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 can scale and grow. A key issue is how IT and CGT teams understand each other’s needs and challenges. Only once they overcome this knowledge gap will CGTs be produced and administered commercially.
Using analogies can play a critical part in this communication and education process and has led BioPhorum to publish IT can be simple: using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies.
The paper uses analogies to help CGT and IT specialists discuss and understand critical issues in commercializing CGTs and essential aspects of IT systems and infrastructure.
Analogies are a literary technique in which two unrelated objects are compared for their shared qualities. When used properly, analogies can act as a bridge between two worlds through creative dialog and allow each side to understand enough, but not too much, of the other’s world.
For example, one of the analogies compares the necessary evolution of IT to support CGTs with the evolution of maps, which have moved in many incremental stages from paper documents to digital route calculators and will eventually be integrated into voice-activated, autonomous vehicles.
“I really liked the map analogy to explain the evolution of systems,” said Juan Jaime, Supply Chain Business Technology Leader at Johnson & Johnson. “We are often trying to build IT capabilities while others are still working out what the business process actually is. So we need solutions in stages – starting simple, each with new benefits, just like how digital maps have evolved.”
The analogies are presented in a standard format with a table that uses narrative and images to explain why one thing is like another. For example, why creating the digital capabilities to support CGTs is like climbing an unexplored mountain. The paper contains 11 analogies organized to support four types of collaborative conversation:
- Working out an IT investment strategy for CGTs
- Architecting IT solutions for CGTs
- Designing end-to-end CGT solutions
- Supporting life-critical CGT manufacturing operations.
The analogies in the document can be used at different points in the project lifecycle – from when the business case for investment is being made to when vendors are trying to understand business requirements. They may not apply to every business but can be used as a springboard for readers to develop their own analogies that suit their specific needs.
Analogies reveal differences in a relatable way that can stimulate creativity and joint problem-solving. Zhuoer Lin, Senior Scientist at Janssen, said the paper gave her the idea of using analogies to simplify and explain concepts to people. “Jumping out of the box and finding other situations that we handle in a similar way can help us think differently, create new ideas and open new avenues on how to manage a situation.”
This paper is for anyone involved in the many discussions around commercializing CGTs, specifically where teams include disciplines from Process Development, IT, Quality, Production, Operations, Scheduling, Project Management, and third-party logistics.
Based on in-depth research and team learnings, the paper advises how best to construct and use analogies to ensure they help systems evolve into robust and stable solutions at the right pace – and not short-term, quick-fix solutions lacking longevity.
Analogies can be a powerful tool for teaching and learning, and help accelerate comprehension, provide visualization, and change perceptions. This BioPhorum document will help readers consider the worlds of CGTs and IT and how they are connected, which is critical in this fledgling but fast-growing industry.