Cristi Stark serves in the role of Associate Director for the Office of Science (OS) within the Center for Tobacco Products (CTP), at the Food and Drug Administration (FDA). In this capacity, she focuses on application review management as well as leading high-priority cross-cutting regulatory and policy efforts. Cristi has over two decades of regulatory experience at FDA and has been with CTP since 2009. Within her time at CTP, Cristi has assisted with the establishment of TPSAC, served as the first TPSAC DFO, assisted with development and implementation of all premarket (PMTA, SE, EX REQ) and modified risk pathways, aided in establishment and reporting of performance metrics, served as a regulatory health project manager, Associate Director for Science Policy in OS, and more recently as the Director for the Division of Regulatory Project Management in OS. Prior to CTP she worked in two other FDA Centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Prior to FDA, she worked as a biologist for the National Cancer Institute. Cristi received her B.S. from the University of Maryland at College Park, and her M.S. from Johns Hopkins University.

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.

Benjamin Apelberg, Ph.D. is currently the Deputy Director for Regulatory Science in the Office of Science of CTP.  Dr. Apelberg has held numerous roles since joining CTP in 2010, including as the Director of the Division of Population Health Science and Chief of the Epidemiology Branch. Prior to joining FDA, Dr. Apelberg was a faculty member at the Johns Hopkins Bloomberg School of Public Health, where he also received his Ph.D. in Epidemiology.

Erin Seder Warren is a distinguished regulatory and public policy leader with deep expertise in tobacco harm reduction and life sciences. She currently leads efforts focused on advancing smoke-free alternatives, grounded in rigorous scientific evidence and public health impact, for Philip Morris International in the United States as the External Affairs, Head of Regulatory and Public Policy.

Throughout her career, Erin has held significant legal and policy leadership positions across the tobacco, nicotine, and cannabis sectors. Her work has shaped regulatory strategy, guided product innovation, and influenced legislative and agency engagement at the highest levels. She is known for her ability to navigate complex regulatory environments, mitigate business risk, and drive cross-functional collaboration in support of consumer safety and corporate integrity.

Erin’s approach is defined by strategic foresight, evidence-based advocacy, and a commitment to transparent stakeholder engagement. She has led initiatives addressing youth access prevention, product integrity, and regulatory compliance, and has been a trusted advisor during high-profile enforcement actions and public health debates.

A graduate of the University of Richmond School of Law and the University of Maryland, Erin brings a unique blend of legal acumen, policy insight, and operational leadership to her work. Outside of work, Erin is a devoted mom who loves cheering at her 10-year-old son's music gigs alongside her husband. She’s also an avid gardener and sometimes golfer—though she admits her short game is mostly three putts and a prayer.

Brian Weinhaus is the Director of Illicit Trade Prevention for the United States at Philip Morris International (PMI), where he leads strategic efforts to combat illegal trade and protect the integrity of the company’s supply chain. His work focuses on complex investigations, risk mitigation, and building strong cross‑sector partnerships with government and industry stakeholders.

With deep expertise in brand protection, intelligence, and stakeholder engagement, Brian collaborates closely with law enforcement and regulatory partners to address global challenges related to counterfeiting, smuggling, and organized illicit networks. Prior to joining PMI, Brian held senior leadership roles at Moderna and with Homeland Security Investigations, where he directed large‑scale international investigations and intelligence programs, bringing more than two decades of experience in federal law enforcement and corporate security to his current role.

Mr. Waqas Khan is a senior executive with over 20 years of prolific experience leading global rollouts for Fortune 500 companies, including British American Tobacco (BAT), Juul Labs, Etisalat, Telenor, and Ooredoo. His expertise spans multiple sectors, including consumer packaged goods, telecommunications, mobile devices, broadband, med-tech, and fintech. He has successfully launched and scaled brands across three continents, building high-performing teams and driving business growth on a global scale.

In addition to his corporate leadership, Mr. Khan is a serial entrepreneur who has co-founded three startups. The most recent, LIX Innovations Inc., was acquired by ITG Brands USA in a multimillion-dollar deal in 2023. Currently, he serves as the Global CEO of CLEW Pouches, a revolutionary nicotine pouch, accepted by the FDA for its innovative approach to harm reduction.

Rick Penney is a Manager for the Anti Illicit Trade Operations, Americas Region at JTI. While being based in the country office of JTI-MacDonald in Mississauga he is part of the Global AIT function reporting into Geneva, Switzerland but has a primary responsibility for all AIT functions in Canada and support to other Americas and Caribbean markets.

Born in Newfoundland, Rick joined the Royal Canadian Mounted Police where he held Senior Policing positions focused on organized crime and national security spanning a 30 year career. Following his retirement, he has performed key roles as a Global Director of Corporate Security and contract consultant to both private industry, government, and policing.  He is the recipient of Commissioners and Commanding Officers Letters of Recognition, Letters of Appreciation from Heads of State, Ambassadors, and numerous partners in law enforcement both domestic and international.

Rick completed his undergraduate studies in Cultural Anthropology at Wilfrid Laurier University (1986) and is currently pursuing studies in Law for the University of London (U.K.)

Rick has lectured and taught internationally on areas of human intelligence gathering and major case investigative techniques and strategies.

Katherine Ilkhani is an Iranian-American entrepreneur and advocate for climate action, human rights, and public health innovation, evidenced by her previous leadership as Deputy Executive Director at Climate Cardinals, the world's largest youth-led climate nonprofit, and as a member of the National Solidarity Group of Iran, a leading organization within the Iranian diaspora. Her experience also includes contributions to the launch of a digital fashion platform and her role as a youth advisor to Revolve. Currently, she is actively tackling the critical public health and environmental challenge of smoking-related deaths and illicit nicotine products by spearheading the U.S. entry of a revolutionary sustainable nicotine alternative, forging a strategic alliance with a leading Swedish harm reduction company and assembling a world-class regulatory powerhouse to ensure its swift and impactful entry.

Braden Adam is a software engineer and entrepreneur with a passion for public health, systems thinking, and mission-driven innovation. His experience includes strategic advisory work at Deloitte and over six years of active investment analysis, sharpening his ability to assess risk, navigate uncertainty, and design solutions built for long-term impact. Currently, he is applying this mindset to one of the most tightly regulated and stagnant industries in the U.S., helping lead the introduction of a next-generation nicotine alternative. By assembling a diverse team of regulatory, scientific, and strategic experts, he is working to deliver a product that not only meets the highest standards of compliance and user experience, but also redefines harm reduction for both people and the planet.

Kellsi Booth is the Chief Legal Officer at Black Buffalo, Inc., a manufacturer of smokeless tobacco alternatives, where she is responsible for providing strategic direction and practical legal guidance. Kellsi has advised companies at all stages of growth in the nicotine and tobacco space. She is well-versed in regulatory, quality, and policy matters, and previously held a series of progressive roles at Turning Point Brands, Inc. and Juul Labs, Inc. driving key initiatives in these areas. Kellsi is also a leader of trade associations, such as the Coalition of Manufacturers of Smoking Alternatives (CMSA), and co-founded and serves on the board of the Organization of Women in Nicotine and Tobacco (OWNiT).

Tiffany Parms is the Senior Manager in Scientific & Public Health Affairs at RAI Services Company, where she leads external engagement on tobacco harm reduction and non-combustible nicotine research. An epidemiologist by training, she specializes in translating complex scientific evidence into insights that inform regulatory strategy, public health dialogue, and stakeholder engagement.

Tiffany brings over a decade of experience across industry and government, including previous roles at the U.S. Food and Drug Administration’s Center for Tobacco Products, where she evaluated epidemiologic evidence supporting tobacco product applications and contributed to policy development. At RAI, she has led study design, analysis, and scientific dissemination for actual use and behavioral research on alternative nicotine products, supporting regulatory submissions and product innovation. In prior roles, Tiffany conducted chronic respiratory disease and infectious respiratory disease surveillance.

She is actively engaged in community and civic initiatives, serving on nonprofit boards and leading efforts to promote health, education, and community empowerment. She is an active contributor to the scientific community, with peer-reviewed publications and conference presentations focused on tobacco dependence, consumer perceptions, and non-combustible nicotine product evaluation. Tiffany holds a Master of Public Health in Epidemiology from the University of Arizona and a B.S. in Biology from North Carolina Central University. She is recognized for her expertise in bridging science and public health communication.

AmeriPouch is a modern U.S.-based contract manufacturer focused on innovative nicotine and supplement pouch solutions. We are building scalable, compliant, and market-ready formats for today’s fast-moving CPG brands.

-Simplifying production for nicotine brands in the U.S. and internationally with a domestic facility

-Developing nicotine, nootropic, and supplement pouches with custom formulations

-Creating proprietary flavor systems and advanced actives delivery tech

-Partnering with brands to prototype, manufacture, and scale new SKUs -Running turnkey operations including R&D, compliance, and fulfillment

-Bringing 20+ years of formulation and flavor expertise to next-gen delivery formats

Chemical engineer with a Master’s degree from Cambridge and 13+ years of experience in healthcare and life sciences strategy consulting. My background spans commercial growth strategy, market analysis, and due diligence support, developed through roles at LEK, Evaluate, and BDO.

Over the course of my consulting career, I advised senior executives and investors on market entry, portfolio strategy, product positioning, and commercial opportunities across the life sciences ecosystem.

In recent years, I have transitioned from advisory to take over as the CEO of Zanoprima Lifesciences. Zanoprima is a UK-based pharmaceutical company and has developed and patented a cost-effective and environmentally friendly process to create innovative synthetic S-nicotine (SyNic™) with unprecedented purity for use in next generation nicotine products. Zanoprima currently works with, and supplies a number of players in the nicotine space, ranging from start-ups to Big Tobacco. Our team has also been involved with developing and manufacturing Nicorette gums/lozenges in the past, working with J&J and GSK.

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.

Nyah Phengsitthy is a reporter for Bloomberg Law covering the FDA's oversight of the tobacco and pharmaceutical industry. She closely tracks and writes about regulations, litigation, and policies impacting those industries. She's a frequent guest on TV and radio, health podcasts, and panels discussing the government's health care actions. Before joining Bloomberg, she wrote about the impact of COVID-19 on orphanages in Ghana for the Pulitzer Center on Crisis Reporting. She's a graduate of Elon University.

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).

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.

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. 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.

Collin Gerringer is the Manager of THR Operations and a Senior Study Manager at DVCR, where he oversees clinical research study site operations from startup through closeout and supports THR client operations. He has over 12 years of clinical research experience in rare diseases, human abuse potential studies, and tobacco and nicotine harm reduction.

Ajesh Raju, Senior Project Manager, has worked in the biopharmaceutical and medical device industry for over 15 years. He brings extensive experience leading cross functional teams, managing complex timelines, and delivering studies from start up through close out. His background includes hands on project management of tobacco harm reduction studies, with a strong focus on THR operations, study planning, vendor coordination, and day to day execution. Ajesh is skilled in stakeholder management, risk assessment, and practical problem solving, and is responsible for overseeing all project management activities to ensure studies are delivered efficiently and in line with regulatory and scientific expectations.

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.

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.

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.

Christopher Russell Ph.D. is the Director of Russell Burnett Research and Consultancy Limited (RBRC), a contract research organization that specializes in the design and conduct of perception, intention, and behavioral studies of tobacco and nicotine products. Studies are designed to obtain information about individuals’ use and perceptions of tobacco and nicotine products; understanding of product labels, labelling, and advertising; and intentions to stop, start, and continue using tobacco and nicotine products. The results of these studies help to inform regulatory assessments of the potential impact of new tobacco products on tobacco use behavior and population health.

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.

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.

Chris Robinson, M.S., is a Principal Scientist and Regulatory Consultant at Accorto Regulatory Solutions with more than 25 years of experience supporting pharmaceutical and medical device development and regulatory submissions. He provides technical and regulatory leadership across CMC, analytical development, clinical and non‑clinical programs, and FDA‑facing documentation.

Chris’s expertise includes analytical method development and validation, impurity profiling, extractables and leachables assessments, stability program design, and toxicological risk assessment.

He has prepared and reviewed PMTAs as well as NDA, ANDA, and IND CMC sections and has extensive experience responding to FDA information requests and Complete Response Letters. His regulatory experience spans multiple FDA centers, including CDER, CBER, CDRH, and CTP.

Chris holds a Master of Science in Chemistry from the University of North Carolina at Wilmington.

Sydney Hiller, Ph.D., MBA, serves as Director of US Regulatory Operations at Inter Scientific, where she supports clients across the development of regulated nicotine products with a particular focus on testing strategy, scientific planning, and evidence generation.

She brings deep expertise across multiple nicotine product categories, helping clients design practical, scientifically robust programmes that align with evolving US regulatory expectations. Her work combines technical depth with strategic insight, enabling clients to make well-informed decisions on study design, product characterization, manufacturing considerations, extractables and leachables, and nonclinical and clinical testing approaches.

Sydney leads cross-functional scientific programmes that help clients build strong testing frameworks, interpret complex requirements, and generate the data needed to support product development and commercial objectives in a changing FDA environment.

She holds a Ph.D. in Chemistry from the University of Southern California, an MBA, and a B.A. from New York University.

Laila is a Senior Strategist with Sanova, a regulatory and scientific consultancy specializing in PMTAs, MRTPAs, SEs, and other tobacco and nicotine product submissions. With extensive regulatory expertise spanning both public and private sectors, Laila brings over a decade of direct experience from FDA's Center for Tobacco Products (CTP), where she held leadership roles developing and reviewing premarket tobacco application requirements. She notably planned, directed, and evaluated high-profile premarket application review programs, solidifying her deep understanding of integrating science and regulations.

At Sanova, Laila guides clients through the ever-evolving tobacco product application landscape, with a focus on novel delivery systems. As an expert in regulatory strategy, Laila focuses on transforming complex regulatory challenges into strategic advantages through practical execution to support innovative product development, regulatory submission, and ongoing regulatory adherence in highly challenging sectors.  Laila also leads Sanova’s literature review cost share program, which is designed to make regulatory compliance more practical and accessible to industry.

Beyond her significant tenure at the FDA, Laila also served in the private sector with Juul Labs, working on complex regulatory submissions for electronic nicotine delivery systems (ENDS). Here, she applied her project management and regulatory acumen to foster collaboration within intricate, highly regulated operations, including managing product integrity programs to ensure regulatory alignment.

Laila holds an MPH in Epidemiology from Emory University, a Master’s certificate in Project Management from George Washington University, and a PMP certification. She is also a proud member of Organization of Women in Nicotine and Tobacco (OWNiT).

Pablo Cano Trilla leads the legal analysis team at Tamarind Intelligence (publisher of ECigIntelligence and TobaccoIntelligence), overseeing regulatory coverage across more than 100 countries, U.S. states, and other subnational jurisdictions.

He holds a Master of Laws (LLM) with Distinction from the University of Aberdeen and degrees in law and political science. Pablo began his career as an assistant at the European Parliament and has since built an international legal career, working as a lawyer and legal analyst in Mexico, the UK, and Spain, specializing in highly regulated industries. He is a qualified attorney.

For over a decade, Pablo has provided independent, in-depth legal and political analysis on the tobacco and nicotine industries to clients including international corporations, governments, tobacco control NGOs, and academic institutions. A seasoned speaker, he has delivered numerous presentations and conferences on key industry issues to diverse global audiences.

George Hardie has an MSc in Applied Toxicology from the University of Surrey and has been in the scientific arena for nearly 40 years. George has worked for four major pharmaceutical companies such as AstraZeneca, GSK, Novartis and Pfizer, one major tobacco company (BAT) and four contract research organizations (LabCorp, DVCR, ICON & HVIVO). George’s expertise is mainly focused on Tobacco Harm Reduction but also has a deep knowledge of respiratory and other therapeutic areas. George has published over 20 manuscripts and is an active member of Coresta sitting on the Biomarker and PUB sub-groups. George is also an active member of the Institute of Clinical Research and the Royal Society of Biology.

Ivan is the North America Consulting Director at GlobalData. With over 15 years of combined industry and consulting experience, he has led strategic growth projects in food & beverage 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.

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.

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.

Molecular and cell biologist that has worked at Nordson for 7 years. Worked in the Regulatory market space for 15+ years and has been an advocate for quality and process control.

Chemical engineer that has worked at Nordson for 7 years. Worked in manufacturing for over 10 years.

Dr. Cheryl Olson is a behavioral scientist internationally recognized for her work on health risk behaviors and the influence of media on youth. She earned a doctorate in health and social behavior from the Harvard School of Public Health, and a master’s degree in community health education from the University of Minnesota. Cheryl spent 15 years on the psychiatry faculty at Massachusetts General Hospital/Harvard Medical School, where she co-directed the Center for Mental Health and Media.

Along with academic work, Cheryl has decades of experience making scientific content meaningful and engaging for a variety of target audiences. She has written/edited a half-dozen popular books on health, and several dozen scientific articles. Her work has appeared in the New York Times, Parents magazine, WNYC (NPR) and Tobacco Reporter. She has advised foundations, universities, politicians and companies on health communication and engagement strategies.

Cheryl’s work in tobacco/nicotine includes developing the influential QuitAssist smoking cessation program for Philip Morris USA, and a CME course on tobacco harm reduction for Physicians Research Institute. As a consultant with McKinney Regulatory Science Advisors, she designed and conducted perception/intention studies on various reduced-risk nicotine products; some involved vulnerable groups such as people in custody and older persons who smoke. Cheryl currently works as a regulatory scientist for Womble Bond Dickinson, based remotely in Richmond, Virginia.

Clifford E. Douglas has worked for 38 years in federal health policy leadership, tobacco and health policy advocacy, academia, research, and litigation. He earned his undergraduate and law degrees from the University of Michigan.

A central focus of Cliff’s work is strengthening public and decision-maker understanding of the continuum of risk across tobacco and nicotine products, the public health consequences of regulatory choices, and the imperative of consumer choice.

From 2023 to 2025, Cliff served as President and CEO of the charitable foundation Global Action to End Smoking, leading a strategic transformation and advancing global evidence-based dialogue about the harms of smoking and the tools now available to greatly mitigate that harm.

For more than a decade, Cliff taught tobacco policy at the University of Michigan School of Public Health and directed the University’s Tobacco Research Network. In 2023, he produced the widely used online course, “Tobacco & Nicotine: Public Health, Science, Policy, and Law.” He also served as Co-Investigator for the FDA- and NIH-funded Center for the Assessment of Tobacco Regulations, a collaboration of the University of Michigan and Georgetown University.

From 2015 to 2020, Cliff was National Vice President for Tobacco Control at the American Cancer Society and, from 2010 to 2015, Tobacco Control Policy Advisor to the U.S. Assistant Secretary for Health and the U.S. Surgeon General. He served previously as Special Counsel on Tobacco Issues in the U.S. Congress, as an attorney in landmark tobacco cases, and helped lead the successful national effort to prohibit smoking on U.S. airline flights.

Cliff currently serves as an independent consultant on tobacco harm reduction for Womble Bond Dickinson (US) LLP, focusing on education, communications, and health policy. He does not represent or speak for the firm or its clients.