Special interest group: De-centralised manufacturing and ‘close to patient’ approach is the future; How do we ensure the business model is viable and supports patients in accessing advanced therapies?

9:00     Opening remarks 

9.10     Group discussion, topics include:

• Viablity and attractiveness of the business model, who is going to hone that business model- will it be pharma, biotech, hospitals?
• What is the product from a regulatory perspective- is the product the cells or the process?
• Patient access: Is this approach cost effective? How do we globalise de-centralised manufacturing for the global patient population? How do we ensure patient safety?
• De-centralised manufacturing 2.0; how can digitisation and AI support the new era of advanced therapies?
• Autologous cell therapies; lets get real! Will they survive or will we find other way to treat patients as a field? How can we ensure the business model supports autologous?  The rise of in vivo, what does this mean for autologous?