New discoveries in Tobacco Regulatory Science (TRS) are occurring at a rapid pace, but translating these advances into more robust research practices and policy faces enormous challenges, including the synthesis and dissemination of these findings to reach a variety of stakeholders. In addition, as the tobacco product landscape continues to evolve, new TRS research is needed, as well as further integration to help inform the FDA?s regulatory actions. A strong coordinating center, serving as a hub and connector for TRS researchers, is critical to overcoming these challenges and to promoting effective TRS research. We have designed our Center for Coordination of Analytics, Science, Enhancement and Logistics (CASEL) to address challenges faced by this rapidly changing environment and expanding knowledge base.
Our specific aims are to: (1) Serve as the scientific research coordinator for TRS by facilitating collaboration and dissemination to advance the science and inform CTP rule-making; and by supporting the adoption of consensus methods and measures, data sharing, and synthesis; (2) Accelerate the progress of TRS by fostering communication, coordinating information-sharing opportunities, and making research resources readily accessible to the TRS community; (3) Enhance the capacity of researchers to conduct impactful research by supporting career enhancement activities across the CTP-funded research community; (4) Establish a logistical and management infrastructure for efficient and effective coordination of a diverse portfolio of TRS research; (5) Provide the scientific expertise and perspective to contribute to the identification of research needs and the means to work cooperatively with Federal partners and the research community to address them; and (6) Serve as a conduit between NIH, CTP, and the Tobacco Centers of Regulatory Science (TCORS) to enhance and accelerate output and facilitate the conduct of rapid response projects to address high-priority questions. We will accomplish these aims with a collaborative structure that builds on our experienced scientific and management leadership, well-developed infrastructure, and ability to bring diverse teams together to make CASEL a successful and supportive partner in advancing TRS. We have held the predecessor Center for Evaluation and Coordination of Training and Research (CECTR), and thus have a wealth of resources, experience, organization, and an established TRS network to step into CASEL seamlessly, to enhance and expand our initiatives, and to introduce nuanced, effective innovation in our approaches. Jeanne Rosenthal and Dr. Robin Mermelstein will serve as Co-PIs and leaders of the Leadership and Logistics Core, providing high-level management and nationally recognized scientific leadership respectively. Our highly experienced Core Leads, Dr. Howard Fishbein (Analytics and Synthesis), Ms. Amy Solis (Career Enhancement), and Dr. Cassandra Stanton (Dissemination), will provide effective and knowledgeable oversight to meet each core?s specific aims. We have brought together a wide range of collaborators to create an ideal environment to foster and promote the conduct of high quality TRS.
The Center for Coordination of Analytics, Science, Enhancement and Logistics (CASEL), serving as a central hub for the Tobacco Regulatory Science (TRS) research community, is a critical mechanism for providing the U.S. Food and Drug Administration?s (FDA?s) Center for Tobacco Products (CTP) with the timely and targeted information it needs to carry out its tobacco product regulatory activities. CASEL will contribute to this objective by providing scientific and logistical coordination, synthesizing and integrating data; facilitating collaboration; promoting use of common methods and measures; strengthening the development of TRS careers; and playing a central and key role in dissemination of TRS research findings.