White Paper
Cell Therapy Process And Cost Model Simulations — Defining Process Improvement Strategy
According to Dawn Driscoll and ISCT experts, defining a good business model for cell therapy cannot be brought to fruition without taking into consideration every relevant aspect of a product lifecycle. Success is not only built on therapeutic effects, it is generated by dealing with each and all innovation aspects. Being able to reach the last clinical phases requires investment. Healthcare agencies are increasingly looking for cost-effective solutions. Besides, regulatory approval and sale license are not necessarily the key to commercial success. Well-defined strategies for reimbursement, prices and commercialization are indispensable. The economic aspects of a product need to be addressed from the very beginning – i.e., the early phase of development – to enable a viable lifecycle.
Efficient manufacturing strategies are the key to tackle commercialization challenges. Within the framework of cell therapy products, we can easily claim that the Product is the Process.
Several brilliant presentations highlighted the main cost drivers for both allogeneic and autologous production. ATMI has developed an efficient cost of goods (CoGs) model (cf. verso) that simulates cell therapy production and identifies key process optimization strategies.
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