Biomarker Analytic and Regulatory Core

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PROJECT SUMMARY Tobacco regulatory science (TRS) is a rapidly evolving field driven by numerous regulatory changes since the inception of the 2009 Family Smoking Prevention and Tobacco Control Act. Because regulatory actions must be based on empirical evidence that demonstrate public health benefits, data are needed to inform potential tobacco control policies. Based on our previous TRS experience, we recognize the need for strong supporting infrastructure within the UP-RU TCORS to take advantage of future opportunities to further TRS. Specifically, projects may benefit greatly from having an existing infrastructure to support: 1) novel analytic approaches, data measures, and data management; 2) biosample collection, analysis, and storage; and 3) regulatory filing and reporting structure. To address this need, we propose a dedicated Biosample, Analytic and Regulatory (BAR) Core to establish this infrastructure and provide support from established investigators in these respective fields who also have strong knowledge in the emerging field of TRS. The overall goal of the BAR Core is to maximize the contributions of projects conducted within the UP-RU TCORS to TRS. The first aim of the BAR Core is to support within-center primary projects with harmonized measures, data collection, and analytic resources. This includes using similar measures across our proposed studies, aligning with PATH, PhenX and other large scale initiatives, study recruitment logistics and centralized data quality check and assurance activities. The second aim of the BAR Core is to support pilot projects with biosample, analytic and regulatory expertise, in order to better align them with center projects and have a greater impact in the TRS research community. We will assemble experts in tobacco-related biosample work, tobacco research-specific statistical approaches and data collection requirements. The final aim of the BAR Core is to support RRPs with biosample, analytic and regulatory expertise. At the formative stages of RRP planning, we will bring in experts in biostatistics, biosample collection and analysis, and regulatory filing, in order to enhance our proposed projects. BAR Core investigators are experts in each of the Core's domains (Biosamples, Analytics, and Regulatory), and have an established history of conducting TRS-relevant research. It is this critical intersection of specific domain knowledge and the understanding of TRS research that is needed to advance the science. This core will be a cost-efficient approach to harmonizing measures and procedures of the primary projects and supporting innovation and creativity in the pilot projects and RRP Program.