The supply of cell and gene therapies (CGTs) involves new levels of collaborative partnership and coordination between organizations. Identifying what each organization does and how it interacts with the others in a coordinated way is a complex challenge. IT solutions are needed to manage this complexity, coordinate all the moving parts, and make CGT supply scalable and cost-effective.
This toolkit – which identifies and describes the organizational units (actors), process blocks and customer-critical paths for a number of CGT modalities – is a small but essential step in promoting understanding of the complexity of CGT delivery.
Readers of this document, whether just entering the CGT field or more established players, are encouraged to use the toolkit to think carefully about the needs of everybody involved in the end-to-end CGT process using this common language. The future will have many more supply partnerships and therapy types, and to remain agile industry needs common ways of working.
Using this document, solution designers can consider future scenarios where their organization may be handling other therapy types. If IT solutions built today can support multiple therapy modalities, then future therapies can be brought to market more quickly and supported more easily.
The challenge is laid down for the vendors and developers of IT systems to adopt this toolkit and work with the organizations and experts involved to develop comprehensive, integrated IT suites that will transform the supply of the full range of advanced therapies, making them scalable and cost-effective.