In a few decades, the cell and gene therapy sector has diversified into many complex technologies. Paul Viggers, chief commercial officer at the U.K. firm TrakCel, explains how the company’s platform can tackle the intricacies of developing cell and gene therapies.
After cell and gene therapy funding smashed records in 2021, the emerging sector has been flourishing. In 2022 alone, for example, the U.S. Food and Drug Administration and EU greenlit the CAR-T therapy Carvykti, and the EU also gave its stamp of approval to the gene therapies Roctavian and Upstaza.
However, each therapy is accompanied by an intricate supply chain, which requires a lot of organization to handle. This is especially the case with autologous cell therapies such as CAR-T, where the patient’s own cells are extracted, engineered in the lab, and reinfused as a therapy.
“The tasks include patient registration, creating the chain of identity number, arranging shipments, scheduling manufacturing, and getting that shipment back to the patient on time and in a timely and effective manner,” said Viggers, chief commercial officer of the UK software developer TrakCel, which recently celebrated its tenth anniversary.
“Those steps require multiple emails, multiple notifications and multiple phone calls. The manufacturer could be on the other side of the world. And that adds more complexity again. As clinical trials scale up into more and more patients, then there’s more and more complexity added.”
As gene and cell therapy involves global players in many different sites, there is also a big need to adapt different schedules to different time zones and local languages depending on the site’s location.
TrakCel’s mission is to allow clients to handle the organization of these cell therapy supply chains — also known as cellular orchestration — on a central software platform called Ocellos. Viggers joined TrakCel in 2021, and has around 15 years of experience in the life sciences with previous roles at the drug development services firms Biotec Services International and PCI.
In the ten years of TrakCel’s operations, the company has learned that clients require a custom approach to cell orchestration. However, it’s often a long process to produce software tailored to a client’s needs. TrakCel’s strategy is to be modular with its software, and allow clients to integrate systems from external partners with Ocellos with the help of an integration tool called Mulesoft.
“When scaling up technology in cell and gene therapy, people don’t tend to expect further development work to connect integrators and the work associated to do so,” said Viggers. “This has been challenging for clients previously given the development work required, cost required and time.”
This approach means that companies can integrate more tools with Ocellos during their scaleup process, when the supply chains get increasingly complex.
“For example, a courier integration may only be required for a phase 1 study, but as the client reaches pivotal studies, scheduling and/or enterprise resource planning integrations become more relevant,” added Viggers.
TrakCel is an experienced player in cell orchestration software among competitors such as Hypertrust X-Chain and Vineti. According to Viggers, TrakCel boasts the most deployments of its software in the space, and Ocellos has helped to orchestrate the therapy supply chain for over 500 patients so far.
One major direction that TrakCel is exploring is the use of artificial intelligence (AI) in its technology. For example, AI could reduce the need for human interactions in the cell orchestration platform, which in turn could cut the number of human errors. Other applications include enhancing analytics with historical data, forecasting supply chain performance, showing common weaknesses or blockages in the supply chain, and identifying the most efficient supply chain for each therapy.
“Cell and gene therapy is a relatively new field and technologies such as AI work best with large data sets so it is critical that thought leaders in the space start to consider the power this type of technology as soon as possible to be in a position to build these data sets so that it can be fully utilized as data volumes build,” explained Viggers.
A constant challenge for supply chain software developers is the ever-shifting cell and gene therapy landscape. As new technologies and companies come and go, the requirements evolve with them. This is particularly true as allogeneic, donor-derived cell and gene therapies begin to gain traction.
Viggers explained that off-the-shelf cell therapies are provoking the question of whether cell orchestration software is even needed. “There are different arguments there, but from the TrakCel perspective: if it’s a matched allogeneic therapy, the supply chain becomes complex because you’re trying to match donor cells to a patient. And therefore you need to start tracking that chain of identity,” he commented.
The same argument applies for gene therapies, which often involve delivering a therapeutic gene straight into a patient. However, there’s always a need to ensure the packaging and labeling are correct with gene therapy products, which have a variable shelf life.
“You want to track that chain of custody to ensure again that the right patient gets the right amount of vials in the right timeframe,” said Viggers. “So TrakCel is looking to diversify to meet the needs of the sector between the wide variety of different therapies.”