Ontologies - A Leading Edge Case Study

The ISO standards for Identification of Medicinal Products (IDMP) provide an internationally accepted framework to uniquely identify and describe medicinal products. Driven by regulatory requirements, the role of IDMP is to align the pharmaceutical industry with data standards that enable the unambiguous identification of products and the substances they contain. IMDP implementation efforts at numerous large pharmaceutical companies have only partially achieved these goals, though. They are diverse, built in silos, not fully standardized, and have already created inconsistencies of interpretation, in part due to ambiguities and gaps in the standards they depend on. As a consequence, there is a very real risk that envisioned benefits from IDMP in drug safety, innovation, and other areas cannot be fully realized. Instead of concentrating on pharmaceutical innovations in new and repurposed medicines, the companies required to use these standards struggle with data issues.

Work is ongoing to specify an ISO IDMP Logical Model that details data requirements in a technology-independent manner. Realization of the full potential of IDMP requires, however, taking this one step further and ensuring that the data is (1) unambiguously specified, (2) fully self-describing, and (3) interoperable across the pharmaceutical companies and regulatory agencies that govern their work. To that end, a diverse team of pharmaceutical companies, regulators, and technologists have come together to augment the existing standard and logical model with an IDMP Ontology that enables deep, semantic interoperability based on FAIR principles. This will ultimately enable entirely new ways of collaboration and enable early adopters to gain a competitive advantage in innovation, drug safety, and overall operational efficiency.

In this talk, Ms. Kendall, who is the lead ontologist for the project, will provide an overview of the project, present the approach taken to demonstrate clear and compelling results to project stakeholders in an initial 6-month phase, and discuss lessons learned in comparison with other industry ontology efforts as well as progress since that initial release in September 2022.

Speaker: Elisa Kendall

Ms. Kendall is a Partner in Thematix Partners LLC and a graduate-level lecturer in computer science, focused on Data Management, Data Governance, knowledge representation, and decisioning systems. Her consulting practice includes business and information architecture, knowledge representation strategies, and ontology design, development, and training for clients in financial services, government, manufacturing, media, pharmaceutical, and retail domains.

Recent projects have focused on the use of ontologies to drive natural language processing, machine learning, interoperability, and other knowledge graph-based applications. Elisa represents knowledge representation, ontology, information architecture, and Data Management concerns on the Object Management Group (OMG)’s Architecture Board, is co-editor of the Ontology Definition Metamodel(ODM), and is a contributor to a number of other ISO, W3C, and OMG standards, including the Financial Industry Business Ontology (FIBO) effort.