Medsider: Learn from Medtech and Healthtech Founders and CEOs - 4 Key Considerations to Win Over Investors: Interview with Glympse Bio CEO Caroline Loew

Episode Date: May 5, 2022

In this episode of Medsider Radio, we sat down with Caroline Loew, President and CEO of Glympse Bio.Caroline has been with Glympse Bio since 2018. Prior to that, she held executive roles at Merck and Bristol Myers Squibb, where she oversaw R&D. Caroline earned her bachelor’s and doctoral degrees at Imperial College, London. In this discussion, Caroline shares her “early-and-often” approach to dealing with regulatory issues and outlines four things to consider ahead of conversations with potential investors. Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors sent to their door at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Caroline if you'd rather read it instead.

a few things that I would take away that I think are universal. The first is that you need to, you really need to understand what your value is, right? This, you know, your science, your value proposition, your story, right? You need to be able to articulate that really clearly. The second is, this is just how you engage. We're very responsive. We share data. We, you know, we got back to investors right away.

You know, it was, we sort of, our integrity was hung on that idea, right? but we, you know, we were who, we weren't just who showed up in the meeting, but we were who we were afterwards. And, you know, that was very important to us. And so, welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott.

In this interview, I sat down with Carolyn Lowe, who has served as the president and CEO of Glimpse Bio since 2018. Prior to that, she held executive roles at Merck and Bristol-Myers Squibb, where she oversaw R&D. Carolyn earned her bachelor's and doctoral degrees at Imperial College, London. Here are few of the key learnings that we discussed in this interview. First, instead of regarding regulatory agencies as a threat, Carolyn has found that being proactive in her dealings with FDA is the smart play. Second, the COVID-19 pandemic and corresponding market collapse had a major impact on investor behavior.

Empathizing with potential backers helped Carolyn lead a success. successful fundraising round in a historically challenging environment. Third, authenticity and integrity are critical to successful investor relations, particularly with those who finance your startup. Backers aren't just funding a product. They're also investing in the people behind the product. Okay, so before we jump into the discussion, I wanted to let you know that we just released the first volume of Medsider mentors, a print-based book that summarizes the key

learnings from my favorite Medsider interviews over the past six months. Look, I fully realize it's tough to listen or read every Medsider interview that comes out. Even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's a way for you to learn from the best thought leaders in our space in one central place. Here's a teaser of what you'll see in this first volume. Gar Hong Kong, founder of Health Quest Capital, teaches you how to successfully pitch your startup.

Patricia Ziliak, CEO of Ivinsens, discusses what you really need to know about clinical trials. Jared Bauer, CEO of Ionic Sciences, shares best practices for avoiding obstacles in your startup journey. That only scratches the surface, so if you're interested in learning more, head over to MedsiderRadio.com forward slash mentors. If you're a premium Medsider member, you'll get free digital access and a print version sent straight to your door. If you're not a premium member yet, you should definitely consider signing up.

In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of LiveCore, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. Again, that's Medsider Radio.com forward slash mentors. All right, without further ado, let's get to the interview. Caroline, welcome to Medsider. Appreciate you coming on. Thank you. It's a great pleasure to be here today. Thanks for the invitation, Scott. No, absolutely. Definitely looking forward to the conversation. And I think your accent will make me

maybe sound smarter than maybe I otherwise would sound. But with that said, let's start out with your professional background. I provided a brief intro kind of at the outset of this interview. But I always like to hear your sort of color commentary, right? And we don't have to go sort of career move by career move, but maybe just kind of provide a little, you know, your sort of elevator, pitch for your story leading up to your transition to CEO of Glimbs Bile. You know, thank you. So, you know, I love science from an early age. And I, you know, I spent my very early days looking for experiences that, you know, fostered research. And, you know, that led to me doing a PhD. And, you know, interestingly, over that experience, I did PhD. I did a postdoc. And during that time, I actually became completely interested in something else. And it was this idea of how do you take that exploration, that research exploration, and all of that basic research and actually work on. its application. And it led to the career arc that I've had this kind of process of, you know,

research and translation. So I, you know, I spent a lot of time reading about business and what it takes, you know, the whole idea of the entrepreneurial ecosystem. And it was, it was, that was what started me on the career trajectory that I've had. And I, I started out my early career in, in drug development. I had some fantastic experiences. I got to lead a, a, a, a, a, drug that came to market and, you know, it's a very unique experience. Very few people get to to do that. And then I very deliberately built my career with a very broad set of experiences. And, you know, that's been a sort of a tenant of how I thought about my career and eventually where I wanted to get to, but also it's how I talk to people a lot about career, this notion of

breadth. And so I spent a lot of time in regulatory. I spend time in, you know, broadly in, you know, in research and development and managing, you know, portfolios. I spent time building and running a global market access organization and eventually a large commercial business unit. And then most recently, before I joined a glimpse, I had the number two position, the R&D organization at Bristol-Myers Squib. And there was kind of coalescing all of those experiences if you want to help run the totality of BMS's portfolio. And so, you know, along the way, a prude of. huge amount of experience, really understanding what it takes to be successful in, you know, in the arena of, you know, in the biopharma arena, in, you know, everything from drug discovery

through drug development, through commercialization. And when I'd done all those things, I felt, you know, kind of finally equipped to go do it myself, right, to go and be part of building a biotech company. That was what led me to get to glimpse. Got it. That's super helpful. And I love how you touch on the breadth of your kind of career trajectory. I had Sanjay Servastava on the program recently. And I got to know him when we were at Cavidian and then Metronic.

And that's one of the things he mentioned. He's now running a couple different cardiovascular startups. And he mentioned, and I guess more his recommendation to other folks who are earlier on in career is is definitely go broad, right? I mean, it was pretty instrumental, right? In his, in his career path, the fact that he led marketing for a short span, then also led R&D for a short, a short time as well, spent time at J&J, leading their BD in the device segment. So, so yeah, the breadth of that kind of that career arc is definitely impressive. And I guess before we get to how, you know, why glimpse or how you landed at glimpse, I'm looking at your LinkedIn,

in profile right now. If I saw all of these titles, I would have, I would have guessed, you know, definitely, you know, some top tier MBA program, business background. But I mean, your PhD is in organic chemistry. It's like notoriously the, you know, the subject that's most difficult, right, for pre-med students. So that's interesting, right? I mean, that's, that's some hardcore science. And you're able to kind of, you know, cross the chasm into like very probably hardcore business, business roles, you know, in these. Yeah, I had a, you know, I had a deep passion for science, but it was really for me. And I think, you know, it depends on what makes you tick.

But for me, I had this, I had this deep curiosity about how do you take this science's basic research, which I love, by the way. And I still have an almost passion for. And I still, you know, probably to the chagrin of our scientists, I spend time with them in the lab talking, you know, really talking about. out what they're doing deeply. And I have enormous respect for them. And I love spending that time and getting back to, you know, in some ways my roots. Heaven forbid I could not go and do that now. But I love having those conversations and really, you know, getting back to that. But, you know, equally,

for me, what was really interesting was how do you take that? How do you take all of that research and turn that into something that can make a difference, right? And there are many ways it can make a difference, right? It can make a difference in, you know, the place that I chose to make a difference was I really wanted to make a difference in human health, and that sounds cheesy, but for me, that was like where I found my passion and interest

and where I wanted to really, you know, be part of the ecosystem. But there are many different ways, you know, science makes an interest in everyone's lives. And what I really wanted to understand was kind of that intersection, right? The intersection in our case between sort of science and the business and the clinic. Because if you don't mesh those three things together and you don't do that successfully, the science can be incredible, like absolutely astonishing and amazing. But if it never makes it to a patient, it never makes it into a physician's hand so the physician can work with a patient to better their condition,

it's all for nothing. And so that whole trajectory, right, how do you go from that amazing idea to something that can make a difference to a patient? That was what I was curious about. And so, you know, I started to explore that and that was what led to my career arc. And I believe I had built a lot of muscles along the way. And, you know, again, this idea of, you know, sort of, you know, first of all, you have to be prepared to step into many people.

places that you don't know things, right? And learn over again, right? I went from being, you know, the expert and having deep expertise and skills to stepping into many worlds where I really knew nothing, but I had to find people who are willing to say, it's okay, we believe that you can do this, right? You can go and, you know, learn finance and you can go and learn how to run of business and you can do this. You know, we have faith in you, right? And we know that you're going to take the time to do this. And I did it. And I, you know, I really, I really took the time to do it, but I also studied a heck of a lot too. And, you know, it was something that I really wanted to do. And I think for anyone thinking about their career path, there's always that kind of

yin and yang. And I talk to people sometimes who say, well, you know, I'm, like, I'm afraid to do it or I'm afraid of failing or I'm, you know, it's just afraid of like something new. Well, but if you really want to do it, like it's, you know, you have to find the right environment. You have to find the opportunity to grow. And I think the best time to do it is early in your career too. It's much harder to do it later to completely step out of your experience set. I mean, you get, you find that you, you kind of, you move inexorably, you know, along one track and it just becomes harder to jump tracks. So I talk about this notion of a pyramid. And so you want to build the breadth, sort of the base of your pyramid as broad as possible. And that breadth is essentially

as many different experiences. And then, you know, as you build layers over from layers, you're building upon that breadth. And, you know, depending on sort of, you know, how high you want your pyramid to be, you build the breadth, you know, wider and wider if you want. Yeah, building those muscles along the way. Exactly. You've been on muscles. Yeah.

That's great. No, no. I was going to ask you, like, what are some of the key things for others that are kind of, like, debating, you know, that next move that may be a little bit out of the comfort zone, but you sort of answer my question, you know, and gave or offered up some really, really valuable tips. On that note, let's transition a little bit to kind of climbing, climbing the pyramid, so to speak, right? And I'm envisioning glimpse, maybe not at the top of the pyramid or like, you know, you're getting closer to the top of the pyramid running a biotech company.

We're going to get into, like, you know, some of the things that you're doing at glimpse, how you're approaching different functional areas of business, et cetera, you know, throughout the rest of this conversation. But talk to me a little bit about like what's sort of the foundational technology at glimpse? Like, how did the idea get started and what attracted you to kind of making that move. I mean, I'm sure you could have chosen a lot of different companies to go to run with your kind of broad, basic experience, but why glimpse? Yeah. So glimpse is founded on a really simple idea. And often, you know, it's like the simplest ideas that lead to kind of the most elegant solution. So a simple idea is, you know,

can we detect real-time biological changes in disease? And we're going to detect those using some kind of, you know, activity-based sensor that we engineer to measuring those changes in our body. So that's the idea, right? Very sort of simple notion, right? When we have disease, things change in our body, can we measure them? And very specifically, what we're trying to measure is that in our body, we have over 600 proteases and natural proteins that are measured in our body that they're present in every aspect of human health and disease. And all we're doing is we're taking advantage of the fact that they vary dynamically in every disease state. And then we're designing custom biomarker panels to measure those changes.

And so we can design a custom panel for any specific disease. We can measure that. We can design it. We design it based on fundamental biology of disease. And then we can measure the disease trajectory. So we can measure baseline disease, how the disease is changing of design over time, whether it's progressing or regressing, which is particularly valuable for patients. And we can do that all in a simple blood test.

So it's incredibly powerful kind of idea and then reduce to practice, right, an incredibly simple diagnostic tool. So that's what we, so that's what we're doing, right? So with simple kind of solution to the patient, right, reduction to practice, right, can you reduce it to practice? That's the idea. Very simple solution to the patient to the physician. We're working on really complex diseases, diseases today where there's no simple solution like

that where you can't actually tell baseline disease. The patients who we are, the diseases that we're focused on today have no ready diagnosis. The patients typically go through terrible diagnostic odysses. It takes them, you know, a year, 18 months often to get diagnosed. When they get diagnosed, there's no good way to kind of measure their disease trajectory. So these are, you know, really problematic diseases. So we're starting with a disease called Nash, which is fatty liver disease. There's actually no particularly good way to measure that today, except the needle biopsy

of the liver, which is pretty horrible. If you have one of those, you don't want to have one again. We're looking at other complex diseases, such as hepatocallia carcinoma, detecting early disease, where it's hard to detect against background cirrhosis of the liver. And very important to have that distinction. We're also looking at autoimmune diseases. There are many autoimmune diseases that are incredibly hard to diagnose. And there again, we also believe that the technology can be deployed.

So very sort of useful, you know, very important application for patients who have, you know, intractable disease and can't get diagnosed. So that's sort of the value. And all in just a simple blood test. But what we've done is taken, you know, something the body naturally does. and we found a way to measure it. So it's very, you know, simple kind of elegant reduction to practice. So where it came from, kind of, you know, back to how I described this translation of science, you know, the original kind of idea of activity-based senses came from our founder,

San Gita Bati, are in MIT. She had done over 10 years of work in the technology before it was, before Glimps was founded. I then joined Glimps, and we've further evolved the technology since then into this blood-face format that you see now, which is very tractable and something that can be easily used by physicians and patients. And so how I was attracted to the technology was something very, very simple, which was the world I came from. So, you know, it's kind of an interesting transition because, you know, you've heard, right, I've spent my entire career in therapeutic. So, you know, someone with a therapeutic background moving to a diagnostic company is a slightly unusual transition. But for me, there was, you know, there was a singular reason why I came to glimpse.

And it was because in the world of therapeutics, the biggest single issue that is hampering drug development is how do you identify the treatment responders? is how do you identify whether patients are going to respond to therapy? And it's a problem that plagues the entirety of the drug development process. It also plagues the therapeutics that are in the marketplace as well. You've probably had the experience. You've had family members or friends who've had the experience. They go on a drug. The drug doesn't work.

They then switch to another one and similar drug. And then eventually find one that works for them. Wouldn't be great if we could figure that out? well, you know, it looks like the way the glimpse technology works is that we have the potential to be able to do that and to work with pharma companies to help identify those patient populations for them. And so for me, when I saw the glimpse technology, I saw the potential to solve a problem that, you know, wasn't just unique to my experience in drug development, but is a problem that has existed for a long time in the drug development. arena is really hampering the acceleration of drug development. And so if we could deploy the technology to do that, to try and decode that drug development process and help unlock some of what, you know, the sort of the potential that is being slowed down because we have, you know, we have too many

patients going through clinical studies who are non-responders and all of those things. That would be incredibly powerful. And so that's, you know, that's the reason that it came to glimpse, and we have, you know, we have discussions underway with pharma companies. We have collaborations that have been entirely anchored around that, that idea. And so, you know, we see all of that coming to fruition. Yeah, tremendous opportunity. And thanks for that, thanks for that background. That's super compelling.

And just so I mean, before we kind of talk a little bit about like how you're approaching these different kind of key functional areas in a startup like glimpse, just so I understand the technology, let's assume I've gotten. autoimmune, on the patient, I've got an autoimmune condition. Is glimpse, is it intended to diagnose the autoimmune disease? And then as I use different therapeutics to improve, would glimpse allow me to kind of measure the progress against that? Okay, got it. Okay. Yeah. Interesting. And are there other applicates, are there other more like kind of general wellness applications for this?

You know, as more and more people kind of get into like longevity, right, and and allocate more of their personal budget towards health and longevity. Is there an opportunity for using a technology like Clems for that? I mean, we've focused right now on very serious diseases, but what we do know is that proteases are involved in every aspect of human health and disease. And so for us, you know, in some future, right, it's really about coding biomarker panels. We can probably code biomarker panels for many things.

We've right now focused, you know, we're early, we're focusing on really serious diseases. Are there other things that we could potentially code for? I'm sure there are. Are there applications that are valuable that potentially? But right now we're really focused on, you know, on this notion of serious diseases. And there's such a need there, right?

You know, and I think everyone's awareness of the sort of the diagnostic void, right? And these diagnostic odysses became front and center with COVID, right? and how, you know, there was just this diagnostic gap with COVID alone. And I think that brought to light that, wow, we just don't have diagnostics at our fingertip in the way that we want them. Yeah. And, you know, right now we're focused on these serious diseases that really need them.

Right, right. Yeah. I'm sure this would be an entirely separate conversation. But one of my friends, Dr. Anthony Guston, who spends most of his time focused on kind of the broader kind of health and wellness community. you know, and like I always like a phrase that he uses, you know, when it comes to like using CGMs, right, continues glucose monitors to measure, you know, um, insulin, uh, our insulin response. It's like, well, he made, he always make, uh, one of his points he, he mentioned is like,

well, you can eat a tub of lard, right? And that, you're, you're not going to see a glucose response, but is that necessarily helpful, helpful? You know what I mean? We need, we need better diagnostics, you know, to really kind of measure metabolic health. But, um, anyway, this is a great, it's a great point. Exactly. Right. Yeah, totally. So anyway, that's why I asked because it's something that stood out when looking at your technology. I know you're focused on very serious conditions, but just I've asked. But so let's, Caroline, let's transition. I want to run through a couple of your, a couple questions here related to kind of your general kind of approach to regulatory and clinical, right?

We've already kind of covered the fact that you've got a really broad background, a lot of muscles that are probably pretty strong when it comes to these, these areas. And I know you spent your first, you know, the first almost, I think, decade of your career at, that's in kind of like with a with a very acute focus on reg. So what were you like when you, when you think about like other early stage companies and how they're approaching their, their broader kind of regulatory roadmap, what do you think are some of the biggest mistakes people people make or miss out on and kind of how are you, how are you kind of with that in mind, how are you approaching kind of the regulatory landscape with, you know, a complicated technology, simple, but complicated technology like Clems? Yeah. So the, the interesting

thing about regulatory that I, you know, I sort of, I learned over the years is that, you know, it's, it's an incredibly strategic function. And you can think about it very operation. There's a very operational piece to it. But the elegance of it or the real opportunity with it is that it's is, is in the strategy, right? And if you think about that early on, you can create incredible value for your organization. And, you know, I, I, I learned that from my early career experience. And so that's certainly how we've approached it at Glimps. We were very strategic from the get-go. We spent a lot of time thinking about, you know, kind of the overall strategic arc for our product. We have had very, you know, sort of early

and often engagement with the agency. And that's something I would encourage. I think a lot of people, you know, have this notion of, you know, trepidation when, you know, they think about engaging with the agency, particularly as a small company. But, you know, my experience has been, I don't you're not in knocking on the door every day, but they really want to collaborate. And they want to help you, particularly with the new technology, they want to help you advance. And, you know, there are sort of this, I think about it as this notion, once you understand sort of where you're going and you're working within sort of the, you know, general. domain of the sort of the regulatory framework that exists.

With a new technology, you're often going to want to push that domain. And so if you're having a good dialogue with the agency, you can really start to then build a discussion around, you know, where can you push and where you can't push or how are you going to be able to push. And, you know, I sort of think about it a little bit as you want to sort of ride the crest of the wave, but you don't want to like, you want to fall off the wave. And, you know, it's an art to do that. You know, there's a little bit, there's some science, so there's an art to doing that.

And that's why it's so important, right? It ends up being driven by your data and ends up being driven by what else is going on around you. You know, what other products are being developed and approved in a world like ours. The area that we're in, it ends up being driven by therapeutic data as well as diagnostic data. So, you know, we have to balance both of those things. and when we've, you know, worked with the agency so that we, we have dialogues that include both Cedar and CDRH appropriately in our, in our discussions as necessary to make sure that we sort of balance both of those conversations. That was sort of in our earlier evolution. So it's just, it's important to, you know, I think, take all of those things into consideration.

And the final piece is, I think, you know, be flexible. There are things that you can't control in the regulatory environment, things that you might plan change because, you know, something happens with another company that causes FDA to retrench, you know, a direction that they were taking or, you know, there's a rulemaking that gets driven because of, you know, the political environments, you know, you always have to be flexible. But as long as you're looking ahead a little bit,

you can generally, you know, generally those things are not unanticipated, right? You'll have, there'll be managing them as risks. But I would say it's not just an operational function by any stretch of the imagination. It should be first and foremost a strategic function. And once you think about it like that, it's guiding the direction of, you know, everything that you're doing. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider premium members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010.

This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadine Miarid, CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs. In addition, you'll get a copy of every volume of Medsider mentors at no additional cost. To learn more, head over to Medsider Radio.com forward slash premium. Again, that's medsiderradio.com forward slash premium.