TrakCel’s presentation at Advanced Therapies Europe 2023 explored essential aspects of orchestration, integration, and innovation within the cell and gene therapy (CGT) industry. We have put together a summary of the key points from the presentation, either as a handy reminder, or for those who were not able to make the event.
1. ATMP Supply Chain Orchestration:
Advanced Therapy supply chains are notoriously complex as well as being time and condition sensitive. For personalized therapies, strong Chain of Identity (COI) is a critical safety feature, and Chain of Custody (COC) tracking is required to ensure regulatory compliance around the handling of cells. Orchestration systems are designed to handle these requirements efficiently, consistently, and compliantly even as a process scales up, without becoming unwieldy or unmanageable.
As the industry continues to mature and more therapies reach commercial supply point, there is a necessity to support the full Value Chain to ensure that remuneration models can be managed as effectively as the supply chain.
Here are the key points:
Partnerships Drive Success: Success in the industry hinges on the collaboration of various partners and stakeholders throughout the value chain. Isolating oneself within the supply chain is unlikely to result in a successful outcome. By offering partners limited access to the orchestration platform, specific information can be made available without the need for it to leave a system controlled by the therapy provider.
Integrations Enhance Efficiency: Integrations between stakeholders can yield significant value. For instance, couriers possess valuable knowledge of delivery routes, which can be leveraged to plan more efficient transportation of vital therapies. Similarly, streamlining manufacturing processes through efficient integration can optimize the supply chain.
Early Planning is Crucial: Dr Matthew Lakelin emphasized the importance of early supply chain planning and integration into the manufacturing process. Decentralized manufacturing, for example, can be more effectively implemented when supply chain considerations are integrated from the outset.
2. Building a Robust Supply Chain Network:
Given the need for secure data transfer and collaboration between multiple value chain partners, integration is an attractive way of achieving this. Automating data flow directly between systems is a fast and error free method of passing only the required information to those who need it. It also allows the therapy developer to collate all of their information in one single system, making reporting and supporting audits far simpler.
Data Security: Robust supply chains rely on the seamless integration of data from various sources and systems. Systems integrations can select specific fields to transfer or make visible to different users which makes data more secure. For instance, ensuring patient credentials remain anonymous while restricting certain data access to authorized users is essential for data security and compliance.
The connections between these systems are also set up to be incredibly robust and secure to prevent tampering. Any subsequent changes made to the data once it is in the Orchestration system is then tracked via the standard audit tracking which registers the change, who made it and why. In many instances, the system can even be configured to alert users when critical information is changed so that they can make appropriate changes to schedules etc.
Efficiency and Optimization: Building a resilient supply chain network involves optimizing processes at every stage, from procurement to distribution. Implementing best practices and technologies can significantly enhance efficiency and reduce the risk of disruptions.
Having integrations with key partners such as Couriers, Manufacturers and Patient Hub Services eliminates the classic ‘swivel chair’ approach where administrators spend valuable time keying information from documents or other systems into a central record, allowing updates to be made accurately and in real-time.
The Data flows even to facilitate a small part of the process such as patient enrolment can be complex and involve information flowing between several parties.
3. The Future of Orchestration in the Cell and Gene Industry:
Given that the Orchestration industry combines both the fast-moving CGT sector and the technology sector which develops equally as quickly, it is unsurprising that the future for the industry has huge amounts of potential for further evolution as the latest technology is harnessed to deliver the latest scientific advances.
Advanced Automation: Automation will continue to play a pivotal role in streamlining processes. Advancements in automation technologies will enable more precise control over data exchange and operational workflows, contributing to greater efficiency and accuracy. But the steps towards automation can be intimidating, particularly with a complex and mature supply/value chain. As a result, TrakCel have focused on bringing more entry level products to market that.
These systems are designed to be quick and cost-effective to deploy at early stages, but more importantly, to be easy to build on when it comes to adding more advanced automation in the form of workflows and processes, connectivity with other systems, or even harnessing the potential of new technology like predictive AI in data analysis and forecasting.
Innovative Supply Chain Models: The future of orchestration in the cell and gene therapy industry may witness the emergence of innovative supply chain models, driven by technological advancements and the evolving needs of patients and healthcare providers.
The industry is being driven to respond to the need for aggressive growth, whether in the format of expanding existing therapies, adding additional or delivering over larger territories. There are many things to consider such as efficient site and supplier set up, efficient training and onboarding of new users and maintaining system relevance and user adoption.
TrakCel are constantly exploring these challenges with customers and looking to new technologies to address them, from e-learning systems to UI improvements and additional products and services focused on the CGT industry.
Data-Driven Decision-Making: Data analytics and real-time monitoring will become integral to supply chain orchestration, allowing for data-driven decision-making and rapid responses to changing demands and market conditions.
If the industry aims to make use of developing technologies such as predictive AI, the volume of data points available for analysis will be critical to success. In a relatively young industry, where some trials and therapies have relatively small patient populations, positioning to build this data resource early will be highly beneficial in implementing these methods in the future.
Dr Matthew Lakelin’s session at Advanced Therapies Europe 2023 shed light on the critical importance of orchestration, integration, and innovation within the cell and gene therapy industry.
Building strong relationships, optimizing supply chain networks, and embracing automation are key elements in ensuring the successful development, manufacturing, and delivery of life-changing therapies. As the industry continues to evolve, staying at the forefront of these advancements will be essential for achieving sustainable success.