The Product Characterization and Manipulation Core, or "Product Core B," will be a critical and overarching component of the TCORS continuously serving and informing the three research projects in the Center by characterizing the toxicity and relative harm of new and manipulated tobacco products. The tobacco products are prioritized in accordance with FDA CTP's mission to safeguard the public health, accomplished via critical scientific discussion among some of tobacco control's leading scientific experts, who will be serving as members on the Center's external and internal advisory committees. Product Core B's leadership, composed of experienced tobacco exposure scientists, is responsible for identifying the analytical techniques most suitable to understand the toxicity associated with the products of interest. An experienced leader of teams made up of multidisciplinary scientists operating in regulatory environments. Dr. Sydney M. Gordon, will facilitate communication between the Core, rapid responses of the Center to CTP requests, the three Research Projects, and internal and external advisory committees. He will also implement the decisions and policies developed by these groups, and monitor timelines, milestones, and deliverables to ensure a successfully functioning Core. Dr. Gordon is supported in carrying out this work by an experienced collaborator, a project control specialist, and a team of qualified human exposure assessment scientists, including aerosol physicists and analytical chemists. His long-standing team has pioneered many of the analytical techniques necessary to conduct the product characterization of smoked and smokeless tobacco products and has access to multiple redundancies in equipment to handle rapid response requests and high volume demand. Additional Product Core B resources available to FDA CTP include high throughput, continuous monitoring, and novel Battelle-developed analytical techniques for quantifying levels of volatile, semi-volatile, and heavy metal components, as well as bacterial diversity in tobacco. All Product Core B measurements will be objective, defensible, and supported by a robust Quality Assurance/Quality Control program.
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