Defining a set of agreed-upon core entities and associated controlled terminologies to service data exchange of Research & Development (R&D) information among Pharmaceutical Industry stakeholders.
Information exchange within and across organizations in the pharmaceutical industry is hampered by lacking or ambiguous formal asset description. These description would allow validation, facilitate discovery and promote interoperability, all of which having the potential to deliver significant gains for data exploitation and value delivery in the drug development pipeline, ultimately bringing better treatments to patients. The purpose of Pistoia Alliance led PGO is to identify and define core entities critical to the business. True to the notion of FAIR principles of data management [1] and their use in the Pharmaceutical Industry [2], the PGO aims to reuse existing semantic resources (ontologies and controled terminologies) as well as open source community software supportting the development of semantic resources and data schemas, rather than creating a new resource. Therefore, the initial goal of PGO is to provide enough coverage to represent essential entities most frequently used or refered to when exchanging data. Unambiguously identifying those, specifying when applicable, value-sets for key attributes by relying on community-agreed controlled terminologies, and documenting them in a machine actionable form will be the primary outputs of the project.
PGO is currently evaluating and using the LinkML for representing and documenting each of the types [3].
Concept | Definition | Status |
---|---|---|
Assay (method) | under development | |
Assay (biological) | under development | |
Biomarker | under development | |
Biospecimen | under development | |
Cell line | under development | |
Cell type | under development | |
Clinical study | under development | |
Compound | under development | |
Equipment | under development | |
Disease | under development | |
Drug | under development | |
Device | under development | |
Gene | under development | |
Indication | under development | |
Molecular target | under development | |
Product | under development | |
Program | under development | |
Project | under development | |
Protein | under development | |
Site | under development | |
Gene | under development | |
Species | under development | |
Subject-Person | under development | |
Target | under development | |
Unit | under development | |
Vocabulary | under development |
- 2023: scoping and use case definition
- 2024: identification formalization of core concepts, testing using LinkML
- 2025: application and field testing with real life scenarios
- Astrazeneca
- Chiesi Farmateuci
- Glaxo Smith Kline PLC
- Merck Group
- Novo Nordisk
- Pfizer
- Pistoia Alliance
- Hoffman la Roche AG