Bio coming soon.
Mrs. Tedesco-Ciavarra is a Fulbright Scholar with a career spanning the pharmaceutical and regulatory writing industries. Vivienne and her team of writers provide regulatory writing services for study level and summary documents for submissions. Vivienne has worked extensively as the nonclinical lead for regulatory submissions of Regulated Nicotine Products in PMTAs since 2016, and she supports pharmaceutical submissions.
Eric Gu advises domestic and foreign clients on the requirements and regulations for a variety of consumer products, including foods, food additives, food packaging materials, drugs, cosmetics, medical devices, and associated labeling, with a focus on China, Japan, Korea, Thailand, and other Asian countries.
Prior to joining Keller and Heckman, Mr. Gu worked as an attorney in law firms in Shanghai and New York and acquired deep understanding of both China and U.S. laws and practice. While attending the University of Wisconsin Law School, Mr. Gu participated in the Thomas Tang National Moot Court Competition and served as an IRS-certified volunteer for assistance in federal individual income tax filing.
Christopher Russell, Ph.D. is a behavioral psychologist and Director of Russell Burnett Research & Consultancy Ltd (RBRC), a contract research organization that specializes in the design, conduct, and reporting of perception and behavioral studies of the potential population health risks and benefits of candidate tobacco harm reduction (THR) products, such as ENDS, heated tobacco products, and modern oral tobacco products. RBRC conducts prospective observational cohort studies to characterize adults’ longitudinal tobacco product use transitions, including patterns of using the same products, switching products, adding products, initiating products, and stopping use of products. RBRC also designs and conducts consumer experience testing, flavor preference and impact studies, and studies of potential consumers’ risk perceptions, behavioral intentions, and understanding of the labels, labelling, and advertising of candidate THR products. Results of these studies help to inform PMTA, MRTPA, and other applicable regulatory assessments of the potential impact of candidate THR products on future tobacco use behavior and population health.
Charles has over 25 years of experience in global health. He has had a varied career including “on the Hill” as a staff person working for the US Congress. Charles has served as a diplomat in India (Health Attaché at the US Embassy), Senior Advisor to the World Health Organization and UNICEF, and Director of global health and child health research programs at three major foundations: The Rockefeller Foundation, the Optimus Foundation and the Foundation for a Smoke-Free World. Charles obtained his PhD in developmental neurobiology from the University of Michigan, and has over 100 publications. Charles is also a former smoker who lost his father to Chronic Obstructive Pulmonary Disease (COPD). He is a fierce advocate for all options to help smokers quit, and for all ex-smokers who use any safer nicotine alternative to toxic tobacco.
Matthew R. Holman, Ph.D. is currently Director of the Office of Science at the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA). He was appointed to that position in January 2017. The Office of Science at CTP is responsible for identifying, developing, and enhancing the science related to tobacco products, their use, and the resulting morbidity and mortality so that regulatory decisions will have the greatest impact on improving public health. To accomplish this goal, they provide the scientific support for regulations and guidance, review tobacco product applications, evaluate the knowledge basis for regulatory decisions, and carry out research to fill the gaps in scientific knowledge related to tobacco product regulation. He received his Ph.D. in Biochemistry from the University of Maryland at College Park in 2000.
Before taking on his current position, Dr. Holman served as Director of the Division of Product Science within CTP’s Office of Science for six years. In this position, he oversaw evaluation of the composition and design of tobacco products. In addition, he was involved in chemical, microbiological, and engineering research on tobacco products, resulting in numerous publications in peer-reviewed scientific journals. During this time, Dr. Holman also served as Technical Project Lead (TPL) in reviewing over a thousand SE Reports. As TPL, he was responsible for the overall scientific review of SE Reports by CTP.
Bio coming soon!
Bio coming soon.
Chris Allen is the Chief Scientific Officer at Broughton Nicotine Services. Since obtaining a Bachelor of Science degree in chemistry, Chris has gained over 20 years of analytical and regulatory experience working in global Medical Device and Pharmaceutical companies and within leading Contract Research Organizations. Chris co-founded Broughton Nicotine Services sister company (Broughton Laboratories) in 2006 and played a pivotal role in obtaining the first UK Medicinal License for an Electronic Cigarette, a project starting in 2010. Now with over ten years of working with ENDS, Chris has become well established as a recognized SME in the regulations and chemistry of tobacco products. In the position of Chief Scientific Office, Chris’ key objective is to support the acceleration of safer nicotine delivery products to market and to deliver value and unrivalled experiences to customer.
Dr. Niaura is Professor of Social and Behavioral Sciences and Epidemiology at the School of Global Public Health, New York University. From 2009-2017, he was Director of Research at the Schroeder Institute, Truth Initiative (formerly the American Legacy Foundation). He has extensive expertise in tobacco dependence and treatment, and he has published over 400 peer-reviewed articles and several book chapters in this area. His interests include studying the biobehavioral substrates of tobacco dependence; evaluating behavioral and pharmacological treatments for cessation; and understanding and addressing public health disparities in tobacco-related burdens of illness and disability. He has been Principal Investigator (PI) or co-Investigator of over 30 NIH-funded grants, and he is the former President of the Society of Nicotine and Tobacco Research. He was also PI of one of the NIH-sponsored Transdisciplinary Tobacco Use Research Centers (TTURC), and is currently a co-I of the Population Assessment of Tobacco and Health Study (PATH, funded by National Institute on Drug Abuse/Center for Tobacco Products, FDA), a national, longitudinal cohort study of more than 40,000 users and non-users of tobacco products ages 12+, including adolescents and young adults.
Azim Chowdhury advises domestic and international corporations on regulatory compliance with the U.S. Food and Drug Administration (FDA) and its global counterparts, particularly focusing on vapor, nicotine, tobacco product and cannabis/CBD regulation, as well as food-contact materials.
He counsels tobacco, e-cigarette, e-liquid and CBD manufacturers, distributors, retailers, suppliers, and trade associations on matters relating to regulatory compliance, as well as public policy initiatives. Azim is nationally recognized as an expert on the Family Smoking Prevention and Tobacco Control Act, which amended the Food, Drug and Cosmetic Act to give FDA authority over tobacco products, as well the Agency’s “Deeming Rule” which extended those authorities to previously unregulated products such as electronic nicotine delivery systems (ENDS), e-liquids, cigars, hookah/shisha, and heat-not-burn tobacco products. Azim also advises companies and trade associations on state and global law compliance, including in Canada, the United Kingdom, the EU, and China.
Bio coming soon.
Russell Quick is QRx Digital’s CEO and the contracted Global Marketing Director for Bidi Vapor . Russ is an expert in category management and has an extensive background in the
convenience store selling space. Russ has effectively written global go to marketing strategies for several Fortune 500 clients.
Tim Phillips is managing director of ECigIntelligence, the leading source of independent data for the e-cigarette and vaping sector globally, providing unbiased information to numerous leading international companies together with government regulators such as the FDA and the UK government. He is also managing director of a sister publication, CBD-Intel, which is a business intelligence service providing professional, independent market analysis and regulatory tracking for the growing cannabidiol sectors worldwide.
He is a U.K.-qualified attorney, having worked at the European Commission, Herbert Smith, BSkyB, AOL Europe, and as director of public affairs at Betfair as it went through its £1.5bn IPO in 2010. He was also a partner in a New York venture capital-funded startup in the diamond sector. Phillips qualified as a lawyer at the College of Law, London, and holds an MA in Geology from Oxford University.
Bio coming soon
Eric has extensive experience advising clients in the cannabis, e-cigarette & vaping industries. He advises clients on FDA and state regulatory compliance and enforcement issues, contractual and transactional matters, and intellectual property issues. Eric was part of a landmark litigation team that helped established the legal framework for the vaping industry as it exists today by successfully arguing against FDA that e-cigarettes are not drugs or medical devices. Eric has won constitutional cases against the State of Indiana on an e-liquid manufacturer licensing scheme and against the State of New York on an emergency rule banning flavored ENDS products. Eric represents clients at all levels of the manufacturing, distribution, and retail levels of the ENDS and cannabis industries and is currently advising a large number of clients on successfully navigating the PACT Act’s requirements.
David Ettinger is the chief representative in Keller and Heckman’s Shanghai, China office. Mr. Ettinger counsels multinational companies on the import and export of food and food-related products to ensure compliance with regulations in the U.S., Europe, and Asia. He also counsels clients on compliance with the laws and regulations in China regarding consumer products and tobacco-related products, such as e-cigarettes. Mr. Ettinger worked in the firm’s Washington, DC and Brussels offices, and is uniquely positioned to counsel foreign companies who need to navigate the regulatory landscape in Asia.
Mr. Ettinger is on the Executive Board and Chair of Mackrell International. He is on the leadership committee of the American Chamber of Commerce Shanghai’s Food, Agriculture & Beverage Committee. He is a frequent lecturer and author on international food safety matters. Mr. Ettinger is a Chambers and Partners ranked attorney in the area of Life Sciences (International Firms) – China and is listed in The Best Lawyers in America® since 2016 (FDA Law).
Prior to joining Keller and Heckman, Mr. Ettinger was a trademark attorney with the U.S. Patent and Trademark Office. Additionally, he has extensive trial experience as a former assistant district attorney in the Nassau County District Attorney's Office in New York where he prosecuted felonies and misdemeanors.
Bio coming soon
Mr. Richardson is an accomplished, results-driven regulatory affairs professional specializing in regulatory submissions, FDA interactions, and project management. He has more than 15 years of regulatory experience and has actively worked with Regulated Nicotine Products since 2015. He has led the successful submission of more than a dozen MRTPA, PMTA, and TPMF dossiers to FDA’s Center for Tobacco Products.
Bio coming soon