In a recent interview, The Medicine Maker sat down with TrakCel CEO, Ravi Nalliah to discuss the excitement around the cell and gene therapy, the growth of TrakCel and what inspires him in business.

Who inspires you?

I’ve always been inspired by the way Steve Jobs conducted himself in business. From Apple’s early days, instead of trying to be all things to all people, Jobs and his team focused on a niche market that allowed the company to thrive and develop into what it is today. I’ve tried to apply that principle to my own working life – and that’s why TrakCel caters to such an exclusive section of the pharmaceutical industry.

What’s the story behind TrakCel?
I left university with a degree in biochemistry and molecular biology, and though a career in science might have seemed a natural progression, I spent a significant portion of my early working life in the financial industry. As a chartered accountant, I provided services to mid- to large corporations, but having the opportunity to interact with varied clientele, particularly those in the pharmaceutical industry, led me to believe that my calling lay elsewhere.
In particular, I was constantly interacting with companies who needed alternative solutions to the issues they faced with low temperature storage, packaging and distribution. I set up TrakCel in 2012 to help address these issues, but the CDMO arena was dominated by heavy-hitters who had resources, manpower and money, so we had to find a way to stand out from the crowd. We focused our energy on becoming a specialist provider of cloud-based software to support the complete visibility of supply chain management for the biotech industry.

What were the initial challenges you faced?
We were distributing primary products to international clients, which meant that we had to find ways to deal with both language and legislation barriers.
Certain challenges were out of our control. For example, we might transport a product to a site in Singapore, but after delivery it may inadvertently be stored in a fridge at the wrong temperature – instantly destroying it. The smallest deviation in temperature is enough to make a difference to a cell
therapy. Of course, there are financial consequences to these situations, but the serious repercussions are for the patient. Our real-time track and trace technology helped iron out these problems; we are able to determine the status of any given product and any point during its distribution.

Why is supply chain management so important for cell and gene therapies?
Compared with the supply chain for traditional small molecule drugs, there are further considerations that supply chain management companies must make in terms of the storage, packaging and distribution of both allogeneic and autologous therapies.With such therapies, which are often for patients living with rare disease indications, any mistakes in supply chain management could result in devastating consequences.
The industry, however, is rapidly adapting to manage the pressure of dealing with personalized therapies. People are looking at ways to improve processes, and we’re seeing the introduction of advanced IT systems, smart technologies (including geofencing and data location tracking), and a
more decentralized approach to supply to help cope with the unique demands.
As the market continues to expand, I hope that the push for standardization continues. Trying to harmonize standards internationally will undoubtedly be
challenging – every market has its own attitude when it comes to CGTs, but there is an inherent and pressing need for practices to be become uniform so
that patients, wherever they are in the world, receive the best care possible.

What is the biggest lesson you’ve learnt over the course of your career?
Every interaction with every customer and every stakeholder will be different. Understanding that every market has its own attitude to dealing with the complexities of the CGT supply chain and being able to adapt to these nuances is important. And it has also influenced TrakCel’s technology; we’ve had to adapt our solutions to ensure they are highly configurable and adaptable to the challenges that come with working internationally. My aim is to see
the standardization of the CGT supply chain across markets but, until that time, having a grasp on the culture of the global marketplace is what will help build long lasting relationships.

Why is the cell and gene therapy space so exciting to work in?
We’re on the cusp of a new era in medicine. When YESCARTA and Kymriah gained market approval, it wasn’t only a huge moment in terms of science, but it marked the start of a new outlook on life for many patients. I remember watching a video explaining what the therapeutic could do for patients’ lives; I felt utterly moved by the fact that patients finally had access to a curative medicine that could take them from a state of blindness to the
point where they were able to see. At the end of the day, I want to see these therapies be a success. And I want to help draw more talent into this exciting area so that we have experts within every aspect of the supply chain who can help pull down the red tape that prevents CGT’s reaching their
potential as quickly as possible.

Where does the future of the industry lie?
Allogeneic therapies. A lot of attention is given to autologous therapies but, as the field develops and changes, more people are beginning to consider the specific challenges and benefits that exist when bringing allogeneic therapies to market – and there’s a lot of investment in this area. The industry is also expecting the approval of several CGT’s by the FDA over the course of the next two years. The evolution of the industry is happening at
such a fast pace; we all have to work extra hard to stay ahead of the curve so that we are able to successfully deliver these novel
life-saving products to patients.

Medicine Maker Ravi Nalliah