Episode 52: Mark McDonough- President & CEO of ChromaCode

Ever wondered how technology could drastically improve early detection in healthcare? Let us take you on a journey with Mark McDonough, President and CEO of ChromaCode, as we unfold the world of molecular diagnostics with a special focus on HDPCR technology. Mark, with his diverse background in the military and healthcare, brings a fresh perspective to the table. He shares his unique insights on leadership and the challenges that come with introducing ground-breaking technologies in a traditional industry.

First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder. Episodes launch weekly on Tuesdays. To view the full transcript of this episode, click here.

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Chapters

• 0:07 HD PCR Technology in Molecular Diagnostics
• 11:36 Early Detection and Future Contributions

Transcript

Speaker 1: 0:07

You are listening to First in Human, where we interview industry leaders and investors to learn about their journey to inhuman clinical trials presented by Vile, a tech-enabled CRO hosted by Simon Burns, ceo and co-founder. Featuring special guest host, rich McCormick, evp of Clinical Strategy and Head of Oncology. In this episode, we chat with Mark McDonough, president and CEO of ChromaCode, delve into the transformative impact of ChromaCode's HD PCR technology in the field of molecular diagnostics and its profound implications for patients.

Speaker 2: 0:43

Hi, I'm Rich McCormick, executive vice president of Clinical Strategy, here at Vile. Today I have the pleasure of welcoming Mark McDonough, CEO of ChromaCode, to our First in Human podcast. Hey, Mark, would you mind giving us a brief introduction?

Speaker 3: 0:57

Good morning and thanks for having me. My name is Mark McDonough. I'm the president and CEO of ChromaCode, based out of Carlsbad, california, and been with the company since the beginning of the year. My personal background is about 26 years now in the healthcare field. It's the fourth company I've run, so I run both private and public companies. Really excited about what we're building at ChromaCode here and leveraging our proprietary multiplexing technology to help patients across the world, so I'm excited to jump into it with you.

Speaker 2: 1:31

Thanks, mark, welcome again. So, as CEO of ChromaCode, what inspires you to push boundaries and lead ChromaCode towards innovative breakthroughs in the diagnostic field?

Speaker 3: 1:41

Two things really.

Speaker 3: 1:43

Number one our goal is to help patients, so we've built this technology with that first and foremost in mind, and so for me personally, cancer as it does for, I think, everybody that strikes close to home.

Speaker 3: 1:58

I lost a good buddy to biliary cancer this year at the age of 54.

Speaker 3: 2:03

I have another friend who's 53 years old and who's just diagnosed with pancreatic cancer and is in stage four in undergoing treatment now, and lost a brother-in-law to lung cancer, and my mother-in-law right now is successfully battling stage four lung cancer because of the advances that we didn't have 10 years ago when my brother-in-law passed. So what's really cool and inspiring to me is that the technology that we're going to talk about a little bit more detail that can give faster results the high quality, comprehensive results quicker has a profound impact, and so my inspiration is helping patients get better answers earlier in the process. And then, secondarily, the success we have as an organization has a trickle down effect. There's 65 employees here, many of whom have families and children, and the more success we can have doing good things for society, but also it's okay to have a little bit of a selfish reason for success too, because that can help, as our company succeeds, those families succeed, and then it can be generational in terms of passing on education and other good things that come with that.

Speaker 2: 3:14

As someone that's been in oncology research for over 20 years, those personal stories that really continue to keep that fire burning for myself, for my team. So, yeah, I appreciate you sharing the personal note there. So your background includes a remarkable mix of experience, including military service as a US naval officer and then extensive healthcare tenure. How these diverse roles shaped your leadership style and guided your approach to steering growth in healthcare organizations.

Speaker 3: 3:43

What I learned very early on as a 22-year-old officer who was in charge to lead people who had significantly more experience, especially tangible experience on board. A shift was that I realized, first of all, people are people and, secondly, doesn't matter what the education level on paper or the demographics that many of these men and women come from. There's a lot of incredibly talented people out there that you just have to bring the best out of. So I was very fortunate to manage large, diverse teams early in my career when I really didn't know I wasn't a subject matter expert or anything like that and I had to learn and work to bring the best out of people and work towards common goals. And that's something that we certainly did is, in part, that we want to be the best at what we do and guide towards common goals.

Speaker 3: 4:35

And then, as I've transitioned out of the military into civilian world and had success as sales executive and then in the leadership, I also learned that there's a number of different styles that need to work and you need to adapt to your team. That's something that, as a young regional manager, I may have had a viewpoint of what the ideal salesperson looks like, and that wasn't always correct. So I really learned a lot over time of how to leverage the mastermind principle and get a number of smart people in the room and come to consensus and make good decisions where you bring the best out of people, and so I've been blessed to be in leadership positions even since the earliest days in my Navy experience. But you never stop evolving and learning how to be the best you can be, especially as the workforce changes, as times change, what's coming out and what. Joining the workforce has a different mentality than maybe 25 years ago on some things, and so trying to get the best out of people is really important.

Speaker 2: 5:35

Yeah, I agree with your comment around different backgrounds. I once had a project manager on one of my teams that had a different background. He was actually a police officer by training and clients would sometimes pass on him for that reason and I would like no, this is someone with that it factor. You don't want to pass on this guy managing your project. So it's interesting and it really rounds out your team when you have those different backgrounds. So in a rapidly evolving like the field of molecular diagnostics, what hurdles have you encountered while introducing your innovative technologies like HD PCR to an industry that's rooted in those traditional methods?

Speaker 3: 6:09

There's a few things. Number one when you're creating like groundbreaking technologies or tests, like we are and I've done this now with a couple of different companies with different technologies and really excited about what we're doing with HD PCR, which we'll talk about you need a few things. Number one you need to realize that it's not necessarily that people have a fear of change, but people need to understand why they have to change. So the body of evidence that you need to produce when you're pioneering is pretty significant. So my advice to someone who's trying to come into that is just make sure that you're planning on the cost and time that it'll take to build that body of evidence, because people aren't just going to take your word for something. What good reason, right? We're talking about making healthcare decisions that lives depend on, so you need to be able to prove what you do. Number two especially in healthcare, you need to secure payment. So with that body of evidence, you then need to prove to government payers, such as Medicare or private payers, like this works, and this is going to have not just an impact on patient care, which is number one important but number two can help obviate or eliminate some costs that are currently in the traditional methodologies and so securing payments really important.

Speaker 3: 7:26

And then number three, and there are a lot of these leading edge clinical investigators, as you know, for your time of research, you need to find someone or several folks with a objectively widely held good reputation to become an adopter of your product and really understand it and be able to communicate the benefits of it. So it's not just a company explaining what the benefits are. There's leadership out there. We call them, as you know, in healthcare, key opinion leaders or KOLs, but you need a cadre of KOLs to actually firmly believe it, not just speaking for you without believing in this. So those are really the three things.

Speaker 3: 8:03

I think that building the body of evidence well, an obvious one. Fourth is you need to have a product that can really stand up as if you're going to pioneer technology and be game changing. So you know you need a great product. You need the folks who are endorsing it that are leaders in the space. You need to be able to articulate that to the payer community so you can get this reimbursed, so that when centers adopted, they can get paid for it, because no one wants to just take on technology and lose money. It's just not the world we live in.

Speaker 2: 8:32

And then, last, I have building evidence. So one of the challenges that labs often face is choosing between speed of real-time PCR and then the comprehensive results of NGS. How does HD PCR provide critical and complete data while maintaining simplicity and affordability?

Speaker 3: 8:52

So HD PCR is an acronym for high definition PCR. The first application that we're using, our high definition PCR, is in lung cancer, and so think of it as a combination of unique chemistries with incredible software back in and intellectual property protected multiplexing capabilities that significantly increase the amount of targets her sample that can be assessed quantitatively on a digital PCR instrument. So that's the platform. So with lung cancer, we have built an assay leveraging our multiplexing technology that looks at 15 biomarkers in three PCR wells, and so those 15 biomarkers are complete according to the national NCCN guidelines. So for the commonly held guidelines that all the oncologists follow of what's recommended for lung cancer, those 15 biomarkers are the comprehensive nature of that. So we're able to leverage our technology to look at the nine key genes which have the 15 biomarkers recommended by the NCCN. The real benefits are we can get answers back in less than 24 hours.

Speaker 3: 10:02

The technology enables using significantly less tissue and with lung cancer and you're taking a biopsy, it's not fun, it's painful and the cliche which is true is tissue is the issue with lung cancer.

Speaker 3: 10:13

So being able to test on a small amount of tissue, like we can with the chroma code HD PCR technology, has a unique benefit to the patient because we can get answers significantly more than what they can with conventional means. And what I mean by that is oftentimes, if you don't have enough tissue, you'll get a what's called quantity non-sufficient. So a patient will be waiting for a result for a week or two, and it's the worst of all worlds. Not only are you waiting a long time, then you don't even get a result because you didn't have enough tissue. So we don't require much tissue. We get answers back very, very quickly. It's less expensive technology. And then, with the software on the back end, the needs from a bifermatic standpoint are significantly less. What you need with sequencing. It's a really great technology. And then, of course, the comprehensive nature is such that it enables you to do a lot more than just traditional PCR but your non small cell lung cancer assay can detect over 200 variants.

Speaker 2: 11:12

So can you explain how this approach could transform how we test for cancer and what it might mean for patients?

Speaker 3: 11:19

Exactly 15 biomarkers, 200 variants, exactly. It's really about kind of what I was alluding to earlier, which is getting the right answers for the most relevant markers and variants much quicker. So what does that enable In the real-world setting? The patient presents lung cancer, they determine that you have that. We're trying to determine exactly now. Are there targetable agents? They'll run test PDL1 by immunistic chemistry. It could then choose to either run HD PCR with us or a single gene or next generation sequencing. But when they run with us they'll run their immunistic chemical testing, which you can be done in-house in less than a day. Run our HD PCR in-house in less than a day. Get the answers back.

Speaker 3: 12:10

If we find a targetable, relevant biomarker, start treatment right away. So what impact does that have? Number one it significantly alleviates any angst from the family. They feel like, okay, we know the stings were in a tough situation, but now at least we know we're dealing with and we can start treatment. That gives us the best chance for a positive outcome.

Speaker 3: 12:31

Like I said, my mother-in-law now has been. We thought she was in really, really rough shape at Thanksgiving and they put her on the right treatment right away. And here we are now, nine months later where things are looking really, really good. So that's what the importance of early detection is. And then, conversely, if we don't find out anything with our assay and the immunistic chemical pathway about 45% of the time you won't and you can reflex to sequencing then and find out if there's anything else in the much wider breadth of 500 genes that we can determine there. So it really helps the clinicians much quicker to determine the treatment regimen, thus helping the patient and again the healthcare system, because we're not just doing treatments that are just shotgunning them.

Speaker 2: 13:26

All right, mark. So switching gears a little bit, maybe outside of your day-to-day at ChromaCode, what's peaking your curiosities in the industry? So what kind of topics are you exploring? What are you Googling just to keep up with what's going on?

Speaker 3: 13:39

Yeah, I mean there's a lot of exciting things going on in the space now that I'm interested in, from proteomics to spatial genomics, and it's interesting to see just kind of where the puck is going, if you will part of the sports cliche in our business and trying to stay educated on that. From a personal standpoint and just from something that we have with my son, I'm very interested in how we can, as a society, manage chronic diseases, chronic diseases better. Too often we're treating symptoms and not root causes, and that's why technology like ours and lung cancer and others we need to find applications across the board and be able to continue to find always the root cause. And how do we best assess how we can leverage therapies and leverage our own immune systems, et cetera, to help people get better in that regard? So those are kind of some of the things I'm looking at, from both what I'm interested in and our space, to things that are intriguing personally to me.

Speaker 2: 14:41

Lastly, maybe looking ahead a little bit, what advancements and contributions in the emerging trend in technology space do you hope ChromaCode will make in the coming years?

Speaker 3: 14:53

One of the trends that we're seeing more and more of is using decentralized testing and using more tools in the laboratory setting as opposed to sending them out to central locations, and this is an area that we think we can really make a huge impact in lung cancer with therapy selection tools optimized on digital PCR instruments and eventually in organ transplant rejection monitoring, where we really feel that we're going to be able to bring the market a application in the next couple of years that will help folks do this testing on site in less than 24 hours to really help patients as they're trying to determine is the organ going to fail and we're not, and so do we need to do a biopsy and stick a needle in that organ to test for that, and we want to preclude that.

Speaker 3: 15:47

So we're going to have at ChromaCode again. It'll take us some time, but over the next couple years we're going to have a way for folks to run this internally in their own laboratory on a digital PCR instrument. Testing in less than 24 hours we think can be gain-changing. So these are some of the contributions we intend to make. We intend to continue to make significant headway in lung cancer as well as other therapy selection tools and we're doing some great work in minimal residual disease in the very early stages that we hope to be able to communicate more about in 2024 and beyond as well.

Speaker 2: 16:24

It's really exciting. So, mark, it's been a pleasure meeting with you today. The team here at Vile wishes you, your family, your ChromaCode team, all the best in the future. Thanks for joining us today, alright thanks so much.

Speaker 3: 16:35

Have a great day guys.

Speaker 1: 16:43

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