The Genesis and Implementation of Labeling Standards to Ensure Patient Safety for CGT Therapies

06 Sep 2023
Stream 3
CGT Catapult

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




Jennifer Rabin
Specialist Leader, Next Gen Therapy Practice
Beth Gardner
Senior Director, Patient Supply
Beam Therapeutics
Karen Moniz
Technical Director
Jacqueline Barry
Chief Clinical Officer
CGT Catapult
William Shingler
Head of Patient and Cell Management
Autolus Therapeutics