Conditional Approval

The TrakCel Life Sciences Blog

Why TrakCel?

January 30, 2018

I was asked recently by a senior executive of a cell therapy developer to summarise ‘Why TrakCel?’. He wanted to share this with some of his colleagues that had not been involved directly with us to date.  The organisation was clear on the business value of introducing a cellular orchestration platform so ‘Why a COP?’ wasn’t the exam question.  It allowed me to reflect honestly on what TrakCel has achieved over the last few years and what is truly important to our customers.

TrakCel has a Released Product.  It may sound an overly simple place to start but this industry is unfortunately not immune to the smoke and mirror sale pitches from the ghosts of software (sometime in the) future.  We are installed and validated at Sponsors, Clinical Sites, CMOs & Logistic Partners across North America & Europe.  That last sentence is simple to say and understand but is not straightforward to achieve.  We have a mature operation that has been built since 2012 solely to focus on cell and gene therapies. Being ‘live’ in a complex industry with complex supply chains is, not surprisingly, complex.  But TrakCel ticks that box.

TrakCel is ready for commercial scale. The industry is evolving, the Alliance of Regenerative Medicine estimated that there were 804 clinical trials underway by the end of 2016 (2015: 631).  The ratio of trials to approved therapies means that our clients are utilising our cellular orchestration during the clinical phase but with the standalone cell and gene biotech market leaders commanding market capitalisations of between $3.2b to $6.3b then it is all about the pathway to approval and commercialisation.  TrakCel is built for scale, it has been pushed to volumes that if this industry achieved would make those market caps look like chicken feed.  Again, we’re not marking our own homework here but have had these load tests undertaken by 3rd parties including one of world’s largest CROs.

TrakCel is open and agnostic. With the word ‘complex’ being mentioned 3 times in one sentence earlier the need for visibility, control and simplification is paramount.  A supply chain, as the name implies, should be a number of interconnected links that provide consistency of process and data, and joined in an efficient manner.  I don’t subscribe to the Internet of (every)Thing – does my toaster really need internet access? – but identifying and delivering true business value from system and equipment integrations across the supply chain ecosystem can be transformational. TrakCel takes an open and agnostic approach to this which means that our clients select their preferred best of breed partners (couriers, shippers, manufacturing systems and equipment).  The only proviso is that we will always push to ensure that business value is at the forefront rather than just connecting because we can.

TrakCel was not built in isolation. Building a new software platform for a new industry is not always straightforward.  Building in isolation is a recipe for disaster.  Building alongside an initial high profile anchor client is also full of traps and risk (usually around over-customisation and stretched resources under unrealistic time constraints).  TrakCel identified in 2013 a collaboration partner.  Not a client, not someone to just get some insight from but a formal collaboration agreement with a big pharma company that truly saw the value in the future of cell and gene therapies and wanted to see an orchestration platform developed to support the upcoming trials and commercialisation of product.  Ensuring that TrakCel owned the resulting intellectual property was key for us as a business and testament to the partner’s desire to see the results as being for the market as a whole.  Iterative development of a platform built by the cell and gene industry for the cell and gene industry.

TrakCel can support our customers’ urgency. The market is bounding forward with July’s FDA Advisory Committee recommendation for approval of Novartis’s CAR-T cell therapy CTL019 as another milestone moment.  The desire for companies, now with added confidence of being allowed to achieve the milestones ahead, to implement a comprehensive platform to support flawless delivery of therapies is increasing.  Although we continue to build functionality we are not building ‘version 1’, we therefore are set up to match the deployment urgency of our clients.

For me the last 6 months has seen an awakening in our clients (and future clients) to the realisation that early supply chain strategy roll out and control, implemented during early clinical trial phases will expedite the route to commercialization.  The early conversations around ‘I see the value of a COP but come back to me in 12 months’ are frequently replaced by ‘Will you help us now to put in the foundations upon which traceability and scalability can be achieved’.  The same approach is not adopted by all companies but increasingly the market is becoming laser focused on what future success looks like and how it can be achieved.

TrakCel is built for purpose. As in other industries that I’ve worked in then there can sometimes be suggestions from proactive internal IT functions that they are willing to add software or system integration design & development to the core skills of the enterprise by building a platform from within.  Clarity and focus on an organisation’s core purpose and objectives provides the best chance of success. Big pharma rarely has a well resourced aim to become a software platform developer.  A market developed platform, like TrakCel’s, offers our clients continued access to the substantial research and development we invest in new functionality, identification / creation and ongoing alignment to industry standards and uninterrupted support for a core application.  Also with the industry full of partnerships, licensing agreements and future divestments and acquisitions, internally developed applications cause unnecessary complexity to support a changing commercial landscape.

TrakCel provides simplicity and choice. When it comes to the deployment of the platform then TrakCel provides simplicity and choice.  We are cloud based and provide secure access from a browser or mobile device.  A single instance of the platform for each client (but which can run multiple therapies) for security and regulatory safeguards that can be hosted in either public or private cloud depending upon the capabilities and requirements of our clients.  The multi tenanted SaaS model that insists all clients take upgrades at the behest of the provider is not workable here – this isn’t a one size fits all salesforce.com model.

TrakCel has a blended team of Experts.  We have, what I know from meeting other providers, a truly unique mix of experience across Clinical Operations, Process Development, CMO, Cold Chain Logistics and Enterprise Software Development.   Clarity of strategy, followed by uncompromising talent acquisition and development, is a key ingredient to our market leading position and will ensure we continue to lead, innovate and evolve.  We have global coverage, currently 60 employees in multiple territories with 2 US and 1 EU office.

TrakCel has clear respect and demarcation of each client’s own Intellectual Property.  TrakCel is cognisant of the importance of trade secrets and proprietary IP especially in the young, competitive cell and gene therapy market with valuations and future funding being directly linked to future success. A platform for an industry must respect the need for market standardization but allow for the protected differentiation that the winners will be built on.

There is absolute clarity between TrakCel’s generic IT building blocks and our clients’ intellectual capital.  These should never be compromised.   Our platform, interaction with clients and contractual agreements are designed to support this.  Importantly, TrakCel doesn’t build a library of its clients’ process and knowledge for the future reuse with their competitors.  Sounds odd having to state that really.

Somehow for my client I did manage to get this summarised onto the one slide they requested but I felt my reflections on TrakCel’s approach and achievements, and importantly why they directly support the ambitious objectives of our clients was useful to share wider.  We’re motivated by the journey so far and excited by the one ahead.  We look forward to working with our existing and future clients to make a truly positive difference.

James Rudolf
Chief Operating Officer

James is Chief Operating Officer at TrakCel. He is also a trustee of @latchwales, father, husband, swimmer, rider, runner and all-round ironman. 

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