Episode’s Transcript

Julio Martinez-Clark (00:02.461)
Welcome back to another episode of the Latam MedTech Leaders podcast. Today, our guest is Javier Handal, Dr. Javier Handal, president of MRX Solutions, a company that is building a network of clinical research sites in Central America. Javier, it's great to have you here today.

Javier Handal (00:27.48)
Well, thank you Julio, thank you for the opportunity. It's a pleasure for me to be part of your podcast. I've been excited since we scheduled this a couple of weeks ago and hopefully I'm gonna give you enough material for you to post this and have a good attraction.

Julio Martinez-Clark (00:35.541)
You

Julio Martinez-Clark (00:43.071)
Beautiful. That's the plan. That's the plan to help companies understand the potential of Latin America and more specifically, Central America, including El Salvador. We're going to be speaking a lot about the country next. all right, let's get started. Tell us about your journey. How is it that you got to where you are today?

Javier Handal (01:02.35)
Well, you know, it's interesting because obviously, Salvador is a really small country. And I think in order to understand my story, I to start with my roots. So I come from a really nice family. My parents were great parents for me. And they have the vision to sign me into a French school in Salvador. So since I was a kid, always had a lot of international influence in my life. I learned French, Spanish.

Portuguese and English since I was growing up. So that helped me to have a different mentality than maybe the usual young kid who had in a country. And I always had the idea to go out to the country, meet the world, and try to do things different. So I always wanted to go to med school. At the time that I graduated school, maybe studying in cyber there seemed like the best option because of the

Julio Martinez-Clark (01:57.001)
Hmm.

Javier Handal (01:58.03)
more hands-on education than just theoretical education. So I went to med school and since I always knew that my final goal was to go to the States and try to go outside the country, I always tried to get advantage of all the opportunities that the university offered me. So I had an opportunity to do some internships in Brazil, Bolivia, Peru, United States.

Julio Martinez-Clark (02:27.103)
Hmm.

Javier Handal (02:27.118)
So that helped me to keep opening my mind to new opportunities, to different scenarios, different health systems. And at the end, when I finished med school, my parents are US residents. My sister was born in United States. At that time, my girlfriend was an American citizen. So I ended up moving to United States, doing all the process in order to be a legal immigrant.

Julio Martinez-Clark (02:30.303)
Yeah.

Julio Martinez-Clark (02:43.347)
Hmm.

Julio Martinez-Clark (02:47.775)
Okay.

Javier Handal (02:53.658)
and in order to do the boards and become a physician there and pursue a specialty. But that was when things, I started noticing different opportunities. And that's why through one of my best friends that after that we graduated med school together, he started working medical research actually here in El Salvador. So talking with him a lot, he started explaining to me the opportunities that El Salvador had.

Julio Martinez-Clark (03:16.095)
Hmm.

Julio Martinez-Clark (03:23.251)
Hmm. Hmm.

Javier Handal (03:23.346)
medical research. And that's where things start making sense to me. So being the States and having all this, let's say different mentality than than a regular Salvadorian because of my traveling and international experiences, I decided to, you know, pursue a different dream and try to start pursuing a career in medical research. So that's where when we start building a company,

Julio Martinez-Clark (03:27.166)
Hmm.

Julio Martinez-Clark (03:47.209)
Mm-hmm.

Javier Handal (03:50.926)
in the United States and in El Salvador as a site management organization in America, trying to manage different sites in Central America starting with El Salvador because of course that's my country but also the country that we knew the better and that we knew all the opportunities that was offering. So that's how the journey started and that's how then going like understanding the scenario better.

Julio Martinez-Clark (03:56.627)
Mm-hmm.

Javier Handal (04:20.994)
help us to start connecting with companies, start offering their services, especially through organizations like SCRS that help us open our eyes on all the opportunities that medical research, the medical research world has, and to see how underdeveloped the market is in Central America, that help us to pursue that dream of developing the market.

Julio Martinez-Clark (04:41.342)
Yes.

Julio Martinez-Clark (04:48.677)
Absolutely. I mean, it's fascinating how opportunities come along. don't see them. Somebody tells them about somebody gives you a tip and then you start putting things together and then you start creating a service that will really help companies that are looking to do fast, cost-efficient, ethical clinical research in Latin America.

Javier Handal (05:02.242)
Exactly.

Javier Handal (05:11.586)
Yes. Yeah. Another dimension that ethical, that's something that we really focus on because you you have much greater experience than the one that I have in medical research. We're fairly new in the market and I know you have a lot of experience in this area. But from our understanding, one of the big problems in Latin America is how you can professional professionalize medical research and move from research that's been done in paper

Julio Martinez-Clark (05:36.679)
Yes.

Julio Martinez-Clark (05:41.406)
Yes.

Javier Handal (05:41.442)
to research that's been done through software, through technology, through ethical parameters that allows you to have the same standard that you look in America, but in countries that offer different things, but without losing the ethical part of it. So that's what we want to bring to the region. We want to bring technology, want to bring ethical ethics, and we want to bring nice work, but adjusted to our countries.

Julio Martinez-Clark (05:52.821)
Mm-hmm.

Julio Martinez-Clark (06:03.871)
Mm-hmm. Mm-hmm.

Julio Martinez-Clark (06:11.252)
Yes.

Javier Handal (06:11.256)
to bring this signal to our people and for our people to have access to this technology and to development and even resources, bringing new resources to our hospitals, to our communities, and that's part of our mission.

Julio Martinez-Clark (06:27.143)
Excellent. All right, so let's talk about trends. What's happening in Central America? What's happening in Salvador that is making the country a potential hub for advanced clinical research?

Javier Handal (06:38.766)
So, you know, I think in El Salvador there's a really interesting political scenario to it. You know, everybody knows our president and he has changed the image of the country internationally for great. So now the country is not, and El is not being known just because of the gang members, but now it's being known because being a safe country, one of the safest countries in the continent.

for Bitcoin and other things. That's why you associate with the country now. And I think that's the first step. Because you cannot be attractive for investment if you don't have security. If people's dying in the streets, nobody's going to invest in the country. So I think that's first step. So that being said, the government has been working to attract investment. And I remember I was at the SCRS Global Summit earlier, well, later last year.

Julio Martinez-Clark (07:09.237)
Mm-mm.

Julio Martinez-Clark (07:17.845)
for that.

Javier Handal (07:36.75)
And in one of the the conference, someone said something that I said I think was really interesting. I asked the IQVIA meeting, I asked Alison Leedy, actually, that's her name, one of the vice presidents for IQVIA. I asked her why IQVIA was now doing research in in less number of countries every year. And what could Latin American countries do?

in order to be more attractive for companies like IKEA. And she said something that I think is exactly what my country is doing. She said that in order to be attractive, companies won't go to a country in order to change the country. The country needs to offer the best scenario in order for the research companies to go there and make things easier. And if you're not doing things easier, then nobody's going to go to your country.

Julio Martinez-Clark (08:08.405)
Mm-hmm.

Julio Martinez-Clark (08:24.725)
Hmm.

Julio Martinez-Clark (08:30.771)
Yes. Yes. Yes. Yes.

Javier Handal (08:35.138)
Like you will go to a country where you know things are really hard. You're looking for the country where it's the easiest to work with. So that's what the country is doing. So what we're doing as an SMO and as a Salvadoran research center is partnering with the government in order to take advantages of the good resources and the goodwill that the government is putting into bringing investments. So we're shortening

Julio Martinez-Clark (08:39.037)
Yeah.

Javier Handal (09:04.396)
the approval terms by having a law that enforces the national entities to respond to studies between 15 and 21 days. So that's what the law says in El Salvador. So obviously that's a tool that you have in order to enforce and to put some pressure into the national entities in order to have faster approvals. And at the end, you better than me know that pharmaceutical companies would speed.

Julio Martinez-Clark (09:05.812)
Yes.

Julio Martinez-Clark (09:12.008)
Mm-hmm

Julio Martinez-Clark (09:16.423)
Excellent. Yeah.

Julio Martinez-Clark (09:30.997)
Hmm.

Javier Handal (09:33.944)
That's what they want. They want exactly, exactly. what, that's what the industry wants. Nobody wants to wait 10 months in order to get approval to, start enrolling. Like you want to start rolling in, two weeks if possible. Impossible. So exactly. You started to start running the next day. So us.

Julio Martinez-Clark (09:34.709)
And medical device companies too.

Julio Martinez-Clark (09:42.437)
Exactly. Yes.

In two weeks, if possible. As soon as you sign the contract with the site.

Yeah.

Javier Handal (09:58.978)
That's what we want, of course. We want to be more appealing. We're a country and we're opening a market. So what we need to do is to take advantage of opportunities like this, like the one you're giving me, for people to understand that we have not just good resources, but we have a government that's backing up our decisions and our industry. So I think that's one of the...

key elements that make El appealing now, that we're working together with the government in order to make things more appealing for companies like yours to bring, to choose our country instead of other countries in the world, because you have all the world to choose from. So why El Salvador? Because at the end, we're trying to do things right and we're trying to do things fast.

Julio Martinez-Clark (10:33.481)
Yeah.

Julio Martinez-Clark (10:41.265)
Exactly, Yeah.

Julio Martinez-Clark (10:49.15)
Mm-hmm.

Julio Martinez-Clark (10:53.919)
Totally, All right, let's talk about speed. Let's talk about the approval timeline, the process. First, what's a process? It's a two-step process, one-step process, three-step process. What are the steps necessary to get approval? How long does it take to get the approval? Let's talk also about the fact that the regulatory agency was just revamped, was just restructured.

Javier Handal (11:21.122)
Yes. Yes.

Julio Martinez-Clark (11:22.195)
recently, which is a great sign for what we're discussing here.

Javier Handal (11:26.659)
Yes, that obviously you know what you're talking about. Definitely, Salvador used to have DNM that was a national regulatory entity and they just switched to the SRS. So now they have more resources and now they're trying to do things better. The government is changing different entities, trying to do things better. And to answer your question about the process, let me talk about

Julio Martinez-Clark (11:30.249)
Yeah. Yeah.

Julio Martinez-Clark (11:35.891)
Yeah.

Yes.

Julio Martinez-Clark (11:45.215)
Yes.

Javier Handal (11:54.324)
what the process is in paper and what in our experience the process has been. So the in paper the process is you need to to have the approval by the SRS now the national regulatory entity now first that's the first step so no no that's the second step yeah so the first step is having the SRS approval and as I was telling you now by law

Julio Martinez-Clark (11:56.925)
Okay.

Julio Martinez-Clark (12:08.223)
First, is that the first approval? Okay, not the ethics committee, the SRS. Okay.

Javier Handal (12:22.798)
they need to answer between 15 to 21 working days. So we're talking about one month. So that's the time they have to get to basically if you have no observations, that's the time where you can expect to have an approval by them one month. Obviously, if you have observations, you have things to get to change, things can be delayed a little bit, but then they still have time in order to answer.

Julio Martinez-Clark (12:27.005)
Okay, yes.

Julio Martinez-Clark (12:36.775)
Yes, okay, exactly, exactly.

Julio Martinez-Clark (12:44.051)
Mm-hmm.

Javier Handal (12:48.588)
those corrections, they cannot make you wait three months in order to do corrections. So if you present your changes in a timely manner, then they need to answer in a timely manner. So that's the first step. So if you get the approval, let's say in one month, then the second step is the National Ethical Committee. And let me explain something a little bit, because I know in Latin America, the scenarios vary a lot. There's a lot of countries with completely different process.

Julio Martinez-Clark (12:53.267)
Yes. Yes.

Julio Martinez-Clark (13:00.189)
Okay. Okay. Okay.

Julio Martinez-Clark (13:07.935)
Okay.

Julio Martinez-Clark (13:13.78)
Yes.

Javier Handal (13:18.272)
And in other countries that have multiple ethical committees, and in some of them, we just have one. We just have the national ethical committee. So if you have approval.

Julio Martinez-Clark (13:25.417)
which is, and I'm sorry, it's a government entity separate from the Ministry of Health. It's okay. Yeah.

Javier Handal (13:29.536)
Yes, exactly. Yeah. So, so the second step is to have the ethical improvement, the approval and that's exactly the same thing. 15 to 21 days. After that, if you have like in medical devices, you need to import the medical device. So you need to get a special visa in order to import the devices that usually takes two to three days. Exactly. Yeah.

Julio Martinez-Clark (13:41.0)
Okay.

Julio Martinez-Clark (13:52.853)
An import permit, not a visa. An import permit. it's called special visa. that's funny. That's interesting. It's confusing. It's an import permit. Okay.

Javier Handal (13:58.176)
It's called special visa. That's how that's how they call them. Yeah. Yeah, so but it is an import permit exactly. Yeah, it's an import import permit. Exactly. So so as soon as you as you have that that takes a couple days, then you can import the product, the devices and and you have all the approvals to start rolling. So you just

Julio Martinez-Clark (14:17.725)
So the import permit takes just a few days, three, four days. Okay. Five days tops. Okay. Who gives you that? The custom agency or the SRS, the Ministry of Health. So you go back to the Ministry of Health. Okay. So it's.

Javier Handal (14:20.962)
Just five days. Let's say the whole process. Yeah, so up At the SRS the SRS again. Yeah. Yes Yeah, well the SRS is apart from the ministry the SRS does it yeah Exactly. Yeah. Yeah

Julio Martinez-Clark (14:38.037)
Well, yeah, yeah, the regulatory agency. That's what I meant. I'm sorry. Yes, yes. So, so, SRS first, then ethics committee second, and then go back to the SRS for the import permit. So the whole process, exactly. And the whole process will take what, 60, 90 days? Tops. I mean, sort of. Okay.

Javier Handal (14:46.765)
Yes.

Exactly and that's a process

Javier Handal (14:55.598)
Exactly. Let's say two months and a half. Two months and a half. Yeah. But now, let me tell you what we've seen and what opportunities the government is giving us. So the ethical, and this is off the record, but the thing is the government wants to be more attractive. So what they're doing is they're allowing us to try to do both things at the same time.

Julio Martinez-Clark (15:00.437)
Two and a half months, okay.

Julio Martinez-Clark (15:05.159)
Okay. Okay.

Julio Martinez-Clark (15:12.06)
Okay.

Julio Martinez-Clark (15:18.826)
Yes.

Julio Martinez-Clark (15:24.849)
Awesome, that's excellent.

Javier Handal (15:24.854)
So if we present, if we give all the paperwork to the SRS, we can do the same thing to the ethical committee in order to give them time to check all the information. They won't give us your ethical approval without the SDRS approval, but at least they will gain time in order to check all the information. And as soon as we get the SRS approval,

Julio Martinez-Clark (15:39.305)
Hmm

Javier Handal (15:52.782)
the ethical committee approval will get faster because they already have all the information prior. So that's what's happening now. So that's shortening the times. And now we can confidently say that obviously if there's no observations, can start running in two months, everything included. So that's a good will.

Julio Martinez-Clark (15:59.838)
Hmmmm

Julio Martinez-Clark (16:13.69)
much.

Javier Handal (16:21.454)
way of working. Because the law doesn't say that. But in order to make the things more appealing and to attract investment, the ethical committee and the SRS are willing to work together and to partner in order to help research companies like ours to be more appealing for companies like yours.

Julio Martinez-Clark (16:35.839)
Sure, yes.

Julio Martinez-Clark (16:44.969)
That's fantastic. All right. I get it. I think it really makes a difference to do parallel applications. I've seen that in a few other places. It's not that common, but it's really a novelty in the clinical research world. And that also signals the fact that

there should be a difference between what the ethics committee reviews in the study documents and what the regulatory agency reviews. Because sometimes you have overlap. And for example, in Columbia, the issue is that you have to get ethics committee approval first, and then you go to the national regulatory agency, which is a branch of the Ministry of Health.

They review everything again and they make corrections to something that the ethics committee already approved. And then you have to go back to the ethics committee to re-correct everything and get, you know, a wait for that approval. So that makes things, I mean, little messy and longer.

Javier Handal (18:02.478)
And you know, now we'll just say that something that's really hopeful for the future is that we were in a meeting with the director of the National Ethical Committee and she was telling, by the way, she's a new one, she just changed a couple months ago, and she was telling us how she's willing to improve the process that they currently have by trying to communicate with the SRS and making sure

Julio Martinez-Clark (18:18.068)
Hmm.

Javier Handal (18:31.074)
that they ask for the same documents on the same format. Because sometimes you need to change the format for two national entities. So by working on the same format, that is even an easier work for us in order to just present the same paperwork in one place and the other. In order not to be switching formats and changing the documents when at the end they want the same information.

Julio Martinez-Clark (18:35.153)
Exactly! Exactly!

Totally.

Julio Martinez-Clark (18:49.459)
Yes. Yes.

Javier Handal (18:59.79)
So I think those are really good signs that makes us be really enthusiastic of what the future can bring in medical research in Salvador. Because we think that the government and the national entities, we're alive. We're for the same things. We just want to pass through a full process that allows the country to be more appealing in order to bring more investment.

Julio Martinez-Clark (18:59.975)
Yes.

Julio Martinez-Clark (19:22.815)
Totally right. Yes. All right. So let's talk about the healthcare system in El Salvador. Patient recruitment potential because on top of speed, you need patient recruitment, right? I mean, you have to combine and of course safety, as you said, you have to combine all these three aspects to make the country attractive for clinical research investment. So tell us about the healthcare system. How does it work? Why do you think we can recruit patients in El Salvador?

Javier Handal (19:26.67)
Yes.

Yes. Yes. Yes.

Javier Handal (19:37.677)
Yes.

Javier Handal (19:52.6)
Yeah. So in the South of the world, think like in most of the countries, there are different systems that work in par. So let me explain a little bit what I mean. So in the South of the world, have the public system. That's a free system completely financed by the government. We have a social security system. That's a part private, part public system where people pay social security and they have access to the hospital. And then we have the private hospitals where you pay and

Julio Martinez-Clark (19:52.65)
fast.

Julio Martinez-Clark (20:05.577)
Yes.

Javier Handal (20:21.89)
you have access to healthcare. So let's start, obviously, usually in Latin America, the public health system is the one that has the least resources. That's usually what it is. But this government, since the pandemic, has been doing good investments in infrastructure. I think that's really.

Julio Martinez-Clark (20:22.345)
Yes.

Julio Martinez-Clark (20:37.161)
Yes.

Javier Handal (20:49.326)
So during the pandemic, one of the flagship projects for the government was to build a whole new hospital in order to fight the COVID pandemic. Instead of building like an emergency hospital, they took what was the National Convention Center and made it a hospital. So now that's the biggest hospital in the country with more than 4,000 beds. And just for you to understand, the whole country

Julio Martinez-Clark (20:57.887)
Yes.

Julio Martinez-Clark (21:08.82)
Yes.

Hmm

Hmm.

Javier Handal (21:18.732)
before COVID had between 25 to 40 ICU beds, the whole country. Now, just inside of the hospital has 260 ICU beds, just inside of the hospital. So what that's doing is increasing the national system infrastructure quality. And then you have the other two systems that are

Julio Martinez-Clark (21:24.341)
Okay. whole country, I mean, that's really, yeah.

Julio Martinez-Clark (21:31.925)
Wow, that's really impressive.

Javier Handal (21:47.002)
the, as I mentioned, the social security system and then the private system that, it's, let's say, just for the islets of the country that can afford a private, a private hospital. So what we've done is reach out to the national ministry of health and to the authorities in the national hospitals in order to partner with them, in order to have access to those hospitals. So that's the final step for us.

Julio Martinez-Clark (22:09.321)
Yes.

Javier Handal (22:16.202)
in order to be a research site that has access to the national network hospitals, that allows us to have access to millions of patients that are part of the national network hospitals, and in order to recruit through that system. So let me explain a little bit how we're doing that, because this is a big step for the national system in order to improve the

Julio Martinez-Clark (22:21.479)
Yes.

Julio Martinez-Clark (22:28.969)
Yes.

Javier Handal (22:45.602)
the equipment and the infrastructure. What we're doing is we're basically partnering with the hospitals and paying them all the expenses that the studies generate in order for them to have own resources to invest in their personnel and in infrastructure. So if we get a study that we need 10 ICU patients,

Julio Martinez-Clark (22:59.017)
Mm-hmm.

Julio Martinez-Clark (23:05.141)
Hmmmm

Okay.

Javier Handal (23:13.986)
What we do is we pay the national hospital that only depends on the national budget in order for resources. So we are different income source for the hospital in order for them to invest on things that they cannot cover through the budget.

Julio Martinez-Clark (23:20.629)
Mm-hmm.

Julio Martinez-Clark (23:28.777)
Yes, resource, yes.

Julio Martinez-Clark (23:36.746)
Yeah.

Javier Handal (23:38.914)
Talking with the director of the hospital, was telling me that one of the problems that they're having now is that they have a lot of young nurses. So in order to qualify them and to certify them in all the research the hospital has, like all the new ICU technology and all the new equipment they have, they're needing to send all these people

to other countries in order to train into all these devices. But they don't have enough resources to do that. So by partnering with us and by using some of the resources that the hospital has, they're having access to extra funding in order to train their personnel. So that's the symbiosis that we're doing with the hospital in order for us to have access to inpatient facilities and for them to have access to more resources and to have...

Julio Martinez-Clark (24:22.227)
Hmm.

Javier Handal (24:36.376)
to make advantages of the investments that us, research center, are bringing to the country, so that money is flowing through the national system too. And it's bringing equipment and technology to hospitals that maybe don't have those kind of equipment too. And also that's allowing us, as you said, to have a big recruitment potential.

Julio Martinez-Clark (24:46.835)
Yes.

Julio Martinez-Clark (24:54.335)
Hmm.

Julio Martinez-Clark (25:01.909)
That's fantastic. I mean, congratulations. You are changing the country. mean, this is mind boggling. Yeah, fantastic. All right. So we're getting close to the end of the show, Javier. What are your final words of advice for a medical device or a pharmaceutical company that is exploring doing a trial in Latin America?

Javier Handal (25:05.798)
thank you.

Thank you.

Julio Martinez-Clark (25:31.445)
What would you say to the CEO of a company that is in front of you talking to you?

Javier Handal (25:36.76)
tell them to trust us. I definitely think and we just had a couple of meetings with our partners in Salvador meeting with the directors of the different hospitals and everything and one of our American partners was telling us why would someone not do research in Salvador? Why would someone go somewhere else anywhere in the world? We have the hospitals, we have the patients and we have the timelines. What else do you want?

Julio Martinez-Clark (25:38.261)
Hmm.

Julio Martinez-Clark (26:00.038)
Hmm.

Julio Martinez-Clark (26:04.723)
Yes. You're making them an offer they can't refuse.

Javier Handal (26:07.04)
Obviously

Yes, yes, we were talking about that and now I'm eager to sit in front of a CEO from American pharmaceutical device company and tell them why would you do research in America if you can do research in the South? That will be my question to any CEO that's in front of me now.

Julio Martinez-Clark (26:22.889)
Yeah.

Yeah, exactly.

Julio Martinez-Clark (26:31.881)
Yeah, well, the competitor is not necessarily the United States, is Eastern Europe, Australia. Why would you go that far to do the same research that you can do in Salvador, which is so close to the United States? And it's safe. Exactly.

Javier Handal (26:42.998)
Yes.

Javier Handal (26:50.158)
two hours away from America. In the same time zones, same currency, because even Salvador's currency is American dollar. So we have the scenario set. We just need companies to trust us and to understand the offering that we have.

Julio Martinez-Clark (26:55.561)
Time zone, yeah.

Julio Martinez-Clark (27:00.955)
Same currency that's also an advantage. Yes.

Julio Martinez-Clark (27:09.429)
Yeah.

Julio Martinez-Clark (27:16.543)
Beautiful. All right, thank you so much for being here.

Javier Handal (27:19.63)
Julio, I really appreciate the opportunity. I really appreciate the scenario. And I hope different companies can trust us, and as you do, and hopefully we can make El Salvador a reference in Latin America in medical research. Exactly. Exactly. Thank

Julio Martinez-Clark (27:37.735)
Yes, we're going to put Salvador in the map of clinical research in Latin America. Beautiful. Thanks.