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Unlocking Latin America’s clinical trial potential with Claudia Rodriguez
24 Plays27 days ago
Sylvain Berthelot welcomes Claudia Rodriguez, CEO of RARAS, a CRO specialized in conducting research across Latin America. Together, they explore the untapped potential of this diverse region and why it is increasingly becoming a strategic priority for global sponsors.
With a deep passion for the Latin American market, Claudia dispels common myths about the region’s accessibility and infrastructure. She shares how the landscape is shifting from a traditional focus on Phase 3 "rescue" trials toward early-phase research, driven by geopolitical changes and a growing need for diverse genetic data.
Sylvain and Claudia discuss the nuances of different markets, from Chile’s rapid regulatory timelines for medical devices to Brazil’s world-renowned Key Opinion Leaders. They also delve into the unique cultural bond between patients and physicians in the region, which results in remarkably high retention rates.
Tune in to our Season 3 finale to discover how strategic planning in Latin America can accelerate regulatory approval, provide a "soft landing" for future product launches, and ensure high-quality data that meets the rigorous standards of the FDA and EMA.
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Transcript
Introduction to Clinical Data Talks
00:00:13
Speaker
Welcome to Clinical Data Talks, a podcast brought to you by CRS-Cube. I'm your host, Sylvain Bertelot. Join me and industry experts as we discuss the latest trends impacting the world of clinical data.
Trends in Clinical Trials Location
00:00:28
Speaker
One of the trends in clinical trials currently is how sponsors consider the location of their trials, depending on specific needs or phase, for example.
Meet Claudia Rodriguez
00:00:44
Speaker
I'm very pleased to welcome Claudia Rodriguez to the podcast. She's the CEO of RARAS, a CRO specialized in conducting research in Latin America.
00:00:58
Speaker
Claudia uses her unique experience and deep knowledge of the Latin American market to help global companies run clinical trials in that region.
Potential of Latin America for Clinical Trials
00:01:09
Speaker
And today we are going to discuss what Latin America has to offer to our industry, how a local CRO can make the region more accessible, and what it means for clinical data on a global scale.
00:01:27
Speaker
Hi Claudia, thank you for joining me. Thank you for having me. Always good to talk about our region and I'm very glad to have joined all your previous important guests. So thank you for having me.
00:01:45
Speaker
No, it's an absolute pleasure. And I'm pretty sure we're going to learn a lot about Latin America. So personally, i'm very excited as well.
Cultural and Historical Context of Latin America
00:01:54
Speaker
and ah And I might actually start with a bit of ah a a dumb question maybe, but for people like me who don't necessarily know Latin America, i mean, I know there are many different countries, but how do those countries differ?
00:02:14
Speaker
m Well, but that that's a good question. Thank you for that. Because um to start with, ah we have a cultural, Latin America is like a cultural denomination for ah something that is very different.
00:02:33
Speaker
ah We have ah Mexico, who's part of North America, like it or not, many people may not like the idea that Mexico is part of North America, but they are Central America and and then South America.
00:02:49
Speaker
And culturally that denomination that I started, I've never heard of that before I started working with ah American companies.
Geographical and Demographic Overview
00:03:00
Speaker
that included everything that was south of the border and that is the nomination of latin america and so we are in a sense tied by by our heritage by our spanish and portuguese colonial times but um So we have a lot of similarities in from from ah our past that we have inherited from our past, but ah it's a geography that is very diverse. We have
00:03:42
Speaker
ah countries that are continent a continent in itself, like Brazil, for example, you have a a country that you have ah nine hours flight from one from the Southern Tiff to the Northern Tiff.
00:03:59
Speaker
um You have deserts, you have jungles, you have an everything in the middle. yeah and And there's a diverse population tied to that diverse geography. You have well Native Americans, African Americans, Caucasian,
00:04:19
Speaker
and everything in the middle. that You have, for example, something some things that are not very well known about, for example, between Peru and bra Brazil, you have the second largest Japanese population out of Japan. japan And so that, for example, that allows for clinical trials to be run in those countries because that is accepted by the agency in Japan.
00:04:48
Speaker
So, um and it's a the region of 650 million people and also something that is not very well known,
00:05:03
Speaker
It's a highly urbanized region. 80% of the total population lives in cities. So people may think that, well, it's a huge region, they live spread out, of they live in whatever. ah and But no, so that makes the region very accessible in terms of logistics and to but from from a clinical trial perspective, accessible to that population because it's in the cities.
00:05:39
Speaker
There's one Latin America for everyone.
00:05:44
Speaker
That's a very, very nice way of putting it. And it's interesting because when you... I had the exact expectation that you you mentioned that when you said nine hours from the bottom tip of Brazil to the north of Brazil, I felt like people would be very spread out, but actually that's not the case. So that's very, very interesting.
Current Clinical Trial Trends in Latin America
00:06:09
Speaker
So we're talking about clinical trials, obviously. So what kind of clinical trials do you see in Latin America?
00:06:18
Speaker
Is it very specific or do you see many different types of clinical trials? Well, the region um traditionally has been a region with a lot of infectious disease trials. um has been a region of mostly phase three trials that, but because of global CROs using the region just to rescue their global trials. So it has always been a ah region for those very large trials, for oncology trials or cardiovascular trials, but that is changing now. That's um something that we,
00:07:09
Speaker
particularly us and when when I started with with my partners and company, that was something that we were pushing hard to bring early phase trials and to the region, because when when you part participate in early phase trials, then you have the possibility to ah start working in the development path of of that new technology.
00:07:35
Speaker
so
00:07:38
Speaker
thanks I would like to think that thanks to that effort, there's a lot more trials, early phase trials coming to the region and we've been helped for some instabilities in in other you know regions of the world that were traditionally destination for those early phase trials, but now due to geopolitical problems.
00:08:05
Speaker
those trials are now moving into Latin America and I believe that's going to be a permanent trend.
00:08:12
Speaker
Yes, and and I mean, the the statement I started with, we really see that now sponsors consider the globe as a place to run clinical trials, as opposed to traditionally it was ah potentially focused on on on one specific continent or a a region within a continent. So that's that's quite interesting. What do you think attracts sponsors to run clinical trials in Latin America?
Advantages for Sponsors in Latin America
00:08:50
Speaker
Do do you think they get any specific benefits?
00:08:55
Speaker
Well, to start with access to a patient who that is eager to receive new technologies. our healthcare systems are mostly, public healthcare care systems are mostly broke, but that's a reality in all over the world, I believe. So, and because um up to 70% of the population relies on the public system. They are eager to participate in clinical research because they get ah you know early access to to trials.
00:09:32
Speaker
But for sponsors, it um so it's accessing to a pool of patients that is nearby, as I mentioned, it's 80% of the population lives in the cities.
00:09:44
Speaker
And also it's In the past, we used the argument of pricing. It's not just the pricing any longer. It's about that genetically diverse population ah that you can have in one place at the same time.
00:10:05
Speaker
And it's also a way to, um how can I put it, soft landing into a region that will probably be your target region for selling your your new technology in the future. So if you ah if you start with your clinical research, you are starting to develop a relationship with those key opinion leaders that are then going to prescribe
00:10:37
Speaker
ah your new treatment and you're going to establish a relationship and understand the cultural an nuances of ah you know selling to a different region start developing a relationship with the regulatory authorities.
00:10:52
Speaker
And that paves the way ah later on for registration. i mean, we we receive, um
00:11:01
Speaker
we we have received a lot lately interest from or consults from companies from Asia, for example, Chinese or Korean companies that they would like to register their products in the region, but they don't have evidence in you know Western population. and And that it's a roadblock for local agencies. Or they use criteria that is not, you know,
00:11:35
Speaker
prioritized by our regulatory agencies. So conducting the clinical trial is in a way, you know knowing the patient that you are going to send to afterwards, knowing the the journey of that patient locally and knowing how the agencies work.
00:11:55
Speaker
And that makes it a lot easier to register farther down the road. So, yeah, So that's basically it. And you have huge markets, as mentioned, but just Brazil is 220 million. and It's a very attractive market. The healthcare um in Brazil, healthcare care sector represents And billion dollars ah which is almost ten percent of the gdp in the country
00:12:29
Speaker
and of of that thirty five billion is of of the 135, 35 billion corresponds to the pharmaceutical sector and is growing at 17% per year. What economy is growing at 17% per year? I mean, it's a a very attractive market. So ah people want to be there, but you have to start thinking early, or not just when you, want to ship the product to the country. it's the The process starts. So that's why it's very attractive. I mean, you can recruit in all time, but but there are other variables.
00:13:13
Speaker
It's very, very interesting hearing you talk, not only about the region, but also how you emphasize the need to plan ahead, essentially. Exactly. and And Latin America is not necessarily the region you go to to run early phase and then you go back to your own region to to run the rest of your of your program. But it's really planning ahead where you want your treatment to be approved and sold. ah Yeah, that's fascinating. and so So specifically, thinking about the different countries in Latin America, are there any countries that are better for certain type of trials or certain phases, for example?
Country-Specific Suitability for Trials
00:14:06
Speaker
Yes, definitely. i mean, um the countries differ in the healthcare systems, differ in their characteristics of the their population.
00:14:22
Speaker
So, for example, if you want to run a trial ah yeah in oncology, Chile is is is a place, for example, to be because they ah have laws that have approved or or give them their population right to us access all the new technologies in oncology. So if you have a protocol that you need to compare your new IP investigation or product with immunotherapy,
00:14:59
Speaker
in Chile, you have all the immunotherapies that are available. So you find those patients, but if you go to Brazil and you have would like to run that trial in Brazil and you have immunotherapy as a comparator, the public healthcare system in Brazil doesn't have that as, you know, as a standard of care.
00:15:23
Speaker
So you are not, you're going to have difficulties in running that country. So knowing those, you know, particularities about the healthcare systems and the journey of the patients in each country ah makes you decide what country is better depending on your um on your development. Or for example, if you're a startup company and you are startup company,
00:15:50
Speaker
um seeking to develop early data for your for your medical device, um Chile is also the place to go because the timely approval timelines are very fast. And you, if you're a startup company, you time is of the essence because your funds, you are short on funds and they run out fast. So you need data fast to continue raising capital.
00:16:20
Speaker
so So there are differences from country to country that we need to sit together and analyze what's better for you. So we started saying, well, Latin America is big and is there's so many different countries and cultures.
00:16:37
Speaker
But now I feel like we've we've gone back up to Latin America as a region. And tell me if that's not correct, but I imagine that when a client approaches you,
00:16:49
Speaker
you look at the region holistically to advise them where is best to run their trials. Is that correct? Yes, it's it's correct. I mean, I'm not very keen in saying or when we I go to a conference or whatever, speaking about specific countries, because as I said already, there's a region for everyone. So so we need to sit together um plan strategic strategically about what you are what's your main objective with with your trial, where you are in the development. So we can choose specifically what are the countries that suit you best, depending on the moment that you are. So you you said earlier that the patient population is 80% urban.
00:17:44
Speaker
ah urban And i mean, in other regions, we see a push for decentralization, for example, or optionality for patients to ah receive treatment at home or or go and see their doctors.
00:18:02
Speaker
What is the interaction, I would say, between patients and their doctors generally in Latin America? Do they like to see their doctors?
00:18:17
Speaker
Well, that that's something mary maybe because of our also cultural area heritage and Latin thing is that people in the region, ah they see their doctors, they are second to God. I mean, it's it's God, doctors. And so they they have a very close relationship and that makes that we don't, ah lose patients to follow up. I mean, the the the region has a remarkable ah rate of ah people that continue in the trials. You never lose patients to follow up.
00:19:00
Speaker
What's something that happens in other regions, like for example, in the United States, that's a well-known issue. So um people trust their doctors,
00:19:13
Speaker
ah They trust their doctors that, for example, if if clinical research is the alternative for a valid alternative treatment for what they have, eight i mean they accept it and they are willing to participate in the trial.
00:19:33
Speaker
But most importantly is that they adhere to the treatment and they keep coming back to the visits because that contact with the doctors ah makes them you know stay in their comfort zone and they nurture that, that continue to nurture that relationship. ah So it's ah that's something that's it's very different from other geographies.
00:20:01
Speaker
but very different and very important because that's a key issue. Recruitment and patient rotation are both big challenges in our industry.
00:20:14
Speaker
Okay, well... Yes, it's it's also, it may be sometimes an issue because because of that tight relationship.
00:20:27
Speaker
Doctors sometimes may be, you know, um ah resistant to refer patients to other ah sites when there are when there' other sites because they they are afraid that they are going to lose that patient. I mean, that that that tight relationship gets even to that point. I mean, and so I'm going to lose contact with my patient that and the patients all feel that. So that's something that, you know, um
00:21:00
Speaker
Sometimes it may be an issue, but it's something that ah overall we see it as very positive. if you work properly with that doctor or that patient that to understand that it will be they will not lose that relationship down down the road.
00:21:20
Speaker
Okay, interesting. And is the clinical data that's produced in trials that are run in Latin America generally accepted by global regulatory agencies for submission?
Regulatory Acceptance of Latin American Data
00:21:38
Speaker
Yes, absolutely. That's something that's also very you know unknown. for example, Brazil and Argentina, they have a seat at the board of the ICH, the institution that regulates on clinical research.
00:21:57
Speaker
So they have a saying, they have a a seat at the board of the ICH. And to have reached to that point, they have to they they went through a process of adapting the regulations and the the evaluation.
00:22:17
Speaker
So it's, ah So it's currently, they they can be considered high regulated agencies. So the data produced in in the in our region, I just mentioned in Brazil and Argentina because they are well, the the biggest in in terms of clinical research and because they have a seat at the ICH. But,
00:22:44
Speaker
ah Data is is very well accepted by the FDA or the EMA. The proof is that 85% of our clients are from the US or Europe and all the trials are for registration in the FDA and EMA.
00:23:07
Speaker
And it has always been accepted, our data. So never had any issues. And... Also, the because there's such you know eagerness to participate in clinical research, ah sites, they pay a lot of attention to data.
00:23:26
Speaker
So the the data is is ah really of high quality. Investigators you know pay attention to data, to pro to ah i mean producing something that's going to pass on you know the highest level of quality audits. So, and there are frequent audits from FDA in Latin America. So it's, they are used to that and and they are fast. I mean, so we are very proud of also something that's not very well known, but currently the regulatory timelines in our countries are
00:24:12
Speaker
shorter than the United States or Europe, or you can sign a contract in at a site here in one month, two months, and signing a contract with a hospital in the United States and going through the illegal can take up to six months or more.
00:24:29
Speaker
So, you know, there are also, oh you know, opportunities in terms of using that data to register in those countries without going you know directly to those countries.
00:24:47
Speaker
Yeah, and that's and that's ah that's another big benefit to investing in the region, again, to make it faster and and get to market faster.
00:25:00
Speaker
Extremely interesting. Thank you for for sharing all this. I just have one last question for you. What's the best piece of advice that you've received in your career that you constantly apply at work?
Career Advice on Authenticity
00:25:18
Speaker
That's a good question. um I think it's, ah you know, be consistently authentic. You need to be ah authentic always and um be yourself, tell what has to be told and not what the client wants to hear. and and because you know people end of the day recognize that you are dependable.
00:25:47
Speaker
I mean, that you are someone that you they can rely on and I'm not going to say, well, that that I think that's the best piece of advice and that's the corporate culture that we have tried to build in our company with my partners where we co-funded the company. We always told ourselves that we we wanted to build a company that we wanted to work for.
00:26:14
Speaker
So we are always you know telling people, you know be authentic, tell the client what it is, that it's not just a client, it's us telling it's be authentic with our employees, with our clients, with the vendors, with the regulatory authorities.
00:26:31
Speaker
So you create, you know, a consistent ah brand, a personal brand that you are a person that you can go to and,
00:26:45
Speaker
well, you will have the truth. So that's I think that's the best piece of advice. and we're I'm not going to you know fall in common places like quality and ethics and things. and we We are living in a world that he is having um a crisis of, you know, with with credibility,
00:27:12
Speaker
and started with our politicians and our leaders. So we we need to do better. And the industry, the pharmaceutical industry, the medical device industry, the healthcare care industry is also having a crisis of credibility with the general public. So we need to do better.
00:27:30
Speaker
We need to be authentic. And um and that's that's the company that we want to be and and the people personally, the person that I want to be. So that's, ah I think that's that's the best description.
00:27:48
Speaker
I love that. And especially, like you said, we're even in a world where truth is not necessarily ah crucial, unfortunately. But I fully agree with you, and that's what
Balancing Authenticity in Business and Personal Life
00:28:02
Speaker
we do. i mean, the the brand of CRSQ is also based on authenticity. And what I find personally, because I'm directly engaged in that, it is that it makes sometimes your work harder because other brands are not authentic and they will over promise and under deliver but i think over time authentic brands have the the upper hand because people will first of all trust what you say trust that you will
00:28:40
Speaker
do what you say and the results will be as expected because you set the right expectations. Yes, exactly. i that's It's a very competitive market and I believe that in very beginning all companies are trying to have values and everything, but somehow we get lost in the middle. So that's, and and it's very difficult, you know, to stay firm in the in your course and stay firm in your values.
00:29:16
Speaker
So that's something that we need, you know, constantly work on and speak up. And sometimes, It's not all about money. It's about sleeping well and, and well, declining some jobs.
00:29:31
Speaker
Why not? So that's where we want to be. Amazing. Well, thank you very much for your time.
00:29:42
Speaker
i really enjoyed talking to you and I learned a lot about the Latin American region. It seems to be an obvious choice to run clinical trials. So I'm sure you'll see more and more.
00:29:56
Speaker
Thank you. Thank you. Great opportunity. We're great talking to you. Thank Thank you and thanks everyone for listening or watching us. You can find more episodes of Clinical Data Talks on the CRS-Cube website.