BIO 2025: Speeding Up Development of Next-Generation Biologics

Coinciding with the Biotechnology Innovation Organization (BIO) International Convention held in Boston from June 16–19, 2025, BioPharm International® spoke with Abzena Chief Executive Officer Matthew Stober and Chief Scientific Officer Campbell Bunce, PhD. Bunce delivered a presentation at the conference, “Accelerating the Development of Next-Gen Bioconjugates & Bispecifics: From Lead Candidate Design to Manufacture.”

“The topic really is around how we can support the accelerated development of these next-generation drugs that are coming through?” Bunce says in the interview. “It's exciting times, I would say, in biotech and pharma where we're seeing new designs of molecules essentially standing on the shoulders of the success of antibodies and antibody-drug conjugates (ADCs). But these molecules that are coming through these next-generation drugs are very complex, even more complex than antibodies and antibody-drug conjugates. There is an expectation that we can deliver those to patients just as quickly as antibodies or ADCs. So, the purpose of our talk really is to walk through the different points in development from early concept through design, lead selection, [and] manufacture—how we can look at certain points in that sort of drug journey and make sure that we are doing our best to deliver those drugs as quickly as possible?”

Click the above video to watch the full interview.

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*Scroll below for a full transcript of the video.

About the speakers

Matthew Stober is chief executive officer and Campbell Bunce, PhD, is chief scientific officer, Abzena.

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.

Matthew Stober

I'm Matt Stober, I'm CEO at Abzena. And my responsibility is to really bring, high tech biotech products through CDMO services offering. And what we do is really partner with folks to develop those. Those products from beginning to end.

Campbell Bunce

I'm the Chief Scientific officer at Abzena, and I'm responsible for looking after our technology, making sure our platforms are state of the art up to date, and suitable to really support our customers, of which they're very diverse, in terms of their stage of development and the requirements, but support them at whatever stage of development to get them through those value inflection points and speedily into patients.

The topic really is around how we can support the accelerated development of these next generation drugs that are coming through. It's exciting times, I would say, in biotech and, and pharma where I, we're seeing, new designs of molecules essentially standing in the shoulders of the success of antibodies and antibody drug conjugates.

But these molecules that are coming through these next generation drugs are very complex that are even more complex than antibodies and antibody drug conjugates. There is an expectation that we can deliver those to patients just as quickly as antibodies or ADCs. So the purpose of our talk really is to walk through the different points in development from even early concept through design, lead selection, manufacture.

How we can look at certain points in that sort of drug journey and make sure that we are doing our best to deliver those drugs as quickly as possible. We know this is really an important subject. We hear a lot in the news of folks that can actually deliver these new complex drugs in six months.

And that's probably possible, but we do need to think ahead and how we're actually gonna do that. And think about levels of risk, think about actually what the regulators expect to see at the end of the day. But most importantly, think about, getting safe and effective drugs into patients.

We're a CDMO with a significant sort of front end research or R&D capability. So while we have this sort of integrated approach that can deliver this concept through to drug product, we also have a lot of other sort of specialist expertise that we can offer, particularly in analytics, analytical method development, immunogenicity assessment, so there's a lot of sort of additional areas of expertise that we can offer and talk about. And again, while we are an integrated business that does a lot, does most of what our customers need to get them from idea to patients, we do need to partner up with folks that fill the gaps that we can't offer, such as drug product manufacture.

Matthew Stober

Yeah, and I would just build on what Campbell shared is, the secret sauce or what makes Abzena really special is exactly what Campbell described is we truly show up as a partner to the small, medium sized biotech companies that are doing drug development, and we can start from the very early phase during that R&D component.

And then manage the entire program from end to end and why that's really important. As you think about ADCs and the convergence of biology and complex chemistry and putting those things together, the analytics around that, all the upfront work that has to happen to get that candidate then into a clinical setting, it's really important that you have an integrated offering.

But equally as important is that you have a partner that treats that batch or two that you're making as the most important thing. And one of the things that really separates us is that is our core customer base. And so we spend a lot of time really working with folks in the early stages to make sure that as they get ready to spend the bigger dollars and make that that first batch that's gonna go into the clinic, that all that work is done well on the front side and that then we have a very quick path to get them into IND because time is money for all these programs, and obviously it's a very competitive sector.

The way we show up, I use the word partner all the time, is you're not hiring. When you come to Abzena, you are not hiring somebody and saying, okay, go do this, and then do that, and then do the other thing like you might do when you got involved with a commercial product, or we're working in a big pharma company where you've got a big research engine and /or team behind you.

We truly show up as that partner for development. We try to understand what you're trying to accomplish in the clinic, the speed at which you're trying to do that. And everybody's situation is different, right? So some people are extremely well funded and speed is everything.

Other customers are still trying to get through the funding process. And those folks, we try to be very creative in the way that we're willing to work with them in terms of the way we structure terms. And again, that comes back to the partner mentality that we have as we show up every day to try to help folks.

And really specifically is that understanding of what folks are doing in the clinical setting. We have a recent customer that's working in the pancreatic cancer setting. Super exciting project, super exciting drug and, seems to be quite effective. Speed is everything with that because we've got patients out there that don't have a lot of options, frankly, and their life expectancy is not long.

And so getting that product into a clinical setting, into the marketplace as quickly as we can, demonstrating that work, helping that customer to work with FDA. To get fast track status, and do work through the regulatory components is something that really, again, motivates our team beyond the financials of running a business, right?

Obviously that's important. We have to run a business as well, and make money on the business side. But what gets us all fired up every day are the patients, right? That's why we're all here. And again, that's how we show up with that partnering mentality is, we love the science, we love the innovation.

People don't come to Abzena necessarily for the easy things to do. They come to us for the more challenging programs. And that's where we excel. That's where our scientists get excited. About the science, about what we're trying to do from an innovation standpoint and frankly, and most importantly, about what we're trying to bring to the patients.

Campbell Bunce

The whole reason Abzena exists, really. I mean, that comes from a biotech drug development background. I come from 20 years in biotech before joining Abzena. So really understand the kind of pressures and urgencies, whether it is financially driven, whether it's market driven, whether we're trying to get something licensed to big pharma or whether, there is a clinical unmet need.

And there's patients out there needing new drugs. Over the 10 years I've been there, and since Matt's been there as well, we've kind of built that kind of service provider, you know, solution provider that supports that kind of urgency and all the technical solutions and scientific capability and understanding these kind of different aspects around urgency, quality, effectiveness, and drug development into our business. I think it's a mixture of all of those things, market pressures. There's big pharma facing a little bit of, maybe a big bit of a patent cliff soon. So they're out looking for a means of filling the pipeline with effective next blockbusters. Patients are crying out for new drugs, particularly in those diseases where there's been not a lot of development. And that's where some of these new technologies are going to be able to help. So it's a mixture of all of these things, but Matt's right, it is a bit of a cliche. Where I get excited too is once we get things into the clinic and we see the impact in patients.

We see in biologics we are in a phase of drug development where we're looking to combine multi-functionality into the one drug. And we're seeing that there's an impetus behind this, particularly as potential alternatives to things like CAR T-cell therapy, T-cell engagers are of particular interest and a few T-cell engagers have been approved.

But we can do better. We can do better in terms of efficacy, balance with safety, balance with productivity, when we redesign into these new kind of production platforms that we have, selling development platforms. So there's a big interest in that. The other area that we're gonna talk about is antibody oligo conjugates.

So again, this is a particular area of interest and we're seeing a lot of momentum in that kind of drug design. We know the design and availability of others that we spearheaded, that platform getting into patients and starting to test and ask the questions as to how effective this is going to be in underserved diseases like Duchenne muscular Dystrophy and others.

And we're already seeing that we've been actually at the front of this as well. About 50% of our programs just now are looking at oligo conjugates of some form or other. So we're seeing this sort of popularity increase and very excited about it because it is something that's going to offer either better treatments, or actually treatments where there haven't been any treatments before.

So I think there's a lot of interest, a lot of drive, and, it's a brief new phase of drug development I'm excited about.

Matthew Stober

One of the things, again, with Abzena where we're a bit different is we have our own internal regulatory team that does exactly what you're describing, is to stay in front of what the regulator's expectations are, whether that's from starting to see folks maybe move away from animal testing and what can we be doing to ensure that that drug safety is not compromised as maybe some of this animal testing gets eliminated.

And we've got some activities going on there, really watching the space carefully, and working with some folks that are innovating in this area to ensure that the safety component is covered and that we understand what the regulators are thinking about there as maybe some of the animal work starts to move away.

But we stay very close to the regulators and what their expectations are around these different modalities that we're talking about. Campbell mentioned antibody oligo conjugates, ADCs. And we're spending a lot of our time in these spaces, bispecific multi specific antibodies, and we get to see all of the feedback because we're at the table and we've got our own internal regulatory group that helps these small to medium sized biotech companies as they go through that IND process with FDA and other regulatory agencies. And so we see what the expectations are and then we're able to apply that broadly as those expectations evolve, as the agencies and regulatory authorities evolve their thinking in this area. And so that's a space that, again, I think we're differentiated.

Because we've got our own internal group, and that's really that end-to-end offering that we talked about that's super important to make sure that if there is feedback from those regulators, that we can iterate on that quickly and make sure we get folks into the clinic very, very fast.

Campbell Bunce

I mean, we do stay very close to the regulators as well. We sit in various forums and committees, global groups, which FDA are part of. We work with FDA on certain sort of aspects of drug design and development and testing such as immunogenicity, for example, and how that's progressing and expectations around that as the new drugs come online and develop.

We publish with them as well. So, as mentioned before, we've got a lot of experience in biotech and drug development and going to the agencies and presenting them with pretty challenging new drugs that we have considered how to present the best data to them so that they're convinced that we know what we're talking about.

We know what the challenges are likely to be, what the safety aspects might be that we need to kind of generate data around. And we've built that within our company. So it's something that we are very close to and we build within our business.