Recently, we sat down and interviewed our co-founder; Dr Fiona Withey, about growing a Welsh technology company within the healthcare sector. Including, the impact of global market conditions, new technology advances within healthcare, and what it has been like developing an international customer base as a Welsh company. Read the full discussion below:

TrakCel turned 10 in 2022, can you give us an overview of the the key milestones and steps involved in growing a Welsh technology company and developing an international customer base? 

TrakCel was the first provider of integrated cellular orchestration solutions (COS) for the management, control and tracking of Cell and Gene Therapy (CGT) products, which are at the cutting edge of medical advancements. We were established in 2012 by a group of co-founders, whose experience in ultra-low temperature-controlled supply chain management who recognized the challenges of managing such complex supply chains, especially those associated with cell and gene therapies. For these therapies to succeed at scale, they require robust supply chain management at the individual therapy level; which is absolutely essential for the supply chain to be successful. 

As a result, TrakCel CGT orchestration software was born; a digital CGT solution that gives users (caregivers, physicians, therapy developers etc.) the ability to streamline the delivery of these therapies to critically ill patients. TrakCel has now produced several generations of CGT orchestration solutions and we continue to develop them, alongside key players in the CGT industry, to ensure they continue to meet future industry requirements.

Our newest platform OCELLOS launched in 2021 and was a major milestone for us as it was designed to help us serve a rapidly evolving client base with high demands for integration and connectivity. In 2022, the latest version of OCELLOS was awarded with a spot on the Top 10 Innovations for the year by The Scientist magazine – a huge achievement to all involved.

Successful growth means staying ahead of the game. We’ve got the largest number of live deployments supporting the broadest number of therapy classes in the industry, from autologous and allogeneic therapies and Personalized Cancer Vaccines (PCV) to Tumor and Marrow Infiltrating Lymphocyte (TIL and MIL) therapies. Over our 10 years we’ve built up a very deep understanding of the unique challenges associated with developing and delivering all these different advanced therapies globally.  

We’re headquartered in Wales, and it is a great place to serve an international client base from. We’re growing but currently have about 90 employees located the UK, Europe, and the US, supporting all sizes of pharmaceutical developers with both clinical and commercial stage therapies. We’re actively growing our footprint in the US which is the primary market for the CGT industry at the moment.  

Why do you think there is such a focus on developing the life sciences sector in Wales? 

The life sciences sector in Wales is constantly evolving and continues to go from strength to strength. Data indicates that the sector employs about 12,000 people and contributes more than 2.5 billion pounds to the Welsh economy highlighting the importance of this sector to Wales.

The First Minister of Wales has recognized the importance of science, research and innovation in Wales identifying key priorities that will build on our research & development and innovation capacity along and health and life sciences, to ensure that Wales is a full partner in delivering the UK life sciences vision. It is incredibly important that Wales, as part of the United Kingdom have a voice in the UK life sciences vision. Although many companies are based in Wales, they are actually trading with the global marketplace too and leading the way with their products, technologies and services.  

What have recent global market conditions meant for TrakCel and its products? 

There have been so many major factors in the last two years, both positive and negative. We were very fortunate in terms of being minimally impacted by Brexit, unlike many of the life sciences companies exporting to the European market, who continue to be severely impacted, many being forced to operate suboptimal supply chains for temperature-sensitive products, which need to reach critically ill patients in hours, rather than days or weeks. 

In our market, the patient is at the forefront of everything we do, and companies are sadly facing greater bureaucracy, supply chain barriers and escalating shipping costs with less resources to manage the increased complexity of these processes, resulting in increased costs to supply critical medication to patients. TrakCel is fortunate to be minimally impacted in that way. However, as a result of our client-base being pharmaceutical companies and predominately those that sponsor clinical trials, the Covid-19 pandemic had a significant effect on TrakCel’s operations and revenue, as clinical trials effectively came to a halt in early 2020. It was an incredibly challenging period for the company.  

On the positive side, it gave us time to transform our business and re-evaluate our software product by considering the learnings which we gained from deploying our original software platform to support incredibly complex supply chains. We did spend a lot of time in 2020 talking to our clients, talking to potential clients, talking to partners and to the industry in general, through virtual advisory boards, to understand their future requirements and redefine COSs.  

This culminated in us bringing our second-generation product to market. This new product not only supports clinical trials, but we’ve also diversified our offering to support commercial therapies as well. The new platform was launched on the Salesforce APPExchange in June 2021. Since then, we’ve had an absolute phenomenal response from the global industry, from clients ranging from small to mid and large pharmaceutical companies, and partner companies looking to integrate with TrakCel software system, to offer really true end-to-end patient supply chain solution for the industry.  

Just in terms of our people, we quickly adapted from working in an office environment to successfully being totally remote. We’ve now established a hybrid working environment, which allows people a lot greater flexibility in a much-improved lifestyle as well. From a terrible global pandemic situation, we have taken some positives out of it as well and we have changed the company around. 

In terms of R&D, did you collaborate with any academic partners in the creation of your OCELLOS platform? 

TrakCel clearly benefited from collaboration with research entities. Back in 2011 there was a collaboration between a university group in Wales and an SME, which I was the Managing Director of chemical biotech service international. The collaboration between the institution and the SME resulted in TrakCel, from very early days of being in a small room in an office in Bridgend, to where we are today. So TrakCel certainly benefited from research institutions and is a great case study to showcase people to how we can collaborate together.

The challenge with advanced therapies is that the industry is still very much in its infancy. R&D is still at an early stage and continues to expand, particularly in the United States. But the gap between research and commercialization really needs to be narrowed in that process and speeded up, so that we can adopt these new therapies.  

The currently extremely high cost of these therapies to patients is significant and limits the number of patients that can be treated with these types of therapies. TrakCel is committed to focusing on innovation and R&D for healthcare and helping to progress affordability and accessibility in the advanced therapy sector.  

TrakCel has been fortunate enough to do some collaboration work with the Midlands and Wales Advanced Therapy Treatment Center as well. There’s a lot more that can be done, but the industry is in its infancy and we’re learning. There is a very much collaborative environment within Wales to make these things happen. 

What kind of impact are digital systems having on the healthcare sector and how important are they?

TrakCel is truly leading the way in terms of digital cellular orchestration systems in an area which is traditionally been very labor intensive, very paper-based and a very manual process, which obviously leads to human errors. The company is a great example of what an initial collaboration between a Welsh university and an SME can achieve.

Prior to TrakCel software platform, cellular orchestration process was typically a very manual process, and took on average about 8 full-time personnel to manage this process, whereas in implementing something by TrakCel is a quick digitized solution: it reduces time and costs, it reduces labor, personnel time, and it avoids human error as well. It’s a great example of digitization in a very innovative environment.

In terms of importance, this type of tool allows processes to be safely scaled up to an extent that would simply not be practical or cost effective if they were managed manually. We just need to showcase some of these examples and encourage more sharing of ideas and collaboration between research institutes, especially on the SMEs as well. SMEs are always looking some innovative ideas to take things forward. 

What resources would you recommend to Welsh SMEs in digital tech and health sciences who are looking to succeed? 

Many companies in Wales are SMEs, they’re the foundation of bedrock of the industry. There’s a huge amount of support from various places, for example, from the Welsh government. It’s not just the financial support; it is advice, webinars, seminars, roundtables and networking. Another great place for support is the organization called MediWales, a fantastic network organization that puts companies in touch with each other and links people up.  

What I would say to any SME in Wales is: Don’t be afraid to seek advice and support from other SMEs. We’re all in the same boat together. Wales is a nation where we want people to be successful. We encourage people to help and support each other and build a network and go to networking events and reach out to people. Even if it’s from a different sector, there’s always learning to be had. Join organizations such as MediWales. CBI (Confederation of British Industry) is another great source of support, just often talking to people, and they’re great connecting you with the right people to talk to and get that support that you need. 

You are a co-founder of TrakCel and became CEO in 2020 and you’ve seen a lot of changes in the market. What’s next for TrakCel?  

I was appointed as CEO of TrakCel in the early 2020, at the onset of Covid, probably the most challenging time to start leading a business. I took the company through a significant business transformation program, to redefine our software product OCELLOS. We are excited now to be deploying that solution, in both clinical and commercial settings to ultimately support patient needs. This is just the start for us.

Our challenge now is to scale the business, to expand and to develop the business into previously untapped markets and develop a truly end-to-end partner ecosystem to support the patient journey, continually innovating and developing our product at the same time. There’s a patient at the end of everything we do. Our mission is to guide our patients through the orchestration of their advanced therapies. We will ensure that TrakCel is the go-to provider of cell and gene therapy orchestration systems to support bringing new therapies and treatments to the global health care markets.  

I’m also very passionate about our people, we have a fantastic, very skilled workforce in TrakCel. Indeed, through the life sciences sector in Wales, there’s a huge amount of resource, talent, expertise and knowledge that we need to use. What gets me out of bed in the morning is seeing these people develop through the organization and develop their careers as well; just making people really successful and having fun at the same time. It’s really important for us. 

Any final thoughts or comments you would like to add about growing a Welsh technology company?

Wales is absolutely a fantastic place to do business. I’m very proud to be here and leading a company that’s on the global stage as well. We’ve got world-renowned universities, innovation centers, SMEs and multinationals here. We are a globally connected ecosystem and a wealth of knowledge, talent and expertise, and really ensuring that we secure a position to play on that world stage. 

Thanks to Dr Fiona Withey for taking the time to speak to us about hints and tips taken from her own experience of growing a welsh technology company through some very rapidly changing times and in such a fast-paced environment and industry. TrakCel owes a great deal of its success to the skillset and experience of our team so this is a key area of investment for TrakCel. Read more about how TrakCel support their growing and diverse workforce by reading Joy Lewis-Middleton’s blog for World Mental Health Day