The NYU-Sage NAMs Data Hub and Coordinating Center: Harmonizing, Analyzing, and Disseminating New-Approach-Methodologies Data

About This Grant

Abstract The Complement-ARIE program aims to develop and implement New Approach Methodologies (NAMs) to reduce animal experimentation. Sage Bionetworks and NYU Grossman School of Medicine propose establishing the NYU-Sage NAMs Data Hub and Coordinating Center (NDHCC) to create an interoperable NAMs data ecosystem that accelerates NAMs adoption. The NYU-Sage NDHCC is organized to support four critical objectives: (1) The development of a new, adaptive framework called FUSION (FAIR, Unified Schema for Interoperability of Ontologies in NAMs) to harmonize NAMs standards and ontologies into a NAMs Common Data Model (CDM); (2) The implementation of a FAIR- compliant repository supporting both centralized and federated data access, data sharing, data analytics, training, and dissemination of NAMs information; (3) The deployment of a battery of analytical and visualization methods applicable across our centralized and federated data network; and (4) The cultivation of a collaborative research community which contributes to the development of standards, analytics, and insights and ensures sustainability of the NAMs ecosystem though their continuous engagement. To attain these objectives the NYU-Sage NDHCC is organized into five cores. The Vision and Management Core provides scientific vision and oversees the internal operations of the NDHCC and engages with the Complement-ARIE Consortium. The Data Hub Infrastructure Core builds a scalable, secure, and FAIR- compliant repository that facilitates data ingestion, integration, and sharing using a hybrid centralized/federated cloud architecture. The Data Standardization and Harmonization Core creates FUSION CDM—an evolving knowledge graph integrating diverse biomedical ontologies to harmonize terminologies in the NAMs world. This core also develops model credibility metrics aligned with regulatory requirements, creating a strong framework for NAMs validation and qualification. The Analytical Tools and Software Development Core provides standardized pipelines enabling researchers to rapidly generate analysis-ready data from diverse NAM sources and developing predictive models using AI methodologies. The Consortium Coordination and Outreach Core fosters collaboration through participatory activities. These activities include interactive workshops within the Complement-ARIE Consortium, benchmarking competitions for an extended community of researchers, and engagement with constituencies vested in the advances of NAMs technologies. By fostering a NAMs data ecosystem that actively contributes to and engages in NAMs advancements, aligning standards with regulatory needs, enabling validation of experimental results, and providing accessible analytical tools, the NYU-Sage NDHCC will contribute to accelerating NAMs adoption, reducing animal testing, and speeding biomedical discovery.