Digital Delivery of Personalised Advanced Therapies

Advanced Therapies have come of age. The spectacular clinical results demonstrated by novel gene-engineered T-cell therapies, with subsequent regulatory approvals in the US and EU, have confirmed the commercial reality of a new class of therapeutics that offer real hope to patients who are bereft of effective treatment options. But behind this hope lies a deep concern that problematical scalability will severely limit patient access to these therapies. Current Supply Chain technologies and Delivery approaches are inadequate to address the needs of complex madicines that require individual manufacture and a 'closed loop' supply chain whereby the hospital and patient themselves are both the provider of input material and the receiver of a personalised medicine. What is required is a sophisticated approach that allows for flawless tracking and tracing of each batch both during manufacture and during delivery. Integratred into this supply chain is a series of intelligent systems that manage all aspects of manufacture, thus permitting the efficient and scalable certification and release of thousands of batches without any compromise to Product Quality. This Project will pilot these technologies at scale and integrate those findings into a full scale UK-based Advanced Therapies Manufacuring Centre. Keywords: Advanced Therapies; Personalised Medicines