Recap Of
JAN 30–31, 2024
2024 Education Seminars and PowerPoints
Cure your FOMO! Don’t you hate missing out on valuable opportunities due to timing and competing priorities? So do we!
We take the time to record and publish our Education Sessions, making it convenient for you to view them on your own schedule.
Through educational sessions and workshops, TPE ensures that you are well-informed about industry trends, regulatory updates, and business strategies. Our education sessions empower professionals to navigate through challenges and capitalize on opportunities.
Industry Outlook:
The Path Ahead
What is the current state of Tobacco Regulation and what product trends are driving the industry.
Four Pillars of a Sound
PMTA Strategy
How sound Legal, Science, Manufacturing and Marketing approaches are mission-critical to a sufficient filing strategy.
Application
Pitfalls
Lessons learned from the ongoing PMTA process and the Top 10 filing mistakes to avoid.
Mike Bond
Labstat
Bonnie Coffa
Chemular
The Essential Value of Good Suppliers
How to identify and select the right suppliers as a part of your PMTA and what to do if you need to change suppliers along the way.
Angela Ho-Chen
FDA
Mike Bond
Labstat
Stacy Ehrlich
KKB Law
Chris Greer, TMA
Lillian Ortega
Chemular
PANEL DISCUSSION 1
Q&A from Morning Session
Morning session speakers answer questions from a Moderator and the Audience.
Tim Phillips
Tamarind Intelligence
Marketing & Product Intelligence
Essential guidance and data-based strategic insights for making informed business decisions in this rapidly changing tobacco, nicotine, alternative and adjacent product categories.
Brad Seipel
MARC Research
Making the Switch
Understanding the reasons why adult tobacco users are adopting reduced-risk products and which product categories are winning.
Henry Sicignanao
Charlies Holdings
Creating Great Products In An Increasingly Regulated Market
Learn how one brand is driving product innovation and market success within the current regulatory environment.
David O’Neill
Imperial Brands
The Growth of Nicotine Pouches
Brand perspectives on the rapid growth of Modern Oral nicotine pouches and where the market is headed.
Bryan Burd
Chemular
FDA Challenges & Practical Implications
How manufacturers can win in the market when the regulatory landscape is often murky.
Jason Carignan
Chemular
Tim Phillips
Chemular
David O’Neill
Imperial Brands
Brad Seipel
MARC Research
PANEL DISCUSSION 2
Q&A from Afternoon Session
Afternoon session speakers answer questions from a Moderator and the Audience.
Tim Phillips
Tamarind Intelligence
The Hottest Product
Trends At Retail
The new and innovative categories and products that are igniting retail sales and profits.
Agustin E. Rodriguez
Troutman Pepper
Ensuring PACT Act &
Excise Compliance
How to stay compliant, how to save taxes and how to run an efficient PACT-compliant shipping program.
David Spross
NATO
Retail/Wholesale FDA
Enforcement Readiness
How to plan for, what to know and what to say when an FDA enforcement agent pays you a visit.
Terry Gallagher
Smoker Friendly
Bryan Hanes
Troutman Pepper
Charlie Minato
Halfwheel
David Spross
NATO
Dr. Jessica Zdinak
Applied Research and
Analysis Company
PANEL DISCUSSION 3
The Future of Flavors
Advice for retailers about the legal status of flavored cigars and menthol cigarettes today, tomorrow and for the future.
Brad Seipel
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Brad Seipel is Executive Vice President and Group Director of Account Management at M/A/R/C® Research, which is a consulting firm focused on providing insights and strategies that enable clients to make informed decisions to move their business forward. In his role Brad serves as executive leader of M/A/R/C’s Nicotine Practice—an area he has been serving on the Commercial front for over 10 years and from a Regulatory perspective since the founding of CTP.
With his knowledge of research and thought leadership in the space, Brad is a frequently sought guest speaker for a myriad of conferences and webinars, including the Next Generation Nicotine Conference in 2020, the Global Tobacco and Nicotine Forum in 2022, and the Tobacco Merchants Association Annual Meeting in 2023. Brad is a member of the Insights Association and sits on the board of directors of Project Evergreen, a national non-profit organization committed to bringing people together to create healthy green spaces for both humans and animals alike. |
Brad Seipel
Brad Seipel is Executive Vice President and Group Director of Account Management at M/A/R/C® Research, which is a consulting firm focused on providing insights and strategies that enable clients to make informed decisions to move their business forward. In his role Brad serves as executive leader of M/A/R/C’s Nicotine Practice—an area he has been serving on the Commercial front for over 10 years and from a Regulatory perspective since the founding of CTP.
With his knowledge of research and thought leadership in the space, Brad is a frequently sought guest speaker for a myriad of conferences and webinars, including the Next Generation Nicotine Conference in 2020, the Global Tobacco and Nicotine Forum in 2022, and the Tobacco Merchants Association Annual Meeting in 2023.
Brad is a member of the Insights Association and sits on the board of directors of Project Evergreen, a national non-profit organization committed to bringing people together to create healthy green spaces for both humans and animals alike.
Bryan Haynes
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Bryan devotes his practice to representing businesses in disputes and regulatory compliance matters involving government agencies, including the Food and Drug Administration (FDA) and state attorneys general, and in other commercial litigation. Bryan is an accomplished trial attorney who has served as lead counsel in state and federal courts across the U.S., representing both domestic and international clients.
As a member of the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and head of the firm’s Tobacco + Nicotine practice, Bryan focuses on representing tobacco manufacturers, distributors, retailers, and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving a federal or state governmental entity, commercial agreements, and tobacco taxation matters. Bryan works with clients in all segments of the tobacco industry, including cigarette, cigar, pipe tobacco, and e-cigarettes, and other novel products. Bryan has been advising clients regarding compliance with the Family Smoking Prevention and Tobacco Control Act since before the law was passed in 2009. Bryan also advises companies that sell products subject to the FDA’s “deeming rule,” which gave the FDA authority to regulate e-cigarettes and other electronic nicotine delivery systems, cigars and pipe tobacco. Bryan assists clients with FDA premarket review requirements, including substantial equivalence (SE) and premarket tobacco applications, and has helped companies obtain numerous SE marketing orders for new products. He also advises tobacco companies in connection with Master Settlement Agreement (MSA) compliance issues, including negotiations with state regulators and in litigation. Further, Bryan represents distributors and retailers in connection with state and federal tax compliance and disputes, and has successfully defended manufacturers and distributors in disputes with the Alcohol and Tobacco Tax and Trade Bureau and state revenue departments. |
Bryan Haynes
Bryan devotes his practice to representing businesses in disputes and regulatory compliance matters involving government agencies, including the Food and Drug Administration (FDA) and state attorneys general, and in other commercial litigation. Bryan is an accomplished trial attorney who has served as lead counsel in state and federal courts across the U.S., representing both domestic and international clients.
As a member of the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and head of the firm’s Tobacco + Nicotine practice, Bryan focuses on representing tobacco manufacturers, distributors, retailers, and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving a federal or state governmental entity, commercial agreements, and tobacco taxation matters. Bryan works with clients in all segments of the tobacco industry, including cigarette, cigar, pipe tobacco, and e-cigarettes, and other novel products.
Bryan has been advising clients regarding compliance with the Family Smoking Prevention and Tobacco Control Act since before the law was passed in 2009. Bryan also advises companies that sell products subject to the FDA’s “deeming rule,” which gave the FDA authority to regulate e-cigarettes and other electronic nicotine delivery systems, cigars and pipe tobacco. Bryan assists clients with FDA premarket review requirements, including substantial equivalence (SE) and premarket tobacco applications, and has helped companies obtain numerous SE marketing orders for new products.
He also advises tobacco companies in connection with Master Settlement Agreement (MSA) compliance issues, including negotiations with state regulators and in litigation. Further, Bryan represents distributors and retailers in connection with state and federal tax compliance and disputes, and has successfully defended manufacturers and distributors in disputes with the Alcohol and Tobacco Tax and Trade Bureau and state revenue departments.
Chris Greer
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Christopher B. Greer (“Chris”) is the current President & CEO of TMA and the GTNF Trust. Chris is an expert in regulatory, corporate, government and external affairs with experience ranging from regulatory strategy, international trade, agency and stakeholder relations, government affairs, corporate governance to communications and trade media. Chris began his career with Verizon Wireless in legal and external affairs. After joining the tobacco industry in 2010, Chris held regulatory and corporate affairs roles with responsibility over the US, Caribbean, and Central American markets for JT International. In 2017, Chris was appointed TMA President & CEO. In 2019, TMA made its first asset acquisition and purchased GTNF Conferences, Tobacco Reporter Magazine, and Vapor Voice Magazine. TMA created The GTNF Trust to manage these newly acquired assets and Chris became President of that organization upon close of the deal. Chris resides in the Raleigh, NC area, with his wife, two young sons, and two rambunctious rescue dogs. |
Chris Greer
Christopher B. Greer (“Chris”) is the current President & CEO of TMA and the GTNF Trust. Chris is an expert in regulatory, corporate, government and external affairs with experience ranging from regulatory strategy, international trade, agency and stakeholder relations, government affairs, corporate governance to communications and trade media. Chris began his career with Verizon Wireless in legal and external affairs. After joining the tobacco industry in 2010, Chris held regulatory and corporate affairs roles with responsibility over the US, Caribbean, and Central American markets for JT International. In 2017, Chris was appointed TMA President & CEO. In 2019, TMA made its first asset acquisition and purchased GTNF Conferences, Tobacco Reporter Magazine, and Vapor Voice Magazine. TMA created The GTNF Trust to manage these newly acquired assets and Chris became President of that organization upon close of the deal. Chris resides in the Raleigh, NC area, with his wife, two young sons, and two rambunctious rescue dogs.
David Spross
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David Spross is the current Executive Director of the National Association of Tobacco Outlets (NATO), a national retail trade association that represents more than 66,000 retail stores throughout the country. He has over 20 years of association, corporate, government relations and community engagement experience.
From 2009-2023, David worked in various government relations roles at Reynolds. David served as the senior vice president of government relations & strategic engagement at Reynolds. In this role, he oversaw the federal, state and local government relations team on implementing the Company’s transforming tobacco vision and strategies. Prior to that, David was the vice president of state government relations where he led a 50-state government relations team managing tobacco legislative issues. His Reynolds career started managing state government relations regions in the Midwest and the West. Prior to joining Reynolds, he worked in the government relations department at United States Smokeless Tobacco Company for nine years. Additionally, he serves on the Association Board of Directors for the YMCA of Northwest North Carolina where chaired the Advancement Committee, leading the development plan for the Y’s Annual Fund and Capital Campaigns. He also served two terms on the Executive Board of the North Carolina State Chamber of Commerce. David received a bachelor’s degree in justice from the American University in Washington, DC. He resides in Lewisville, NC with his wife, Catherine and two children, Katie (13) and Matthew (11). |
David Spross
David Spross is the current Executive Director of the National Association of Tobacco Outlets (NATO), a national retail trade association that represents more than 66,000 retail stores throughout the country. He has over 20 years of association, corporate, government relations and community engagement experience.
From 2009-2023, David worked in various government relations roles at Reynolds. David served as the senior vice president of government relations & strategic engagement at Reynolds. In this role, he oversaw the federal, state and local government relations team on implementing the Company’s transforming tobacco vision and strategies. Prior to that, David was the vice president of state government relations where he led a 50-state government relations team managing tobacco legislative issues. His Reynolds career started managing state government relations regions in the Midwest and the West.
Prior to joining Reynolds, he worked in the government relations department at United States Smokeless Tobacco Company for nine years.
Additionally, he serves on the Association Board of Directors for the YMCA of Northwest North Carolina where chaired the Advancement Committee, leading the development plan for the Y’s Annual Fund and Capital Campaigns. He also served two terms on the Executive Board of the North Carolina State Chamber of Commerce.
David received a bachelor’s degree in justice from the American University in Washington, DC. He resides in Lewisville, NC with his wife, Catherine and two children, Katie (13) and Matthew (11).
Jason Carignan
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Jason Carignan serves as Chief Commercial Officer at Chemular, Inc, and its affiliated companies, where he spearheads overall business strategy, revenue enhancement, strategic partnerships, and intellectual property management. Formerly, he was President of the Phillips & King and Tobacco Plus Expo (TPE) divisions of Kretek International. He also founded and served as President of Dryft Sciences, which was acquired by British American Tobacco in late-2020. Earlier in his career, Jason founded and led Vapur, an outdoor recreation brand focused on ultra-portable hydration products and Tonic, a leading SoCal-based brand management consultancy.
Throughout his career, Mr. Carignan has helped champion growth and win markets for B2C and B2B companies across diverse industries including consumer products, premium tobacco, alcoholic beverages, outdoor products, manufacturing, technology, hospitality, financial services, wellness and healthcare. With pioneering vision, he has lead start-ups and middle-market companies manage ground-up business unit development, go-to-market strategies, marketing strategy, customer experience optimization, brand management, design management, digital modernization, mergers and acquisitions and public deal transactions. |
Jason Carignan
Jason Carignan serves as Chief Commercial Officer at Chemular, Inc, and its affiliated companies, where he spearheads overall business strategy, revenue enhancement, strategic partnerships, and intellectual property management. Formerly, he was President of the Phillips & King and Tobacco Plus Expo (TPE) divisions of Kretek International. He also founded and served as President of Dryft Sciences, which was acquired by British American Tobacco in late-2020. Earlier in his career, Jason founded and led Vapur, an outdoor recreation brand focused on ultra-portable hydration products and Tonic, a leading SoCal-based brand management consultancy.
Throughout his career, Mr. Carignan has helped champion growth and win markets for B2C and B2B companies across diverse industries including consumer products, premium tobacco, alcoholic beverages, outdoor products, manufacturing, technology, hospitality, financial services, wellness and healthcare. With pioneering vision, he has lead start-ups and middle-market companies manage ground-up business unit development, go-to-market strategies, marketing strategy, customer experience optimization, brand management, design management, digital modernization, mergers and acquisitions and public deal transactions.
Stacy Ehrlich
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Stacy Ehrlich draws on 30 years of experience to counsel her clients in the pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device industries with respect to matters involving the FDA, USDA, FTC and other US federal and state agencies. She assisted with drafting the small business provisions of the Family Smoking Prevention and Tobacco Control Act and has been advising clients regarding FDA’s regulation of tobacco and nicotine products for well over a decade. A prolific author and speaker, Stacy is frequently called upon to educate others on topics of food and drug law, including nicotine and tobacco product regulation and enforcement. She has also regularly authored chapters in the Food and Drug Law Institute (FDLI) publications, Food and Drug Law & Regulation, How to Work with the FDA, and Top 20 Food and Drug Cases & Cases to Watch. She has also recently authored the tobacco chapter in the FDLI publication, How FDA Really Works: Insights from the Experts. Stacy has served one term on the Board of Directors of FDLI and two terms on the FDLI Tobacco and Nicotine Products Committee, and has been consistently recognized by The Best Lawyers in America© and Super Lawyers for FDA Law. She received her Juris Doctor from Harvard Law School (cum laude) and her Bachelor of Arts degree in English (magna cum laude) from Emory University. |
Stacy Ehrlich
Stacy Ehrlich draws on 30 years of experience to counsel her clients in the pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device industries with respect to matters involving the FDA, USDA, FTC and other US federal and state agencies. She assisted with drafting the small business provisions of the Family Smoking Prevention and Tobacco Control Act and has been advising clients regarding FDA’s regulation of tobacco and nicotine products for well over a decade. A prolific author and speaker, Stacy is frequently called upon to educate others on topics of food and drug law, including nicotine and tobacco product regulation and enforcement. She has also regularly authored chapters in the Food and Drug Law Institute (FDLI) publications, Food and Drug Law & Regulation, How to Work with the FDA, and Top 20 Food and Drug Cases & Cases to Watch. She has also recently authored the tobacco chapter in the FDLI publication, How FDA Really Works: Insights from the Experts. Stacy has served one term on the Board of Directors of FDLI and two terms on the FDLI Tobacco and Nicotine Products Committee, and has been consistently recognized by The Best Lawyers in America© and Super Lawyers for FDA Law. She received her Juris Doctor from Harvard Law School (cum laude) and her Bachelor of Arts degree in English (magna cum laude) from Emory University.
Tim Phillips
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Tim Phillips is the Managing Director of Tamarind Intelligence, a global independent market and regulatory intelligence service providing data for businesses operating in a number of fast-moving consumer sectors facing regulatory change, including vape, cannabis and tobacco alternatives. Tamarind Intelligence provides market leading insights and regulatory tracking for clients ranging from governments and academic institutions to multinational companies and professional service providers.
Phillips is a UK-qualified attorney, having worked at the European Commission, international law firm Herbert Smith Freehills, media companies BSkyB and AOL, and Betfair (now Flutter Entertainment), where he ran global public affairs 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 Tamarind Intelligence for the past 9 years. |
Tim Phillips
Tim Phillips is the Managing Director of Tamarind Intelligence, a global independent market and regulatory intelligence service providing data for businesses operating in a number of fast-moving consumer sectors facing regulatory change, including vape, cannabis and tobacco alternatives. Tamarind Intelligence provides market leading insights and regulatory tracking for clients ranging from governments and academic institutions to multinational companies and professional service providers.
Phillips is a UK-qualified attorney, having worked at the European Commission, international law firm Herbert Smith Freehills, media companies BSkyB and AOL, and Betfair (now Flutter Entertainment), where he ran global public affairs 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 Tamarind Intelligence for the past 9 years.
Lillian Ortega
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Lillian Ortega has over a decade of expertise in leading strategic and complex compliance and regulatory projects at the Food and Drug Administration. Ms. Ortega’s deep-rooted experience in FDA regulatory processes is not just extensive but current. Her specialization encompasses a broad range of sectors including tobacco products, biologics, and FDA-regulated clinical research.
Ms. Ortega’s understanding of FDA regulatory processes and requirements for tobacco products is based on firsthand experience. Before joining Chemular Inc., she held the pivotal role of Director of Enforcement and Manufacturing at the FDA’s Center for Tobacco Products. This position entrusted her with a breadth of responsibilities, including leading manufacturer compliance and enforcement programs, directing inspection activities, overseeing compliance actions, coordinating tobacco recall operations, and managing import activities. Lillian’s academic foundation is in Microbiology and Public health policy. Her unique blend of experience, both in regulatory oversight and in guiding businesses, enables her to provide invaluable insights. She empowers organizations to not only comprehend but also adeptly navigate the maze of FDA regulatory processes. Her consulting services are designed to position products and operations for optimal success in a highly regulated landscape. |
Lillian Ortega
Lillian Ortega has over a decade of expertise in leading strategic and complex compliance and regulatory projects at the Food and Drug Administration. Ms. Ortega’s deep-rooted experience in FDA regulatory processes is not just extensive but current. Her specialization encompasses a broad range of sectors including tobacco products, biologics, and FDA-regulated clinical research.
Ms. Ortega’s understanding of FDA regulatory processes and requirements for tobacco products is based on firsthand experience. Before joining Chemular Inc., she held the pivotal role of Director of Enforcement and Manufacturing at the FDA’s Center for Tobacco Products. This position entrusted her with a breadth of responsibilities, including leading manufacturer compliance and enforcement programs, directing inspection activities, overseeing compliance actions, coordinating tobacco recall operations, and managing import activities. Lillian’s academic foundation is in Microbiology and Public health policy.
Her unique blend of experience, both in regulatory oversight and in guiding businesses, enables her to provide invaluable insights. She empowers organizations to not only comprehend but also adeptly navigate the maze of FDA regulatory processes. Her consulting services are designed to position products and operations for optimal success in a highly regulated landscape.
Angela Ho-Chen
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Angela Ho-Chen is the founder of FDA Regulatory and Legal Services. Angela received her Bachelor of Arts degree from Emory University, her Master of Public Health in Cancer Epidemiology and Biostatistics and Master of Public Administration from the University of Miami, and her Juris Doctorate from American University.
Angela’s career has spanned nearly 20 years in the medical device and tobacco regulatory arenas. Angela is an attorney and practiced criminal food and drug law as outside counsel prior to transitioning into FDA’s Center for Devices and Radiological Health (CDRH) where she leveraged her Master of Public Health degree to take a role as a Consumer Safety Officer in the Office of Compliance. In her 15 months at CDRH, Angela worked on several task forces and served as an acting case expert. In January 2010, Angela took a Regulatory Counsel position at the Center for Tobacco Products (CTP). Angela was one of the founding members of the Office of Compliance and Enforcement at CTP and left CTP in February of 2017 as Division Regulatory Counsel. She then transitioned into the legal and regulatory departments at Altria Client Services and Juul Labs prior to establishing her own consulting firm. Angela has extensive cross-functional regulatory and legal leadership and project management experience. Her legal and regulatory review portfolio specifically includes pre-market and post-market regulatory submissions strategy and execution, gap analyses, marketing and labeling reviews, inspection/audit readiness, compliance analyses and enforcement mitigation in medical devices and tobacco. Angela has assisted clients with interpreting the Food, Drug, and Cosmetic Act (FDCA), the Family Smoking Prevention and Tobacco Control Act (TCA), their implementing regulations as well as other federal agencies’ statutes. |
Angela Ho-Chen
Angela Ho-Chen is the founder of FDA Regulatory and Legal Services. Angela received her Bachelor of Arts degree from Emory University, her Master of Public Health in Cancer Epidemiology and Biostatistics and Master of Public Administration from the University of Miami, and her Juris Doctorate from American University.
Angela’s career has spanned nearly 20 years in the medical device and tobacco regulatory arenas. Angela is an attorney and practiced criminal food and drug law as outside counsel prior to transitioning into FDA’s Center for Devices and Radiological Health (CDRH) where she leveraged her Master of Public Health degree to take a role as a Consumer Safety Officer in the Office of Compliance. In her 15 months at CDRH, Angela worked on several task forces and served as an acting case expert. In January 2010, Angela took a Regulatory Counsel position at the Center for Tobacco Products (CTP). Angela was one of the founding members of the Office of Compliance and Enforcement at CTP and left CTP in February of 2017 as Division Regulatory Counsel. She then transitioned into the legal and regulatory departments at Altria Client Services and Juul Labs prior to establishing her own consulting firm.
Angela has extensive cross-functional regulatory and legal leadership and project management experience. Her legal and regulatory review portfolio specifically includes pre-market and post-market regulatory submissions strategy and execution, gap analyses, marketing and labeling reviews, inspection/audit readiness, compliance analyses and enforcement mitigation in medical devices and tobacco. Angela has assisted clients with interpreting the Food, Drug, and Cosmetic Act (FDCA), the Family Smoking Prevention and Tobacco Control Act (TCA), their implementing regulations as well as other federal agencies’ statutes.
Agustin E. Rodriguez
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Specializing in tobacco industry regulatory compliance and enforcement matters, Agustin Rodriguez is a Partner in the Regulatory Investigations, Strategy and Enforcement (RISE) practice group of Troutman Pepper Hamilton Sanders LLP. He leverages his extensive background to assist clients based in and outside the US in navigating federal, state, and local regulation of highly regulated consumer products such as tobacco and cannabis. Before joining the firm, Agustin was Vice President and Associate General Counsel at Altria Group, Inc., the largest tobacco company in the United States. Agustin attended Princeton University, Woodrow Wilson School of Public and International Affairs, B.A., 1990 and University of Chicago School of Law, J.D., 1994. He is fluent in Spanish and proficient in Portuguese. For additional information, please click here. |
Agustin E. Rodriguez
Specializing in tobacco industry regulatory compliance and enforcement matters, Agustin Rodriguez is a Partner in the Regulatory Investigations, Strategy and Enforcement (RISE) practice group of Troutman Pepper Hamilton Sanders LLP. He leverages his extensive background to assist clients based in and outside the US in navigating federal, state, and local regulation of highly regulated consumer products such as tobacco and cannabis. Before joining the firm, Agustin was Vice President and Associate General Counsel at Altria Group, Inc., the largest tobacco company in the United States. Agustin attended Princeton University, Woodrow Wilson School of Public and International Affairs, B.A., 1990 and University of Chicago School of Law, J.D., 1994. He is fluent in Spanish and proficient in Portuguese. For additional information, please click here.
Will Woodlee
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Will Woodlee is a partner in the law firm of Kleinfeld, Kaplan & Becker, LLP. His practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco, cannabis/hemp, and consumer product companies on regulatory and advertising law matters. He was included in the2021-2024 editions of Best Lawyers in America under the “FDA Law” category. For 2015-2021, Super Lawyers named Will a “Rising Star” of the Washington, DC, metro area’s “Food & Drugs” bar. Will earned a B.A. from Wake Forest University, graduating magna cum laude, with Honors in English, and as a member of Phi Beta Kappa, and a J.D. from Wake Forest University School of Law, where he served as an Executive Editor for the Wake Forest Law Review. |
Will Woodlee
Will Woodlee is a partner in the law firm of Kleinfeld, Kaplan & Becker, LLP. His practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco, cannabis/hemp, and consumer product companies on regulatory and advertising law matters. He was included in the2021-2024 editions of Best Lawyers in America under the “FDA Law” category. For 2015-2021, Super Lawyers named Will a “Rising Star” of the Washington, DC, metro area’s “Food & Drugs” bar. Will earned a B.A. from Wake Forest University, graduating magna cum laude, with Honors in English, and as a member of Phi Beta Kappa, and a J.D. from Wake Forest University School of Law, where he served as an Executive Editor for the Wake Forest Law Review.
Mike Bond
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Michael Bond is an accomplished healthcare research and testing professional with over 20 years of experience, having held senior positions with three Fortune 500 companies, ThermoFisher, ConMed Canada and Becton Dickinson Canada, prior to joining Labstat/Labs-Mart in the summer of 2020. Mr. Bond attended the University of Western Ontario, where he received an Honours in Biochemistry and Business.
A dynamic leader with a proven track record for developing highly engaged teams, Michael employs his People, Product, Profit maxim to move organizations to exciting new horizons. The heart of Michael’s leadership strategy is based on one important principle: when a company takes proper care of its people, the people take care of the customers, and the customers take care of the business. As a people-first leader, Michael recognizes the individuals within a company are its greatest asset. That’s why the primary focus of his strategy is to attract, develop and engage the right people that will ultimately shape an organization’s future. At Labstat his teams are empowered to continuously enhance, refine, and rethink the company’s solutions and develop future-ready answers to problems the industry hasn’t even thought of yet. Michael realizes that running a fiscally responsible organization creates greater value throughout the corporate ecosystem. A healthy and profitable business creates stronger futures for the organization’s teams, customers, and markets. |
Mike Bond
Michael Bond is an accomplished healthcare research and testing professional with over 20 years of experience, having held senior positions with three Fortune 500 companies, ThermoFisher, ConMed Canada and Becton Dickinson Canada, prior to joining Labstat/Labs-Mart in the summer of 2020. Mr. Bond attended the University of Western Ontario, where he received an Honours in Biochemistry and Business.
A dynamic leader with a proven track record for developing highly engaged teams, Michael employs his People, Product, Profit maxim to move organizations to exciting new horizons. The heart of Michael’s leadership strategy is based on one important principle: when a company takes proper care of its people, the people take care of the customers, and the customers take care of the business.
As a people-first leader, Michael recognizes the individuals within a company are its greatest asset. That’s why the primary focus of his strategy is to attract, develop and engage the right people that will ultimately shape an organization’s future. At Labstat his teams are empowered to continuously enhance, refine, and rethink the company’s solutions and develop future-ready answers to problems the industry hasn’t even thought of yet.
Michael realizes that running a fiscally responsible organization creates greater value throughout the corporate ecosystem. A healthy and profitable business creates stronger futures for the organization’s teams, customers, and markets.
David O'Neill
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David O’Neill born Manchester, the UK and living in Germany since 2008, has nearly 20 years with Imperial Brands having joined direct from Manchester University, Manchester UK.
He has extensive international experience in the nicotine industry, varying from headquarter based brand and insight roles, to regional and market roles in brand and sales leading large teams. In the last 7 years he has been exclusively working in the Next Generation Product sphere leading teams in Germany, a major market for Imperial Brands and in the Northern European region. His current role is General Manager Nordics Cluster and Global Category Director for Oral Nicotine Delivery, and since 2020 he has been driving the growth of Traditional and Modern Oral Nicotine products inside the Nordics countries and Austria with the brands such as KNOX, Skruf and ZONE X, where they are one of the fastest growing companies in the region. His Oral Nicotine category expertise pertains to brand building, strategic portfolio management, new product development pipelines, consumer experience, business development, trends, and foresight. David resides in Hamburg, Germany with his wife and two young daughters. |
David O'Neill
David O’Neill born Manchester, the UK and living in Germany since 2008, has nearly 20 years with Imperial Brands having joined direct from Manchester University, Manchester UK.
He has extensive international experience in the nicotine industry, varying from headquarter based brand and insight roles, to regional and market roles in brand and sales leading large teams.
In the last 7 years he has been exclusively working in the Next Generation Product sphere leading teams in Germany, a major market for Imperial Brands and in the Northern European region.
His current role is General Manager Nordics Cluster and Global Category Director for Oral Nicotine Delivery, and since 2020 he has been driving the growth of Traditional and Modern Oral Nicotine products inside the Nordics countries and Austria with the brands such as KNOX, Skruf and ZONE X, where they are one of the fastest growing companies in the region.
His Oral Nicotine category expertise pertains to brand building, strategic portfolio management, new product development pipelines, consumer experience, business development, trends, and foresight.
David resides in Hamburg, Germany with his wife and two young daughters.
Dr. Jessica Zdinak
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Dr. Jessica Zdinak builds trusted partnerships by providing a unique perspective of behavioral science research principles as it relates to complex business dimensions supporting rigorous, scientific objectives. Eastern Shore Virginia native, Zdinak received her B.S. Psychology from Christopher Newport University followed by an M.S. & Ph.D. in Quantitative Experimental Psychology from Oklahoma State University. While attending OSU, was awarded the Women’s Research Award due to demonstration of exemplary abilities and research contributions. Jessica served as Social Scientist at the National Institutes of Health followed by Director of Applied Research and Evaluation at a consulting firm. Research Program Evaluation responsibilities led to the design of a one-of-a-kind U.S. e-learning curriculum that trained 7,000+ healthcare professionals on the Intimate Partner Violence/Domestic Violence Prevention and Response. Dedicated 5-years within the Federal Government sector leading research evaluation teams with a focus on CDC, NIH, NSF, FDA, and other large-scale grants and projects. Following public health, Dr. Zdinak spent 6-years at Altria where she was 1:3 researchers to develop the Perception & Behavior Program. Served as Lead Principal Scientist for first-ever Perceptions & Behavioral Intentions Study which led to the development and validation of the Intentions to Use Scale, published in a leading scientific journal. Highly-proficient with ITP, PMTA, MRTPA, as well as, product innovation, and future tobacco harm reduction opportunities. Award-winning publisher of foundational research and recognized for her unique research contributions, Zdinak travels worldwide as a keynote speaker to various U.S. and international conferences and forums. In 2015, Dr. Zdinak launched Applied Research and Analysis Company LLC as Owner and Chief Research Officer. Internal team of psychologists, statisticians, and behavioral scientists offer tailored services of unbiased integrity and exceptional client experience for government, education, business, and nicotine and tobacco harm reduction industry. |
Dr. Jessica Zdinak
Dr. Jessica Zdinak builds trusted partnerships by providing a unique perspective of behavioral science research principles as it relates to complex business dimensions supporting rigorous, scientific objectives.
Eastern Shore Virginia native, Zdinak received her B.S. Psychology from Christopher Newport University followed by an M.S. & Ph.D. in Quantitative Experimental Psychology from Oklahoma State University. While attending OSU, was awarded the Women’s Research Award due to demonstration of exemplary abilities and research contributions.
Jessica served as Social Scientist at the National Institutes of Health followed by Director of Applied Research and Evaluation at a consulting firm. Research Program Evaluation responsibilities led to the design of a one-of-a-kind U.S. e-learning curriculum that trained 7,000+ healthcare professionals on the Intimate Partner Violence/Domestic Violence Prevention and Response. Dedicated 5-years within the Federal Government sector leading research evaluation teams with a focus on CDC, NIH, NSF, FDA, and other large-scale grants and projects.
Following public health, Dr. Zdinak spent 6-years at Altria where she was 1:3 researchers to develop the Perception & Behavior Program. Served as Lead Principal Scientist for first-ever Perceptions & Behavioral Intentions Study which led to the development and validation of the Intentions to Use Scale, published in a leading scientific journal. Highly-proficient with ITP, PMTA, MRTPA, as well as, product innovation, and future tobacco harm reduction opportunities.
Award-winning publisher of foundational research and recognized for her unique research contributions, Zdinak travels worldwide as a keynote speaker to various U.S. and international conferences and forums.
In 2015, Dr. Zdinak launched Applied Research and Analysis Company LLC as Owner and Chief Research Officer. Internal team of psychologists, statisticians, and behavioral scientists offer tailored services of unbiased integrity and exceptional client experience for government, education, business, and nicotine and tobacco harm reduction industry.
Henry Sicignano
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Henry Sicignano, III, is an accomplished executive with a 25-year track record leading companies that provide adult smokers with better alternatives to conventional combustible cigarettes. Mr. Sicignano currently serves as the President of Charlie’s Holdings, Inc. (OTCQB: CHUC), an industry leader in the premium vapor products space. Charlie’s has received FDA acceptance filings for more than 500 Premarket Tobacco Product Applications (PMTAs) for the Company’s conventional products. This year Charlie’s launched SPREE BAR™, a flavored disposable pod system that features nicotine substitute Metatine™ and is not subject to FDA PMTA review.
Previously, Mr. Sicignano served as President and CEO of 22nd Century Group, Inc. (NASDAQ: XXII), a plant biotechnology company with more than 200 issued patents on the genes in the tobacco plant that regulate nicotine production. Mr. Sicignano assembled scientific and regulatory teams to develop Very Low Nicotine (VLN) cigarettes with at least 95% less nicotine than any of the 100 leading cigarette brands in the US. In December 2021 the FDA deemed 22nd Century’s VLN brand cigarettes the world’s first – and only – modified risk cigarettes. Previously, Mr. Sicignano built the super-premium consumer brand Natural American Spirit and sold the parent company to RJ Reynolds for $356 million in 2002. Mr. Sicignano currently serves as Chairman of the Audit Committee for Kartoon Studios (NYSE American: TOON) and also as a board member of Greenwave Technology Solutions, Inc. (Nasdaq: GWAV). He served on the Board of Directors of Anandia Laboratories, Inc., a cannabis-focused science company, from December 2014 until the company was sold in 2018 to Aurora Cannabis (NYSE: ACB). Mr. Sicignano holds a B.A. degree from Harvard College and an M.B.A. degree from Harvard University. |
Henry Sicignano
Henry Sicignano, III, is an accomplished executive with a 25-year track record leading companies that provide adult smokers with better alternatives to conventional combustible cigarettes. Mr. Sicignano currently serves as the President of Charlie’s Holdings, Inc. (OTCQB: CHUC), an industry leader in the premium vapor products space. Charlie’s has received FDA acceptance filings for more than 500 Premarket Tobacco Product Applications (PMTAs) for the Company’s conventional products. This year Charlie’s launched SPREE BAR™, a flavored disposable pod system that features nicotine substitute Metatine™ and is not subject to FDA PMTA review.
Previously, Mr. Sicignano served as President and CEO of 22nd Century Group, Inc. (NASDAQ: XXII), a plant biotechnology company with more than 200 issued patents on the genes in the tobacco plant that regulate nicotine production. Mr. Sicignano assembled scientific and regulatory teams to develop Very Low Nicotine (VLN) cigarettes with at least 95% less nicotine than any of the 100 leading cigarette brands in the US. In December 2021 the FDA deemed 22nd Century’s VLN brand cigarettes the world’s first – and only – modified risk cigarettes.
Previously, Mr. Sicignano built the super-premium consumer brand Natural American Spirit and sold the parent company to RJ Reynolds for $356 million in 2002.
Mr. Sicignano currently serves as Chairman of the Audit Committee for Kartoon Studios (NYSE American: TOON) and also as a board member of Greenwave Technology Solutions, Inc. (Nasdaq: GWAV). He served on the Board of Directors of Anandia Laboratories, Inc., a cannabis-focused science company, from December 2014 until the company was sold in 2018 to Aurora Cannabis (NYSE: ACB). Mr. Sicignano holds a B.A. degree from Harvard College and an M.B.A. degree from Harvard University.
Bonnie Coffa
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Bonnie G. Coffa, PhD, DABT
Regulatory Toxicology Consultant – Chemular / Scientific Director Toxicology – Labstat Consultant Bonnie is a Regulatory Toxicologist at Chemular specializing in ingredient and product risk assessments, in vitro regulatory assays for product stewardship testing, and regulatory applications for tobacco-, nicotine- and cannabinoid-containing products. She is also a consultant for Labstat in the role of Scientific Director Toxicology. She has over a decade of experience in tobacco and nicotine regulatory testing, FDA applications and scientific communication. Bonnie has been a consultant for the past 5 years and previously was the Business Development Manager at Enthalpy Analytical, a nicotine and cannabis contract testing laboratory. Prior to that role, Bonnie was a Principal Scientist at Altria Client Services, where she managed e-vapor in vitro toxicology testing, authored non-clinical sections of Premarket Tobacco Product Applications and literature reviews on several topics including health effects of nicotine, potential reinforcing effects of tobacco minor alkaloids, very low nicotine and non-clinical toxicology of nicotine containing products. Bonnie received her PhD in Pharmacology from Vanderbilt University, where she studied the involvement of dopamine systems in neuropsychiatric disorders, including schizophrenia and Parkinson’s Disease using a variety of approaches, ranging from neuroanatomical to pharmacological. She completed postdoctoral training in tobacco regulatory science at Altria Client Services. |
Bonnie Coffa
Bonnie G. Coffa, PhD, DABT
Regulatory Toxicology Consultant – Chemular / Scientific Director Toxicology – Labstat Consultant
Bonnie is a Regulatory Toxicologist at Chemular specializing in ingredient and product risk assessments, in vitro regulatory assays for product stewardship testing, and regulatory applications for tobacco-, nicotine- and cannabinoid-containing products. She is also a consultant for Labstat in the role of Scientific Director Toxicology.
She has over a decade of experience in tobacco and nicotine regulatory testing, FDA applications and scientific communication. Bonnie has been a consultant for the past 5 years and previously was the Business Development Manager at Enthalpy Analytical, a nicotine and cannabis contract testing laboratory. Prior to that role, Bonnie was a Principal Scientist at Altria Client Services, where she managed e-vapor in vitro toxicology testing, authored non-clinical sections of Premarket Tobacco Product Applications and literature reviews on several topics including health effects of nicotine, potential reinforcing effects of tobacco minor alkaloids, very low nicotine and non-clinical toxicology of nicotine containing products.
Bonnie received her PhD in Pharmacology from Vanderbilt University, where she studied the involvement of dopamine systems in neuropsychiatric disorders, including schizophrenia and Parkinson’s Disease using a variety of approaches, ranging from neuroanatomical to pharmacological. She completed postdoctoral training in tobacco regulatory science at Altria Client Services.
Bryan Burd
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Bryan brings 20 years of practical experience to Chemular, including small business owner, product marketing, production, and finance across multiple industries. Bryan has extensive experience with world-wide regulatory compliance for the Tobacco industry, starting with the Tobacco Products Directive (TPD) in Europe in 2015, and continuing on with US market. He has been involved in all aspects of PMTA submissions, as well as other US Tobacco regulatory needs. |
Bryan Burd
Bryan brings 20 years of practical experience to Chemular, including small business owner, product marketing, production, and finance across multiple industries. Bryan has extensive experience with world-wide regulatory compliance for the Tobacco industry, starting with the Tobacco Products Directive (TPD) in Europe in 2015, and continuing on with US market. He has been involved in all aspects of PMTA submissions, as well as other US Tobacco regulatory needs.
Charlie Minato
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Charlie Minato is a co-founder and editor at halfwheel.com, a blog dedicated to writing about the premium cigar industry on a daily basis. He has written extensively about FDA’s Deeming Regulations and their impact on the premium cigar industry. For more than a decade, his reporting and commentary on the cigar market has been a daily read for those working in the cigar industry and passionate cigar smokers around the world. Charlie graduated from Wake Forest with a B.A. in history. In his free time, he enjoys playing tennis and watching college football. |
Charlie Minato
Charlie Minato is a co-founder and editor at halfwheel.com, a blog dedicated to writing about the premium cigar industry on a daily basis. He has written extensively about FDA’s Deeming Regulations and their impact on the premium cigar industry. For more than a decade, his reporting and commentary on the cigar market has been a daily read for those working in the cigar industry and passionate cigar smokers around the world. Charlie graduated from Wake Forest with a B.A. in history. In his free time, he enjoys playing tennis and watching college football.
Terry Gallagher
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Terry Gallagher, Jr. began his career in the family business, Gasamat Oil Corp. of Colorado (GOCC), in 1984 and was a Founder and President of The Cigarette Store Corp. (TCSC) which incorporated in 1991. In 2003 the retail operations of GOCC merged into TCSC and the company now operates 290 Smoker Friendly, Tobacco Depot and Smoke N Go tobacco, fuel and liquor stores in 13 states.
Terry sits on the Board of Directors of TCS Inc., NACS, Tobacco Merchants Association (TMA), Cigar Association of America (CAA), Tobacconist Association of America (TAA) and previously was a director with the Colorado Association of Distributors (CAD) and the Premium Cigar Association (PCA). He is a member of the Colorado/Wyoming Petroleum Marketers Association (CWPMA), Society of Independent Gasoline Marketers of America (SIGMA), National Association of Convenience Stores (NACS), National Association of Tobacco Outlets (NATO), PCA, Tobacconist Association of America (TAA), TMA and formerly was seated on the Advisory Councils of Philip Morris US, Altadis US and Scandinavian Tobacco Group. Previously, he served as President of the Denver Oilmen’s Club, Treasurer of the Colorado Promotion Association and the Board of Directors for Always Buy Colorado. Terry is a 1983 graduate of the University of Colorado, Leeds School of Business. He is a native of Boulder, Colorado, where he lives with his wife, Windy. They have 3 sons and two grandsons and two granddaughters. |
Terry Gallagher
Terry Gallagher, Jr. began his career in the family business, Gasamat Oil Corp. of Colorado (GOCC), in 1984 and was a Founder and President of The Cigarette Store Corp. (TCSC) which incorporated in 1991. In 2003 the retail operations of GOCC merged into TCSC and the company now operates 290 Smoker Friendly, Tobacco Depot and Smoke N Go tobacco, fuel and liquor stores in 13 states.
Terry sits on the Board of Directors of TCS Inc., NACS, Tobacco Merchants Association (TMA), Cigar Association of America (CAA), Tobacconist Association of America (TAA) and previously was a director with the Colorado Association of Distributors (CAD) and the Premium Cigar Association (PCA). He is a member of the Colorado/Wyoming Petroleum Marketers Association (CWPMA), Society of Independent Gasoline Marketers of America (SIGMA), National Association of Convenience Stores (NACS), National Association of Tobacco Outlets (NATO), PCA, Tobacconist Association of America (TAA), TMA and formerly was seated on the Advisory Councils of Philip Morris US, Altadis US and Scandinavian Tobacco Group. Previously, he served as President of the Denver Oilmen’s Club, Treasurer of the Colorado Promotion Association and the Board of Directors for Always Buy Colorado.
Terry is a 1983 graduate of the University of Colorado, Leeds School of Business. He is a native of Boulder, Colorado, where he lives with his wife, Windy. They have 3 sons and two grandsons and two granddaughters.