Democratizing Cell Therapy: A PhD's Quest to Change Medicine Forever

Toon Lambrechts: 0:00

I was intrigued by cell therapy. I think it was at the time where the first cell therapies came on the market. So it was the first time you could really see cell therapy picking up. So that was kind of intriguing. And as a student and bioengineering I followed the evolution there just because

Harsh Thakkar: 0:18

what's up everybody, this is harsh from qualtivate.com. And you're listening to the life sciences 360 podcast. On this show, I chat with industry experts and thought leaders to learn about their stories, ideas and insights, and how their role helps bring new therapies to patients. Thanks for joining us, let's dive in. Hey, welcome to the life sciences 360 show a passion for cell therapy. In this PhD researchers mind made him to go on a quest and democratize access to cell and gene therapy. When he did that, he was focusing on three things he wanted to cut manufacturing costs, he wanted to reduce the production times. And he also wanted to simplify quality. Well, guess what? He just did that. And he co founded MyCellHub in 2018. My guest today is Toon Lambrechts. Welcome to the show.

Toon Lambrechts: 1:06

Hi harsh, nice speaking to you.

Harsh Thakkar: 1:09

Yeah, I want to I want to start off by asking you walk walk us through the journey you're in, in university, you have this idea of starting MyCellHub, walk us through what was that experience like? And how did how did MyCellHub start?

Toon Lambrechts: 1:27

Sounds like such a long time ago but basically needed started university I was kind of by accident, looking for an internship and stumbled upon octane biomedical, which is now the law that Cocoon actually technology. And I was working there for a couple of months and the university asked me like, like in Belgium, we have a similar project would you mind working for university doing your PhD on this new biometric technology that we are developing for basically a customized 3D Bone implants and based on cell therapies, that was that was the start. So they they asked me to do a research project on this. And how this led to MyCellHub kind of a coincidence, I must be honest, this this lab was developing personalized cell therapy basically. And I noticed that there was so much data lying around in the lab, I was always looking for the data of two years ago of PhD students that left difficult to find the right the right stuff. And some basically my free time, together with my now co founders, we basically started building your tool to manage the data of that. And that was myself in a very embryonic stage, basically, just just for our own sake, making sure we could track all the bioreactor runs we were doing, link them to specific cell populations and patient or patient IDs, donor ID at that moment. It was preclinical. But that was basically the start of MyCellHub.

Harsh Thakkar: 3:15

Yeah, I was curious. And I wanted to ask you when I was going through your background, like why why cell therapy? Like, was there a reason? Like, I know, you did some research in that space, but it sounds like you did the research, you got this project. And then you also had some data available in that therapeutic area. So you basically merged all of that together? Was that how it felt? Is that how it went through?

Toon Lambrechts: 3:41

I was intrigued by cell therapy, I think it was the world, the time where the first cell therapies came on the market. Like in Europe, it was iGenex of its own cell therapy product. So it was the first time you could really see this cell therapy picking up. So that was kind of intriguing. And as a student I, in bioengineering, I followed the evolution there just intriguing to see how we can re engineer our own cells to heal crazy diseases or maybe even augment or our physiology. So that was kind of intriguing. That cell focus has remained. But first of all, because that's what I know best of my research at the network that I've built up, of course, but also because the challenges in terms of data management, let's say and quality control, is one of the biggest in my opinion. Many cell therapies are very new. So in novel technology, many of them are not even super well characterized. So it's difficult to manage quality and there's so much data going around the cell therapies that We need better tools. So the cell therapy kind of remained because it was the most critical pain point. In the meantime, we're actually using the same technology for other drugs like CBD RNA, a completely different use cases, but hence the name as well, MyCellHub, it's still, it's still the main focus. And it still is still the biggest pain point, especially, for example, like personalized therapies, every batch of product that you make for a personalized therapy, often a cell therapy, you need to go through all that paperwork, you cannot have this, let's say economies of scale, over typical a classical pharma products, where you have one big batch record, and basically that effort, keep that history sealed and batch record is distributed over 1000s, or hundreds, maybe even more patients in a cell therapy, especially personalized cell therapy, keeping track of all that paperwork has to get done per patient. So it's a huge scalability issue. Maybe you want to scale these, if you want to bring this to the market at an affordable price. It's something we need to solve and automate as much as possible.

Harsh Thakkar: 6:12

Agreed. Yeah, I also got my start in 2018 in the cell and gene therapy space, and that time, I started this quality manager position at a Juno therapeutics cell therapy company based in Seattle. Right. And then that went up, got through two acquisitions. It was acquired by Celgene. And then Celgene, was acquired by BMS. And then in 22 years, they launched their first product. So yeah, it's, it's, I hear what you're saying. Because the chain of identity and the chain of custody is super important when it comes to personalized medicine, because you're dealing with either the patient's blood or whatever it is, it's not it's one to one, it's not like you're making product at scale in a manufacturing facility. So I got to I got a lot to learn from that role, how it's different. And I'm so glad I have that experience now, because it's it is, it is the same concept, but applied differently.

Toon Lambrechts: 7:08

Yeah, and especially at that time, I think it was very novel, honestly, for now, we are getting used to it. It's still a challenge, but we keep getting used to it. But I think in this 2016 2018 period, no one really knew how it was done. Many people were still managing everything on paper, while like you said this, this chain of custody of those cells and where they travel. It's quite complex to keep track of it. Yeah.

Harsh Thakkar: 7:38

Yeah. So you have this, you have this. I don't know if it's a mission statement, or it's a tagline that you're democratizing access to cell therapy using, you're using the platform. So walk me through, like, what does the solution do that it helps achieve that mission for cell and gene therapy companies.

Toon Lambrechts: 7:57

It's indeed our mission statement. Pricing of medicine is something super complex. And I'm not claiming that we controls the pricing of cell therapy, or that in order to bring the price down, one of the main things for cell therapies that need to happen is to check on the manufacturing costs. At this moment, there's still a lot of manual handling has to be done. There's very expensive raw materials that go into it. There's a lot of complex logistics required. So all these just made the price the raw, the manufacturing, because manufacturing sorry, of such a product is super high. I know it's a bit disconnected from the eventual selling price. But still we need to bring down that manufacturing cost. And in one on the things that we saw that all the manual work that goes into keeping track of all the record keeping, think about basically the start cleaning the cleanroom maintaining the clean, all this is done in a GMP environment and all those processes need to be documented with good documentation practices, and some cleaning, maintenance, manufacturing, material, release environmental monitoring. Everything that happens in your cleanroom needs to be documented and resolved at 25-30% of the cost of the product went into what I would call paper pushing and there's so much paper to be reviewed paper to be filled out. And if we could just take out part of that cost we would be able to reduce the cost of manufacturing. So that is one of our main goals. Another goal of my self is also to make sure that the manufacturing becomes more you Easy, I would say. Even if it's done manually, the goal would be that the operators can focus on producing the product, highest quality, and not have to put brain power, let's say making sure paper is filled out. Also, with our more device integration and automation tools, our goal is also to make sure that much of the complex manufacturing process can be automated. And there I think is also a big key into decreasing the manufacturing cost, basically, by using small agile bioreactors that you can completely automate all the critical process, do unit operations of the process, for example. And by putting that all together, basically, making sure we can isolate the documentation, making sure we can guide the operators through the complex manufacturing processes without making edits. And by automating some of the recipes, or the automation on the manufacturing, combining those will really bring down the cost of production.

Harsh Thakkar: 11:10

It's really interesting that you mentioned you 25, or 30% of the cost, just goes into the authoring reviewing approval of all the paper workflows. Is that Is that something you came through public research? Or is that something you figured out after working with one or two clients?

Toon Lambrechts: 11:30

It's a combination. And it's not only reviewing, but we take the whole lifecycle of take all the paper into accounts, we also take into account that you have to store those papers in other climate controlled rooms, also that has a cost. Also, the logistics of the paperwork has a cost. Imagine a large cleanroom facility, just cleaning the documentation of the cleaning, you need to make sure that every week someone puts the paper in the clean room where cleaners can check off what have been done. And at the end of the week, someone has to pick it up, we do take into account the logistics of the paperwork there as well. And that is a combination of internal research and, and publicly, publicly available information.

Harsh Thakkar: 12:20

Okay. And when you started in 2018, with the company, you I'm assuming you must have had a prototype or MVP of the product that you had imagined or visualized what it should look like. So what were some of the challenges that you faced in working with your first two or three customers? And how did that help in your evolving the product over the last five years or so?

Toon Lambrechts: 12:47

Interesting? Yeah, it's a good question. Because we originally built the tool for self, and we build it in a preclinical lab at university to manage preclinical data of donors that sometimes we're humans, but quite often, we're sheep reddish light. So let's say that bringing the homemade I would say tool that we built for our own research lab and getting it up to let's go to GMP standards. Dallas, a challenge when we're moving into the first customers for sure. I think we were very lucky that the university we worked at, kind of helped us to incubate the idea for two years actually, are within University walls. We basically got a lot of freedom to figure out, okay, how do we bring this to the lock system up to the right standards make sure we have the proper documentation 21 CFR 11 compliance in Europe annex 11 compliance, stuff like this was a bit of a culture shock for researchers to bring to bring it into the, into the real GMP. But yeah, nice, nice learn learning curve there. We also hire the right people to bring it to the right level. And that was a big hurdle in the beginning.

Harsh Thakkar: 14:13

Okay, and you talked about hiring the right people. So going from as a researcher working on this project to sort of now you have a product, you've validated the idea that there's a demand for this product. And you found your audience, which is cell and gene therapy companies or CDMOs, or suppliers who could benefit from this. How did you go into, like building your dream team, like the first five people that you hired to sort of scale this to now you're as a business owner or an entrepreneur? How did you go about hiring that first five people?

Toon Lambrechts: 14:54

Well, we first noticed very quickly that we didn't know enough about cell therapy development as the bioengineering students we had, we could do basic coding, but not enough to, to really build a platform. So the first, the first challenge was to find a more technical co founder Thomas, also joined the team then one of our co founders. And then there was mainly the technical challenges to be solved, like, we know, okay, this is the regulation, we know we need to have electronic signatures, we know we need to have audit trails, we know we need to have backup or restore procedures, stuff like this. So basically, we started from, what are the regulation? What do we need to know platform and make sure we kind of translate those? We also did the same for okay, what is typically in a batch record, we kind of reverse engineer from there, what does that for me to capture in terms of data, so that was on the theta social requirements level was fairly easy. I think, then the next step is a bit more niche knowledge in terms of how to validate the system like, I don't know if this is too boring, but the computer system validation background that you need to have to validate such a system is, at least in Belgium, it's a bit of a niche skill. So there we hired, we hired a consultant to do that. They helped us to, to bring the documentation to the right level. And now only more recently, we're hiring QA people internally, to keep it up to standard, but we worked often for a long time with external consultants on this.

Harsh Thakkar: 16:44

And and I know this is this, my next questions may be a little bit off topic. But a lot of people have this inclination to start a venture on their own. And maybe they have the subject matter expertise, they have an idea of a solution through one of their projects, but they don't have the technical expertise. So how did you find Thomas? Was he like your colleague in university? Or did you find him at a networking event? How did you, I guess, convince him to jump on the ship with you? Yeah, it was quite clear that I had the idea I struggled with wrangling the data myself, I struggled with finding the right data from the past and analyzing data where I don't have the right lack of data. So I knew what I wanted. Building the thing was, I Yeah, it was it was very hard to isolate. It works only for my use case. So finding this technical person was really critical. At that time, together, it was jam we, we rejoined a lot of these startup incubator type of sessions or an end one of these, it was like three days. Some kind of startup bootcamp, we came into contact with Thomas, we actually Thomas was building a completely other app. But he was using the same technology, the same technology stack as we were using. And we were stuck on something we asked Thomas to have a look at a technical issue where we were stuck for I don't know, saying something a couple of days. Thomas fix it in 10 minutes. And that was a That's your guy.

Toon Lambrechts: 18:26

Wherever, okay, yep. Okay, this, this could work. And that's how that's how, that's how we came together. Also, the University was very supportive, because they actually helped us to hire Thomas, and are so big thanks to the university to integrate our project in the beginning.

Harsh Thakkar: 18:47

Yeah, that's such a fascinating story, you meet the right person at the right time, in your case, he was able to come in. So it's great to hear and I'm sure other people are inspired and probably think of it like it's not a limitation. That's if you if you feel like you don't have the expertise, just reach out network, tell people what you're working on. And those conversations could lead to stuff like this, where it now it's history, you met him at that event, so

Toon Lambrechts: 19:16

and don't be afraid to talk about your ideas and ask help the people that you think might help no one will steal the idea just because you have thought about them. Yeah. And that really helped to get some enthusiasm from external people for the idea. And they came up with a maybe have to talk with this guy. He started just went bankrupt. So maybe he's free to help you out. So that's the in the beginning. How, how we got a lot of smart people on board.

Harsh Thakkar: 19:47

Yeah, and that again, I might be going on again, off topic on the second tangent, but that's one of the biggest misconceptions people have is if I tell somebody what I'm working or my idea they're gonna steal it? No, they're everybody's obsessed with what their job, their personal life, whatever, they don't have time to steal your idea. And the one thing I've learned in consulting and talking to tech co founders, like you over the 10 years in my 15 years of my career is, it's never about the idea, right? Everybody has an idea to start a podcast or to start a newsletter or to start a SaaS solution. But they're not all successful. So it I'm not saying the idea is not important. If the idea is completely unique. Yes, it carries a lot of weight. But it ultimately comes down to execution, right and to execute. You need the right people on your company, they need to be bought into your mission or whatever you're trying to achieve. And I think people just stop at that idea stage and they don't, they don't make the move to go to execution. That's when you start getting traction and nothing happens overnight. Right.

Toon Lambrechts: 21:01

And maybe to add one more element, I think a good portion of luck is needed as well though you need to good ideas, good execution, and then you need to be lucky and for example, meeting Thomas is really good example. Sometimes you just need to meet the right people at the right place to land at the right customer at the right time. To the right investor at the right moment. But you need luck for sure as well.

Harsh Thakkar: 21:26

Definitely, yeah, luck is luck is a big part. But again, luck doesn't mean that people are going to fall into your inbox. Luck is something you have to maybe be a little bit more intentional, like you found out, hey, my chances of finding a co founder are higher if I go to this event, or if I go to the startup incubator because I know other people are coming there. So you couldn't have just sat in your university and expected to get a DM or a message from Thomas saying, hey, I want to work with you. Right? So luck, when people think of luck. They feel like oh, it will just magically happen. And I don't have to do anything. No, you have to be find your way into that room like you did. And then you find luck, which is you found Thomas to come on. So yeah, looking into the future? What? When you look at all the digital innovations, the tools, everything that's happening in the cell and gene therapy space or just in biotech? What do you what do you see in the future? What kind of technologies or solutions do you expect to see in this industry?

Toon Lambrechts: 22:33

It's probably not a surprise. But I think especially everything that has to do with DOCUMENT MANAGEMENT finding, maybe patterns that can help us and finding information. I think this natural language processing, I, I would say that we see now will revolutionize all of these things. For sure. It's no surprise, I think what else we'll see that's maybe more on the manufacturing side to the electronic batch recording. I would say the decentralized manufacturing. So typical classical sigh amalgam, massive clean room or facility where you manufacture one specific product in mass doesn't play well with the more high tech novel, often personalized therapies, where I think we will go to a distributed model with many more products made in smaller, more agile facilities. This brings a lot of challenges, but also a lot of opportunities, I think. So I guess the combination of those two, and I guess also, of course automation, I mean, it sounds quite old school, but still in, in cell and gene therapies, a lot of the things are done manually, not only the paperwork is done manually, but also quite often still there is, manual operations, people having their hands in the lab or, airflow, and manipulating cells, and so on. So for sure, this will still need some quite some way to go to, to, to revolutionize the manufacturing space.

Harsh Thakkar: 24:15

And and when you so when you're looking at the industry landscape, and you are thinking about my cell hub and where it needs to go in five years. Are you like developing some of these features for my cell hub, like natural language processing or automation?

Toon Lambrechts: 24:35

More and more? Yep. So at this stage, I would say we focused mainly to get, I would say the best data, the data that is closest to the manufacturing process, and that it's quality controlled by the QA in Europe, the QP and has QCtests. That's basically the data that we have in a batch. We nailed this today. Now we can start building on okay, we know we have the present data collected, how can we leverage that data. And there are more easily go into this into this field. I do believe in GMP that we need to be kind of careful with AI and everything that's black box, it's still not that easy to bring that into k and v. But for sure, we were experimenting, let's say on the sidelines, with making sure we are ready to deploy the technology. And it ends well.

Harsh Thakkar: 25:33

Yeah, it's, I would say like, it's definitely something new that not a lot of companies are maybe they are working on it. But it's not, there's still some challenges working with it in the GMP space. So from my experience working in consulting, we've worked on couple of AI projects. And we've had challenges trying to get that project through the validation or software development teams to approve that project. Because there's a lot of API access to different AI models, and then getting the data back and forth, extracting it, storing it. So right now it's all it's a fun space to be in. If you can get a project or two, as a consultant, or service provider, or even a software company, if you're building those features. It's a very interesting space to be in. Definitely start with something simple and small. Like if you have deviations for a QMS, how do you automatically classify the deviations or watch trends? Like those are the easy examples that a lot of software companies are already working on? And many QMS already offering those AI features. But it's interesting to see what will come in the next five years as more and more companies adopt or open to

Toon Lambrechts: 26:53

I'm sure that I'm sure it will come unstoppable at this moment, they think in five years, we will look at a perpetual record says paper maps. We also don't ride car with a paper map anymore. We we have ways or whatever on our phone Yes, yeah, we're the car that is that is telling how we should drive and we trust it blindly and it's doing a better job than we did with our maps. So we will see the exact same. So it's possible.

Harsh Thakkar: 27:21

That's such an interesting example. Because I still remember the app called Mapquest. I remember printing like going, so I don't I don't know if Mapquest is still around. But I know what you can, yeah, you can go to Mapquest and say I'm going from point A to point B, and it will give you like, direction guidance. Yes, I remember doing that back in like 2009, or something when I was had an internship or a job and I had a car and I was very new to driving in US at that time. So I didn't have a GPS or anything like that. But I was like, Okay, I need to print the directions, and then watch where I need to go. But I haven't done that. I don't even remember the last time I had there. It's mostly on my phone. So yeah,

Toon Lambrechts: 28:11

Yeah. But that's the stage where I think Batch Records are now at we print them out from the ERP system, or maybe the MES system then we start selling them then we have a paper pile of piles of papers sorry, that we have to basically go through manually, while driving the car. It will change into more like, what what MyCellHub is offering, but other companies as well, digital work instructions that guide the operators through the complex workflows. And while the executor work and while we collect data, of the work so we can kind of guide them it's like what he tells you Oh, there's a traffic jam on your normal route. Maybe the detour is a better option. And this is a type of stuff where I believe we're quickly going towards and where data analytics, maybe not as blackbox AI is probably not even needed. But data analytics will help a lot to make sure based on this and this and this perimeter in my in my previous data that I can maybe advise the operator to do this. And that is exactly where I think that batch recording and the documentation of manufacturing will go once.

Harsh Thakkar: 29:26

Yeah, 100%. Like the data, the data creation, and generation is not stopping or not slowing down, in fact, is getting more and more. It's growing a lot. So to meet that demand of companies generating data, they have to come up with something different to manage those expectations. Because manual is not going to be manually it's not going to be able to keep up with the amount of data companies are generating. So yeah, and it's like I said, it's a very exciting space to be in

Toon Lambrechts: 30:01

Yep, I think I don't remember what the cutoff tool in the UK, I think they calculated that there's just not enough QAs and QPs to manually check all the Batch Records that we are generating, if we want to roll out the most novel cancer therapies like CAR T to, to, to the whole world. So that is one of the things we should keep in mind and that we, it's super nice, modern technologies, very nice medicine. But if we cannot manufacture them, why are we even trying so this is to come back on the democratizing the axis of cell therapies? I think that's one of our main goals is to make sure that we can scale them up, we can do them, we can manufacture them at a reasonable cost so that they are accessible for everyone.

Harsh Thakkar: 30:52

Yeah, definitely. So I really appreciate you coming onto the show and sharing your story and the journey of MyCellHub. And for the listeners who are inspired by what you've done in the cell and gene therapy space and what you're doing with MyCellHub, where can they connect with you or bounce off ideas?

Toon Lambrechts: 31:13

It was my pleasure for sure. If you want to know more, I would say visit our website, mycellhub.com or reach out to me via LinkedIn. Happy to happy to chat.

Harsh Thakkar: 31:28

Yeah, thanks. Thanks so much Toon , I would we haven't met in person. But I hope someday if we run into a conference event or something of that sort, we'll get a chance to I wish you tons of success with Yeah, thank you. meet in person but it was great chatting with you today.

Toon Lambrechts: 31:44

Thanks a lot. You too, bye.

Harsh Thakkar: 31:47

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