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Pistoia Alliance aids compliance ahead of EMA 2023 regulation deadline

The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has completed the first phase of its IDMP Common Core Ontology project.

Key highlights:

The project supports companies in complying with the upcoming implementation by the European Medicines Agency (EMA) of the five IDMP standards set by the International Organization for Standardization (ISO)  by developing the IDMP Ontology to enable data integration and automate processes.

The Alliance – together with experts from Bayer, Novartis, Roche, Merck KGaA, GSK, Johnson & Johnson and Boehringer Ingelheim – has developed and successfully tested on live proprietary data a minimal viable product (MVP), focused on the substance domain of the IDMP standards. The Alliance is now seeking funding and involvement from more pharma companies, publishers, software companies, and vendors for the next phase to extend the data model to further IDMP domains, including vaccines, gene-technology, and botanical substances.

"Multiple implementation requirements are imminent – the EMA is just the first health agency to mandate compliance with ISO IDMP, and other international domains are likely to follow. Yet, from discussions with our members, we know that many organisations are not yet prepared because of the scale of the data challenge. Companies must invest in their data management now to minimise compliance risks and reduce the costs and time associated with data processing," commented Dr. Gerhard Noelken, project lead, Pistoia Alliance.

"We are proud to announce we have delivered this first phase on time and within budget ahead of the EMA deadline and that it's freely available to all. Our initial data model has proved valuable to our members, who are excited to keep the momentum going and move onto the next phase, expanding the ontologies to new IDMP domains."

Currently, there is no overarching body for the governance of IDMP standards. This means the terminology to describe substances used in the regulatory, supply chain, pharmacovigilance and clinical sectors is inconsistent. There is a risk that when the new EMA implementation becomes mandatory, companies will suffer increased costs associated with manual tasks to keep up with compliance and interoperability issues. For example, the Alliance estimates it takes three months to set-up a CRO collaboration without a harmonised IDMP Ontology and 40 FTE’s to gather and submit IDMP-SPOR (EMA’s Product Management Service) data.

The freely available ontology in development at the Alliance will mean the drug data involved in the R&D processes can be created, stored, and translated to an IDMP-compliant machine-readable format automatically so that researchers can refocus on innovation and the discovery of new medicines. 

"The Pistoia Alliance's legal framework, combined with its global network of life sciences and technology leaders, is perfectly positioned to drive this collaborative initiative. The project has been a huge success at the monthly community of interest meetings, where we demonstrate examples of how the project brings real-world data together," continued Dr. Noelken.

"But ontologies aren't linear – expanding our data model to the other IDMP domains will require involvement and input from even more experts. That's why we are calling on companies to get in touch with us so we can continue our successful work and extend the project's benefits to even more stakeholders across the industry." 

The MVP from the first phase of the IDMP Ontology project is now available under MIT open-source licensing.

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