In this episode, we speak to Andreas Olpeter, Vice President of Sales & Business Development Healthcare at Arvato Supply Chain Solutions, and Andrea Zobel, Senior Director of Personalized Supply Chain at World Courier. We discuss the emerging wave of new C&GT therapies and whether they are a niche, only available to small numbers of people, or if there is greater potential for wider patient access in the future. What are the complex ecosystems required for logistics success, and how will greater industry collaboration get more of these life-saving therapies to patients?

Transcript

Mike Iorfino: Welcome to the World Courier Insights Podcast. I'm Mike Iorfino, Manager of External Communications at AmerisourceBergen, and your host for this podcast series where we'll cover the latest industry news and trends across the pharmaceutical logistics sector. Today, our discussion will focus on the rapidly growing market of cell and gene therapies, with a specific look at the complex ecosystems required for logistic success and the need for greater industry collaboration. 

I'm thrilled to be joined by two industry experts:  
Andreas Olpeter, Vice President of Sales & Business Development Healthcare at Arvato Supply Chain Solutions, and Andrea Zobel, Senior Director of Personalized Supply Chain at World Courier.  
Andrea, let's start with you. There's a tremendous amount of discussion about these innovative therapies. From the science point of view, what are cell and gene therapies? 

Andrea Zobel: Yes, this is a very good question because we are now entering a completely new situation and a completely new class of pharmaceuticals and therapies. You all know chemical entities, which are used as medicinal products. You all know biopharmaceuticals, which are proteins or fatty acids, also some biological origin, but now in cell and gene therapies, we have cells. This is the smallest unit of the body, or we have genetic information, DNA, RNA. 

All of this is coming out of the patient. We have even the situation that the patient himself is giving, is donating his own cells, his own genetic material, and then the therapy is made out of these cells or specific for the genetic information coming from the patient. We have, for the first time, the situation in pharmaceutical development that the patient is part of the whole manufacturing and development process and, therefore, also part of the logistics supply chain when we are talking about so-called autologous therapies where the patient is really donating its own material and then the therapy is made out of that material. 

There are also other cell and gene therapies where we have donations of cells, donations of genetic material, which is used then to develop batches used for therapy of many patients.  

It's a completely new class of medicinal treatments. 

Mike: That's a really interesting point about patients being a part of the supply chain. I imagine that creates new logistics considerations specific to these therapies. Andreas, how does the logistics ecosystem of cell and gene therapies differ from other products? 

Andreas Olpeter: Oh, very much. Andrea just mentioned it. It's new. The products are new, the therapy is new, the whole manufacturing of these therapies and also the way that this therapy is brought to customers or to patients is new and hasn't been there before. That also means that the entire ecosystem to deliver that therapy and to bring that therapy to patients is new. 

The pharmaceutical industry, Andrea mentioned that being it now synthetically produced pharmaceuticals or biological produced pharmaceuticals, there is an ecosystem around it being it for tablets or for liquids or for whatever. There's a solution around it to bring the therapy to the point of care, established ways of working, temperature-controlled, two to eight degrees, normal retail chains by the wholesalers to pharmacies, and so on, and so on. Cell and gene is different. Cell and gene is new. Unlike there are solutions for the traditional pharmaceuticals if I may say that, cell and gene also bring a lot of new challenges for the entire industry around the therapy itself. The whole ecosystem is totally different. We're talking about basically just like an organ transplant logistics. Andrea mentioned that before, it's a patient that donates cells for treatment later on. 

Also, the entire ecosystem regarding temperature, regarding having an eye on that therapy is completely different. It's not a mass shipment. If one shipment fails, another will certainly replace this one. That's not the case. We know that basically, these kind of therapies currently on the market, they may be lifesaving. This may be the last chance for a patient to stay alive. If we look at these treatments for these threatening conditions, they are making the difference between life and death. That's also why the ecosystem, which is yet still to be built up for that therapy, needs to be a zero-failure, zero-defect ecosystem. There's a big criticality of that entire therapy. It's also a big challenge for service providers like ourselves in that area with our partners to come up with a corresponding new ecosystem. 

Mike: Andrea? 

Andrea: What I want to add really to Andreas' statement is that there are a lot of logistics considerations we have to consider for cell and gene therapies. We have completely different requirements for storage and for transportation. All the licenses we need for cell and gene therapies are different and specific for cell and gene therapies. There are a lot of regulations already available in this, also evolving infrastructure of regulations for cell gene therapies. 

We have much more than traditional therapies. We have to consider temperature excursions because this can really harm the therapies, can destroy the therapy completely. It's also specific for cell and gene therapies that they are very often highly temperature-sensitive. We have to create, really, a completely different infrastructure. We have, very often, bespoke solutions, both for storage and for transportation. 

Mike: It's very clear that these are pretty targeted therapies. Generally, what is the patient population that these therapies serve? Are they benefiting mass populations, or are they more limited? 

Andreas: Maybe I can take this point. Today, they are really niche therapies. If I just think of what is there on the market right now, talking about the KYMRIAH from Novartis or the Yescarta from Kite or now Gilead, these are really niche therapies. As Andrea outlined, they require a very particular and bespoke infrastructure, being shipped at -196 degrees Celsius with liquid nitrogen, being it really this B2B supply chain, this closed-loop B2B supply chain, patient individual. 

That is something which is very bespoke indeed, and yet again, there are solutions that these companies and these therapy providers, they worked out, but these solutions are very, let's say, manual. They are very, let's say, specific. They are not really geared up to scale up. When you then see what is there to come in the next couple of years, just looking at the study saying that per year, as of 2025, we expect 10 to 20 new therapies to be launched each and every year, there's a huge wave of new therapies on cell and gene to come. When you then see the infrastructure currently, more or less, manually put together, I wonder if that is something that can be scaled up and certainly needs some further attention there. 

Mike: Andrea? 

Andrea: I see the very specific therapies for very small patient populations at the moment, but the wave is really coming of many therapies. Also, these therapies are for very common diseases. We have now solid tumors, which are in clinical research to be treated. We have diseases like diabetes, multiple sclerosis, Parkinson's disease. Large patient populations are affected by these diseases, and now, therapies are in development for these diseases. 

Yes, this really requires that we have to develop the infrastructure that these cell and gene therapies can be used on large scale. What we see currently are very bespoke solutions, each pharmaceutical company, each manufacturer has specific protocols, how to take donations, how to manufacture, how to treat so that we'll need also a higher level of standardization so that these therapies really are accessible for a large number of patients. 

Mike: Just hearing you both speak about these therapies, it's clear how passionate you are about this topic. I'd really love to unpack your personal motivations for being in this industry. Andrea, given your background as a scientist, what drove you to work in pharmaceutical logistics? 

Andrea: This is a question I'm often asked by many people because I was educated as a scientist. I worked really in the scientific field and really, my motivation was really to develop new therapies with the methods of cell and gene therapy from the early beginnings when I studied biochemistry, but now I'm at the last mile. I see I can really bring a lot of benefit to logistics for my colleagues because, with my background, I understand the requirements of cell and gene therapies. 

One very important requirement are requirements for cells. We have two possibilities for living cells, and I know them in detail because I worked in tissue culture, I know how to grow a cell, what other requirements? You have two possibilities in cell gene therapy, in cell therapy especially. Either you shape the living cells. Then they have only a short shelf life in 2 to 8 or ambient conditions, just a few hours, 24 to 72 hours, a cell can survive outside tissue culture. 

We have no other chance than to be very, very fast with our shipments. There is an alternative possibility. You can freeze cells, but freezing is required at liquid nitrogen conditions. In these conditions, you can store cells for decades, forever, so we have the chance to increase the shelf life by freezing the cells. These are two completely new requirements in pharmaceutical logistics, either to be very fast within hours, we have to ship, or we have to freeze the cells, both the donations and the finished therapy, and at liquid nitrogen conditions. 

For this, we really need the whole infrastructure, so it's really important to understand completely when we look at the therapy. Very often, we have many steps in the therapy manufacturing, not even the donation of cells of the patients, sometimes also two more biopsies, in addition, and out of this at the end, the therapy is made, and each of these logistics lanes have other requirements. It's important to understand completely which product we have in front of us to define the right temperature conditions, to define the right shipper material. 

Here's really the nice situation for me that I can bring together my scientific background with my logistics and clinical supply experience and help, together with the colleagues in logistics, to set up the right logistics infrastructure but also to educate the manufacturers, what is available, what is standard in the logistics world and to avoid that they are starting their developments with, sometimes, unusual temperature conditions, which are not widely used and to educate them, to consult them how to set up also their research and their development that at the end, they have a feasible logistics concept. 

Mike: That's excellent, Andrea. Andreas, I'll ask the same question to you. What is your motivation personally to be in this industry? 

Andreas: Thank you, Mike. That's an excellent question. Actually, I'm in this industry now for over 30 years, of which half I spent with the service provider, Arvato, and the other half I spent in the industry myself having worked for various manufacturers in various positions there. Actually, within these 30 years, I saw a lot of opportunities arising, a lot of opportunities also just passing by, which the industry didn't grab, actually. 

With all these connections I have, my aim is to really have a more collaborative approach for, let's say, solutions required for these unanswered questions which are there, like creating a new ecosystem for the delivery of advanced therapies like we have here. There have been many examples in the past. I saw a lot of launches of great initiatives how companies can collaborate as these companies can also identify, and they understand that they are not really gaining any advantage if they do it different. This industry collaboration is certainly something which I would like to foster in order to have more finishes from the various launches that we see over here. 

Mike: You mentioned industry collaboration, and I think we can really look to what we've seen over the past year or so in terms of the collaboration and logistics support needed to distribute COVID vaccines that require frozen or deep-frozen storage and handling. In your opinion, what are some of the key lessons for setting up logistics ecosystems for specialized therapies, and how can we apply those lessons moving forward? 

Andreas: Yes, I think I can give you a good example. Andrea mentioned that before. When all these biopharmaceutical products came to market, probably 20, 25 years back, that was also a big challenge for the industry, actually, because these biopharmaceuticals required a refrigerated or a cold chain at two to eight degrees Celsius, and that was something which the industry at that time didn't really focus on, but in particular not at the last mile, so delivering to end customers. 

I was in the industry myself at that time, and we were looking for solutions. How can we find a transport provider that brings these products in a closed-loop supply chain, in a cold environment to the end customers, being it wholesalers, hospitals, or pharmacies? Because we were all fed up to use these cool boxes, especially if you have mass products just like insulins that you need to put on the cold chain, it's difficult to put them all into cool boxes. 

We were looking for carriers to develop something actively cooled. I remember, at least for Germany, the area that I was in at that time, that there was one innovative carrier who listened to the industry, who listened to all of the providers, and who basically came up with a solution. He said, "Look, I invested. I invested into an infrastructure, I invested in the depot, I invested in the cars. I invested into that seamless two-to eight-degree environment." He then went to those customers and to those manufacturers who asked him - to please build up something. You know what happened, when he offered his services, they all told him, "Okay, that's nice to hear. For whom are you working today?" He said, "Well, I need to start somewhere, so please give me a bit of work because I need to feed my system so that all my investments pay off." You know what, all of these people in the industry, me included at that time, we said, "Okay, that's fine. Come back if you have three references." 

I think this conservativeness of the industry and maybe also the fear of taking a risk, whereby I would not really stress risk here, is something which is also blocking innovations and collaboration at a certain point in time. My idea, and my personal driver is to change that and to bring these people to the table so that we can all further collaborate. 

Mike: Just based on what you're saying, it's clear that this is an extremely complex process across the clinical and commercial journey and one that seemingly does require a high level of collaboration to drive success. Andreas, you just hit on it a little bit in that last response but would love for you to elaborate a little bit on why there isn't more collaboration across the industry and maybe what we can do to address that issue. 

Andreas: One also has to bear in mind this industry is different to other industries. Of course, each industry is different to other industries, but this one may be particular. We are moving products that have a severe effect on a patient's life, being it positive, and if we do failures here and if we do mistakes, also negatively. I think to talk about outsourcing, to talk about deciding which carrier to take, which service provider to take is a very responsible decision to take. 

I believe the industry is in a position where they need to ask themselves, "Okay, do we want to continue working in silos? Do we want to continue working on our nice, niche environment?" I'm pretty sure that let's say the golden times of the industry are over. There's far more competition to come, and we see that more and more with the cost pressure on the manufacturers. 

They need to be a little bit more innovative, operating less in silos, really working together with each other, and in order to be successful there, you need to find a collaboration group, a group of interest to exchange, to work together, to exchange on the best practices, to exchange on the experiences the one made and the other did in order to avoid these, let's say, difficult situations that I tried to elaborate before, meaning, "Okay, we need something, but basically we take care that what we need is not put on the market." 

Mike: Andrea, anything to add? 

Andrea: It is really a challenge to come at the right time. We have seen already therapies, for example, the first gene therapy was used for one patient, and then it was taken off from the market because the whole infrastructure, the time was not ready for this therapy. This is another example that we really have to consider: is logistics following science or science following logistics? 

Now with the broader number and a broad range of therapies coming to the market, we have now the right time to develop the infrastructure which is required but also this collaborative approach really to discuss with each other, to define requirements, which are really necessary for the therapies. Standardization, this is really necessary to have not so broad a scope of different logistics possibilities but really a smaller range of logistics, especially temperature ranges, which are used then for a very high number of therapies. 

This makes the whole logistics also more cost-effective, and it's really important that all players are talking to each other, really think about, is it really necessary to have these five-degree lower temperature just for extension of shelf life of perhaps a few months when the therapy itself, when the life cycle is only for one month? It makes not a lot of sense to do this. Instead of insisting of an already developed protocol would be really good when all the parties are talking to each other, exchange what is available, what can be developed, and then change also a little bit, the requirements, for example, also to have new ability data and change orders of submissions of the therapies that at the end, we have really a larger number of therapies which have the infrastructure they need. It's this, and also great technology solutions which are developed used on a broad range and not that we have the situation that such a company is getting bankrupt because nobody is using a very good solution. 

Mike: Yes. I guess if I could just go back, Andreas mentioned the wave of therapies expected to hit in the next five to ten years. I guess knowing that's on the horizon, there is some real urgency in organizing or putting together a more structured approach that would enable more efficient access to these therapies. Andreas, who's the driving force behind setting this all up? 

Andreas: Again, a good question. I think the ultimate driving force will be the pressure and the pain that is put on the therapy providers in order to bring their therapies on the market. Like we outlined before, and Andrea mentioned that today it may be just two or three therapies, but more therapies are to come, the harder it is for the existing, very manual eco-system to cope with that. It's not scalable. 

I think the driving force, ultimately, will be, and we shouldn't forget that, will be their freezer centers, will be the treatment centers, where the actual work is done if I may say that the actual patient work is done. Just imagine that each of these manufacturers creates its own solution and comes up with a very individual story. 

Just imagine in that freezer center, they have to work with 30, 40 different systems, different ways of working, different IT connections, different whatever, that isn’t working, it just isn’t working. 

Then on the other side, you see that there is a patient need. The ultimate driving force, certainly, I guess will be the entire ecosystem. It is companies like World Courier, like Arvato, and together with our friends, we try to really create this discussion group. I think I can mention that here. We created a discussion group, an industry circle called Accelerator where we've tried to bring the industry together to discuss exactly this, to create this, let me call it, Star Alliance for selling gene supplies, to make sure that whatever is on the pipeline can also be on the road in the future in a manner which is handleable for those that have to do the treatment, that have to do the collection, that have to do the infusion later on, for those that have to bring the product through a warehouse, bring the cryo-storage, do the transportation, and ultimately for those that are in need of the therapy: the patients. 

Mike: Andrea? 

Andrea: Yes, I think it's all about costs at the end. The patients have only access to therapies when these patients are also cost-effective, both on the health systems but also, at the end, for the pharmaceutical companies who have the license on this. We have to reduce costs for the whole of manufacturing and logistics, and I think this is a natural development. Think about the first computers, how expensive they were. We will have the same situation that these therapies, there's more standardization. When it's more common, we can reduce the cost of manufacturing and logistics and on the other hand, the expectations. How much the pharmaceutical companies are earning with these therapies, they also must be relative to the value and also to the number of therapies on the market. 

We cannot go ahead with a therapy costing one or five million. When we have more standardization and we can have the chance also to reduce the cost at the end, these therapies can be paid also by the health systems, and patients will have access. At the end, it must be more efficient, with the whole process. 

Mike: That's a great point, Andrea. I think it's the perfect message for us to close on. Andrea and Andreas, thank you both for joining the podcast and for this fascinating discussion about cell and gene therapy, delighted to speak with you. Hopefully, we'll speak again soon. 

Andrea: Thanks a lot for the opportunity that we could share our opinion on this and make suggestions for these therapies. 

Andreas: Also, from my side thank you, World Courier, and thank you for this opportunity to exchange. Yet again, let me express this invitation to the industry. We are dependent on your collaboration to really do that together with you, so we must come together. 

Mike: Thank you for listening to the latest World Courier Insights Podcast. I'm Mike Iorfino, speak to you again soon.