Benefits and Limitations of De-Centralizing Cell Therapy Manufacturing and Clinical Development
4:15 PM - 5:15 PM (EDT), Wednesday, June 7, 2023 ・ Session Room 206AB
As more and more diverse cell therapies are progressing through the pipeline, innovators are confronted with capacity and capability bottlenecks in manufacturing and clinical development which prevent them from reaching global patients efficiently. Taking an autologous cell therapy manufactured in a US facility and administered to patients in other regions of the world as an example, the current supply chain may be unnecessarily complex and excessively cost intensive. Fully integrated, highly scalable, automated and closed systems for manufacturing and release are still in development and there is uncertainty about how to achieve future global coverage. For allogeneic therapies, supply of HLA-matched cells for use in different types of global populations requires sourcing cells globally and in sufficient quantity. Regional hubs for manufacturing and development may be a suitable model, especially where these hubs support a global clinical development strategy. The session intends to explore how global market trends, emerging technology and global development strategies shape the future manufacturing base of cell therapies.
Managing Director Finance & Enterprise Performance/Real Estate & Location Strategy
Deloitte Consulting LLP