Bo Wiinberg on Bridging Research and Trials with Cell-Based Therapies

October 7, 2025

Are cell therapies the key to bridging the gap between discovery research and clinical trials? In the inaugural episode of the Bioprocessing Unfiltered podcast, Bo Wiinberg, chief business development officer at Novo Nordisk Foundation Cellerator, sat with Ran Zheng, CEO of Landmark Bio and shared his expert insight on the promise cell therapies hold for diseases with only treatments but no cures. Their conversation covers the challenges of navigating cell therapy programs through pre-clinical and clinical development journeys, how Cellerator is creating innovative spaces in CMC and manufacturing to fulfill critical needs in the translational space, and what a sustainable global cell therapy manufacturing landscape looks in 5-10 years.

GUEST BIO

Bo Wiinberg, PhD, Chief Business Development Officer, Novo Nordisk Foundation Cellerator
Bo is a seasoned leader with extensive experience from both academia, the pharmaceutical and biotech sectors, focusing on strategic and operational leadership throughout the drug development value chain. Bo was previously an Entrepreneur in Residence at the BioInnovation Institute and at Novo Nordisk A/S, Bo held several leadership positions over the years, including Head of Strategy & Operations for the Stem Cell unit. Bo is a Doctor of Veterinary Medicine, earned a PhD from the University of Copenhagen and has numerous publications in peer-reviewed journals.

HOST BIO

Ran Zheng, CEO, Landmark Bio
Ran is an accomplished biotech leader with deep experience in business strategy, therapeutic development, and technical operations across both established biopharma companies and innovative biotech startups. Over the past four years, Ran has successfully built Landmark Bio from concept to a thriving business. Previously, Ran served as Chief Technical Officer at Orchard Therapeutics (now part of Kyowa Kirin), where she played a key role in advancing the product pipeline and securing the European approval of Libmeldy—the first gene therapy product for metachromatic leukodystrophy (MLD) in the region. Earlier in her career, Ran held various leadership positions with increasing responsibilities at several major biotechnology companies including Genzyme (now part of Sanofi) and Amgen, where she contributed to the development and commercialization of multiple groundbreaking medicines.

TRANSCRIPT

Welcome to the Bioprocessing Unfiltered podcast. Each month we host conversations with the researchers and leaders tackling and solving the day-to-day challenges of the bioprocessing industry.

Hello, greetings from the beautiful Seaport Boston. I'm Ran Zheng, CEO of Landmark Bio. I'm here with Bo Wiinberg, Chief Business Development Officer at the Novel Nordisk Foundation Cellerator to talk about South Europe. Bo, you have an amazing career spanning across academia and industry. Before we get started, would you like to tell us a little bit about yourself?

Yes, of course. Thank you for having me, Ran. It's a pleasure to be here. Yeah. I have a background in veterinary medicine and uh ever since uh my career started, I've had this passion for working on translational issues where you can move things from you know ideal and concept into applied uh reality, basically, right? And and beyond that, I've had the opportunity to work both in academia and biotech startups and in pharma companies. So that has given me uh kind of a good insight into some of the issues that are across the sector uh from different vantage points. Yeah.

That's fantastic. So given your current role as a chief business development officer at Cellerator, solely dedicated to advancing cell-based therapies by bridging the gaps between discovery research and clinical trials. We would love to hear your perspective on this field. As you and I both believe cell therapies holding incredible promise to patients and their families and could be game changers in many diseases that only have treatments but no cures. So, however, many cell therapy programs struggle to navigate through the preclinical and the clinical development journey. And even after achieving successful regulatory approvals, it still takes many years for some of them to reach a broader patient population and deliver successful uh commercial outcomes. So there have been many challenges, such as you know, inconsistent product qualities, unscalable manufacturing processes, and those are all the CMC challenges, supply chain complexities, high cost of goods, just to name a few. So, from your perspective, what is driving these challenges and what shifts need to happen to overcome them?

Yeah, those were a lot of questions. I'll start by saying, so from the foundation's point of view, uh we definitely believe that the regenerative medicine and stem cell-based therapies and specifically high-tipping point, uh, there's a lot of promising data coming out right now where we see that biology seems to be actually working, right? The clinical trials are moving into phase three, which means that, you know, there is a huge potential here, right, to treat diseases that are uncurable today or, you know, where we don't have good uh treatments uh for them. So there's a huge opportunity. On the flip side of that, we also see that some of those uh, you know, products that are now moving into late-stage clinical development have had a very, very long and complex journey to get there, right? So what we're trying to do here as an organization is to develop entities that can help uh solve some of those issues. And the foundation has invested in both the early research uh for years now, actually, to get the basic science and discovery engine going. It has uh invested in the in a community or an institute in Copenhagen where that's called the Bio-Innovation Institute, where you can kind of spin out companies from academia to get them going, to get that translational part going. And then now the latest initiative, as you said, is the accelerator that is focusing solely on the journey of translating good science into something that can be manufactured for clinical trials. Because the reality is that that's an extremely complex uh task to solve. And I think what we are seeing right now is that there needs to be some sort of standardization and approach where we come together and kind of bridge that gap in an efficient manner. And that's what we're trying to do with the survey.

That's fantastic. So I heard about the salary tears a couple of years ago. It's a huge investment to establish a state-of-the-art facility and to accelerate the translation uh and of uh the cutting-edge research into clinical trial products. So you worked in both academia and entrepreneurial environments and big pharmas. How does salary bring together the players from different sectors in academia, biotech, pharmaceuticals, to create an environment where innovations in CMC and manufacturing can thrive to fulfill the critical needs in the translational space?

Yeah, so so I think we can start by looking at so what are some of the issues that we're trying to solve here, right? And some of them are inherent in the product and some are more systemic in the in the in the ecosystem that needs to solve as well, right? So at the core, we're dealing with living therapies here, right? We're living, it's a it's it's a living cell that we're trying to treat patients with. And that means that it's extremely difficult to standardize the product that you're actually going to treat the patients with, right? So we had inconsistent product quality, we have unscalable manufacturing processes that we're currently looking into, and that all leads to high cost of goods in the end, right? Uh and that then in the end also becomes prohibitive for patient access. So these are symptoms that are structural as well. Uh, because the major challenges is, as we see by our couple of things that we would like to work with. There is a disconnect between the early discovery and then that manufacturing that has to take place before you can go into clinical triumph.

I think you've also been in the field for a while, and and you know that what when we meet these projects early, uh the processes that they've been working on at an academic level to show proof of content in animals are not fit for uh GMP manufacturing at all. So a lot of changes need to take place uh to make those um processes fit for manufacturing in that GMP uh grade. Uh and so what we can do is to help them kind of get that process going and change the the critical parameters in that process to make sure that that the that it's fit for human use. So that's one thing. How can we actually redesign those processes? But it's also interesting to think about, you know, they've gone down that road for a while and they've invested a lot of time and effort into that uh developing processes that we then have to change. So, what can we do to get them on early so that we change early and don't invest in going down a road that has to be, you know, rethought later on. So that's one element.

I think the other element that we're also looking into here is harmonizing standards across uh the ecosystem as well. Because one thing is that we can change and help them adapt to what they need to do to get into clinical trials. But we also need to be as an organizer or as a kind of a bigger ecosystem, agree on what does good look like from a quality perspective. And that means a little bit about, you know, so what are do we have any globally aligned quality frameworks to doing? No, we do not. We don't have a good understanding of what are the critical quality attributes we are trying to develop for a drug product. We don't necessarily have a very strong understanding of what type of analytics do we need to have in place to characterize the product. Uh and all of those things, of course, lead to some sort of uncertainty on a regulatory kind of uh level about are we getting it right? Are we actually doing the right thing? Well, the regulatory regulators who are in the end going to assess these products are going to say, yes, this looks great.

So there's a lot of uncertainty there where we have to bring the regulators into that dialogue early on to make sure that what we are doing is actually also what they think is the right thing to do. And that's not just something we need to do locally, it's something we need to do probably on a broader scale, so we agree on what looks good in the US and Europe and in Asia, for example, as well, right? So those are those are two elements that I think are extremely important to talk about. And then what we are trying to do here is to have a shift from saying when you do these different elements, when you do the process development, when you do the GMP manufacturing, when you do the lake stage uh I and D preparation for the regulatory interactions, usually when you do drug development, you engage with different entities along the way. And you have to find the preferred partner on each step of the way, and then you have to combile all of that into a strong package at the end. And what we're trying to do with accelerator is say, okay, so how can we create a hub where it almost becomes a one point of entry? So we say we take you on that journey together with you.

Well, we go on the journey very early. We look at your process, we decide what needs to be changed, and then we bring in the experts that are necessary to guide you in that process. We had them in-house and accelerator, but we also have the regulatory interactions, we know the regulatory frameworks that we need to work up against. Uh, and then, you know, it becomes a more holistic approach to you know that journey, which of course, also hopefully in the end, that's the idea at least, will lead to a higher chance of success, a more efficient process, and you know, a quicker and and hopefully also cheaper and more efficient journey to the first human dose, right? And that's kind of what the idea is with accelerator. We're trying to do that, right? A little bit uh bring on the CMC thoughts earlier, get it right earlier, and then bring all those entities who need to be brought into play together in the accelerator context to solve it together, right? So we all have a stake in the game and we're all part of the you know, bringing the solution to the table.

That's fantastic. That sounds like a very ambitious uh endeavor.

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So, specifically, can you talk a little bit what you try to build within Cellerator to really address some of the key points that you just mentioned?

Yeah, I mean, so so part of the idea to the Cellerator actually came out of some of the experiences we had in the Novo Nordisk pharma company, the Novo Nordisk, that you know is very well known for the diabetes drugs, but also actually has a rather large cell therapy unit. Uh and what that did, uh, the experiences there were that it went out early and engaged in some with some academic projects. Some of those actually now have moved into clinical trials. But the point was that that those realized the realization there was that they were not nearly mature enough to be plugged into a pharma machine, right? So many things had to be changed. The starting material was not right, the raw materials were not right, you know, the analytics were not uh fit for purpose, and all of those things. So it was clear that we had to do something to kind of bridge that gap from great science and into something where you say now it's actually ready for pharma grade manufacturing and process development and clinical trials and all of that, right?

And and to be honest, pharma companies are not good at that. Pharma companies are not super good at translating that, you know, and having the patience uh to have a long process to do that. So, where could we incubate them to actually take care of that problem and get them ready to a stage where pharma companies could then engage? And that's how we kind of came about this idea about having this hub that could be kind of uh that center of excellence for translation of cell therapies. Um I in the beginning we thought it would be very focused on on GMP. It's like we'll just build something and then we can GMP manufacture and for the first phase one trials and then we'll figure out how we scale it and all of that later. Um but then as we had dialogues uh with the community and and and visited different entities that were already engaged in this type of work with the early kind of interactions. We also realized that, you know, we need to focus much earlier. It's it, you know, GMP is too late.

We need to go in very early, engage very early when they're kind of almost just have proof of concept and animal studies and say, okay, now we'll engage you. We'll engage in understanding your process, we'll guide you on how you need to change it. The CMC, the process development, the analytics, the whole package just to get ready for GMP manufacturing. So we actually redesigned the whole facility based on that understanding. Originally we thought, you know, we'll just have GMP manufacturing, but then we redesigned after we visited and talked to people and said, you know, we need to have much more process development labs. So we developed the, you know, we actually took almost half the lab space and changed that into process development space. And a little bit with a tweak because when we've visited a lot of facilities, we've seen that that is often in a in one big space, the process development lab is one big space. A ballroom kind of thing where you have a lot of projects that work simultaneously.

But to kind of take it to the next level, we've designed it in a way where each project gets their own little process development lab where they can work and live, which means that we can actually incubate the companies in the cellar at the same time. And we're going to incubate both academic groups, biotech startups, and also early pharma projects if they want to come in and leverage the facility. Uh, so that with that, we also get that engagement across the value chain that they learn from each other. Uh and up on top of that, we will then have regulatory experts there. We will have business development experts, we'll have IP experts. We'll have the access to a community of experts that they can then tap into where they're both learning from each other, but also experts who know how to develop these uh drugs uh in an efficient manner. And then hopefully over time, that will be kind of this learning loop, right? Where some of their projects are learning from each other, and the team that are supporting them are finding the learnings from earlier projects to the next level project, right? So almost democratizing what a pharma engine can do, uh, but applying it to very early stage, right?

It's such a normal business model. Um, so it looks like Cellerator will not only provide the resources and uh capabilities required to take those kind of early cell therapy programs and going through the preclinical development, eventually guide to GMP and guide to patients. But also sounds like also provide some kind of the funding support, which is very challenging, as you know, in today's environment.

Yeah, absolutely. We uh that that's a that's an issue for everyone, right? Right. But but I think we have the approach that absolutely we need to fix funding. We we do. But once that funding starts flowing, we also need to make sure that that funding is then being put to good use. Because as I said, we're at a tipping point, right? And if we do have investment in too many assets or projects that fail along the way, then the investors will back off even more than they are backing off right now, right? So we need to choose carefully. We need to do it in ways where we, you know, are successful with what we're trying to do so that we also show investors that with this approach we're actually de-risking how we develop these types of drugs, right? So absolutely, you know, there will also be access to venture capital. We're already building that community so that we link everything to the investors. Uh, that is something that we need to solve uh as an you know on a global scale uh to make sure that companies also stay where they are uh originally uh, you know, uh in what where they came from and don't go to China where there's public funding or necessarily or the US where there is a lot of VC funding available from a European perspective. You know, we need to do what we can to keep them in our ecosystem as well, at least some of the companies as well, right?

So you really try to cultivate an environment where those small companies can can grow and and can deliver and eventually will be part of the pharmaceutical ecosystem with the large farmers that really um propel the innovations in um in Europe.

Absolutely. And and beyond that, uh the foundation is also now actually uh carrying out uh regenerative medicine landscape analysis on what's going on in Europe. Uh what is what is good in Europe, what's missing in Europe? Because you know, the accelerator is only part of the solution, right? Now we have a strong scientific uh community in Europe. We have a lot of biotech startup communities and hubs that are coming on that can support these projects when they grow. We have something like the accelerator where we have the infrastructure to actually develop it and manufacture it. Um but we need to look at it holistically as well. So where are the products going afterwards? Do we have the right clinical trial setups and support to actually conduct the clinical trials afterwards? Do we have the right regulatory support to actually assess these in an efficient manner? Do we have uh country setups where we ensure that it's not just about, you know, we have to rethink the value creation here.

And it's not just about regulatory approval anymore, it's about access. So there are things here about health technology assessment frameworks that we also need to perhaps think about, you know, and and how do we do that on a European scale? Who, why are we strong, where are we weak? Where can we learn from the US and China? Uh, where should we go it alone and do it differently? But you know, we need to make sure that once we then start to be able to manufacture these drugs and maybe even run some clinical trials, that you know, at the end we only succeed if they get two patients, right? So we need to think also a little bit ahead, like five, ten years ahead, and say, okay, so how are we solving those issues as well, right? Um, so that we once we can manufacture at scale, the patients also get access to the drugs.

Well, that's uh that's a great segue. You know, we're talking about the five, ten years ahead. What does a sustainable global cell therapy um landscape actually should look like?

So, first of all, the end point I hope is that we have access and we have affordability, right? Because not just access for those who are have a lot of money or the right insurances, but I mean just broader access in general, right? That would be fantastic. To me, that is the end goal of what we are trying to achieve here, right? Get these types of therapies to patients. But in order for us to succeed on that, we need to do it in a sustainable way. So not just bid on single assets and get them there or single products or indications, but do it in a way where we are building a robust approach to how we develop these drugs where they are, you know, so we ensure that the next generation are being developed more efficiently and continuously more efficiently, right? So it's also about developing robust processes that can be scaled efficiently once they reach pivotal trials or market, right? So it's also about that whole machine that we're trying to build now and say all the learnings about, you know, how do we take that variability and that, you know, of working with a living product out of the equation and make that something that is more uh comparable to what we are used to seeing with small molecules and biologics, right? What are the things that we need to solve together as an as an ecosystem, also with technology providers, about, you know, you know, how do we get there where we actually do have robust processes and we do know what critical parameters that we need to measure and how we do it, uh that that's also something we need to solve along the way, right? Uh in a reproducible manner. But first and foremost, get these to the patients, right? Thank you to the patients. Let's let's start treating some patients.

So Bo you just touched on the technologies and what the technologies or modalities would do better.

Yeah. So if we look uh five to ten years ahead, uh I think that uh something like AI is going to be a critical component of what we do. Uh I think it can help tremendously uh in the process development phase where we have a lot of data and a very hard time figuring out what to do with that data. So plugging in the right type of uh AI tools uh at that stage could be uh a game changer, I think. Uh, we're in the lucky situation in Copenhagen that we have a supercomputer that's also funded by the foundation called Gefium, uh, together with NVIDIA, uh which we can tap into. It's one of the biggest in the world. Uh, and we're talking a lot about as we design and build the facility, how can we capture data that we can then plug into this uh infrastructure to make sure that we uh kind of leverage what we have uh right next door. So that is going to be one interesting component that I hope uh I am envious about that.

And and the other thing I I would be great to see uh come to fruition is is you know more automation in our development and manufacturing, right? Because whatever we can do to remove the human component and the uncertainties associated with handling open steps and uh and all of those things in a in a proposed process development, but certainly in manufacturing, uh that will uh that will de-risk uh the manufacturing process uh and also bring down costs uh significantly, right? So automation is the other thing that I would uh absolutely uh put my money on.

Great. Um here's my last question. Um there have been a few organizations um that um are trying to accomplish something similar, uh just like accelerators. Um you probably know uh we have an incubator space here, a fantastic incubator called the Lab Central in Cambridge. Uh and in UK, there's a gene therapy catapult in UK that also plays a big role to uh accelerate gene therapy development in uh in the area. And also my own company, Lamarck Mile, here in Boston. Um so you you are familiar with all of those entities. What have you learned from those organizations that might help inform your strategies as your stand-up accelerators in Copenhagen?

Yeah, so and I mean one of the things that we did as we designed the facility was we traveled uh globally to figure out to look at facilities and talk to those who had established facilities to understand, you know, what had worked, but also what had not worked in that process, right? We might as well both learn from the great things, but also from some of the mistakes and absolutely a lot of the design features that have gone into the accelerator have been inspired by similar facilities like yours and Landmark Bio, but also when you look at something like Lab Central, you know, how do you create a community where you can actually bring those companies together so that they don't only leverage what's inside the accelerator, but also each other, right? And how do you how do you kind of build a community in a facility like this?

And then and then for Catapult, of course, it's it's also a little bit about funding and how do you develop uh uh strong programs around what what we're supposed to do. Uh so so absolutely there are learnings that we're trying to pick and choose from the different uh entities that we've engaged with. Uh I wouldn't say we've copied anyone. I think we've had that great opportunity to steal with pride and then combine the things into the solution that we thought would be the right one in the future, right? So it's been a, you know, and we've met tremendous openness in the ecosystem, you know, to share uh learnings and knowledge. Uh no one has been the, you know, saying we will we want to protect what we know and what we've developed. And that has been great, and I really hope we can continue to build on that and also accelerate that grows and matures can share the learnings that we generate with the next generation, right? So so that has been fantastic. So thanks for for sharing what you've done in that markbar.

You know, that's that's great. We would love to build a global network to work together and accelerate the development of cell uh therapies. So thank you very much both for being with me here. I really enjoyed our conversation. Best of luck on building accelerators, and I look forward to hearing many, many success stories from you in the near future.

Thank you. Thanks for having me.

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