Trials with Maya Z

Hello, everyone, and welcome again to Trials with Maya Z. This is Maya, your host, and today I'm with Andreas Beust, the CEO of GCP-Service and the president of AICROS, an organization that unites multiple CROs. We're going to tell you more about that. A little bit more about Andreas. Andreas is actually generally new to the CRO business.

Actually not so new, six years already, but he's a part of the new generation of CRO leaders having new ideas and concepts of how we can bring better clinical research service to the market. So Andreas, extremely excited to have you here. Give me a few words about yourself, about your background.

Sure. Thank you for having me. And I'm very happy to talk about what I cross today a little bit and, what we are doing in the space, myself, I'm a biologist, always had, I think, a fascination for natural sciences and decided to go down the road of biology. The other option was mathematics.

But in the end, I decided for that, spent quite a bit of time during my studies and then do my PhD in the lab. And in the end, decided to switch over to the industry and I think as a lot of people from natural sciences move over into clinical research because this critical analytical thinking and the experimentation that is at the base of developing new medicines was always really fascinating to me.

I got an opportunity to work here, actually, through a referral of an old colleague, a study mate of mine who had joined the company before, and I've loved it ever since. So I started more in the data-driven field of statistics and data management. And, uh, took over two departments here medical writing, and today I'm on the biostats team.

And then eventually now I'm the managing director. So I didn't found this company. We are 20 years old next year. But I was given the absolute opportunity of a lifetime by taking over a management position here. And, yeah, as you said, from a different perspective, moving into this field was very dynamic.

And I think here, the data-driven side and an approach that probably aligns with, the younger generation of people also moving into the field of clinical research hemming this and moving forward. So I'm extremely excited. To have this opportunity and to leave my mark over the next decades also in the industry, hopefully.

Exactly.

Listening to you, first of all, let's just make sure that the audience understands which company you're speaking about. You speak about GCP service, right? And GCP service is a German located, German-headquartered clinical research organization with lots of years of experience. Yeah. You actually reminded me of a conversation that I had yesterday with one gentleman who actually works in the clinical research training and education space.

And he told me that the average age of a CRA and like, actually average age of someone who works in clinical research is around 42 years old. I'm not sure that that's global statistics because he's from the States. So maybe it's just the States, but honestly, I think it's like across the board. And that's not bad.

Like nothing bad with the age or anything. It's just that his observations are such that not many young people actually see clinical research as an opportunity to grow to build their careers. Sometimes there is a lack of connectivity between universities, and academia. And the clinical research industry, which was a very interesting observation to me.

And yeah, like you, it was your friend that brought you to the clinical research space. Right. Okay. But during your education, you haven't heard of that or like that wasn't attractive.

No. Really, I feel very strongly that if you are not inside clinical research, it's so hard to understand anything about it. And maybe this is a bit weird from a perspective now because, ever since the outbreak of COVID, we've heard a lot about clinical research, and how our vaccines developed.

And I think there is a general higher awareness of what this industry does now. But even like. giants like, you know, AstraZeneca or Pfizer, they were largely unknown to the majority of the, you know, population, and now it's household names. And clinical research is much more well known and people have a general understanding.

This was not the case before, and I agree with you. I think there's a gap that connects the younger generation with such a rich field that has so many opportunities and is so important for all of us. And I myself am very vocal about that. And I tried to provide a lot of opportunities also to connect people to this field.

So now every year I give a dedicated day to my old study course at the university and tell them about clinical research because I want them to know this. They don't need to come here, but I think they should know about the field at the minimum or see that this is actually an opportunity for natural science to move into. I also teach the course for biostatistics here at the Competence Center for Clinical Research here at the university, because I feel I can give a very practical impression of what the industry has to offer there as well. And these are things I think that more people need to do, be vocal about it, and share about our industry and really interest the new generation that comes with new solutions to our problems.

Yeah, I would definitely have one episode, especially dedicated to education, clinical research and

how we can spread awareness. We always raise awareness among patients, but maybe we need awareness among professionals as well. So definitely kudos to what you do to educate other people. I would say that my first meeting with you inspired me a lot. It was in a completely different setting, but it was for a very concrete thing. And, I actually used the new generation of leadership on purpose when I introduced you because you and the organization that you're currently heading. I speak about AICROS, the union of multiple CROs, is definitely out-of-the-box type of thinking. Very innovative and interesting. And the purpose of inviting you here is actually to learn more about it. So, first of all, can you tell us what AICROS is?

Yes. Okay. So AICROS is the Association of International CROs. I will take no credit. Yes. I'm heading it now. I did not find the company. I mean, it's very clear. We have existed since 2013. More than 10 years now, on the verge of our 11th year. And the founding principle of AICROS is to bridge a gap that still largely exists now between more hands-on local CROs that are very dedicated to the projects that they're running.

But are sometimes limited in their reach, especially in their well-structured, well-experienced reach because they have their region, and other than that, they need to work with, vendors and that comes with his own host of problems versus then going to global CROs, which are largely disconnected from their clients because it's just another, project in their pipeline, massive organizations that move at their own pace, which is not very fast and adaptable in most cases.

And here in between, there's somehow a gap. And the founding idea of AICROS was to be more than vendors to one another, but be truly partners and to share and grow together. And especially from this experience of sharing a more communal approach. This is, I think, the very innovative part because getting separate companies that are technically competing in a space to cooperate together to want to share information to have this collaborative spirit, is something that requires a lot of alignment and a lot of work together. And we are very happy that we have been doing this extremely successfully for the past decade.

Yeah, and you mentioned that you're eight clinical research organizations plus three associated partners at this stage. So how do you align so many companies under one vision? Well,

Continuous work. And in the end, that's just it. I cannot say we're there 100%. And I don't think we will ever be there because it's not only that it's, it's eight companies. It is eight companies that are spread from Australia to Canada that are, you know, from South Africa to India to Europe.

You know, it's the cultural differences, the mindset behind it, the size, even of the companies, GCP-Service is one of the larger members, we have smaller members there as well. So the dynamics and, sort of like what's in the focal point of the individual companies is also at times a bit different.

I think what unites us all is really an interest in collaboration, and that is also why we don't grow massively. That's not what we want. Obviously, we want good coverage of the words to really be able to help our clients work. But more importantly, so we need the right partners in it. And that not only takes time and getting people on board, why we have associate partners to sort of like have an entry-level to understand whether we can really gel well together.

But it also means that we need to exchange a lot and we need to align. We need to argue whether, you know, one direction is another and it cannot be a single mind that drives it and everyone else needs to follow. That's also not how I understand my position. My position is more to structure the conversation around how we move forward and not to dictate the direction we are going.

This is not what I want to do with it. And so, yeah, this is how we do it and fundamentally it can only work and that's the core principle of AICROS by having a non-compete in place. We don't want to compete with one another in these regions. We are all distinct individuals. We don't interfere with one another's core business.

We only see ourselves as an extension and as something that enriches what we are doing together. So that's. United, we are stronger. That must be the founding principle of it. And this is what we have at its core. There is no change in this. And then we just see how can we be more efficient and better for our clients in enabling clinical research globally without going to the global CROs

It's very interesting because indeed you mentioned that many of the clients like pharma, and biotech companies. And I had these conversations firsthand, they're all challenged, how do they make the right decision on what the right clinical research organization is? And the question is, how do you balance this global coverage with the local and hands-on support? Some companies are trying to balance that by bringing some local partners, like vendors, for example, like, like they're vendors, and sponsors are still not happy about it because like who has the responsibility, who owns the accountability, and so on and

so forth. But in your case, for example, how do you ensure that you leverage your local hands on approach, but ensure, let's say, the same level of quality and focus on the client in the same way?

Right. To me that has two components. The first component is a mindset question. When you're talking about vendors and that's always the alternative, you can go to any local CRO and they will probably know someone in some region and they can reach out to them and say, okay.

Can you support us for this project?

Then you have a contract for one project. That's it. There is no long-term commitment. Obviously, you want additional business and there's always an interest in developing this further and utilizing it as a business opportunity. But at the end of it all, you don't know one another and you're not in it for the next 10, 15, 20 years.

This is different here. It's not for the one project, but it's for what we can do over the next decade and more. That's foundation number one. I think the mindset is different. So therefore the willingness to talk to one another, to exchange, and to immediately grow and improve is there. And since we have been doing this for 10 years, we are not starting at zero.

We are already starting far down the way in improving our relationships and how we work together. That's the one part. The other part is at the core, AICROS is basically a framework. In which each company operates sort of individually, with their own processes and so on. But when we come together as a company, we already have a starting ground from a quality point of view.

Overseeing the level of quality of our individual members. It starts from an initial qualification that we have with every member to biannual requalifications to make sure that every single service provided is, you know, vetted to the level of quality that we need.

And, then we have quarterly alignments of all companies, and all CEOs get together. We have online meetings, three here, and then one in-person meeting for two days or three days where we exchange, where we not only personally connect better, which helps with the communication aspect, of course, but where we also see where are our gaps, how can we improve them and, really work on it.

And we have joint project management workshops, for example, where project managers from all regions get together just to understand what's my mindset as a US PM versus a European project manager versus an Indian project manager versus, you know, a South African project manager. It's quite different. You need to talk about it.

You need to align the expectations. And then. It just, it just gets better. You don't do this if you're just another vendor, you're not going to invest the time and resources in it. And this is really what differentiates us. So we are really a very tightly-knit extension of one another, and that shows in the quality of our jointly executed projects.

So in reality, you are multiple companies, but acting as one, acting as one,

but at the same time, because you're separate companies, like each leader has its own accountability to make sure that they're He's performing like the other partners, basically, and that makes this unity. And I always wonder if that's even possible, this model, but even not with separate companies, what if let's say global clinical research organization or global corporations in general are able to manage their local teams as mini companies with mini CEOs and actually giving this independence and freedom so that they can actually be the leaders.

And I just wonder. Would that actually change anything? It's just a question out there.

I think in the end because even like the larger companies, they have their local subsidiaries, yes, a hundred percent. They have their own teams, but they don't have that freedom of decision. They don't have their own identity and character. They don't have their own interest, beyond a bottom line that they need to report up.

They don't have their own interests as my own business of how I want to grow it at which pace. It all doesn't have that individual character that allows each company also to be unique and to position themselves differently in each region because it needs to be streamlined.

And I can understand that on a global scale, frankly speaking. It is also good at times that it's so, so uniquely positioned. If we are talking about a trial with 50, 000 patients, I don't think we are the right people. Like it's good if you have one, which is like, you don't think about anything that you're doing.

It's like you have a million processes in place. It slows it down, but it shows that everything is following exactly one trail. And here adapting to our clients or projects, this is where we can really gain efficiency and also benefit from each company's own experiences and character that can help in such a project because people have solved things on one end that we are happy to consider and incorporate into our solutions, which you wouldn't if you really feel that you are like, you know, distinct units and incorporate to that level. So here, I think. If I am a large organization and I want to manage. All of my units, I think it makes sense to standardize it to that level. If this is the type of client that I'm approaching, and this is the type of project that I want to conduct. But for that reason, if you are coming in with your small 50-patient project, that's why you don't get the same attention because you're almost too small to be interesting.

It can be done, but it's not good for you. And I think this is a core issue that's sort of like trying to be addressed. And I don't know if. Okay. We could ever get to the point where a large corporation says, no, let's split up and still unite under one umbrella. Yeah. I don't see that working.

I don't see there also being an interest in it. I'm sure there are advantages also to having that United front. And I think we would also not be better off if all of the large ones would be separated really into a lot of smaller ones. But there's so much out there that really benefits from such a solution rather than going to the global CROs.

Hmm.

Yeah, I think that you said it very correctly at the beginning. It's about the focus. In your case, AICROS is focused on the local, let's say being the expert in your area

and focus on the quality and the best service. Where bigger organizations, also focus on the quality and best service, but number one is growth at the end of the day. And then this sometimes is a line, but not always. And it's very hard to balance, I guess. So that's one of the things. The other thing that I actually took from your words are keywords like mindset, character,
independence, that only shows actually the type of a new generation of leadership that we all need in clinical research. Actually thinking about not just growth, not just performance metrics, which are absolutely essential, but at the same time, character, mindset, and independence, which actually can bring a lot better productivity among teams and inspiration and motivation at the end of the day.

So thank you for sharing that. I wonder, though, it sounds very positive, let's say, but I wonder what is the most challenging part of planning and conducting a clinical trial as an organization like AICROS, this type of an organization?

Yeah, from my point of view, it's, it's clearly communication. Because at the core of it all, we are all aligned, but still, we perceive the word from our own perspective, from our own background, from our own prior experience. And although I would say that even GCP-Service in and of itself is already a very diverse company with, you know, 25 nations represented in our 110 people.

So it's very, it's a very diverse team and we feel that diversity is a strength to us. It is still a difference if we go abroad and I'm not saying like, you know, EU, US, yes, even there is a cultural difference, but it's still, you know, close enough. But even if we are talking like less distance, if we go to Israel, the mindset and conversations with clients is different.

If we go to, you know, India, it's also different, you know, to Japan, Singapore, uh, China, different, different settings. And. In the end, even though we are aligned, the way we communicate our position is still different and there's a continuous need for us to reflect on how we communicate with one another, how we express what we want, how we also receive the correct message from the other party by accounting for the differences in how we communicate.

And so a lot of emphasis, not only as with us internally, but also within AICROS. Has to be also put on the communication path and really align with them. And so the more we talk, the easier it is to really understand what we want from one another and in-person meetings and exchanges really help with that as well to to lower the bar that we need to jump over whenever we talk with one another.

So this is if I had to say that's. Going in there I can ask for all of the requirements. I get a summary of them, but I need to also be able to read between the lines or ask the correct questions and be able to switch positions to align really everyone together. And in the end, I cannot just say like I have a European mindset and wherever I go, it doesn't matter.

I run this trial as a European project. If this is not how it works, the sooner you understand that the better and the more efficient it can then also be.

I guess that this is also a benefit for the clients because they also come from different places of the world. So I guess that you get this luxury. Okay, if it's a client from Israel, then we connect them with the Israel partner because then they will speak like

the same language and just the Israel partner will actually translate to the rest. This is what the client actually values the most what is more important for them. So that's that. Has a positive side of things, but I understand it can be complicated. I think that's a challenge for like everywhere.

A hundred percent.

Because you work again with different clients, different vendors, different teams.

So it is a challenge besides that, besides the communication, I wonder how you then handle situations when you have to select, for example, other vendors. Technological partners, for example, data management. So how do you make decisions? Do you have the same vendors for data management, the same vendors for, I don't know, clinical supplies?

How do you make decisions for that?

Right. So generally in the concept, usually, I mean, AICROS can be approached, but that's not a very frequent concept is usually individual members that are approached and they weave in the AICROS partners

and the person who's being approached takes the lead on all of the decisions, including which vendors to include, and so on.

It makes it very easy and it makes it very seamless and, you know, as a full-service CRO, they can come to us and ask us for it. So they can come to our US partners. They also have data management and stats in-house. Our Indian partners as well. Or they have pre-existing established relationships with people for 10 years because they have their own identity and they had their own identity even before AICROS.

So, basically, already a process that serves them best is established, then why would we force ourselves onto them just for the sake of it?

It should work in the end. What should supersede everything else is the client's interest and making it as seamless as possible for them and going with solutions that are established, going with solutions that are the risk-freest.

And, that aligns with the processes and is more seamless. That's what we want. And, obviously, we always try to work on how to improve our cooperation together, how we can cooperate more. But there is liberty in all of these things. And, it is up to the individual members to align on that.

And everyone else is also happy to support. And often enough. It comes to different regions and we need someone in the U. S. I asked someone, Hey, you probably have 15 years of experience with a drug vendor in Israel. Why should I select one? You have good experience and you can refer them over to me.

I trust you. I've worked with you for 10 years, so,

Exactly.

So that was actually the key thing I was going to say. I mentioned mindset, character, and independence, but actually the core thing here is trust. You build this layer of trust throughout the years, working together, also deciding that you want to work together, deciding where your boundaries are, and how you can grow together. And once you have this trust. Then you can grow. And actually, you know that everyone's focused on the quality at the end of the day, the client satisfaction, as long as this is the case, you know that you can trust the other people's decisions. This is awesome. , and this actually, brings me to another tricky question though. It's very trendy nowadays, especially among investors, to discuss the topic of the new generation of clinical research organizations, virtual clinical research organizations, clinical research organizations disrupting the world, and so on and so forth. So, you work in the space, you're leading a clinical research organization, and you're also leading an organization with multiple other clinical research organizations worldwide. What is your perspective on the future of clinical research organizations? What will be a clinical research organization five years from now?

I think like I don't want to sound pessimistic, but I think in five years from now, they'll look much closer to what we have now than I think a lot of people are anticipating. And I mean, maybe that's a bit of a European perspective, I think in Europe, we are always lagging behind a bit.

There is a lot of pushing that we need to do to get our regulators to move. I think especially in terms of clinical research and data protection, we haven't really been the ones to react the fastest. And I think there we will see what works and what serves. In the end, the beneficiaries of clinical trials best, that's the patients and how can we all serve them better? And not only patients but also actually clinical research sites, because I think both of them are underserved in parts of the system. And so when you're asking me, like, how does it look like in the end? You know, it's in, it's a large part of our economy, worldwide there is opportunity to make a lot of money whenever there's opportunity to make a lot of money.

I think you will have people that chase that and only that, and that will also continue to be the case. So, new companies will arise and move forward. I don't think we will have a complete 180 as some people would want you to believe though, in terms of how we approach clinical research. I think the perspective of the sites and the perspective of the patients are sometimes ignored in, especially on the, like a lot of tech sites, it's sort of like moved in as long as you put artificial intelligence or tech on something, it increases the value.

And then you say you work in clinic research and everything seems very promising. But if you forget that perspective, you can say that I have the solution. There is no one solution. We are all individuals. And especially. The people that everything, everyone works for patients have every individual ourselves.

I don't think we will completely move away from patients seeing doctors. I don't think we will completely move into a space where everything is decentralized or where you are being treated at home. Some patients don't want it. Some patients want it. I think we need to understand that we need to be a bit more flexible.

Flexibility requires that we have a sense of security that it works. If the hurdle. To jump over a DCT application is 10 times higher than over a regular one because this was more seen. It is clear that we will not go for the DCT ones because we want to risk minimize as well. And we want to move fast.

And so I think we'll move with the space at the pace of regulatory adaptation. This is slow, especially in Europe, because it's like 30, 23 countries or so that need to align, but we'll get there and I think it'll look probably different in 10 or 15 years, more digitalization, more digitalization of the health system, the more data is available, the more we can use.

All of that information may have to run a little bit fewer trials and reward evidence, which I think will be more important in the future, but probably 5 years from now, more so, and then in 10 years, even more. I don't think we're there yet for another 25 years when it comes, maybe that's a bit too much because it's actually growing a lot, but for another 20 years, at least I would say, um, in terms of virtual triads, where you, I don't think we understand the human body enough.

Let's put it this way. Uh, we

But maybe general AI will understand that, at least that's the promise. We'll see.

Sure, in the end, you will have a black box that tells you I understand it and you have to run, you have to confirm a lot of the things that are being predicted by AI, in actual settings with actual humans. And then you need to understand that, Hey, your patient population is more diverse than male Caucasian patients, which would probably make up the majority of the data that's going into the validation models. Then you understand, oh, it doesn't actually predict people of African descent or, uh, from Asia. And I think there are a lot of problems that we will encounter. Hopefully, we will actually acknowledge them because I think I have a feeling we always run ahead and say like, well, it works for, you know, the white man.

And, we forget a lot about the rest of the demographics, and yeah, if we get there, we will get there. I think then we are ready to do it and I have the feeling there's a right mindset again, also from a regulatory perspective what can be allowed and what is the pace that we can move on?

It's not like, oh, no, we need to do it, but rather let's do it right. Um, so I'm hopeful, but it'll be at pace.

Yeah. So, let's make it right. This is important. Uh, yes. Elevation and innovation are important, but

making it Right. is more important, especially in an area like clinical research and healthcare in general. And a last question, Andreas, it's my favorite question that I ask every single guest. But from your perspective. What will make or break clinical trials or what makes or breaks clinical trials today?

Yeah. I think the word that you highlighted is really important to me. And that's trust. Uh, for me, the difference between a project that works well or not is also based on, but penultimately not determined by our processes or the people that are put in there.

But is that, Our clients trust us and we can trust our clients that the sites can trust us and we can trust the size of the patient can trust the size and the system. I think there's so much in there. That's where a loss of trust in the system, between the parties that are involved. can ruin clinical trials, even those that should work well, that should be easy to do.

And I think going in with an open mindset and wanting to work sort of like on equal footing with all parties that are involved, and really see eye to eye with everyone can make for a great clinical trial. So, if it was one to choose, I would say this is the one that I would least want to be missing in the equation.

Yeah, trust, trust between every single stakeholder, everyone that contributes in being open to, to listen. That's super inspiring, Andreas. Thank you so much for the awesome conversation that we just had. Good luck with everything you're doing and thank you for the leadership.

Thank you. very much. It was a pleasure being on. It's always great. I'm talking to you.