With personalized cell and gene therapies (CGTs), it is critical that the patient receives the therapy that has been made specifically for them. However, traceability for personalized CGTs has not yet reached digital maturity. As a result, there are many approaches but little standardization across CGT license holders, which means that treatment centers and contract organizations must remember many subtle differences in processes and deal with unnecessary complexity.
Some IT providers offer isolated or disconnected solutions to tackle parts of this challenge. However, the proliferation of slightly different approaches creates a cognitive load for those involved, which increases the chances of human error while obstructing a fully integrated approach. Traceability is an issue that impacts the whole process and systems architecture and should not be seen as a single-system solution.
“Most of our healthcare providers are already working with more than five portals: it tends to be one portal per therapy,” said Tour Ala, IT Lead for Cell and Gene Therapy Industrialization for Manufacturing and Supply Chain at Roche. “As more advanced therapies come to market, this is unscalable and unsustainable. As an industry, we desperately need to standardize.”
BioPhorum’s Standardizing traceability of personalized cell and gene therapies will help you meet this challenge by presenting a practical vision and reasoning for standardizing the traceability of CGTs across your value chain.
A user-centric design leads to an architecture that integrates complementary services and a model for connecting data across the systems throughout the supply chain. It considers the current situation and process flows, envisions a series of user stories from the perspective of several key personas, and outlines the benefits of a more holistic approach.
Using the standards outlined in this document will help you accelerate the analysis of your business challenges and solution designs, highlight key issues to be resolved, and make it easier for you to align and partner with others working on similar or connected solutions.
This approach will help you standardize the traceability of personalized therapies, automate the enforcement and review of traceability data, and enable robust end-to-end integration. Once traceability is automated and robust, your product release will be faster and anomalies will be resolved more quickly, meeting tight turnaround times and improving patient outcomes.
The paper is a key resource for:
- Digital leaders, application and interface architects, and designers supporting the supply of personalized CGTs
- Business leaders who are designing, implementing, and validating chain of identity and chain of custody processes
- IT solution providers whose systems play a part in the supply of personalized therapies.
“Deployment of systems solutions and integrations is orders of magnitude speedier when there is an industry-standard definition,” said David Gray, Global Solution Architect at Emerson. “It is not just the basis of technical scope and details, but also provides a common vocabulary for conversations among stakeholders.”
The challenge is now for CGT license holders, contract manufacturing organizations, and their IT solution providers to work together to make this a reality. As an industry, we must achieve standardization and a consistent approach that allows us to reach digital maturity, become efficient and flexible, reduce human error, and pave the way for a new generation of advanced personalized therapies to change the lives of people who need them.