PROJECT SUMMARY / ABSTRACT OF THE FUNDED PARENT AWARD In his State of the Union address on January 20, 2015, President Obama announced his intention to launch the Precision Medicine Initiative (PMI). The goal of the PMI Cohort Program is to enroll one million volunteers into a national cohort that broadly reflects the diversity of the U.S. population and accelerate progress toward a new era of precision medicine on a larger scale than previously possible. The objective of this proposal is to utilize the full resources available through the Mayo Clinic Biorepositories Program and Mayo Medical Laboratories to efficiently and cost effectively support the activities of the PMI Cohort Program with respect to the Biobank, namely, biospecimen collection, kit assembly, biospecimen accessioning, tracking, processing, quality assurance, storage, and distribution. Mayo Medical Laboratories, the third largest reference laboratory in the United States, will enable efficient specimen transportation, routing, and information management between PMI collection sites and the Mayo Clinic Biobank. The aims of this proposal are to: (1) To provide collection kits and leverage existing sample shipment logistics to ensure specimens arrive at Mayo Clinic Rochester in the most expedient, efficient, and safe manner possible, in accordance with all federal and state regulations; (2) Scale up existing state-of-the-art laboratory automation and robotics to process, label, and store biospecimens, using established protocols compliant with laboratory best practices for all steps of specimen handling; (3) Use our high-quality, robust, and secure research laboratory information management system (RLIMS) for detailed tracking of sample receipt, processing, storage, retrieval, and distribution, while protecting participant confidentiality; (4) Apply our comprehensive Quality Management Program to ensure all work carried out is of the highest quality, and safeguard the collection with robust back-up systems and plans for disaster recovery; and (5) Work closely with the Coordinating Center, Collection Sites, and all other PMI Cohort Program Steering Committee Members to share biobanking expertise, infrastructure, and data to further the goals of the PMI. Overall, the Mayo Clinic Biorepositories Program laboratories combined with Mayo Medical Laboratories provide an unparalleled ability to collect, accession, process, distribute, store, and manage virtually any type of biospecimen on behalf of the Precision Medicine Initiative Cohort Program.

PROJECT NARRATIVE The goal of the Nutrition for Precision Health (NPH) study is to develop algorithms that predict individual responses to food and dietary patterns. The biobanking infrastructure established at the Mayo Clinic for the All of Us Research Program will be used to support the biobanking requirements of the NPH study. The Mayo Clinic Biobank will provide a state-of-the-art facility and cost-effective services to ensure the success of this study.