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Delivering Data Driven Value

Resource Tag: Delivering Data Driven Value

CMC Process Ontology Community of Interest May 2025

The Pistoia Alliance is building a pharmaceutical CMC process ontology based on the ISA88/95 framework.

Our aim is to standardize laboratory and plant production process recipes to establish standardized definitions, facilitate digital technology transfers and integration with execution systems to capture structured process data for material lot genealogy tracking, streamlined technology transfers, and advanced process analytics; thereby enhancing efficiency and transparency throughout the pharmaceutical production lifecycle.

Having shown value of a semantic approach to CMC process management during the initial PoC phase, we have now continued with the next phase of the work to move beyond the PoC to a usable Ontology.

For more information please visit our dedicated project page: CMC Ontology.

AI-Ready Data and Why FAIR Data Matters in Life Science Companies

As life-science organizations race to adopt (generative) AI, one point begins to stand out: your AI is only as good as your data. While large language models (LLMs) offer powerful capabilities, they’re not tailored to specialized scientific data—and do need a solid data foundation. Making data Findable, Accessible, Interoperable, and Reusable (FAIR) enables AI systems to deliver more accurate, reliable, and cost-effective outcomes.
 
Key points include:

  • Why many AI projects are still fundamentally reliant on robust data management
  • How FAIR Data complements LLMs through explicit semantics and structure
  • The critical role of data quality and governance in AI success

Whether you’re a data steward, scientist, or innovation leader, this session will help you get more perspective aligning your data and AI strategies for maximum impact. Join us on May 21 to explore why durable AI strategy needs a robust data strategy including FAIR Principles. Don’t let unstructured data hold your AI back—make it FAIR.

Speakers
  • Angelika Fuchs, Roche, Chapter Lead, Data Products & Platforms
  • Martin Robbins, Ontoforce, Product Manager
  • Tom Plasterer, XponentL Data, Managing Director, Knowledge Graph & FAIR Data Capability
  • Ted Slater, EPAM, Managing Principal, Scientific Informatics Consulting

Hosted by Giovanni Nisato, Project Manager, Pistoia Alliance

FAIR Business Survey Report

Beyond Research: Realizing the Value of FAIR Initiatives

The FAIR Community has undertaken an extensive survey to assess the impact of FAIR data in life science companies. Our new report examines the most significant business drivers for implementing FAIR data principles and the key outcomes being delivered.

Pharmaceutical companies are applying FAIR in research and extending it to development, clinical, and operational functions. FAIR initiatives that started five or more years ago now deliver tangible improvements in data management processes and enhanced operational efficiency. Thanks to all our members who contributed to this vital research.

The Pistoia Alliance’s Methods Database Project

The Pistoia Alliance has successfully completed a pilot on the digital transfer of analytical High-Performance Liquid Chromatography (HPLC) methods and results between chromatography data systems (CDS) via a central data storage system using a standardized machine-readable data format, which transforms methods from paper documents to digital instructions.

Navigating the New IDMP Era: Data Quality, Ontologies, and AI-Powered Compliance

 
With the EMA’s Product Master Data Service live since 2024, ISO IDMP conformance is no longer looming at the horizon but an urgent regulatory imperative. Yet aligning complex medicinal product data to IDMP standards remains a major challenge for many Marketing Authorization Holders (MAHs).

 
Join experts from ACCURIDS and MAIN5 to discover a proven, data quality-driven method to assess and boost IDMP conformance using the IDMP Ontology. Learn how to automate maturity assessments, resolve common data issues, and rapidly build high-quality IDMP knowledge graphs. We’ll explore how AI supports intelligent data alignment across substances, products, and terminologies, and provide concrete examples of conformance measurement and remediation. This webinar is your practical guide to turning regulatory requirements into achievable data quality objectives — and ensuring your organization is ready for IDMP 2025 and beyond.
 

Agenda
  • Overview of latest IDMP timelines and actions for MAHs
  • Summary of pharma challenges in medicinal product data management
  • Why product data conformance with ISO IDMP is a MUST-Have?
  • Measure and increase IDMP data conformance with the IDMP Ontology and AI
  • The investment case for data standardization with the IDMP Ontology
Speakers
  • Raphael Sergent, ACCURIDS
  • Michiel Stam, MAIN5

Advancing Pharmaceutical Manufacturing

An Ontology to Standardized CMC Process and Enhanced Digital Tech Transfer

Pistoia Alliance 2025 London conference presentation by Nisha Bhudia, CMC Data Standards & Governance Expert, GSK

From Interoperability to Automation

Where next for FAIR Data Standards in AstraZeneca?

Pistoia Alliance 2025 London conference presentation by Mathew Woodwark, Head of Data Standards, Astrazeneca