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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.

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

GSRS Key Takeaways from in-person meeting held March 2025, speakers from GSK

Insights gained from the Pistoia Alliance in-person GSRS workshop, in partnership with Cognizant, undertaken in March 20205.

Hear from our project experts Ian Mawer, Vasu Sampath, Veronica Glyn from GSK, and Raghu Sridharan from Cognizant discuss their journey with GSRS, your host Birthe Nielsen from Pistoia Alliance.

To discover more about how you become involved within the GSRS project, contact birthe.nielsen@pistoiaalliance.org.