Transforming Supply Chains into Quality Systems for Advanced Therapies

In this Dedicated Dialogue episode, Adam Fox, Chief Quality & Regulatory Affairs Officer of Cryoport Systems, explores how escalating regulatory expectations and patient-centric risk considerations are reshaping how advanced therapy supply chains are designed and scaled. Fox examines the quality infrastructure and end-to-end control strategies required to protect high‑value, temperature-controlled materials in an era where regulatory expectations and patient impact are higher than ever.

He also discusses why traditional supply chain models fall short in the context of cell and gene therapy and how leading organizations are embedding quality into the foundation of their supply chain strategy.

Listeners will gain insight into the quality-driven playbook guiding modern therapeutic supply chains, and how Cryoport Systems serves as a trusted partner to help organizations maintain compliance and continuity across the world’s most complex distribution networks.

Learning Objectives:

1. Identify the current-state supply chain limitations that create quality and compliance risks for cell and gene therapies.
2. Understand the quality systems and controls required to ensure GxP compliance across global CGT workflows.
3. Learn strategic approaches to building a quality-driven, risk‑mitigated CGT supply chain capable of supporting clinical and commercial growth.