Developing software for cell and gene therapy supply chain tracking

insights from industryMartin LambExecutive VP,TrakCel

An interview with Martin Lamb, EVP, TrakCel, conducted by April Cashin-Garbutt, MA (Cantab)

What are the main challenges in logistics and supply chain management in the cell therapy industry?

The first thing is, to always remember that we're 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 it's 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 who's 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 it's 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 patient's 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.

How are these challenges likely to intensify as the number of clinical trials, patients, samples and approved therapies continues to increase?

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 we're trying to solve.

What impact can lost or delayed treatment have for patients and companies?

With a lot of cell therapies, because they're still very new, they're almost given as the last line of defence, you'll 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 patient's 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 patient's chance of survival could be lost forever so that's 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. They're 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 you're talking about 300,000 pound therapies being sent from one place to another, you don't want them to be in the warehouse when a patient urgently needs treatment.

Can you please outline the vision behind TrakCel’s solution?

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. It's only available in a very small number of centers, mostly in the West, and it's 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 there's 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 hadn't 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 we're 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 don't want to be the company that leaks 1,700 patient records if we can help it! Everything in the system's 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 there's a problem with the product.

It is a cloud-based fully compliant platform that is secure as well. We've been security tested by leading pharmaceutical companies and  one of the world's largest CROs.

The basic functionality we offer is full traceability, that is the number one aspect and was the original design behind the platform. Traceability of material from the initial patients for an autologous therapy, to make it back to the same patient for allogeneic therapy to anybody who then receives the drug produced from that starting batch of cells.

We create a lot of workflows and no matter who is processing the cells, they can login to TrakCel to follow a very prescriptive process, which ensures that they get consistent handling across the supply chain.

We integrate with third party systems, so for example manufacturing and courier systems to give the clients, or in some cases the doctor or patient, a full view from where the cells are first collected, right through to when they came back, who handled them, under what conditions they were handled, quality test results, whatever they want to be integrated into that record.

It is also very useful to regulate this because if they want to see a full chain of custody for a cell therapy product to demonstrate for example safety controls by the manufacturer, they can login to the system or we can print them out a report which gives them that full end-to-end report of what happened at each stage and who did what.

What impact do you hope the platform will have on the cost of gene therapy products?

One of the other challenges is around scheduling of activities. For example, when cells are collected from the patients, it is critical that the cells have somewhere to go, that there's manufacturing capacity available.

One of the newer additions to the system has been scheduling, so before doctors collect starting material, they know that there's going to be manufacturing slots available and it's not going to go to waste. Putting a patient through apheresis is not particularly pleasant for the patient and having to repeat that because cells were collected and then there was nowhere for them to go, is something we want to avoid.

A big part of the scheduling is it's going to increase efficiency of the supply chain. A big driver of the cost of the medication is low utilization of manufacturing assets. By scheduling manufacturing with cell collection with infusion dates, we believe we can contribute to a more efficient supply chain, which should impact favorably on the cost of those therapies.

Other areas where we feel we can add value is by putting prescriptive workflows into clinical sites. It means that they're collecting the data they need to collect in the way that they're supposed to collect it. They're not deviating from protocol. That in turn can reduce monitoring costs for a clinical trial. It means that people don't need to return and retrain staff at the sites because the site has very clear instructions that they follow. The biggest benefit is the efficiency and the speed of getting products back to patients, and then the overall cost of doing that is where we add real value.

What feedback have you received from users so far?

Our first roll out was to a clinic in Milan and so we did some post-market research on that site. We got some extremely favorable feedback from the clinical staff on how well the system was working.

When the process was being used for a US buyer, we again, got excellent feedback from the sites in terms of the system itself but also the training we delivered around the system because we've done this quite a lot now so we've got very adapted understanding where sites might struggle and what they need to know about TrakCel. We focus very heavily on making sure the sites are comfortable with the systems before we go live.

What are the next steps for TrakCel?

The next steps are around reimbursement of the products and this is yet another challenge that we're going to have. Obviously, this is a very expensive product and NICE tend not to like expensive therapies. Developing models that are going to work for people and bodies like NICE and insurers in the US is going to be a challenge.

There are some very stunning results from the therapies but there is also a risk that some patients could go back into remission. If you're paying half a million dollars for a product, you need to know that that it is going to be a cure, and that the patient is not going to need to go back for another half a million in six months’ time and another half a million after that.

There are various models being suggested as to how cell therapies can be charged and paid for, a lot of which are related to outcomes. For example, you get paid for every year you add to the patient's life would be one way it could be done. I know for the GSK product I mentioned, they're offering a full refund if the patient's condition deteriorates after therapy.

There are different models being looked at but one of the things that is unique in cell therapy is that there is a requirement at the moment to follow up patients following their treatment for up to 15 years.

This long-term monitoring is tied to payments and then getting agreements by payers to actually pay for the treatment in the first place, there's a whole lot of data capture around that as well and that's the next area that TrakCel is going to look at.

What do you think the future holds for cell and gene therapy supply chain tracking?

I think as we gather more and more data, the industry is going to pool a lot of that data and use it to help other cell therapies come to market, so everybody isn't reinventing the wheel as far as supply chain management goes every time you launch a new therapy. There is a lot of talk about what information do we need to capture, what shipping routes should we take, what procedure should we employ to maintain efficacy of the product.

Although these are commercial enterprises at the end of the day, it does seem to be that because the whole industry is very collaborative. I come from a traditional pharma company and it's something that's certainly jumped out to me is the level of collaboration, best practice sharing between different organizations in the industry.

Where can readers find more information?

About Martin Lamb

Martin Lamb is the Executive VP of Sales and Marketing at TrakCel, a developer of software to support efficient, safe and scalable supply chains for cell and gene therapy products.

Prior to joining TrakCel, Martin worked in pharmaceutical contract services for 25 years the majority of which we spent in Clinical Trial Supply Chain services. Martin spent the majority of his career with Almac Clinical Services, where he was part of the leadership team that saw the company grow from a niche UK-based service provider to a global business employing more than 2,500 staff in Europe, the US and Asia.

During his time with Almac, Martin developed a deep understanding of the use of technology to optimise the management of complex supply chains for high-value pharmaceutical and biological products, skills that will be invaluable in the burgeoning cell and gene therapy industry.

Martin left Almac in 2014 to join the leadership team at Biotec Services International, a company focused on the management of supply chains for specialised, temperature-sensitive pharmaceutical products include cell and gene therapies. Biotec was one of the original investors in TrakCel’s technology. Following acquisition of Biotec by PCI, Martin spent two years heading European Sales for the Clinical Supply Services business of Catalent Pharma Services, one of the world’s largest contract development and manufacturing organisations, with more than 9,000 staff in 30 countries.

Martin is a Chartered Marketer and holds a Bachelor of Science (BSc), Pharmacology from the University of Leeds.

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