CGT personas and user stories

This document, with the associated spreadsheet and presentation, form a unique toolkit detailing the needs of all the key players involved in end-to-end cell and gene therapy(CGT) processes. It can be used by anyone who wishes to better understand how IT systems can support the manufacture and delivery of CGTs.

Context

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.

Content

In this document, the relevant organizational units (actors) and roles (personas) for CGT supply are defined and shown in diagrams, prompting readers to identify where those roles sit in their partner ecosystem. For each persona, a set of user stories describes what they need the systems to do for them to support the supply of CGTs, and why. The focus is on what is distinctive about CGTs, and on finding commonalities across a range of different CGT modalities.
The toolkit includes a spreadsheet and presentation which can be adapted to the unique needs of each partner ecosystem. The models can be extended to cover new modalities as they emerge, while still leveraging the commonalities.
The companion document CGT actors and process maps explains who does what in the supply of different CGTs.

Audience

The toolkit provides a common language and framework for collaboration that can be used by:

Manufacturers of CGT products
Contract manufacturing organizations
Treatment centers
Shipping partners
Vendors and developers of IT systems
Regulators.

Benefits

Using these models will accelerate the analysis and design of IT solutions to support CGT supply. These models draw on a wide pool of industry experience, consider the needs of each stakeholder and explain the reasons as well as requirements. The detail is full of nuances and tips based on reallife experience that will smooth the path for others taking this journey. By adopting the toolkit, IT systems can be developed that will support the needs of the industry.