? BIOSTATISTICS AND BIOINFORMATICS CORE 3 The overarching goal of the P01 application ?Molecular Targeted Radionuclide Therapy for Tumor Immunomodulation and Enhancing Immunotherapy Response? is to develop a broad mechanistic understanding of the immunomodulatory capacity of molecular targeted radionuclide therapy as part of the next generation of immunotherapy approaches to improve the treatment of immunologically ?hot? and ?cold? tumors. The overarching goal of the Biostatistics and Bioinformatics Core (BBC) is to promote excellence in pre-clinical translation research proposed in this P01 application by providing dedicated and outstanding consultation and collaborative support and expertise in biostatistics, bioinformatics and research data management for the P01 Projects 1-4, Administrative Core, Core 1 (Radionuclide Production and Radiochemistry Core), and Core 2 (Advanced Imaging and Dosimetry Core), and as needed. The biostatistics component will provide support for all four projects and two cores. The biostatistics team draws its strength from biostatistics faculty with many years of collaboration with the P01 investigators. Biostatistics support for Project 1 and Core 2 (Advanced Imaging and Dosimetry Core) will be descriptive and exploratory in nature and involve statistical modeling and estimation in dosimetry studies. Biostatistics support for Projects 2- 4 will involve statistical modeling and inference and will be comparative in nature. The bioinformatics component proposes to provide support for Projects 2-4. The bioinformatics team draws its strength from bioinformatics faculty who have active collaboration with the P01 investigators. More specifically, it will provide bioinformatics support and analysis expertise with 1) T cell receptor sequence data, 2) RNAseq data from selective tumors of mice that show curative eradication of tumors in comparison with control tumors and to tumors receiving sub-optimal therapy resulting in escape of immunotherapy, and 3) single cell RNAseq data. In supporting the Administrative Core and the P01 overall, the BBC will develop a P01-wide database using a relational database management system that will serve as the database of record for all projects and cores for this P01. The BBC will provide support in research data management using this database, which will hold all data generated from the Projects and Cores of the P01 and serve as the central data hub upon which all biostatistics and bioinformatics analyses will be based.
? BIOSTATISTICS AND BIOINFORMATICS CORE 3 The Biostatistics and Bioinformatics Core will provide dedicated expertise and cost-efficient support in biostatistics, bioinformatics, and research data management for the P01 application, ?Molecular Targeted Radionuclide Therapy for Tumor Immunomodulation and Enhancing Immunotherapy Response.? This data science core is critical for the P01 to achieve its overarching research goals of 1) developing a broad mechanistic understanding of the immunomodulatory capacity of molecular targeted radionuclide therapy (TRT) and 2) evaluating TRT as part of the next generation immunotherapy approaches to improve the treatment of immunologically ?hot? and ?cold? tumors, and ultimately advance scientific knowledge and help all people live longer, healthier lives.