The Benefits of End-to-End Services

Smaller biopharmaceutical companies that own the molecules in early clinical development and outsource most of their development and manufacturing operations, often have limited resources, according to Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company, and therefore might benefit from a contract development and manufacturing organization (CDMO) that offers end-to-end services.

“They perhaps have limited number of people who are really going to be in a position to manage their service providers. So that really brings you to the first benefit, where having a single partner actually reduces the complexity you have in managing multiple partners, you have a single point of contact across the continuum,” Dowdeswell explains. “There can actually be some really more tangible benefits than that. So where you have a single partner developing both your drug substance and drug product, and in fact, in some of the areas around it, what you can find is that they're able to talk to each other directly without any barrier to communication because they're part of the same company, there's no confidentiality issues. It also means that maybe there's some work that can be overlapped. So, you can start work on drug product before you've finished all the work on drug substance, which might not be quite so easy when you have separate parties.”

Arcinova, a Quotient Sciences company, will be exhibiting at stand 5.1D104 , zone Contract Manufacturing and Services, at CPHI Frankfurt, being held Oct. 28–30, 2025.

Click the video above to watch the interview.

About the speaker

Christian Dowdeswell is an experienced commercial leader in the CDMO industry. A former scientist with a PhD in organic chemistry and a long track record in CDMO organisations, most notably VP Head of Commercial, Small Molecules at Lonza & Chief Business Officer, Drug Substance at Siegfried. His current role as Head of Arcinova builds on his extensive experience in Early Phase development across Drug Substance and Drug Product gained in prior roles.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Hello. So I'm Christian Dowdeswell. I am the MD of Arcinova, which is a part of quotient science is limited.

I used to be a scientist, but moved into commercial roles some 20 years ago, and have been in commercial leadership roles at a number of cdmos, most notably Lonzo, where I was head of commercial for the small molecules business for nine years. Spent some time as chief business offers Officer at seafree, before deciding that I wanted to return to where I started. So back with much smaller cdmos, which is in a roundabout way, led me to this new role leading Arcinova, which is an early phase drug provider, drug development provider, offering services across drug substance, drug product, global clinical trials, supply and answer adjacent services.

How is early development of drug products enhanced by a cdmo that offers end to end services?

I think to some extent, this depends a little bit on who you're doing the work for. So if I was to take a small biopharma company, for example, and they're important because they own the majority of clinical molecules in early clinical development, typically, that sort of company has limited resources

to conduct that sort of work themselves. So they outsource heavily. They perhaps have limited number of people who are really going to be in a position to manage their service providers. So that really brings you to the first benefit, but actually having a single partner reduces the complexity you have in managing multiple partners, you have a single point of contact across the continuum.

And actually there can be some really more tangible benefits than that. So where you have a single partner developing both your drug substance and drug product, and in fact, in some of the areas around it, what you can find is that they're able to talk to each other directly without you having to get in the way of communication because they're part of the same company, there's no confidentiality issues.

It also means that maybe there's some work that can be overlapped. So you can start work on drug product before you've finished all the work on drug substance, which might not be quite so easy when you have separate parties.

It may be an example to bring that to life. One of the things that we find here is that we can have great communication between the team that's working on the API around the material form of the drug substance, with the drug product team who's doing the work to translate that into a viable drug product. So that interplay between, how do we optimize the drug substance, how does that feed into what we're doing with drug product that can actually bring you to stronger technical outcomes as well?

I think, I think in our particular case as well, because we're part of quotient, we're actually able to go further downstream, actually into clinical work. But, but really the main benefits of that continuity of work through a single provider brings those key benefits, reduction in complexity, especially those smaller companies, reduction in time, which you know can be, can be quite meaningful, and the reduction in the total cost of ownership. So.

What role do artificial intelligence and digital technologies play in accelerating drug discovery and improving manufacturing efficiency? And what are some unresolved barriers to full adoption?

I think there's, there's actually quite a lot to unpack within that, but so I'll try and deal with it, with it through giving some examples of things that are happening, things that we've been looking at. So one of the clearest examples of how digitalization and AI is changing drug discoveries in the use of AI to help design new molecules that target a specific protein site.

Now that is quite effective in tailoring a drug to the activity or molecules the activity you hope it will have, but it has an unexpected consequence, in that the number of synthetic steps is increased quite dramatically with that approach. So I have some data that shows around about the year 2000 there was a paper published by Pfizer and AZ, I think that showed the average number of synthetic steps to get to an API was eight, round about 2020, you do the same analysis, and you see that number of steps has almost doubled. So it's like 14 or 15.

And earlier this year, I found some more data, which suggested that the new molecules coming out of novel approaches to drug discovery have often in excess of but 30 steps of chemistry to get to the target. So that is a really dramatic step change, that over the last 25 years, you've gone from eight to 30 steps, and that's whilst that's quite an unexpected consequence, cdmos are going to have to find a way to deal with that. Now, the time that we have available for CMC is not going up, in fact, if anything is coming down. So you have more complexity, more work to do on the API synthesis. We can leave aside the problems with that you have in drug delivery beyond that. But just for the API synthesis, you have to find a way to get all of the work done on CMC and building the synthesis towards providing the small molecule API in the same time. So you have to find ways to do that much more efficiently, much more quickly.

One of the things that we've been looking at is around the use of digital twins. We're not alone in doing that, but one of the reasons we've done that work is because it gives us a really great pathway to look at how do we move from the small scale lab experiment into the initial scale up, which might be to a small kilo lab, 510, 20 liters, liters, and then take that further into the next scale, which might be one, 150 200 liter scale. And even then, how do we provide data that enables a customer or a future service provider to take that further? So we've done that work to enable us to model how the reactor is going to behave, how the kinetics of the reaction are going to behave, to enable and facilitate that scale up. And we actually did that. It was actually part of a sustainability push, originally, that we wanted to be able to do this in a in a quicker fashion, that we're using less resources to get to the same endpoint. But actually, when you tie that into the complexity part, the amount of work you've got to do, that starts to become essential. And I think your question asked about some of the difficulties, you know, the difficulty in the work that we did was to look at the data architecture, the way that you receive the data from all of the different sensors, because it's not standardized today, requires a lot of data manipulation adjustment to get it into a format where you can actually do the modeling. So here's where we're planning on bringing AI in, because AI can help do that data manipulation work in a much smarter, quicker, frankly, quicker is the key here, why that enables us to get that modeling done much more quickly, which starts to build this, then from a single product or single reaction solution into something that's much more of a platform that you can use across the board. Some of the other advantages you have is that, by how you can also look at should be operating in batch or continuous and attend on a particular stage of development, you might want to change that might be more appropriate a certain stage, stage of development, to do it continuous and later fit to batch, because that fits a large scale CD, most manufacturing assets. So there's a lot there. I think, as an industry, that's maybe a microcosm of the challenges we face. There's a, there's a there's inconsistency around the state of digitization, and that not just company to company, but acid to acid within companies, because, you know, different assets have different ages and different ability to support digitalization.

Innovation, the lack of standardized data architecture, is something that we've seen, really in a microcosm, but a macro level, I think, is something everybody faces. And I think the third one, I'm pretty sure, is an industry across the industry as well, is the is the availability of expertise. Is there a suitably qualified workforce? Do we have access to the right people that can really support and drive digital initiatives, and, in fact, even who fully understand the true potential of what could be done. I think that's one of the key challenges that as an industry, we're still coming to grips with.

How is the sector reimagining supply chains to protect against rising tariffs and geopolitical shocks and global disruptions?

Yeah, I think that's, that's a question I get a lot, actually, and I probably play back a little bit the the answer that I quite often give which is the quite frankly, at the moment, nobody knows there's a huge amount of change around tariffs and what's happening with some of the other geopolitical situations. And certainly I don't look to base strategy on social media posts without really understanding how actually is that going to be implemented. But I think overall, this is part of a an ongoing regionalization trend that I think has really been driving for quite some time, certainly, certainly over the last 10 years, this has been happening where, certainly for innovative Pharma. So companies working in the innovative space, their focus has moved away slightly from just being let's get things done at the lowest cost, which meant moving to Asia, to actually a realization that their success is much more dependent upon getting their drug advancing through the clinic and hopefully to market in a timely fashion. Not being first to market or being delayed is a real hit on their revenue. It's a real hit on the business case for developing the drug in the first place. So we're seeing them move away from a cost first basis to look at how do they best ensure their drug gets through that, and the way they do that is by making sure that their cdmo providers are underpinned by strong science, who are able to provide good data, who are able to execute a plan, who have no compromise on quality, who are able to really communicate them within in a very optimal fashion, depending what that means for an individual organization and overall, finding that they are able to get more security of supply, more security of delivery of what they're asked, asking for by using Western providers. And you can really see that in the last 10 years, the cdmo industry has had quite a revival, and a number of companies have that are public demonstrate that really well across Europe and US. So I see the trends, the questions around tariffs, bio secures, re emerged again. You know, the geopolitical factors around

the over dependence on China, I just see that simply accelerating that trend. Because I think our industry has been moving that way anyway. This just maybe makes people much more conscious of it. For a company that can't get Nova, which is really an early phase company, what it means for us is we have to be consistent or continually re evaluating what we offer as service, services to understand is that still addressing customer problems, what aren't we doing that we should be doing? Are we relevant? Are we going to remain relevant in the future? So really having that continuous dialog with our with our customers and future customers about what do we need to be doing to really be giving you what you need.

What are you looking forward to most at CPHI Frankfurt?

CPHI, I think have a love hate relationship with it. I've been going for 25 years, and perhaps, as I answer, you can see why I have a love hate relationship with it. I actually think the timing couldn't be better. I am less than three months in a new role with an organization that's been been rebranded is based in the organization as well, so that timing almost couldn't be better, because I get the chance to meet with a huge number of customers, and hopefully future customers, and actually other people industry, and really start to test myself firsthand. What are we doing?

Is that addressing your needs is, are we actually providing what you need to what aren't we doing that we should be doing? Basically what I talked about in the previous answer, it's a perfect opportunity to do that. I mean, it's a great place to connect with old friends, to meet up with other people in the industry who have an incredible amount of knowledge.

I think I'm not alone. I think a lot of people go to cphi and are very guilty of burning the candle at both ends. So You're up early for breakfast meetings and you're out late having having dinner and after dinner events. So it's a very tiring event, and that's why I have a love hate relationship with it. I always come back exhausted because I have burnt the candle at both ends, but it's always worth it. I always come back with with, you know, a huge amount of new information, new people met old people reconnected with so it's actually a fantastic event. It's just really tiring.