This document presents a practical vision and reasoning for standardizing the traceability of CGTs across the value chain. A user-centric design perspective leads to an architecture that integrates interrelated services and a model for connecting data across the systems throughout the supply chain. It considers the current situation and process flows, envisions a series of user stories from the perspective of several key personas, and outlines the benefits sought from a more holistic approach.
IT for Cell and Gene Therapy
Viewing related articles
CGTs and their patient-specific delivery of therapeutics are seen by many as the future of medicine. However, the field of CGT manufacture is currently immature and typically involves multiple organizations in the delivery of a single CGT treatment. As well as the established biomanufacturers, there are many small players who are attempting to scale up from lab-based processes. Many of these CGT companies are working to establish their IT requirements, but there is no common understanding of a pharma company’s ‘normal’ CGT needs or those of the multiple organizations and experts involved.
This document contains a set of reference models explaining who needs to be involved in the supply of different types of Cell and Gene Therapies (CGTs) and, at a very high level, what they do. It can be used by anyone who wishes to better understand the manufacture and delivery of CGTs, and in
particular how IT systems can support that.
IT can be simple: Using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies
Cell and gene therapies (CGTs) are medicines with enormous potential to create personalized therapeutics for patients with diseases that were once untreatable. However with these opportunities come challenges. One is how IT and CGT teams understand each other’s needs and challenges – only once this knowledge gap is bridged will CGTs be produced and administered commercially. This paper uses analogies to help specialists from CGT and IT to discuss and understand the key issues in commercializing CGTs and important aspects of IT systems and infrastructure. The analogies also reveal those differences in a relatable way that stimulates creativity and joint problem solving, which are critical in this fledgling but fast-growing industry.