New Approaches
Conference  

Dr. Derek Yach is an independent global health consultant who has focused his career on advancement of public health around the world. He was the founder and president of the Foundation for a Smoke-Free World, former Executive Director at the World Health Organization (WHO) where he led the development of WHO’s Framework Convention on Tobacco Control (FCTC), and has held senior positions at Yale, PepsiCo, and the Rockefeller Foundation. He has served on the advisory boards of private, public, and philanthropic organizations and published over two hundred peer review articles.

Rachael Trimpert Schmidt, CAPT, USPHS (Ret.), is a former senior officer with the U.S. Food and Drug Administration’s Center for Tobacco Products and a regulatory strategy advisor with more than two decades of experience in federal public health, laboratory compliance, and tobacco product regulation. As Assistant Director for Laboratory Compliance and Coordination at FDA, she led national initiatives supporting implementation and enforcement of the Family Smoking Prevention and Tobacco Control Act.

During her tenure, CAPT Schmidt established and coordinated FDA’s tobacco regulatory laboratory framework and oversaw product testing and compliance programs. Her work spanned premarket application reviews, post-market surveillance, adverse event assessments, and development of tobacco product standards. Drawing on deep institutional knowledge and an extensive regulatory network, she advises organizations navigating complex regulatory, enforcement, and compliance challenges across the tobacco and nicotine sector.

Yusuff Adebayo Adebisi is a pharmacist, Oxford-trained epidemiologist, and Director of Research and Thought Leadership at Global Health Focus Africa. His work focuses on tobacco harm reduction, nicotine science, smoking cessation, and health equity, with particular attention to Africa and other low- and middle-income settings. He is an inaugural Kevin Molloy Fellow of Knowledge Action Change and has contributed to research, policy dialogue, and capacity building on reduced-risk nicotine products and pragmatic approaches to reducing smoking-related harm. Yusuff has authored more than 200 peer-reviewed publications across global public health, including work on tobacco and nicotine use, antimicrobial resistance, pandemic preparedness, and population health inequities. His leadership in public health research and advocacy has been recognised internationally, including through the Diana Award.

Andrei Andon-Ionita has been covering the European Consumer Staples sector as a sell-side analyst since 2018. He has initiated coverage of the Global Tobacco sector as the lead analyst in 2025, having previously worked as a European Beverages analyst for Jefferies.

Matthew P. Bergman is an attorney, law professor, philanthropist, and advocate who has become the nation’s leading legal voice on social media accountability.  He pioneered the use of product liability law to get around Section 230, which the social media companies had been using for decades to evade responsibility for their dangerously defective platforms. His firm now represents more than 2,500 clients harmed by social media companies.

Samrat Chowdhery is a former senior journalist with two decades of experience at major Indian publications. He is a leading advocate for tobacco harm reduction, having founded the Harm Reduction Policy & Research (HRPR) and the Association of Vapers India (AVI). Globally, he served as president of the UN-recognized International Network of Nicotine Consumer Organisations (INNCO). Chowdhery is a prominent international speaker and author focused on advancing harm reduction policies in lower- and middle-income countries. His advocacy and research specifically targets accessible, lower-risk alternatives for marginalized users of bidis and smokeless tobacco.

Azim Chowdhury, Partner at Keller and Heckman LLP, is a leading expert on U.S. Food and Drug Administration (FDA) regulatory compliance, particularly in the areas of vapor, nicotine, tobacco products, and cannabis/CBD. He advises domestic and international corporations on navigating complex regulatory frameworks, including the FDA's Deeming Rule and the Family Smoking Prevention and Tobacco Control Act. Azim counsels manufacturers, distributors, and trade associations on compliance and public policy initiatives. He is a recognized thought leader, frequently speaking at industry conferences and contributing to publications on tobacco regulatory matters. Azim also spearheads his firm’s annual E-Vapor and Tobacco Law Symposium and serves as editor of The Continuum of Risk blog.

Cliff Douglas is an independent consultant specializing in tobacco harm reduction policy and strategies to reduce smoking-related disease and death. Over four decades, he has held leadership roles spanning academia, government, nonprofit organizations, legal action, and advocacy, including President and CEO of Global Action to End Smoking, Vice President for Tobacco Control at the American Cancer Society, advisor to the U.S. Assistant Secretary for Health and the Surgeon General, special counsel on tobacco issues in the U.S. Congress, adjunct professor at the University of Michigan School of Public Health, and service as an attorney in landmark litigation.

Dr. Dukes was the lead facilitator and mediator for the Southern Tobacco Communities Project in the late 1990s that brought together tobacco farm and public health interests and where he first encountered Scott Ballin. He also co-facilitated the first several Morven Dialogues concerning harm reduction, working closely with Scott to design and convene them.

Håkan Engqvist is Professor of Materials Science and Engineering with a background in engineering and biomaterials. His research focuses on the development and translation of advanced biomaterials for medical and dental applications. He has authored more than 300 scientific publications and is the inventor on numerous patents.Professor Engqvist has founded Emplicure and several other medical technology companies, with innovations that have progressed from academic research to successful commercialization. His work spans academia and entrepreneurship, with a strong emphasis on transforming research into clinically relevant technologies.

Sydney Hiller, PhD, MBA, is Director of US Regulatory Operations at Inter Scientific, where she advises companies on regulatory strategy, scientific evidence, and market access for innovative nicotine and reduced-risk products. With a multidisciplinary background spanning chemistry, regulatory science, pharmaceuticals, medical devices, biologics, and consumer products, Sydney focuses on translating complex scientific evidence into practical regulatory strategies. Her work sits at the intersection of science, regulation, and commercialization, helping companies navigate evolving regulatory frameworks and bring evidence-based innovation to market.

Kendall K. Gurule is a shareholder at Polsinelli whose multidisciplinary patent practice spans strategic counseling, portfolio development, prosecution, and complex patent disputes. With a background in chemical engineering, she works with technologies involving formulations, materials science, energy storage, polymers, and industrial systems. Kendall helps innovators build strong, defensible patent positions and navigate complex prior-art and competitive landscapes. She brings a practical IP perspective to how product development, regulatory requirements, and commercialization decisions can shape patent strategy and vice versa.

Bethea “Annie” Kleykamp, PhD, MA, is an Assistant Professor of Psychiatry at the University of Maryland School of Medicine and Director of Research and Evaluation for the Maryland Addiction Consultation Service. An experimental psychologist with 20+ years of addiction research experience, she focuses on aging and substance use, particularly tobacco, opioids, and polysubstance use among older adults. Dr. Kleykamp serves on the Board of Directors of the College on Problems of Drug Dependence and as a Consulting Editor for Experimental and Clinical Psychopharmacology. Her translational work aims to inform clinical practice, regulatory science, and public health.

Kuttruf is the founder and CEO of Evapo, a leading fast growing vaping retail chain in the UK and Germany with over 60 stores. Prior to founding Evapo in 2014, Andrej had a successful career as a professional poker player, ranking among the top 20 worldwide for two consecutive years. Evapo is dedicated to helping smokers quit, has expanded to include a diversified manufacturing plant in Northern Ireland and has become a key supplier with its products to hospitals, Mental Health Trusts, and Stop Smoking Clinics.

Dr. Bret Koplow serves as Acting Director of FDA's Center for Tobacco Products (CTP), which carries out the Family Smoking Prevention and Tobacco Control Act – the landmark 2009 law granting FDA broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. CTP advances public health through a comprehensive approach: developing policy, issuing regulations, conducting research, educating the public, and reviewing new tobacco product applications. These efforts aim to discourage initiation, promote cessation, and reduce the harmful consequences of tobacco use.

Dr. Koplow joined CTP from the Immediate Office of the Commissioner, where since early 2020 he served as Senior Counselor focusing on CTP regulatory, policy, and operational matters. He previously held senior roles in FDA's Office of the Chief Counsel and Office of Legislation. Before joining FDA in 2011, he practiced food and drug law as a partner at international law firms in Washington, D.C. Dr. Koplow graduated with honors from the University of Chicago Law School and holds a Ph.D. in clinical psychology, having previously directed the Divisions of Child and Adolescent Psychiatry at Case Western Reserve School of Medicine and University Hospitals of Cleveland.

Dr. Liu is Founder and President of Riskwise Solution, a scientific consulting firm specializing in U.S. regulatory strategy and full-service PMTA support. With nearly 30 years of experience, she is a recognized expert in product characterization, manufacturing controls, toxicology, and risk assessment across tobacco and nicotine products, food additives, medical devices, and consumer products. She has supported successful PMTA submissions for leading tobacco and ENDS companies and pioneered the use of quantitative risk assessment (QRA) in tobacco regulatory submissions. Her expertise aligns with FDA’s growing use of QRA to evaluate nicotine product toxicological risk.

Lillian Ortega is the Founder and Chief Regulatory Compliance Strategist at WOW Solutions LLC, where she guides businesses through the complexities of FDA regulatory processes. She previously served as Director of Enforcement and Manufacturing at FDA’s Center for Tobacco Products, overseeing compliance, inspections, recalls, and import operations. With over a decade at FDA and expertise spanning tobacco, biologics, and clinical research, Lillian combines regulatory insight with strategic consulting. Her background in Microbiology and Public Health Policy strengthens her ability to deliver tailored solutions that position clients for success in a highly regulated environment.

Kat Murti has spent nearly two decades working to end the global War on Drugs. She serves as Executive Director of Students for Sensible Drug Policy (SSDP) — the world’s largest grassroots network dedicated to replacing punitive drug policies with approaches rooted in evidence, compassion, human rights, and harm reduction — where she has spearheaded tobacco harm reduction initiatives, including developing SSDP’s nicotine and THR education course and convening the Rethinking Nicotine Conference. Before leading SSDP, Kat’s career spanned political campaigns, journalism, and more than a decade in public policy and communications, including overseeing digital strategy at the Cato Institute and Mercatus Center. Her work brings lessons learned from decades of drug prohibition to today’s nicotine debate, advocating harm reduction over a new War on Nicotine.

Professor Tikki Pang is an Indonesian citizen and is presently a senior academic at a leading university in Asia. He was formerly Director, Research Policy & Cooperation, World Health Organization (WHO), Geneva, Switzerland (1999-2012). He has held senior academic positions at the University of Malaya, Kuala Lumpur, Malaysia, including as Professor of Biomedical Sciences. He holds a PhD in Immunology from the Australian National University, Canberra, Australia and is a Fellow of the Royal College of Pathologists (UK), American Academy of Microbiology (USA), and Academy of Medicine of Malaysia. He has published >250 scientific articles, and was lead author on several major WHO reports including the World Health Report: Research for Universal Health Coverage (2013), Knowledge for Better Health (2004), and Genomics and World Health (2002). Professor Pang has a recognisable profile as a global health expert and his research interests are in the fields of infectious diseases, biosecurity, global health governance, linkages between research and policy, and harm reduction approaches to mitigate health problems.

Riccardo Polosa is a full professor of internal medicine at the University of Catania and founder of its Center of Excellence for the Acceleration of Harm Reduction. A respiratory physician and clinical immunologist, his research focuses on tobacco-related disease, smoking cessation, tobacco harm reduction, and e-cigarettes. He was principal investigator of the ECLAT study, the world’s first randomized controlled trial evaluating e-cigarette effectiveness and tolerability, and is among the most prolific researchers in the field. He also serves on international scientific and standards committees focused on tobacco and nicotine products.

Huub is an independent consultant on business strategy and public policy. Prior to starting his own consultancy, Huub was responsible for leading transformative change at PMI, where he helped steer the company on its path towards a smoke-free future. During his 26 year career at the company, he led PMI’s global product tax strategy, was in charge of economic research and international trade, and became the company’s first Chief Sustainability Officer. Huub is a Dutch national with a degree in Business Econometrics. He is married, has one daughter and lives in Switzerland.

Global consumer healthcare General Manager with 20+ years of experience managing P&Ls, building teams, transforming and creating brands, fostering innovation and accelerating growth across Europe, North America and Asia – with the last 11 years focused entirely on smoking cessation businesses for GSK, British American Tobacco (Niconovum) and Philip Morris (Aspeya).

Agustin Rodriguez is a partner at Troutman Pepper Locke with more than 30 years of experience spanning private practice and senior in-house leadership. He provides multidisciplinary counsel to consumer goods and marketing firms, specializing in the complex regulatory landscapes of tobacco, cannabis, and other highly scrutinized sectors. Agustin previously served as Vice President and Associate General Counsel at Altria Group, Inc., where he managed legal teams for the international consumer packaged goods leader. He advises clients on federal, state, and local compliance involving the FDA and FTC, focusing on product standards, excise tax laws, licensing, and legislative developments. His work centers on navigating the intricate interplay between product innovation, marketing regulation, and evolving rule-making frameworks.

Mr. Martin Steinbauer is the Chief Engineer and President of SKYX Group Inc. At SKYX, he works on creating drug delivery systems, access control technology, and child-resistant packaging solutions. His work has led to over 100 patents and patent applications on novel delivery and access control platforms. Prior to SKYX Group, he served as an investment analyst at BlackRock in New York, and worked at the European Central Bank, German Central Bank, and National Bureau of Economic Research. He holds an A.B. in Applied Mathematics from Harvard University.

Bradley Tusk is a venture capitalist, philanthropist, and political strategist who founded Tusk Strategies, Tusk Ventures, and Tusk Philanthropies. Tusk Ventures was the first venture capital fund focused on early-stage startups in highly regulated industries. He also launched the Mobile Voting Project and Solving Hunger and founded P&T Knitwear, a bookstore and event space in Manhattan. Earlier in his career, Tusk managed Mayor Bloomberg’s mayoral campaign, served as Communications Director for Senator Schumer, and was Deputy Governor of Illinois. He is also an author, columnist, and host of the Firewall podcast.

Jindřich Vobořil is CEO of Podané ruce, one of Czech Republic's leading public health organisations, and Chairman of the Board of the Institute for Rational Addiction Policies (IRAP), an independent think tank promoting evidence-based addiction policy. As former Czech National Drug Coordinator he counts with more than 25 years of experience developing national and European policies on addiction, tobacco, nicotine, alcohol, gambling and other addictive substances. He has represented the Czech Republic in high-level negotiations at the European Union and the United Nations and is internationally recognised for his work on evidence-based regulation, harm reduction and innovative public health policy.

Pieter brings 30 years of experience as an investment analyst with leading global banks and fund managers, including Credit Suisse and UBS, with more than 20 years focused on the tobacco sector. In 2020, he founded Idwala Research Ltd, a research and advisory firm focused on tobacco transformation and harm reduction. He also served on the Technical Committee for the 2022 Tobacco Transformation Index, which ranked the world’s largest tobacco companies on their progress away from combustible cigarettes. Pieter holds a B.Com (Hons) in Investment Management from the University of Johannesburg.

Mr. Ao Weinuo is the Secretary-General of the Electronic Cigarette Professional Committee of the China Electronics Chamber of Commerce (ECCC), China’s only vaping industry association, and one of the main founders of ECCC.

During his eight years in office, he has been committed to being the coordinator of the global vaping industry, promoting the regulation, leading the formulation of the industry standards, and sparing no efforts to protecting minors and guiding the standardized development of the vaping industry.

Mr. Ao is one of the founders of the Global Vape Alliance and has been invited on behalf of China’s vaping industry to speak at various international vaping forums.

Dmitry Yanin is a global health advocate with 25+ years driving policy change in public health across Eastern Europe and Central Asia. As Chairman of KONFOP, he leads a coalition of 35 NGOs and serves on the Global Council of Consumers International. A recognized tobacco control leader, Dmitry spearheaded Russia’s landmark legislation and advised the WHO (2011–2018) across six countries. Recently, as Principal Economist at Healthy Initiatives, he pioneered research on harm reduction across nine nations. His accolades include the Judy Wilkenfeld Award and Bloomberg Philanthropies Award. He holds a Master’s in Economics.

Mitch Zeller, J.D., retired from federal service in April 2022.  He was Director of FDA's Center for Tobacco Products from March 2013 through April 2022.

Zeller is a graduate of Dartmouth College and the American University Washington College of Law.  He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest (CSPI). In 1988, Zeller became counsel to the Human Resources and Intergovernmental Relations Subcommittee of the House of Representatives Government Operations Committee where he conducted oversight of enforcement of federal health and safety laws.

In 1993, Zeller began his first stint at FDA.  He became Associate Commissioner and Director of FDA's first Office of Tobacco Programs. In 2000, Zeller left FDA to serve as Executive Vice President of the American Legacy Foundation. In 2002, Zeller joined Pinney Associates where, as senior vice president, he provided strategic planning and communications advice on the treatment of tobacco dependence.  He left Pinney Associates in 2013 to return to FDA as Center Director.

Zeller has an academic appointment at the Dartmouth Medical School as a Clinical Instructor and is also a Member of the Koop Institute at Dartmouth College.