner - Business Litigation and Regulatory, Thompson Hine

Speakers

3 PM

Afternoon Refreshments and Networking

3:30 PM

Session reserved for sponsorship

3:45 PM

State of Vape: A Focus on Legal-age Smokers

  • Sharing best practices of successful marketing to grow business and reduce youth access and appeal to products.
  • Finding Balance: Preventing youth use while meeting the needs of adult smokers looking for alternatives to combustible cigarettes.
  • Urging companies to spearhead initiatives to crack down on youth initiation.

Speakers

4:05 PM

Upcoming Research on Quantifying Carbon Emissions and Recycling Rates for ENDS

  • Examining the current state of ENDS manufacturing and disposal: the lifecycle of nicotine, hardware, batteries in various ENDS categories
  • Conducting a landscape review of ENDS recycling, highlighting industry participants, and described by comparison to other FMCG industry recycling practices
  • Quantifying consumer recycling habits of ENDS in various jurisdictions as well as the propensity of ENDS users to recycle before and after implementation of a recycling program.
  • Creating a Recycling Model Framework using findings and best practices from this research for dissemination across industry and government

Speakers

4:25 PM

Harpooning Leviathan: Ways and Means to Hold Regulators and NGOs Accountable

  • FDA knows that vaping is a low-risk, effective quit-smoking tool
  • FDA’s doubletalk
  • Reporters fail to hold FDA accountable
  • Solutions

Speakers

4:45 PM

Chair’s Summary and Close of conference

Speakers

Select a speaker to learn more

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Todd Cecil
Deputy Director for Regulatory Management, FDA

Session Details:

FDA process updates and things you need to know for new applications

2023-06-28, 9:00 AM

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

Session Details:

Current regulatory landscape and views from in-house counsel

2023-06-28, 10:00 AM

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Tony Abboud
Executive Director, Vapor Technology Association and President, Strategic Government Solutions

Session Details:

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

2023-06-28, 4:30 PM

Session Details:

Addressing the contradictions of FDA and US regulatory policy on tobacco and nicotine

2023-06-28, 11:30 AM

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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:

The conscious smoker in the modern world: growing hemp to grow business

2023-06-29, 1:40 PM

Session Details:

Panel discussion: Where is the cannabis industry headed?

2023-06-29, 2:30 PM

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Martin Steinbauer
Founder, SMOOD LLC

Martin Steinbauer co-founded nicotine vaporizer company SMOOD, serves as the chief engineer, and holds 9 granted and pending patents. 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:

Upcoming Research on Quantifying Carbon Emissions and Recycling Rates for ENDS

2023-06-29, 4:05 PM

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Catharine Dockery
Founder and GP, Vice Ventures

Session Details:

Why harm reduction nicotine is the only investible category for the future of nicotine delivery

2023-06-29, 9:00 AM

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Samy Hamdouche
Cofounder and COO, Lucy Goods Inc.

Session Details:

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

2023-06-28, 4:30 PM

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Jeff Connell
CEO, Innevape Eliquids

Session Details:

Panel Discussion: What’s happening in the rest of the world?

2023-06-28, 12:30 PM

Session Details:

Live Long Vapor – Our 10-year journey from a small Florida business to a worldwide brand

2023-06-28, 5:15 PM

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Saadiq Daya
CEO, VanGo Vapes

Session Details:

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

2023-06-28, 4:30 PM

Session Details:

Youth vaping “Epidemic”

2023-06-28, 2:00 PM

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Niraj Patel
CEO, Bidi Vapor

Session Details:

State of Vape: A Focus on Legal-age Smokers

2023-06-29, 3:45 PM

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Dr. Jessica Zdinak
Chief Research Officer and Owner, ARAC

Dr. Zdinak holds a Ph.D. in Social Psychology, and a doctoral specialization in statistics. She has led research teams since 2005, supporting CDC, NIH, NSF, and other large-scale grants and projects. She has served as a Social Scientist at the National Institutes of Health in Bethesda, MD, and later as a Director of Applied Research and Evaluation at a management consulting firm in Maryland. In these capacities she helped to design research program evaluations, with her most memorable efforts leading a team of researchers and physicians to develop an Intimate Partner Violence/Domestic Violence prevention and response e-learning curriculum. This was one of the only programs of its kind in the United States at that time, training over 7,000 health care providers to assess for and respond to domestic and sexual violence in over 80 clinical settings. Dr. Zdinak is passionate about developing this type of program related to nicotine and tobacco products.

Following her public health experience, Dr. Zdinak spent 6 years at Altria, where she designed, led, and reported on Perception and Behavior studies for various PMTAs. She also spent time leading product research focused on innovation and future harm reduction opportunities. She now serves as Chief Research Officer and Owner of Applied Research and Analysis Company (ARAC), where she leads a team of Ph.D. and Master’s level behavioral scientists in conducting quantitative and qualitative research. This team specializes in TPPI studies, Human Factors and Label Comprehension research, and Actual Use and Longitudinal Experimental Switching Studies. The ARAC team understands that in this regulatory environment, outside researchers must be strategic thinkers and partners in the product innovation, PMTA, and MRTPA process.

Session Details:

Getting into the minds and hearts of the consumer: how to use behavioral science from product development to product applications

2023-06-28, 2:20 PM

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Allison Boughner
VP, American Vapor Manufacturers Organization

Session Details:

Roundtables

2023-06-29, 9:30 AM

Session Details:

Harpooning Leviathan: Ways and Means to Hold Regulators and NGOs Accountable

2023-06-29, 4:25 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.

Session Details:

Full Court Press: Vapor Litigation Update

2023-06-28, 3:10 PM

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Fadi Maayta
Co-Founder and President MEA, ANDS

Session Details:

Role of innovation to protect consumer

2023-06-28, 2:50 PM

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Dr. Vincent J. Angelico
Chief Scientific Officer, Accorto Regulatory Solutions

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

Session Details:

Nicotine Addiction: Politics, The Media, Regulation, and Science

2023-06-28, 5:00 PM

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Dr. Jennifer H. Smith
Associate Fellow - Scientific Strategy and Advocacy, Altria Science

Jennifer H. Smith, Ph.D. serves as Associate Fellow, Scientific Strategy & Advocacy, for Altria Client Services (ALCS) in Richmond, VA. In this role, she leads and coordinates the development and execution of scientific strategies that support regulatory submissions and engagement for innovative smoke-free tobacco products, including oral tobacco derived nicotine.

Since joining Altria in 2003, Dr. Smith has held numerous research and leadership positions within Altria. Most recently, she served as Director, Regulatory Advocacy, where she led the development of advocacy strategies for reduced-risk tobacco product standards and the creation of responses to FDA dockets related to proposed rulemaking.

Prior to joining Altria, Dr. Smith earned a Ph.D. from Virginia Tech. There she studied novel materials for chromatographic separations, conducted research supporting Homeland Security, and taught short courses for the American Chemical Society. She also holds a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.

Regulatory Affairs Certification, Regulatory Affairs Professional Society, 2019

Ph.D., Analytical Chemistry, Virginia Tech, Blacksburg, VA, 2002

B.S., Chemistry, Emory & Henry College, Emory, VA 1998

Session Details:

Revolutionizing Innovation: The Harm Reduction Opportunity of Modern Oral Nicotine Pouches

2023-06-29, 8:30 AM

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Michael Saxon
Chief Executive Officer and Board Director, TAAT Global

Session Details:

Panel Discussion: What’s happening in the rest of the world?

2023-06-28, 12:30 PM

Session Details:

FIRESIDE CHAT Unlocking the potential of herbal tobacco amidst regulatory changes to flavors

2023-06-28, 4:10 PM

Session Details:

FIRESIDE CHAT Unlocking the potential of herbal tobacco amidst regulatory changes to flavors

2023-06-29, 12:00 PM

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Robert Burton
Group Scientific and Regulatory Director, Plxsur

Session Details:

Panel Discussion: What’s happening in the rest of the world?

2023-06-28, 12:30 PM

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Sky Carman
Master Scientist, Reynolds American

Sky is an experienced electrical engineer with over 25 years of experience ranging across numerous industries including telecommunications, appliances, petrochemical, and tobacco. As a Master Scientist within the Reynolds American Group, Sky supports regulatory submission activities through device product development, testing and reporting for Electronic Nicotine Delivery Systems (ENDS) and Tobacco Heated Products (THP). Sky has supported several of Reynolds American’s Premarket Tobacco Product Applications (PMTA), including Vuse Solo, which received a Marketing Granted Order from the FDA in October of 2021. He also supports engineering design projects related to youth access prevention. Sky is a strong advocate of Tobacco Harm Reduction and potentially reduced risk products, and he is an expert on ENDS and THP devices.

Session Details:

Navigating the FDA PMTA landscape from a device engineering perspective for next generation product submissions

2023-06-29, 11:15 AM

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Tim Phillips
Managing Director, ECigIntelligence

Tim Phillips is the Managing Director of Tamarind Intelligence, publisher of leading business intelligence services ECigIntelligence, CBD-Intel and TobaccoIntelligence. These independent market data and regulatory tracking and analysis services for the vape, CBD and tobacco-alternatives industries provide market-leading insights into the sectors they cover for clients ranging from governments and academic institutions to multinational companies and professional service providers.

Tim Phillips is a UK-qualified attorney, having worked at the European Commission, international law firm Herbert Smith, media companies BSkyB and AOL, and Betfair, where he worked in various legal and government relations roles as the company went through its IPO. He was also a partner in a New York venture capital-funded start-up in the diamond sector. Tim holds a postgraduate diploma in legal practice from the University of Law, London and a masters degree in geology from Oxford University. He has run for Tamarind Intelligence for the past 6 years.

Session Details:

Panel Discussion: What’s happening in the rest of the world?

2023-06-28, 12:30 PM

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Peter Joza
Chief Scientific Adviser, Labstat

Chief Scientific Adviser

As Labstat’s Chief Scientific Advisor (CSA), Mr. Joza monitors the development of new and emerging technologies, to adapt the testing services offered by Labstat to these products. Mr. Joza joined Labstat in 1990 and was actively involved in the growth of Labstat through the development and implementation of procedures used by both the food and tobacco characterization programs. Mr. Joza is highly experienced in the development, management and translation of testing information to a variety of audiences.

As Labstat’s Chief Technical Officer (CTO), he occupied a senior role in facilitating the company’s scientific research and analytical functions. He has been the presenter or co-author of more than 40 presentations at international research conferences or workshops, and has co-authored 10 peer-reviewed publications. As a Chartered Chemist with the Association of the Chemical Profession of Ontario, Mr. Joza is a recognized global expert in his field and is an active member of several CORESTA (Cooperation Centre for Scientific Research Relative to Tobacco) study groups involved with various types of product testing.

Peter is an active member of the World Health Organization (WHO) Tobacco Laboratory Network (TobLabNet), as well as the International Standards Organization ISO TC126 (Tobacco Products), ISO TC126/WG3 (Vaping Products) and ISO TC126/WG22 (Heated Products). Mr. Joza attended McMaster University and received his B.Sc (Majors) Chemistry in 1988.

Session Details:

Roundtables

2023-06-29, 9:30 AM

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Shelly Blackwell
Senior Director for Dietary Supplement and Tobacco Services, EAS Consulting Group

Senior Director for Dietary Supplement and Tobacco Services

Shelly Blackwell brings over 22 years of quality and compliance experience in highly regulated environments to the EAS Consulting Group. After starting her career as a Microbiologist, she gained expert knowledge of a variety of domestic and international regulations while holding senior leadership positions in the dietary supplement, pharmaceutical, and medical device industries. These positions include 7 years as the Quality Assurance Director for GNC / Nutra Manufacturing and most recently leading the Quality Systems and Compliance Team at Bausch and Lomb in Greenville, SC.

Shelly’s accomplishments while leading Quality teams include developing supplier qualification programs, sourcing and implementing electronic QMS systems, implementing inspection readiness programs resulting in improved regulatory standing, risk-based quality system development, data integrity program development, and numerous successful continuous improvement initiatives. She has lead FDA and other regulatory inspections throughout her career and is also a lead auditor herself, auditing raw material suppliers and finished product manufacturers all over the world. Shelly holds certifications from the American Society of Quality and the Institute of Food Technology and has a Biology degree from James Madison University.

Session Details:

Roundtables

2023-06-29, 9:30 AM

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Bonnie Herzog
Managing Director, Goldman Sachs

Session Details:

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

2023-06-28, 4:30 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.

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 the 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 incorporation of Broughton Nicotine Services, a sister company to Broughton Laboratories, 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 the EU Tobacco Products Directive (TPD), US Premarket Tobacco Product Application (PMTA) and other global
markets. With over ten years of working with ENDS, Allen has become well established as a recognized
subject matter expert in the science and regulation of tobacco 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:

Panel Discussion: What’s happening in the rest of the world?

2023-06-28, 12:30 PM

Session Details:

FDA PMTA Deficiency Letters – Are you prepared?

2023-06-28, 12:00 PM

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Mark Dempsey
Global Consulting Director, GlobalData

Mark brings over 20 years experience in the foodservice, retail and FMCG sectors to GlobalData.  Mark joined the GlobalData team in 2017 following 5 years living in Canada where he was an insights leader for PepsiCo and strategy consulting leader for the NPD group.   In his role at GlobalData, Mark brings bold thought-leadership to global partners across the manufacturer, retailer and distributor segments; always striving to find new ways to create growth by positively influencing shopper behaviour.

Mark brings significant FMCG knowledge and expertise to the conference having led research around the world on topics from shopper segmentation, to category market sizing to innovation planning and the study of global best practices.

Mark will be chairing the conference whilst sharing his views on the changing nature of next generation product offerings, the demands and expectations of today’s consumer, and the innovations and trends that will shape the future…

Session Details:

Chair’s opening remarks

2023-06-28, 8:50 AM

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Panel discussion: Where is the cannabis industry headed?

2023-06-29, 2:30 PM

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Using consumer insights to understand future opportunities

2023-06-29, 1:20 PM

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David DeJean
Head of Sales and Business Development, Systech International

Dave DeJean is responsible for Systech’s strategic opportunities. He supports and educates customers and stakeholders on best practices for implementing enterprise serialization, traceability and authentication solutions. Dave brings over 35 years of market knowledge and hands-on experience in regulatory compliance, brand protection and supply chain traceability solution development and project methodology. He is a subject matter expert in packaging execution systems, product identification and supply chain transparency with a focus on pharma—one of the world's most heavily regulated industries.

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Roundtables

2023-06-29, 9:30 AM

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Eric Heyer
Partner – Business Litigation and Regulatory, Thompson Hine LLP

Eric, a partner in the firm’s Washington D.C. office, is a member of the Business Litigation group and co-leads the Cannabis practice. He has extensive experience in the cannabis, e-cigarette and vaping industries, advising clients on FDA and state regulatory compliance and enforcement issues, contractual and transactional matters and intellectual property issues. Eric was part of a landmark litigation team that established the legal framework for the vaping industry as it exists today. On behalf of an e-cigarette distributor, he argued that the product was the functional equivalent of traditional cigarettes and not unapproved drugs or medical devices, as the FDA contended. This resulted in the FDA amending its scope of authority to regulate e-cigarette use under the FD&C Act and the 2009 Family Smoking Prevention and Tobacco Control Act. Eric also successfully led the team for the Vapor Technology Association suit against New York state’s emergency ban on the possession and sale of flavored vaping products. Eric is advising more than 30 clients on navigating the PACT Act.

Session Details:

Panel discussion: Where is the cannabis industry headed?

2023-06-29, 2:30 PM

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Joe Smith
Partner - Business Litigation and Regulatory, Thompson Hine LLP

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: Where is the cannabis industry headed?

2023-06-29, 2:30 PM

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Dr. Cuie Yan
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: Where is the cannabis industry headed?

2023-06-29, 2:30 PM

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Jerry Donnini II
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:

Challenging the tax man: an update on state tobacco and vape tax issues and refunds

2023-06-29, 11:45 AM

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Anuschka Merson
Director, Regulatory and Scientific Affair, ITG Brands

Session Details:

Why isn’t synthetic nicotine doing as well as predicted?

2023-06-28, 4:10 PM

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Ken Sickles
Executive Vice President, Chief Product Officer, Digimarc

Ken Sickles is responsible for developing, delivering, and supporting Digimarc’s world-class global technology platform that advances the reach and effectiveness of automatic identification of media across multiple industries. Ken has expertise in products, technology and marketing over 25 years building software-as-a-service (SaaS) products in both the B2B and B2C space. He has helped define, build, and bring multi-sided platforms to market from the ground up, as well as extend platforms currently in the market. He has a passion for using his experience to enable technology to make our world a better place.

Session Details:

Reducing the risks of inauthentic nicotine products

2023-06-29, 11:00 AM

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Ethan Still
Smoke Lab Manager, Enthalpy Specialty Labs

Ethan Sill is the Senior Manager of Enthalpy’s Sample Generation department located in Richmond, VA. Ethan has been in the tobacco industry for six years with specialized skills in people management, quality assurance, and client relationship management. His knowledge of linear, rotary, and sidestream smoke machines has been invaluable to improving laboratory efficiency. Ethan has a Bachelors of Science in Biochemistry from Christopher Newport University. He is also an active member of CORESTA, participating in various subgroups including Cigar Smoking Methods, Physical Test Methods, and Smoke Analysis Group.

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Roundtables

2023-06-29, 9:30 AM

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Jake Hilldrup
Technical Director, Enthalpy Specialty Labs

Jacob (Jake) Hilldrup is a Technical Director of Enthalpy’s chemistry department for nicotine products located in Richmond, VA. Jake has been at Enthalpy for over 7 years and has helped the company expand its capabilities into numerous new product categories including cigars, e-cigarettes, heated tobacco products, and oral pouches. He has extensive experience in project design, new method implementation, adherence to ISO 17025 compliance, and data review of finished results. Jake is also a member of the ISO US (ANSI) Technical Advisory Group as well as CORESTA. He actively contributes to collaborative and proficiency studies while helping form and continuously improve international standards used to test cigarettes, cigars, ENDS, and tobacco products. He has submitted several topics for discussion including cigar analysis and alternative collections for in vitro toxicology testing. Jake has a strong analytical and regulatory background with a bachelor of science in chemistry from Virginia Polytechnic Institute and State University.

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Roundtables

2023-06-29, 9:30 AM

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Plan Your Visit

Venue

Hilton Miami Airport Blue Lagoon

5101 Blue Lagoon Dr, Miami, FL 33126, United States

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SPONSORSHIP ENQUIRIES

Ben Gemmell

Head of Consumer Portfolio

+(44) 207 661 8841

SPEAKER ENQUIRIES

Kim Palfrey

Head of Production

+44 (0) 20 7936 6960

MARKETING ENQUIRIES

Monica Chan

Marketing Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Ben Gemmell

Head of Consumer Portfolio


+(44) 207 661 8841

SPEAKER ENQUIRIES

To enquire about speaking opportunities for the conference, please contact:

Kim Palfrey

Head of Production


+44 (0) 20 7936 6960