Tyler O'Malley is the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen, Inc. Tyler shares his journey in the MedTech industry and discusses Exagen's innovative approaches to autoimmune testing solutions, including cutting-edge diagnostics for lupus and other diseases. With over a decade of experience, Tyler provides insights into the challenges and breakthroughs in the field, highlighting the significance of early diagnosis and personalized treatment, while also discussing the challenges and opportunities in effective leadership during different stages of company growth.
 
Guest links: https://exagen.com/
Charity supported: Save the Children
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PRODUCTION CREDITS
Host & Editor: Lindsey Dinneen
Producer: Velentium Medical
 
EPISODE TRANSCRIPT
Episode 066 - Tyler O'Malley
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Tyler O'Malley. Tyler serves as Associate VP of Clinical Affairs and Market Access at Exagen, Inc., a leader in autoimmune testing solutions. In his role, he oversees clinical trials, bioinformatics, and medical policy development for Exagen's current diagnostic portfolio and pipeline of proprietary solutions. With more than a decade of experience, O'Malley has contributed to more than a dozen clinical trials focusing on clinical validity and utility evidence for autoimmune diagnostics.
His expertise is widely recognized with numerous publications in esteemed peer reviewed journals, and notably, he's the first author of one of the largest clinical utility studies in lupus diagnostics. O'Malley graduated from Georgia Gwinnett College with a Bachelor of Science in biology, concentrating in biochemistry. His 11 year career in research and development and medical affairs encompass medical science, education, assay development, and clinical research coordination.
Well, welcome to the show, Tyler. I'm so excited to have you here today.
[00:02:01] Tyler O'Malley: Thanks, glad to be here.
[00:02:02] Lindsey Dinneen: Yeah, absolutely. Well, I would love just starting off by telling us a little bit about yourself, your background, and what led you to MedTech.
[00:02:11] Tyler O'Malley: Sure. So, I'm the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen. We're a specialty diagnostics company focused on autoimmune rheumatic diseases. So we develop proprietary testing technology for conditions like lupus, rheumatoid arthritis, Sjogren's disease, as well as many others. And yeah, our focus is trying to find solutions for patients who are dealing with what are many times challenging chronic diseases that can present themselves in very mysterious ways oftentimes. And so, these are challenges that patients have that have, for the most part, gone unsolved for many decades, and so there's a lot of opportunity out there.
In terms of, myself, my background, I've been with Exagen for the past 11 and a half years. So I've been doing this for a while now, and I've worked in a couple of different areas within the organization, doing work within the lab assay development, as well as outside the lab doing clinical research, statistical analysis, which led to the bioinformatics role. And then as well as doing some work trying to align our clinical evidence with medical policy for our tests which is the market access role. So, a little bit of everything, but there are some through lines that I assure you do make some sense if you really think about it.
[00:03:33] Lindsey Dinneen: Excellent. Excellent. Well, thank you for sharing a little bit about that. There's so much to dive into, but going back a little bit in your story, when you were thinking about careers-- you're a eager high school student ready to embrace college, and you're ready for the next step --is this something that you could have imagined yourself doing or has this always been a passion of yours? Or is this something you kind of found yourself in?
[00:03:57] Tyler O'Malley: Not at all. So, no I, so I will say I've always been interested in autoimmunity. So that's always been something that has always piqued my interest, whether I was in high school or college. And so I guess in that sense, it's not a surprise. But the laboratory diagnostics component of it was not something that was on my radar when I was in high school or college.
And I guess the journey to Exagen was, after graduating from high school, went and got a bachelor's degree in biology with a biochemistry focus. So, that's sort of my background there. And while I was getting the degree and focusing on biochemistry, I had the opportunity through a resource scholarship at Georgia Tech to work in a graduate lab, which was a really interesting experience where, you know, for a little over a year I had the opportunity to work alongside PhD candidates, postdocs, on a research project that was partially funded and get the experience and understand what it's like to work towards a PhD and what it would look like to kind of go down that path of graduate level research.
And I think it had the opposite effect that it was intended to have in that it kind of showed me I didn't want to do that. So, I think in a lot of ways I was happy I had that experience 'cause it showed me before I went down that path that it was something I didn't wanna do. Nothing against it, I guess I wanted to do something that maybe had more of a translational impact, a little bit closer to the patient.
And so, finished my degree, and at the time I was living in Georgia, so I finished my degree in Georgia, left and moved out to California, and ended up at Exagen by pure chance through a recruiter. And that was back in 2014, and basically just joined Exagen at the time when it was a smaller company, and grew with the company, and was fortunate enough to have the ability to learn a lot of different functions within the company as it grew, and there were a lot of different things that needed to be done a as the company was growing. And so it, it's been kind of a, an interesting ride since then.
[00:06:08] Lindsey Dinneen: Yeah, absolutely. And of course all of those different experiences, I'm sure, have woven their way in, like you said. Sometimes you have to kind of look for that line, but there is one that's, apparent when you look back. So, can you talk a little bit more about the company, what it does, especially in regards to its testing technology, and I'd love to hear about some of the innovation that's just coming out of this incredible organization you're a part of.
[00:06:35] Tyler O'Malley: Sure. So our our testing, again, primarily focuses on addressing unmet needs in patients who have autoimmune connective tissue diseases. And specifically we have some proprietary technology around biomarkers that help diagnose systemic lupus. And lupus is kind of the prototypical autoimmune disease in that it can manifest in just about any different way. It can show up in your skin, your heart, your lungs, your kidneys, just about any way you can imagine, and sometimes in multiple different ways. And so in that way, it can be challenging to diagnose 'cause it can look like so many different things. And much of the testing that is used for lupus or has been used traditionally is very antiquated. Antibody tests that were developed many decades ago that have been refined to some extent over the years, but for the most part are not overly sophisticated.
So, what Exagen has done over the past 15 or so years is brought forward some technology, that was originally licensed from University of Pittsburgh, looking at measuring a form of the complement system, which is a part of our immune system. It's a very ancient form of our immune system. It's a collection of proteins that come together to help fight off pathogens and help clear debris to keep our our immune system healthy. And what we're able to do is measure essentially the buildup of a complement fragment that builds up on your red blood cells and on your B lymphocytes. And what this does is it gives us a unique ability to detect lupus that's much more sensitive than the conventional means. And what that means, when I say sensitivity, is that it's able to pick up more lupus patients than the conventional testing.
So, one way of thinking about this is like, if you have a hundred patients in a room that all have lupus, right? Because they've been assessed by a doctor, they've been clinically diagnosed, and you were to test them, and say your conventional test is 50% sensitive, meaning half of the room would test positive on this test and the other half would test negative. This test that we're talking about here, it would pick up two thirds of the room, right, as opposed to conventional testing, which would pick up fewer patients.
So, that's the kind of technology that we're trying to develop here, which is trying to be more inclusive, pick up more patients sooner, give better insights to physicians to combine with their clinical assessments such that patients can get earlier treatments and hopefully stave off some of the more kind of disastrous outcomes of the disease that come with not getting treated soon enough and not getting treated appropriately for their symptoms.
[00:09:31] Lindsey Dinneen: Yeah, of course. That's incredibly important and I'm so glad that the company is working to create those solutions, like you said, because previous methods while maybe somewhat useful, are more antiquated at this point. And so it's really important to have these new strides in innovation. So as you're dealing with all of this, I'm sure that there are stories that have come up about real people having impacted lives because of the technology that your company is bringing. Do you have any examples that you could share with us about that?
[00:10:05] Tyler O'Malley: Sure. Yeah, there's been a number of individuals that we've had the fortune of meeting over the years. And they come and share the story with our team. We like to bring folks in with, for example, when we bring on new sales team members, we try to bring on a patient just to be able to share their story. So, recently we had an individual, who is connected to someone who works in our organization-- again, just pure chance-- who happened to have a very unique story.
So first of all, lupus, for those who don't know, is a condition that primarily affects women. Lupus is a disease that affects women at a ratio of nine to one, nine to one female to male or so, in other words, around 90% of lupus patients are women. But that's not to say that it isn't an issue for that subset of of men that do develop lupus. And in fact, the disease tends to be more severe in that 10% of lupus patients that are men.
So this individual who we've had the chance to meet and hear his story, really interesting because he's-- you would never know if you met this guy-- because he's a CrossFit guy. He is probably the healthiest guy you can imagine looking at him. But he went a harrowing journey to get to his diagnosis. And it all started with, relatively -- well, I don't wanna downplay it-- but let's call it "less severe symptoms" like alopecia and rashes, things like this that sort of make you think, "Well, gee, that's strange," or "I wonder what that is all about." And then leading up to much, much more severe symptoms like severe edema and pericarditis that was ultimately life threatening.
And ultimately, he was able to get the right testing and get to the right doctors, but it was not a short journey from the time that these symptoms initially presented themselves to the time where he was able to get to the test and to get to the right diagnosis and onto the right treatment. The good news is, he's in a much better place now after finding out what's causing his symptoms and getting to a treatment management plan that works for him and he's even back to getting to an exercise routine that works for him.
It's maybe not exactly the same as what it was before, but I mean, that's the thing. Now, you can lead a relatively normal life with lupus. It wasn't that long ago, call it several decades ago, where the mortality rate for lupus was as high as 50% in the first year after diagnosis. Treatment advances have greatly improved that and have changed the lives of people who live with Lupus now, but it used to be a very severe diagnosis. It still is, but it's very manageable now.
[00:12:54] Lindsey Dinneen: Wow. Yeah. And so catching it and having that answer to, like you said, really difficult health journey where you're just not sure what's going on. And I really appreciate you talking a little bit about how Lupus looks different and manifests itself differently in different circumstances so it can be difficult to initially diagnose. So I love the fact that the company is focusing on things like that, when caught early can maybe make a huge difference in somebody's life like the gentleman you mentioned. Thank you for sharing about that.
So now your own career has been really interesting in that you have gotten to do a lot of different things within the company and learn so much. Now as you've continued to grow with the company, you've, I'm sure, developed a lot of different leadership skills along the way, and I'm curious what it's been like in that sense of your journey to embrace leadership and how do you go about it? What have you found works really well, and maybe what advice would you have for somebody who's a little bit earlier in their career?
[00:13:58] Tyler O'Malley: Yeah. Really interesting question. And I, I guess, my experience was, I came into an organization that was, I think at the time, maybe in the entire company was maybe 60, 70 people. So, as you can imagine, it was a very flat organization. I reported directly to the Chief Scientific Officer when I first joined the organization as a relatively low level R&D employee. So that afforded me, I think, a unique opportunity because I was often involved with project planning and discussions that I don't know that you get that opportunity in different types of corporate settings.
And I think what has proven very useful in terms of my development, and as I look back and reflect on kind of what's led me here is, I can just recall, so, so many times, especially early on in, in a startup-- which can sometimes be chaotic and there's a lot of moving parts and things are moving fast-- there would be times where I would be in meetings where I wasn't necessarily expected to do very much, I think, or contribute much. And I would just sort of observe, right? And I think there's so much you can learn through not just listening to the conversation, but the body language of the people around the table. The way that people present, the way that people take criticism, the way that they respond. It was almost like a, it was a lesson every day just watching that.
And I think where I thrived and maybe added value at times was realizing when people were talking past one another and just, at times, trying to find a way to come into that and say, "Well, right, but did you consider maybe what this person was trying to communicate here?" And, you can't always resolve those sorts of situations, but sometimes you can. And that's really valuable when you can help two individuals get past an impasse like that. So, and I think it helps you build credibility doing that too, being a bridge builder in that sense.
And, and I think, that was something I don't know-- whether intuitively or purely by accident, I don't know-- I figured out over time was that, maybe as a young person in your career, sometimes it can be easy to get caught up on sort of the X's and O's of your job, whatever it is that you're doing-- if you're a computer programmer, you're doing bioinformatics or whatever the case may be-- you can get really caught up in the technical skills that you're trying to hone and develop. But there's so many soft skills that you have to build as well at the same time. And there's the relationships that you build, as well, that you don't know when you're gonna need them or when they'll pay off. But things change at organizations and you're glad when you have those relationships when it comes time to need them.
[00:16:51] Lindsey Dinneen: Yeah. Absolutely. Yeah. I love your discussion on the idea of being a bridge builder, because I've been thinking a lot about that recently where there's so much unintentional missed communication, just literally just passing by where, one person is saying something, the other person's saying something, and as an outsider, you're able to have a little bit of a distance to go, "Oh, you're kind of saying the same thing, but I'm not sure that you guys realize that, and here's how." Yeah, that translating is a really important skillset and a fun one when you can nail it down. So as you look towards the future of your own career and the company's trajectory, what are some things that you're looking forward to?
[00:17:35] Tyler O'Malley: Well, we obviously have a number of exciting pipeline initiatives that bring a lot of energy to me as I think about what we're trying to do going forward. I'm excited about where the company is headed in terms of its trajectory. I've described my time at the company as, even though I've been at the same company for 11 and a half years or so, I really feel like I've worked for three different companies in that time, in that, there was a period of time that was a startup up until the point the company went public.
And then there was this time from when the company was public, where we raised a lot of money, there were a lot of expectations and didn't exactly kind of work out exactly as we had hoped. And then there was a leadership change. And now we're sort of in this third phase now where the arrow's pointing up and we have realigned our strategy here and we found a way to be sustainable and to be able to continue to build on something where hopefully we can continue to find interesting technology that's out there.
We have an ongoing partnership with, as an example, Johns Hopkins University to try to develop a test to help address lupus nephritis. So this is a particular form of organ manifestation of lupus. It's one of the more common manifestations of lupus, and one of the more devastating forms of lupus, in that almost 50% of lupus patients will have kidney involvement at some point in their disease. And as much as 10 to 20% of patients who do have lupus nephritis will go on to unfortunately develop end stage kidney disease and require dialysis or kidney transplant. So it's obviously life altering and can be, very impactful to individuals. So, to be able to work on something like that and be able to potentially alter the trajectory of someone's life in that way is pretty cool to think about.
And, not everyone gets to do that. I mean, it's not that other jobs aren't meaningful, it's just not everyone gets the opportunity to do that kind of thing. And if you can also find joy in what you're doing in your job. I think that's also great too. I mean, it's really cliche, the things people say, and so I won't do it. The whole, like, " If you like what you do, you never work." Believe me, it's work. I do feel like I'm working sometimes, for sure, but I can't complain. I do, for the most part, have fun with what I'm doing. I'm fortunate enough, I have a great team of people, well-- three teams of people-- that I really enjoy working with, and being able to work with people and see them grow and develop and be a part of that is also super rewarding as well too. So, yeah, I'm just, I'm having a lot of fun.
[00:20:26] Lindsey Dinneen: Yeah. Excellent. Wonderful. Well, gosh, I'm gonna pivot the conversation just for fun a little bit. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. Now, this could be within your industry, but it doesn't have to be. What would you choose to teach?
[00:20:45] Tyler O'Malley: I think that-- maybe this is kind of fun, probably not-- but I think that ,I don't know why, and it's funny because it's-- I don't even know if this qualifies because I don't even know how I would teach it-- but I think I'm fairly good at guesstimating numbers and it's really useful in that it helps in a lot of different situations to be able to shortcut math. And to be clear, it's not that I'm doing long division in my head or anything like that, but it's, if you can kind of shortcut and get the approximate number, it can be really useful. And it's a nice kind of party trick too kind of thing. Again, I don't know how I would teach it 'cause it's sort of like it's up here, and I don't know how I would externalize that, but yeah, that's something I feel like would be kind of cool to figure out how I could teach that.
[00:21:35] Lindsey Dinneen: Absolutely. Yeah. It's a superpower. So it would be very cool to try to then-- you've got this innate ability-- so then to try to break it down into how does somebody else develop the skill sets that you just sort of possess, and go from there. That would be really entertaining. I love it. Great answer. Okay. And then the next question is, how do you wish to be remembered after you leave this world?
[00:21:59] Tyler O'Malley: Yeah. Well, that's a deep question. I think that the most meaningful impact that you can have is the impression you leave on the people that you interacted with, right? And I think, for me, I would just hope that the people that I've had the chance to spend time with-- obviously family, friends, people I worked with, people who worked on my teams-- I would just hope that as they would reflect on the time that we had together, that it would be a memory that was time well spent and that hopefully there are some good shared experiences that we had and that hopefully I left something that was meaningful. But as it relates to the work that we're doing, I hope that the impact that we're having-- some of it has a longer reach than even what we can see today, 'cause I think, truly being selfless is trying to build things that you'll never realize the benefit of: planting trees that you'll never sit under yourself. It's for someone else down the line in the future.
[00:23:14] Lindsey Dinneen: Yeah. Yeah. I love thinking about it in those terms too: being willing to do your bits of good and let them go out into the world and not necessarily know the ripple effects and still use that as a worthwhile use of your time. I love that. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:23:39] Tyler O'Malley: Yeah, I think the easy answer is probably my kids. So I have two kids, and that's kind of the reprieve from the work life and kind of focusing on all this important stuff that we're trying to do here at work, but being able to kind of break away from that and focus on building them up and watching them grow and develop and become their own person is really cool. It's obviously a unique experience and it's a nice thing to be able to think about when you need something to kind of bring you back up.
[00:24:12] Lindsey Dinneen: Yeah, absolutely. Just a different way of looking at the world from such a fun perspective. I love that.
[00:24:19] Tyler O'Malley: Yeah.
[00:24:20] Lindsey Dinneen: Yeah. Well, Tyler, this has been such a great conversation. I so appreciate your time today telling us a little bit about your story, the company, and all the incredible work that you guys are doing to change lives for a better world. And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and thank you so much for being here and thank you for doing what you do.
[00:24:59] Tyler O'Malley: Thank you. It's it's been a pleasure.
[00:25:01] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.
[00:25:14] Dan Purvis:  The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world. 

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