SUMMARY Early-life environmental exposures (e.g., social-environmental, parental risk factors, nicotine, diet, infection) are increasingly implicated in the early pathogenesis of childhood diseases that have life-long consequences. Mechanisms linking these exposures to longer-term outcomes remain limited. In 2016, the NIH established the Environmental influences on Child Health Outcomes (ECHO) Program, a collaborative multi-dimensional research initiative to characterize the impact of early-life environmental factors on childhood health (>70 cohorts, >50K participants). While targeted assays within ECHO are likely to lead to disease-specific insight, broad, comprehensive, unbiased assessment of the molecular space for novel discovery—a key mission of ECHO— will necessitate centralization of biobanking efforts/laboratory management with capability for high-throughput “OMICs”/non-“OMICs” assay as well as novel assay development, bioinformatics, and cloud architecture/data sharing for collaborative science. In response to RFA-OD-22-016, Vanderbilt will address this need by establishing the ECHO Laboratory Core at Vanderbilt for Integrated Sample Biobanking and Processing (ELVIS). ELVIS facilitates the collection and processing of biospecimens; manages the biorepository; performs a wide range of biospecimen assays (including novel development), and coordinates metadata and assay data transfer to the Coordinating Center. ELVIS is organized in core “resources” to provide leadership/integration to manage ECHO biobanking, assay performance, and data delivery: (1) administrative/LIMS/biobanking; (2) metabolomics; (3) proteomics; (4) nucleic acid assessment; (5) metagenomics; (6) bioinformatics/study design. We are uniquely positioned for this initiative, leveraging Vanderbilt’s unique long-term strategic investment in functional biobanking and assay: (1) large-scale, reliable biorepository receipt and laboratory management (“LIMS”) capability (>350K patients currently with biospecimens; many other NIH funded biobanks); (2) nationally recognized systems for clinical metadata capture (REDCap, REDBrics; used in NIH initiatives, like All of Us); (3) cutting-edge laboratory cores with capability for novel assay development/validation. We will establish harmonized protocols and workflow for ECHO cohort biospecimen collection and tracking infrastructure from the point of sample collection to long-term storage (Aim 1); perform high-quality, well-powered multi-OMICs and targeted assays to identify molecular correlates of disease trajectories in early life (Aim 2), and provide comprehensive data management platform to facilitate integrated data analysis (Aim 3). ELVIS is an ideal mechanism for ECHO given (1) deep, funded experience in handling the requisite sample sizes in banking and high-throughput assay, including quality assurance measures; (2) prior track record in ECHO to ensure ECHO- specific metadata collection, curation, and harmonization; (3) secure methods for cloud infrastructure for data analysis pipelines and data flow to clinical sites and data analysis center. Successful completion will enable the success of ECHO’s mission to discover molecular underpinnings of early childhood determinants of disease.

NARRATIVE The NIH has established the Environmental influences on Child Health Outcomes (ECHO) Program, a collaborative multi-dimensional research initiative to characterize the impact of early-life environmental factors (e.g., social-environmental, parental risk factors, nicotine, diet, infection) on childhood health. Vanderbilt will support ECHO by establishing the ECHO Laboratory Core at Vanderbilt for Integrated Sample Tracking and Processing (ELVIS), to facilitate the collection and processing of biospecimens; manage the biorepository; performs a wide range of biospecimen assays (including novel development), and coordinate metadata and assay data transfer to the Coordinating Center. Successful completion will enable the success of ECHO’s mission to discover molecular underpinnings of early childhood determinants of disease.