TrakCel’s Dr Fiona Withey Reflects on 2022 in CGT Orchestration

Following a jam-packed 2022 for the Cell and Gene Therapy (CGT) Industry and at TrakCel, we took the opportunity to grab a quick coffee with Dr Fiona Withey, CEO and Co-founder of TrakCel to chat through some of the key events of the last year and to get her predictions on what 2023 will bring.

“As always, the end of the year at TrakCel has been incredibly busy and filled with fantastic projects which in turn is no doubt a reflection of the pace in the industry. Post COVID we have seen an acceleration in the industry with more companies than ever approaching TrakCel with both clinical trial and commercial supply chain requirements and projects. We see this as a really positive step change in the industry and a reflection on the success of advanced therapies over recent years.  We are seeing a pattern of more therapies being approved, more indications and conditions being tackled, and existing therapies being approved for earlier-line treatments.

Many of the challenges around developing these therapies remain the same, with complex trial designs relatively common and constraints of supply chain and manufacturing capacity, tools like TrakCel’s cellular orchestration platform OCELLOS that help to manage and streamline these processes are becoming pivotal to the industry. This is set to continue as suppliers are looking to support better patient engagement and patient experience, not only through co-ordinating scheduling and resources more effectively but by opening this information to critical stakeholders in the value chain, allowing them to inform and manage their patients in a sympathetic and efficient way with a view to improving engagement and participant retention in the clinical trial space.

The experience and expertise in the sector is growing, and every year we are speaking with new supply chain partners, CROs and CMOs who are building up presence and knowledge in the CGT sector and this is in turn a fantastic resource for therapy developers to lean on, allowing them to focus on the science over and above the operational challenges.

Within TrakCel this has been reflected by the launch of our OCELLOS Lite product early in the year, a product designed to accommodate those developers in early clinical trials and allow them to grow the system with them as the therapy matures. We have added a range of partners to our product eco-system and now support integration to manufacturers and patient hub services in addition to couriers, labelling and a range of others.

We have also focussed on developing the core platform, adding functionality to help with scale-up and multiple indication therapies more efficiently. We were thrilled that OCELLOS 3.0 was recognised by The Scientist as one of their top 10 innovations of 2022, this being testament to the team that deliver, develop and support the product and work so hard to innovate alongside the developing needs of the industry.”

TrakCel’s Dr Fiona Withey Looks Ahead to The New Year:

“Looking forward to 2023 it is so exciting to see successful therapy types such as CAR-T being developed to target solid tumors as well as blood-based cancers. If these therapies are proven to be effective, they will potentially target very broad indications with significant global patient populations. This is going to pose a significant but very welcome challenge to therapy developers. The possibility of producing personalised therapies in such large quantities is really exciting, but the supply chain will have to be intricately managed to prevent errors and efficiently schedule manufacturing and supply chain resources that are already under pressure.

The variety of therapies where orchestration is required will also grow over the coming years, as allogeneic and gene therapies start to employ the management tools that have been proven in the personalized medicine areas. High cost per dose and reimbursement models that are linked to specific patient timelines and outcomes are seeing more developers looking to digitize orchestration and supply chain to support these demands.

The TrakCel team continue to focus on providing excellent customer service through client deployments whilst investing in R&D to ensure OCELLOS remains the cutting-edge cellular orchestration platform for both clinical trials and commercial therapies. We already have a broad range of integrated partners and have further plans to grow the digital eco-system.”

About TrakCel’s Dr Fiona Withey

TrakCel’s Dr Fiona Withey is the CEO as well as one of the co-founders. Fiona has over 25 years experience in senior leadership and CEO roles within the pharmaceutical industry primarily focussed on clinical and commercial supply chain management. She holds a PhD in Biochemical Engineering and a first degree in Biology and Chemistry. View Fiona’s profile.