Archives: Speakers

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.

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.

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.

Within Sharp IRT Services, Richard is responsible for managing a variety of different initiatives in addition to the delivery and maintenance of Client IRT systems. These initiatives include designing and oversight of new system functionality such as the Sharp Drug Accountability Modules and Shipment Management functionality. Richard also is an integral part of the development of new processes and setting best practices within the IRT department. Richard manages the team’s day to day activities to deliver multiple projects in an efficient fashion. Richard has over 8 years’ experience in clinical systems development and 11 years of clinical trial experience.

Richard trained at the University of Nottingham Medical School where he gained his degree in biomedical sciences.

Dr. Knudsen is a globally-recognized cancer scientist and executive leader who joined Paradigm Health’s board following a successful term as Chief Executive Officer of the American Cancer Society (ACS) and its advocacy affiliate, ACS Cancer Action Network. Dr. Knudsen previously served as EVP of Oncology Services for Jefferson Health and Enterprise Director of the Sidney Kimmel Comprehensive Cancer Center, a National Cancer Institute (NCI)-designated center of excellence. She has served on the NCI Board of Scientific Advisors and as President of the Association of American Cancer Institutes. She has been a professor at Thomas Jefferson University for over seventeen years, now serving as Professor Emerita.

Kent Thoelke is a pioneering healthcare executive with over 30 years of clinical research experience. As CEO of Paradigm Health, he leads the company’s mission to create equitable access to superior healthcare for patients worldwide. Prior to joining Paradigm Health, Kent served as Chief Innovation Officer at ICON plc following its acquisition of PRA Health Sciences, where he was Chief Scientific Officer. Throughout his career at these organizations, he has driven digital transformation in clinical trials and championed data-driven approaches to make drug development more efficient and equitable across multiple therapeutic areas and geographic regions.

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.

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.