Ontologies

The European Medicines Agency (EMA) will be the first health agency to mandate compliance with ISO IDMP (Q4, 2024), with the FDA not far behind. Governance of essential IDMP standards and implementations is not assigned to a specific, overarching governing body. Diverging implementations of IDMP across geographical regions and jurisdictional domains are already causing inconsistencies in the interpretation across implementing organizations. Given that there is no semantic alignment between regulatory bodies, there exists a risk that regulatory compliance needs will lead to large integration and interoperability costs and that the benefits from IDMP in drug safety, innovation, and other areas will not be fully realized. Rather than concentrating on the discovery of new medicines, organizations will be struggling with data issues, e.g., the need to map product data across the organization, throughout the product lifecycle.

Due to our robust framework for pre-competitive collaboration. The Pistoia Alliance was selected to manage this initiative with the goal of creating an ontology that demonstrates added value to the ISO IDMP standards for data usability across organizational boundaries and regulatory jurisdictions. We have pulled together a core team consisting of Pharmaceutical stakeholders, regulatory bodies, standards organizations, non-profit groups, and solutions providers for this project.

The key objectives  for the project include:

1. Provide a digital, machine-processable standard.
   – The Pdf document provided by EMA is not enough as different groups implement it differently
2. Solve ambiguities of the ISO IDMP standards enabling feed improvements back to ISO through systematic reviews
3. Bridge different views with ONE product data model between internal pharma departments and between industry groups
4. Provide a vendor-agnostic, and open-source model. The ontology is fully standards-based without any proprietary aspects
5. Reduce implementation effort through a common core

This project supports the implementation of the Findable, Accessible, Interoperable, and Re-usable (FAIR) guiding principles by sharing best practices.

Implementation of the FAIR guiding principles is important for the Life Science industry, as described in Drug Discovery Today. FAIR Implementation releases far greater value from data and associated metadata over a much longer period of time, including enabling more likely and effective secondary reuse.

As the life science industry continues to transform digitally, this project will help foster greater collaboration and more effective industry partnerships.

The project is enabled by a world-class community of  experts practitioners  implementing the FAIR principles in pharmaceutucal companies and other life-science organisations.

The community collaborates pre-competitively through regular online meetings, workshops, and live events e.g. during Pistoia Alliance’s yearly conferences.

Active participants in working groups develop closer ties with world-leading experts across industries, co-creating cross-industry pre-competitive resources while contributing expert time or other in-kind resources.

The currently active Working Groups include:

• Business value of FAIR
• Best-practices and thought leadership

The Sponsor members of the Steering group ensure governance and strategic support and provide guidance to the working groups enabling strategic cross-industry alignment.

Ontologies can include hierarchical relationships; taxonomies; classifications and/or vocabularies which are becoming increasingly important for support of research and development. They have numerous applications such as knowledge management, data integration and text mining where researchers need to analyse large quantities of complex data as part of their daily work. Mappings between ontologies extend their scope for application in a scalable and efficient manner.

The Ontologies Mapping Project helps users to select top performing tools, methodologies and services for mapping and visualisation of ontologies, to understand ontology structure, potential overlaps and equivalent or similar meaning. The project enables better integration and analysis of data through better usage of public ontologies and mappings between them.

The project has built a Community of Interest of considerable size and influence in the ontologies field. It has delivered a set of guidelines for use as a checklist to facilitate the selection of ontologies for application. The Ontologies Guidelines for Best Practice are available on the public wiki for Ontology Mapping resources.

We have evaluated ontology mapping tools and algorithms through and organised the phenotype track of the Ontology Alignment Evaluation Initiative (http://oaei.ontologymatching.org). Collaboration with EMBL-EBI has demonstrated a prototype ontology mapping service for public ontologies in the phenotype and disease domain, which has been extended successully to the lab analytics domain.