Annual Meeting of the GTA
May 3-4, 2018
John M. Clayton Hall Conference Center
University of Delaware
Workshop I: Deriving compound specific exposure limits for chemicals used in pharmaceutical synthesis
Wednesday, May 2, 2018 (1:30 - 5:30 pm)
Chairs: Krista Dobo, Pfizer Worldwide Research and Development and Will Drewe, Lhasa Limited
Presenters: Joel Bercu, Gilead; Trish Parris, Astra Zeneca; John Nicolette, Abbvie; Zhanna Sobol, Pfizer Worldwide Research and Development
Abstract: The calculation of compound specific Acceptable Intakes (AIs)/Permissible Daily Exposures (PDEs) to establish allowable limits for impurities in pharmaceuticals is an accepted practice. However, the process is often time consuming and costly, with the potential for duplicative and/or non-equivalent assessments being generated at multiple companies and submitted to regulatory agencies. Led by Lhasa Limited, the AI/PDE project has brought together an expert, cross-industry consortium to share and harmonise AI and PDE monographs for reagents and solvents commonly used in pharmaceutical synthesis. This workshop will seek to introduce the AI/PDE data sharing project and explore, through a series of case studies and discussion topics, some of the common challenges encountered when developing a monograph, including data selection, assignment of safety factors, approaches to use in absence of data, and approaches for establishing limits for different routes of administration.
Workshop II: Latest developments in regulation and assessment of combustible and alternative tobacco products
Wednesday, May 2, 2018 (1:00 - 6:00 pm)
Sponsored by: Altria Client Services, British American Tobacco, Charles River Laboratories, Japan Tobacco, Reynolds American Incorporated Services Company, Philip Morris International
Chairs: Leon Stankowski, Charles River Laboratories, Martha Moore, Ramboll Environ International
Presenters: Phil Yeager, US FDA Center for Tobacco Products; Hans Rosenfeldt, US FDA Center for Tobacco Products; Julie Clements, Covance; Kei Yoshino, Japan Tobacco; Jingjie Zhang, Altria Client Services; Marianna Gaca, British American Tobacco; Betsy Bombick, Reynolds American Incorporated Services Company; Daniel Smart, Philip Morris International
Abstract: Genetic toxicity testing has been used for many years to assess tobacco products, particularly as a part of product stewardship. They have been applied to a variety of products, including individual ingredients, combustible cigarettes, heat-not-burn cigarettes, cigars, water pipes, smokeless tobacco, etc. These test have provided data to: 1) evaluate the potential toxicity of individual additives; 2) provide direct comparison of combustible tobacco products; and 3) compare traditional combustible tobacco products with various newer tobacco products with potentially reduced health risks. In recent years, new regulations and guidances have been adopted in a number of countries that recommend or require specific genetic toxicology tests as a part of a battery of tests that are to be conducted and submitted. More recently, electronic nicotine delivery systems (ENDS) have become subject to these regulations and guidelines, and genetic toxicology tests are now being applied to these products. This workshop will provide a general overview of the international regulation of tobacco products, and the associated – and challenging – technical issues, as related to genetic toxicology testing of these products. Specific research approaches and studies, using several different genetic toxicology assays for assessing combustible or heated tobacco products, as well as ENDS, will be presented.