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

Biologics are reshaping the architecture of modern medicine and, with it, the operational backbone of clinical research. What was once a world defined by generics and small molecules has become a landscape driven by complex biologics, biosimilars, and increasingly, personalized therapeutics.

In this episode of Clinical Capital Conversations, I sat down with my business partner, Pavlina Walter, and Jiri Raska, Chief Commercial Officer at Quinta Analytica, to explore what it takes to turn the next generation of biologics into clinical reality.

Jiri’s story is deeply rooted in science. Trained as a chemist, he has evolved from lab work to leading business strategy for one of Europe’s most dynamic contract research organizations (CROs). That dual lens, scientific and commercial, is what makes his insights so relevant today.

From Laboratory Precision to Strategic Scale.

Quinta Analytica is not just another CRO. It represents a new class of partner, one that combines deep analytical capabilities with end-to-end clinical execution. Headquartered in Prague and part of the Conscio Group in Germany, Quinta spans the entire value chain: analytical chemistry, method development, formulation, and clinical studies.

As Jiri shared, “Everything around biologics is booming, both biologics and biosimilars. Yet there’s still a massive void. Nearly 90% of biologics going off patent have no biosimilar replacements.”

That statistic defines both a challenge and an opportunity.
While small-molecule generics are reaching saturation, biologics are only at the beginning of their industrial curve. They are more complex to develop, more expensive to test, and more dependent on integrated infrastructure.

For CROs, this means moving from transactional service delivery to strategic partnership.
The future of biologics belongs to those who can reduce friction across analytics, regulation, and execution without compromising data integrity.

The End of the Generic Era and the Rise of the Value-Added Molecule.

As Pavlina pointed out during our discussion, the generic market in Europe is under pressure. Pricing ceilings and insurance-driven reimbursement caps have made pure generics economically unsustainable.

Jiri agreed: “Pure generics are gone in Europe. Companies are now looking for value-added products, smarter formulations, improved delivery, and differentiated chemistry.”

That shift aligns perfectly with the rise of biologics and biosimilars. They offer differentiation rooted not in marketing, but in molecular engineering.
For CROs, that means developing capabilities in bioanalytics, advanced mass spectrometry, and method validation for highly sensitive compounds.

The scientific complexity is immense. Detecting impurities like nitrosamines at single-digit parts-per-billion concentrations requires world-class expertise. But it also demands business agility, the ability to deliver regulatory-grade data at startup speed.

This is where operational structure becomes a competitive advantage.

Small Biotechs, Big Challenges, and Why Integration Matters.

In my own work with early-stage biotech founders, one pattern repeats: the science is often extraordinary, but the infrastructure behind it is thin.
Young teams lack regulatory experience, vendor networks, and the operational rhythm needed to reach their first clinical milestone.

That’s where strategic CRO partnerships matter most.

As Jiri explained, “Small and mid-size biotechs don’t want ten vendors. They want one trusted partner who can take them from analytical development through clinical studies. We’re not a one-stop shop in the marketing sense, but we build a continuum of services that de-risks their path.”

This continuum approach is what I call infrastructure leverage, turning a fixed cost base into a platform that multiple innovators can share.
It’s also what makes CROs central to biotech scalability. The old model of fragmented outsourcing no longer fits. Founders now seek orchestration, not just execution.

Europe’s Regulatory Crossroads: CTIS and the Path to Pragmatism.

Regulation can accelerate innovation or paralyze it.

Europe’s transition from CTA to CTIS (Clinical Trial Information System) was intended to harmonize the approval process. Instead, it initially created bottlenecks, stretching 30-day approvals into 4-month delays. But the story is shifting. As Jiri shared, “We worked with our local authority to restore efficiency. Today, if documentation is complete, we can get approval in 25 days. That’s a massive improvement.”

This is the kind of pragmatic adaptation Europe needs. Where bureaucratic uniformity once slowed progress, local innovation is now restoring competitiveness. Czechia, Hungary, and others are quietly demonstrating that speed and safety can coexist.

For investors, this signals an opportunity: operationally efficient regions will become the new nodes of biotech acceleration.

The New Geography of Clinical Research.

Quinta’s expansion into Ostrava near the Slovak and Polish borders illustrates how geography and demographics shape strategy.
By opening a second clinical unit outside Prague, Quinta diversified its volunteer base and increased capacity without compromising oversight.

Cross-border recruitment and local hospital partnerships are transforming how mid-size CROs scale. The model is simple but powerful: replicate excellence regionally, rather than concentrating it centrally. For Europe, this distributed model could become a blueprint for resilience in the next wave of biologics trials.

Biologics, ADCs, and the Road Ahead.

When asked where he sees the future, Jiri didn’t hesitate: “Antibody-drug conjugates (ADCs) are incredible. They combine biologic and small-molecule expertise, and very few labs can test both. We’re proud to support these programs.”

He’s right. ADCs are a convergence point of science, analytics, and manufacturing, all meeting at the frontier of complexity.
For CROs, this means dual fluency: the physics of molecules and the economics of scale.
For investors, it means a new asset class emerging from the intersection of chemistry, biology, and operational excellence.

The next generation of CROs won’t just manage trials. They’ll shape the clinical pathways that define entire therapeutic categories.

Personalization, Technology, and the Human Factor.

Beyond molecules and data, there’s another layer: personalization.
From 3D-printed tablets to QR-coded oral films that combine digital identity with dosage control, the boundaries between formulation and information are disappearing.

Yet, as Jiri cautioned, regulation and insurance frameworks still lag behind.
Innovation is ready. Policy must now catch up.

At the center of it all is still human communication, the bridge between operators, scientists, and sponsors.
“The client doesn’t care how many people he talks to,” Jiri said. “He just doesn’t want to repeat himself.”

That’s project management at its most accurate definition, not software or dashboards, but clarity, consistency, and accountability.

Biologics as Infrastructure, Not Trend.

Biologics are not just another scientific wave. They represent a structural shift from chemistry to systems biology, from vendor networks to integrated ecosystems.

For founders, it’s a call to partner early and build operational trust.
For investors, it’s a reminder that ROI follows reliability.
For regulators, it’s proof that pragmatism is not compromise; it’s a strategy.

What Jiri and Pavlina reminded me of in this conversation is that the future of clinical research will be built not by the biggest players but by those who collaborate with precision, transparency, and shared vision. Biologics are the bridge between science and scalability. Strategic CROs are the builders of that bridge.

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:

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

Peter M. Kovacs Personal Website:https://www.petermkovacs.com/

PMK Group Website: https://www.pmk-group.com/

Guests:

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

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

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, uh, 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.