Episode Transcript
[00:00:16] Speaker A: Welcome to the Few and Far between podcast. I'm your host, Chris o'. Brien. Take a look at the news lately and you'll see that the clinical trial and healthcare industries are rapidly changing and becoming a bit confusing to new players and even veteran organizations. Wouldn't it be great to have an experienced resource to guide you through unfamiliar territory and mitigate some of the potential risk? My next guest is a true font of knowledge for understanding the benefits and risks of running clinical trials in Latin America. Julio Martinez Clark is the CEO and co founder of BioAccess, a CRO that empowers medtech and biopharma innovators to optimize early feasibility studies and first in human trials in Latin America, Eastern Europe and Australia. On today's episode, who Julio provides important insights into the advantages of choosing the Latin American region for clinical trials, especially when it comes to data quality, clinical sites and GCP certification. We'll also zoom in on the surge of private investments in the region and take a deep dive into the countrywide focus on speed on approval for biotechs. This was a fascinating topic to explore with Julio, and I urge you to find your own guide to Latin America and other countries before expanding into global operations. Okay, let's start the podcast.
Okay. Julio Martinez Clark, welcome to Few and Far Between.
[00:01:37] Speaker B: Thank you, Chris, for having me here. It's a pleasure.
[00:01:39] Speaker A: Well, the pleasure is mine. You are my first local ish guest as we are both Miami denizens here.
[00:01:45] Speaker B: Yeah.
[00:01:46] Speaker A: And I'm excited to talk to you about a whole bunch of things, including clinical research in Latin America. But let's start a little bit with your personal journey so the listeners can understand how you come to be here. So can you talk a little bit about how you came to lead BioAccess and what the backstory is?
[00:02:03] Speaker B: Yeah, the backstory is what I think is a very intriguing story and combination of different factors that probably the universe put together. We, when I mean we, I mean my brother Pedro and me, we left Colombia. We were born and raised in Colombia and we left the country around 1995 or so. Before Pedro settled in the Boston area, he worked for a couple of global networking and telecom companies. I have a degree in electrical engineering, by the way. I got my degree in Bogota, Colombia and I worked for Lucent for Nortel. I got my MBA in the Boston area and Pedro, he is a physician. He prepared for medical school in Columbia and he came to Boston. He did a couple of years of basic research at one of the Harvard labs. After that, he got matched and he went to Cleveland, Ohio, to the Mental Health Medical center, the Case Western University, to do internal medicine. And then after that, he moved back to Boston, Boston at the Harvard Medical School. He did cardiology, interventional cardiology at the Beth Israel Medical Center. And after that, Pedro decided to move to Miami and he became a professor at the University of Miami. And he worked at the university between 2008 and 2013, something like that. He met his mentor, Dr. William O', Neill, at the university, and he was involved in research, of course, in training that he received in internal medicine in Cleveland and Boston. But he really got to understand the industry, the innovation ecosystem of the United States, when he joined forces with Dr. Bill O', Neill, who became his mentor and still is his mentor and good friend. Bill o' Neill is one of the top authorities in the world in interventional cardiology. So Pedro received an extraordinary training from one of the best in the world. And they together were advising many medical device startups, US Startups from Boston, from Minneapolis, from San Francisco. We're developing advanced structural heart technologies. You probably know, Chris, a lot of these companies, they finish their animal studies and they look for hospitals outside of the United States where they can do the first in human work. And the University of Miami is well connected all over Latin America for obvious reasons. And Pedro had his Colombian background. O' Neill has a Bolivian background, believe it or not, is fluent in Spanish. And they started collaborating with Latin American investigators in many first in human clinical trials. And they quickly realized that the work to set up these trials is complex. And it was being done inside the university in a small desk in the international patient office, which is not really set up as a contract research organization. It's just an international patient office that coordinates travel for patients from Latin America to Miami, hotels and things like that. But they were trying to act as a CRO, and it wasn't really the best fit for that office. So they decided to create a company outside of the university, which is now BioAccess. So fast track, 15, 20 years later, BioAccess is the company that I lead. And we are the only medical device control research organization more specifically focused on first in human clinical trials in the US that operates in Latin America and other parts of the world as well.
[00:05:23] Speaker A: US Sponsors, but executed in Latin America, recruiting in Latin America, that makes a lot of sense to me. I mean, we see this, Julio, with academic medical research centers in the US as well, that there are many studies that are run. They're not run quite the same way as the ones that CROs execute. So they are, it is usually less expensive. We know there are lots of, there's a lot of interesting stuff that gets done with investigator initiated trials. We, you know, respect all that research. But there's a reason that when you start to move towards and through the regulatory approval process, I think you want specialist help there. And it makes sense to me that Latin America would be certainly no different in that, if anything, more challenging. So what gave you, Was it just obvious to you guys from the very beginning, given your backgrounds, that Latin America was the place to go? Did you consider any place else when you were forming the company? Did you feel like, well, we have, given our backgrounds and our experience, it's a no brainer to go to Latin America. Maybe it was that.
[00:06:18] Speaker B: That's exactly right. Yes. It was a no brainer for us. It was organic. It's natural. In Latin America, especially in Colombia, we have tons of connections. Latin America, even though it's a huge geographical region, over 670 million people, double the size of the United States, it's very fragmented. So if you're from Colombia, a country of about 50 million people now, you know pretty much everybody who you need to meet if you're educated enough and you're in the right circles. So Colombia was a natural country for us. And also that time Colombia had a very nice regulatory agency. That has changed a little bit now, but it was pretty straightforward and predictable and fast to get trials approved. So we started in Cali, Colombia, the third largest city in the country. We found or they found a great investigator, o' Neill and Pedro. Then from Cali, which kind of Medellin, Bogota, Valentia and other cities. And after things warped or transitioned in Colombian regulatory agency, we expanded to other countries.
[00:07:16] Speaker A: So let's talk a little bit about that now. I think first maybe you can dispel a couple of myths about clinical research in Latin America. I think the naive assumption is that regulators will be very slow and there'll be questions about data quality. And I think you think of it as more complicated than that, for sure. So we.
Will you talk to us a little bit about that? About how do you break the region into different targets?
[00:07:39] Speaker B: Yes. Data quality topic is something that of course it happens all over the world.
[00:07:46] Speaker A: Yes.
[00:07:46] Speaker B: Even in the United States.
[00:07:47] Speaker A: Yes.
[00:07:48] Speaker B: Issues with data quality, there's a lot of fraud and everything. However, it's really up to the sponsor to correctly select the site and investigator and properly train the investigator on gcp, if he or she is already trained and make sure the staff is so you as a sponsor, have a responsibility to choose the right side. Basically, that's what I'm saying. And that's connected to what you were alluding to, Chris, about seeking the right help. If you work with a specialist with a CRO that knows the country and the regulations and the sites, they will guide you. The local help will guide you towards the right sites. If you go blind, a gringo trying to navigate the waters of Brazil, we're going to hit a wall.
[00:08:31] Speaker A: Bu sort in Brazil, right?
[00:08:34] Speaker B: Exactly, yes.
[00:08:34] Speaker A: Yeah.
[00:08:35] Speaker B: It's going to be really difficult. So local help is really key. Ensure select quality sites. For example, Colombia has an approach that is unique in Latin America. Most of the countries around the world, and specifically in Latin America, all the countries except Colombia have the American approach of let the industry autoregulate in terms of quality. I mean, you select the site that portray the best quality, that gives the best quality data, et cetera. They have the right metrics. But in Colombia is the opposite. The Ministry of Health mandates that every hospital that is involved in clinical research needs to be GCP certified. And that's a very rigorous and long and expensive process to get these Colombian certifications. And it's very unique in Latin America. And this is to ensure quality data that gets out of the country. Very few people know this, but that's one of the reasons why Big Pharma, Big CROs, ppd, Paraxel, they all are in Colombia and of course in other countries in Latin America, but they have a very strong presence in Colombia. So data quality is not necessarily an issue in Latin America. From my perspective, if you choose the sites right with the local help, and if you go to Colombia and choose a hospital that is certified by the national government, you have 100% assurance that you are dealing with a top hospital. And there's another trend. To finish my answer, there is an international accreditation certification organization out of the uk, the international Accrediting Organization for Clinical Research. They are promoting these site certification and individual accreditation for professionals. And they just launched their program in Latin America. So I've been helping them, advising them on how to penetrate the market and it's been very successful. In the past three, four months, we have like five different sites already certified in Latin America. So this is a new thing in the region because the region is maturing a lot.
[00:10:31] Speaker A: Yeah, that's powerful. I think the idea, especially for foreign companies, there are two takeaways there. One, I love that point about. I didn't know that about Colombian sites. Yes, all having to be GCP Certified. And then the idea of a third party organization as well. Yes, but if I come back to your first point. Get advice. Right. This is sort of a theme, I think, in clinical research. We see there are more and more places in the value value chain where expertise is required. And I think biotech companies, startup companies, med tech companies, they can sometimes feel like, well, we know the science quite well and we're a bunch of really smart people and we'll take a little advice, but not that much advice because we think we can figure it out, or we think we have enough people on our board or whatever who have experience. But man, it is a tough and confusing and rapidly changing world. I think getting great advice is one of the keys to at least risk mitigation. We can't eliminate it, but we can mitigate it.
[00:11:23] Speaker B: Yeah. Can I give you a quick example of that?
[00:11:25] Speaker A: Please.
[00:11:25] Speaker B: It just happened to me a couple days ago, actually. A startup company, the CEO calls me. I've been in conversation for several months already, and he calls me and he's like, julio, I am planning this trial in Brazil and I am not so sure about the regulatory pathway because Brazil just enacted a research law. So there's a little bit of confusion. So he asked me a few questions and then he said, I want to activate this site in Sao Paulo. He gave me the name of the site and everything. And then I asked him, so what CRO are you using in Brazil? And he's like, no, the hospital will do the submission to a visa.
Like the hospital doing the submission to a visa. So do they have a CRO inside the hospital? No, no, they said that they can do it.
[00:12:08] Speaker A: There's a guy. Yeah, right.
[00:12:09] Speaker B: Yeah, there's a guy.
I'm like, why were you, I would ask, how many submissions from Visa have you done in the past three months? Yeah, right, right, Something like that. So what are your metrics? Are you a CRO or a hospital? I mean, what's your core business?
[00:12:23] Speaker A: It's a perfect point. And it's funny, we can imagine. I'm sure that person, the CEO is a smart person, but they've got this, if it's a medtech thing, they've got a device that they've invested a lot of money in and a lot of effort in to get to this point. And the idea of then taking the incremental risk trials are risky enough. Right. So we want to want to mitigate where possible. That's a wonderful example.
[00:12:48] Speaker B: Hi, this is Julio Martinez, clerk. We'll be right back with the rest of this episode shortly, I wanted to introduce you to the Global Trial Accelerators podcast. Hosted by Big. The Global Trial Accelerators podcast delivers actionable insights for medtech and biopharma innovators battling lengthy timelines and costly delays. Each episode features candid conversations with clinical trial pioneers, regulatory strategies and startup founders who slash six to 12 months of approvals by leveraging emerging regions like Latin America, Eastern Europe and Australia. You can find the episodes in Apple Podcasts, Spotify and other streaming platforms. Thanks for listening. And now back to the episode.
[00:13:43] Speaker A: Talk to us a little bit about the industry and what trends you're seeing in medtech, either generally or specifically for Latin America. What do you see happening in medtech today?
[00:13:52] Speaker B: I would say in general, the region is maturing a lot. One of the signs that indicate that the region is maturing or has matured sufficient enough for private equity to take an interest in Latin America.
[00:14:08] Speaker A: Interesting.
[00:14:09] Speaker B: You saw probably the news about Velocity Research, the largest site network in the world, private equity backed and they announced last year, late last year, that they're going to start an operation in Brazil. And from that operation to another office, they're going to start buying sites in Brazil, Argentina, Mexico on the first stage of their expansion. And then Colombia and Argentina, et cetera, and other countries. The point is that that is a great sign. I mean, that's validation of validation.
[00:14:43] Speaker A: That's perfect.
[00:14:43] Speaker B: Word.
[00:14:43] Speaker A: Yep.
[00:14:44] Speaker B: Latin America of a global destination for quality clinical research. And there is another private equity site network called Scope. They also announced recently their acquisition of a second site in Brazil. So I see great wins for Latin America on top of what I just said about these international crediting organization coming into the region and the interest that I've seen because I am the one making the introduction. So I've seen a lot of interest from sites.
[00:15:15] Speaker A: You're getting the calls.
[00:15:16] Speaker B: I'm getting the calls, exactly. And also Chris, another trend that I see in clinical research, not necessarily medtech or biotech, but in general in Latin America is that country after country after country are issuing laws to make the country attractive for foreign direct investment of clinical research. They want sponsors, foreign sponsors to bring money to benefit patients, to transfer knowledge to the local investigators, to have co authors from their countries being on the top journals. So it's a win win for everybody.
[00:15:51] Speaker A: Julio, is that a change? The reference for me on that is India, where not so many years ago, because of the legacy of colonialism, you know, there was a feeling of we don't want foreign companies coming in and experimenting on Indian people. And there's been a real change there.
[00:16:05] Speaker B: Right.
[00:16:05] Speaker A: A move to recognize that the power of clinical research, how that adds to an overall life sciences ecosystem and has lots of benefits for the country. Was Latin America similarly. Were countries similarly skeptical at one point?
[00:16:18] Speaker B: Yeah, yes, agree, agree. Yes, totally, totally. The laws are new. Brazil just issued a law a year or two ago. Argentina issued the law around 2017, 2018. Mexico COFRE priest. I mean, it's really, really streamlining the processes. After the pandemic, corporate priests really changed for the better. El Salvador is about to have a new law. The president's about to sign it. Ecuador just signed a new law recently, a few months ago. I mean, country after country, Panama.
I mean, it's just amazing to see the trend in Latin America in the openness about bringing clinical research, because as you said correctly, countries have recognized that is more beneficial than negative.
[00:17:01] Speaker A: Yeah, it's a critical part. I agree. It's a critical part of the community. Right. That you're building in life sciences. And if you want primary research to happen in your country, you want your own domestic drug industry, which I think most of these countries would like to see happen, you want your people contributing on research, you have to also be able to, you know, be part of the trial infrastructure.
[00:17:20] Speaker B: Exactly.
[00:17:21] Speaker A: So tell us a little bit about. For someone who doesn't know the region, I know that you are a fan of all of Latin America, but if you were to bucket it into the easiest countries, Colombia and others like that, countries that maybe are a little bit harder and countries that are more advanced, that are probably not the places to go right away, would you do that for us? Tell us a little bit about. You've listed a number of countries. Which ones are in that category of. You think they make a lot of sense for running trials right now?
[00:17:46] Speaker B: Yes. Yes. Really depends, Chris, of what you're looking for. If you're looking for speed to approval. No IDE submissions.
[00:17:54] Speaker A: Yes.
[00:17:54] Speaker B: Then Panama, Chile will probably be your top places for no ID submission. I mean, meaning no Minister of Health involvement, you just notify the Ministry of Health. However, there are other countries like El Salvador, Dominican Republic, which require an IDE or Ministry of Health involvement. But that involvement is pretty fast. It's pretty efficient and predictable. So they fall into the third category of the bucket of fast countries. Again, Panama, Chile first. Then second level will probably be Dominican Republic, Salvador, Honduras, countries like that.
[00:18:31] Speaker A: What does that category look like in terms of path to approval for regulatory approval?
[00:18:35] Speaker B: Yes. Panama, Chile, you can get a trial approved in 45, 60 days.
[00:18:40] Speaker A: Yeah, that's really fast.
[00:18:42] Speaker B: Yes, it's really fast. As compared to the United States. 9 months, 12 months, or whatever the FDA takes. We're speaking about innovative technologies, interventional studies, phase one studies, first in human studies, biotech. So, yeah, that's pretty fast because you're dealing with a private irb, not a governmental entity or anything. On the second tier of countries that I describe, like El Salvador, Honduras, Dominican Republic, we're probably looking at about 90 days, 120 days, to be conservative. And the third tier, then you have the larger countries. You have Brazil, Mexico, Colombia. In Brazil, things are a little unpredictable now because of the new law. Nobody really knows what's on paper is going to translate to reality. But Brazil, you should be able to get a trial approved in six months. Same in Mexico and same in Argentina and Colombia. Colombia will probably take a little longer. The regulatory agency is going through transition, but it's around that. I mean, the larger the country, the longer it takes. That's kind of the takeaway. Yeah.
[00:19:44] Speaker A: Okay, that makes sense. So, you know, if you need larger patient population.
[00:19:47] Speaker B: Exactly.
[00:19:48] Speaker A: You know, as usual, you got to be willing to wait a little bit longer.
[00:19:50] Speaker B: Yes.
[00:19:51] Speaker A: What about the quality of site staff and medical education in top tier sites in countries? Obviously every country has variability there. But would you say that if you think about Colombia versus Mexico versus Brazil, that in the research sites, do you think that you get generally similar levels of expertise and consistency, or do some countries stand out in terms of the quality of the medical education site staff, et cetera?
[00:20:15] Speaker B: Well, if having the presence of big pharma and big CROs is an indication.
[00:20:23] Speaker A: Yes.
[00:20:23] Speaker B: Of quality and research and infrastructure and education, I will say that you have offices of all the big pharma players or the big shuttle players. They all have offices in Mexico, Brazil, Argentina, Colombia, maybe Peru. Right. The rest of the countries, they don't necessarily have an office. They may have a staff, somebody working remote, a CRA or something like that. But from these big countries, they manage pretty much all the region. So those are probably the best countries in terms of quality and infrastructure and education. And a lot of investigators. You'd be surprised, Chris, being all over the region. And a lot of investigators train in Europe or in the United States and they go back to the home countries.
[00:21:06] Speaker A: Yeah, absolutely.
[00:21:07] Speaker B: Fluent. Well trained in top institutions in Europe or the U.S. so yes, that matches my experience.
[00:21:14] Speaker A: Julio.
[00:21:14] Speaker B: Yes.
[00:21:14] Speaker A: At the top places you get terrific.
[00:21:16] Speaker B: Yes.
[00:21:17] Speaker A: People. And that makes sense to me that it would be true in most countries, maybe not in some of the smaller ones. I don't know. I don't have experience.
[00:21:22] Speaker B: Exactly. Yes. Yes, exactly. Yeah. In some of the smallest ones, the sponsor probably have to do a lot of heavy lifting in making sure the staff is properly trained and things like that. Or bring somebody from another country to monitor the study, to do the coordination of the study.
[00:21:38] Speaker A: Julia, when you think about when people come to you and say, hey, we'd like to, we're considering running a study in Latin America, two part question here. How do you think about the cost advantage of Latin America versus United States? United States. And maybe you can talk a little bit about bioaccess and what you bring that you think is special to enable people to get started with those studies. So first a little about, you know, how to think about cost and then the.
[00:22:00] Speaker B: Yes. Well, it's well known that the cost of living in Latin America is lower than the United States. All of us have gone to the region, probably on vacation to Mexico, Costa Rica. A hot dog on the streets is just a quarter.
Right.
So a meal with rice, beans, soup and drink is probably a dollar or two. So it's something that you don't get in the US Or Western Europe. So just by the way the local currencies are in these countries, the way the economy works and everything, the cost of living in general is way lower than in the United States.
So by definition, you're going to be saving at least 30% of what the same procedure central will cost in the United States, sometimes even more. I've had cases where we were doing an orthopedic study in Colombia, and it was an implant, it was a hydrogel for back pain. And that procedure, we paid the hospital about $11,000. And the CEO of the company told me, julio, this procedure will probably be about $40,000 in the United States.
[00:23:01] Speaker A: Yeah, right.
[00:23:01] Speaker B: $40,000 in the United States. I mean, that's amazing. And patients want to be part of it. Patients want to participate. The US Is difficult. And I mean, even recruiting investigators in the US is sometimes challenging, not to mention patients. Right.
[00:23:15] Speaker A: You're 100% right. I think it makes a lot of sense. And it is one of the reasons, I think, that people look to run studies outside of the U.S. if you look around and you realize that in your indication, there are several other studies in the clinic or headed to the clinics, you're going to be competing with those guys.
[00:23:29] Speaker B: Right? Yeah.
[00:23:31] Speaker A: And we oftentimes spend time reminding sponsors that while you are really excited about your study, you know, the key investigators are, are being courted by everyone else who's trying to run a similar study and you're competing, but you've got to get them excited about what you're doing. Easier, as you say, if you're in a region where there's been a little less competition.
[00:23:49] Speaker B: Yes. Yeah. So savings is a given in Latin America by definition because of the way the economies are and the currencies in these countries. But the main reason companies go to regions like Latin America, Chris, in my opinion, in my experience, and I have conversations with CEOs of medical device and biopharma startups almost on a daily basis, is speed. Speed to activation. That's really what we deliver at Vitalysis.
[00:24:15] Speaker A: That's great. And I think if you don't know clinical research in the region, that's surprising, right? I would think people would say, oh, I would have thought it would be slower moving, more bureaucratic and all that stuff. And so you're saying absolutely not partially. That's about faster regulatory pathways in some of these countries. Are there other factors that are important, important to understand about that, that make it easy, easier for you to deliver faster?
[00:24:36] Speaker B: Well, one of the problems that we saw When Pedro and O' Neill started BioAccess, the first obvious problem was the issue that there was nobody to talk to.
If you're a startup, you really have nobody to talk to you because if you call IQV or ppd, even though they have an office in Bogota or in Mexico City, they're not going to even pay attention to your email or to your phone call because you're busy with Big Pharma. You're a small startup, you only need five patients. Come on. I'm dealing with a 500 patient, five site study.
Don't call me for five patients on a one site study. There was really nobody to help these startup companies in the US so that was the main driver to startup BioAccess. But the other driver, Chris, was the lack of professionalism and the fragmentation. So if you wanted to have a study done in Chile, you needed to find through your friends, through your colleagues in the industry, somebody they knew in Chile was just a former cra cubia, unemployed, who helps US companies once in a while with very broken English. Yes. He or she doesn't even know how to put together a proposal, a professional proposal, you know, so it was difficult to deal with these individuals on a country by country basis. There was nobody who could cover and give you a strategy for the whole region. All right, so this is your study, this is your patient population.
Based on my experience, you should go to Argentina, based on my experience, you should go to Panama. I mean, so there was really nobody to advise these companies professionally on how to strategize the regulatory and recruitment and activation strategies. And that's part of the problem that we solve at Bioaxis. I mean, we're a professional company, we deliver on our promises, we deliver on time that we promise our clients in the recruitment and with their professional.
[00:26:24] Speaker A: Yeah, it's funny, I think sometimes people don't understand that services business, even business to business stuff like clinical research, in some ways it's not that different from someone that you hired to do work at your house. If you simply are professional. You show up, you meet your commitments, you price fairly. You've differentiated yourself from 90% of the competition out there.
[00:26:43] Speaker B: Yes, absolutely. And also another thing that we saw was you had these individuals in these different countries, fragmentation, unprofessionalism. And then if you're a US startup company, you don't know anything about Paraguay, anything about Colombia, then somebody's asking you to wire money to Paraguay, to Colombia, to Bolivia. I'm like, should I wire the money?
I like the guy, but that's a great point. Yeah, yeah, yeah.
[00:27:08] Speaker A: I met this guy on a phone call once or something, but I don't know.
[00:27:11] Speaker B: Yeah.
So yeah, BioActive is a US based company. You're wiring the money to a Bank of America account. You have a U.S. contract with Common law.
[00:27:19] Speaker A: So yeah, that all makes sense to me.
I'm sure that's a compelling proposition.
[00:27:25] Speaker B: Exactly.
[00:27:25] Speaker A: So I want to close with two questions. First, maybe to talk a little bit about the future of research in Latin America, what you think that looks like. And then we'll get to a little bit of advice for people who are considering careers like this. But let's talk first just about the future of research in Latin America. What do you think the world looks like in five years or something like this?
[00:27:43] Speaker B: Well, the world will look fantastic in Latin America. Chris and I alluded to the fact that private equity and portfolio companies are already invested in the region. So it's going to be very different when Velocity and Scope and the others are already buying sites in Latin America. They're going to be bringing more and more trials to the region because as I said, the region is mature enough for that. And second, the laws are already in place to make it easier for these companies to come and to attract more research investment.
And the quality is increasing and increasing. Alluding to what I described about the International Organization of Nuclear Research accreditation from the UK that is already making inroads in the region. So I think the future for Latin America is very, very promising, especially when we have issues in Europe with ema and the MDR, etc. And also we have political issues in the United States with uncertainty at the fda, things like that. So. But besides that, I mean, I think the future is very good for Latin America and also the political changes in the region are being favorable. I mean, the left is not as common as we saw years ago, so that's very positive as well.
[00:29:01] Speaker A: Yeah, it sounds like you're saying the trends are all positive and there's actually quite a lot of good already. So the brand of Latin American research will catch up with the reality.
[00:29:11] Speaker B: Exactly.
[00:29:11] Speaker A: Of what's happening. That's really great. That's really great, Julio. It's encouraging to hear and really, really helpful. Now, you've had an unusual career. You didn't train to come into this industry. We're lucky enough to have a brother who is a medic. I'm sure you do get this question. Imagine you're a young person now who's getting started and interested in research or broadly in life sciences. Do you have any advice for that person? Or if you want to aim that as a CEO of a startup company. That's also interesting, whichever path you want to go down.
[00:29:39] Speaker B: Well, I tackle the question of if I were in front of the CEO of life science company Startup, what would it say to him or her?
[00:29:46] Speaker A: Yes.
[00:29:47] Speaker B: I think a lot of companies misunderstand Latin America because there's lack of education.
There are certainly bad news about the region. The Mexican cartels, the Colombian mafia.
I totally understand that. But things are not that bad. Things are not that bad because if you watch cnn, they sell bad views.
[00:30:04] Speaker A: Right.
[00:30:06] Speaker B: There's really no compelling reason. Even though we have an operation that we just launched in the Balkans, in Eastern Europe, there's really no compelling reason. Only you really want to be in that part of the world because you have an investigator there or something.
[00:30:19] Speaker A: Yes.
[00:30:19] Speaker B: Or an investor. I see that a lot. There's no compelling reason to go that far. There's really no compelling reason to go to Australia and travel that far in the time difference for 43% tax rebates. If you can have probably the same savings in Latin America because of the currency exchange ratio. And also you're going to have a study done in the same time zone that's incredibly powerful. Travel.
Yeah. I mean, two and a half hours from Miami, you're already in Colombia, you're already in Mexico City. So. Yeah. On the same Time zone. I mean, there's really no competitive reason to go that far, to be honest with you. So that's what I will say to the CEO of a life science company looking to do a ous clinical trial. Continue Latin America. I mean, yeah, it should be in your list.
[00:31:05] Speaker A: I love that. I think you also just suggested they move their company to Miami because then they're even closer to Latin America, which is lovely. It is lovely here.
[00:31:17] Speaker B: Well, is becoming a hub little by little.
[00:31:20] Speaker A: Yeah, it is.
[00:31:21] Speaker B: More innovation.
[00:31:21] Speaker A: Yeah, I totally agree. Well, terrific. Julio Martinez Clark. Muchizima gracias for spending time with us today on few and far between. And it was really, really a fun conversation. Thanks.
[00:31:32] Speaker B: Thank you for having me, Chris. My pleasure.
[00:31:38] Speaker A: Welcome, producer Adam.
[00:31:39] Speaker C: Hey, Chris. You know, Julio is just like a wealth of knowledge when it comes to clinical trials in Latin America. It's amazing. Would you say that it's still an undiscovered gem when it comes to running clinical trials?
[00:31:50] Speaker A: Yeah, I think that's probably right. I think two things. First, things are changing in real time in Latin America as some countries get more of a focus on quality. Some the administrative burden or the regulatory burden is getting easier in some places. In other places it is not. I think things are changing and as a result, whatever our priors are on Latin America and clinical research there probably need to get updated.
[00:32:13] Speaker C: I agree with that. He did make it sound like a very interesting area that's just kind of ripe for new trials and to go along with that. You guys also spoke about the bias and some cases prejudice that countries like Latin America and India face in the ecosystem for studies. Is there a key to graduating these regions to more mainstream acceptance?
[00:32:33] Speaker A: Yeah, a great question. I think a couple of parts to the answer. First of all, I think it's incumbent on sponsors and CROs that are not not specialists in these regions and countries to take the time to understand what the reality is on the ground in these places. Not all countries in a region are the same within countries. Not all therapy areas or even indications make sense. So I think it's one where we would encourage sponsors and CROs to come with something of an open mind. It's okay to come with some cautious skepticism because, you know, some countries are going to be better at data consistent and we'll have simpler regulatory processes, et cetera. I don't think we should assume that all are created equal here, but let the actual facts on the ground drive our decision making. And then for the countries, not that they are necessarily listening carefully, but boy, lean into trying to talk to sponsors and make it as appealing as possible for people to run clinical research in your country. So what does that mean? That means things like certification of sites. It means leaning into training for site staff and credentializing people or encouraging international credential, providing organizations to work in your country. And, of course, making the regulatory pathway as smooth as possible and as predictable as possible. It's very, very reasonable for countries to have some concerns about wanting to make sure that trials are run ethically and carefully, as they are in Europe, the United States and other places. But I think you can do that without creating a lot of bureaucratic obstacle that makes sense. It hard for people to get things started or makes it unpredictable.
[00:34:00] Speaker C: Yeah. It kind of brings me to my next question. When we were talking about mainstream, you know, back when you and I started at the company, there was a lot of focus on speed, speed to getting trials done and other aspects of that. And it kind of really became a dirty word in a way in the industry, especially during the pandemic. But as we were talking to Julio, it seems to be making a renaissance with speed to approval or speed to actually activation or speed to market. What do you think about this change?
[00:34:27] Speaker A: Yeah, I think that's right. I think that when speed feels synonymous with sloppiness, we have a problem because, you know, faster isn't better if the data quality isn't there and if the trial hasn't been conducted in a predictable, careful way, that's consistent with gcp, et cetera. But of course, when it does, faster is better. So if we can maintain data quality and integrity and execute trials in a manner that. That regulatory agencies are going to feel good about that, they're going to have confidence in the results. Of course, if we can do it faster, it's better, and that's better for sponsors and ultimately better for patients because it means a faster path to approval for effective medicines.
[00:35:02] Speaker C: You were just talking about data quality, and it made me think about the conversation you were having with Julio about how it seems like it's the sponsor's responsibility to ensure data quality, especially when it comes to clinical sites and investigators.
Is that true?
[00:35:16] Speaker A: Well, I think it's a shared responsibility, Adam. I mean, certainly sponsors need to come into this with a point of view on quality, and most sponsors that we would work with or other CROs would work with think a lot about this. On the other hand, part of what you're hiring a CRO to do is to help you navigate the quality pitfalls and challenges that you'll have in study execution. So you're counting on your CRO partner to help with that. And sites have to be responsible for quality themselves. So I would say everybody has responsibility. All sort of aspects of the chain have responsibility for quality. Nobody gets to outsource that entirely. On the other hand, we can neither outsource it entirely nor should we expect that anybody else carries that load. And we should all be sort of looking at the entire process to make sure that we're maintaining quality standards, you know, from the beginning of the trial through to completion. That's really the path for regulators to sort of take seriously the results we all generate.
[00:36:05] Speaker C: That's an excellent point. Just one final question. Question. Let's talk about competition for patients and clinical sites. What advice would you give to biotech and other industries about quickly locking in your patients and your site networks?
[00:36:18] Speaker A: Yeah. So I think, especially if you're in a competitive indication, considering looking outside of the most obvious places, which are of course the United States and Canada, but also some of the main countries in Western Europe, if it is a competitive environment, you may find it's hard to get the patients that you need by just looking in those places. And that's where Latin America, where other places in Europe, whether that's Greece, places like Turkey, all of the Eastern European countries become very interesting. If we believe that we've got good GCP expertise, good data quality, those can give us an opportunity to access patient populations that may not be as competitive because not all of your competitors will go to all of those markets. So I think we should be thinking carefully about the competitive environment and frankly, many biotechs aren't thinking enough about that up front. What is it that I'm going to do to make this study appealing to the site staff and the PIs that are going to be involved in driving this thing forward? So we encourage folks to think carefully there.
[00:37:13] Speaker C: Yeah, it sounds like a lot of proactivity needs to be at the forefront of your strategies in order to move things forward. Otherwise you're leaving some really important things out.
[00:37:22] Speaker A: Yeah, I think that's right. It's understandable that if you have an asset that you have cultivated over many years and it is your baby, you're excited about the potential that it could have for patients to assume that that's going to be obvious to everybody. But the truth is there are a whole bunch of other companies out there maybe competing in the same indication and they're telling their version of the story as well. So we think communicating about why this study matters, thinking carefully about geographic regions, et cetera. That's the path to an accelerated patient enrollment strategy.
[00:37:49] Speaker C: Very good. Good episode.
[00:37:50] Speaker A: Yeah, lots of fun. Julio was terrific and really interesting to dive in there. Thanks Adam.
Thank you for listening to the latest episode of Few and Far between conversations from the front lines of drug development. Our podcast is now available on Apple Podcasts and other streaming services. Please take a moment and leave us a user review and rating today. It really helps people discover the podcast and we read all the comments. Those comments help us make Few and Far between better and better. Also, be sure to subscribe if you enjoy Far between so you don't miss a single episode. Got an idea for a future episode? Email us at fewandfarbetween.com or contact us on our website at bio rossi.com I'm your host, Chris O'. Brien. See you next time.
