Manufacturing cell and gene therapies (CGTs) usually involve the coordinated efforts of staff in treatment centres, shipping partners, and more than one manufacturing facility. It has become complex because each new therapy seems to define a contrasting way of doing things and has a different way of interacting across various combinations of the same companies. So how can we align processes? And how can we get to a level of digital maturity?
Overcoming this challenge needs new levels of collaboration and coordination between people and systems in different organizations. This should identify what each person needs from their IT systems and bring together data and processes in a coordinated way.
This is a complex challenge and is where BioPhorum is playing a key role. Its latest deliverable is a new toolkit that will support industry needs while reducing the costs for CGT manufacturers and software vendors, and the overall times for CGT treatments. It will also improve flexibility, regulatory compliance and integration between systems.
CGT personas and user stories: What people need the systems to do to support the supply of cell and gene therapies is a part of a unique toolkit that details the needs of all the key players involved in end-to-end CGT processes. It comes with an associated spreadsheet and editable presentation slides so that the combined knowledge of the authors can be directly used and adapted to accelerate analysis and design activities for systems to support CGTs.
The toolkit details what each of the key players (personas) in the end-to-end CGT supply process needs from the systems (user stories). It reveals commonality across therapy types and pinpoints where users in different organizations have similar IT needs. Most importantly, it explains what those users are trying to do and the reasons why, so that solutions can be built with a proper understanding of the true underlying needs.
The toolkit provides a common language and framework for collaboration that can be used by manufacturers of CGT products, contract manufacturing organizations, treatment centres, shipping partners, vendors and developers of IT systems, and regulators.
The companion document CGT actors and process maps explains who does what in the supply of different CGTs.
The toolkit will accelerate the analysis and design of IT solutions to support CGT supply – and is full of nuances and tips based on real-life experiences that will smooth the path for everyone taking this journey. These will fast-track the delivery of well-formed solutions that are useful, usable and used.
It will help designers consider scenarios where their organization may be handling other therapy types in the future. If IT solutions built today can support multiple therapy types, future therapies can be brought to market more quickly and be supported more easily.
Whether you are just considering entering the CGT field or are a more established player, the toolkit will help you think carefully about the needs of everybody involved in the end-to-end CGT process using a common language. The future will have many more supply partnerships and to remain agile as an industry, we need to work in common ways.
By identifying and describing the actors and personas, and listing the distinctive user stories for each, this toolkit is a small but significant step in understanding the complexity of CGT delivery.