Why flexibility is essential when serving the pioneering CGT sector 31st August 2022
By Fiona Withey, CEO, TrakCel*
Known as Cellular Orchestration Solutions, TrakCel systems are configured precisely to match the complex supply chain processes that are needed to provide cutting-edge medicines based on cell and gene therapies.
The company formed in 2012 when the cell and gene therapy sector was in its infancy, identifying the need to deliver these therapies quickly to preserve the viability of the live cells being transported, and in the case of personalised therapies, ensuring that the right patient received the right therapy. This novel supply chain model required for personalised therapies incorporated the patient both at the beginning and the end of the process, therefore making issues like patient data privacy part of the wider supply chain challenge where they had not been before.
Evolution to meet market demands
As the cell and gene therapy sector has gone from strength to strength, so has TrakCel, launching its second-generation cell orchestration solution OCELLOS in 2021, followed by OCELLOS Lite, a platform created specifically for developers making the jump into first stage clinical trials, in 2022.
The needs of clients, who are developing different therapy classes, all at different stages vary hugely, both between clients and even for individual clients over the course of the therapy development. This created the unique challenge of designing a platform that could be deployed to match each customer’s processes in very fine detail and could be easily evolved as processes and needs changed. Alongside that, it obviously needed to be viable and sustainable for both the client and TrakCel. This need drove a change to both the platform the solution was built on and the fundamental system architecture, and OCELLOS, TrakCel’s evolving digital cell orchestration platform was the result.
OCELLOS launched on to the salesforce.com platform in 2021 and OCELLOS Lite, designed to be a starting point for customer’s cell orchestration journeys followed in January, 2022. OCELLOS Lite was developed to meet customer demand for orchestration from the first patient, negating the need to transition between paper-based and digital orchestration later in the trial process. The entry level solution is designed to be quick and efficient to deploy and keeps the Chain of Identity and audit records in one place right from day one.
The concept of an evolving product was critical for OCELLOS Lite, to best leverage a single deployment model, as opposed to one where the customer ‘outgrows’ the initial solution and must replace it with a commercial solution later in the journey. The alternative, historically, was to take on the risk and cost of deploying a system with full commercial features before they were needed or even potentially understood, opt for a low-level solution that would require replacement if the trial progressed or delay digital automation altogether, reducing the control and visibility of the supply chain and potentially impacting the quality of early patient journey records. However, the product changes instigated have allowed TrakCel to address a gap in the market for these early clinical developers that is both accessible and sustainable.
Harnessing digital automation
In an industry that is constantly diversifying and by its nature, always looking for new ways to tackle diseases and conditions, this increasingly involves even more complex supply chains with more stakeholders, critical decision points and supporting partners. As these newer, more complex processes appear, the automation of the supply chain becomes an ever-higher priority as the risk associated with human error multiplies as more stakeholders and steps are added. Each small task within the supply chain process is critical; a single quality check or screen going unrecorded or a deadline being missed could result in a recall or failure of the therapy product that negatively impacts both the patient and the developer. Within this environment, connectivity and digital workflow automation become key.
Integration directly between systems not only saves time, allowing users to access real-time information from a single system, it also protects data accuracy, removing the opportunity for error as data is rekeyed. However, connectivity between third party systems can be challenging, both in terms of establishing and maintaining it. So, another focus point that the OCELLOS platform was developed for was facilitating connectivity in a way that would support clients in building complex integrated eco-systems of supply chain partners to achieve the most efficient data exchange possible.
As a result, the network of integrated partners now stretches deeper into the value chain than ever before, with integration to patient hub services being added to the portfolio in January, 2022. This type of integration will be critical to commercial therapies moving forward, speeding time to treatment by automating the process of checking patient eligibility and benefits, as well as making it easier for patients to access appropriate support services when they need to attend appointments.
With a nod to the uniqueness of each therapy process, the API technology that OCELLOS uses to facilitate integration is secure and stable, as well as allowing clients to specify which data is transferred between the systems based on the data requirements of their process. This means that each customer or therapy set-up can in fact use the ’same’ integration slightly differently to ensure that their processes are followed precisely.
Investing in the future
TrakCel remains focussed on product and service development to stay ahead of the growing demands of the cell and gene therapy sector that has increasing numbers of candidates advancing to commercial approval. This has been reflected in the latest 3.0 release of the OCELLOS platform, with expanded features that give developers with multiple therapies or therapies with multiple indications more flexibility to manage them simply from the same platform, as well as having a number of features to help developers cope with the additional complexity that comes with global scale-up, such as co-ordinating scheduling over multiple time zones.
TrakCel remains committed to working with the industry and looking for these improvements both small and large that will help developers get more therapies to more patients safely.
*Based in Cardiff, Wales, TrakCel develop, build and support digital solutions that help developers of cell and gene therapies deliver these therapies safely to patients from the first clinical trials to therapy commercialisation.