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E4 - Preventing Disease Before It Starts | Nikole Kimes (Siolta Therapeutics)
10 Plays10 days ago
Most biotech gets funded to treat disease after it happens. Nikole Kimes built a company to stop it from happening at all.
Nikole co-founded Siolta Therapeutics with her UCSF postdoc mentor, Susan Lynch, to chase a radical idea: that a defined set of naturally occurring organisms could reprogram an infant's immune system toward tolerance instead of allergic disease. She started as VP of R&D, then became Chief Scientific Officer, and only took the CEO title once it was obvious she'd already been doing the job: Steering a brand-new kind of live biotherapeutic through the FDA and into the hardest population to study: newborns.
In this conversation we talk about:
- Why she never planned to become a CEO, and evolved into the role instead of choosing it
- The gut microbiome science behind preventing allergic disease before it ever starts
- Why dosing newborns with a novel live drug was seen as a dead end and how Siolta found a path through
- The fork in the road between building a probiotic food product and a regulated drug
- Why prevention is so much harder to fund than treatment, and how Siolta found investors willing to play the long game
- How the Bay Area biotech incubator community shaped building a company in a field that didn't exist yet
If you enjoyed this conversation, subscribe for more honest conversations with founders, builders, and operators about what it really takes to build something worthwhile.
Get future episodes, insights, and lessons from people who chose to build anyway — it's genuinely worth it:
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Connect with Nikole:
- LinkedIn: https://www.linkedin.com/in/nikole-kimes-4b357786/
- Siolta Therapeutics: https://www.sioltatherapeutics.com/
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Transcript
Introduction to SciAlta Therapeutics
00:00:00
Speaker
All right. So today I'm talking with ah Nicole Kimes. She's the ah co-founder and CEO SciAlta Therapeutics, a company developing microbiome-based therapeutics aimed at preventing diseases before it starts, basically.
00:00:16
Speaker
um And it kind of grew out of microbiome research and has evolved into a clinical stage biotech company. And this is pretty interesting because a lot of Healthcare care is built around preventing disease after it appears.
00:00:33
Speaker
um But see, Ulta is more of a bet that understanding the gut microbiome early in life can prevent diseases, some diseases altogether.
Academia to Entrepreneurship: Nicole's Journey
00:00:45
Speaker
And So, Nicole, i I wanted to start out with when when you first left academia and sort of transitioned into into entrepreneurship, I guess. um What was the first time where you realized that you kind of know the science of this, but you don't really know this new thing you're doing?
00:01:06
Speaker
ah From the very get-go, I would say from the first day we started talking about forming a ah company. So I co-founded Schulte Therapeutics with ah Susan Lynch, who's a professor of medicine at UCSF and was my mentor for my postdoc work at UCSF.
00:01:26
Speaker
ah Prior to starting the company, I would say six months prior to that, had you asked me if I was going to start a biotech company, I would have laughed and said, not a chance.
00:01:38
Speaker
It was not something that was on my radar. I i really have had approached business. my curiosity and my professional trajectory up until that point around sort of academic science and um really thought that would be the route to go.
SciAlta's Systems Biology Approach
00:01:59
Speaker
Interestingly enough, the science was telling us something really cool. And and that was that, know, by embracing systems biology and the complex complexity that we know is involved in dynamic living systems, that we would have a much better chance at getting at the underlying causes of some of the chronic diseases that have really been, you know plaguing us over the last couple decades.
00:02:27
Speaker
Yeah. And
00:02:31
Speaker
At that point, it took other people coming in and saying, this is really interesting. you know, nobody's doing this. who' who's Who's going to translate this into something that's going to help patients?
00:02:44
Speaker
And my initial reaction to that was, surely there are companies out there that do this.
From Research to Prevention Solutions
00:02:50
Speaker
And after some time in looking into that and having people m continue to challenge us on that question, it it became more apparent that it wasn't really something that people were pursuing. And and what we do really well, particularly um in Western medicine, is identify you know molecules of interest that impact very well-defined pathways and that thereby
00:03:25
Speaker
can treat or mitigate symptoms of a disease. We do that really well. ah There's some areas, you know, infectious disease, we've gotten pretty good at identifying ways of mitigating that as well. But these complex chronic diseases, whether it's metabolic, neurodegenerative, yeah allergic disease that we initially focus on, um all of those have been much more recalcitrant and harder to to deal with. And part of that is by the very nature of being a chronic disease, right? yeah
00:04:02
Speaker
It is established over a long period of time and it's ah there becomes redundant pathways that are um involved in such a thing. So this very linear approach that we have perfected ah to some degree in Western medicine just hasn't been beneficial.
00:04:25
Speaker
So the science we were looking at, which is, you know, we take an ecological and systems biology approach to trying to figure out dynamic communities. And that was where we were starting to see the pieces come together that we could actually have an impact.
Challenges in Pioneering Prevention
00:04:45
Speaker
So knowing that this was going to be a challenge for sort of the traditional pharma design, that's that's when we first started thinking, oh, we might have to do this ourselves just to prove the concept is viable, scientifically speaking.
00:05:06
Speaker
um and And then from there, build out all the other elements that are going to support support this, whether that's you know commercial, ah regulatory, all of those things.
00:05:18
Speaker
And so, it it yeah, it was literally when Sue came to me and said, I i think we should start a company. And i think you would be great.
00:05:30
Speaker
to lead it, that I first started thinking about what it would mean to be an entrepreneur and be in biotech. And it started very gradually ah for me.
00:05:43
Speaker
I always so thought we would start the company and bring somebody else in to run the company. And we made an agreement that at each stage, stage of development, we would just keep revisiting, you know, who was the right person to take this forward.
00:05:59
Speaker
And to date, and based on the novelty of what we're doing, you know, we've become the experts in how to develop live biotherapeutic products moving forward.
Leadership Evolution at SciAlta
00:06:17
Speaker
And so we just keep pushing the bar forward ah in a sort of incremental way as we are developing all of the different facets of a biotech company within a novel field.
00:06:33
Speaker
So it was very clear we were going to put together multiple challenging things. We were going to go after prevention rather than treatment. We were going to go after a novel modality and use live drug product.
00:06:49
Speaker
And to do that, we were going to go into newborns, which is typically not the population you start in. And so we were taking a number of challenging elements and putting them together because as science was telling us, that's where we're going to have the greatest impact.
00:07:13
Speaker
there's ah There's a lot there. It's very interesting. um So you went from you went from not basically not realizing that you wanted to start you were going to start a company to being CEO within a year or nine months or six months.
00:07:28
Speaker
what what What was that like? Well, interestingly, i we started the company and I did not take the title of CEO. ah In fact, when we started the company, i so i was the only person, Sue and I co-founded it, but she remained in academia. So I was the only paid employee of the company. And we gave him ah myself the title of VP of R&D. Okay.
00:07:59
Speaker
And that should tell you something about where my mindset was when we started the company, right? a Yeah. and I was naive in a way that was beneficial.
00:08:13
Speaker
How so? In that I didn't know all of the aspects or understand the the complete ah role that I was going to be playing in driving this forward. And I think had somebody said, we want you to be the CEO of a biotech company and spend the next 10 years of your life growing that company to you know phase three at trial readiness, that would have been really overwhelming. And I don't know how I would have
Community and Collaboration in the Bay Area
00:08:44
Speaker
responded to that.
00:08:45
Speaker
um Instead, it was, let's start a company ah We will bring in the people we need as we need them. ah But we're going to be very focused on the science and proving that we can do what we think we can do in a human population before building out a large machinery um there are a large business plan that's going to support um a whole pharmaceutical company, right? a but Those are two very different approaches.
00:09:26
Speaker
And so for me, it it was important that we were moving forward in more of a stepwise fashion, trying to build from the ground up in a very lean and focused manner.
00:09:45
Speaker
I actually, after VP of R&D, the next title I held was Chief Scientific Officer. We still did not have a CEO.
00:09:55
Speaker
okay ah And then eventually it became obvious ah that I needed the title of CEO because we were raising large funds and um clearly i was ah adopting that role regardless of what we were calling it.
00:10:11
Speaker
Okay. All right. So you kind of just sort of fell into it, sort of? Evolved into it? Yeah. Yeah. I would say. Yeah. Yes. Yeah.
00:10:22
Speaker
And I think it was important as a first-time CEO also to
Microbial Signatures and Infant Research
00:10:28
Speaker
not only prove to myself that I wanted to do this, but to prove to those around me that I was capable of doing these things. Because I certainly didn't come to this with the experience of CEO right from a background perspective. Yeah.
00:10:46
Speaker
That's interesting. were you were you worried that you Were you worried about your capabilities? Because that's a big difference between being ah being a researcher, being being in academia and and being a CEO of a biotech company. That's a big step.
00:11:00
Speaker
Yeah. And I wouldn't say I was worried about that. It's just not something I had ever really considered. Like what what would that all entail? What are the skill... set required to develop a team to ah understand both broad strategy and focused science, and you know, to navigate financial, regulatory, intellectual property ah entities.
00:11:30
Speaker
And I have to say, it's it's been an amazing journey that I have loved for the last decade. And I can't imagine having not done it.
00:11:43
Speaker
At this point. At this point. Yeah. it It was simply something that was not on my radar and I didn't know much about. it's so it's it's.
00:11:55
Speaker
Well, so it's something that you wouldn't, if you were, if you knew what you were getting into, you, you're not sure that you had said, you would have said yes, but now that you're in it, you wouldn't, you wouldn't trade like.
00:12:06
Speaker
Wouldn't trade it for anything. That's very interesting how that, how that happens. Yes, and i'll um I will give my co-founder Sue Lynch a lot of credit. She was ah very supportive and I think she had a better understanding to some degree of what I was getting into than I did ah and was very helpful and encouraging um that I had the capacity to do so.
00:12:38
Speaker
Right. Yeah, that can give a lot of, that can really help having someone sort of saying that, well, basically saying that it'll be all right and that you can. Yeah. yeah Yeah. And ah another piece that was very necessary and beneficial for me was the community and the environment here in the Bay Area. i don't think it's unique only to the Bay Area, but.
00:13:04
Speaker
It is certainly cultivated here and celebrated here. and So when we started the company, we housed it within a biotech inc a incubator called NBC BioLabs, we're still here.
00:13:22
Speaker
um We've stayed here. But it allows you to be in the same environment as other startup companies. and And on my side of the equation, running the company, that gave me exposure to a lot of other people going through similar processes so I could learn from them um and get resources and um advice on daily occurrences. Right. And then from a team perspective, it allows you to develop that the team in an environment where they also have support from other scientists, other modalities, other disciplines and and
00:14:04
Speaker
When you have a small focused scientific team, it could be very isolating. um but in an environment like this, it really gave us a lot more, uh, and broader support.
00:14:20
Speaker
Right. Yeah. yeah that would Yeah, I would imagine that could be lonely, especially for well especially for someone at the top or who's like, you're the only CEO, right? like that would Yeah, that makes a lot of sense. So any an incubator, is that is that just a a bunch of biotech startups in the same building? What is that exactly?
00:14:40
Speaker
Yes, it is. So it... We have two different business models that you will hear about, incubators and accelerators. My understanding is that in an accelerator, ah that the folks who are running it are typically also investors ah and are trying to help.
00:15:03
Speaker
foster development of specific companies. In an incubator setting, it is ah the there can be investment involved in it, but it's not required.
00:15:14
Speaker
And it um certainly for NBC BioLabs, it's ah a really innovative concept where you rent space. So it's a pay-as-you-go model.
00:15:24
Speaker
um And it just allows you to be very... ah
Navigating Regulatory Landscapes
00:15:30
Speaker
capital efficient and utilize the space that you need as you grow and develop.
00:15:38
Speaker
Yeah. Yeah, that makes sense. and So yes, it is a you know a laboratory building that will have, you 20 to 40 companies in our experience, all in early phase development of some sort.
00:15:56
Speaker
Right. And and or you're also like ah just like are you able to like use some of the same equipment as the other? Yeah, they All that stuff? Yes.
00:16:07
Speaker
They do have a core facility
00:16:12
Speaker
access that you can use with different equipment. you can have You can only use shared space or you can have private space and you can do a combination thereof.
00:16:24
Speaker
Interesting. Interesting. i didn't Yeah. Very cool. And so, and the Bay area is is big on, yeah, obviously. So that's big on yeah biotech. Yeah. That makes a lot of sense.
00:16:34
Speaker
And so, okay. So I want to, there's so many interesting things I want to ask about here, Nicole. When you, when you, um back to when you were starting out, like the the first, ah what was the first observation or piece of evidence that made you think that there could be a company here?
00:16:56
Speaker
So when we were doing research looking at clinical data from larger infant cohorts.
00:17:07
Speaker
ah Sue had been working on this for some time, and they had started showing that there were microbial signatures very early in life that would predict the kids that go on to develop allergic disease or not.
00:17:22
Speaker
So when I joined her lab, the the question was if we can predict who's going to develop disease based on those microbial signatures? Could we actually prevent it from ever happening by addressing those microbial signatures?
00:17:38
Speaker
yeah And unlike ah infectious disease or many diseases where you are looking at a nefarious organism that is causing disease,
00:17:52
Speaker
issues in chronic disease, what we tend to see ah more often is that you're lacking beneficial organisms. and So the concept going in was, could we rationally design ah ah defined set of organisms that would reprogram the community impact metabolism in a way that directed immune trajectories early in life towards immune tolerance rather than in inflammatory state.
00:18:26
Speaker
So during my work with Sue, we did animal studies with defined cocktails that we had worked on. And what we started to see was that indeed we could dampen the immunological cascade that underlies allergic disease.
00:18:47
Speaker
And in the evidence that we saw, we weren't just reducing the downstream inflammation. We were actually um
Hype vs. Evidence in Microbiome Therapeutics
00:18:57
Speaker
impacting the entire immunological cascade from the the front end of it.
00:19:04
Speaker
So we were rebalancing the immune status in those animals. So in allergic disease, you typically, it's a Th2 driven mechanism.
00:19:21
Speaker
So you have high t h two reactivity and ah low T regulatory activity, which is anti-inflammatory. And what we were seeing is that we could actually shift at the balance of those scales and we would dampen the Th2 and increase the T t regs.
00:19:40
Speaker
And so that evidence is what made us start thinking that we could actually prevent it from happening rather than just treating symptoms downstream.
00:19:54
Speaker
yeah And that's when we started to get really excited. Yeah. Yeah. so it's ah it's an imbalance that you're basically trying to correct. Correct.
00:20:04
Speaker
Yeah. Yeah. That makes sense. Very interesting. Yeah. Yeah. and And what, and when was this, was it, was this within like, when was this timeline wise? Was that like right around when you started the company or was it way earlier or when was this?
00:20:19
Speaker
No, it was around, it was that data that was driving us to want to then investigate this in humans. yeah And that was, um, you know, as an academic institution, we weren't going to be running clinical trials necessarily.
00:20:38
Speaker
m At the scale that we wanted to do. So at that point, it made sense to start the company and ah move it more towards translational science rather than just and basic science.
00:20:55
Speaker
Right. Right. Okay. And it's it's where we see a lot of failures in drug development is translation. We can do a lot of things in animal models that we have not been able to translate into human populations. Right.
00:21:11
Speaker
Yeah. And so that was the biggest question is, okay, we're seeing this very interesting impacts, but is that going to bear any resemblance to what we see in humans? Right.
00:21:22
Speaker
And so our our philosophy from the get-go was utilizing an approach like this from a safety perspective. We would expect it to be safe. These are naturally occurring organisms associated with healthy humans and seen throughout the development of the first years of life. So we thought safety would be something we could establish safely.
00:21:53
Speaker
In early studies. yeah And then that would also allow us to see if from a more of a efficacy perspective, are we having the impact we would expect to have?
00:22:07
Speaker
Right.
00:22:11
Speaker
that it's an interesting approach for a new modality ah that, you know, if as a small molecule, you have to do a lot of things around toxicity and pharmacokinetics and pharmacodynamics ah with a replicating live drug that stays confined to the gastrointestinal system.
00:22:34
Speaker
um that There's less around that because we can't induce toxicity. These organisms stay in the gastrointestinal system. They they don't um invoke toxicity at any level that we've seen.
00:22:49
Speaker
um so There's a different ah approach and considerations, even from a safety perspective, that allowed us to move forward very quickly, working with the the regulators and the FDA.
00:23:05
Speaker
Right. We were able to move into to humans rather efficiently. Did you have to prove that it stayed within the the GI tract or... It is some of the evidence that we provided in our IND initially was from the animal models of showing there was no translocation of organisms to other systems.
00:23:27
Speaker
yeah Very interesting. Very interesting. And so, okay, so and this is ah the whole gut microbiome field. has There's a lot of, well, there was a lot of excitement, then there was a lot of skepticism.
00:23:42
Speaker
There's a lot of excitement. Then there's like, it goes back and forth. How do you, how, how did you decide what to pursue and what not to pursue? We remained wholly focused on the scientific evidence that was before us. And it's one of the reasons we focused in on allergic disease. It's where we saw the greatest amount of ah evidence, not only coming out of Sue's lab, but coming out of other global labs.
00:24:11
Speaker
and There was work being done in Canada. There was work being done in Denmark. and different labs within the U.S. s that were focused on the gut microbiome and its relationship to allergic disease. So we had a fair bit of confidence that this was something being seen across different labs.
00:24:34
Speaker
ah And I would say that the hype cycle that comes and goes, there's there's a reason for it. Yep.
00:24:47
Speaker
And so trying to understand and embrace that, which is, ain I don't know if you're aware of this, but you are only half human. The other half of you is microbial on a cell to cell ratio. Conservatively, ah you have microbial cell for every human cell.
00:25:06
Speaker
But what's even more interesting than that is that they, the microbial cells contain a hundred times more genes than your human genome. Wow.
00:25:18
Speaker
So yeah i I feel like I should know that impact of that is immense, right? It has your microbiome associated with your body has the capacity to impact almost everything in your physiology.
00:25:36
Speaker
And so there's a reason there is hype is that there's this vast um repertoire of capacity. in our ecosystem that we have not been aware of or ah accounting for in our health.
00:25:53
Speaker
yeah And so it can have a lot of great impacts. Now, the issue is is a very complex. And there's a lot we still don't know.
00:26:07
Speaker
um So trying to direct and harness that knowledge in a manageable
Collaborative Innovation with the FDA
00:26:14
Speaker
way that's going to have the positive impacts that we believe it will eventually um is is new and it's hard.
00:26:24
Speaker
And it really requires a different approach ah in many ways. And that's where then there's the skepticism about, it you know, is there the regulatory m path forward? I think we have established that there is a regulatory path forward. in Manufacturing, can we consistently manufacture these things?
00:26:49
Speaker
And if you're doing it under an IND at, you know, a GMP level for drug development, yes, there are standards for which you can reproducibly manufacture ah these types of products in a reliable way.
00:27:06
Speaker
ah And so then the question is clinical. You know, can we have the clinical impact that we think we can? And the only way to know that is to do the tests, to do the studies and measure in well-controlled, rigorously powered studies know that we can do what we're doing.
00:27:29
Speaker
So when you were, you mentioned like regulatory challenges, was that, was that because of the, because you're, you're focused on basically newborns, right?
00:27:40
Speaker
And that's a, that's a big thing to, youre Well, okay. So from my so knowledge base, like i don't I don't know a lot about all of this, even though i'm ah I am a physician and I do ah and i have you know had lectures and stuff, but I don't know that that much about it. But I do know that generally when we develop new medication, ah testing it on adults is usually what we start out with.
00:28:10
Speaker
And generally, it's harder to test stuff on children because they're children. um So is that was that part of the challenge there? ah Yes and no, I would say. ah So we're gonna I'll come back to that piece of it.
00:28:27
Speaker
Okay. The first question was, as a novel modality using microbiome, specifically orally, ah There is a path in which you could do this as a food.
00:28:44
Speaker
And those are the products that you see in the market on the shelves, probiotics. Or you can go the route of a drug. And this is unique. Most drugs can only be developed as a drug, right? There is no other option for most drugs.
00:29:00
Speaker
In our case, there was a different option. And you could do a food, which ah is much less oversight, much less rigorous from a regulatory perspective.
00:29:14
Speaker
ah And the defining difference from the FDA's perspective in the U.S. is the intention of use.
00:29:25
Speaker
If you are intending to treat, cure, prevent, or mitigate a disease, you are a drug. okay
00:29:37
Speaker
Otherwise, if you are for sustenance, you can be the food. yeah So from our perspective, We were very much in the camp of we want to prevent allergic disease from occurring.
00:29:55
Speaker
And we want to have the evidence to make those claims and state that that's what we're doing so that people know and understand what they're getting and why they're doing it Right.
00:30:08
Speaker
And because it's a novel modality from a safety perspective, we wanted the rigorous oversight of the regulatory body. um Also, we think that's very important and that in how we develop these products.
00:30:23
Speaker
Yeah. so So that was the first question. Are we a food or are we a drug? And once we realized we were a drug, then you it's the interactions of, okay, you are correct. Most drugs are developed in adults for safety reasons and then you know ah introduced into younger populations as safety is established. Okay.
00:30:47
Speaker
Right. This is a unique category again with a a, a product that would be presumed to be relatively safe compared to your typical small mall molecule and biologics.
00:31:02
Speaker
These are naturally occurring organisms seen in the first years of life. So
00:31:12
Speaker
we went to the FDA to get their opinion. ah And what I would say is this is one of those areas where bringing in somebody with a new perspective is a benefit because all of the experts told us there's not a chance. There's no way you're going to go into newborns with a novel product in this manner. That's going to be extremely challenging.
00:31:38
Speaker
And you're going to have to show that it works in adults. But if you think about the concept of what we are saying is that, you know, the the first years of life is a unique window of opportunity for which we could have an impact that we may not have in adults.
00:31:53
Speaker
yeah ah and And so we had to make the argument that the the infant population was being targeted for a very specific purpose.
00:32:04
Speaker
right And from our first interactions, the FDA was actually quite helpful and supportive and understood the the premise of what we were trying to do.
00:32:16
Speaker
and we worked together to come up with something that was a safe. I say work together. ah i certainly cannot speak for the FDA on a any level. um But they they were open-minded about our approach and they understood the rationale for our approach. hu And so we actually, for our first in human study, proposed...
00:32:45
Speaker
doing an age descending safety study. So we dosed adults and then adolescents and then children down to the age of two or four as a safety um study.
00:33:01
Speaker
And that allowed us in our next proof of concept study to go into newborns and, and young infants following that.
00:33:12
Speaker
um And the the main thing was that we were showing safety. and We did not have to prove that this could work in an adult before moving into an infant because conceptually we, we don't know that.
00:33:26
Speaker
We don't know that it needs to, or has to.
00:33:30
Speaker
Very interesting. Wow. Okay. So like when you're, you mentioned getting someone with a fresh perspective and all of the, all of the experts saying this is going to be a this is a dead end. um yeah How, how did you, well, how would you do that? Because i imagine coming up against that whole wall of ah this is a bad idea. right And then, and then going to find someone who's saying something else.
00:33:59
Speaker
You know, i I give credit to the FDA. ah I actually heard the FDA give talks at conferences for microbiome ah development.
00:34:14
Speaker
And what they said was, this is a novel, innovative arena. There is not a lot of guidance. So come talk to us.
00:34:27
Speaker
We will right they tell us what you want to do and we will see if we can help do that or if that's a good idea. um And so I literally called the FDA.
00:34:43
Speaker
which is, again, not something most drug developers would do. They would try to limit their interactions with the FDA some degree. And that was just not our experience. I found them to be very helpful and open about ah what we were trying to do. And again, they're they're focused on safety, right? They want to make sure that you are putting the right controls in place to provide a a safe product and that you are being streamlined and how you investigate that to minimize the risk.
00:35:23
Speaker
And so i found the FDA actually to be one of the more open and innovative entities that I dealt with, which is not what you often hear from a traditional perspective.
00:35:39
Speaker
No. And so you said that normally biotechs try to sort of, well, maybe not try to, but more limit their interaction with the FDA?
00:35:50
Speaker
I'm not sure. What I would say is in more of your traditional therapeutics, there is a very well-known route. through the regulatory process.
00:36:03
Speaker
So everybody knows, it's very clear what is required. And therefore, you just follow the rules. you You follow the standard steps. You know that the toxicity studies that need to be done. You you know you know the PKPD package that needs to be provided in your investigational new drug application.
00:36:30
Speaker
it's So there's not as much of a need to interact in a one-off type of conversation. Right, right. When you are talking about a novel modality that doesn't have that same well-established pathway, then interactions but with the FDA early on in the process can be very beneficial.
00:36:56
Speaker
Yeah. And that was the piece that was important for us and saved us time and money by having those conversations.
Transforming Healthcare through Prevention
00:37:09
Speaker
Right. Yeah. Well, that's, that's good. Yeah. whether there like Yes. I, I feel like they have been, and certainly the individuals that we have had the opportunity to work with are there because they want to help develop safe products and make sure that, um, it's being done in a responsible manner. And we, we are aligned in that.
00:37:38
Speaker
Yeah. Yeah. So important. In that scenario. So, um, we work more, um, as collaborators or that's how I envision them.
00:37:52
Speaker
Yeah.
00:37:55
Speaker
Yeah. Do you find that's a, well, I don't know. I find that's a better way to envision things like that. Envision people as collaborators versus I think in general, i would say that's part of just my philosophy on life and my leadership style and the way I like to interact with people is bringing together folks who have experience.
00:38:23
Speaker
a shared vision and are willing to address all of the hurdles along the way in a collaborative manner with the same end goal in mind.
00:38:35
Speaker
You can have difference of opinions, difference of, um you know, hypothesis, difference of ah problem solving approaches, ah but keeping in a alignment on that end goal and having the trust that collectively you can get there.
00:38:59
Speaker
Right. Yeah. Yeah. Very interesting. i It's almost, I think of it from a systems biology perspective, right? like There's a lot of little complex um structures that have to interact with each other to make something functional.
00:39:20
Speaker
And trying to support those systems ah is is our goal and really how we can intertwine ourselves, allowing for complexity and diversity, ah but supporting a movement towards a healthy outcome is what we're all looking for.
00:39:45
Speaker
How do you use that that systems biology thinking on like the day-to-day? How does that work?
00:39:52
Speaker
ah Really making sure that we're not trying to silo everything. All right. Right. We need our regulatory people talking to our scientists and talking to our bioinformatics, talking to our legal. You know, it it's a way of.
00:40:11
Speaker
um making sure that we're integrating all of the different systems in the way we function and communicate because they all play important pieces of how we move forward.
00:40:25
Speaker
And I think um we have a tendency to be reductionist as humans and try and pull out individual pieces and focus on those pieces. And sometimes you have to do that.
00:40:38
Speaker
hu ah But you have to remember to bring it back in the context of everything that's going on. Right. Because on its own, you're only going to get so far. It is really the dynamic nature of that integration of all the pieces that are going to determine whether you're successful or not.
00:41:01
Speaker
Right. So sure it's it's like ah it's... It's sort of having like a a respect for the influence of the different pieces on each other? 100%.
00:41:14
Speaker
Very interesting. Very cool. So, okay. So I wanted, that you touched on this in the beginning. um And i I want to dig into that a little bit more, just...
00:41:26
Speaker
talking about preventative medicine versus treating a disease and ah sort of ah getting people along on that idea and securing funding for it because that must have been hard for you guys now.
00:41:42
Speaker
Yeah, it's I find this fascinating. i mean, you talk to most people and explain why we focus on prevention, ahha both from a scientific perspective and from just a ah human experience perspective.
00:41:59
Speaker
mean, would you rather have a disease and treat it or would you rather never experience that disease? It seems pretty straightforward. and does. And from a scientific perspective, even it it can be straightforward in that it's a lot easier to intervene early when you don't have these recalcitrant mechanisms that are well-established and involve redundant pathways.
00:42:26
Speaker
yeah So from multiple angles, it seems self-explanatory. However, we have developed systems that don't seem to support that. Yeah. And make it more challenging.
00:42:46
Speaker
ah So... Yes, oh so has it has been a challenge and it's a challenge when you think about it um from more of like a commercial side of the equation. yeah And that is who's going to have access and who's going to pay for this is typically where that the system starts to to break down.
00:43:11
Speaker
um Also in development, you know it is a lot easier to test a therapeutic. If you are already seeing a negative outcome, a therapeutic, you can go in and very quickly, are you improving it or not improving it?
00:43:27
Speaker
For prevention, it requires more time and money up front. Yeah. ah so So it's the upfront side and the backside where you are running into some of the hurdles associated with prevention.
00:43:46
Speaker
Right. On the front side of that, what I would say is we were very careful to align ourselves ah with investors that understood what the ultimate goal of what we wanted to accomplish yeah and really being...
00:44:03
Speaker
clear that there may be an easier route forward. Yeah. but it's not going to be the most impactful route forward. right If we really want to transform the way we think about healthcare you know, do things differently, that it was going to take a little bit more time and effort on that front side. So that was important from the initial stages. And I i can say pretty much at every stage of development of the company,
00:44:35
Speaker
had we listened to a lot of the expert advice we were getting, we would have never progressed to where we are because they would have suggested and did suggest often that we should not do prevention and that we should move towards therapeutics. And um it's just an easier route.
00:44:59
Speaker
ah So from that perspective, it really just took fortitude. to be quite honest, that we wanted to to remain aligned on that vision of transforming healthcare care and really getting at the underlying causes of disease.
00:45:17
Speaker
And then on the back end, from a commercial perspective and a payer perspective, that's just taken education and conversations. We actually do have examples of you know targeted prevention in at-risk populations that are economically viable.
00:45:37
Speaker
and I worked with John Martin at ah Gilead, ah who was a mentor of mine before he passed away. And he was responsible for bringing a along ah PrEP for the prevention of and in at-risk populations. And that was one of the earliest economic examples of a very viable approach to prevention. It was a multi-billion dollar success story in preventing HIV in at-risk population.
00:46:08
Speaker
So that was the the model that we started with in our minds. and Since then, we've seen other things, you GLP agonists, that GLP-1 arena has exploded over the last couple of years.
00:46:26
Speaker
And that was initially marketed as the treatment of pre-diabetes. hope m That is simply prevention of diabetes.
00:46:37
Speaker
Right. yeah Yeah. In a at risk population. Right. And we're seeing that being embraced.
00:46:48
Speaker
Right. and In our system. So, you know, the main pushback was really from the the insurance side of the equation of um Are insurers willing to pay for something that's going to have an impact, you know, 10 years down the road when because of our disparate system in the U.S., you're swapping and jumping from insurer to insurer? Right.
00:47:21
Speaker
I would argue if all of the insurers are covering it, then everybody benefits that. ah That would work out. Yes. Then then it still works out. Right. and so but Even if you don't grant that premise and say, okay, you know, typically folks stay with an insurer for about four years.
00:47:41
Speaker
Okay. Four years of no disease. That's still it economically viable. equation to consider.
00:47:52
Speaker
yeah and So those are the the conversations that we continue to have as we develop and have to think about how this gets integrated from a commercial perspective.
00:48:03
Speaker
Right. Wow. Yeah, there's so many things, so many questions to
00:48:11
Speaker
go. makes it fascinating and ah a thrill to have been a part of and to continue pushing down the road because at every layer we learn more about how we can improve our system.
00:48:28
Speaker
And ultimately that's what we're looking for is and how how we can really benefit healthcare across the board.
00:48:40
Speaker
Is that what you're trying to do? Is that kind of what you're trying to do? Revolutionize healthcare care a little bit? Ultimately, that's to the big vision, 100%. We have to do it in a very focused step-wise process.
00:48:53
Speaker
And um that's the day-to-day operational side of the equation. Like becoming a CEO. Yeah. Yeah. Nice. Very cool.
00:49:04
Speaker
Very cool. Okay. So we're, we're getting towards the end, Nicole. Like I, it's very interesting, but I don't, I don't want to keep you forever. Is there, um is there something you, yeah you'd like to say something that you feel like you've, you've left out or you're missing?
00:49:23
Speaker
I, I would, I like to highlight. Mm-hmm. And I'm not sure exactly who your audience is, but even for you, as you go through your quest to understand how we how we build things, and keep in mind that innovation is built on really individuals pushing boundaries.
00:49:49
Speaker
So... If you're going to do something that's innovative, it is by its very nature going to be hard and difficult. Right. And you should go into it knowing that and being okay with that.
00:50:03
Speaker
And ah really standing strong in the vision that you have around those innovations.
00:50:14
Speaker
Because at almost every point, you're going to hit hurdles where you could... ah lose sight of the end goal and take an easier route. That's going to actually put you further away from the the ultimate innovation that you're working towards.
00:50:34
Speaker
Um, so sort of embracing the difficulty and the complexity is the way that we're really going to change systems and innovate.
Embracing Challenges and Opportunities in Healthcare Innovation
00:50:47
Speaker
And so, um,
00:50:50
Speaker
I would encourage people just to recognize that and to take it head on. i love it. Awesome. Very good. Yep.
00:51:01
Speaker
I appreciate your time and ah your interest in in all kinds of creative new in endeavors. We appreciate we We often make assumptions that there's somebody else out there that's going to do these things.
00:51:17
Speaker
And I have learned in this process and that there is so much we still don't know or understand in so many areas where there could be improvement.
00:51:29
Speaker
We need people showing up and trying to do that. Yeah. Yeah, that's awesome. Yeah, I like that. I like that.
00:51:40
Speaker
That's scary, eh?
00:51:45
Speaker
That's funny. i I don't think of it quite as scary. I think of it as an opportunity. There's a lot of opportunity for improvement. I think people get ah focused on the the negative side of things and um feel like there's no room for change. We can't change things. But what I'm seeing is there's so many opportunities for change.
00:52:09
Speaker
Yeah, right. So I see it as a great positive in how we can improve ah our experiences. You're 100% right, by the way. I i completely i completely agree. it's ah it's ah it's a massive it um It's a massive flaw in my in my way of thinking. Those are your words, not mine.
00:52:37
Speaker
absolutely. hundred percent hundred percent um yup absolutely it's a well That's a whole, um I think um ah Carol Dweck had a very interesting book about it called Mindset or something. And basically it's having a growth mindset versus whatever the opposite was.
00:52:56
Speaker
um And basically it's ah it's how you see things. You can see them as something, as an opportunity or as something that's bad for whatever reason.
00:53:09
Speaker
And, and there's opportunity in everything and there's something bad in everything. That's how you look at it. It's how you frame it. um Yeah. So that's a, yeah, that's been a big thing for me trying to frame things differently. And that's, that's part of the reason why the show is called good build anyways, because the good is sort of a ah homage to the, to the struggle basically. Yeah. A reminder.
00:53:32
Speaker
Yeah. And, and something I, you know, On any given day, we need we we need may need more encouragement than others yeah yeah to remember that framework and that mindset 100%.
00:53:49
Speaker
one hundred was that Very cool. Yeah, very cool. Okay, well, ah thanks thanks a ton for coming on. it was was a pleasure. It was very interesting. I really enjoyed it.
00:54:00
Speaker
Thank you. I appreciate your interest and the opportunity. hope we can stay in touch.