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.

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.

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.

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.

Sonny serves as the Regulatory Science Integration Director for Japan Tobacco International. Sonny joined JTI in 2020 and is responsible for the implementation and refinement of the JTI Regulatory Science Strategy, including the continuous review of the evolving global RRP regulatory landscape and overall regulatory trends.

Prior to joining JTI, Sonny spent over 10 years with British American Tobacco in charge of a conventional-type RRP development as scientist who covered multiple fields, such as leaf, smoke emission and human exposure. After leaving BAT, Sonny worked across global organizations and provided strategic direction for the efficient rollout of RRP into heavily regulated markets. Sonny oversees the studies being conducted for the joint venture between the JT Group and Altria Group, to commercialize Ploom® in the U.S. market.

He received his BS in Pharmacology from University College London, MS in Biomedical Sciences Research from Kings’ College London University and Ph.D. in Pulmonary Physiology from the University of Sheffield.

Joshua Karelitz, PhD is a Principal Regulatory Scientist II, Regulatory Affairs for Altria Client Services. In this role he leads abuse liability assessment and oversees design and conduct of studies in support of Premarket Tobacco Application and Modified Risk Tobacco Product Application submissions to the Food and Drug Administration.

Prior to joining Altria, Dr. Karelitz was a Postdoctoral Scholar in the Division of Cancer Control and Population Sciences at the University of Pittsburgh. During his postdoctoral and graduate training, Dr. Karelitz’s research focused on sensory perceptions and reinforcement of reduced nicotine content cigarettes and heated tobacco products. He has authored and co-authored over fifty peer-reviewed publications on tobacco product use behavior and has presented his research domestically and internationally.

Derek Yach is a global public health leader with deep experience based on years of work for WHO, leading corporations including PepsiCo, investment funds, academia (as Professor of Global Health at Yale), and not-for-profit organizations such as the Rockefeller and Smoke Free Foundations. His focus in these diverse settings has been to lead initiatives with impact on chronic diseases and their risks, and on mental health. Looking forward, he believes that governments, industry and investors need to give far greater focus to the health of adults as the pandemic recedes if we are to build more resilient and productive populations. He has focused on ways to implement harm reduction strategies within the context of substance abuse, tobacco control and food and nutrition policy. He has degrees in medicine and public health.

Lillian Ortega is the Owner and Chief Regulatory Compliance Strategist at WOW Solutions LLC, a consulting firm dedicated to guiding businesses through the complexities of FDA regulatory processes. With over a decade of distinguished service at the Food and Drug Administration, Lillian has extensive experience leading strategic and complex compliance and regulatory projects. Her expertise spans a broad range of sectors, including tobacco products, biologics, and FDA-regulated clinical research.

Before founding WOW Solutions, Lillian served as the Director of Enforcement and Manufacturing at the FDA’s Center for Tobacco Products. In this pivotal role, she led manufacturer compliance and enforcement programs, directed inspection activities, oversaw compliance actions, coordinated tobacco recall operations, and managed import activities.

Lillian’s academic background in Microbiology and Public Health Policy complements her professional experience, enabling her to deliver invaluable insights to her clients. Her unique blend of regulatory oversight and business acumen empowers organizations to successfully navigate the FDA regulatory landscape. Through WOW Solutions, she provides tailored consulting services to position products and operations for success in a highly regulated environment.

Guy Bentley is the director of consumer freedom at Reason Foundation. Bentley's research focuses on the taxation and regulation of nicotine, gambling, alcohol, and food. Bentley's work has been featured in The Washington Post, USA Today, The New York Post, and other publications in the U.S. and U.K.

Before joining Reason Foundation, Bentley served as a reporter in London and Washington, D.C.

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.

Ivan is the Consulting Director for the Consumer division at GlobalData. With over 15 years of combined industry and consulting experience, he has led strategic growth projects in consumer sectors in 30+ countries. Prior to working for GlobalData he worked for Canback Consulting, the consumer division at The Economist Group, and Euromonitor. Ivan holds a BS in Economics (Cum Laude) from Boston University, and an MBA (Cum Laude) from the University of Notre Dame. Born and raised in Argentina, but a Chicago resident for over a decade, Ivan is fully bilingual in both English and Spanish.

Tony Abboud is an attorney and government affairs expert who represents companies in the tobacco and vapor space and who serves as the Executive Director of the Vapor Technology Association (VTA) – the U.S. based trade association representing the vapor industry. Abboud was instrumental in founding, growing and leading this important national trade organization, which advocates for rational science-based regulations that will enable a diverse and robust nicotine products industry to thrive as well as promoting tobacco harm reduction policies. Abboud has extensive experience in law, public policy, government and politics. He has represented companies on legal and regulatory issues for more than 25 years, and has advised and consulted with companies in the tobacco and vapor industries on regulatory issues for more than a decade. Among many other things, as the Executive Director of VTA, he crafted VTA’s successful multi-faceted strategic campaign to stop President Trump’s vapor-only full flavor ban from being enacted in 2020. In his work as a state lobbyist, Abboud developed and implemented successful strategies for companies facing simultaneous multi-state legislative challenges in the vapor industry and in the tobacco industry. Abboud is recognized as a leading voice for essential regulations and a balanced discussion of vapor products. He is a frequent speaker at national symposiums and has been extensively quoted in the media, including national print, television and radio.

Abboud left the international law firm Greenberg Traurig, LLP in 2010 to found his consulting firm, Strategic Government Solutions, which focuses on companies and associations in heavily regulated industries, including the tobacco and vapor industries. He has a unique blend of grassroots organizing, political campaign, governmental service, private sector representation and legal experiences to draw on when crafting effective lobbying and communications strategies. Tony lives near Chicago with his wife, a former Cook County prosecutor, and their three children. Tony earned his B.A. in Political Science from Carleton College in 1988 and his J.D. with distinction from the University of Iowa College of Law in 1994.

Dr. Charlene Liu is a renowned expert in regulatory strategy development and nonclinical studies for tobacco harm reduction products. She brings nearly a decade of leadership experience in toxicology and risk assessment at R.J. Reynolds, JUUL Labs, and RELX International. With nearly 20 years of prior experience in human health risk assessment at Environmental Protection Agency Superfund sites, Dr. Liu was a pioneer in applying quantitative risk assessment (QRA) to evaluate the relative health risks of tobacco harm reduction products over a decade ago. She has successfully developed and applied QRA methodologies for PMTAs and substantial equivalence filings. Her work has influenced the FDA to adopt QRA as a key component in evaluating toxicological risk in ENDS PMTA for regulatory decisions on APPH.
In 2023, Dr. Liu founded Riskwise Solution, a consulting firm providing expertise in nonclinical science, including chemical characterization, stability, toxicology, and risk assessment, to help clients navigate the evolving PMTA regulatory landscape.

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.

Andrew gained his PhD in physics in 2008.  Since then he has been involved in numerous start-ups commercialising and bringing to market innovative technical solutions.  He joined Innovative Technology in 2019 where he heads up their Biometrics Division developing age and identity verification technology ICU Lite, MyCheckr and MyCheckrMini. These devices are now widely used across tobacco, retail and gaming to help control underage access to age restricted products and services. 

John Patterson is President of IKE Tech, a leading provider of identity verification (IDV), biometric authentication, and tokenization technology across a range of everyday consumer products.  A passionate champion of Tobacco Harm Reduction, John has spent the last decade leading programs for some of the biggest brands in vapour technology including NJOY, JUUL and Aspire. As current Head of IKE Tech LLC, he is steering the organisation's focus on solving some of the biggest industry challenges by utilizing innovative solutions to address youth access and illicit products.

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.

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.

George Hardie, Executive Director of Tobacco Harm Reduction Research, has over 38 years of experience in Inhalation Toxicology and clinical research. George has an MSc in Applied Toxicology. He possesses extensive knowledge of respiratory disease and tobacco harm reduction. Previously, George served as the head of clinical research for a major tobacco company and has authored/co-authored over 20 peer-reviewed papers on tobacco harm reduction.

Neil Sherwood has a degree in Experimental Psychology from the University of Oxford and a Ph.D. in Psychopharmacology from the University of Leeds. After a period in academic research, he joined Novartis Pharma AG as a clinical pharmacologist, and then Japan Tobacco International in 2001 where he oversaw clinical and behavioural research programs. Since 2016 he has acted as a consultant on scientific and regulatory issues. In addition to publishing several studies and reviews, he has been an active member of the CORESTA organisation and currently serves on the Tobacco Harm Reduction committee.

Claudia Kanitscheider, has over 15 years of leadership experience and scientific expertise in behavioural research working at a well renowned CRO. Claudia has focused on the potential of various new nicotine and tobacco harm reduction products in multiple study types that supports industry regulatory requirements. Claudia is a highly respected behavioural scientist and has collaborated with multiple major tobacco companies.

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.

Agustin Rodriguez is a seasoned business partner at Troutman Pepper Locke with extensive experience in guiding clients through complex regulatory landscapes in industries such as tobacco, cannabis, and gambling. As a partner in the firm's Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and its Tobacco + Nicotine and Cannabis law practices, he provides strategic counsel on complex regulatory compliance issues, including licensing, taxation, marketing, and advertising.

Before joining the firm, Agustin served as Vice President and Associate General Counsel at Altria Group, Inc., where he managed compliance, corporate governance, litigation, and transactional matters globally. Fluent in Spanish and proficient in Portuguese, Agustin has developed compliance programs across Europe, Latin America, Asia, and Africa, addressing risks related to antitrust, anticorruption, the FCPA, and corporate social responsibility.

Bryan Haynes is an experienced attorney at Troutman Pepper Locke, specializing in regulatory compliance and enforcement within the tobacco industry. As a key member of the firm's Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and head of the Tobacco + Nicotine practice, he adeptly assists clients in navigating complex regulatory landscapes. Bryan's expertise spans FDA requirements, tobacco taxation, and administrative disputes. He has been instrumental in advising on the Family Smoking Prevention and Tobacco Control Act and the FDA's deeming rule. A skilled litigator, Bryan has successfully represented clients in state and federal courts, ensuring compliance and mitigating risks aligned with business objectives. His comprehensive knowledge and strategic approach make him an invaluable asset to tobacco manufacturers, distributors, retailers, and suppliers.

Azim Chowdhury, a partner with the law firm of Keller and Heckman LLP, counsels domestic and foreign corporations on U.S. Food and Drug Administration (FDA) and international regulatory compliance matters and on tobacco and e-vapor product regulation.

Mr. Chowdhury advises corporations in establishing clearances for food and drug additives in the U.S., Canada, and European Union, with an emphasis on indirect additives used in drug and food-contact materials. He has expertise in the tobacco and e-vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act and spearheads the FDA Tobacco and Electronic Cigarette practice at Keller and Heckman LLP. 

Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance. He represents clients on tobacco, e-cigarette and e-liquid matters before the FDA and the Consumer Product Safety Commission (CPSC). He is also a frequent contributor to the Food and Drug Law Institute (FDLI) Update Magazine, has served on the Editorial Advisory Board of the Food and Drug Law Journal, and edited and co-authored FDLI’s recent publications, Tobacco Regulation and Compliance: An Essential Resource and FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer. Mr. Chowdhury is a frequent speaker and author.

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.

Dr. Meinhart is a strategic technology advisor to Greentank and a professor of Mechanical Engineering at the University of California – Santa Barbara. He completed his PhD and Postdoctoral work at the University of Illinois in 1995. Since moving to UC-Santa Barbara in 1996, his research has focused on developing microfluidic devices and exploring their fundamental transport mechanisms. Dr. Meinhart is a fellow of the American Physical Society and has co-authored over 160 publications

In 2012, Dr. Meinhart founded Numerical Design, a company with expertise in microfluidics and microfabrication. Numerical Design pioneered the application of microfluidic-based chips for vaporizer cores. Dr. Meinhart served as CEO of Numerical Design until it was acquired by Greentank in 2023.

Since joining Greentank, Dr Meinhart advises on research and development of Greentank’s advanced heating chip technology. His expertise is pushing the boundaries of the chip and its potential applications within the inhaled delivery vertical.

Dr. Roxana Weil leads the Business Development and Scientific Engagement team and serves as Chief Regulatory Science Officer for McKinney Specialty Labs. Roxana holds a PhD in Pharmacology and Physiology from the University of Florida, a MSc and BSc in Biology from University of Waterloo, Canada. She is a Diplomate of the American Board of Toxicology (DABT) with specialized expertise in human health risk assessment and toxicology, and extensive experience spanning across U.S. FDA and Global Regulatory Strategy, Organizational Development, Risk Management and Tobacco Regulatory Science and Policy. Prior to joining McKinney Specialty Labs, Roxana successfully lead and implemented JUUL Lab Inc.’s Product Integrity function and Toxicology programs, and served as a Lead Toxicologist at the U.S. FDA Center for Tobacco Products (CTP) where she was responsible for leading an interdisciplinary team of scientists, providing science-policy recommendations and developing the scientific basis to support regulations, guidance and review of tobacco product applications via all regulatory pathways.

Dr. Sarah Baxter-Wright serves as the Vice President, US Life Sciences for Reynolds American (Reynolds), a wholly owned subsidiary of British American Tobacco. In this role, she leads a team responsible for analytical testing, clinical studies, population health, consumer behavior, and statistics as part of Scientific Research & Development.

Dr. Baxter holds a Ph.D. in Biochemistry from Vanderbilt University, Nashville, TN, with training in biomarkers and systems biology, focusing on proteomics and metabolomics. Since joining Reynolds in 2016, Dr. Baxter has held positions including Senior Director of Clinical Studies, Vice President-Scientific and Regulatory Affairs, Head of Analytical and Preclinical Sciences, and Head of Clinical and Behavioral Sciences. Prior to joining Reynolds, Dr. Baxter held scientific research positions in several organizations focusing on cancer research, agriculture, health and nutrition, pharmaceutical testing, and biodefense.

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.

David is a leading regulatory expert in nicotine-containing products, with over 15 years of experience across the pharmaceutical and tobacco sectors. He played a pivotal role in the approval of e-VOKE, the world’s first medically licensed e-cigarette, and has since been instrumental in shaping regulatory strategies for next-generation nicotine products.

David’s cross-sector expertise spans product development, toxicological assessment, and global regulatory compliance, with a focus on supporting manufacturers through complex submissions such as Premarket Tobacco Product Applications (PMTAs). His multidisciplinary background enables him to bridge scientific, legal, and commercial perspectives in regulatory decision-making.

David holds a BSc. (Hons) in Biochemistry, an LLB in Law, and a Master of Business Administration (MBA). He is a qualified medical toxicologist and a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA).

Owner & Principal Consultant, QualReg Solutions LLC
Former Director of FDA Regulatory Quality Compliance, JUUL Labs
Former FDA Director & Investigator, Office of Regulatory Affairs (ORA), U.S. FDA

Gabriel Muniz is the Owner and Principal Consultant at QualReg Solutions LLC, where he advises tobacco and ENDS manufacturers on regulatory compliance, quality systems, and FDA readiness. With over 15 years of experience spanning federal oversight and private industry leadership, Gabriel offers a uniquely integrated perspective on compliance strategy and operational excellence.

Prior to founding QualReg Solutions, Gabriel held multiple leadership roles at JUUL Labs, including Director of Regulatory Compliance and Quality Systems, where he led ISO certification efforts, managed global supplier quality, and directed eQMS implementations. He was instrumental in building the company's audit and inspection readiness framework and regulatory submission infrastructure.

Gabriel also served as an Investigator and Director at the U.S. Food and Drug Administration (FDA), where he was the first to lead the Tobacco Operations Staff within the Office of Regulatory Affairs. There, he developed nationwide enforcement strategy, oversaw high-impact inspections, and coordinated regulatory responses tied to the Family Smoking Prevention and Tobacco Control Act.

Gabriel’s expertise spans tobacco, medical devices, biologics, and food safety. He is known for his ability to translate complex regulations into actionable strategies, helping clients achieve both legal compliance and business continuity. From quality systems and document control to supplier audits and FDA communication, Gabriel is a trusted advisor for companies navigating the evolving nicotine delivery landscape.

Melis Coraggio is a Consultant in the FDA & Life Science practice group at King & Spalding LLP. She works closely with clients in navigating the pre-market tobacco product application and review processes and advises in the tobacco and nicotine space, including pre-market tobacco product applications (PMTAs), Substantial Equivalence Reports (SEs), Exemption Requests (EXRs), and provides strategies to assist in facilitating stakeholder engagement.

Prior to King & Spalding, Melis was a Regulatory Review Scientist at FDA’s Center for Tobacco Products’ Office of Science from 2015-2023 where she held roles as a Regulatory Health Project Manager and, primarily, as a Chemistry Reviewer. During that time, she was instrumental in drafting the Center’s first published Product Standard to limit the quantity of nicotine in cigarettes and certain other combusted tobacco products. Among her accomplishments, she was involved in drafting of the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products” Guidance which she presented at 2022 Tobacco Science Research Conference to industry and other tobacco stakeholders as well as served on the Q&A panel.

Before joining the tobacco and nicotine space, Melis spent nine years as a Scientific Researcher at Genentech, Inc.’s Division of Drug Metabolism and Pharmacokinetics performing analytical method development, method validation, and quantitative bioanalysis of small molecule pharmaceuticals for drug discovery and development. During her tenure, she specialized in beta testing of new mass spectrometry instrumentation in collaboration with Thermo Fisher Scientific and presented data at various stakeholder meetings.

Melis holds a Master of Science in Biotechnology with a focus in Molecular Biology from Northeastern University and a Bachelor of Science in Biochemistry with a minor in Biological Sciences from the University of Delaware.

David Oliveira is a consultant specializing in government and regulatory affairs. He most recently served as Deputy Director of the Stakeholder Relations Office in the Office of the Center Director, at the Center for Tobacco Products at the FDA. Prior to that, he held two different supervisory positions within the USDA. He also spent over 10 years in the private sector as a government affairs professional where he represented numerous colleges and hospitals, businesses, state agencies, municipalities, and other non-profits. He also worked in the US Congress for seven years, as a staffer in both the House and Senate. He is a graduate of the University of Connecticut School of Law, and of the University of Massachusetts at Amherst.

Matt Fields is the Vice President of AgeChecker.Net, a leading provider of online age verification solutions for retail and ecommerce businesses. Based in Westlake Village, California, Fields has played a pivotal role in developing and scaling the company’s technology to help retailers comply with age-restricted sales laws while enhancing user experience and data security.

Fields has also emphasized the importance of regulatory compliance and social responsibility in ecommerce. He highlighted the company's commitment to replacing outdated “age gate” methods with real-time verification using public records and secure ID uploads, ensuring that businesses avoid underage sales without disrupting the customer experience.

With a focus on innovation and adaptability, Fields continues to lead AgeChecker.Net in expanding its integrations across ecommerce platforms and enhancing its fraud prevention capabilities, positioning the company as a trusted partner in the rapidly evolving landscape of online age-restricted commerce.

Sarah has broad experience serving pharma, medical device, and consumer products industries, with a focus on integrating science, quality processes, and business goals in a regulated environment. She has a proven ability to develop resilient, cross-functional teams and champion complex projects across diverse groups of stakeholders. Sarah specializes in helping clients develop and successfully execute strategies to access the U.S. market.

Sarah works closely with clients to plan and submit premarket tobacco product applications (PMTAs) and modified risk tobacco product applications (MRTPAs) across various nicotine product categories, including novel, emerging delivery systems. She combines her extensive industry experience, scientific expertise, and business acumen to navigate the rapidly evolving regulatory landscape and provide practical solutions to regulatory challenges. Sarah supports regulatory strategy across all scientific areas including product design and development, manufacturing, and nonclinical and clinical study programs.

She specializes in helping clients create and navigate multi-product regulatory strategies and product line extensions. These strategies leverage existing scientific evidence through use of supplemental PMTAs (sPMTAs) and tobacco product master files (TPMFs) to minimize regulatory costs and timelines. She also supports preparation for Tobacco Products Scientific Advisory Committee (TPSAC) meetings.