Pharma companies remain at differing levels of readiness for implementing ISO IDMP product data standards, and in their maturity around adopting FAIR data principles, geared to making data more Findable, Accessible, Interoperable, and Reusable. Here, MAIN5’s Michiel Stam unpacks the findings of new research which benchmarks the industry’s progress, as well as plans to adopt Pistoia Alliance’s IDMP-Ontology to optimise standardised data use.
Although ISO IDMP standards, designed to harmonise the way the life sciences industry records and manages data about its products, have been more than a decade in the making, companies’ state of readiness to implement and harness IDMP still varies considerably.
The same is true of their relative maturity in supporting FAIR data principles, geared to making data more Findable, Accessible, Interoperable, and Reusable. These are goals that are actively promoted by Pistoia Alliance, a nonprofit industry coalition working to lower barriers toward innovation in life science and healthcare R&D through pre-competitive collaboration. Its IDMP-Ontology (IDMP-O) project, launched in early 2024, aims to create a shared ontology (a representation of data properties and the relations between them), to encourage uniform adoption of the IDMP standards and, by extension, consistent information exchange.
With renewed momentum around EMA’s IDMP implementation in Europe, FDA’s own related plans in the US, as well as the cross-industry initiatives outlined above, MAIN5 recently partnered with Pistoia Alliance and data registry specialist Accurids to conduct new benchmark research to determine companies’ latest progress and planning around IDMP implementation.
Silos & a Lack of Standardisation Have Compromised Companies’ Digitalisation Ambitions
Large pharma companies now generally have good awareness of the value of IDMP-based product data standardisation as part of wider process digitalisation ambitions, the survey confirmed. More than 70% of those surveyed identified IDMP’s value as an enabler of cross-functional data integration; only 11% saw compliance as the primary goal of IDMP projects.