Episode 1: Kindeva Drug Delivery’s CEO, Aaron Mann on the critical role of CDMOs

John Price:

Welcome to coffee with Kindeva a series of thought-provoking conversations about complex drug delivery. Today, we will be talking with Aaron Mann about the critical role of contract development manufacturing organizations.

Today I have the honor of hosting the CEO of Kindeva drug delivery, a leading global CDMO or contract development manufacturing organization with over 1000 employees that serve pharmaceutical and biopharma companies. Kindeva was spun out of 3M in May of 2020. Kindeva’s technology platforms include inhalation, transdermal and microneedles, and our capabilities span from preclinical work through regulatory processes and approval into commercial scale and supply. At 3M Aaron led the drug delivery systems business earlier. He ran corporate development strategy and marketing at Phillips metricized, a Molex company. He also led operations at remedy senior care, a Centerbridge partners portfolio company. He began his career at Bain and company spending significant time across four continents in multiple industries and a wide range of capabilities. He is a graduate from the Harvard business school and Carlton college. Welcome Aaron Mann. Talk to me about the importance of CDMOs and where they fit in the complex chain between drug creation and drug delivery.

Aaron Mann:

Well, I think CDMOs have evolved over time as you know, large pharmaceutical companies focused on what they are particularly good at or where they’re differentiated, which I think is evolved to being both research or early drug discovery, the early research, and then the marketing and the distribution of those products globally. And that’s created then opportunities for firms to rise up these CDMOs to arise, to take on some of the assets that large biopharmaceutical companies historically operated, and get more productivity out of them. And then I think they’ve also evolved over time as more and more startups have entered the market as drug development has continued to evolve and move into universities. You know, many companies start and are looking to be more virtual in nature and being able to access a CDMO for your development and manufacturing can be a pretty efficient way to utilize resources if you’re a startup looking to develop a technology or a small molecule.

John Price:

Talk to me a little bit more specifically about the unique role that Kindeva can play as a CDMO and some of the points of differentiation between us and perhaps some other CDMOs.

Aaron Mann:

Yeah, I think I think for Kindeva, you know, we’ve historically focused really over the entire arc of, of history for the company on complex drugs or combination products where, where you have some kind of delivery device or delivery technology and you have a drug and the way those, those two elements interact together can in fact impact the performance of, of the drug for the patient and in a, in a space that is complex across the board, that is a particularly complex challenge. And it’s one that we really focused on throughout our entire history, whether it’s the first pressurized meter dose inhaler or the first seven day drug in adhesive patch, the success of developing those complex products, those complex drugs is, is really what is a differentiator for Kindeva.

John Price:

And some of that has to do with kind of the, the, the complexities in inhalation where we’re, you know, these aren’t just kind of reverse engineered formulas from, from a pill or a tablet. This is, you know there’s a little bit added some added complexity with, with some of the drug formulations that, that we focus on. Is that, that kind of correct the way, the way I see it, I guess.

Aaron Mann:

Yeah, I think that’s right. I think when, when you’re, when you’re thinking about inhalation in particular, the, the nature of the delivery device, the meter dose inhaler, or another technology actually impact how much drug gets to what point in the lungs and, and the volumes that, that arrive at those different locations at those different depths in turn impact the way the drug then performs for the patient. So you have this, this linkage between the delivery device, the meter dose inhaler in that instance, and the drug itself in terms of performance. And you, you have to think about them in combination or in concert. And that’s, that’s really, I think the driver of the complexity here and, and what we’re particularly adept at developing.

John Price:

Okay. what you, you touched a little bit on the, the historical nature of, of Kindeva. What would you say historically has been the role for Kindeva as a CDMO?

Aaron Mann:

Yeah, I think there’s a, there’s a long  and rich your history of, of the business dating back even to a Riker laboratories, arguably over a hundred years ago and particularly focused on then developing technologies. And I think some scientists they’re asked the question or worked to answer the question in response to one of their daughters asking why wasn’t it easy for her to take her asthma medication. And that led to the innovation that is the pressurized meter dose inhaler. The business was then for many years under the stewardship of 3M as part of the 3M company, continuing to work in those complex spaces, leveraging many of the terrific scientific accomplishments and achievements, you know, of an applied research company like 3M but, but really, you know, very focused within historic boundaries, meaning meter dose inhalation transdermal patches. And now as we step out into Kindeva on our own, we’re really thinking more broadly about how we apply those skills our, our prowess in developing complex drugs and talking with customers about all the different ways in which we can help them apply those skills against their biggest challenges.

John Price:

So, so I know it’s always hard to ask somebody to pick a favorite, but is there a particular accomplishment in the first year that that you’re, you’re proud of, that that Kindeva’s achieved with kind of the kickoff of the company here?

Aaron Mann:

Yeah, I think in, in, in many ways, what I would point to is all of the accomplishments together in the sense that we have, I think evidence that I see almost every day, every week of people rising to the opportunity and rather than shying away from the change embracing it, getting excited about it and saying, well, what if we did X? Or what if we did, Y you know, we’ve, we’ve had some tremendous successes in partnership with our customers. We’re doing some, some really interesting early work developing cannabinoid based pharmaceutical products with an Israeli company. We have made tremendous progress in partnership with our customer Radius Health on their micro structured system, their microneedle program, but that’s really just the tip of the iceberg. And it’s one of the things that gives me just tremendous satisfaction is I get to see so many of the wonderful achievements that our folks are, are accomplishing kind of day in and day out that it, it becomes a little tricky to pick just one, one favorite.

John Price:

Understandable. So as a, as a CDMO of, of complex drugs, where, where do you see Kindeva, you know, in the future five, 10, 20 years from now, if you can speak to that?

Aaron Mann:

Yeah, I think it’s a, it’s a great question. It’s one of the fun parts I think for, for all of us at Kindeva is thinking about what’s possible and what our potential is. I think there is a tremendous move in the direction of increasing complexity of drugs that our customers and our partners are looking to bring to market. And so I think we’ll be applying that lens increasingly to opportunities for growth and for expansion, you know, whether that is in the microneedle platforms, our MTS platforms, where people are looking to get complex vaccines and other molecules across the skin, whether it’s novel transdermal technologies that that customers are coming to us to talk about or expanding the range of what we do in, in inhalation thinking both about, you know, the continued greening of, of that space and CO2 emissions, but also alternate forms of delivery. And I think we’ve got some exciting things in the works across all of those. So I see us just looking to be extending our lead in the complex drug CDMO space over the next five to 10 years.

John Price:

I’m assuming those are going to build on some of the, you know, the strengths we currently have that, that we’ve been talking about maybe, maybe specifically highlight some of the, the strengths that we currently have and, and how those might help us grow into the future here.

Aaron Mann:

Yeah, absolutely. I think one of the strengths is, is just our tenure. You know, we’ve just been at this complex drug development and manufacturing for an incredibly long time. And I think we have a track record of success in the lab success with regulatory bodies, success, with commercial manufacturing at scale, that that really stands up to scrutiny. And so, you know, that track record, I think gives customers confidence in our ability to tackle their biggest challenges and be a priority partner for them.

John Price:

You mentioned quality or regulatory in, in, in that you know, what’s the importance of having kind of this in-house expertise of regulatory perhaps quality the lab in Kindeva that, that maybe somebody is not going to get with a different CDMO.

Aaron Mann:

Yeah, I, I think it’s a great question. I think it, when you’re starting out a project, having that expertise all, all at the table, you know, gives, gives customers a perspective on some of the downstream implications of early tradeoffs or choices that they may be presented with. And so, you know, rather than, than being presented with an answer that just says, well, if you, if you choose to spend X, you get, you, you get Y out of the lab, you know, we’re able to help them understand, well, if you choose X, you may have these implications when it comes to your regulatory approval, your filing package, you know, here are some of the implications potentially around the manufacturability of it. And then, and then alternatively, from a manufacturing perspective, knowing that we’ve got the development capabilities in house, when, when we run into challenges and inevitably we do everyone in this industry, does, you know, having access to the teams that worked on developing the programs to partner with manufacturing and our customers to troubleshoot on those challenges I think gets us to a good answer just that much faster than if it was a separate relationship.

John Price:

Yeah. We’ve kind of been focusing in internally here, what, what might be some of the trends that you see externally that, that are up and coming in the pharmaceutical industry that, that excites you, or, or may be disruptive to the current marketplace?

Aaron Mann:

Yeah, well, we, we’ve certainly been through a very challenging year with COVID pandemic. And I think that has raised the conversation or raised awareness of, of the supply chains in these industries and both the strengths and the challenges of some of those, I think for, you know, for Kindeva to be separating as our own company now, with manufacturing in the UK and in the U S it’s an exciting time to be a participant in those conversations about how we build resiliency into supply chains. And where does it make sense for them to be global and where does it make sense for them to be to be local? The other, the other trend, I think, is we’ve seen the importance of the fundamental research and development work that happens in this industry as through the speed with which COVID vaccines have been able to come to market. And I think we understand increasingly as a, as a society that sustained investment there is, is incredibly important. And the complexity of what’s been what’s been accomplished is, is remarkable. And I am excited about government and industry continuing to think about how we put more resources behind this, so that we are even better prepared next time we’re faced with a pandemic like that. And, and, and then excited about the opportunities it creates for our colleagues at Kindeva to be a part of those solutions.

John Price:

So, so that, that naturally just kind of makes me want to talk a little bit about the, you know, the elephant in everybody’s room here is COVID, which, which we’ve all been under for, you know, a year plus now. And talk to me a little bit about how this current pandemic has affected operations at Kindeva and how that might influence how we grow in the future.

Aaron Mann:

Yeah. I mean, I think I should start by commenting on just how proud I am of, of all of our colleagues, John, the resilience and creativity that everyone has demonstrated over the past year navigating through this, you know, whether it’s folks sorting out how to work from home with kids around, you know, doing school or not doing school, whether it’s folks who needed to be in labs continuing vital work and making sure that we’re doing that in a way that’s safe for them and safe for their colleagues. And certainly our manufacturing colleagues, you know the majority of our portfolio today are respiratory therapies and demand for those has been up over the course of, of COVID given the respiratory nature of that, that disease. And what we’ve just seen is remarkable resilience across all of our sites. All of our functions, really our entire company is folks who said, we’re going to, we’re going to step up and meet that challenge and deliver against it while making sure that they’re keeping themselves safe, keeping each other safe and keeping their family safe.

Aaron Mann:

It’s, it’s really remarkable. So that’s, that’s a little bit backward looking if I think about how, how we grow in the future. I think, you know, many of, of the trends around vaccines and some of these, these illnesses really make the technologies and the capabilities that we have more important. We’re seeing more interest in microneedle delivery as an example for some of these complex vaccines. And that’s, that’s, I think driven by a couple of factors. One is the, the, the, these wonderful vaccines have some real supply chain challenges. And it’s certainly possible that formulating into something that’s delivered through a microneedle might reduce some of those refrigeration or, or, you know, other requirements. And the other element is, is self-administration. You know, today we have to go to a trained pharmacist or other, other healthcare professional to draw the dosing properly and give it to you. If, if we’re able to get some of these vaccines into a form where they could be self-administered through a microneedle device, you know, that could, could help us react even faster to a pandemic in the future. And I think so those are some of the factors and, and that will influence how we continue to build the business at Kindeva.

John Price:

Finally, we we’ve announced that we’re, we’re building a new headquarters here in, in Woodbury. Tell me about how this new space will help us serve our customers better.

Aaron Mann:

Yeah, it’s an exciting time for, you know, for our colleagues here in the, in the Twin Cities, we’re actually quite fortunate that we have a terrific lab in the UK that was actually kind of refreshed and modernized just a couple of years ago. And so this presents us with the same chances we move off of the former 3M center campus to do the same here in the US and what it means is, is whether customers are, you know, in Europe or the UK, or here in the US you know, they’ll be able to partner with us at, at really a very modern kind of world-class development center for their programs. And, and we’ll be able to work, you know, in the same time zone or a similar time zone. It’s also going to be really energizing for our people, you know, to be fortunate enough, to move into kind of state-of-the-art modern, bright new facilities as they do the hard and important work that they do every day, I think will be a real energizer for everyone. As you know, as we begin to kind of thoughtfully all returned to working in an office at some point, hopefully later this year,

John Price:

Great, Aaron, I really appreciate your insights into the CDMO industry and where Kindeva is at, and potentially where we’re headed in the future. Thank you for your time.

Aaron Mann:

Time. Thank you, John. Appreciate it.

John Price:

Thank you for listening to coffee with Kindeva, a series of thought provoking conversations about complex drug delivery. Join us next time as we talk with Dr. John, Vasilakos about the role of microneedles in the delivery of cancer vaccines.