FarmaTrust is a company firmly delivering on its maxim of Saving Lives, Building Trust, with a blockchain solution that’s eliminating counterfeit drugs and delivering innovative supply chain management, personised medicine and clinical trial data solutions.
Can the UK succeed where we lost ground with 5G, and win the race to become the world leader in Cell and Gene Therapy and blockchain solutions? FarmaTrust CEO Raja Sharif believes we can and must, and with China’s declaration last October that its poised to invest heavily in blockchain, the time is now.
Like many innovative companies in the life sciences space, FarmaTrust can trace its roots back to a personal and human story. Sharif, a barrister by background, started the company in 2016 following the experience of a relative exposed to counterfeit medicine. At the time Sharif was reading a lot about smart legal contracts and blockchain, and how lawyers were ‘any day now’ going to be made surplus to requirement. The blockchain rabbit hole ignited the spark that led to Sharif developing a product to eliminate fake drugs from the emerging market segment, and the company grew from there.
The chairman of FarmaTrust, Lord Anthony St John, is a former colleague of Sharif, as is Deputy Chairman Peter MacLean. Other team members, like Data Strategy Lead Najib Rehman, were recruited in, albeit arguably somewhat hesitantly in the beginning.
“I met Naj at a Disrupt event, where I was espousing the benefits of blockchain in a supply chain and logistics session. He heckled me from the audience, declaring it would never work in the pharma industry because they just weren’t ready – nine months later he joined the team,” chuckles Sharif. As it turned out, Rehman was an expert in the field, with a background in big pharma, managing IT and DATA systems for falsified medicine at companies like Pfizer.
“In my defence, my heckling was because I was all too familiar with the complexities of supply chain logistics and management in big pharma from my industry work in the EMEA region. But at the time I was supporting some research work at the ABPI looking at using IoT for blockchain technologies to support real world evidence, and I was intrigued by the logistical applications,” counters Rehman.
The service FarmaTrust has developed is truly a working solution, in that it began life as a bespoke commission for a German company with US FDA (which, shares Sharif is “very proactive” when it comes to investigating new technologies) approval to explore blockchain. And because of the company’s origins in emerging markets, all its products have full global coverage.
“In emerging markets where there isn’t sophisticated technical infrastructure we can use the mobile phone networks, which cover everything. We’ve really cracked the nut on giving pharma companies full global coverage of their assets from anywhere in the world” says Sharif.
FamaTrust is a blockchain distributed ledger technology solution company that aims to solve the problems of: lack of data integrity, data sharing and a holistic view of the complete supply chain from the point of production to the point of consumption. No small feat in a complex global pharmaceutical supply chain with many different participants and regulatory requirements.
“Our solution ensures data integrity. Once the data is recorded it is immutable, incorruptible and cannot be manipulated. That’s great for consumers, regulators and government enforcement, and means we can eliminate counterfeit drugs from the supply chain completely. We can provide full proof of provenance, of the full chain of custody, identity and environment,” says Sharif.
On top of these core aspects to the service, the company can use the smart contract capability of blockchains to automate many processes including regulatory reporting, tax collection, and complex payment schedules. Clients have access to real time data and a single source of truth, meaning everyone is working off the same data, updated in real time, as opposed to having to wait for different players to sync databases with each other. That provides trust, transparency and cost reduction.
“We’re really unique in the field,” explains Sharif. “There are two other players we know of that use the cloud, but that only tracks a very small part of the chain, especially when you look at an area like Cell and Gene Therapy. It tracks collection of therapies when they’re ready and to destination delivery only.” In contrast, FarmaTrust’s service starts when the sample is taken from the patient, all the way through the whole process, even plumbing into the MES’s (the software that monitors the manufacturing of the treatment itself), all the way back to reintroduction to the patient.
Rehman’s experience supporting national immunization projects in sub-Saharan markets, where many big pharmas have multi-million-dollar governmental contracts to support National Immunisation Projects (NIPs), taught him a lot about the challenges of managing upstream demand. Challenges he believes we’ll see replicated in the advanced therapies market.
“When you’re working at scale you need to make sure that your factories can bring in enough raw materials to put out enough product to meet demand on tight SLA’s – commercial contracts that will cost you tens of millions. You’ve got highly sensitive products being produced in challenging climates, where you might see a pallet with $200 million worth of product sitting on the tarmac at an airport.
Those sorts of challenges were very real for me and my colleagues working in markets with complex fragmentation and intermediaries. The constant for us was not getting enough notice or understanding of what was happening at each point to get a true immutable record to manage upstream demand. The information was never trustworthy, and we were always over-manufacturing, at maximum utilisation and at the worst end of the logistics Bullwhip.”
It’s easy to see the relevance of this to the field of advanced therapies, where you have a chain that requires, certainly for autologous therapies, a more just in time approach and much closer to real time analytics. It’s a subject Rehman feels passionately about. So much so that he argued the case for the adoption of FamaTrust’s technology using the same construct put forward by John Lunger, VP of supply chain at Adaptimmune, in his paper on supply chain strategies for new therapies, who he later wrote to thank for the inspiration.
Cell and Gene Therapy Solution
FarmaTrust has a needle to needle solution for CAR-T treatment, which not only tracks where a particular asset is, but also anonymises patient data so that compliance issues and costs are reduced substantially. Users know where an asset is at any given moment, and what environment it is in. If it goes outside certain conditions or a certain process is delayed, the solution will send a notification so that it can be resolved.
The technology is digital, modular and is fundamentally trying to address the issues presented by older technologies, which essentially see users battling paper in triplicate. Even in the best institutions in the world, innovators are using Excel and Access to manage quality, which is unsustainable in the long term, explains Sharif.
“We’ve removed paper completely, as well as improving the processes from the differentiation between cloud solution and distributed ledger solutions, in that you have true data incorruptibility. This can be used with any tissue therapies, including stem cell, and blood and organ transplant.”
The company is currently working with the Cell and Gene Therapy Catapult, which has connected it to the ATTC’s and academics around the country including the University of Birmingham, King’s College London and NHS Wales. FarmaTrust is keen to use the traction and interest in its services to really get it implemented from the outset.
“We’re not just talking about the later stages, once you’ve got your license and you’re commercialising, but getting the technology in at the very early stages when you’re manufacturing small batches. We want to see these processes embedded early; the ability to have a compliance standard like CFR 21 part 11 set up from the outset. Otherwise, by the time you get to scaling you’re already fighting the age-old problem of changing an embedded habit. When you’re dealing with one or two patients it’s manageable, but once you get to 20-30 patients, dealing with therapies that are costing hundreds of thousands of pounds, it’s a different story”.
The company is now getting a lot of interest from early stage companies looking to see how they can integrate the solution and use it to scale and grow. Rehman explains a common problem they’ve seen when it comes to spin-outs taking therapies from the bench to commercialisation and preparing to be exit ready – they’re often not as ready as they think they are.
“Whether its exiting in a small sense or a Nasdaq type exit, many companies aren’t nearly as ready as they think. Investors regularly observe that many spin-outs are only about 20-30% ready to exit. They think they’re 60% ready to exit, but when you go and dig down into the data and numbers needed, they’re just not there. If you have our technology embedded from the minute you discover a molecule in a test tube on a bench and start capturing that data on the ledger, you’re going to be 50-60% ready at that point alone. And if you keep that technology going the whole way along the process and grow with us, you’re going to remain at that level of readiness. And that’s key if exiting is a conversation you’re going to have, which let’s face it, many are.”
Farmatrust’s solution was chosen for FDA trials due to its interoperability. The technology does not fix itself to one blockchain platform, meaning it can quite easily switch between different mechanisms. Sharif explains that the company believes that as we’re in the nascent stages of blockchain it has to be able to move clients at any time to a different platform if something better or faster comes along for them.
“In terms of interoperability, in terms of the single source of truth, we are aiming to replace historic practices where in some cases a multitude of systems are being used. It doesn’t matter which trust is using what system, whether its Microsoft Systems, Great Plains, SAP or oracle, we can bring them all together. Even in remote locations where there aren’t systems, we can use mobile phone apps to ensure data can still be collected. We’ve really mastered tackling the different challenging environments.”
Interoperability is so much a company policy that FarmaTrust doesn’t force clients to use its own dashboard, but instead allows them to take the data and visualise it any way they want. This gives the solution a truly neutral position, enabling it to integrate with any hard or software.
“We bring everyone together using this single source of truth in a secure manner. One of the advantages of this is that you can also control which participants have access to which part of the data, for example showing different parts to couriers, regulators and so on.”
This is also great news for collaboration and openness when developing nascent innovations, as it means two competitors can work on a platform together, compartmentalising and sharing data securely while still protecting their respective ‘secret sauce recipes’. This will allow the sector as a whole to grow, ensure uniform quality and make it easier for regulatory compliance so that more patients can benefit from these pioneering treatments in greater numbers.
Looking to the future
FarmaTrust’s ambition is to see its unique needle to needle blockchain solution for the CGT sector installed as widely as possible with clinics, labs, universities and other supply chain participants.
Its tracking and data solutions are operational, already installed in companies like McKesson. Naturally, FarmaTrust wants to on-board many more clients, but from a product development perspective, it really wants to develop AI capabilities as well as the automation of payments, tax collection, regulatory reporting.
“We have a pioneering solution to give pharmaceutical companies, NGOs, regulators and Ministries of Health a transparent and holistic view of the complete end to end pharmaceutical supply chain. With AI capabilities we will be able to ensure accurate demand planning, reduce shelf times and make sure there is no over-supply or stock outs of medicines and medical devices,” says Sharif.
Finally, the company wants to drive forward its clinical trials solution, which can eliminate data manipulation and falsification, ensure better data collection and guarantee integrity. This translates to faster regulatory approval, quicker routes to market and more effective regulatory control.
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