← DGTL Voices with Ed Marx
DGTL Voices with Ed Marx
Streamlining the Clinical Trial Process Using Innovative Technology (ft. Scott Chetham)
00:30:06
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- [00:02]
A
Thanks for tuning to Digital Voices podcast where we chat digital transformation challenges and opportunities across healthcare and life sciences. And now your host, Ed Marx.
- [00:18]
B
Hey, welcome to another edition of Digital Voices. I am with Scott Chettam. Scott, welcome to Digital Voices.
- [00:25]
C
Hi, thanks for having me.
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B
Scott is the founder, co, CEO and founder of Faro Health. And we're going to jump into Farrow in just a second, but I want to share how we first met, which is really just sort of online, so LinkedIn and seeing some of the things that Faro Health is doing. And we haven't really covered clinical trials much on Digital Voices, so I thought it'd be great to have you on. And Scott, as you know from perhaps listening to previous episodes, the most important question we ask is the first one, and that is what songs are on your playlist?
- [01:02]
C
Oh, wow. Mine is very eclectic because my son is close to three years old and to try and introduce him to Australia, my actual most played song right now is Give Me a Home Amongst the Gum Trees, which is a very famous Australian song that any Australian will probably be able to sing for you. So I've been trying to indoctrinate him early into that. And then it's everything between Morgan and Wallen, some other Australian artists, and like Powder Finger, I doubt anyone's heard of here all the way through to Marshmallow. So it's a little bit all over the place.
- [01:37]
B
No, we love that because we do have a Digital Voices playlist and we love adding new material and you definitely drop a couple of new ones for us that aren't on that playlist yet. So that's awesome. And I like the fact that you're trying to incorporate your heritage with your. With your family. And I imagine we'll touch a little bit on that in a minute before we get there. Scott, what about your life message or mantra? Are there words that you sort of live by or help guide you?
- [02:07]
C
Yeah, that's always a very interesting question. I think for me it's just keep putting one foot in front of the other. Hard things are just hard, but they don't happen to get good at something. It doesn't happen overnight. You just have to start somewhere and then learn from it and keep improving on it. I think that's the main thing is if you get knocked down, you've just got to get up again and keep going.
- [02:31]
B
Yeah, sounds like another song. I know I get knocked down get up again Now I'm showing my age because I think that was from the 80s or 90s or something. I have Some favorite Aussie bands. Again, it's going to show my age a little bit, but split ends, I think they're part of. Ellen. I think maybe some might be from New Zealand, but some from Australia. And then of course everyone knows men.
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C
At work, so there's.
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B
So those are the, those are some of the 1. The Aussie bands I grew up listening to. But tell us about yourself because obviously we sort of identified your accent a little bit.
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C
Yeah, it depends what you kind of want to know in that question. You know, everybody is a lot of things, but I guess if I'm going to abstract out a little bit, you know, I'm a father, a husband, a son, a brother, friend to a lot of people and I'd say, you know, also the CEO of a company. Yeah, probably the order of importance as I kind of listed it out. But yeah, I've had a lot of titles. But the one thing, you know, that surprised me is I think dad is the most important that I've ever had.
- [03:49]
B
How many kids do you have?
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C
Just one. We'd love to have more, but you know, I think we aged out of that, unfortunately. Waited later in life to have kids, which I don't regret because we were focused, you know, my wife and I were focused on, you know, other important things. I think we just. I underestimated how much I'd actually enjoy being a dad.
- [04:11]
B
Yeah, that's very cool. Really important role. What about growing up in Australia and then when did you, you know, move?
- [04:24]
C
Yeah, so, yeah, I was born in a little city called the Gold coast, which is spectacular. It's about 100 miles of perfectly white sand. Whenever I take people or family members from the US home and friends, they go, why on earth did you leave? One of the values that underpins Australia is a sense of fairness. I think that kind of percolates through the entire country. Yeah. And so it kind of, if you could mix, I would say the United Kingdom with the US that's probably explains a lot of Australia. But I was there. I went, did all my university study that studied there for nine years, then around 29. So quite nearly 18 years ago I moved to the US for work. So it was a two year trip that turned into 18 years as of, I think actually about a week ago. So obviously I, I really love living in the United States, but it's hard. I mean, I miss my. I'm lucky in that I've got two places I can call home. But you know, if I go there, I'm always going to miss the family. And friends I've built here and, and vice versa. So that, that's the tough part. Yeah, yeah.
- [05:39]
B
No, it's a beautiful country. I've spent quite a bit of time there, including this year, and I'm headed back in the spring of 2025 to climb. I cannot pronounce it right. It starts with a K. Mount K, you know, it's the highest peak in Australia. North.
- [05:56]
C
Yeah, it, it's Polish.
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B
It starts with a K, but I'll get a climb it, so it'll be a lot of fun. It's a great country.
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C
You can drive almost to the top. Yeah, I think I've done the shortcut.
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B
Yeah, don't tell people about that. Yeah, it's actually, it's funny because it's one of the seven summits highest peak on every continent. And you can. Yeah, you can also take at least part of the way. There's a chairlift and I think you can drive to the top or near the top. But we're going to do the climbing route, obviously. But it's still a very. Out of all the seven summits, it's the easiest one of the seven, so. But it's going to be good to knock that one off our list. So you come to the United States after growing up in Australia. So how does feral health happen? There's had to be a couple things that happened before that.
- [06:45]
C
Oh, quite a few things. So I joined a company that was working on a diagnostic for congestive heart failure. So congestive heart failure is basically, as the heart fails, fluid kind of backs up into the lungs. It's one of the leading reasons for hospitalizations. But surprisingly, you can't look at someone and really easily know that, okay, they're carrying an extra, like, I don't know, quarter of a gallon of fluid around in their body, in their lungs. And so what we were working on in a way was to quantify that. And it was one of these problems that, you know, I forgot the name of the fable where the frog jumps closer to the wall and each time it closes half the distance and half the distance and you never quite get there. That was, unfortunately, my experience with this technology. We got better and better and better and it got more accurate. But the main population it needed to work in was in obesity. And we just never got it to work correctly with that particular, with that level of body fat. And so we tried and we tried and so in the end we ended up kind of selling it off because we couldn't quite close that final gap. And Then I was a venture partner at Versen Ventures for a little bit, and they were one of the leading investors in biotechnology, pharma companies and biotech companies. And then. And my main role, so if you understand my background is a clinical scientist, is my specialty is how do you prove something is safe and effective in a clinical trial? So I'm very focused on the science, and it very much is a science. But how do. If I put a molecule on someone, what am I looking for to make sure that, you know, there's no safety signals? It's a safe thing to give to someone, which is also separate to this other question is how well does it work? And then does it work well enough? And then you've got to weigh the two. Is this a good trade? Because whenever you. The way I kind of explain this to people is whenever you give anyone, let's say, a drug, it's a trade. You're trading one series of effects from the drug versus the benefits. And that's what medical practitioners should be helping you do, is how do you weigh those effects for you? And so what we try to do in clinical sciences is put enough scientific information together and work with the FDA to make sure that that is clearly written and articulated. By the way, that's what you call a label. So everyone kind of, you know, that big packet insert, like, you know, whenever you buy something that's huge and it unfolds. That's what we spend all our time creating. That's weirdly the output of 10 years worth of work in tiny little print you can barely read. But what we're trying to do there is really summarize for everyone all the scientific evidence that we've collected about what the safety profile is. Does it affect the liver? Might not. Or the kidneys or something else of this drug. How does it interact with other drugs? And then how well does it work and who does it work well in? And. And we articulate. That's what that huge piece of paper is about. That's actually what the FDA does. I'm probably going a little bit segue. But in reality, their job is they approve that label. They approve the wording that goes on that. And that's one of their main things on life. And that the data that you use to produce that label is true. So they come through and check everything. And so I was doing that for a job, and then Alphabet reached out. So Alphabet, which is the parent of Google, had at the time, this is probably 2016. Google X is kind of what I would say their Experimental arm, Google X employed me. They said, well, we've got all these interesting things that we've been working on. How do we prove they're safe and effective and how do we get them to help impact the lives of potential patients? And it was about as wild as you think. As a tech company going in there, I come from a very formal scientific background of training. And like, you work with regulators and this is, you know, things are black and white. And I would say a lot of the things that Alphabet was working on had a lot of gray. They could go in all sorts of different directions depending on what they chose to do with it. And they said, well, come in and help us think about this. So I joined them and it's public now. We spun out Verily Life Sciences, they had Google Health, and they started to organize all of these things into different, I would say, company vehicles to be able to move them forward. And then it's public too, that Verily Life Sciences, which is a subsidiary of Alphabet, kind of like a sister of Google, who does most of their healthcare work, has partnerships with the big pharma companies. And I am, by the way, it's a long, roundabout story of how farahealth came about is when we partnered with these big companies, and I've worked previously for big companies and small companies in kind of clinical designing trials. They worked across a large number of them at the same time. So I got to see across a huge number of the really large pharma and a few small ones all at once. That we actually all design trials the same way and we implement them. And it hasn't changed in the 25 years I've been doing this at all. And then there's certain implications to that in that every other field where you, if you're designing a home or a high rise, you have simulation software, we can go, all right, what would happen if I did X, Y and Z? We have none of that. The vaccines for the pandemic, the trials were designed in a table in Microsoft Word, and that's state of the art. And so when I started to think back and it was like, okay, this is, this is the source of a lot of our problems now. How do we fix that? So I took us, I basically said to Alphabet politely, I want to go off and do my thing. And so we kind of had a. I'm still friends with everyone there. We put in a kind of separation package and I hide several of my replacements and they let me unwind for six months. But what was nice is they Kind of paid me for. To surf for six months in Costa Rica. And so that's actually what happened is one day is I was like, okay, I want to solve this problem. They didn't quite know how to go about doing it. So I started listing off all the things I really hated about my job, which is I'm sick of reviewing clinical trial protocols. The thing that describes what has to happen for other scientists and then commenting on them because, hey, I went to school for nine, ten years as well. It's an argument of opinion. I'm sick of having them. And then red lines. It's like, well, because it's. My opinion's better than your opinion. Well, you went to school for 10 years. And then it comes down, I went to Union. It's terrible. And I was like, how do we get away from this and actually have arguments in data like, okay, this is most likely what's going to happen. And trials involve humans. You know, this is the key of everything we do is like, how does my trial design impact the patient who has to participate? And that is a huge problem for us in this field right now is because we've got much more complicated sciences. We have to measure more than we ever have before from patients. But ironically, it's actually really hard with the way we design trials to know before fire is how long am I even asking a patient to come in for a single day? If I ask them to come in for too many days? As a working person who has a job and probably has kids and has X, Y and Z, can you even do this? And so that's a lot of how far I came about is how do we give real time information back to the people as they make all of these decisions on is this thing feasible? Could you even do it? And then from there it kind of grew. And that was the kind of idea behind it is me sitting off one day in a surf break thinking, I hate all these things about my job. Then I realized that this is actually a specification for a product. Yeah. And I called my co founder and was like, I've got an idea. What do you think? And he was like, that's actually because I've had several coming up to this. And he politely tolerated them because they were pretty bad. By the time we got to this one, he was like, no, that's a real idea. That's good. And so we started to work on it and refine it. And then I got lucky. There's some venture capital funds that follow people that leave some of the big tech companies and ironically about that week, what one of them reached out to me and said, hey, what are you doing? If you're doing something, tell me about it. And so that's kind of how even the funding started. There's a lot of, I would say lucky timing.
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B
Yeah, no, that's, that's super interesting. I'm on the board of Mary Crowley Cancer Research, which is a Phase 1 clinical trials company. And where, where we, we do this, the trials and on patients. And so what you're talking about makes complete sense to me. But for those who don't understand sort of how the clinical trials works and the process that you're talking about improving. Can you describe Scott, just at a high level sort of the, the process as it exists today and then how Thyro health is sort of transforming that process.
- [15:48]
C
Yeah. So I'll keep it pretty high level, but let's say I have a molecule. It's something that we believe is safe to give to humans and has some efficacy things. So what we're hoping for, I'm going to stick to a common 1 GLP1 agonist. So the big weight loss drugs ever, because I'm familiar with how they came about, they had this idea for that molecule and so they will always start pre clinical, which means in an animal model to make sure it's to look for any early safety signals. But then humans are biologically much more complicated than anything else. The next step is humans. We have to start to design a series of experiments and we call them clinical trials where we slowly first off expose people to first it's very small doses of the drug and we don't even care what the effect. We don't care that it works or does anything positive. We just want to make sure that nothing awful happens or anything at all. We want to make sure that it's incredibly safe. So we start with a very small amount and then we add more and more and more. Then that's kind of early stage research. It's actually very methodical and how you come up with those dose calculations and scale it is really is a science. I always say sometimes it's a science combined with an art. There's a lot of deep experience that goes into that planning, but you kind of have to. It's like being an investigator in some regards because you have to think about anything that possibly could esoterically ever go wrong and you have to kind of look for that.
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B
Yeah.
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C
So these early stage trials in humans often collect a lot of information, but you're guessing a lot of it is guesswork in the beginning, it's like, could this happen? And some of it is out there and you kind of try to rein that in. Then once you've kind of got a feel for this thing is safe to give people. So we've given it to small and we start off like in it's usually like two or three people, only with a very small dose. Then if we wait and see what happens and if that goes well, we'll escalate up and we keep. And we keep escalating. And then we also expand the dosage, often over time as well, because some drugs accumulate and so the effects are different. So we have different kind of designs that take that into account. Once we feel that it's safe, we then usually start looking. Is there some sort of efficacy signal if I give this to people? Hopefully this, in our case, these GLP1 agonists, we're going to reduce weight. That's what they're looking for. And to lower blood sugar. And how long does it take to see that you'll design a trial to answer that scientific question? I believe it's safe. So my next step in that would be probably to choose a couple of doses that look like they might work. I usually always want to. The thing we're always looking for. What is the least amount of a new drug we can give someone to see an effect? Yeah, that's partly what we're trying to answer. And so we'll design a trial that kind of meets those requirements. And then later on, once you answer that, it's all sequential. Once you've answered that, you can go on to what we call like phase three or market access studies, where these are in large numbers of people now, where you really have to scientifically prove that. Does this thing answer a question like, let's show this thing reduces weight by 10 or 20% over let's say a year or something like that. So all of that today is done in Microsoft Word. And these are complex documents. They have hundreds of pages long. They take three to six months to write. And what I think is the biggest sin of all is in my. And unfortunately this is still the case before fire is every time I learn something, I make a change to the Word document in Redlines, which we're all familiar with. We all review it and we sign off. Then we clean it up and put it in a filing cabinet. It's an electronic filing cabinet. And we forget anything we ever, ever learned. And this is unfortunately the state of the art. So what does FHIR really solve in this is that if you reimagine this whole thing, that instead of using complex, huge amounts of words to describe everything, we can capture the essential concepts in tables that are kind of very easy to understand. And they're already in the documents. Look. They look. So we haven't changed a lot that way. But what happens when you work in our system, when you start putting these tables together, saying, like, I'm going to measure, like weight on day one versus day. Very simple. This drug reduces weight. If I measure on day one and the last day of the year, it should have gone down by 10%. So what would have to happen traditionally is I'll write weight and I'll put like a table. I'm going to measure it on day one, I'm going to measure it on day 365. And then you'll have to have meetings with people to go, okay, if I'm measuring weight, I need weight scales because this is being done in lots of sites. I'm going to have to calibrate them. What units are we measuring this in? Because this is medicine. It'll be kilograms, so it'll be metric. What's the precision? Is it like three digits? Like 1-1-00-1.1? So, and this is the tip of the iceberg. When you start to get into labs and all the other stuff, the amount of information we're collecting and the amount of meetings you have to have to determine this is huge. But what Faro does is when you put into our system weight, it's smart enough to know under the hood that for these particular things, here is all the information required to measure it, operationalize it. Here's actually what it would mean for a patient. Here's much costs across the United States to do this. And so all this really complex, laborious work is done for you.
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B
Yeah.
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C
So what it really means is as people who teams, the best trials are designed by teams, takes a lot of people. It means that teams can spend their time on better stuff. And then we use LLMs, which are really exciting right now, AI to automate writing and other things. And again, it's not about. None of this is about, I would say saving human labor is having people spend time, you know, very highly trained, very expensive people spend time on more valuable things.
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B
Yeah.
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C
And then compressing the timeline down because one of the things. This is a step sideways, but I think we all hear drugs are expensive. They are. But the reason drugs are expensive is a general clinical program to get a drug to market now is between 10 and 12 years, we're nearly up to $2 billion. And you have, I think the current status, you have a 6% chance of success as of this year. Now to financially, what other industries outcomes are so bad that are so expensive with such a small percentage chance of working. So to do that, you have to have a big return on capital. Well, no one would invest in new drugs. No one would. It would be. And so just inherently to get that return, you have to charge a higher price. And I think this is, that this is not me justifying bad behavior and other things in pharma. It's just the reality of what is actually driving the price of drugs. And we hear a lot in politics and it's like it's not, it's just the science is complicated. If you want to impact this, the best thing we can do is pull that 10 to 12 years down to six.
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B
Yes.
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C
And that's kind of what Faro and some other companies like mine are highly focused on is we control the work we do and we know how long it takes to design a trial, six to 12 months to do all this work. If we pull this into one to two months over the next several years, we're pulling these timelines of 12 years eventually down to 5, 6 years. And that's how you reduce the price is you have to kind of work on the, you got to work on the infrastructure of the system that's running this.
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B
Yeah, it really comes down, you know, time to value and in this case the value. Yeah, there's definitely monetary value, but it's saving people's lives faster. Right. Because these drugs, you know, the ones that do successfully go through the various phases and get to market, they're helping people, helping in their lives. So the sooner we can get them out there in a safe way, the better.
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C
Yeah. One of the things that's nice about sitting in my seat, even though we don't really get to see our customers data, it's all private when I do interact with our customers. These are some of the big enterprise pharma companies. There's some really exciting things coming in this, particularly mental health. A lot of next generation antipsychotics with none of the side effects of the current ones. It's an exciting time and they get finally getting pretty close. These things we should start to see in two to three years now.
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B
Yeah.
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C
So it is really exciting time in this field.
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B
Yeah, no, I'm thrilled. That's why I wanted to have you on and talk about it a little bit because I know that it's been a legacy of a very manual, intensive process. And like you said, there's not been a level of sophistication when it comes to automation and modern tools. And now Faro Health has taken that to the next level. And again, getting the drugs out faster as a market means more people can be helped. So that's really cool. You know, throughout your talk, Scott, you know, it's clear that you're a great leader. Was there anything specific that you can point to that had helped you like early in life that helped you become a successful CEO?
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C
I don't know. I seem to get leadership positions because when I'm not in the room, that's a little bit of the story in my life. I always tell people I'm the reluctant CEO. I never ever set out to be one. That was never my life aim. It was actually just to be in healthcare and medicine. And so the I think what helped though from a leadership perspective, ironically, if my parents listen to this, they're going to never let me hear the end of this. They sent me to an in Australia and all boys, religious and military affiliated high school boarding school. It is very much set up for leadership training. And I think the motto of the school, translated from Latin is let's see if I get this right. It's if you want to bear the palm of victory, you have to bear it. And so the other way to say that is if you want to. Basically if you want something good, you have to put in the work. Yeah. And I think as much as I hated that school, it actually was very good training from that perspective because, you know, from a very early age, I think you just kind of did get indoctrinated that if you really want something, you're gonna have to work for it. Because most of this stuff's not easy. It's really not. And there is a lot. I mean, the other thing I tell people, there's luck and timing.
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B
What about recharging your batteries and remaining fresh? So what do you like to do when you get some downtime?
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C
Up until three years ago when my son was born, I just surfed every day. That was my main thing that kind of had to take for those people with young kids that kind of had to. And my wife works as well, so we kind of had to step. I've just come to accept that this is the three to five years of my life. I don't surf much and then instead I spend time with, you know, him and probably friends who have kids around a similar age. I Mean, that's kind of just the phase of my life, being an older dad. I think one of the good things about it is you kind of know everything is for small period. You know, it's a phase. And that this phase will come to an end. I'm looking forward to when he's a little bit older and, you know, he, like, I actually can teach him how to surf because I think that hopefully he's interested in that. Yeah, yeah.
- [27:34]
B
And then there'll come a day when he'll be teaching you a few moves on the board. So. Yeah, that sounds like a lot of fun. And it's just so important to, as, you know, to de. Stress and decouple every once in a while. We talked about a lot of different things, everything from Australian music to the concepts of iteration, taking steps one step at a time, putting in the work. And then we talked a lot about Pharaoh Health, how it came about, sort of the clinical trials process today and how Faro health disintermediates that. Talk a little bit about leadership. What did we miss? Or what would you like to double down on? I'll give you the last word.
- [28:08]
C
Yeah. I think what's really interesting for those who are considering doing a startup, so maybe this is particularly targeted at people who. Who want to do that. I would say it is a journey. I think we tend to look at the rare exceptions where you see someone explode in one year. Like, I don't know, Facebook and these other companies, they're really more of the exception to the rule. I mean, most really good companies, much more linear, and it just takes a lot of time and continuous improvement to get going. But I think that's the main thing is you really have to constantly focus on product, market fit, listening to your customers, and then just slowly growing and improving. I think that's my main piece of advice to anyone who wants to consider doing one. They're a lot of fun and they're very rewarding. Yeah. But make sure it's also something you're very passionate about. Yeah. Because that's. There is going to be some dark times and you're going to need that to carry that vision in your head is going to be the thing that keeps carrying you through the times where you just frankly want to smash your head against the wall.
- [29:29]
B
Scott, this has been a really great conversation, learning more about the clinical trial process and the things that I already summarized and lots of great advice, especially the. The last piece there applies to a lot of different aspects of our work and personal life, so thank you so much for being a guest on Digital Voices.
- [29:48]
C
Thank you for having me.
- [29:51]
A
Thank you for listening to Digital Voices Podcast with Ed Martin. If you enjoyed this episode, subscribe on your preferred streaming service and leave a rating and review. And most importantly, thanks again for listening.