Latest / BioSpace / Automation, Collaboration and the Future of Advanced Therapies
Transcript
- BioSpace: Hi, my name is Jennifer Smith-Parker, Director of Insights at Biospace, and you're listening to Denatured. In this episode, I'm joined by Jason Jones, Head of Global Business Development at Cellular Origins, and Alexander Safe, Founder and CEO of Autolimus. They discuss how robotics, digitization, and data-driven manufacturing are helping cell and gene therapies scale more efficiently, improve patient access, and move the field closer to truly global delivery. Alexander and Jason, thank you so much for joining this episode of Denatured. If you can please introduce yourselves, that would be great. Let's start with you, Jason. All right. Yes. Hello. I'm Jason Jones. I head the commercial division at Cellular Origins. Cellular Origins is bringing robotics to cell and gene therapy manufacturing. I'm sure we'll go through the challenges in the field and we can talk about the solutions to those. We're really digitalizing the operational end. We are... working at the bottom of a digital stack and actually bringing those physical operations of manufacturing into digitalization. And we're doing that for the purposes of scale. We're at an age now of patient delivery. We have approved therapies about scaling those up to reach patients. Perfect. ⁓ Alexander, if you can please ⁓ introduce yourself as well. Sure. My name is Alexander Saif. I'm the founder and the CEO of Ptolemas. So Ptolemy's ambition is to digitize the manufacturing and also supply chain of cell and gene therapy. And now we come into the next era of our journey ⁓ to not just only think about cell and gene therapy, which is the main focus of us has been and is going to continue to be, but also expand the capabilities we have brought into this industry further to life sciences. Actually we started working with ⁓ Cellular Origin back three years ago. And we are very proud of that because I think digitization is a good gateway for automation and robotization and basically cutting the costs down, bringing more efficiency, but far most importantly, bringing the therapies closer to patient, both in terms of the prioritization of the therapy as cell engine therapy, but also make it more viable. There are three P's that are very essential for any therapy manufacturer. There is a patient, physician. And payers, those need to be really the light at the end of the tunnel for any therapy manufacturer. I believe that working together with automation and robotization company like Celo Origin and together with us handling the data and the flow is going to really bring that equation to a better reality and make it more accessible. Ryan, well, thank you so much for the introductions, both of you. So let's go ahead and get cracking. So you've both built platforms aiming to bridge clinical and commercial cell therapy manufacturing. Autolomas with its digital Lego-like modularity and cellular origins with mobile robotics. So what's the single biggest bottleneck today that neither closed systems nor manual ops can solve? And how do your approaches compliment each other? I can jump in. ⁓ And first of all, we're would challenge what we're bridging. ⁓ I think we've seen over the last few years, in fact, since 2016, that therapies can get approved and can move into commercial manufacturing, but it's what that commercial manufacturing is. would say then, well, I'd reframe what we're talking about here is what we're working hard at Cellular Origins on is bridging from approval to patient delivery and those products might be approved, but At the moment, they're not being phased up to a high enough degree to be able to deliver to all patients that are indicated for those therapies. And as we know, there's that tsunami of other therapies and other therapy development companies coming that are in clinical phase right now that will get to, or a good number of them will get to commercialization, that will also need to phase up their manufacturing to deliver to patients. In indications that go way beyond what we've experienced up to now. ⁓ we do already have some approved therapies that could reach more patients. You know, I think leading away is Carvicti. but we have others like Cascadev for sickle cell disease, which could reach so many more patients. And this thing needs solutions around fuller automation and digitalization, such as we'll talk about. So the bottleneck then coming out of that is scale. We've never before, I think the lead manufacturing that probably is J &J legend at the moment is manufacturing five to 6,000 products a year at most. And we probably need to be delivering to 10,000 plus patients in the next year to two years. That's a step change and that's, that's the bottleneck, right? So what does it mean in detail? So you say we need to scale manufacturing. Can we do it the way we can now? I think we're seeing through the lack of progress there. that the answer is no. We need too many people to do it, too many highly qualified people to do it. We need too much GMP space and that equates to too high a cost of goods. And that's what I spend my days putting my efforts into solving. Right. Thank you for that. It's quite interesting as you're saying to see where this field can go, but also where the challenges remain regardless. Alexander, how about yourself? I mean, I agree with what was said, but I would say One of the main challenges is what we don't know, right? We have been accustomed for past decades since the inception of cell and gene therapy to have everything in our mind and to have everything on a paper. Now we want to go to robotization and digitization and it's a little bit of a challenge because we don't want to abandon what we have learned, but also we don't know where to focus first, right? Look, everybody around the table has one why. reach out to patients, treat as many patients as possible, as many diseases as possible and so forth and so on. But the how is a little bit of the bottleneck, right? Because the how and the approach we take, it's very determined in our success. Today, we are living in a very resource, scarcity, both from a financial perspective, but also how much we can spend on what we have. So I think we need to really think about what we can do more with what we have. And that's really what digitization and automation and robotization come to play. We need to put more in practicality. And as we all discussing about robotization, how we can make it more accessible, how we can make it more scalable, how we can make it to be reached to more patients and treat more patients. mean, the whole ecosystem of really make it scalable and accessible, you know, there's patients. patient journey to therapies, physician need to be educated and also the payers. And all of these feeds into the equation that we are trying to solve, right? We need to really think about is how we can really streamline the knowledge sharing. So I agree with much of that. I think, do you see, maybe I'm being overly positive here, but I do see that the field in general is moving forward incrementally. in all the areas it needs to. I've been amazed over the last six to 12 months hearing about how CUTI patients are being set up to be treated in an on an outpatient basis. I think that's an incredibly important step for, as you say, Ali's under that clinical delivery, those clinical networks. We do have a bit of a PR, I mean, when I say we, I mean the industry have a PR job to do around clinicians in general. And that'll expand actually. So as we... As we go into autoimmune diseases, these aren't oncologists. These these are clinicians with different specialities and we have to, we have to expand that PR job to make sure that these clinicians know about cell and gene therapy. They know the right facts and that they, they know the benefits and that they're moved to prescribe them to their patients. But I see those steps forward being made where, where it does chime with exactly what you're saying, Alexander, is that these are being done by individual organizations pushing things forward and they share their information, but it's not necessarily being done in partnership. And I think it's a very important part of why Alexander and I are here today. We're working in partnership to push forward robotics and digital solutions for manufacturing. Wider than that as well, we're also working with device manufacturers and of course the therapy developers and the therapy manufacturers themselves. People sometimes ask me, know, well, how do you work with different device manufacturers? that kind of have their own interests in mind. Like you were saying, Alexander, and I was thinking, well, it's happening because we're at a stage now where it happens or it doesn't. Um, our partnerships with Saitiva, Xenia's, are there and they're very deep because we're, it's a mutual win all around without working together. It's not going to happen and it needs to be done now, but there's a certain amount of, you know, Robotically operating devices as they stand now and consumable sets. And if we try and change it too much, it's going to be too much of a leap for regulatory authorities to go on. So there's automating what we've got now, but then also working with those same partners to look at how things could be better. So in three, four years time, if we start actions now, we might be, we might be able to build in more efficiencies and reduce costs even more so. Thank you, Jason. But I wanted to actually bring back to a point that each of you had mentioned about patience. And that is just since patient access sits at the center for both of you. How does that ethos influence decisions like building global configurability or error-proof redundancies? And I'm curious, too, with what global perspective, let's say from your multicultural teams or from your decades of experience, ensures equitable access beyond early adopters? So if I may, one of the things for me is really benchmark what we have done in other industries. I've had it many industries in this, as seven years has been with cell and gene therapy and biotech. I see the spectrum, right? Probably a decade ago, very few people talked to each other. Everybody was trying to defend their own turf and their own solution and so forth. And now. in stage that we start collaborating. mean, collaboration is coming to more maturity. agree. Because ultimately we are doing not only for patients, I think there is a self-prophecy here, which is good, right? Given the economic situation for the Selenjil from investment, we are thinking about a little bit of greater good for the industry. We are thinking this will bring inevitably more sustainability for the industry, i.e. is good for the industry, is good for us. Look, one spectrum, let's say 10, 15 years ago, people didn't collaborate because they didn't even contemplate to collaborate. Then you see the ultimate collaboration in one of the industries that I always look at it as benchmark is aviation. So in 1950s, people really understood that if one plane crashes, it's not my plane for my airline crashing, but he's actually crashing the confidence of passengers. people... rather not travel or take other means of travel rather than taking flight. And it really formed the black box thinking in 1960s. They said, look, if something awfully happens, then we all need to understand and learn from it. So that's kind of a proper sharing of, I do protect my services and my clients, but at the same time, I'm caring about the greater good. So we need to think how we can work together and share. our mistakes and learning to some extent so we can make more viability for the industry. Got it. Got it. I think Jason, I, cause I like we're coming back to collaboration. So that's something we talked a bit about Jason ourselves with our initial conversation, but yeah, if you can add to that too, to just finish us up, that'd great. Firstly, I like the analogy of the black box. That's, there's something that's, that's digitalization and certainly of data handling, but still has. still has human end effectors. And in fact, in causes, probably in terms of causes of problems, they're normally human led problems. And so this is where we're, we're taking the next step to, to automate those end effector actions as well in synergy. They'll be manufacturing, take out the problems. So I like that. I've got to use that Alexander. Thank you. Please. I'll credit you. And, but to go back to your original question, I think it's, you know, and Alexander mentioned the why and I think we do all have the same why in this industry. It's a great industry for that. Everyone's, there's a lot of people that have been in it for a long time and are clearly passionate. They wouldn't want to reach patients. They want to undress this unfairness of these diseases, but you draw different boundaries, different people, different organizations draw different boundaries. And, ⁓ you know, you talked about globalization and this, think it's important that we, we, we get ourselves together and prove that this is viable, cell and gene therapy. I'm talking about my industry hat on again. And we do that in the, I say the developed world, what does that mean? But in, certainly in North America and Europe right now, more and more so in China, we can prove this, this, this new pillar of medicine now, but it has to have a global effect and it has to be able to spread out from there. And we're really becoming closer and closer to, to really having to enact that. mean, we've got therapies now. I mentioned Casgevier earlier, this is a sickle cell disease therapy. And certainly I, I, know the developers, are they developers now? They're more suppliers or manufacture these therapies. I know they have in mind globalisation because sickle cell disease is more common in parts of Africa and Middle East sections. So absolutely it's on their roadmap to get there. And I think that they're going to lead the way in being able to globalise these therapies. How we do this, does this mean different manufacturing facilities in different regions or countries or continents potentially? They will all have to be standardized and best way to do that is through thorough automation. But also there may be a possibility of a more continental manufacturing centers that are larger, but that standardization has kept control of and in-house. So I think all of these avenues being looked at for the sake of inclusion for these therapies. So none of us in this industry, think have in mind an elitist medicine here. We need to be able to deliver these medicines. globally, but look to do it in a stepwise manner. Add one piece, I may, just one great skill that we always need to deploy and I believe both parties here have deployed is listening skills. And we did a little bit further in autonomous, we created Act for Hope, which is a non-for-profit organization and they have five topics currently on their agenda for us. is about standardization, which I think is close to what Jason and I, we're talking about. Number two is information. So how we can educate not only the physician and the industry about what's happening, but also the patients who are the recipient. Today, very factional part of the patients, they know about these therapies. Number three is about knowledge sharing. So how we can really make sure that the knowledge has been shared between the parties and that comes to collaboration. Number four is about payers, know, how we can create an ecosystem which shows financial benefit for investors and for healthcare providers and so forth. And fifth, but not least, patients and is about patient journey pre and post. So I think we need to have really collaborative platform to go beyond what we just dream about and we all have the same why. So let's do this how together. Well, thank you so much, Jason. Thank you so much, Alexander, for joining this podcast. It's been an absolutely fascinating discussion to hear about automation and digitization and the scaling up within this industry and kind of where we can go. If you'd to listen to more episodes, please turn into biospace.com.