Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science

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PROJECT ABSTRACT Tobacco regulatory science (TRS) provides the evidence base needed to inform the U.S. Food and Drug Administration's (FDA's) regulatory actions and activities. In partnership with the National Institutes of Health (NIH), FDA's Center for Tobacco Products (CTP) established a large, diverse, transdisciplinary research portfolio that aims to advance TRS and generate scientific evidence that FDA CTP can use to inform tobacco regulatory decision-making and protect public health. Additional TRS research is needed to address the ongoing changes in the tobacco product landscape and to continue to understand the health effects and related behaviors of the full complement of tobacco products. A strong and experienced coordinating center will help ensure maximum achievement of these goals by providing scientific leadership and analytic expertise to the research community; bringing researchers together to share methods, measures, data, and findings; providing resources and infrastructure to facilitate collaboration; support TRS career development; and disseminate research findings and relevant resources to the TRS community. The coordinating center will serve as the hub to effectively and efficiently accelerate the impact of research from the TRS community. Through this renewal application to serve as the Center for Coordination of Analysis, Science, Enhancement and Logistics (CASEL), the Westat team proposes to build on our existing infrastructure, approaches, experience and relationships to support the TRS research community and its Federal partners. Our specific aims are to: (1) m aintain a dynamic central hub that supports effective and coordinated collaboration and engagement across the TRS community, NIH, and CTP partners; create synergies and provide valuable resources to advance and accelerate timely high impact research ; (2) provide a robust logistical and management infrastructure within a strong leadership framework for meaningful coordination of the large and diverse portfolio of TRS research; (3) provide scientific leadership and facilitate timely responsiveness to regulatory scientific priorities; (4) coordinate career enhancement activities across the CTP-funded research community that increases research capacity and dissemination, provides mentorship and leadership opportunities for early career scientists, facilitates education in diverse disciplines in TRS, and offers networking and professional development resources; and (5) disseminate research resources to the TRS community through multiple channels, synthesize research findings across the community, provide opportunities to highlight emerging research findings, and coordinate information sharing to accelerate TRS. We are prepared to step into CASEL 2.0 seamlessly, to enhance and expand our initiatives, and to introduce nuanced, engaging innovation in our approaches. Our MPIs, Ms. Jeanne Rosenthal and Dr. Robin Mermelstein have both served effectively in their respective senior management and scientific leadership roles and will continue to oversee the work on the center, along with Core Leads, Dr. Cassandra Stanton and Dr. Andrea Stroup and Program Manager, Ms. Miriam Galbraith. These leaders and our knowledgeable scientific and administrative staff will work together to create a strong and supportive environment to foster and promote the conduct of high quality TRS.