The Future of Biologics: How Strategic CROs are Powering the Next Generation of Clinical Research

In modern medicine, progress no longer depends only on discovery. It depends on the execution of the ability to translate breakthrough molecules into therapies that reach people faster, safer, and at scale.

Behind every life-changing drug is a network of scientists, regulatory experts, and clinical partners working quietly but relentlessly to turn data into outcomes. One of these partners is Quinta Analytica, a Czech-based contract research organization whose work spans analytical chemistry, clinical trials, and regulatory support.

In this episode of The Bridge, I sat down with my business partner, Dr. Peter M. Kovac, and Jiri Raska, Chief Commercial Officer of Quinta Analytica, to explore how CROs like his are enabling the biologics revolution.

From chemistry to collaboration.

Jiri’s story begins in the laboratory. Trained in physical chemistry, he has spent more than two decades bridging science and business development. “Chemistry was my first love,” he said. “But over time, I realized that innovation happens when people collaborate  when science meets structure.”

At Quinta Analytica, that mindset has become the foundation of a unique model that combines deep analytical expertise with clinical execution. Founded in Prague and now part of the Conscio Group in Munich, the company operates as a full-service CRO providing analytical development, bioanalytical testing, clinical study management, and regulatory support.

The biologics wave.

Biologics are reshaping the pharmaceutical landscape. As patents on original biologic medicines expire, demand for biosimilars is accelerating. “We are living in what many call the biologics void,” Jiri explained. “Nearly 90 percent of biologics going off-patent still have no replacement. That is a massive opportunity for developers and for the CROs supporting them.”

According to Evaluate Pharma, global biologics sales are projected to exceed $550 billion by 2029, with biosimilars accounting for a growing share. Europe plays a central role in this transformation, balancing scientific capability with regulatory depth.

Quinta Analytica’s expertise lies in bridging both. “We combine analytical chemistry with large-molecule bioanalytics,” Jiri said. “From method development to full clinical studies, our goal is to help innovators move faster without compromising quality.”

The end of the generic era.

The European generics market, once a growth engine, is now under heavy price pressure. “Pure generics are gone,” Jiri said plainly. “The future lies in value-added products, and biologics are the natural next step.”

As small biotech startups enter this space, they face a familiar challenge: limited funding, limited teams, and limited time. What they need most is not a supplier, but a partner, a CRO capable of guiding them from early analytics to clinical validation.

“Big pharma is complex,” Jiri observed. “Negotiations take months, sometimes years. Startups need speed, flexibility, and trust. They need one partner who can manage the whole journey.”

That philosophy is now embedded in Quinta’s model. From analytical development and bioequivalence studies to formulation and Phase I–II trials, the company supports clients across the entire pipeline.

Redefining the CRO relationship.

In the past, CROs were often viewed as external vendors. Today, they are strategic allies. “We are not just testing samples,” Jiri said. “We are helping shape strategies, navigate regulations, and anticipate market trends.”

To make that possible, Quinta Analytica introduced a new role inside the company, the Customer Success Manager, bridging business development and operations. “Our goal is simple,” Jiri explained. “Clients should never have to repeat themselves. Communication must flow as seamlessly as the data.”

This structure reflects a deeper truth about the future of clinical research: success depends as much on human connection as on scientific precision.

Innovation through biologics and ADCs.

Among the fastest-growing areas in Quinta’s portfolio are antibody-drug conjugates (ADCs), complex molecules combining biological and chemical expertise. “Testing ADCs requires both large- and small-molecule knowledge,” Jiri said. “Few companies can bridge that gap.”

Their collaboration with leading biotech firms, including long-term partnerships with Sotio Biotech, illustrates how Central Europe is building world-class capacity in biologics development.

These advances are not limited to oncology. The next frontier may include neurological and autoimmune diseases, expanding access to personalized and precision therapies across continents.

Regulatory realities and regional strengths.

No discussion of clinical research in Europe is complete without addressing regulation. The EU’s Clinical Trial Information System (CTIS) introduced new harmonization goals but also new delays.

“In the past, approval for a bioequivalence study in Czechia took 30 days,” Jiri recalled. “Under CTIS, it sometimes took four months. For small companies, that is a critical time lost.”

Working closely with the Czech State Institute for Drug Control (SÚKL), Quinta Analytica helped establish an optimized procedure that now delivers approvals in roughly 25 days. It is a small victory, but a meaningful one for innovators balancing timelines, costs, and investor expectations.

As Peter M. Kovacs noted, this regional efficiency has become a strategic advantage. “Europe’s strength lies in collaboration. If we align speed with integrity, we can compete globally.”

From Prague to Ostrava, expanding capacity and access.

To meet rising demand, Quinta Analytica opened a new clinical site in Ostrava, expanding its volunteer base and enhancing cross-border recruitment with Slovakia and Poland.

“This was both a logistical and a human decision,” Jiri said. “Volunteers don’t want to travel five hours for a study. By expanding geographically, we bring research closer to people  and people closer to innovation.”

The site also strengthens collaboration with regional hospitals and specialists, reinforcing Quinta’s model of combining private precision with public partnership.

Personalized medicine and the next decade.

The conversation naturally turned toward the future from biosimilars to personalized medicine. Jiri spoke passionately about the potential of 2D and 3D printing technologies for customized dosage forms, including oral dispersible films with QR codes linking patients directly to digital instructions.

“It sounds futuristic,” he smiled, “but it is already technically possible. The challenge is not science. It is regulation and reimbursement. We need systems ready to support innovation.”

While widespread adoption may still be years away, these ideas signal where healthcare is heading: precision, personalization, and patient participation.

Where science meets purpose.

For all the complexity of chemistry and regulation, the heart of this story remains simple impact. “What motivates me,” Jiri said, “is seeing small companies succeed. When you help a biotech move from preclinical to clinical, when you see that molecule become medicine, it reminds you why we do this.”

That sense of purpose defines the next generation of clinical research. It is no longer about volume or visibility. It is about the value of scientific, ethical, and human.

The bridge forward.

As biologics and biosimilars continue to evolve, CROs like Quinta Analytica are proving that strategic partnerships can accelerate progress while maintaining integrity.

Europe’s challenge is not innovation; it is integration. When scientists, regulators, and investors align around shared values, the result is faster trials, better data, and safer therapies.

At The Bridge, we believe that collaboration is the true competitive advantage. The future of biologics will not be built by one company or one country. It will be built by the bridges we create between them.

Let’s connect to make healthcare faster, fairer, and more human.

Timecode:

00:00 Introduction to Jiri and Quinta Analytica

01:09 Jiri's Background and Passion for Chemistry

01:56 Transition to Business Development

03:43 Current Trends in Biologics and Biosimilars

05:57 Challenges and Opportunities in Clinical Studies

09:17 Supporting Small Biotech Startups

13:08 Customer Success Management

14:47 Expansion and Collaboration

16:43 Future of Personalized Medicine

19:26 Regulatory Challenges in Europe

23:58 Ostrava Subsidiary and Cross-Border Recruitment

27:00 Future Directions for Quinta Analytica

29:50 Jiri's Personal Career Aspirations

31:49 Conclusion and Final Thoughts

Links:

Pavlina Walter: https://www.linkedin.com/in/pavlinawalter/

Website: PavlinaWalter.com

Guests:

Jiri Raska: https://www.linkedin.com/in/jiri-raska-pharma/

Peter M. Kovacs: https://www.linkedin.com/in/petermkovacs/

Episode Transcript:

Pavlina Walter: So I would like to introduce Jiri. Um, short name is Jirka and he'll also introduce to all of you. But, uh, we all, we all three cooperated together on a projects and Jirka is a business development, um, director of Quinta Analytica. So I let him to introduce to you. So welcome. Okay.

Jiri Raska: Thank you. Thank you. Thank you.

Uh, thank you better. So my name is, uh, Jiri, I like to say myself Jiri, but uh, I'm a Chief Commercial Officer of Quinta Analytica. Mm-hmm. It's, uh, uh, the Czech based, uh, CRO located, uh, headquartered here in Prague. And, uh, we have, uh, we are part of actually, uh, the German group, uh, Conscio group with, uh, headquarter in Munich.

And basically what we do. Is, uh, that we are, uh, doing basically all kind of services for, uh, testing and, uh, you know, analysis of, uh, drugs. Uh, it means analytical chemistry, it means analytical development and also clinical studies mainly. And this is what we are going to discuss, I believe. Yeah. So, uh, maybe couple of words about myself.

So thanks for having me actually. Yeah, this is, this is big pleasure. And, uh, so I actually studied, uh, chemistry actually. Since my, I don't know, like 15, I'm, I was, I was passionate about chemistry, so. I, uh, studied chemistry here in Czech Republic, uh, on University of Pardubice, and then I did my PhD in physical chemistry as well.So basically I'm chemist by education. I completely fall in love, uh, with chemistry, which is, which was a really passion from the beginning. Then I, uh, tried several positions in the area of, of course, like head of quality control laboratory. Uh, I was, uh, project manager. I was head of, uh, manufacturing actually in a very nice botanical, actually, uh, company producing botanical drugs.

And then, uh, step by step, I moved rather to business development area. So last, like 15 years now, actually I'm in a purely a business position. Uh, so basically in Quinta, I'm uh, uh, already from, I think since March, 2018. So we're a couple of years and, uh, actually I'm responsible for all the business activities and marketing activities in that area.

Dr. Peter M. Kovacs: Do you miss the, the chemistry and the laboratory work? Or not? Actually, a little bit, 

Jiri Raska: yes, but I'm a little bit afraid that, you know, coming to the lab already would. Not be actually a good end at the end. They changed a bit. Yeah. Changed especially what, what I really, really, you know, uh, admire is like, you know, the expertise of our colleagues, you know, who are like experts in that area.

I'm pretty sure that, you know, that nowadays, for instance, it's a little bit a part of the clinical studies, but I'm sure, you know, especially nowadays this, uh, big problem with nitros means it's a big issue and it's one of the flagships we have and it's, it's really, really, you know, very nice piece of art, I would say in chemistry.

Because, you know, when you consider on a, on a concentration level, which you, which you need to actually detect and measure, it's, it's unbelievable. It's like, you know, single digit PPB, uh, yeah, which is unbelievable. So we really need to know some, uh, some very nice, uh, you know, expertise and know how, how to do it.High tech as well. Of course, of course. Yeah. 

Pavlina Walter: And as you mentioned, so you are the head of several like services departments in, uh, like for commercial, uh, in Quinta Analytica. Which era is right now, the number one and which era you see in last five years has been, um, a little bit put on hold or is the era uh, the clients are not so much interested.

Jiri Raska: Uh, what I would say that number one at the moment is really everything around biologics. Actually, this is, this is big boom. Uh, it can be biologics or biosimilars, both of them, because of course, at the moment, as you may know, there nowadays, there is, uh, on a market this biologics void as they call it, that actually very soon there will be plenty of, uh.

Plenty of, uh, drugs where I think it's like maybe even 90% of those biologics we are going off patent will have no, you know, replacement by the biosimilars, which is, which is huge. Uh, so there is plenty of, um, opportunities in that area for both the developers as well as for the companies as as, uh, we are like service providers.

Uh, so biosimilar studies. Generally, I would say PK studies with the biosimilars, but also with, uh, small molecules still, uh, are of very, very high interest. I would say that basically the. Era of pure generics. Uh, these are gone in Europe, I would say, because, uh, there are so big pressure, uh, there's some pressures on, on, uh, price, you know, on the markets and, uh, from, you know, from the insurance companies and so on that, uh, you know, purely generics are debt, I would say.

Uh, but you know, companies are rather looking for what they call value edit products, and this is where I believe is the future of a small molecules. Yeah. So this is one thing. And, uh, of course, uh, any type of analytics, especially as I said, like we name it already, nitrosamines, for instance. This is a very nice example of very interesting, uh, you know, area because, uh, this is, uh, something very, very unique, I would say.

It's not just already like, you know, to measure like, I don't know, loss on drying or I don't know, some, I didn't want to say like stupid essay of the drug, but you know, this very, you know. Unique, challenging impurities, uh, you know, development of the method, uh, which are very, very tricky. Uh, and also in a combination of it's still, uh, the equipment which, uh, is super expensive nowadays.

This makes, you know, this, uh, of very high interest of the both originators as well as generic manufacturers because you will always have something to solve in that area. 

Pavlina Walter: Mm-hmm. How about the clinical studies? 

Jiri Raska: Clinical studies. Uh, I would say that, uh, the golden era of typical PK or bioequivalence studies, I mean the core business, what we are doing, uh, was I would say maybe a little bit like, or is like in history, I would say, uh, for this typical generics, as I said, because nowadays plenty of companies are rather going to I India or Jordan and so on, where it's super, super cheap.

Uh, on the other hand, uh, there are still quite big interest, uh, from the companies who are going for European market or US market, that they want to be 100, not 100, 120% sure about, you know, the integrity of the data, about the quality of the data you are providing. So, uh, many companies, especially for those.

Difficult  bioequivalence studies are still, uh, still prefer actually to stay in Europe. Um, so basically you can always do some nice business with measuring  bioequivalence of, I don't know, 20th paracetamol on the market. But when you have some interesting drug where you need maybe even two proof, like, you know, how, how.

The pH in stomach actually, for instance, might, it might be influenced. So, you know, there are not so many actually companies in the world who can, who are able to, to do this kind of testing because it really needs a very big, uh, uh, experience team. I would say one. Second, really the like integrity of, you know, of the processes and, uh, and the data to be provided.

Because nowadays we all know it. I mean, FDA, they can knock the door every day, uh, without any like invitation, I would say. Uh, so you have to be ready. Uh, 100, 100%. 

Dr. Peter M. Kovacs: And how you started. So you started with the laboratory services and extended to the clinics because you see the, the demand for that or, or you started parallel?Yeah. 

Jiri Raska: Yeah. Actually it's, uh, it's quite a long history. I think we don't have so much time, but, uh, but I, the make it short, we started with the bio analytics, uh, basically because it was one client who actually, uh, was uh, really, really struggling with, uh, some kind of like, you know, instability of one product.

And we were actually the last resort for him. Yeah. So he, he shared very openly. Uh, it was in 1990s basically, I would say. Yeah. And, uh, the owner, the, the founder of the company in those days, Mr. Ryska Who is now quite senior guy already, but still very active and one of the best LCMS mean, uh, Mass chromatography, you know, specialist, uh, uh, he actually, um.

Accepted the, the challenge. And, uh, basically with his, uh, team, he solved this. So this is how it started. And then, you know, it was with the company Synon, basically, which is not the secret nowadays because I mean, it's quite, uh, known that, uh, uh, we are still good partners, uh, so far. And, uh, it's a, it's a great partnership for years and, uh, basically.
From that we started to add, you know, additional services. Uh, and one of the last actually was, h, uh, the, the clinical unit. It was in 2007. And the very last one was actually, actually I was mentioning about large molecules. So the biopharmaceutical department. So we have it already, like I know, more than 10 years now.

Uh, and, uh, it's still visible, you know, that there is growing interest and, uh, the demand on the market is definitely there. 

Dr. Peter M. Kovacs: We currently, we are really trying to help, uh, small biotech startup companies, uh, to reach, uh, the next milestone, going from preclinical to, to clinical stage and completing the first phase one up to phase two eight studies.

Which is really challenging, not just because they don't have a funding, but also they don't have expertise, they don't have the proper vendors. Um, how do you see the, the, the current market, how we can help as a service providers here, or how we can help these small companies compared to the big corporates and big pharma companies?

Jiri Raska: I think it's a very good point actually. Uh, because, uh, you know, it, it's funny that. Plenty of companies like, uh, like ours actually are trying to go to big multinational players. You know, we all know them. We don't need to name them, but actually they seem to be like a holy grail. Yeah. On the other hand, the negotiation with them is a little bit complicated, I would say.

Even more than a little bit. Yeah. Yeah. Uh, there are plenty of, you know, like, um, processes with their, with their procurement, uh, lengthy negotiation. They are very, of course, price sensitive as well, and so on and so far. Uh, while these small to mid-size companies actually, they are really, uh, rather focused on, uh, on uh, having as, uh, less partners as possible to cover maximum work.

So basically, this is where we are really strong, I would say that, and we have plenty of, such, such examples. Basically you can start with a small analytical development. Then you can go to analytical method, validation, routine testing, release, and then clinical studies and bioanalytics. So basically. We can cover all, and this is what they really like.

So this is of course service. This is exactly, uh, I, I don't like to say, I mean, everybody's saying now, nowadays, like, you know, OneStop shop, I mean, nobody's OneStop shop, of course, but it's nice, it's fancy. Um, but, uh, it's, it's like that. Uh, and, uh, we believe this is. Usually very nice success story when you, when you succeed together, and we have plenty of such examples.

Just recently on our LinkedIn page actually, we, you know, announced a very nice partnership with Finnish based company, uh, who is developing, uh, some, uh, drug, uh, against Parkinson. Yeah. And it's, it's absolutely amazing to be part of that story when you can, when you help them, you know, with the development and you see how they are progressing.

So you select phase one, then you go, then they go to phase two and so on. And when you are part of that story, I mean, it's something which really makes you, that you can feel that you, you feel that it makes sense actually what you are doing. Yeah. 

Dr. Peter M. Kovacs: So I, I feel that also you prefer to work with these small, medium sized companies.It's more. Interesting. It's more straightforward. Uh, it's 

Jiri Raska: uh, yes and no. Uh, because on the other hand that they are, they're having, of course, this problem with you are saying that actually they may struggle with the funding from time to time. So many times, and especially this is what I see like last one or two years, that basically, uh, they ask you for some proposal, uh, request proposal, then you actually do the exercise.

You spend like, I dunno, two weeks on that. And then at the end of the day of the day. Uh, they say, yes, this is perfect. Now we will wait like one year to get the funding. Yeah. And then 

Dr. Peter M. Kovacs: just postponing, postponing, postponing. Exactly. Yeah. 

Jiri Raska: So this might be, this might be the, the biggest struggle for them, but when they're ready then it's, that is absolutely amazing.Yeah. 

Pavlina Walter: Uh, those usually companies, they have very small team. How you solve this problem because you need a partner that you will discuss with them what they need and also you need to a little bit navigate and to give them advices. So how you solve this issue? 

Jiri Raska: Well, uh, everything's about of course, communication, project management.

This is also another. Like bold and fancy name project management today. I mean, everybody wants to be a project manager. Uh, but uh, what I believe it's still, I mean, we all are still human beings, so it's just about communication, nothing else. And uh, like one year ago we actually started to implement, uh, implement some kind of, uh.

Experiment, I would say in a company, something what we call customer success manager. So it's kind of like a project manager and uh, uh, also, also kind of like a maybe business person. So it's some, because you know, usually typical problem is that when you get the business for the business people, usually after that, uh, this project is gone because you need to develop some new bit.

Yeah. However, it's still not properly handled, uh, by the man, uh, manufacturing, I mean, operations. Yeah. Uh, so you need somebody who will, you know, take, uh, like take a, how do you call, like take a step ahead and, uh, you know, fill this gap. Uh, so it'll be like a bridge between the, you know, the, the business and operation.

And, uh, so we started, uh, in a, in the area of analytics with that. And I, I think, uh, uh, it, uh, it shows that, uh, it has some nice benefits at the moment. Uh, so we, we would like to extend it to farther, you know, areas, even like to clinical and so on. But basically if you have really somebody, uh, who is the, uh, you know, taking care about the client and he feel that he's being taken, taken care, this is very important for him because for client, it, it doesn't matter usually if he needs to discuss with, uh, person one, person two, person three.

What he hates is to repeat himself. So when you have three persons, but they are communicating very well, it's perfectly fine, but the clear client doesn't want to repeat himself. Mm-hmm. So then, then it doesn't matter for him if, uh, one day he's communicated with John and second, then with Frank. Yeah. 

Pavlina Walter: And you mentioned that Quinta Analytica is a part of a German corporation.It's a private equity actually behind Yes. Private equity. Okay. Mm-hmm. So what actually your subsidiaries or the other subsidiaries that you, they are doing. 

Jiri Raska: Yeah, actually with, uh, with this, uh, like, uh, membership, I would say mm-hmm. That we, we become, uh, you know, the member of  Conscio Group. Uh, actually it's a nice extension of the services we have because as I told you, we, we have several lines, like I said, analytics, we have development, we have clinical analytical, but now actually, uh, being part of  Conscio group means that we can also offer a formulation development.

This is actually a very important thing because one thing is of course, somebody's interested about like, formulation of, um, some, some new medical, medical product. Uh, on the other hand, uh, many companies, uh, especially if they're coming from, uh, so-called third countries, uh, they need to have, uh, uh, IMP, uh.

Um, we believe, right? Yeah, I, uh, uh, on the same page, uh, so IMP batch produced according the, like European standards or ideally in Europe, uh, which might be from time to time problem, or you can either like audit them, inspect them, you know, and so on. But it's quite lengthy process. While if you do it in Europe, then it's pretty simple and straightforward.

So while having now this formulation actually. Located in Germany, uh, means that we are really now this one stop shop, I would say, because basically we can help them to formulate, uh, I mean, formulate and produce this IMP in Europe, release it in Europe, and then continue with the clinical study. So basically it's a very nice extension of what we are doing because without, uh, without that, we still would need to rely on some third party, which can bring another, another, like uncertain things, you know, uh, and contribution to, to the problem.Yeah. 

Pavlina Walter: And um, right now you mentioned this kind of the services. Yeah. Um, you do also the personalized medicine. 

Jiri Raska: It is actually a good question because this is what resonates nowadays, every day, uh, everywhere. Uh. Well, there are plenty of things what might be considered like a personalized medicine. You can do it like, um, 2D printing.

You can do even 3D printing and it's actually super nice when you see like, you know, 3D printed tablet just be just prepared for you or for you. So it's, it's great. On the other hand, I still believe that there is not the right time for that on the market. The regulation around that is a little bit complicated.

But we already have, uh, some nice, um, requests and projects where companies are, you know, approaching us, asking us about, uh, I dunno, like 2D uh, oral Dispersable film, for instance. Mm-hmm. This is very interesting. But there you can, you can do this way, or you can put it even to, to the level, which is, in my opinion, super fantastic when you have like ODF film with a QR code printed on that.Mm-hmm. And it's printed with the, with the ink, which basically is the API, the active substance. Mm-hmm. And, uh, you know, the, the thickness, let's say, of the ink is just like the dose. So basically this QR code, when you read it with the phone, everybody's using that. It can, uh, it can serve as, um, S-M-P-C basically like a, you know, like a, you know, procedure, how to use it.

And the good thing is actually that this, this SmPC is actually, uh, provided by, I would say like, kind of like avatar. And it can be you, it can be me. So even for your kids, basically, it can be like. The mommy is showing to the kid like, you know, Johnny, you now need to take it like twice a day and so on.And so, so it's interesting actually and it's uh, it's unbelievable. But as I said, I think it's still a little bit early actually to have it everywhere. You, 

Pavlina Walter: okay. You mentioned the issue with the regulation, but is it also the problem because of the price? 

Jiri Raska: Um, regulation is definitely still number one, but I already read many things that authorities are now looking the way how to do it.

And I heard actually that in the US is of course, it's more advanced already, uh, for some years. Uh, but uh, the regulation in terms of price and maybe insurance is the second point. And I think maybe even more important because we all know how is the situation nowadays with, with the insurance companies.

Mm-hmm. Obviously they, they don't need to, they don't want to pay for that, obviously, because it's still, you know, a little bit like gray zone, you know, nobody knows how, how it'll be and, uh, to actually have some kind of like a payment condition for something which actually still is not 100% approved, and no one actually, even to the, to the patients.This can be tricky. Yeah. Mm-hmm. 

Dr. Peter M. Kovacs: You mentioned this regulation, uh, regulation barrier. How do you see that? Europe has a new regulation since, um, since a few years, uh, compared to the us So Europe was always a bit slower in the, I mean, in clinical research regulation. Mm-hmm. And us and Australia was much further away.Are we able, or are you able to, uh, to overcome with this, uh, delayed regulatory approvals based on your more efficient service provider? More efficient, um, uh, conduct of the clinical studies and analytics, and also with, with, with the cost effectiveness? Mm-hmm. 

Jiri Raska: This is very good and sensitive question. I would say, well, a couple of years ago, of course, that is, uh, let's stay with this clinical trial approval.

Yeah. As you, as you know, it was the CTA process. Now it's, it was changed to CTIS clinical trial information system. Mm-hmm. Uh, I mean, in past CTA, uh, when I were referred to Czech Republic, uh, for pure  bioequivalence study, it was maximum like 30 days, uh, for approval. Um, I mean, of course you need to prepare all the documentations.Yes, I prepare. Yeah. Uh. Necessary. Necessary to say that actually even the, and the amount, the volume of the documentation is pretty heavy, actually comparing to, I don't like Canada or, or other countries, but, uh, but okay. Uh, then CTIS came and it was absolutely no nightmare because, because for companies like us who are doing purely PK  bioequivalence studies.

To wait for the approval up to four months. It was, it was disaster. So basic, basically, we were always, uh, able to find some way of a discussion with, uh, our local authority, which I, by the way, is, is a great, a great, uh, authority, I have to say, you know, comparing to other authorities. So, uh, as far as I know, so there are always, you know, supportive and so on, but they still need to actually comply with the CTIS period.

Uh, so within last. To rears or something like that. We were able to. Identify the, and agree actually, uh, on, uh, with suko, with the authority on a certain procedure, which taking us back to the previous one, which basically means that now if everything goes well, because of course, it always depends on the quality of the documentation of the data from the sponsors and so on.

But if everything goes well. We are able to get the approval in like 25, 26 days. That's nice. Which I 

Pavlina Walter: think is a great benefit. Or even for the small startups, because they'll save the money for, uh, like personal costs, timelines and everything. So this is the great news. 

Jiri Raska: Exactly. And, and this is what I believe, but I believe in Hungary is the same, right.I mean it's very, it is very. Very, uh, convenient, uh, uh, environment, I would say. Yeah. 

Dr. Peter M. Kovacs: For, for a single center or single country studies. They, they, they, they get, let's say a fast track. Mm-hmm. Not official fast track, but they're doing faster because they don't need to wait for other member states, feedbacks.

Exactly. 'cause the problem is that if you enroll more than one country. They have to communicate, which is not always going well. Mm-hmm. They have to wait for each other. They're overloaded. Especially in the first one, one and a half year, you know, all the old studies, they were shifted to the new system.So there was thousands of studies to be upgraded to the new system. So it was a significant delays, but unfortunately, yeah. So, so still, still much longer than it should be. 

Jiri Raska: You know, honestly speaking for me, there is still one question mark I have, uh, because when I compare it, for instance with Canada. I mean, plenty of companies are going to Canada.

The disadvantage with Canada is still that they are significantly expensive comparing to like European price and so on. On the other hand, if they are able to get the approval in like, I don't know, seven days or two weeks or something like that, with, with the, just a, just a fraction of the documentation what is needed in Europe.Yeah. Then the question is, you know. Why they are able to do so and, uh, not us. I mean, you know, and I'm not aware that basically it should be, it is some problem with the, uh, quality of the medicines, you know, in Canada or something like that, that they will just fake something or something like that. Yeah, 

Dr. Peter M. Kovacs: it's the same in Australia.Yeah, 

Jiri Raska: exactly. Exactly. So I think it's, it's, uh, it's, uh, European Union is, is a super great, you know, like element or how to call it a group. But in this way we are complicating the things a little bit. It's a bit 

Dr. Peter M. Kovacs: over administrative, over complicated. 

Jiri Raska: But then I believe, uh, uh, that it's still good that, you know, each country can take a lead, you know, in their own initiatives.Uh, what did, for instance, because I heard that there is plenty of similar things, like in, I know the Netherlands, you know, the Belgium and others. Yeah. So, 

Pavlina Walter: and also, I guess it was two years ago last year, you open a subsidiary in Ostrava For clinical trials, uh, how is it going? 

Jiri Raska: Um, it's interesting actually. And uh, it's, uh, you know, the main idea was that basically, um, here in Prague when you run certain number of studies, then basically you.

I don't want to say the nasty way, but you consume basically all the volunteers which are able to go or join, you know, the clinical studies in certain time. You always can like recycle them if you put it this way, like you know, after the proper wash out and so on. On the other hand, when there is a still growing demand on studies, you need to look for some different solution for the population.

Exactly. And of course. If you nowadays with the, the great connections, like, I don't know, you know, trains, uh, uh, highway in Czech Republic, we know that it's not super, super well and it's not working super well. But, um, you know, volunteers, they, they would love to go to the clinical study, but they hate to travel like four, five hours, something like that.

So then we said, okay, so maybe let's open something which will be on completely different edge of Czech Republic, and of course Ostrava as a. I would say capital city of Moravian, you know, um, let's say part of Moravian-Silesian, uh, , you know, part of Czech Republic. Um, it's actually the biggest part of Czech Republic in terms of like density of population and the number of the population actually in Czech Republic as well.

Um, so we said that it might be a good, uh, alternative. Because we will be at the end of the day, like on, in a two very big, uh, and heavily populated part of Czech Republic Plus in Ostrava. The idea was that it's very close to Polish and Slovakian border. And of course, nowadays with all of these regulations, uh, and being like free freed up, actually it means that you can recruit not only.

Czech citizens, but also people with like Slovakian or Polish citizens, citizenship and so on. Cross border recruitment. Exactly. Exactly. So I'm not saying we are doing that at the moment, but we are doing maximum to make it happen as soon as possible. And we are on a very good way, especially with the slovacian population.

Mm-hmm. Because it's is literally like, I don't know, 30 minutes, you know, the from Slovakian border. So in that, uh, in that way, uh, it's, uh, we are, we're trying to progress. Of course. Uh, another point was, uh, that of course you, you know, in cooperation with the local, with the local hospital, because we work with, uh, with the, um, uh, city hospital of Ostrava, you know, there.

So there are another experts who can help and expand our, you know, uh, knowledge and expertise. Uh, so this is another thing. Uh, plus of course, as I said, when you are coming to the capacity edge, this is the problem because nobody would like to hear that. Uh, you need to wait six, seven months, you know, until we free up, you know, the capacity.

So this is another extension of the capacity, uh, uh, for, for us. Uh, and we are very happy to have. 

Pavlina Walter: And, um, you mentioned here that actually the biologics are number one. Also, the personalized medicine will be in a few years, maybe number one. When, um, were you actually see the development of your business in few years?

Jiri Raska: Uh, I believe that, uh, as a baseline, let's call it this way, uh, we still, uh, for us, number one, number one. Pillar, let's say our business is still analytical, analytical stuff. So method development, uh, qc, routine testing, routine, routine, you know, uh, analysis and so on. Uh, on the other hand, uh, we believe that with all of that, uh, let's say we around biologics nowadays, uh, in.

Hard, it's hard to predict. Like three years maybe, something like that. We believe that it'll be still, uh, very high grow in terms of the biosimilars or, uh, you know, I would say even advanced biologics because nowadays what we see, um, ADCs antibody drug conjugates, this is amazing, amazing market. And, uh, also amazing type of products because I mean, we are from Czech Republic, so we all know, SOTIO.Mm-hmm. You know, it's, um, it's a great company. Who is working on great ADC products, and we are very proud to be their partner for many years. So we are supporting not only the bioanalytical programs, but also, you know, like a development of the methods. And with the ADCs it's something which not everybody can test because you are really, you really need to combine the expertise in, uh, in the large molecules, analytics with the small molecules.

Uh, because, because of the characteristic of the ADC drug and uh, uh. There are plenty of companies who are amazing in biologics, but they're missing the small moleculars part, for instance, or vice versa. So we are, we are very happy that we can combine both. And um, I was recently on in, I think it was in Switzerland on some, uh, on some event and it was very nice lecture there.

And what I heard was that basically, uh, despite the fact that ADCs are growing still already for some several years. We are still just on the beginning of that wave because nowadays, even despite the fact that ADCs are rather considered like unique because you can hardly, you know, like, um, produce genetic of that, uh, there is some idea of producing, let's put it in apostrophe generics of ADCs.And nowadays it's only a majority of, of the ADCs is really. Vast majorities for oncological treatment. But now there are, there are some ideas to maybe go into other therapeutic categories as well. So I believe if you ask me, you know, where I see us, you know, in the future I believe that, you know, working about these ADCs and biologics and like this type of molecules, this is where I see the future.

Dr. Peter M. Kovacs: Okay, thank you. And where do you see personally yourself in the next five, 10 years? Hmm, because you started, you mentioned at the beginning, you started in chemistry now and very deeply involved in the business development. Well, 

Jiri Raska: you know, I, I'm actually, uh, pretty happy on, on a position where I am because it's really combining of, I really like to, you know, interact with the people.

This is how I met Pavlina, of course. And you. So this is, this is great. And I really like to interact with, uh, you know, with, uh, with the various, um, experts from different, um, uh, different areas. And combining, combining that with, um, kind of like knowledge, you know, from the chemistry, because I still believe that my background of physical chemistry is a very, very good one.

Um. I have to admit that when I joined Quinta, I knew absolutely nothing, nothing about clinical studies. But, you know, during the years actually, I mean, I was able to, uh, with the help of all of my friends and colleagues, I was able to develop some, like, at least, uh, solid knowledge, you know, a little bit solid knowledge to, uh, discuss with the clients without, uh, without any like, super big hesitation.Um. But of course I said in the beginning, I'm, I'm, I'm still too far, you know, from the, uh, companies myself with, uh, these experts we have, but, uh. Um, coming back to your question, where I see myself, I still would like to do what I'm doing in terms of like, you know, business development, exploring new opportunities, um, and uh, you know, with, uh, having like a network of very good partners, uh, like what we do together as well.For instance, uh, you know, to expand, uh, our, our, um, audience of the clients because I believe there are still. Plenty of very nice ideas, uh, on the market in terms of, you know, like, uh, targets for the medicines. Uh, what might be some, some new, uh, like in America, 5 0 5 B 2, you know, these type of products that basically establish drugs you reformulate and use it for the different, I don't know, either like, uh, path of, you know, uh, the indication.Indication, yeah. Yeah, exactly. So, uh, yeah, this in a, in a nutshell. Yeah. I, I, I most likely I will not come back to, uh, be like a head of lab already. 

Dr. Peter M. Kovacs: So thanks so very much for, for this nice summary and I hope we can collaborate further and even more and more in the future. Thank 

Jiri Raska: you. Yeah. Thanks for having me.It was a pleasure. Thank you. Thank you. It was excellent.