Ravi Nalliah is the CEO of TrakCel, a company that develops software for cell and gene therapy supply chain tracking. Ravi Nalliah, born in Colombo in Sri Lanka before moving to Cardiff, Wales, started his professional career in Corporate Finance before moving to the pharmaceutical industry in 2009 when he joined Biotec Services. Ravi originally joined Biotec as Finance Director, but quickly became involved in strategic initiatives such as the design of their ERP/Supply Chain Management system and their decision to set up TrakCel in 2012. Ravi stayed with Biotec following their acquisition by PCI Pharma Services, before deciding to move full time to TrakCel in 2016. Ravi’s key interests are golf and travel.
GoINPHARMA™: Mr. Nalliah why don’t we start by describing what is TrakCel today and what has been the journey so far?
Ravi Nalliah: Prior to joining TrakCel, I was part of the Leadership team of Biotec Services, a clinical supply chain management company specialised in ultra-low temperature cold chain products. This brought us into contact with companies developing cellular therapies, and gave us early exposure to the unique challenges associated with the cell therapy supply chain. Around the same time, we became aware of a unique tracking software system in development at a local university, which the university was looking to spin out. We were confident the software would address the needs of the cell and gene therapy industry and invested in the company in 2012. TrakCel was born. We were fortunate that a leading Pharma Company was interested in engaging with us to develop the TrakCel platform to support their own cell therapy for rare diseases. Having an experienced partner enabled us to develop a product that met the needs of the market, but also helped us quickly develop our experience of the industry’s specific requirements in terms of meeting functionality, quality, regulatory, security and validation standards. Our first system went live in a hospital in Italy in 2014. Participating in this initial, and subsequent, roll out in a clinical setting gave us first-hand experience of developing the product to not only satisfying our clients, but also of ensuring the platform fulfils the expectations of end users at the clinic. Since this initial project, TrakCel has engaged with other leading cell and gene therapy developers in the UK and US. We attracted significant funding from Telegraph Hill Partners in 2016, which has allowed us to further develop our product and increase our headcount to support a growing number of clients and projects. We now employ almost 60 staff at our UK headquarters, and have opened local offices in California and New Jersey, USA to support our North American client base. Our product capabilities have expanded away from our original track and trace concept to include data integrations with other companies involved in the supply chain and a scheduling tool that allows our partners tightly co-ordinate activities across multiple clinics and service providers.
GoINPHARMA™: Can we now talk about how your technology enables an end-to-end supply chain control and what have been the challenges to develop the tools you have now in place?
Ravi Nalliah: To successfully manage the supply chain, cell therapy developers need to:
- Ensure the identity of a sample is maintained so that the correct therapy is used to treat the right patient, especially for autologous cell therapies. This is challenging without technology as the therapy may pass through multiple pairs of hands (multiple collection centres – up to 35 in the case of CTL019, couriers, manufacturing sites, testing labs, treatment centres). TrakCel provides this traceability from initial patient registration through to final dosing.
- Ensure a full history of each batch is maintained across the multiple providers mentioned above, so any potential impacts on product quality can be identified. By integrating our data with those of other parties in the supply chain, TrakCel can provide a full needle-needle history for each batch of cell therapy as required by the Regulations.
- Minimise any deviations from approved processes that could impact on product quality or result in gaps in batch history as described above. Client-specific processes are configured into the TrakCel platform through our unique TrakFlow business process mapping tool. This can help enforce client handling process requirements by ensuring users follow the correct sequence of events and record appropriate data before they can proceed to the next step in each process. Our system is fully compliant with electronic record keeping regulations (e.g. 21 CFR Part 11) so all activities are date- and time-stamped.
- Schedule activities, and ensure communication is automated, between all providers in the supply chain to ensure that downstream activities can be planned based on real time execution of upstream steps.
Key challenges we have faced in developing TrakCel include:
- Understanding local site requirements for labelling cell and gene therapy products, and how they would like to use a system like TrakCel. While national regulations exist and compliance with these can be developed in system, it was only during roll-outs at clinical sites that we were able to identify local requirements we also have to meet. Fortunately, we are in a position where we have been through this process several times, and we are confident that we now meet the needs of all parties in terms of what functionality is essential, what is a nice to have, and what training is required to support adoption of TrakCel by all users.
- Market readiness has been a major challenge for us. While track-and-trace requirements can be met using manual approaches or spreadsheets when cell therapy developers have only a handful of patients, this becomes a challenge when therapies scale up in pivotal trials, or following commercialisation. Persuading companies to adopt our technology early was a challenge for us in our early days, although this has changed in the current year – no doubt helped by the growing likelihood that CAR-T therapies would be commecialised this year, encouraging companies to plan ahead. We are delighted that some companies are adopting our technology earlier – one of our most recent partnerships was with a company not yet in clinical development.
- Commercial models for cell therapies remain a challenge to the industry as a whole, largely as a result of these treatments being so new and carrying a high price. I think everybody is watching Novartis’s progress with their proposed model of payment only for patients showing a favourable response to treatment after their first month following infusion. Given the potential difficulties in gaining funding approval for treatment, and the need for post-treatment follow up and outcomes capture to trigger reimbursement, TrakCel is working with a partner to develop a joint offering to support our clients in this challenging area.
GoINPHARMA™: Last week FDA has approved the Novartis CAR-T cell therapy CTL019, and it is clear that its future commercialisation will pose incredible challenges in terms of logistical pathways and tracking complexity. How will your company take the challenge to support commercial partners active in this particular sector?
Ravi Nalliah: We have captured many of these earlier, but the key change (apart from reimbursement models) will be one of scale and maintaining compliance with local regulations as therapies are approved in an increasing number of geographies. It is important to note that the above supply chain challenges will multiply as cell therapies are adopted commercially. For example, based on work we did as part of the EU’s CARAT initiative, we identified 151 processing steps in a ‘typical’ CAR-T supply chain from collection to infusion. Of these steps, 54 were identified as decision points, where decisions had to be made or data captured. This is for a single CAR-T therapy. Without the implementation of data management systems, how can management of such a complex supply chain be maintained when there are 1000s of patients per therapy…and multiple therapies? As described above, this is what TrakCel has been designed to support and we look forward to working with our commercial partners to help them manage the complexity associated with scale-up and scale-out of their products.
GoINPHARMA™: and now a glimpse into the future: what comes next from TrakCel in terms of new programs and new products?
Ravi Nalliah: TrakCel has a full roadmap of new developments, many of which are aimed at supporting our clients when their products reach the market. Cell therapies will have complex approval and reimbursement models, and we are working with a partner to make this easier to manage for our clients through the provision of a case management service, supported by a Patient Portal in the TrakCel system. The patient portal will include functionality such as therapy information, appointment diary, communication and therapy status. Also, since payments for cell therapies are likely to be based on outcomes data, we need to work with companies capturing this data and linking this to reimbursement models in place with organisation responsible for payments. While payment models are likely to vary between therapies, and are not yet clearly defined, we have started this work already.
We already invest a large amount of resource into integration with other supply chain partners. Our clients want to see all of their data in one place, regardless of which partners they choose to work with, and our goal is to make TrakCel the single source of data for our customers. As new companies enter the cell and gene therapy market, we expect partner integrations will remain a key part of our development plans. As with any software product, TrakCel will need to continue working to stay ahead of the curve in terms of regulatory compliance, security and ease-of-use of our platform. Our roadmap includes several new functions aimed at addressing these areas such as a new user interface, custom reporting dashboards, device-independent mobile interfaces, and enhanced security technologies.
TrakCel is a Clinical Orchestration Platform designed to efficiently safeguard patients and orchestrate processes across regenerative and cell-based therapies. TrakCel’s focus is in on ensuring that the right patient gets the right therapy at the right time – in a scalable and efficient way. TrakCel, founded in XXXX, is headquarted in Cardiff (UK) and with operations in US.