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The Pistoia Alliance is building the advanced semantic architectural design for a Pharmaceutical CMC Process Ontology.
The initial MVP involves the domain lexicon and taxonomy building to extend the ISA88 framework 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.
This initial phase of the project will deliver a series of critical improvements to inefficient technology transfer and data integration between stages and scales, as well as integrating data across production systems. An ontology will improve efficiency and transparency throughout the pharmaceutical production lifecycle.
The project team is working on three use cases (Process definitions, process monitoring, and comparative analysis). As an industry first, this 1-day workshop will demo the outcome from this initial MVP phase with data to show the value of a semantic approach to recipe and process management.
Collaborative development will drive success, and if industry-wide data standards and approaches to data management are to be agreed upon and implemented successfully, organizations need to collaborate.
This 1-day workshop aims to widen the project team to propagate the pharmaceutical CMC process ontology project to become an integral part of the system infrastructure in all pharmaceutical and manufacturing facilities. We now also welcome vendor support to develop implementation guidelines for the application of the Process Ontology to process recipes within electronic Laboratory Notebooks (eLN) and Manufacturing Execution Systems (MES) and the creation of ePTDs.
Introducing and adopting shared standards improves the efficiency and effectiveness of R&D. It improves quality and reduces the cost and time burden on scientists and their organizations.
We are keen to welcome new contributors to the project to continue discussing common barriers to successful process recipe management and work together to extend the ontology and use cases beyond this initial phase.
Agenda:
08.30: Registration and Coffee
09.00: Welcome by the Pistoia Alliance and host Amgen
- Safety and Logistics
- Objectives and structure of the workshop (Birthe Nielsen/Tom Mistretta)
09.15: Session 1: Why are we doing this?
- Keynote #1: Ontologies: Secret Sauce to Structured Data & Enable Digital Pharma 4.0
- Keynote #2:Overview of the Pistoia Alliance’s CMC ontology project / Vision and goal of the CMC Ontology project
- Q&A
10.15: Coffee
10.30: Session 2: What have we achieved? DEMO and output from Phase I
- Keynote #3: Overview of the ontology
- Keynote #4: Protein and synthetic molecule processes – mock up recipe to show step by step instructions
- Q&A
12.00: Lunch
13.00: Session 3: Data analytics
- Keynote #5: Alignment with IDMP-O and AFO – Data analytics 4.0
- Keynote #6: Case study from Merck KgaA (data analytics)
- Q&A
14.30: Coffee
14.45 Session 4: What is the Next Phase and Engagement Process?
- Feedback & opportunities
- Sustainability / governance of ontology?
- Roadmap for needed infrastructure?
- Industry aligned approach / Vendor adoption of ontology
- Business needs?
- How much in the pre-competitive mode can we do?
- Next set of challenges
- Final outputs of this project
16.00 Closing remarks and wrap up
Sponsorship and collaboration opportunities exist – please contact zahid.tharia@pistoiaalliance.org for sponsorship details and birthe.nielsen@pistoiaalliance.org
for collaborations.
Please note registration is now closed. If you would like to participate in the event, please email birthe.nielsen@pistoiaalliance.org