The Genesis and Implementation of Labeling Standards to Ensure Patient Safety for CGT Therapies
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14:00pm Chair Introduction
Chairperson: Jennifer Rabin, Specialist Leader, Next Gen Therapy Practice, Deloitte
14:05pm Presentation: Anchoring Patient Safety (and Site Sanity) with New Labeling Standards
- Why do we need labelling standards?
- How did this initiative start? Where are we now?
- Overview of ISBT-128 ST-018 (Labeling of Collection Products for Cellular Therapy Manufacturing) and ISBT-128 ST-028 (Chain of Identity Identifier)
Beth Gardner, Senior Director, Patient Supply, Beam Therapeutics
14:20 Presentation: International Labeling Standards Impact Patient Safety by Decreasing Complexity and Improve Traceability and Interoperability
- What are the international ISBT 128 labeling standards?
- How can they decrease complexity?
- How do they improve traceability and interoperability?
Karen Moniz, Technical Director, ICCBBA
14:35pm Presentation: Implementation of ISBT 128 labels for Cell Therapy products in a Healthcare setting.
- Discussion of the barriers and benefits to implementing the ISBT 128 label for cellular materials as starting materials for Advanced Therapy Medicinal Products manufacture
Jacqueline Barry, Chief Clinical Officer, Cell and Gene Therapy Catapult
14:50pm Presentation: How has the Industry Implemented the Labelling Standards (Case Study: Adopting a Standardized Chain of Identity Identifier to Enable Smooth Running of Operations Across Sites)
- Autologous Patient Cell Journey
- Clinical Phase Considerations
- Transition to Commercial Launch Readiness
William Shingler, Head of Patient and Cell Management, Autolus
15:05pm Closing Panel with Q&A
With all session participants
Speakers
