IT for CGT

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Bridging the worlds of IT and CGT through analogies

Cell and gene therapies (CGTs) have enormous potential to create personalized therapeutics for patients with diseases that were once untreatable – but they come with some challenges. Many of these are because the end-to-end process differs from conventional biologics and, crucially, requires new IT capabilities. When rapidly bringing new therapies to market, it is challenging to work out a practical IT architecture and investment strategy that...

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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.

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Digital capabilities to support cell and gene therapies: What are the process blocks? How does it vary by therapy type? What digital capabilities do we need? How is it best to implement them?​

A member only webinar focused on how the required digital capabilities vary according to the type of cell and gene therapy platform and provide learning on reference capability descriptions to provide a starting point for IT discussions.

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IT for CGT: Digital capabilities for cell and gene therapy

There are many differences in manufacturing cell and gene therapies (CGTs) compared to established small molecule and biologics platforms and this profoundly affects the IT systems requirements. Some products are personalized so the process includes personal screening and sequencing data, with traceability and data privacy throughout. Starter cell variability adds complexity to a manufacturing process that must have a rapid turnaround, very dynamic scheduling and rapid deviation management. Outcomes must be tracked for the long term to improve patient outcomes as well as to support novel reimbursement models.Industrialization of CGTs therefore needs the support of advanced systems for manufacturing execution, orchestration, traceability, scheduling, patient data and outcome tracking. Some processes will be encapsulated in closed systems, and there may be analytical requirements for continuous process verification and dynamic adjustment. Operators distributed across the globe will be supported remotely by augmented and virtual reality technologies. This paper helps executives and IT professionals to understand the IT needed to support CGT manufacture, and stimulates collaboration across the industry to meet these challenges.

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IT for Cell and Gene Therapy

In 2020 only a few cell and gene therapies (CGT) are approved for commercial use, but hundreds of clinical trials are underway, and demand for manufacturing capability is set to grow. However the manufacturing equipment platform and associated digital capabilities are early in their maturity life cycle, in contrast to the established equipment platforms and digital capabilities for small molecule and biologics manufacturing. This is because...

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