How On-Demand Cleanrooms Can Speed Up Drug Development

Sarah Stevens: 0:00

I think something that struck me right from the beginning is that there is still very much a kind of entrepreneurial mindset. So I kind of make it happen. We don't say no to customers, we say, Okay, well, let's figure out how we can do that together. And that's huge for me. So capability to be kind of collaborative, creative, the mindset within the organization that leans that way.

Harsh Thakkar: 0:21

What's up everybody, this is harsh from qualtivate.com. And you're listening to the life sciences 360 podcast. On this show, I chat with industry experts and thought leaders to learn about their stories, ideas and insights, and how their role helps bring new therapies to patients. Thanks for joining us, let's dive in. All right, so I was doing research for this episode. And I found out that the cleanroom, technology market in 2023, was estimated at 8.2 billion. You want to guess what that number is? In 2028. It's approximately 11.5 billion. And so I had to pick out a person who can come and talk to us about this, who knows a thing or two and turns out, my guest today knows a lot more about this. Please welcome to the show, Sarah Stevens, president of Azzur labs and cleanrooms on demand. Welcome to the show, Sarah.

Sarah Stevens: 1:13

Thank you. Thank you for having me.

Harsh Thakkar: 1:15

Yeah. So I want to start off by asking you, what are your thoughts on that statistic?

Sarah Stevens: 1:19

Yeah, it's exciting. I guess I'm probably not surprised. And again, I think it's just encouraging to hear of such buoyant growth and kind of reflects, I guess, where we are in terms of, you know, demands on cleanroom capacity, evolving needs of drug development and, and et MPs, advanced therapies in particular. So yeah,

Harsh Thakkar: 1:43

yeah. So it's a very innovative concept, right? cleanrooms on demand. And, and the way I like to think of concepts is compared to other existing, you know, companies or images. So the first time I heard of clean rooms on demand, it clicked to me, oh, it's like Airbnb, but just clean rooms? Is that a good way to put it?

Sarah Stevens: 2:05

I think it's, you know, I think the thing about the cleanroom on demand concept, really, is the flexibility that it affords that differs somewhat to other, you know, cleanroom, or facility infrastructures, particularly in the kind of drug development space. So, not quite Airbnb may be comparable in its innovative nature. But yeah, I think that, you know, we tend to think about this as, as beyond simply, you know, there's a room go stay in it, and everything that you need is there, it's much more kind of facilitative approach. So we are, you know, providing expertise and wraparound services, to really enable best use of the cleanroom footprints that we that we have.

Harsh Thakkar: 2:53

Yeah, and I want to double click on that, because you mentioned flexibility, right? And obviously, for a biotech or pharma company, investing in building out their own lab space that can take a lot of, you know, qualification, validation, setup, all of that stuff versus going and working with a company like Azzur, who already has the space, what are some of the other benefits that, you know, maybe are putting Azzur as a separate than other companies who are doing this? Or just in general? Why would companies, biopharma companies want to get a clean room on demand versus building their own?

Sarah Stevens: 3:29

Yeah, no, I mean, I think you've hit on, I guess, one of the, one of the two biggest diverse that we see and and one is that there's a huge expense, capital outlay to build a facility to build the infrastructure and the expertise to run that. So you have the capital outlay, and then ongoing operational expense. And that, of course, is regardless of what's happening. So if you're an early fees, innovator, you know, you've embarked on this large capital expenditure, but then your use of that footprint, the utilization may be sporadic. And that's just, you know, that's just science. And that's just falling in line with, you know, clinical programs and so on. So, a huge draw towards our footprint, which, of course, is operational, it's ready to use, we can, you know, support with all of the ancillary services around a process development and batch manufacturing is really exactly that there's risk mitigation, cash conservation, you know, do the work, you're still in early development, things can still happen, you know, so you want to be able to have the flexible the flexible, flexibility, I should say, to, to understand your process, understand your product. And again, doing that in a way where as I say, You're conserving cash and really mitigating a lot of risk, especially in the early early phase spates. I think the other thing Part Part Two, is as our Customers are kind of, in a weighing up the options it's build. And I think there's much less of that going on now. And or it's, you know, working with utilizing CDMO capacity. So that kind of, which again, works for many. But what it does not afford as that same degree of flexibility to kind of come in and out, you're not kind of at the mercy of schedules and, and other things. So it's really your own cleanroom space to be used as and when it's required. So again, ties back to that point on flexibility. But again, risk mitigation being a big one.

Harsh Thakkar: 5:38

That's yeah, that's interesting. And in, you know, overall, in the industry, we're seeing this trend where companies are moving towards, you know, outsourcing activities, or collaborating with other partners versus doing it in house, we've seen it with, you know, CROs, and we've seen so many CROs in the past 20 years that have started, as you know, even look at North Carolina, where I'm from, you know, Research Triangle Park, is one of the biggest hubs for CROs in the world with all the big names out here, then we've seen cdmos. And now here's another concept, you know, same idea, why do it on our own? Why spend the money when you know, we can collaborate and leverage a site that can you know, do that? So, do you know if there are any other areas where this model would apply? Like, do you know any other areas in the industry, where companies would be like, Hey, we're doing this in house, but maybe there is a market for some other player to come in and outsource this? I'm just curious if you don't have any, that's fine. But I was

Sarah Stevens: 6:41

Yeah, I mean, we see. I mean, I agree, I think that's full kind of democratization of drug development, either outsourcing, as you know, fully embedded as a methods across, you know, drug development, even med device. And so I think it's interesting, just on your point about, you know, cdmos, that's my, my entire experience until a zero does, obviously within the cdmo space. And there's such a kind of evolution of cdmos, from very much transactional kind of vendor, to really becoming, you know, collaborative partners, and debating that basis of, of innovation in themselves has been quite a remarkable cycle over the last, I guess, 20 years or so. And I think what's interesting now is these kind of disruptive innovations, like the Azzur concept, are really speaking to the evolution towards advanced therapies. So, you know, there needs the traditional drug product development, something goes well, you're sort of scaling up and becomes a higher throughput in a larger volume, play perhaps with us with some of the novel putative therapeutics, cell therapy for an example. It's, that's not how it goes, you know, your scaling act, so that the footprint doesn't necessarily need to go up, but it may need to be kind of duplicative. And so it's again, it just feels to me like this, another and see there was to you, you know, evolving in the same way a to accommodate these slightly differing outsourcing needs that we see. But yeah, we see it from everything from kind of, you know, big, big traditional pharma, through some of the rapidly growing biotechs to the kind of innovative university spin out incubator type folks. So definitely needs, but that that point in common that kind of flexible access, and always, you know, mitigating with, yeah, I shouldn't

Harsh Thakkar: 8:33

No it did. Yeah it did. And and I was, I was curious to know, like, So you touched on some of the areas where the cleanrooms, on demand concept where you specialize in? So from it from an ideal customer perspective? Like, what are some of the segments or types of, you know, biopharma customers that would benefit from this technology? Or do you have any case studies of an ideal project or a collaboration that you want to talk about?

Sarah Stevens: 9:02

And yeah, and I think that we, you know, without doubt our kind of dominant customer sets within ETMPs in general and specifically cell therapies. And I think that a lot of that has to do with Well, that, you know, the high kind of degree of risk, I guess, that's inherent there. And the fact that our infrastructure footprint and expertise can really enable that whether it be you know, within some of our purpose built facilities, which are just, you know, truly kind of state of the art in terms of their construction specification, our geographies, you know, we kind of span East Coast, West Coast and so on. And so without doubt, I would say that's our dominant customer group. We also work with several and the gene therapy space and these tend to be, you know, innovators. And again, I mentioned some med device, so, you know, we have the opportunity to serve a really diverse customer base across, you know, different parts of, of Life Sciences, broadly speaking, but we certainly see a kind of a lean towards cell therapy innovators, we have a couple of examples of, you know, customers that have really, I guess we've grown alongside each other is probably the best way to put it and from Azzur's kind of entrepreneurial beginnings and creating the cleanroom on demand concept, we do have a couple of customers, as I see who were there, right from the beginning. And, you know, what's kind of phenomenal about those partnerships, those relationships is that we have evolved with them. So we have evolved to meet that kind of, you know, developing customer need, you know, even more exciting as, of course, the success that those customers are seeing, and that they have progressed all the way from, you know, very early development through to now thinking about, you know, phase three, and, and then, you know, commercial production. So, yeah, as I say, we have, you know, taking even Massachusetts as an example, where we have three facilities, you know, going from Waltham, closer to the center of Boston, which is really conducive to kind of early development work through to our latest facility, which is in Deven's where we actually have our opening ceremony coming up a soon, and again, it's just been, you know, truly state of the art facility, 30, clean rooms, each one, you know, isolated, segregated, and just really well put together and again, at some of that kind of, you know, learnings I guess, and as I say, working alongside our customers, and I think that we are, the company has been, you know, kind of really fortunate privileged to be able to do that.

Harsh Thakkar: 11:42

Yeah, it reminds me of, you know, those are Waltham and Devens. I actually started my career consulting in Boston, in 2012, at Millennium pharmaceuticals that, you know, ended up being acquired by Takeda and then I worked at Biogen and bunch of other Boston startups. So yeah, I haven't been to Boston in a long time. But I hear that there's tons of, you know, always tons of stuff happening there. So that's, that's actually a segue into my next question that I was going to ask you. In terms of geographical presence. You mentioned that three facilities in Boston. So what is it today? Like how many facilities in US Europe? And when you know, can you share some numbers, if you will?

Sarah Stevens: 12:22

Yeah, no, absolutely. So the three here, as I've mentioned, we have one very close to where you are now, in RTP. So again, just a real state of the art facility there, we have 24, cleaning rooms within that facility, and also have our Azzur labs, including our ATMP testing capabilities within that same facility. So again, that's kind of an evolution or development for us where Azzur Labs was historically operating somewhat independently. But now kind of bringing these two service lines if you like, together, again, just really kind of recognizing capitalizing on the need that our customers have, which is for, you know, whether it be fundamental microbiology testing capabilities alongside the cleanroom, and evolving more recently into ATMP testing capabilities. So North Carolina and Raleigh, as one example of where we have was all within the same footprint. Deven's here in Massachusetts, is another. And we also have a facility across very near San Diego and Vesta. Again, smaller facility 9 cleanrooms. There, but similar in the sense that our Azzur labs footprint is not not yet in the same building, but very less than a mile away. So really trying to provide that kind of holistic a service offering to to customers that complement, you know, what they're doing within the cleanroom footprint. We have other lab locations, the largest actually our original Azzur lab has been in near Philadelphia. And so again, as we think about, you know, future growth, where do we want to be we kind of think about clearly we'd are the sort of biopharma pubs you'd rather be close, probably not right in the center of but close by and really thinking about, again, that sort of synergy between Azzur lab's capability and the, you know, the value that that brings directly into every one of our customers.

Harsh Thakkar: 14:19

Okay, so you mentioned Boston, San Diego, North Carolina and Philly. No, how about Europe, you don't have any facilities there or planning on?

Sarah Stevens: 14:29

As of today, we are not operating outside of the US. That is there's definitely a Never Say Never change of mindset. And, yeah, clearly, I'm not from the US and so operating outside and UK, Europe is certainly something that we you know, have very open mind about,

Harsh Thakkar: 14:46

okay. And, you know, my introduction to Azzur was, like I said, back in 2012 when I was in the consulting world, and that's the first time I interacted with a bunch of people at Azzur who were like, you know, account executives or recruiters working with biotech startups, I might have even interviewed for a couple of consulting roles with Azzur, or some client, I don't remember. But so I always thought like, okay, Azzur is in this consulting space. And then I hear about clean rooms. And I see that now. So what what all is Azzur doing? Because I haven't kept up obviously, with a lot.

Sarah Stevens: 15:21

And I think it's been a rapid evolution. But you're right, in the sense that consulting was really the the origins of Azzur Group. And it has grown exponentially, too. So we have consulting practices that are really dotted all across the nation, you know, benefits to our, our customer base of that, of course, is that, you know, the locale, the close proximity of our consultants to, to customer. And, and again, we work so so that, I guess, was the kind of jumping off point, if you like, for the Azzur Group. And again, that sort of line of sight, that kind of intelligence of what's going on where the needs are, where the pain points are, is, again, part of the or has been part of that kind of entrepreneurial philosophy, philosophy of what do we, you know, where do we go next, what makes sense really responding to what the company saw as kind of market and customer needs. So, consulting came first, as I say, it's about half of our company today, it's grown exponentially. And we work very collaboratively across, you know, the cleanrooms labs and consulting today.

Harsh Thakkar: 16:28

Okay. And you I was looking at your profile and your background, you have, you know, extensive, you know, academic background, and you did a lot of, you know, research and and education, advanced education. How walk me through, how did you end up in life sciences?

Sarah Stevens: 16:47

Yeah, I mean, it wasn't, it was not exactly a straight line. So I was kind of a little bit of a late starter, I thoroughly enjoyed my teens and early 20s and working in the hospitality industry. By that I mean, bars and restaurants.

Harsh Thakkar: 17:02

Yes, I figured that.

Sarah Stevens: 17:05

Yeah. So something about something of a late starter, I was drawn originally to study pharmacy. And my mom was actually a professor of pharmaceutics. So she was an academic. So I had some, you know, awareness line of sight to, to what that was all about. And I was intrigued by this as a course of study at that time, especially because it was just really interesting to meet medicines development. And I was never, you know, I didn't study pharmacy because I intended to be a pharmacist. And so I really enjoyed the kind of scientific content, just understanding how medicines were developed that science that underpins that. And so I went on to do a PhD. So really furthering some of the, you know, scientific research, as, as you mentioned, but all this time, I had a pretty clear goal to work in industry. So, again, dabbled might be the words in terms of kind of, you know, academic research, phenomenal foundation. So, you know, I think that's kind of held me and held me in good stead, but very quickly kind of fell into really services provision started out at a small a cdmo. That was at that time called Encap Drug Delivery in Scotland is where I'm from. And from there joined what again, was at the time to your point on all the various acquisitions and changes in names at the time was accurate. And Scotland, we became part of AMRI by acquisition. And so I'd really progressed through various you know, bench scientific roles, operational leadership, and then use that fairly quickly into a general management position where I've always enjoyed that kind of intersection of, you know, commercial financial growth alongside, you know, science and various technologies and the opportunity, you know, certainly within the cdmo space to really see so many different, you know, innovative drug products, ideas, customers is just, I've always really, really been drawn to that and enjoy that type of fast paced interaction moved to the US eight years ago now. And that was as part of AMRI as it was its now curia So yeah, I've always as I say, been in that kind of customer facing services provision. And after leaving AMRI, I joined a company called quotient sciences, another really kind of innovative company that provides a platform called translational pharmaceutics. So they are truly differentiated in the sense that they are integrating all the way from, you know, discovery, early formulation development through to commercial manufacturing of a range of dosage forms and what they did again that you know, I guess always looking for something a little bit different in the services provision space so they have in house clinics in which they can run fresh and human studies and really you know pressure test the dosage forms that are being developed. So that was a, you know, phenomenal experience exposure to the real clinical end. And so after caution, again, I sort of I always say that Azzur Group was a bit of a, it's kind of like an itch that I couldn't scratch, I kept hearing more and more much like you say about this company that was aware of the consulting capability, I was so intrigued by the cleanrooms on demand concept, and very much drawn, as I say to, you know, it as a differentiated and really innovative approach that really speaks to the needs of, you know, particularly advanced therapeutics, innovators. But again, just that broad just the concept of the flexibility, the risk mitigation or ability to enable others to really create value within the footprint. So yeah, it was intriguing, couldn't quite shake it off, and then joined here in September of last year.

Harsh Thakkar: 21:01

Yeah so you've been there less than a year, but then, you know, given your time in the company, and interacting with your colleagues and understanding the business model, it sounds like you're very excited at that you made that right decision. You I can sense that from all the work you're doing and how passionate you are about this. But what are a couple of things that you love about, you know, working with your colleagues at Azzur?

Sarah Stevens: 21:26

And I think something that struck me right from the beginning, is there, there is still very much a kind of entrepreneurial mindset. So I kind of make it happen. You know, we don't, we don't say no, to customers, we say, Okay, well, let's figure out how we can do that together. And that's huge for me. So the ability to be kind of collaborative, creative, the mindset within the organization that leans that way. And people here, I mean, I think fundamentally, it's, it's the people they are, or they have been, again, right across, I guess, the last six months or so very open to change, which again, is that's unusual, actually, to have that overwhelming, you know, willingness to think differently, all the way from people who, you know, were part of the inception of Azzur. And so I've really enjoyed the kind of culture. And yeah, as I say that sort of the kind of thoughtful bias to action and willingness to evolve and change. And, you know, that's kind of the cliche of what got us here won't get us there. But I think Azzur embraced that.

Harsh Thakkar: 22:31

Yeah and you you mentioned, I think, a couple, like maybe a few minutes before, you mentioned about collaboration, and you know, having that being an important part of your experience, how you work in the services, different type of services, industry and roles. So in terms of when you are leading this lab and cleanrooms, on demand workstream within Azzur, what are some of the guiding principles around collaboration that you want your team to remember when they're interacting with clients? What's your vision on that?

Sarah Stevens: 23:04

Yeah, it's a great question, actually. And I think it should, I think how we interact with our customers should and does kind of reflect how we interact with one another. So a huge focus always, for me, on our ways of working, I talk about that a lot, it doesn't really matter where we sit in an organization, but our ways of working together are the most important thing and that extends to you ever, customers. So looking for kind of the opportunity to be greater than the sum of the individual parts, you know, how can we do more together? How does this foster, you know, our value proposition or value creation opportunity for whatever, and customer so a lot of transparency tends to be my MO So transparency, you know, collaborative thinking, and again, just focusing on how we do things. So, you know, it could be just as simple as are we doing this as efficiently as we can, are we capitalizing on all the capability that we have, and then as I see kind of extending that to the customer interaction, where again, transparent communication, sharing of the brain power is most definitely, you know, the way to operate.

Harsh Thakkar: 24:15

And, and when you think about from what you know, because I know you you said you mentioned you started in September of last year, and based on your conversations with other leadership team at Azzur, what what can we expect in future I know maybe you cannot share everything, but if you can, you know, maybe give us a trailer of what Azzur is looking to do, you know, in the future to maybe extend its collaboration with the global life sciences industry.

Sarah Stevens: 24:45

Yeah, no, I think we are we are open and focused on both organic and inorganic growth. So I think that we will see the demand we are feeling you know, the early demand for increased cleanroom on demand footprint. So I think, you know, we're actively exploring how would we go about? Where would we, where would we go to kind of grow that service line, I think that what we will continue to do is operate our lab testing capability, you know, somewhat hand in glove. So I think that, you know, future cleanroom on demand locations will have lab capability alongside and, you know, within that same footprint, we're most definitely seeing benefit to our customers, and certainly to us of operating in that way. And then we are exploring and considering, you know, partnerships, partnerships that, of course, can always, you know, develop into into something more than really looking at the kind of the front end and the back end. So where do our customers come from, many of them come from, you know, kind of incubator style footprints, and so looking to build on existing, you know, relationships and partnerships that we have there, bolstering our consulting capabilities. So we talk often about, you know, CMC consulting expertise, and again, always from the premise of what do our customers need, what, you know, what enables them to create value, what brings momentum and again, affords that that flexibility. So those are the kind of, I guess, in general terms, the lines of lines of thinking.

Harsh Thakkar: 26:13

Yeah, that's, that's, you know, it's fascinating to see the growth, like, I know, a lot of other consulting firms from when I started my career and the necessarily haven't grown as much or grown in the direction or the pace at which Azzur has grown. I mean, some have, but some haven't. Right. So it's really interesting for me to see that, you know, Azzur sort of branched out of consulting, like, other companies have been in consulting, but just have gone to the next level in consulting. But Azzur is sort of, you know, like, going to a completely different service model. And, you know, adding value there. So it's very interesting for me to see that. And I'll be you know, definitely following Azzur and you on social media, and, you know, listening to what else you're doing, because it's a it's a fascinating story from what I see in the last 10 years.

Sarah Stevens: 27:08

No, absolutely. Thank you. And you're welcome to come and see any of our, Meet me in Raleigh

Harsh Thakkar: 27:12

that yes, yes, yeah, I was gonna see if you're in Raleigh, or if I'm in Boston, I'll definitely send you a message we can connect. Thank you so much for your time. This was a very interesting topic. Like I said at the start. I have not talked about this with anyone, any of my past guests. I was super excited to have you on and talk to us. Any last words you want to share with our audience?

Sarah Stevens: 27:34

And well, first to say thank you for having me. I've also thoroughly enjoyed the conversation. And yeah, I also look forward to Azzur Group's progression. And I'm sure there's lots more growth and evolution to come. So yeah, thank you very much for having me. Appreciate it.

Harsh Thakkar: 27:52

Yep. My pleasure. That's it. That's the pod. And if you enjoyed this conversation, please subscribe and like us on YouTube. Really appreciate that. And we can get bring you more guests like Sarah and others in the future. So thank you. Thank you so much for listening. I hope you enjoyed today's episode, check out the show notes in the description for a full episode summary with all the important links. Share this with a friend on social media and leave us a review on Apple podcasts, Spotify, or wherever you listen to your favorite podcast.