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Session Details: Setting the Scene - the significance of the role of the global Framework Convention on Tobacco Control (FCTC Treaty) in shaping global nicotine regulation. 09-06-2021, 11:50 am PANEL Navigating the Waves To & From the Vaping and Smoking Industry 09-06-2021, 6:25 pm View In Agenda

Biography: 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.

Session Details: Tobacco Reset? A look into the future of the New Nico Industry: 2021 and Beyond – 09-06-2021, 1:00 pm PANEL Navigating the Waves To & From the Vaping and Smoking Industry 09-06-2021, 6:25 pm View In Agenda

Biography:

Session Details: A look into the Future : Next Gen Nico & Oral Products 09-06-2021, 5:20 pm View In Agenda

Biography: An experienced legal, regulatory and compliance department leader, Patricia I. Kovacevic’s career comprises leading senior legal and regulatory positions with FDA-regulated multinationals, including Philip Morris International and Lorillard, as well as partner roles with premier global law firms. At present she is General Counsel and Head of External Affairs for Andina Gold Corp (corporate name change to Cryomass Technologies Inc pending), a U.S. listed company providing adjacent services to the cannabis industry, which has recently acquired patented technology (the CryomMass Refinement System) to fully separate trichomes from biomass. Her expertise includes senior management roles and leading multinational, cross-disciplinary teams, with focus on corporate law, FDA and EU regulatory, compliance, M&A, US and global food, drug, nicotine and consumer goods regulation, cannabis/CBD regulation, external affairs and the legal framework applicable to marketing, media communications, investigations, FCPA, trade sanctions, privacy, intellectual property, product development and launch. She also led cross-disciplinary teams engaged in scientific research efforts. Kovacevic served on various trade association bodies and conference advisory boards. She authored several articles on nicotine regulation, co-authored an academic treatise, “The Regulation of E-Cigarettes”, as well as various other papers, and is often invited as a keynote speaker or panelist before global conferences and government agencies public hearings. Kovacevic is an attorney admitted to practice in New York, before the U.S. Tax Court, before the U.S. Court of International Trade and before the Supreme Court of the United States. She holds a Juris Doctor (doctor of law) degree from Columbia Law School in New York and completed the Harvard Business School “Corporate Leader” executive education program. Kovacevic speaks several languages fluently, including French, Italian, Spanish, Romanian and Croatian.

Session Details: FDA Update and Communications Surrounding Comparative Risk of Nicotine Products 09-06-2021, 2:10 pm PANEL Navigating the Waves To & From the Vaping and Smoking Industry 09-06-2021, 6:25 pm View In Agenda

Biography:

Session Details: A look into the Future : Next Gen Nico & Oral Products 09-06-2021, 5:20 pm View In Agenda

Biography: Tim Phillips is the Managing Director of Tamarind Intelligence, publisher of leading business intelligence services ECigIntelligence, CBD-Intel and TobaccoIntelligence. These independent market data and regulatory tracking and analysis services for the vape, CBD and tobacco-alternatives industries provide market-leading insights into the sectors they cover for clients ranging from governments and academic institutions to multinational companies and professional service providers. Tim Phillips is a UK-qualified attorney, having worked at the European Commission, international law firm Herbert Smith, media companies BSkyB and AOL, and Betfair, where he worked in various legal and government relations roles as the company went through its IPO. He was also a partner in a New York venture capital-funded start-up in the diamond sector. Tim holds a postgraduate diploma in legal practice from the University of Law, London and a masters degree in geology from Oxford University. He has run for Tamarind Intelligence for the past 6 years.

Session Details: Through the Eyes of the New – Age Nicotine User: The evolution of the pouch, e-tobacco and nicotine landscape 09-06-2021, 4:20 pm PANEL Navigating the Waves To & From the Vaping and Smoking Industry 09-06-2021, 6:25 pm View In Agenda

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Session Details: Scientific studies for Regulatory submissions: An update on Vapour and Modern Oral science 09-06-2021, 3:10 pm View In Agenda

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Session Details: PANEL Navigating the Waves To & From the Vaping and Smoking Industry 09-06-2021, 6:25 pm View In Agenda

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Biography:

Paul has vast experience in inhaled product development across pharmaceutical and consumer products.

He commenced his career working at a specialty pharmaceutical company where he gained experience of dry powder and metered dose inhaler development including treating local lung conditions and for systemic absorption for all stages of product development and commercial scale up. He also managed and successfully led the Quality Control department in a multinational pharmaceutical company that manufactured generic nicotine lozenges.

Paul led the product characterisation team at Imperial Brands, where he designed the testing strategy for the chemistry of inhaled and oral next generation nicotine products assessing a variety of prototypes at the early stages of development and for regulatory submissions, including PMTA.

He joined Broughton Nicotine Services in 2021 as Head of Scientific Affairs and is responsible for consulting on and developing next generation nicotine product testing strategies for clients.

Session Details: What ENDS companies should be considering when developing new products and how trends in global regulations could impact such decisions. 09-06-2021, 12:30 pm View In Agenda

Biography: Ian is an independent consultant with expertise in regulatory and scientific aspects of nicotine and tobacco products. His current consulting work focusses on advising manufacturers on regulatory requirements for e-cigarettes as both consumer goods and medicinally-licensed products, in the US, UK and Europe. His consulting work also provides human studies services to companies, including clinical and behavioural studies.  Prior to independent consulting, Ian worked for JUUL Labs as Senior Director of Clinical and Regulatory Affairs EMEA, and previously he was Director of Tobacco Research at Celerion, a provider of clinical research capabilities and regulatory expertise to the tobacco and e-cigarette industries. Prior to that, Ian was Principal Scientist and Head of Clinical Research at British American Tobacco's central research and development centre in Southampton, U.K. He specializes in the biological and psychological effects of nicotine, , clinical and behavioural studies to assess the individual and population impact of electronic cigarettes and tobacco heating devices, and the scientific basis for regulation.  Prior to working in the industry, Ian pursued an academic career as a Lecturer in Physiology at the University of Manchester and an Assistant Professor in Biology at McMaster University in Hamilton, Canada.  Ian is a highly-cited scientific researcher and writer, contributing to more than 50 peer-reviewed papers and book chapters which have generated over 2,900 citations.

Session Details: So, you’ve got your PMTA. What next? 09-06-2021, 8:15 pm View In Agenda

Biography:

Session Details: OPEN DISCUSSION: Sink or Swim: What does the future of Nicotine hold? do post PMTA in the nicotine landscape? 09-06-2021, 3:40 pm View In Agenda

Biography: Neelam Gill advises clients and supports Keller and Heckman Partners in the areas of food and drug law and tobacco ande-vapor law, counseling both domestic and international corporations on product and regulatory compliance issuesinvolving the U.S. Food and Drug Administration (FDA). In her tobacco and e-vapor practice, Neelam advises tobacco, e-cigarette, and e-liquid manufacturers, distributors, retailers,suppliers, and trade associations on FDA, state, and global regulatory compliance issues. In the food and drug arena, sheassists clients with a variety of FDA regulatory matters and labeling issues. Neelam’s background and experience in thepharmaceutical industry serves her well in advising clients on the complexities of the Family Smoking Prevention andTobacco Control Act, in particular with quality systems and good manufacturing practices. Neelam advises clients on preparation of FDA submissions, including premarket tobacco product applications (PMTAs),substantial equivalence (SE) reports, tobacco product master

Session Details: Remote Regulatory Assessments for Vapor Product Manufacturers in PMTA Review: What to Expect and How to Prepare 09-06-2021, 2:40 pm View In Agenda

Biography: Bonnie is the Business Development Manager at Enthalpy Analytical, LLC. Her background is in regulatory toxicology and has extensive experience managing in vitro toxicology studies for ENDS products, supporting nonclinical sections of FDA PMTA ENDS submissions and conducting toxicological evaluations of ingredients in tobacco, nicotine and cannabis products. Bonnie received her BS in biology from Texas State University, and PhD in pharmacology from Vanderbilt University. She completed a postdoctoral training in tobacco regulatory science at Altria Client Services, and was hired on as a research scientist in 2014 and later as Principal Scientist until 2019. Prior to joining Enthalpy, she was the principal toxicologist and founder of ToxPharm LLC, a regulatory toxicology consulting company created in 2019. Enthalpy is the largest independent tobacco, smoke and e-vapor testing lab in the U.S. offering regulatory and research services to commercial, governmental, academic and regulatory agencies since 2000. We are an International Organization for Standardization (ISO)-17025 accredited lab offering comprehensive and exhaustive analysis of cigarette smoke, filler, smokeless tobacco, e-liquid, e-vapor, in vitro toxicology and product stability testing.  Enthalpy operates three smoke labs capable of e-vapor sample collection between its Richmond and Durham laboratories, allowing for redundancy and flexibility in our testing processes.  Enthalpy offers analysis and testing of e-vapor and e-liquids for the presence of nicotine, propylene glycol, glycerin, carbonyls (i.e., diacetyl, formaldehyde, etc.), particle sizing, and the FDA list of HPHCs. Enthalpy has analytical methods in place to meet requirements of the 2019 FDA Final Guidance for Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) Regulations and European Union Tobacco Product Directive (EU-TPD).

Session Details: PANEL DISCUSSION The synthetic nicotine loophole: Regulatory issues and technical challenges associated with testing 09-06-2021, 7:45 pm View In Agenda

Biography: Stan is the Practice Lead for Materials Science with Consilium Sciences, LLC. His specialty includes investigating complex material science and addressing regulatory science through a varied background in nanotechnology, chemistry, engineering, and biotechnology.  Stan received his BS in biotechnology from James Madison University, MS in chemistry from Virginia Commonwealth University, and PhD in nanoscience and nanotechnology from Virginia Commonwealth University. He completed a postdoctoral training in chemical and life science engineering at Virginia Commonwealth University. Stan is an author on 12 peer-reviewed publications in leading chemistry and material science journals. Currently, he leads the tobacco regulatory team at Consilium which supports numerous clients as they prepare for Premarket Tobacco Product Application (PMTA), Substantial Equivalence (SE), and Tobacco Product Masterfile (TPMF) submittals. He often leads projects by guiding clients through every step of the complex tobacco regulatory process including designing regulatory-facing studies or submitting regulatory applications. In addition to his project leadership and management expertise, he often specifically focuses on the chemistry aspects of regulatory submissions including nonclinical study design and data analytics. He is well versed in all areas of tobacco regulatory including chemistry, manufacturing, and control (CMC), nonclinical studies, and clinical studies as well as compiling all information and studies of a PMTA into the electronic tobacco technical document (eTTD) format.   Consilium employs a core group of full-time, senior-level Principal Scientists, combined with the broader Consilium Scientific Network of more than 300 consultants from across the globe.  This unique distributed-consulting approach allows us to build cost-efficient, project-specific teams that solve our clients’ needs quickly and effectively.  Typically, a Consilium project team will have one or more of our full-time consultants leading the project. Our teams are custom-built and project-specific, ranging in size from one individual up to a 40-person team. At Consilium, we present goals, explain requirements, embark on study design, conduct research, develop strategy, and prepare complete regulatory submissions. Consilium also supports clients beyond submission with follow-up correspondence, responses to deficiency letters, post-market surveillance, and design and execution of annual reporting requirements.

Session Details: PANEL DISCUSSION The synthetic nicotine loophole: Regulatory issues and technical challenges associated with testing 09-06-2021, 7:45 pm View In Agenda

Biography: Kevin is the CEO of North American Nicotine and Chemular, a group of regulatory consultants comprised of ex-FDA officers and colleagues from pharmaceuticals and tobacco medical device sector that guide companies through the PMTA process. Kevin has a BS in Industrial Engineering from California State Polytechnic University and an MBA in Business from Edinburgh Napier University.

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Biography: Liz is the Regulatory Compliance Manager for Pyxus International, LLC and joined the company in 2019. Ms. Sprowl oversees the regulatory filings for its e-liquid division and supports day-to-day company compliance and regulatory efforts for its multiple e-liquid brand companies and its joint venture Purilum LLC, a manufacturer of flavors and e-liquid products for a number of industry brands. Prior to joining the company, she was the Regulatory Compliance Attorney for Turning Point Brands, previously served as a defense litigator for a number of national and regional law firms, and was the quality control manager for a division of a national food company. Ms. Sprowl currently serves on the Coalition of Manufacturers of Smoking Alternatives Board of Directors. She holds a J.D. from the Salmon P. Chase Northern Kentucky School of Law, an M.B.A. from Bellarmine University, and a B.A. in Biology from Washington University in St. Louis.  

Session Details: PANEL DISCUSSION The synthetic nicotine loophole: Regulatory issues and technical challenges associated with testing 09-06-2021, 7:45 pm View In Agenda