Dr Fiona Withey, CEO and Co-Founder, explains how UK-headquartered TrakCel identified its market niche and how its integrated technologies support the management of the international autologous and allogeneic cell, gene and immunotherapy value chain.

Founded in 2012, UK headquartered TrakCel is a leading innovator of cellular orchestration solutions for the precise management, control and tracking of cell and gene therapy products. The company was the idea of a group of co-founders with deep experience in ultra-low temperature-controlled supply chain management services to the biotechnology industry, the team having had early exposure to the challenges of managing complex supply chains associated with cell and gene therapies and having realized that for these therapies to succeed at scale, robust supply chain management at an individual therapy level was essential. As a result, TrakCel was born.

“As the cell and gene therapy industry has grown, so too has the competition in cellular orchestration and the industry continues to look for the best solutions to ensure that the right patient receives the right therapy at the right time. For this to happen, companies such as TrakCel need to work to standardize processes in the delivery of these innovative medicines,” says CEO and Co-Founder Fiona Withey. “TrakCel has become the leading innovator of cellular orchestration platforms due to the knowledge and experience the company has gained as the first provider. We have worked with many biotechs and witnessed what works and what doesn’t. We are in a unique position in that we cater for the largest number of therapeutic classes in the industry, and with that comes a plethora of challenges that we have helped our clients solve.”

Diverse client portfolio

“As the first dedicated developer of cellular orchestration platforms, we are proud to have built a truly diverse portfolio of clients that spans multiple therapeutic classes across clinical and commercial stages,” says Withey.“The therapies that we support include autologous and allogeneic CAR-Ts, personalized cancer vaccines, MILs, TILs and more, and TrakCel has the most live deployments in the cell and gene therapy industry, something we are very proud of.

“With regards to industry collaborations, TrakCel has built a partner ecosystem and strong relationships with some of the leading technology and service provides to support our mission of standardizing the delivery of advanced therapies,” she adds. “These range across cold chain logistics and 3PLs through to labeling providers. Our Integration Hub module, one of the key modules of our OCELLOS platform, leverages MuleSoft middleware technology to quickly and seamlessly provide users of OCELLOS with a complete view of the value chain.”

To date TrakCel has primarily served the North American and European markets and continues to play an active role in providing industry collaboration and guidance to ATMP bodies in the UK and the Standards Coordinating Body in the US. In addition to this, however, and in line with market growth, the company has plans to expand its footprint to provide cellular orchestration solutions to developers in the Asia-Pacific region.

Next-generation technology platform

Withey adds that although the past 18 months have been extremely challenging for global businesses, TrakCel has continued to move “from strength to strength”, the company’s next-generation cellular orchestration platform, OCELLOS by TrakCel, which was developed using Salesforce technology, entering the market this year. “OCELLOS is the first platform developed using Salesforce end-to-end, which in turn brings many benefits, from integrating with clients’ existing technologies through to improved accessibility as one of the world’s leading technology platforms. Our clients face higher competition and user expectations, they demand much more than Chain of Identity and Chain of Custody from their orchestration software. OCELLOS is designed to support the needs of the newest therapy launches and developments,” she says.

In addition to this,TrakCel has closed its latest funding round, benefitting from strategic investment from AmerisourceBergen and LabCorp: “The close of this funding delivers a unique opportunity to propel the evolution of our product and services portfolio in order to exceed expectations across the quickly evolving cell and gene therapy space,” Withey says, adding that the additional investment and new product offering have naturally led to more strategic hires both at the company’s headquarters in the UKand across North America. “We have strengthened and expanded our C-Suite and management teams with significant cell and gene therapy experience, specifically around commercialization of therapies and enterprise level IT Management,” she states.

Remote working and business management

Because of the COVID-19 pandemic, TrakCel has had to embrace remote working and collaboration, the company’s Business Development, Product Management, Project Management and Delivery teams being located at both the company’s US offices in California and New Jersey as well as in its headquarters in the UK.

“As a technology company we have adapted well to this,creating new systems and processes to ensure that we can collaborate even more effectively and efficiently,”says Withey.“With a global team, many of the tools required to facilitate this were already embedded within the company. In addition, we have increased our efforts to improve internal communications in the absence of ‘water cooler chats’, which has been well received.

“However,” she adds, “the pandemic has severely disrupted our ability to conduct face-to-face meetings with clients and prospective clients.In response to this we have designed innovative ways to allow therapeutic developers to experience our cellular orchestration platform and help inform our product roadmap remotely. Our virtual ‘Commercial Advisory Boards’ have proved extremely successful, allowing our clients and potential clients to help shape the future of our platform from across the globe. It has been extremely rewarding to demonstrate how we have leveraged industry feedback to develop our products and services to meet and surpass industry needs.”

Withey says that moving forward, TrakCel will continue to employ its hybrid approach to working: “Our people’s wellbeing is incredibly important, and we will continue to provide flexibility,” she says. “We have listened to our teams’ views on remote working and will ensure that we offer a supportive working environment. I am incredibly proud of how we have adapted, and the aforementioned achievements area testament to the efforts of our people during a challenging period for us all.”