Will 2025 be a defining year for IDMP progress?
Summary
Up to now, the pharma industry’s advances in implementing ISO IDMP product data standards have been patchy. New research has looked more closely at companies’ IDMP readiness, as well as their progress with FAIR data principles and plans to adopt Pistoia Alliance’s IDMP-Ontology. MAIN5’s Michiel Stam discusses the findings.- Author Company: MAIN5
- Author Name: Michiel Stam
- Author Email: michiel.stam@main5.de
- Author Website: https://www.main5.com/
With renewed momentum around ISO IDMP internationally, MAIN5 recently partnered with Pistoia Alliance and data registry specialist Accurids to determine current progress toward IDMP implementation. The benchmark study[1] also explored companies’ relative maturity in supporting FAIR data principles, geared to making data more Findable, Accessible, Interoperable, and Reusable. These are championed by Pistoia Alliance, whose IDMP-Ontology (IDMP-O) project aims to encourage uniform adoption of the IDMP standards.
Ambitions are high, but interoperability barriers remain
More than 70% identified IDMP’s value as an enabler of cross-functional data integration, suggesting that the more strategic potential of the standards is now widely understood. Companies typically plan to integrate IDMP data from Regulatory, Manufacturing, Pharmacovigilance, Supply Chain, and Quality functions within the next three years. Research, (pre-) Clinical, and Commercial data integration will follow in the mid-term (within five years).
Product data management continues to pose a challenge for companies, however. The study identified particular issues with manual data collection, data silos, and a lack of data integration across systems. An unclear source of truth and insufficient use of trusted external sources were also flagged as barriers to harnessing product data more strategically.
Those actively striving toward more seamless data integration across and between functions felt that a lack of resources and issues with ‘ownership’ were the main barriers to achieving this (indicated by 44% and 41% of respondents), beyond a current lack of data standardisation (the main obstacle, cited by 56%). Curiously, the quality of data (which determines its usefulness) was ranked below these factors (cited by 33%).
The importance of an agreed ontology
Encouragingly, 43% of the participating pharma companies expressed a willingness to take Pistoia Alliance’s IDMP-Ontology into production within their organisations in the very near future. It must be noted however that many of the organisations taking part in the survey are already close to IDMP-O.
IDMP-O’s main perceived value is around the scope to enhance the integration and exchange of product data. Other identified benefits are linked to supporting greater process automation, and AI - positively impacting analytics, and ultimately reducing costs. That’s as long as companies put in the groundwork - in devising an optimum strategy; implementing supportive system capabilities; and recruiting and training a workforce to collect, transform, and submit data according to what is needed in each setting.
[1] The IDMP benchmark survey of 18 pharma companies was conducted in Q3 2024 by Pistoia Alliance, MAIN5, and Accurids, and supported by the IDMP-Ontology project with participants from Abbvie, Amgen, AstraZeneca, Boehringer Ingelheim, Bayer, and Novartis.
