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

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

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

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

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

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

Angela Ho-Chen is currently a Managing Counsel at RAI 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, FDA Regulatory and Legal Services, PLLC.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

CEO, Chief  Executive Officer

At Haypp Group since September 2017.

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

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

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

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

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

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

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

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

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.

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

Dr. Willie McKinney is an established regulatory and inhalation toxicology expert with over two decades of research, product development, and regulatory strategy experience in the Consumer-Packaged Goods industry. As the founder and CEO of McKinney Regulatory Science Advisors, LLC, he leverages his extensive background, including his previous role on the FDA’s Tobacco Product Scientific Advisory Committee and his past position as Vice President of Regulatory Sciences at Altria, to guide clients through multiple constantly evolving regulatory landscapes.

Dr. McKinney’s knowledge and experience are widely respected. He holds a Ph.D. in Environmental Toxicology from the University of North Carolina School of Public Health and is certified by the American Board of Toxicology. He launched McKinney Specialty Labs, LLC in January 2024 to offer specialized aerosol testing services as well as chemical and GLP toxicology analysis.

Together, McKinney Regulatory Science Advisors, LLC, and the newly established lab provide over 25 years of combined expertise in regulatory strategy, application filing, and product testing. This suite of services is customized to meet the unique needs of each client, guaranteeing integrity and quality at every step. Dr. McKinney’s leadership remains instrumental in driving scientific research and regulatory compliance forward.

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

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

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

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

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

Representative Matters

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

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

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

Memberships

American Bar Association (ABA)

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

Awards

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

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

Education

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

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

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

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

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

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.

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

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

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

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

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.

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

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

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

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

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

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

TrinityTech significantly expanded its global presence and consistently achieved revenue growth

exceeding 70% year over year.

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

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

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

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

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

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

President of Sales and Support.

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

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

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

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

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

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

regulated organizations.

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

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

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

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