Episode’s Transcript

Julio Martinez-Clark: (00:00)
Welcome to the LATAM 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. Today our guest is Luis Alvarez. Luis is the CEO and founder of Theradaptive and developed a concept for targeted therapeutic delivery during and following a combat tour in Iraq where several of his soldiers suffered severe extremity injuries. So, Luis, welcome to the show. Thanks for being here.

Luis Alvarez: (00:46)
thank you so much, Julio, for the invitation. I look forward to the conversation.

Julio Martinez-Clark: (00:50)
Excellent. Alright, Luis, let's get started with your journey to Latin America. How is it you got connected with the region?

Luis Alvarez: (00:57)
Well, my family is originally from Cuba, and I've always had connections and friends and family in Latin America. And then professionally as we started to develop the company and look at options. We have had several conversations with companies in Latin America that run clinical trials and that would be interested later on in licensing. So now we're having, I would say a growing interest in doing business in Latin America.

Julio Martinez-Clark: (01:26)
Excellent. All right. So what trends do you see happening in the industry or in Latin America that are relevant to, to the discussion today, Luis?

Luis Alvarez: (01:36)
Well, I think a lot of companies that provide let's say clinical services and companies that would be distributors for products that are approved from those studies are starting to grow quite a bit. And they've experienced growth not only in activity in Latin America, but a lot of those Latin American companies are now actually multinational. So they're looking for partnerships in the US and in Europe and other regions. And we see a lot more activity, more appetite, more interest in this type of across-regional collaboration.

Julio Martinez-Clark: (02:11)
Very good. What's been your experience doing studies? I mean, in the US or outside of the United States?

Luis Alvarez: (02:18)
So, as a US-based company, we've actually looked abroad first. So we have partners, for example, in Japan. we also have a third Adaptive Australia, which we set up as a new entity. Yeah. And we do have experience doing, preclinical work. And now we'll be launching our first phase one, two combined studies. We'll enroll first and dose, its first patient in Australia. Excellent. So, you know, we're familiar with overseas types of operations, and actually, we're looking with great interest toward Latin American clinical study sites.

Julio Martinez-Clark: (02:51)
Okay. Any particular reason why you are looking at Latin America to diversify your patient enrollment? no diver diversity or to acquire more clinical data to expand outside Australia or for recruitment reasons? I mean, what's your driver to go to Latin America now?

Luis Alvarez: (03:09)
Well, overall Latin America, I think it's very attractive because medical practice, there is world-class in several of the regional medical centers in each of the countries. so, they are no strangers to doing, you know regulated clinical studies. Also, it's an attractive market. It's a growing market, and for us is something that, you know, if you already have a connection clinically, then you have a much easier time launching products because physicians are familiar with your product. So it makes sense to do clinical studies in each of the regions where you want to have your business, but also for diversity because the FDA in the US actually has very strict measures of how effective your therapy is in different populations.

Julio Martinez-Clark: (03:55)
Yes. Yeah, good answer. And so let's go back to Australia because I see the companies are exploring Australia a lot or have been exploring Australia for quite a bit, and I understand there are some incentives. Can you elaborate a little bit more on that? Why do you go to Australia?

Luis Alvarez: (04:11)
Yes, and we're not the first, and every time we turn our heads, there's another company going to Australia. Oh. And the reason is very simple, and it's maybe a model that regulators in Latin America might borrow because it's a successful model. Yeah. That is the Australian authorities allow you to take a 43.7% refund through their tax system on any expenditures that you have in, in the country related to clinical work. So for a company, it makes absolute sense to do that, and it's created a huge incentive for many, many, from large to small, many companies to do this work there. So I think in Latin America, there may be opportunities for this type of economic creativity to attract more business.

Julio Martinez-Clark: (05:02)
Absolutely. Absolutely. What about the regulatory approval process in Australia? Do you find it to be, do you find it to be expeditious, I mean efficient? Or have you gone through that yet? Or not yet? What stage are you in?

Luis Alvarez: (05:19)
Yeah, so we have actually experienced what it is like to get approval to start a clinical study. In Australia it's very straightforward because you do not require the way you do in the US you require FDA approval of an IND or an IDE In Australia, you really need local ethics approval in the study site where you're operating, and then a notification to what's called the TGA, which is the equivalent of the FDA. So in Australia, the entry barrier to a study is satisfying the ethics questionnaire. And that also makes it very attractive. So I would say in Latin America, if there are some ideas around entry points for phase one studies or phase one, and two studies, allowing a local ethics approval as the standard could really facilitate new entry into the market.

Julio Martinez-Clark: (06:11)
Absolutely. Yeah. There are some, in Latin America, it's just a matter of finding the right country because every country has its own ways of doing things. But there are a couple of countries in Latin America where that can happen, but they don't have that incentive, that tax incentive that Australia has. So, but has other advantages. It's closer to the us same time zone, less travel, other advantages. Okay. So, in terms of other colleagues or other companies that you know about is Latin America always in the conversation? Is Australia always in the conversation? Is Eastern Europe always in the conversation? Because it used to, and now I'm not so sure. So that's why I wanna get your take on that. What countries are in the conversation about exploring geographies for clinical research, in your opinion?

Luis Alvarez: (07:07)
Y yes. I would say Australia ranks at the top, but I have heard in many conversations about studies in Latin America and especially in Colombia Mexico, Brazil, Argentina, where there are favorable environments to do those studies. Eastern Europe has fallen to a less prominent role, maybe for various reasons. But, I would say in Latin America, I've seen an increase in the discussions around having studies down there.

Julio Martinez-Clark: (07:37)
Very good. Very good. Yes, certainly. One of the advantages of Latin America, as I mentioned is way closer to the United States and also cost savings. I'm, I'm not sure how costly Australia is, but certainly the currency is stronger than the Colombian peso, for example, the Mexican peso. So that in itself is also an advantage of Latin America. Also the size of the country. I'm not so sure if you know that but Latin America is one of the most urban organized regions in the world. And according to the trends, it will soon be the most organized region in the world. So for patient recruitment, that helps a lot. 'cause you don't have to go through five cities to find subjects if you have all your subjects in just one city, so you don't have to

Luis Alvarez: (08:27)
Yes, that's very attractive. Very attractive.

Julio Martinez-Clark: (08:29)
Yeah. Yeah. Australia, I understand has what, like 30 million people, something like that, but it's all spread out. I mean, it's a large territory.

Luis Alvarez: (08:38)
Yes. And Australia actually is very sparsely populated, and most of the population lives on the coasts, whereas in Latin America, you have like you said, a lot of urban centers that offer really good advantages for,

Julio Martinez-Clark: (08:50)
Yeah. Okay. So let's go back to the United States. Why are companies going overseas? I mean, in your opinion, what's the driver for these companies to look at places like Australia or, or Latin America?

Luis Alvarez: (09:03)
I would say the simplicity and effectiveness of the studies in the overseas locations cost. so the number of advantages of going to Latin America or overseas and I think it really has to do with the requirements that are imposed to do studies in the US. sometimes it's not even the FDA, it's these large medical centers that become, you know, almost bureaucratic. They become their own government entities in a way. Whereas in overseas sites these centers are more practical. They operate quickly, they get to the point which is treating the patient. And that's attractive.

Julio Martinez-Clark: (09:42)
That's a great point. You know, I've never heard that point before, I mean, having bureaucracy in the middle of the approval in these large hospital systems. But you're bringing up a great point. I mean, in, in the US you don't find smaller hospitals anymore. 'cause of the consolidation of the, of the healthcare industry, you find huge hospital systems and, and as you said, they can be extremely bureaucratic. Whereas in places like in Latin America, Colombia, Mexico, and Brazil, you find smaller clinics where you can pick up the phone and call the CEO of the clinic and get things done. Yes. Quickly. Yeah, that's, that's a great point. Yeah,

Luis Alvarez: (10:22)
That's a huge benefit. That's

Julio Martinez-Clark: (10:23)
A huge benefit. Awesome. So, the trend is clear I understand there is a program in the United States called the Early Feasibility Study Program or something like that. Have you heard about it? Is that something that is making a dent in this trend or not?

Luis Alvarez: (10:43)
I haven't actually heard about that. but now that you mentioned I should look into it.

Julio Martinez-Clark: (10:48)
Yes. It's, so the FDA started about probably seven years ago. And actually, one of my clients the CEO of a company who did a study with us is leading or used to be leading that program. last time I checked, he was leading that like two years ago. But anyway, the point is that the FDA realized that these studies are going overseas and the US is missing out on this business and patients have, are not having us, patients are not having access to these advanced medical technologies earlier and they're doing something or they're trying to do something to attract these companies back to the United States, and so that they don't have to go overseas. But of course, as you said, there are some things that are outside of the control of the FDA that make it difficult, like dealing with the bureaucracy inside of the private hospital system. But regardless there's that, that's a very good initiative. I mean, not good for countries like Australia or Colombia, but it's good for us, companies that wanna be in the US don't, don't venture overseas. I also understand that I've been doing this for 15 years, and it can be a little scary, especially for companies going to Latin America. You hear all these bad news about political instability and, and riots and all these things that you see in the news. So that is not something that is making the region attractive. But once initially, I mean, on the surface, but once you, you, you pass that point and you realize that, that the, the good is more than the bad in Latin America. Companies are pleasantly surprised about what they find in Latin America. So, yeah, that's the early feasibility, study program, I invited you to check it out. It will probably give you another angle to explore and you search for locations.

Luis Alvarez: (12:57)
That's very helpful. Thank you for that. And you know, the point about instability, I almost feel in some ways, is over overstated because the news will want to highlight this, but every time I visited anywhere in Latin America, I felt very safe. And I don't even think that should be a real consideration for anybody considering you know, studies in Latin America that's that has not turned out to be, you know, a real effect in limiting any

Julio Martinez-Clark: (13:25)
Good for me. Good, good, good. Yes. And what countries have you have you visited in Latin America besides Cuba, of course?

Luis Alvarez: (13:33)
So Mexico, Brazil, Argentina, and Uruguay, to name a few. But yeah, it's been it's good to visit. And just the, the urban centers, as you said are really rich in populations for recruiting, for clinical studies. And the medical practice is of course, world-class in these cities the main cities. So yeah, I found it to be a very attractive location, which is part of the reason we're you know, we're exploring expanding our phase one, two for spine, actually to Colombia.

Julio Martinez-Clark: (14:05)
Excellent. Very good. Very good. So in, in your search in, in Latin America and Colombia, have you found good experienced CROs? I mean, what's been your experience in, in, or I don't know if you've spoken with a CRO or not, but have you found investigators motivated to lead in your study or professionals willing to help you set up the studies? I mean, what's been your journey towards exploring Colombia, for example, as your destination?

Luis Alvarez: (14:34)
Yeah, actually in Colombia, we do have a very nice CRO that we've been talking with that we think that we will probably move ahead with them. And they've been very supportive in explaining everything about how to start a study, even the regulatory requirements in Colombia. And so we feel very comfortable with 'em. and I think having a good strong CRO partner is important because, for all the reasons you mentioned, the logistics, the language the contacts are something that you rather plug and play than try to develop from scratch.

Julio Martinez-Clark: (15:11)
Very good. Yes. Agreed. Alright Luis, I, I think we're close to the end of the show. I thank you so much for your insights. They're priceless. And I wish you an extraordinary experience in Latin America, in Colombia is my home country. And I am sure that you're gonna have good study I mean clinical data, clinical results in the country. And the country is one of the most experienced, countries in Latin America in early feasibility. First in human proof of concept type of medical device studies, and more so than the other country that you mentioned, Argentina, Brazil, because of the speed of the reg regulatory approval process, the hospital infrastructure, and the openness of the investigators to collaborate with US physicians, proctors, and, and US companies. So it's actually the friendliest country to the United States, like the closest ally in Western America.

Luis Alvarez: (16:16)
Yes. Well, I look forward to visiting and maybe seeing you when I go down there, Julio.

Julio Martinez-Clark: (16:19)
Yes. It'll be fantastic. Thank you, Luis. Sure, sure. So, before we sign up for today, do you have any final thoughts, mores of wisdom, or other musings for our listeners?

Luis Alvarez: (16:32)
I would say whenever you have curiosity, especially in investigating Latin America as a potential site take the dive, make the jump, and go visit, then you'll be pleasantly surprised.

Julio Martinez-Clark: (16:46)
Excellent. Well said. Alright, Luis, thank you so much for being on the show today. Bye-Bye.

Luis Alvarez: (16:52)
Thank you so much.