Episode’s transcript

Julio Martinez: 0:00

Welcome to the Latin MedTech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform. Apple Podcast, Spotify, Google Podcast. Amazon Music is teacher Tune in iHeart Radio, Pandora or Deezer . Welcome to the Latin MedTech Leaders podcast, a conversations with leaders who have succeeded or plan to succeed in Latin America. And today our guest is John Ritz , CEO of threat. It's great to have you here on the show. John , thank you for accepting our invitation.

John Reites: 0:40

I'm excited to have the conversation and really focus on LA Am today. So thanks.

Julio Martinez: 0:45

Fantastic. So listeners, John is a digital health entrepreneur with 18 plus years leading global drug development, clinical research and decentralized trials for life science organizations as CEO of threat. John is looking to change the way clinical research is conducted, focused on the centralized approaches enabling the use of threat's platform for conducting motor research studies. So John , I'm really looking forward to this , uh, episode today is a very timely topic, especially with the pandemic. And , uh, I wanna hear everything I can get from your experience in Latin America and with decentralized clinical trials and, and where the industry is heading and, and, and clinical trials is, is, is, is a topic very dear to me. I, I became a clinical trial entrepreneur 10 years ago, and I'm still doing traditional trials, and I wanna learn from you how to conduct better trials <laugh> . So <laugh> , the first question that I have for you, John , is what's your link with Latin America? But before that , I mean, how do you get involved with the region initially from a personal or professional level? So let's get started again .

John Reites: 2:01

Yeah, personally, I, I have connections to the region. I have an aunt who's Costa Rican , and I actually had a great opportunity growing up. I got to stay summers in Costa Rica and, and live in kind of, I had to learn Spanish, I had to read children's books to learn. And, and so , um, even though my, my wife and kids would've admit my Spanish is awful today , um, I I , it was an amazing opportunity for me as I was younger to, to not be a vacationer, to, to live and learn and, and shop for myself and do some things that, that I had just learned a tremendous about, you know , uh, in my life. And so, on a personal front, I have connections to the region through family, but , um, you know, from a business perspective, because I live my life in a global CRO when you're in a global CROI, I had team members. I had departments that I ran over time that were based in Columbia and Brazil and Mexico and Argentina, and some of the main hubs you see for, you know , clinical trials. And so , so from my perspective, I had a lot of opportunity to do different types of clinical trials, you know, early to late phase in the region. So, yeah, so I , I've kind of run into and had the , a great opportunity to work in , in LA Am over the years.

Julio Martinez: 3:10

Okay. Very good. So let's get started with , um, uh, general conversation about the region. What do you think about the region as a place to do trials? Why does the region represent an opportunity for companies to recruit patients and gather clinical data?

John Reites: 3:27

Sure. Well, let me start by saying, you know, our focus, you know, when you think about clinical trials overall, there's already a market for clinical trials in Ladia. Uh, what I would actually focus you on is what I know how to do, which is how do you take digital trials or decentralized clinical research? How do you do that and what are the benefits of doing that in latam? So if I take that steering a little bit, what I would tell you is when you look at decentralized studies, you know, one of the things that helps you to , um, to be successful with digitizing or, or decentralizing moving research out of the clinic as the primary and only location to where research can be done outside in the home and remotely. When you think about that, a lot of countries in , in Latin America actually have a very high digital enablement score. And what I mean by that is, if you look at the amount of individuals in Brazil and Columbia and Mexico, Argentina, different locations, you'll see that their ability to have a smartphone, because this is life. This is your credit card, it's your shopping, it's everything is in this, which is unique to some places in Europe and AsiaPac and North America. When you think about the ability to be digitally enabled , uh, 4G to 5G LTE access, the ability to have mobile, the amount of people that are on social networks, you know, LATAM is a very high usage for digital enablement. So if you think about individuals regardless of age, demographic, where they, you know, how much money they have, none of that really matters. This becomes a core component to life. And so when that's the case, your ability to bring a trial in a digital format becomes more natural. So I would actually tell you that when you think about latam and you think about recruiting people with the basis of, I wanna recruit you through digital models, when recruiting and studies that are done, not just in the clinic, but outside, when you go to a population that already says, I get digital, I do this all day long, it's not that far of a leap for them to use these types of tools in clinical research.

Julio Martinez: 5:21

Yeah, well said. Yeah, I like that, that answer <laugh>. So John , um, what country specifically , um, can we talk about , uh, based on your experience, what , uh, challenges you've had in the countries where you worked ? I wanna steer the conversation in that direction. Let's, let's go and let's talk about Mexico. Let's talk about Columbia, Brazil. I mean, what do you see happening in these countries?

John Reites: 5:48

Yeah, so you know, what's really interesting is when you look from a regulatory framework perspective, there's a lot of regulatory backing and support to digitizing clinical trials in , in , in latam because a lot of latam regulators are following, you know, or coming alongside of what you're seeing in North America, but also some of the sort of GDPR equivalent type of regulations you see in Europe and Asia pac. And so what that means is, is that LAD AM's able to take advantage of what's already been set up and kind of enhance it for their countries. Now, every country is a , is its own country. Every country has its own cultural nuance, its own regulatory framework. And when we treat latam like a country, that's a complete misappropriation of what we're doing, right? Each country is unique, right? I , I had somebody, and I kid you not, someone said, oh, well if you wanna work in laham , you just use a Spanish language. And I would say, oh my gosh, no, no, there's variations of Spanish, there's Portuguese, right? There's all these models that , so what I would tell you is the understanding of specificity around requirements is really important. And so when you think about , um, our experience like working at latam , uh, you know, being able to do things like digital recruitment, telehealth, electronic consent, and eCOA in countries like Brazil, Argentina, and Mexico, which frankly are three of the biggest recruiters on average as a country in latam . But when you go to countries like Columbia , you go to , um, smaller countries in the region that you see in some studies because of maybe rare disease populations happen there , um, those become advantages. But what I would say is , um, it's not just like everything else, you know, in life, you know, you have to have a specific model for each country. But the, the thing I really like about latam is when we went to go do digital recruitment, the numbers were really high. Again, 'cause those digital name scores , um, what I would say is some of the things that we've learned is not too dissimilar from other countries, but there are regulators and groups in Latin America that do not understand what telehealth looks like. They do not understand how you would, how you would do something in a video call versus only going in the clinic . So one of things that we've applied globally, but a specific , uh, specifically for Latin countries is helping customers to convey the context of use. And what I mean by that is, when you go in and you make a submission to say, I'm gonna do a clinical trial, I'm gonna do it in a decentralized trial model, here's all the patient facing screens. You have to give training and education and context to say, when we go do this visit at visit two , we're gonna do telehealth and eCOA this way. Why? Because it'll be easier for the patient. Why? Because it'll be easier for the site and the education is still needed. 'cause what we're running into is there's still , um, relatively new use in lat Amazon digital tools. Right? And that's not a problem. It just means that you have to, you can't come in sort of running through and think, oh, the same way I would pitch this in North America or uk, you can't do that Slightly different.

Julio Martinez: 8:54

Yeah. Interesting point. So what countries do you see that have more advanced regulations or more open to these type of trials? Because I'm sure presenting an e-consent to an ethics committee in a country like Peru probably will , Bolivia will be a challenge. I mean , we'll be questioning all this. Imagine a , a patient just signing a , a a a consent form on their phone. I mean, this is like, Hey, come on. It has to be paper. That's the way we've done it for 20 years or 30 years, or whatever that is. And also we need to put the fingerprint of the patient and the two witnesses. So how do you handle those challenges in, in, in those countries where, where people have not really, regulators have not adapted , or even in sites , not only in regulators. That's right . Sometimes that's the issue with the actual investigators and, and the, at this committee at this site.

John Reites: 9:50

Absolutely. So , uh, it's, and in this way, it's, there's some equivalent to this. When you think about, AsiaPac has a very similar model. There's not a signature. It's actually a stamp that they use, right? It's a very , so they're not the same. But, but the world has different ways of viewing things. So what I would tell you first and foremost, when you look at everything we do in a decentralized trial, all the innovation like telehealth and medical devices and sensors, integrated full sweetie coa , all these really innovative novel things, electronic consent is what you called out is the one area that is the most dispersed and done differently. So you actually call out probably the worst case scenario. So , but I like it. We live our life in worst case scenario. So let's do that. What you do is you build flexibility in, because what I , what we found interesting, two points on e-consent is when you take e-consent into some latam countries, you're gonna get approval because you'll see like , uh, I , I believe it's Argentina has some regulations to allow it. And when Covid came in and you couldn't consent, otherwise everybody got very helpful because whatcha gonna do, you gotta get proper consent. So your witnesses were remote during telehealth. Okay , same reg follows same method. It's just the how, not the why that's being done differently, right? But let's just say you go into some, like Peru, a great example and I , I've done just a few studies in Peru in my career , um, and where you look at a country like that, that's still catching up on IE six and some other things that are still, still moving forward. And you think about e-consent that's just in the US we'd say, that's just not the hill you wanna die on, right? It's not, it's not the battle you wanna really fight. So what we've done is we've built solutions in the technology to allow for paper upload in place of electronic consent so that people or sites and sponsors don't say, oh, well you can't do that in Peru. You say, no, you can, you can do all these things, but this one thing's a nuance. And so you do it this way and you move on , right ? So you don't , don't sort everything . Feature functionality is , that's, that's where latam is right now, is we see advancement covid actually changed and opened up mindsets. But one of the things that we're watching closely is we've contributed to some of these , um, um, you know, by public comment and stuff like the, the regulations that are coming out from FDA on decentralized studies, they've been publishing things as you know, what Landam does really well is they're watching European agencies and US agencies and saying, how can I take from those and make an <INAUDIBLE> to be part of the global community of research? And so what I think we'll find is, I , I hope we'll see some innovation in some movement when those start to come out later this year that may actually progress some digital things in Latin America a little faster.

Julio Martinez: 12:35

Okay. Alright , John , so let's talk about trends happening in Latin America that are relevant to our discussion today. What about patient recruitment? I mean, what is, what trends are happening around the world with regulators in, in, in the , in, in the United States, in Europe , uh, in regards to inclusion or , um, diversity in clinical research? What do you have , uh, in mind in regards to these trends?

John Reites: 13:02

Sure. One of the three points of threads mission is to make studies more inclusive. And it's not because it's timely, it's been in the mission statement for five years, but we all know today, and I , and I think you know this, all of our friends in this industry, no one says let's make studies less inclusive. The reality is, is we all want studies to look like and look more like the global population. We want them to be representative of everybody. So we all have the same goal. But what I would say is everybody has a part to play. And so thread's part to play, the thing we're trying to impact and change and help our customers with through the platform is to be able to do a couple things. One is open up the geographic footprint in which you recruit from. So when you think about digital recruitment, it's one thing to recruit somebody from a 35 mile radius around a clinic. It's another, if you have a decentralized trial offering or model where you can recruit from a larger geographic span like maybe 250 miles and here, and who , the reason why is if you think about a decentralized trial, if you look at the primary secondary exploratory endpoints in a study, if you can capture those with the same rigor and validation in four visits in the clinic as opposed to 10 visits in the clinic and you do the rest through telehealth and in the home, the offering to a participant, which is, Hey, you can come to the clinic 10 times or we can do four times in the clinic, all these in your home is more conducive to somebody's lifestyle. So what happens is people go, I can take off work four times. I can't take off work 10 times. So remember the thing that is one of the things that I love about the global community we live in is that convenience is highly regarded. No matter where you come from, it may look different, but it's regarded. And so when you think about these models that contributes , and the reason that connects to recruitment is that when you think about recruiting, remember, remember recruiting is about helping somebody understand they can contribute to science and bringing new products to market that help them and others. So it's the altruistic arm, but the reality is we have to balance that with what does a participant get out of being a clinical trial and how easy can we make it for them to participate because they are giving up a lot of their time and effort. And so when you think about that, these decentralized trial models provide a different type of study design for participants to recruit from. And so when you do that, we see really high digital recruitment rates on studies when the offering for a decentralized trial is made. And it's very clear.

Julio Martinez: 15:27

Hmm , okay. So how is recruitment actually happening in Latin America or in North America or Europe, whatever, in whatever location you guys are operating now? Is the , is the actual initial contact with the potential subject offline or is what is increasingly , uh, done online now? What do you think about that ?

John Reites: 15:53

Sure . It's , uh, so lemme be clear, you know, we're in , uh, 50 plus countries doing actual running decentralized trials, right? Not PowerPoint thinking about it doing it. And so when you think about North Latin America, you think about Europe and Asia Pac and, and Africa and other places , uh, the nuances are different. So any answer I give here has nuance. But as , as a whole , lemme answer it this way , when you think about digitally recruiting people, it's not a, it's not just social media ads. It's not just working to work with partners who may have access to medical records to highlight potential participants to a provider, right? It's not just the site looking through their own database and finding people. It's not just these influencer communities we connect to, right? Where you go to people who have a , a , a , um, like a nonprofit network or social community, they, outside of social , it's the combination of those things that actually matter. That's a digital recruitment strategy, not a digital recruitment solution . Okay? So when you think about that approach, what's really interesting is digital recruitment, and I've been doing it a long time. Like a lot of people have digital recruitment, used to be called supplemental recruitment, if you remember this. Supplemental

Julio Martinez: 17:03

Recruitment . That's right, yeah .

John Reites: 17:05

Clinical trial. And you would, their sites are gonna recruit, but you're gonna need to go find 10% to help them with. It was all this like, eh , supplemental recruitment. Fast forward to today, sites are good recruiters and good digital recruiters, but also sites are using and used to these different models where they get supplemental people added to their databases. And so what I would tell you is that that's, that's become pretty normal across the board. I'm not saying normal in that it's in every study, but where it makes sense. But what I really like about a decentralized trial model and what we've been doing is when you go to recruit people from a site, from an EMR , from a social network, from an influencer community, you've got an opportunity to do what we call the bridge a recruitment bridge. And recruitment bridge is simply put that instead of sending all these patients directly to a study coordinator and overwhelming them with all these people they have to talk to and go through, you send them through digital recruitment components on web, they can just answer on their phone and you're filtering the screening, then you can take them to another process for them to consent to complete more entry data in the screening process on the app . They still haven't talked to a coordinator. And then the third tier is you can actually bring in telehealth. So we have a con , uh, recruitment consent telehealth, and they do screening through telehealth because you know, you might, a screening visit might be five minutes, but for them to come to the clinic, take off work, study coordinator get line , you take what could be done in five to 10 minutes and you make it hours . So the reality is that process can go really fast and digital to then get to this is the right patient to bring in and baseline in the clinic. So what we would say is in hybrid decentralized studies, which we do a lot of this ability to better screen and have a better white glove experience for participants as they come through that recruitment process, but then also not overly burden the site to give them an opportunity to screen better and frankly not waste their time or the patient's time becomes a really interesting bridge that ordinarily we find patients and say, study coordinators, please sift through them . And that's just in the world we live in today is really hard to do.

Julio Martinez: 19:05

Okay . And who is in charge of that bridge?

John Reites: 19:09

So we, you know, I mean , uh, not that you paid me for this answer, but that's what thread does we I built . Oh , really ? Okay . Yeah. So, you know, in our platform what we noticed is, you know, we always were sort of a data collection platform for sites and home health nurses and participants and caregivers. And so we were helping all these stakeholders and we had always done digital recruitment. 'cause you know, decentralized trials, t fully decentralized in some hybrid always had a mix. And so we had a , an early technology, we had that, we've been doing this for about four or so years. And then what we did is we were learning from that and we built, we just launched a version three of it , uh, late last year. And it's a fully automated process that you can do and you conform it to each study. And then what we did is we made partnerships with a number of some of the best recruitment companies around the globe and said, Hey, why don't we do integrations with what you guys do best and what we do best, and we'll build the bridge technology 'cause we're a technologist. That's what we do. So we fascinating build the bridge so it connects so you can see all the metrics, the data, the optimization, and it flows through. So from a business perspective, they go from add web app and it's just super seamless. It's like seven clicks, not 21 clicks to get through. Right? And so what we say is we say it's the appropriate amount of friction. So a lot of technology companies, a lot of tech companies, and you know this are all about remove friction. I want click button , buy something. But in clinical trials, remember we're putting experimental medications in people's bodies. Yeah . We cannot, we have to introduce friction 'cause we need people who are going through this process to see this is what I might sign up for. I need to learn, I need to get educated. I need to, 'cause I, as a person, when I was a patient in a clinical trial, I had to make a personal decision if I wanted to invest that time and effort and if it was safe for me. Right? And so , uh, that same thing as what we try to do in that bridge.

Julio Martinez: 20:58

Okay. Alright . Let's switch gears a little bit. Let's talk about therapeutic areas. What areas or specialties have you seen more relevant in Latin America recently? Uh, trials in mental health. Uh, of course COVID-19 is a , is a sure of course is a , is a <laugh> Yeah. Is an obvious answer. But , uh, what areas have you , uh, seen a growth in in Latin America?

John Reites: 21:26

Yeah, so when you look at growth overall oncology, rare disease, there's some a a lot of treatments that go through that are global treatments. And so you see them naturally get used. And so I think the easy answer is COVID-19 oncology, rare disease, some things like that. Some of the ones that you may not think of though is cardiovascular still a heavy level cardiovascular and metabolic diseases that you see , uh, research happening. Um, the other one is , um, we actually did quite a bit of pediatric research in the area , uh, for newborns. So newborns with specific , um, challenges, issues with digestion, issues with , um, uh, uh, I'll be careful what I say, different indications around newborns. And what was really interesting is, is that in some Latin American countries, there were high incidence rates of like, of, of things that could be studied better in newborns. And so we've actually seen quite a bit of pediatric research there, which I think is really interesting. Um, the two , like, we had one study where , um, we actually had new mothers. So newer mothers, so they'd have a , a , they'd have the baby, so mothers, fathers, caregivers, whoever that is, they would , uh, track things like feedings . And so what we had to build in our, in our platform, we just configured up an app where mothers, you know, primarily who we saw were doing the work would have to get up and feed at two and 4:00 AM Okay. So like I would be the worst patient for this, right? But, but the reality is is that, you know, we had to build a tool that, that they had to feed and then track it for the purposes of the study. So for them to get in and go, it's 2:00 AM and at 2:00 AM everything looks blurry to me. I'm old and I have kids, right? So like, you know , being able to click an app, answer the three questions and close it and go back to sleep was really important. But what's really interesting is you see study designs like that and latam as well. So what I would tell you is, is that , um, I don't think there's a nuance or some therapeutic area we see less. I think , um, if you look at the market where it's shaping up to have a global product distributed, you're in a few Latin American countries and you're starting to see that become the default , um, which is exciting and still new. But you know, a lot of these therapies, you know, just keep in mind pediatrics, cardiovascular and , uh, some respiratory around like COPD and things related to smoking. So you do see some , um, some efforts there as well.

Julio Martinez: 23:49

Yeah. And I'm sure rare diseases, I mean, I guess , uh, some places in Latin America, hotspots for specific rare diseases, have you seen that too? I mean, are you involved in rare disease trials or not a

John Reites: 24:00

Lot. It's a pretty large part , our portfolio. But you know, what's, when you think about rare diseases, and we have some , uh, we have studies active today in rare disease that are recruiting a LA Am countries. Okay. What , what the difference though is, is, you know, rare disease studies typically recruit where the patients with the rare disease are. Right? And so if you, so if you've got a , and again, there's a lot of rare disease and , and sort of precision diseases there, but if you look at like a , a particular rare disease and you find that it just happens to be a high concentration of it in Brazil, Brazil's obviously gonna be a country because they're selected on the basic , uh, basis of their participants who have sites . So we need to open the country. Yeah.

Julio Martinez: 24:38

Yeah . I see. I see. All right . So let's talk about , um, trends happening in, in, in, in Europe and North America that may be conducive to Latin America receiving more research, for example , E-U-M-D-R . What do you think HAP is happening or will happen now that UMDR will take place, I guess in, in, in a few months or a month? Or actually this month may, I think , uh, the new regulation in Europe will make things a lot harder for companies to certify their products or to get regulatory approval for the product. They have to validate their technologies way more. I mean, the bar is higher, so I guess they're gonna have to do way more trials, right? And, and, and probably sites in Europe will be floated , uh, with requests for research. And also you have this COVID-19 , uh, wave, third wave , uh, or whatever wave is gonna have , we're gonna have next ,

John Reites: 25:47

Whatever

Julio Martinez: 25:47

Next looks like next month or next week . That's right . And , and , uh, you're gonna have an increasing , uh, challenge recruiting patients , uh, because of that . So it's my perception that Latin America may receive a lot more trials in the next coming years. Uh, John , what do you think about that?

John Reites: 26:05

I , I think it's, it's the right statement. I mean, if I had a crystal ball and I could predict it, I would love to, you know, and I, I think, I don't know. What I would say though is when you look at regulations around the expansion of confirming data validation, data, evidence, digital endpoints , all these things are coming in, they are requiring smaller, more smaller studies to be conducted. Maybe that's the most simple way to think about it, right? It's one avenue. But I would actually tell you the other side of this coin is, is you've got more, you got regulation kit coming out to do more extensive validation research. On the other hand, you have , um, you have new GDPR and GDPR equivalents for data privacy, security, and protection coming out in parallel. So what you're doing is you're packing on the fact that I might have to do more work with more regulatory scrutiny, and I've got more data privacy and data requirements at the same time. So what, here's what I would say, you know, platforms like us, like our company, this is what we're, we do as a business, this is how we grow and how we differentiate from competition because we understand the market. We've all been doing clinical trials our whole life, and we apply it to technology. So for us, being able to do, that's great. But what I would say is, when you think about some of the things that sites , um, and, and CROs and other groups in LATAM can do is they can start to make positions around, here's how we take on scaled studies, here's how we help with smaller studies, right? So in other words, the strategy is to open not five countries here in latam, start with these two, and we can recruit X percent. But what I'd tell you the flip side, Hulu is really important, is being very clear about how data privacy and GDPR equivalents are managed in latam, which I hear all the time, and I'm not, I'm not a regulatory expert by training. I just run into a lot of regulators in the innovator work we do . And it's striking to me that, that , um, every time I go to present to a regulator or I, I , I demo, I do telehealth virtual visits for regulators all the time because I want them to see, like, this is what it looks like. And they, and it's fun to see trained medical professionals go cool. Like, because they just see something of that's, that's neat . I I think our patients would love that. But the reality is, as you know, the , the details of privacy and regulation and compliance are really important. So the ability for LATAM sites and CROs to really say, Hey, we have these equivalents, this is how we manage it, and it's not dissimilar from what you see in North America and Europe is actually an advantage that I , I just don't see talked about as much . And that might just be the circles I'm in. But I do think that that conversation typically doesn't include Latin America. And it should,

Julio Martinez: 28:41

Should, yeah. Should we're actually running into that right now with a recruitment campaign that we have. We're we, we totally ignore , um, data protection laws and , and , and , and now I'm, I'm , I'm getting up to speed on that and redesigning the website, the landing page and everything to comply with local Colombian , um, uh, data protection laws, which are really strict. They follow the European model, which is probably , uh, more stringent than the American model. Yes . Because in the US you don't have a , a federal data protection model. You have all these state , um, uh, laws and stuff. It's very disparate. Yeah . And the, I think it's the , uh, federal of Trade Commission. They only have like two lines that talk about that. They don't have much. I mean, the US is is not famous for that at a , at a federal level. But , uh, but , uh, countries in Latin America are getting really , really tight on that.

John Reites: 29:37

Yeah . And , and what I would say that's an excellent statement , that I don't think everybody, and when I say everybody, I think there could be better education around that to the market. Because I think what some people by default think is that, is that latam looks more like North America, not like your statement like Europe. And , and so when if you go in thinking like that, you have the wrong planning and wrong premise in your design and operational plan . So, you know, the , this all goes back to what we're discussing here today, right? It's education. Yeah . Right . atium is an amazing place to be. It's been a great contributor to research a great recruiter in research. But I do think that , um, the education around what you can and can't do, and the regulatory frameworks that are there are not as clear. So we, we built this global matrix, which is our method for, we looked at every country, 'cause we're available in I think like 80 countries. And we did this matrix and went through and worked with regulators and partners to figure out what can you, can you, and can you not do, not just per country and per region, but per feature and functionality. So what I mean is, is what can you do e-consent, but then what's the age of consent? Is the digital signature not allowed? And what's interesting is, you know, just to say a little bit, when we did our research on Latin America, we actually had to meet directly with regulators. Why? Sure. Yeah . 'cause we couldn't find published information. No,

Julio Martinez: 30:57

There's not, yeah .

John Reites: 30:58

The information up. And so what I would say is I think that there's , um, any, anything organizations like yours and others can do to, to, to , uh, amplify that education information. Oh my gosh. If you, if you wrote a report and said , here's what you need to know about what you can and can't do in Latin America, it would be immensely important and helpful to Mm-Hmm,

Julio Martinez: 31:19

<affirmative> . Yeah. Well said. Yes. That's exactly the spirit of the podcast. To disseminate and amplify that type of information. And because I couldn't find it either. I had to do it myself. I had to research it myself. I have to speak with so many people because many , I came from another industry 10 years ago, and I joined the medical device industry, specifically clinical research because of the work of my brother, who is a cardiologist. And , um, it's just that , uh, I, I, I needed to have a platform to talk about topics that nobody is talking about . And , and that's another reason why our column on med device online is so popular. We get so many hits every time we write an article about Chile, about Columbia , Brazil, because nobody else is doing it. And somebody needs to do it. Because at the end, John, it really benefits the patient that more companies are more familiar with how to do business and how to operate, how to do trials, how to commercialize innovative technologies in, in Latin America. So,

John Reites: 32:18

That's right. Yeah. And I would say, you know, from my perspective, you know, this, if we, if we wanna do what we say we wanna do, which is we wanna make studies more inclusive, we wanna recruit faster, we wanna finish studies with more data and higher quality , um, the best way to do that is to have a wider scope than what we've done. Right? And so, so, you know, know, I'm, look, I'm, I'm here talking to you because I follow your work, but also because I believe in what I am . I've seen it <laugh>. Um , and I , and I think it's an amazing place, especially these digital , I can't, I can't tell you enough how much digital enablement, this, this sort of natural ability to be digital regardless. And you know, this, regardless of your age and where you live now , that is such a , um, a , a prerequisite to really lean into digital trials. And that's why customers and sponsors should be thinking about lanam for these types of work.

Julio Martinez: 33:07

Great. I'm really happy to hear those comments , uh, coming . Especially from, from you, somebody like, I mean, somebody with , of your caliber <laugh> No . Saying something's like that about Latin America. That's true . I

John Reites: 33:19

Love it . That's true. Yeah .

Julio Martinez: 33:20

Yeah. So let's talk a little bit about the sector, about where your company is and, and the type of clients that you guys have. Um, what's the profile of your clients? I mean, or their pharmaceutical companies mostly, or their CROs mostly. Are those , are they larger companies, medium-sized companies? And, and also if you can talk , uh, about the competition, I mean, who else is getting into this space? Or are you guys the only ones doing whatever you're doing differently from the rest? So please go ahead . Sure .

John Reites: 33:51

Yeah . So when we look at our, our customer base, it , it's a pretty broad mix. You know, for us, we started in, in biopharma so large, you know, top 40 pharma, which we service the majority of that. Um, and then that moved into biotechs as biotech started looking at decentralized trial approaches. Because again, novel innovative companies who need to cut cost and deliver studies quickly, because they have a lot more writing on that. They don't have a lot of shots on goal, as we would say. That's right. Um, and so what they need to do is they need to be, they're willing to be more innovative. 'cause in some cases they need to be , um, so you've got a mix of customers at large pharma and biotech that may look at DC decentralized trial approaches differently, but they're looking for the same effect, right? Which is, how do I make my studies more comprehensive? How do I get the data quality? How do I make them more flexible? How do I make them more reclusive ? Um , we do work with a large number of CROs because there are a number of CROs who have moved into the market of decentralizing studies, but s are service companies and they need tech companies with tech enabled services to fill the , all the gaps that they have, right? And, and I grew up in a CRO , I've been in the Ccro agency my whole life, you know, before I became an entrepreneur to start , uh, thread. And when you, when you think about , uh, the tech side, you , you cannot do, you typically can't be amazing at tech and amazing at service. You have to, we always talk , you need to be amazing at a few things, not mediocre at a lot. Yeah . And so when you think about thread and what we're trying to do, that's what we're trying to do, right? So it's broad based across those customers. We also have worked with a lot of non-traditional customers, customers that are in, that are doing clinical research that no one would even think of really . And so I would tell you that just know that clinical research and who's doing and who are sponsors of clinical trials is changing in the last five years.

Julio Martinez: 35:33

Oh , that's fascinating. Yeah . What do you think that's happening? What's the trend behind that?

John Reites: 35:37

Yeah, I think it's , um, you know, if you look at the amount of like big tech companies and other companies that are out there that have solutions that when applied to clinical trials might bring a lot of value, but they need people to understand the clinical trial space to deliver it because they're so far removed from it, and it's not their core competency, right? So what I would tell you is that clinical research, you know, building hypothesis, you know, having a comparator, like the, the thing that we all do is science , um, is actually getting a lot of traction. When you look at all the new medical devices and sensors coming out, remember there's a lot more players in the research space than there was even five to six years ago .

Julio Martinez: 36:12

Yeah, yeah. Pretty much everybody now is a medical device company. Even Google, even Apple

John Reites: 36:18

<laugh>, you know ? That's true . I mean, yeah. So, you know, and it's public. We did , uh, you know, we launched for the first eight research kit studies with Apple and others and built just a lot of things for Apple Watch and contributed, you know, amazing people. We just contributed to make those happen through technology. Um , but what I would say is , um, you know, that's kind of the first part of your question. The second part of your question is what's the competition? And what I would say is that , um, anybody who says they don't have competition is wrong and doesn't understand their market, that's insane. Right ? There's competition. What I really like about the market today is that we have competitors, but they, they see things slightly different. They have different competencies than we do. In some ways, their end goal for what they see a decentralized trial to look like is materially different. And so, so let me just be clear that our perspective, and we're a leader in it, not 'cause we say it or we make PowerPoint because we've done more studies globally than anybody. And when you compare the numbers that are public, you know, let's be honest, it's about experience. It's about doing. But at the same time, let's also be be clear that when you do this type of novel and innovative work and you do it globally , um, the how you get there becomes really important. And so what we've really focused on , um, contrary to other solutions, is we're not trying to remove sites from clinical research. I'm not trying to fully digitize a clinical trial. We've done that a lot of times. It's very complicated and it has a lot of cons to the list of pros. It has, what we are trying to do is change and transform how research is done by enabling and augmenting patients to have a completely different experience. Yeah . But not forgetting about the people that do research every day . Sites, PIs, sub study coordinators, home health nurses, call centers , <inaudible> , right? People that are, that are instrumental to doing research. But we've spent so much time focusing on the patient, which is great and needed that I think a lot of focus has come off of the people contributing and moving research forward. And so we as a company think about how do we support every stakeholder in the research process and make their work easier, more automated and more configurable, which means, means they can not do a bunch of administrative work that they shouldn't be doing. We need their brains, not their fingers clicking all day. So we instrumentally have been been changing that. And that's what's important to us when we look at the, the climate and what matters. It's how do you help people adopt and scale a new way to doing clinical trials through a decentralized model. That's what we're passionate about. That's how we separate from competition.

Julio Martinez: 38:49

Okay. Well , uh, John, it feels like we can talk <laugh> about this topic four years . Uh , I have a a a couple more , uh, things to, to , uh, ask you about. One is , uh, the question that I always ask my guests , which is, I'm gonna leave that question for the end of the show. Um, but um , before we get to to that, let's talk about inclusion in, in , uh, diversity, I should say is probably the better word in clinical research. I was just speaking last week with a , with a sponsor, and , uh, he's working on a cardiovascular device for heart failure. And he's like, Julio , did you know that most of the heart attacks in women? And no , nobody talks about this. I'm like, is that true? I mean, yeah. And, and most of the research has been conducted on wild males. I'm like, wow, this is really interesting. And he kept going and going and going, do you know that this and that, this and that? I mean, it was all the same. Most of the research happens in, in , in white males, but most of the disease actually, the incidence of the disease is in, is in females or, or, or , or a big percent of the, of the, the population of , uh, that is the suffer from the disease. Female. But nobody researches the female population is like nobody's researching. I had a , I had a discussion the other day with a sponsor that was working on a, on a female device, and he couldn't get funding. He was male and he couldn't get funding for a female device. And my sponsor , uh, last week , um, I mentioned to him this same , uh, uh, anecdote. And he said, yes, and if he were a female, he will probably have a worse time finding funds. So a female founder or CEO seeking funds for a female device, for a device that was gonna be used on on females, is not gonna get money. It's not gonna get funding. So for some reason, a lot of the, the incidents of common diseases that we know about, like, like, like cardiovascular disease happen in women and nobody researches the disease in women, everybody researches the disease in, in white males. It's like in African Americans in the United States or in the Latino population, you have specific diseases that behave differently in , in those populations, right ? So do you see a, an initiative or a trend or something to change this? Because what you are doing is contributing for these to , to get better. 'cause there's certainly a problem here, but what do you have in mind in , in terms of this topic?

John Reites: 41:34

Yeah, there's definitely a trend. There's definitely, and , and I'll give you the equivalent, if you might recall. I feel like , uh, 10 years ago we would talk about this term called patient engagement. And everybody go, what's patient engagement? And then seven years ago you went to a conference and everybody's booth had patient engagement written. It was like, bingo. It was like, it had to be on everybody's boot two to three times. Why not? Because that's a bad thing. 'cause people realize , oh my gosh, we're not focusing on engaging people in our studies, so we should shift the focus. So what I would tell you is our industry, at least in my experience, is always trying to do the right thing. We're all scientists at nature, right? What are we doing? We're doing clinical research, brilliant, smart people who can make money doing anything else, building the best gamification, this and that are spending their lives focused on bringing medicines and devices to people, right? So let's be, let's start there that I think our industry is not, is not, has not sought out to have this problem. It's happened over time. And I think what's really interesting about our industry because of that nature we have is when we, when something surfaces and we see something, we go, how do we fix that? But the trick is our industry, as you know, again, putting experimental medications in people's bodies, not building an app to do better. Stock trading is slower to move. We've all been trained to be methodical and stepwise. And to make, I always say, you know, our industry's really good at taking evolutionary steps, not revolutionary steps. Why? Because we love the idea, but it's so complicated because of the world we live in, that we, we we take a stepwise approach. So I would tell you is that the trend is absolutely that not just our companies like thread, everybody is talking about and putting groups in place to focus on patient diversity. A hundred percent . The reality though is, is it's, we, we have to move, as you know, as an industry from talk to action. And so we're seeing customers putting actions in place. So how do we better educate? How do we build transparency into protocols for different reading levels? How do we go lower reading level than sixth grade, which has kind of been the same for a long time, right? So things like that, they don't solve the entire problem. They start to take evolutionary steps to begin to solve the bigger challenge, right? But what I would say is, you know, when you take actions like this to openly say, this is something we're doing that we're trying to fix and research, help us fix it. Our community of researchers and sites and patients, when they hear the message, they look at it as , great, I'm on board . Sign me up for that. And so what I like about the work we do is that you have to have an altruistic end to you to really maximize your contribution to research. And so when we just tell people we're trying to increase diversity and this is what we're trying to do, you don't have to hide it or be afraid of it or be scared of it, just say it and have caner and be honest and open and transparent with people. And that's what we do in science, right? We measure and we take data, right? And then we measure again. So I think, you know, yes, there's a trend it's coming, but if everybody listening to this isn't do , isn't pulling their weight doing apart , it's gonna take us a lot longer to get there.

Julio Martinez: 44:45

Okay. Great answer. All right. So we're close to the end of the show , John . Um, the question I always ask my guests is , uh, what are your words of wisdom? Um, if you had the CEO of a medical technology, biotech, biopharma , medical device company in front of you, and he or she's thinking about Latin America as a place to do research, what would you say to him or her?

John Reites: 45:10

Yeah. Um, so what I would say is, is that LATAM is a place to be because it's already enabled to be a digital population. It's a group that understands inherently in its culture how to modernize a clinical research just by how, how people in the region live their life. Um, so what I would say is that one, that's a tactical advantage in the region that other regions didn't have. A lot of people went desktop, you know, internet, then mobile latam went connectivity mobile. And, and so I would tell you is if you understand how much that has been helpful to , um, commercial businesses, to consumer businesses, to delivery businesses, if you see the how fast and how well they've done in the region, and you don't apply that to clinical research , um, you're really missing an opportunity by not going to that amp . So listen, I, it'd be me. I would just tell 'em I'm a big fan and I've seen results and I know that people want to be helpful and participate, but I would tell you that , um, I would also be equipped with those tools. We're talking about bringing your podcast to bear to say, Hey, these are some of the reasons and some of the specific reasons why you should be contributing. I I actually think it's an easy sell. I think it's just one that we have to really be educational about these days.

Julio Martinez: 46:27

Yes. Yes. And just to add to that , uh, John , it is a great answer, by the way. I loved it. And , um, but , uh, my contribution will be that , uh, countries in Latin America are starting to realize how important clinical research is for their local patients because they receive better care. That's right. And also for foreign investment, they are moving away from exporting coffee and mangoes and avocados or oil right, or mining products or commodities. They wanna diversify their , their import base , or I'm sorry, their export base and also , uh, bring more foreign investment because clinical research, in essence is foreign , uh, direct foreign investment , uh, that is coming into , uh, the local economies. And, and it helps everybody and also increases the level of the local scientific community because they start interacting with investigators overseas, et cetera . These companies start putting money into sites in, in, in , in this country . So it's a win-win for everybody and the patient benefits, which is really the ultimate goal here.

John Reites: 47:32

That's right. That's right. And I would tell you too , uh, you know, being a, on the, you know, on a technology with service company, right? So being a tech company , uh, we know and see as we've started to look at operations and some things that we're doing in the region as thread, looking at talent that's out there , there, there is a technology community that you see rising in different locations. And, and those are the communities that I like. I I want those people to reach out to me and to reach out to thread because, you know, technology prowess is very different in regions and , and a , a la point of view and perspective on UI and UX is actually really helpful to make sure that when you build something you're thinking with global , global in mind. And so, yeah, I , I'm excited for the region, but I do think that the , um, technologists that really want to contribute to life sciences and clinical research have a amazing opportunity to connect to companies like Thread these days. But they've gotta reach out to them and say, Hey, I'm , I'm a technologist and clinical , you should be talking to me because that's really, that's how we're gonna make this market move. Yeah . When it's really hard to find people.

Julio Martinez: 48:33

Yeah. Yeah. And I applaud your, your enthusiasm. I applaud your initiative to build threat and to contribute, to bring more research to Latin America. The region really needs this, right ? So thank you John . It was really a pleasure and I'm sure listeners enjoy our conversation. It's being actually one of the longest conversation I had, almost an hour. Oh . But it was great

John Reites: 48:58

Part , sir , my friend . Bye .