March 1, 2024
Luis Alvarez, CEO and Founder of Theradaptive
Luis is the CEO and Founder of Theradaptive and developed the concept for targeted therapeutic delivery during and following a combat tour in Iraq where several of his soldiers suffered severe extremity injuries. Previously, Luis was the co-founding Deputy Director of the Department of Defense Regenerative Medicine Program and led the department's largest recombinant biologics program through Phase II. Luis was a DARPA Service Chief Fellow and Academy Professor at the United States Military Academy, West Point. Luis received his PhD in Biological Engineering from MIT where he was a Hertz Foundation Fellow.
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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 .
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Today our guest is Luis Alvarez. Luis is the CEO and founder of the Adaptive and developed a , the concept for targeted therapeutic delivery during and following a combat tour in Iraq where several of his soldiers suffer severe extremity injuries. So, Luis , welcome to the show. Thanks for being here.
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Uh , thank you so much, Julio , for the invitation. I look forward to the conversation.
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Excellent. Alright , Luis , let's get started with your journey to Latin America. How is it you got connected with the region ?
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Well , uh, my family originally, of course from , uh, from Cuba, and , uh, I've always had connection and friends and family in Latin America. And then , uh, professionally as , uh, we started to develop , uh, the company and, and to look at options. We have had several conversations with , uh, companies in Latin America that , uh, run clinical trials and that , uh, would be interested later on in licensing. So now we're having , uh, I would say a growing interest in , uh, doing business in Latin America.
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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 ?
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Well, I think a lot of , uh, companies that provide , uh, let's say clinical services and companies that , uh, would be distributors for products that are approved , uh, from those studies , uh, are starting to grow quite a bit. And they've experienced , uh, growth not only in , uh, 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 , uh, across regional , uh, collaboration.
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Very good . What's been your experience doing studies? I mean, in the US or outside of the United States?
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So, as a US based company, we've actually looked abroad first. So we have , uh, partners, for example, in Japan. Uh, we also have , uh, a third Adaptive Australia, which we set up as a new entity. Yeah . And we do have experience doing , uh, preclinical work. And now we'll be launching actually our first , um, phase one , two combined study. We'll enroll first and dose , its first patient in Australia. Excellent. So, you know, we're familiar with over overseas type of operations, and actually we're looking , uh, with great interest towards , uh, Latin American , uh, clinical study sites.
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Okay. Any particular reason why you are looking at Latin America to diversify your patient enrollment? Uh, 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?
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Well, overall Latin America, I think it's very attractive because , uh, medical practice, there is world class in , in, in several of the , uh, regional medical centers in each of the countries. Uh, so , uh, they are no strangers to doing, you know , uh, regulated clinical studies. Also, it's an attractive market. It's a growing market, and , um, for us is something that , uh, you know, if you already have a connection clinically, then you have a much easier , uh, time launching , uh, products because physicians are familiar with your product. So it makes sense to do clinical studies in each of the regions where you want , uh, to have , uh, your business, but also for diversity, because the FDA in the US actually has very , uh, strict , uh, uh, measures of how , uh, effective your therapy is in different populations .
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Yes. Yeah, good answer. And so let's go back to Australia , uh, because I, 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?
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Yes, and we're not the first and , uh, every time we , uh, turn our heads, there's another company going to Australia. Oh . And the reason is very simple, and it's maybe a model that , uh, uh, regulators in , uh, Latin America might , uh, borrow because it's a successful model. Yeah. And that is that the Australian authorities , uh, allow you to take a 43.7% , uh, um, 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 , uh, economic , uh, creativity to attract , uh, more business.
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Absolutely. Absolutely. What about the, the regulatory approval process in Australia? Do you find it to be, do you find it to be , uh, uh, expeditious, I mean , uh, efficient? Or have you gone through that yet? Or not yet? What stage are you in?
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Yeah , so we have actually experienced , uh, what it is like to get , uh, approval to start a clinical study. And in Australia it's very straightforward because you do not require , um, 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 , uh, 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 ethics , um, questionnaire. And , uh, that also makes it very attractive. So I would say in Latin America, if there are some , uh, ideas around , uh, entry points for phase one studies or phase one , two studies, allowing a local ethics approval as the standard could really facilitate new , uh, new entry into the market.
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Absolutely. Yeah. There are some, in Latin America, it's just a matter of finding the right country, because every country has its own , uh, ways of doing things. But , uh, there are a couple countries in Latin America where that can happen, but they don't have that, that incentive, that tax incentive that Australia has. So, but, but has other advantages. It's closer to the us same time zone , less travel, other advantages, . Okay. So , uh, in terms of , um, so in terms of , uh, other , uh, colleagues or other companies that you know about, is , is, 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 , uh, 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?
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Y yes. Uh , I would say Australia ranks at the top, but , uh, I have heard , um, in many conversations , uh, studies in Latin America and especially in , uh, Columbia , uh, Mexico, Brazil, Argentina , uh, where there are favorable environments to do those studies. Eastern Europe has fallen , uh, to, to a less prominent role, maybe , uh, for various reasons. But , uh, I would say in Latin America, I've seen an increase in, in the , uh, discussions around having studies down there.
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Very good. Very good. Yes , certainly. Um, one of the advantages of , of Latin America, as I mentioned, is, is, 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 , is is stronger than the Colombian peso, for example, the Mexican peso. So that in itself is also a , a , an advantage of Latin American . Also the size of the country. Uh , I'm not so sure if you know that, but , um, Latin America is one of the most urban organized regions in the world. And , and , and , 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 a , uh, five cities to , to find subjects if you have all your subjects just one city, so you don't have to
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Yes , that's very attractive. Very attractive.
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Yeah. Yeah. Australia, I understand is, is has what, like 30 million people, something like that, but it's all spread out. I mean, it's a large territory.
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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 ,
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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?
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I would say simplicity , uh, effectiveness of the studies in the overseas locations , uh, cost . Uh , so the number of advantages of , uh, going to Latin America or, or overseas , uh, and I think it really has to do with the , uh, the requirements that are imposed to do studies in the us . Uh, sometimes it's not even the FDA , it's these large medical centers become, you know, almost bureaucratic. They become their own government , uh, entities in a way. Whereas in overseas sites , uh, these centers are more practical. They operate quickly, they get to the point which is treating the patient. And that's attractive.
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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, 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, in, in , in places like in Latin America, Columbia , Mexico, 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,
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That's a huge benefit. That's
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A huge benefit. Awesome. So the, the, the trend is, is is clear , um, I understand there is a , there is a , 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?
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Uh, I haven't actually heard about that. Uh , but now that you mentioned I should look into it. Uh ,
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Yes. It's , so the F fda a , so the F FDA A started about probably seven years ago. And , and actually one of my clients , uh, the CEO of a company who did a study with us , uh, is leading or used to be leading that program. Uh, last time I checked , he was leading that like two years ago. But anyway, the point is that the FDA realized that , uh, that, that these studies are going overseas and the US is, is missing out on, on, on, on these business and, and patients have, are not having us , patients are not having , uh, access to these advanced medical technologies , uh, earlier and, and , uh, they're doing something or they're trying to do something to attract these companies back to 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 , uh, makes it difficult, like dealing with these bureaucracy inside of private hospital system. But regardless , uh, there's , uh, that , that's a very good initiative. I mean, not good for countries like Australia or Columbia , but , uh, it's good for, for us , companies that wanna be in the US don't, don't venture overseas. Because I also understand, I've been doing this for 15 years, and, and it can be a little scary , uh, especially for companies going to Latin America. You hear all these bad news about political instability and , and riots and, 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, is is more than the bad in Latin America. Companies get pleasantly surprised about what they find in, in, in , in Latin America. So, so yeah, that's, that's, that's , uh, the , the early feasibility , uh, study program, I invited to check it out. It will , uh, probably give you another angle to explore and you search for locations.
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That's very helpful. Thank you for that. And you know, the , the point about instability, I almost feel in some ways , uh, uh, is over , uh, overstated because , uh, the news will want to highlight this, but every time I visited , uh, anywhere in Latin America, I felt very safe. And , uh, I don't even think that should be a real consideration for anybody considering , uh, you know, studies in Latin America that's , uh, that , uh, has not turned out to be , uh, you know , a real effect in limiting any
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Good for me . Good, good, good. Yes. And what countries have you have you visited in Latin America besides Cuba for of course.
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Uh , so , uh, Mexico, Brazil , uh, Argentina, , uh, to name a few. But , uh, yeah, it's been , uh, it's good to visit . And , uh, just the , the urban centers, as you said , uh, are really rich in , uh, populations for , uh, for recruiting, for clinical studies. And the medical practice is of course, world class in these cities , uh, the main cities. So yeah, I found it to be a very attractive location, which is part of the reason we're , uh, you know, we're exploring , uh, expanding our , uh, our phase one , two for spine, actually to , uh, Columbia .
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Excellent. Very good. Very good. So in , in your search in, in Latin America and Columbia , have you found , uh, good experienced CROs? Uh, 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, your journey towards exploring Columbia , for example, as your destination?
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Yeah, actually in Columbia , we do have a very nice , uh, CRO , uh, that we've been talking with that , uh, we think that we will , uh, probably move ahead , uh, with them. And they've been very supportive in explaining everything about how to start a study, even the regulatory , uh, requirements , um, in Columbia . And , uh, so we feel very comfortable with 'em . Um, and I think , uh, having a good strong CRO partner is, is important because , um, for all the reasons you mentioned, the logistics, the language , uh, the , the , the contacts is something that , uh, you rather plug and play than try to develop , uh, from scratch.
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Very good. Yes. Agreed . Alright , uh, Luis , I, I think , uh, we're close to the end of the show. I, I thank you so much for your insights. They're priceless. And , uh, I wish you a, an extraordinary , uh, experience in Latin America, in Columbia is my home country. And , uh, I am sure that , uh, you're gonna have , uh, good , uh, study , uh, I mean clinical data, clinical results in , in the country. And the country is one of the most experienced , uh, countries in Latin America in early feasibility. First in human , uh, proof of concept type of medical device studies, and , uh, more so than the other country that you mentioned, Argentina, Brazil, because of the speed of the reg regulatory approval process, the , the hospital infrastructure and, and the openness of the investigators to collaborate with , uh, US physicians , proctors, and , and US companies. So it's actually the, the friendliest country to the United States, like , uh, the the closest ally in, in, in Western America.
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Yes. Well, I look forward to visiting and maybe seeing you when I go down there,
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Julio . Yes . It'll be fantastic. Thank you Louis . Sure, sure. So , uh, before we sign up for today, do you have any final thoughts, mores of wisdom or other musings , uh, for our listeners?
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I would say , uh, whenever you have curiosity , uh, especially in, in investigating Latin America as a potential site , uh, take the dive, make the jump and , uh, go visit, then you'll be pleasantly surprised. .
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Excellent. Well said , . Alright , Luis , thank you so much for being on the show today. Bye-Bye .
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Thank you so much .
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