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Alliance seeks participants and funding for an ontology project that will harness AI to semi-automate time intensive IDMP data process ahead of 2023 regulation

The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, launches its newest project: IDMP Common Core Ontology. The project will augment the existing Identification of Medicinal Products (IDMP) framework (ISO 11615:2021) defined by the International Standards Organization. The project team will devise a common core ontology under FAIR data principles to enable semantic interoperability and consistent representation of medicinal products across regulatory bodies, companies, and regions. From 2023, drug submissions to the European Medicines Agency (EMA) must comply with select IDMP standards. By developing an IDMP-compliant ontology with machine-ready data, the Alliance will support the move to automate this process, improving efficiency and patient safety, reducing costs and time burden, and driving innovation in the drug development pipeline. The project is managed by the Pistoia Alliance, with a project team of experts from Bayer, Novartis, Roche, Merck KGaA,  and GSK.

“Our legal framework for collaboration in the life sciences, combined with our experience in FAIR data implementation and ontology development makes the Pistoia Alliance the ideal organization to drive this initiative. The primary aim of IDMP standards is to protect patient safety. This project will ensure that life sciences organizations can meet these requirements by automating time consuming processes, whilst freeing them up to pursue more innovative work at the same time,” commented Dr Gerhard Noelken, Project Lead, Pistoia Alliance. “New IDMP requirements will come into place as early as 2023, yet we know from discussions with our members that many organizations do not have the applicable IDMP data ready for the future variation applications. This project will tackle this by helping companies de-silo processes and approaches, remove inconsistencies, and realize the predicted time and cost benefits of IDMP.”

In 2021 the European Medicines Agency (EMA) announced that starting in 2023, the Post-Authorization variation applications, for medicinal products for human use, will need to include IDMP structured data as part of the application form.  Currently, the language used in the regulatory, supply chain, pharmacovigilance and clinical sectors is inconsistent, with different terminology being used to describe the same products and active substances. This makes it difficult to correctly align information. Without a global ontology, the manual labour required to meet the IDMP mandate is substantial. Companies will suffer increased costs associated with data processing and longer workflows, loss of insight due to inability to access data, and non-compliance fines. Patients will also be affected through delayed drug approvals and insufficient safety profile data. The Pistoia Alliance’s IDMP Common Core Ontology will mean the drug data involved in the R&D process can be processed, held, and translated to an IDMP-compliant machine-readable format automatically.

“Inconsistencies in IDMP interpretation are a major time and financial burden for development organizations and create barriers to sharing data with regulatory bodies and other sectors. By using pre-existing standards to build an ontology, the project team aims to realize the full potential of the data currently contained within IDMP, and ensure standards are correctly implemented,” continued Dr Noelken. “Through collaboration with IDMP stakeholders, including WHO, ISO, EMA and FDA standards, the Pistoia Alliance will produce an ontology that is fit for purpose and can be applied globally. We also call on interested development companies to get in touch with us to contribute to the project and help shape the future of the ontology by sharing expertise, financial support and use cases.”

The first phase of the IDMP Common Core Ontology project will involve developing a minimal viable product (MVP) focused on the substance domain, which will be used to demonstrate value, provide use cases, and standardize data language before extending to further IDMP data domains for other regulated substances, including vaccines, gene-technology, and botanical substances. The Pistoia Alliance will provide this ontology as an open-source tool, and this implementation blueprint will provide value to development organizations of every size.

The governance and hosting framework for the project is provided by the EDM Council and its Open Knowledge Graph Innovation Lab. The EDM Council is a global non-profit trade association created to elevate data management best practices and the advancement of open-source industry ontologies. The ontology will be developed by digital R&D consultancy, Osthus. Whilst use-case implementation will be provided by Accurids’ data registration platform, Chemantics offers the required semantic and FAIR-compliant chemical integration capabilities.

About The Pistoia Alliance

The Pistoia Alliance is a global, not-for-profit members’ organization made up of life science companies, technology and service providers, publishers, and academic groups working to lower barriers to innovation in life science and healthcare R&D. It was conceived in 2007 and incorporated in 2009 by representatives of AstraZeneca, GSK, Novartis, and Pfizer who met at a conference in Pistoia, Italy. Its projects transform R&D through pre-competitive collaboration. It overcomes common R&D obstacles by identifying the root causes, developing standards and best practices, sharing pre-competitive data and knowledge, and implementing technology pilots. There are currently over 150 member companies; members collaborate on projects that generate significant value for the worldwide life sciences R&D community, using The Pistoia Alliance’s proven framework for open innovation.