Developing software for cell and gene therapy supply chain tracking
The first thing is, to always remember that were dealing with a living drug, cells, which are very sensitive to environmental conditions, such as temperature and humidity etc. All of those things can impact on the viability of the drug and its effectiveness. Controlling the conditions under which its collected, manufactured, shipped, received, defrosted and infused are critical to the success of therapy and this is a big challenge.
The first thing is, to always remember that were dealing with a living drug, cells, which are very sensitive to environmental conditions, such as temperature and humidity etc. All of those things can impact on the viability of the drug and its effectiveness. Controlling the conditions under which its collected, manufactured, shipped, received, defrosted and infused are critical to the success of therapy and this is a big challenge.
The number of parties involved in the supply chain is a key aspect of this challenge, for example, cells are initially collected from the patients at an apheresis center. They then have to be shipped to a manufacturing site and once received at the site, they are passed through the manufacturing process where they are genetically modified and expanded.
Once the therapy is ready, it needs to be repacked for shipment, again handled by a logistics provider, received by the hospital, not necessarily by the doctor whos going to be giving the drug. Passed on to that doctor, potentially defrosted, then used in the patient.
Cell therapies pass through a lot of different hands and maintaining the right conditions across all of those people, making sure its handled in a consistent manner across all of those different change of hands, is a major challenge for autologous cell therapies.
Autologous cell therapies are where the patients own cells are used to treat them. For obvious reasons, it is vital that the same cells go back to the same patient, so maintaining that traceability throughout the supply chain is another major challenge. It can be done manually in early clinical development, but as more and more patients enter clinical trials or as the products themselves are commercialized, maintaining that tracking mechanism is going to be more and more challenging which is where our software comes in.
The more patients there are, the more clinics that are going to be involved in handling the products and is important from a consistency point of view to make sure you get the best possible starting material, and that they all work in a consistent manner.
There are going to be more potential manufacturing sites involved because a lot of autologous therapies are currently shipped fresh, which means producing in Australia and shipping to Alaska for example is not possible, because the material is not stable enough to survive that length of shipment.
What occurs is that there will be a lot of different manufacturing sites at different parts of the world, meaning multiple couriers, different personnel sites, all of which also have to be managed.
We must turn around these treatments very quickly, therefore often the person who took the cells in the first place is not the same person who receives them back because of their working hours etc., and so achieving consistency and traceability is going to become increasingly challenging as more patients get involved.
Last year it was estimated around 3,500 patients received autologous cell therapies. That number over the next 9 years is expected to increase to more than 200,000. Each one of these, is about as personalized as medicine can get, so you can understand the problem were trying to solve.
With a lot of cell therapies, because theyre still very new, theyre almost given as the last line of defence, youll see in a lot of studies patients have already been through chemotherapy, radiotherapy etc., and this is really their last chance.
The biggest impact is from a patients perspective rather than purely a cost perspective. It might be their last chance of getting a treatment that works for them. If we lose a shipment, the patients chance of survival could be lost forever so thats the biggest cost.
In terms of the value of the treatments themselves, GlaxoSmithKline have a cell therapy that they was licensed last year and the selling price of that product is around 600,000 Euro, so it is a very valuable product, in all aspects.
In a recent Financial Times article on the scalability of cell therapies and the cost price alone for producing a cell therapy is estimated by Novartis and others who are likely to be the next companies to get products to market. Theyre estimating around 300,000 dollars just to manufacture the drug, before you get into logistics, marketing and they need to make a profit as well.
It was recently in the news in the UK that 1,700 patient records had been left in a warehouse, which contained cancer test results and so on. When youre talking about 300,000 pound therapies being sent from one place to another, you dont want them to be in the warehouse when a patient urgently needs treatment.
The original vision was to democratize cell therapy. The way cell therapies are currently produced, because everything is manual, you need very highly skilled people to take cells to manufacturers, modify the cells, scale them up etc. Its only available in a very small number of centers, mostly in the West, and its a very expensive process.
By capturing data on the supply chain, you can make it more efficient, eliminating some potential errors from the supply chain. We, along with other people who work in the supply chain, are hopefully going to make these products more accessible, more affordable for a wider number of people.
This goal is not just of TrakCel but a lot of people who work in this area too. I think theres great potential if you look at some of the results in Novartis JULIET study, which is running at the moment, they have 93% remission in patients who hadnt responded to any other treatment. Making that type of effective therapy available to a wider population is ultimately on the philanthropy side of us what were aiming to do.
Regarding the platform itself, it is a cloud-based platform, as increasingly a lot of things are. It has to comply with regulations around patient confidentiality. We dont want to be the company that leaks 1,700 patient records if we can help it! Everything in the systems encrypted, so the only people who need to see information on patients can see this.
We also have to comply with regulations such as CFR21 Part 11, which basically looks at ways around electronic signatures to make sure that at each step of the process, to ensure that people are processing in the correct way, they have to sign off on that and that is done by electronic signature, which means we know who did what and when if ever theres a problem with the product.
It is a cloud-based fully compliant platform that is secure as well. Weve been security tested by leading pharmaceutical companies and one of the worlds largest CROs.
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