Pre-Conference Workshop Day | Tuesday, March 11 2025

7:30-8:30 am Coffee & Registration

Workshop A

8:30-10:30 am Supply Chain Considerations When Expanding into New Regions

  • Darcy Weyant Associate Director, Clinical Supply, REGENXBIO

Synopsis

  • Outlining different chain of identity & custody (COI & COC) requirements for different major regions
  • Carrying out effective training into shipping, storing, handling, and administering CGTs
  • Identifying shipping requirements, vendor identification, and storage facilities with suitable infrastructure
  • Highlighting key differences in supply chain regulations between different regulatory bodies
  • Supply chain-specific considerations to be aware of when looking to globally commercialize a CGT

10:30-11:00 am Refreshment Break

Workshop B

11:00-1:00 pm Mastering the Selection, Timing & Implementation of Digital Solutions

Synopsis

  • Creating a framework for system integration across all COI & COC activities
  • Finding solutions that encompass both product and patient journeys
  • Product- and IT- related considerations to smoothly integrate these
  • Data harmonization across multiple platforms to simplify processes for clinical sites
  • Regulatory considerations for the data transfer being implemented

1:00-2:00 pm Lunch

Workshop C

2:00-4:00 pm A 101 in Allogeneic Cell Source-Specific Supply Chain Requirements

  • Kevin Liao Director, Supply Chain, Caribou Biosciences
  • Kellen LaVigne Associate Director, Supply Chain & Logistics, Aurion Biotech

Synopsis

  • Fine-tuning donor selection, accessibility and supply chain security
  • Practical solutions for the current cryogenic shipping bottleneck
  • Considerations for product handling and secondary labelling of a cryopreserved product
  • Setting out a robust pick and pack fulfilment strategy
  • Understanding the skillsets needed to set up and monitor interactive response technology (IRT) systems

4:00 pm End of Pre-Conference Workshop Day