March 1, 2024 • 16 mins
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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Speaker 1 (00:00):
Welcome to
the Latin MedTech Leaders
Podcast, a conversation withMedTech leaders who have
succeeded or plan to succeed inLatin America. Please subscribe
on your favorite podcastingplatform. Apple Podcast,
Spotify, Google Podcast. AmazonMusic is teacher Tune in iHeart
Radio, Pandora or Deezer .
Speaker 2 (00:20):
Today our guest is Luis Alvarez. Luis is the CEO
and founder of the Adaptive anddeveloped a , the concept for
targeted therapeutic deliveryduring and following a combat
tour in Iraq where several ofhis soldiers suffer severe
extremity injuries. So, Luis ,welcome to the show. Thanks for
(00:44):
being here.
Speaker 3 (00:46):
Uh , thank you so much, Julio , for the
invitation. I look forward tothe conversation.
Speaker 2 (00:50):
Excellent. Alright , Luis , let's get started with
your journey to Latin America.
How is it you got connectedwith the region ?
Speaker 3 (00:57):
Well , uh, my family originally, of course from ,
uh, from Cuba, and , uh, I'vealways had connection and
friends and family in LatinAmerica. And then , uh,
professionally as , uh, westarted to develop , uh, the
company and, and to look atoptions. We have had several
conversations with , uh,companies in Latin America that
, uh, run clinical trials andthat , uh, would be interested
(01:19):
later on in licensing. So nowwe're having , uh, I would say
a growing interest in , uh,doing business in Latin
America.
Speaker 2 (01:26):
Excellent. All right . So what trends do you see
happening in the industry or inLatin America that are relevant
to, to the discussion today,Luis ?
Speaker 3 (01:36):
Well, I think a lot of , uh, companies that provide
, uh, let's say clinicalservices and companies that ,
uh, would be distributors forproducts 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, buta lot of those Latin American
companies are now actuallymultinational. So they're
(01:58):
looking for partnerships in theUS and in Europe and other
regions. And we see a lot moreactivity, more appetite, more
interest in this type of , uh,across regional , uh,
collaboration.
Speaker 2 (02:11):
Very good . What's been your experience doing
studies? I mean, in the US oroutside of the United States?
Speaker 3 (02:18):
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, athird 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 launchingactually our first , um, phase
one , two combined study. We'llenroll first and dose , its
(02:41):
first patient in Australia.
Excellent. So, you know, we'refamiliar with over overseas
type of operations, andactually we're looking , uh,
with great interest towards ,uh, Latin American , uh,
clinical study sites.
Speaker 2 (02:51):
Okay. Any particular reason why you are looking at
Latin America to diversify yourpatient enrollment? Uh, no
diver diversity or to acquiremore clinical data to expand
outside Australia or forrecruitment reasons? I mean,
what's your driver to go toLatin America now?
Speaker 3 (03:09):
Well, overall Latin America, I think it's very
attractive because , uh,medical practice, there is
world class in , in, in severalof the , uh, regional medical
centers in each of thecountries. Uh, so , uh, they
are no strangers to doing, youknow , uh, regulated clinical
studies. Also, it's anattractive market. It's a
growing market, and , um, forus is something that , uh, you
(03:30):
know, if you already have aconnection clinically, then you
have a much easier , uh, timelaunching , uh, products
because physicians are familiarwith your product. So it makes
sense to do clinical studies ineach of the regions where you
want , uh, to have , uh, yourbusiness, but also for
diversity, because the FDA inthe US actually has very , uh,
strict , uh, uh, measures ofhow , uh, effective your
(03:53):
therapy is in differentpopulations .
Speaker 2 (03:55):
Yes. Yeah, good answer. And so let's go back to
Australia , uh, because I, Isee the companies are exploring
Australia a lot or have beenexploring Australia for quite a
bit, and I understand there aresome incentives. Can you
elaborate a little bit more onthat? Why do you go to
Australia?
Speaker 3 (04:11):
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 thereason is very simple, and it's
maybe a model that , uh, uh,regulators in , uh, Latin
America might , uh, borrowbecause it's a successful
model. Yeah. And that is thatthe Australian authorities ,
(04:32):
uh, allow you to take a 43.7% ,uh, um, refund through their
tax system on any expendituresthat you have in, in the
country related to clinicalwork. So for a company, it
makes absolute sense to dothat, and it's created a huge
incentive for many, many, fromlarge to small, many companies
(04:54):
to do this work there. So Ithink in Latin America, there
may be opportunities for thistype of , uh, economic , uh,
creativity to attract , uh,more business.
Speaker 2 (05:02):
Absolutely.
Absolutely. What about the, theregulatory approval process in
Australia? Do you find it tobe, 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?
Speaker 3 (05:19):
Yeah , so we have actually experienced , uh, what
it is like to get , uh,approval to start a clinical
study. And in Australia it'svery straightforward because
you do not require , um, theway you do in the US you
require FDA approval of an INDor an IDE In Australia, you
really need local ethicsapproval in the , uh, study
(05:41):
site where you're operating,and then a notification to
what's called the TGA, which isthe equivalent of the FDA . So
in Australia, the entry barrierto a study is satisfying ethics
, um, questionnaire. And , uh,that also makes it very
attractive. So I would say inLatin America, if there are
some , uh, ideas around , uh,entry points for phase one
(06:02):
studies or phase one , twostudies, allowing a local
ethics approval as the standardcould really facilitate new ,
uh, new entry into the market.
Speaker 2 (06:11):
Absolutely. Yeah.
There are some, in LatinAmerica, 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 couplecountries in Latin America
where that can happen, but theydon't have that, that
incentive, that tax incentivethat Australia has. So, but,
but has other advantages. It'scloser to the us same time zone
(06:32):
, less travel, otheradvantages, . Okay. So
, uh, in terms of , um, so interms of , uh, other , uh,
colleagues or other companiesthat you know about, is , is,
is Latin America always in theconversation? Is Australia
always in the conversation? IsEastern Europe always in the
(06:55):
conversation? Because it usedto, and now , uh, I'm not so
sure. So that's why I wanna getyour take on that. What
countries are in theconversation about exploring
geographies for clinicalresearch, in your opinion?
Speaker 3 (07:07):
Y yes. Uh , I would say Australia ranks at the top,
but , uh, I have heard , um, inmany conversations , uh,
studies in Latin America andespecially in , uh, Columbia ,
uh, Mexico, Brazil, Argentina ,uh, where there are favorable
environments to do thosestudies. Eastern Europe has
fallen , uh, to, to a lessprominent role, maybe , uh, for
(07:30):
various reasons. But , uh, Iwould say in Latin America,
I've seen an increase in, inthe , uh, discussions around
having studies down there.
Speaker 2 (07:37):
Very good. Very good. Yes , certainly. Um, one
of the advantages of , of LatinAmerica, as I mentioned, is,
is, is way closer to the UnitedStates and also cost savings.
I'm , I'm not sure how costlyAustralia is, but certainly the
currency is , is is strongerthan the Colombian peso, for
example, the Mexican peso. Sothat in itself is also a , a ,
(07:58):
an advantage of Latin American. Also the size of the country.
Uh , I'm not so sure if youknow that, but , um, Latin
America is one of the mosturban organized regions in the
world. And , and , and , andaccording to the trends, it
will soon be the most organizedregion in the world. So for
patient recruitment, that helpsa lot. 'cause you don't have to
go through a , uh, five citiesto , to find subjects if you
(08:23):
have all your subjects just onecity, so you don't have to
Speaker 3 (08:27):
Yes , that's very attractive. Very attractive.
Speaker 2 (08:29):
Yeah. Yeah.
Australia, I understand is, ishas what, like 30 million
people, something like that,but it's all spread out. I
mean, it's a large territory.
Speaker 3 (08:38):
Yes. And Australia actually is very sparsely
populated, and most of thepopulation lives on the coasts,
whereas in Latin America, youhave, like you said, a lot of
urban centers that offer reallygood advantages for ,
Speaker 2 (08:50):
Yeah. Okay. So let's go back to the United States.
Why are companies goingoverseas? I mean, in your
opinion, what's the driver forthese companies to look at
places like Australia or , orLatin America?
Speaker 3 (09:03):
I would say simplicity , uh, effectiveness
of the studies in the overseaslocations , uh, cost . Uh , so
the number of advantages of ,uh, going to Latin America or,
or overseas , uh, and I thinkit really has to do with the ,
uh, the requirements that areimposed to do studies in the us
. Uh, sometimes it's not eventhe FDA , it's these large
(09:27):
medical centers become, youknow, almost bureaucratic. They
become their own government ,uh, entities in a way.
Whereas in overseas sites , uh,these centers are more
practical. They operatequickly, they get to the point
which is treating the patient.
And that's attractive.
Speaker 2 (09:42):
That's a great point. You know, I've never
heard that point before, . I mean, having
bureaucracy in the middle ofthe approval in, in these large
hospital systems. But you'rebringing up a great point. I
mean, in , in the US you don'tfind smaller hospitals anymore.
'cause of the consolidation ofthe, of the healthcare
industry, you find hugehospital systems and, and as
(10:05):
you said, they can be extremelybureaucratic. Whereas in, in,
in , in places like in LatinAmerica, Columbia , Mexico,
Brazil, you find smallerclinics where you can pick up
the phone and call the CEO ofthe clinic and get things done.
Yes . Quickly, . Yeah,that's, that's a great point.
Yeah,
Speaker 3 (10:22):
That's a huge benefit. That's
Speaker 2 (10:23):
A huge benefit.
Awesome. So the, the, the trendis, is is clear , um, I
understand there is a , thereis a , a program in the United
States called the EarlyFeasibility Study Program or
something like that. Have youheard about it? Is that
something that is making a dentin this trend or not?
Speaker 3 (10:43):
Uh, I haven't actually heard about that. Uh ,
but now that you mentioned Ishould look into it. Uh ,
Speaker 2 (10:48):
Yes. It's , so the F fda a , so the F FDA A started
about probably seven years ago.
And , and actually one of myclients , uh, the CEO of a
company who did a study with us, uh, is leading or used to be
leading that program. Uh, lasttime I checked , he was leading
that like two years ago. Butanyway, the point is that the
(11:08):
FDA realized that , uh, that,that these studies are going
overseas and the US is, ismissing out on, on, on, on
these business and, andpatients have, are not having
us , patients are not having ,uh, access to these advanced
medical technologies , uh,earlier and, and , uh, they're
(11:30):
doing something or they'retrying to do something to
attract these companies back toUnited States, and so that they
don't have to go overseas. Butof course, as you said , there
are some things that areoutside of the control of the
FDA that , uh, makes itdifficult, like dealing with
these bureaucracy inside ofprivate hospital system. But
regardless , uh, there's , uh,that , that's a very good
initiative. I mean, not goodfor countries like Australia or
(11:53):
Columbia , but , uh,it's good for, for us ,
companies that wanna be in theUS don't, don't venture
overseas. Because I alsounderstand, I've been doing
this for 15 years, and, and itcan be a little scary , uh,
especially for companies goingto Latin America. You hear all
these bad news about politicalinstability and , and riots
(12:15):
and, and all these things thatyou see in the news. So that is
not something that is makingthe region attractive. But once
initially, I mean, on thesurface, but once you, you, you
pass that point and you realizethat, that the, the good is, is
is more than the bad in LatinAmerica. Companies get
(12:36):
pleasantly surprised about whatthey find in, in, in , in Latin
America. So, so yeah, that's,that's, that's , uh, the , the
early feasibility , uh, studyprogram, I invited to check it
out. It will , uh, probablygive you another angle to
explore and you search forlocations.
Speaker 3 (12:57):
That's very helpful.
Thank you for that. And youknow, the , the point about
instability, I almost feel insome 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 considerationfor anybody considering , uh,
you know, studies in LatinAmerica that's , uh, that , uh,
(13:20):
has not turned out to be , uh,you know , a real effect in
limiting any
Speaker 2 (13:25):
Good for me . Good, good, good. Yes. And what
countries have you have youvisited in Latin America
besides Cuba for of course.
Speaker 3 (13:33):
Uh , so , uh, Mexico, Brazil , uh, Argentina,
, uh, to name afew. But , uh, yeah, it's been
, uh, it's good to visit . And, uh, just the , the urban
centers, as you said , uh, arereally rich in , uh,
populations for , uh, forrecruiting, for clinical
studies. And the medicalpractice is of course, world
(13:54):
class in these cities , uh, themain cities. So yeah, I found
it to be a very attractivelocation, which is part of the
reason we're , uh, you know,we're exploring , uh, expanding
our , uh, our phase one , twofor spine, actually to , uh,
Columbia .
Speaker 2 (14:05):
Excellent. Very good. Very good. So in , in
your search in, in LatinAmerica and Columbia , have you
found , uh, good experiencedCROs? Uh, I mean , what's been
your experience in, in, or Idon't know if you've spoken
with a CRO or not, but have youfound investigators motivated
to lead in your study orprofessionals willing to help
(14:26):
you set up the studies? I mean,what's been your, your journey
towards exploring Columbia ,for example, as your
destination?
Speaker 3 (14:34):
Yeah, actually in Columbia , we do have a very
nice , uh, CRO , uh, that we'vebeen talking with that , uh, we
think that we will , uh,probably move ahead , uh, with
them. And they've been verysupportive in explaining
everything about how to start astudy, even the regulatory ,
uh, requirements , um, inColumbia . And , uh, so we feel
very comfortable with 'em . Um,and I think , uh, having a good
(14:58):
strong CRO partner is, isimportant because , um, for all
the reasons you mentioned, thelogistics, the language , uh,
the , the , the contacts issomething that , uh, you rather
plug and play than try todevelop , uh, from scratch.
Speaker 2 (15:11):
Very good. Yes.
Agreed . Alright , uh, Luis ,I, I think , uh, we're close to
the end of the show. I, I thankyou so much for your insights.
They're priceless. And , uh, Iwish you a, an extraordinary ,
uh, experience in LatinAmerica, in Columbia is my home
country. And , uh, I am surethat , uh, you're gonna have ,
(15:35):
uh, good , uh, study , uh, Imean clinical data, clinical
results in , in the country.
And the country is one of themost experienced , uh,
countries in Latin America inearly feasibility. First in
human , uh, proof of concepttype of medical device studies,
and , uh, more so than theother country that you
mentioned, Argentina, Brazil,because of the speed of the reg
(15:57):
regulatory approval process,the , the hospital
infrastructure and, and theopenness of the investigators
to collaborate with , uh, USphysicians , proctors, and ,
and US companies. So it'sactually the, the friendliest
country to the United States,like , uh, the the closest ally
in, in, in Western America.
Speaker 3 (16:16):
Yes. Well, I look forward to visiting and maybe
seeing you when I go downthere,
Speaker 2 (16:19):
Julio . Yes . It'll be fantastic. Thank you Louis .
Sure, sure. So , uh, before wesign up for today, do you have
any final thoughts, mores ofwisdom or other musings , uh,
for our listeners?
Speaker 3 (16:32):
I would say , uh, whenever you have curiosity ,
uh, especially in, ininvestigating Latin America as
a potential site , uh, take thedive, make the jump and , uh,
go visit, then you'll bepleasantly surprised..
Speaker 2 (16:46):
Excellent. Well said , . Alright , Luis ,
thank you so much for being onthe show today. Bye-Bye .
Speaker 3 (16:52):
Thank you so much .
Podcast, a conversation withMedTech leaders who have
succeeded or plan to succeed inLatin America. Please subscribe
on your favorite podcastingplatform. Apple Podcast,
Spotify, Google Podcast. AmazonMusic is teacher Tune in iHeart
Radio, Pandora or Deezer .
Speaker 2 (00:20):
Today our guest is Luis Alvarez. Luis is the CEO
and founder of the Adaptive anddeveloped a , the concept for
targeted therapeutic deliveryduring and following a combat
tour in Iraq where several ofhis soldiers suffer severe
extremity injuries. So, Luis ,welcome to the show. Thanks for
(00:44):
being here.
Speaker 3 (00:46):
Uh , thank you so much, Julio , for the
invitation. I look forward tothe conversation.
Speaker 2 (00:50):
Excellent. Alright , Luis , let's get started with
your journey to Latin America.
How is it you got connectedwith the region ?
Speaker 3 (00:57):
Well , uh, my family originally, of course from ,
uh, from Cuba, and , uh, I'vealways had connection and
friends and family in LatinAmerica. And then , uh,
professionally as , uh, westarted to develop , uh, the
company and, and to look atoptions. We have had several
conversations with , uh,companies in Latin America that
, uh, run clinical trials andthat , uh, would be interested
(01:19):
later on in licensing. So nowwe're having , uh, I would say
a growing interest in , uh,doing business in Latin
America.
Speaker 2 (01:26):
Excellent. All right . So what trends do you see
happening in the industry or inLatin America that are relevant
to, to the discussion today,Luis ?
Speaker 3 (01:36):
Well, I think a lot of , uh, companies that provide
, uh, let's say clinicalservices and companies that ,
uh, would be distributors forproducts 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, buta lot of those Latin American
companies are now actuallymultinational. So they're
(01:58):
looking for partnerships in theUS and in Europe and other
regions. And we see a lot moreactivity, more appetite, more
interest in this type of , uh,across regional , uh,
collaboration.
Speaker 2 (02:11):
Very good . What's been your experience doing
studies? I mean, in the US oroutside of the United States?
Speaker 3 (02:18):
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, athird 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 launchingactually our first , um, phase
one , two combined study. We'llenroll first and dose , its
(02:41):
first patient in Australia.
Excellent. So, you know, we'refamiliar with over overseas
type of operations, andactually we're looking , uh,
with great interest towards ,uh, Latin American , uh,
clinical study sites.
Speaker 2 (02:51):
Okay. Any particular reason why you are looking at
Latin America to diversify yourpatient enrollment? Uh, no
diver diversity or to acquiremore clinical data to expand
outside Australia or forrecruitment reasons? I mean,
what's your driver to go toLatin America now?
Speaker 3 (03:09):
Well, overall Latin America, I think it's very
attractive because , uh,medical practice, there is
world class in , in, in severalof the , uh, regional medical
centers in each of thecountries. Uh, so , uh, they
are no strangers to doing, youknow , uh, regulated clinical
studies. Also, it's anattractive market. It's a
growing market, and , um, forus is something that , uh, you
(03:30):
know, if you already have aconnection clinically, then you
have a much easier , uh, timelaunching , uh, products
because physicians are familiarwith your product. So it makes
sense to do clinical studies ineach of the regions where you
want , uh, to have , uh, yourbusiness, but also for
diversity, because the FDA inthe US actually has very , uh,
strict , uh, uh, measures ofhow , uh, effective your
(03:53):
therapy is in differentpopulations .
Speaker 2 (03:55):
Yes. Yeah, good answer. And so let's go back to
Australia , uh, because I, Isee the companies are exploring
Australia a lot or have beenexploring Australia for quite a
bit, and I understand there aresome incentives. Can you
elaborate a little bit more onthat? Why do you go to
Australia?
Speaker 3 (04:11):
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 thereason is very simple, and it's
maybe a model that , uh, uh,regulators in , uh, Latin
America might , uh, borrowbecause it's a successful
model. Yeah. And that is thatthe Australian authorities ,
(04:32):
uh, allow you to take a 43.7% ,uh, um, refund through their
tax system on any expendituresthat you have in, in the
country related to clinicalwork. So for a company, it
makes absolute sense to dothat, and it's created a huge
incentive for many, many, fromlarge to small, many companies
(04:54):
to do this work there. So Ithink in Latin America, there
may be opportunities for thistype of , uh, economic , uh,
creativity to attract , uh,more business.
Speaker 2 (05:02):
Absolutely.
Absolutely. What about the, theregulatory approval process in
Australia? Do you find it tobe, 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?
Speaker 3 (05:19):
Yeah , so we have actually experienced , uh, what
it is like to get , uh,approval to start a clinical
study. And in Australia it'svery straightforward because
you do not require , um, theway you do in the US you
require FDA approval of an INDor an IDE In Australia, you
really need local ethicsapproval in the , uh, study
(05:41):
site where you're operating,and then a notification to
what's called the TGA, which isthe equivalent of the FDA . So
in Australia, the entry barrierto a study is satisfying ethics
, um, questionnaire. And , uh,that also makes it very
attractive. So I would say inLatin America, if there are
some , uh, ideas around , uh,entry points for phase one
(06:02):
studies or phase one , twostudies, allowing a local
ethics approval as the standardcould really facilitate new ,
uh, new entry into the market.
Speaker 2 (06:11):
Absolutely. Yeah.
There are some, in LatinAmerica, 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 couplecountries in Latin America
where that can happen, but theydon't have that, that
incentive, that tax incentivethat Australia has. So, but,
but has other advantages. It'scloser to the us same time zone
(06:32):
, less travel, otheradvantages,
, uh, in terms of , um, so interms of , uh, other , uh,
colleagues or other companiesthat you know about, is , is,
is Latin America always in theconversation? Is Australia
always in the conversation? IsEastern Europe always in the
(06:55):
conversation? Because it usedto, and now , uh, I'm not so
sure. So that's why I wanna getyour take on that. What
countries are in theconversation about exploring
geographies for clinicalresearch, in your opinion?
Speaker 3 (07:07):
Y yes. Uh , I would say Australia ranks at the top,
but , uh, I have heard , um, inmany conversations , uh,
studies in Latin America andespecially in , uh, Columbia ,
uh, Mexico, Brazil, Argentina ,uh, where there are favorable
environments to do thosestudies. Eastern Europe has
fallen , uh, to, to a lessprominent role, maybe , uh, for
(07:30):
various reasons. But , uh, Iwould say in Latin America,
I've seen an increase in, inthe , uh, discussions around
having studies down there.
Speaker 2 (07:37):
Very good. Very good. Yes , certainly. Um, one
of the advantages of , of LatinAmerica, as I mentioned, is,
is, is way closer to the UnitedStates and also cost savings.
I'm , I'm not sure how costlyAustralia is, but certainly the
currency is , is is strongerthan the Colombian peso, for
example, the Mexican peso. Sothat in itself is also a , a ,
(07:58):
an advantage of Latin American. Also the size of the country.
Uh , I'm not so sure if youknow that, but , um, Latin
America is one of the mosturban organized regions in the
world. And , and , and , andaccording to the trends, it
will soon be the most organizedregion in the world. So for
patient recruitment, that helpsa lot. 'cause you don't have to
go through a , uh, five citiesto , to find subjects if you
(08:23):
have all your subjects just onecity, so you don't have to
Speaker 3 (08:27):
Yes , that's very attractive. Very attractive.
Speaker 2 (08:29):
Yeah. Yeah.
Australia, I understand is, ishas what, like 30 million
people, something like that,but it's all spread out. I
mean, it's a large territory.
Speaker 3 (08:38):
Yes. And Australia actually is very sparsely
populated, and most of thepopulation lives on the coasts,
whereas in Latin America, youhave, like you said, a lot of
urban centers that offer reallygood advantages for ,
Speaker 2 (08:50):
Yeah. Okay. So let's go back to the United States.
Why are companies goingoverseas? I mean, in your
opinion, what's the driver forthese companies to look at
places like Australia or , orLatin America?
Speaker 3 (09:03):
I would say simplicity , uh, effectiveness
of the studies in the overseaslocations , uh, cost . Uh , so
the number of advantages of ,uh, going to Latin America or,
or overseas , uh, and I thinkit really has to do with the ,
uh, the requirements that areimposed to do studies in the us
. Uh, sometimes it's not eventhe FDA , it's these large
(09:27):
medical centers become, youknow, almost bureaucratic. They
become their own government ,uh,
Whereas in overseas sites , uh,these centers are more
practical. They operatequickly, they get to the point
which is treating the patient.
And that's attractive.
Speaker 2 (09:42):
That's a great point. You know, I've never
heard that point before,
bureaucracy in the middle ofthe approval in, in these large
hospital systems. But you'rebringing up a great point. I
mean, in , in the US you don'tfind smaller hospitals anymore.
'cause of the consolidation ofthe, of the healthcare
industry, you find hugehospital systems and, and as
(10:05):
you said, they can be extremelybureaucratic. Whereas in, in,
in , in places like in LatinAmerica, Columbia , Mexico,
Brazil, you find smallerclinics where you can pick up
the phone and call the CEO ofthe clinic and get things done.
Yes . Quickly,
Yeah,
Speaker 3 (10:22):
That's a huge benefit. That's
Speaker 2 (10:23):
A huge benefit.
Awesome. So the, the, the trendis, is is clear , um, I
understand there is a , thereis a , a program in the United
States called the EarlyFeasibility Study Program or
something like that. Have youheard about it? Is that
something that is making a dentin this trend or not?
Speaker 3 (10:43):
Uh, I haven't actually heard about that. Uh ,
but now that you mentioned Ishould look into it. Uh ,
Speaker 2 (10:48):
Yes. It's , so the F fda a , so the F FDA A started
about probably seven years ago.
And , and actually one of myclients , uh, the CEO of a
company who did a study with us, uh, is leading or used to be
leading that program. Uh, lasttime I checked , he was leading
that like two years ago. Butanyway, the point is that the
(11:08):
FDA realized that , uh, that,that these studies are going
overseas and the US is, ismissing out on, on, on, on
these business and, andpatients have, are not having
us , patients are not having ,uh, access to these advanced
medical technologies , uh,earlier and, and , uh, they're
(11:30):
doing something or they'retrying to do something to
attract these companies back toUnited States, and so that they
don't have to go overseas. Butof course, as you said , there
are some things that areoutside of the control of the
FDA that , uh, makes itdifficult, like dealing with
these bureaucracy inside ofprivate hospital system. But
regardless , uh, there's , uh,that , that's a very good
initiative. I mean, not goodfor countries like Australia or
(11:53):
Columbia
companies that wanna be in theUS don't, don't venture
overseas. Because I alsounderstand, I've been doing
this for 15 years, and, and itcan be a little scary , uh,
especially for companies goingto Latin America. You hear all
these bad news about politicalinstability and , and riots
(12:15):
and, and all these things thatyou see in the news. So that is
not something that is makingthe region attractive. But once
initially, I mean, on thesurface, but once you, you, you
pass that point and you realizethat, that the, the good is, is
is more than the bad in LatinAmerica. Companies get
(12:36):
pleasantly surprised about whatthey find in, in, in , in Latin
America. So, so yeah, that's,that's, that's , uh, the , the
early feasibility , uh, studyprogram, I invited to check it
out. It will , uh, probablygive you another angle to
explore and you search forlocations.
Speaker 3 (12:57):
That's very helpful.
Thank you for that. And youknow, the , the point about
instability, I almost feel insome 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 considerationfor anybody considering , uh,
you know, studies in LatinAmerica that's , uh, that , uh,
(13:20):
has not turned out to be , uh,you know , a real effect in
limiting any
Speaker 2 (13:25):
Good for me . Good, good, good. Yes. And what
countries have you have youvisited in Latin America
besides Cuba for of course.
Speaker 3 (13:33):
Uh , so , uh, Mexico, Brazil , uh, Argentina,
, uh, it's good to visit . And, uh, just the , the urban
centers, as you said , uh, arereally rich in , uh,
populations for , uh, forrecruiting, for clinical
studies. And the medicalpractice is of course, world
(13:54):
class in these cities , uh, themain cities. So yeah, I found
it to be a very attractivelocation, which is part of the
reason we're , uh, you know,we're exploring , uh, expanding
our , uh, our phase one , twofor spine, actually to , uh,
Columbia .
Speaker 2 (14:05):
Excellent. Very good. Very good. So in , in
your search in, in LatinAmerica and Columbia , have you
found , uh, good experiencedCROs? Uh, I mean , what's been
your experience in, in, or Idon't know if you've spoken
with a CRO or not, but have youfound investigators motivated
to lead in your study orprofessionals willing to help
(14:26):
you set up the studies? I mean,what's been your, your journey
towards exploring Columbia ,for example, as your
destination?
Speaker 3 (14:34):
Yeah, actually in Columbia , we do have a very
nice , uh, CRO , uh, that we'vebeen talking with that , uh, we
think that we will , uh,probably move ahead , uh, with
them. And they've been verysupportive in explaining
everything about how to start astudy, even the regulatory ,
uh, requirements , um, inColumbia . And , uh, so we feel
very comfortable with 'em . Um,and I think , uh, having a good
(14:58):
strong CRO partner is, isimportant because , um, for all
the reasons you mentioned, thelogistics, the language , uh,
the , the , the contacts issomething that , uh, you rather
plug and play than try todevelop , uh, from scratch.
Speaker 2 (15:11):
Very good. Yes.
Agreed . Alright , uh, Luis ,I, I think , uh, we're close to
the end of the show. I, I thankyou so much for your insights.
They're priceless. And , uh, Iwish you a, an extraordinary ,
uh, experience in LatinAmerica, in Columbia is my home
country. And , uh, I am surethat , uh, you're gonna have ,
(15:35):
uh, good , uh, study , uh, Imean clinical data, clinical
results in , in the country.
And the country is one of themost experienced , uh,
countries in Latin America inearly feasibility. First in
human , uh, proof of concepttype of medical device studies,
and , uh, more so than theother country that you
mentioned, Argentina, Brazil,because of the speed of the reg
(15:57):
regulatory approval process,the , the hospital
infrastructure and, and theopenness of the investigators
to collaborate with , uh, USphysicians , proctors, and ,
and US companies. So it'sactually the, the friendliest
country to the United States,like , uh, the the closest ally
in, in, in Western America.
Speaker 3 (16:16):
Yes. Well, I look forward to visiting and maybe
seeing you when I go downthere,
Speaker 2 (16:19):
Julio . Yes . It'll be fantastic. Thank you Louis .
Sure, sure. So , uh, before wesign up for today, do you have
any final thoughts, mores ofwisdom or other musings , uh,
for our listeners?
Speaker 3 (16:32):
I would say , uh, whenever you have curiosity ,
uh, especially in, ininvestigating Latin America as
a potential site , uh, take thedive, make the jump and , uh,
go visit, then you'll bepleasantly surprised.
Speaker 2 (16:46):
Excellent. Well said ,
thank you so much for being onthe show today. Bye-Bye .
Speaker 3 (16:52):
Thank you so much .
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