Cell and gene therapies (CGTs) and their patient-specific delivery of therapeutics are often seen as the future of medicines. However, CGT manufacture is complex and typically involves multiple organizations delivering a treatment. In such complex ecosystems of delivery partners, it is vital to define who does what, and how it is all orchestrated.

A new BioPhorum document contains a set of reference models explaining who needs to be involved in the supply of different types of CGTs and, at a high level, what they do. It can be used by anyone who wishes to better understand the manufacture and delivery of CGTs, particularly how IT systems can provide support.

CGT actors and process maps: who does what in the supply of different cell and gene therapies defines the relevant organizational units (actors) for CGT supply using clear diagrams, prompting readers to identify where those actors sit in their own partner ecosystem. The function of each actor in the supply process is shown in a few simple process blocks.

Using these models will accelerate the analysis and design of IT solutions to support CGT supply by establishing a holistic end-to-end view of the supply process. Also, it highlights the commonalities and differences with other types of products and reveals the key touchpoints between partner organizations that may require systems to be integrated.

Cutting costs and saving time

By adopting the toolkit, IT systems can be developed that will support industry needs. These will cut costs for CGT manufacturers and software vendors while reducing the overall time for CGT treatments. At the same time, it will increase flexibility, regulatory compliance, and integration between systems.

Six common types of CGT are analyzed (e.g., targeted genetic vector and autologous cell therapy), showing how the pattern of actors and process blocks varies by therapy type. Particular attention is paid to the customer-critical path, i.e., the sequence of steps that need to happen within the tight turnaround times of advanced personalized therapies.

The toolkit includes a spreadsheet and presentation that can be adapted to the unique needs of each partner ecosystem. The models can also be extended to cover new modalities as they emerge while still leveraging any common aspects. 

It also 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.

Readers of this document, whether new to the CGT field or more established players, should 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.

By identifying and describing the actors, process blocks and customer-critical paths for several CGT modalities, this paper is a small but essential step in giving a common shape to the complexity of CGT delivery. The soon-to-be-published companion document CGT personas and user stories will explain what people need the IT systems to do to support CGT supply.