Episode’s Transcript

Julio Martinez-Clark (00:01.587)

Welcome to the Latin America leaders podcast, a conversations with leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform, Apple podcasts, Spotify, Amazon music, et cetera. Today, our guest is Paulo Fernandes, a Brazilian clinical research executive with experience in international clinical trials in various phases and therapeutic areas.

Paulo, I'm very delighted to have you here. I look forward to our conversation.

Paulo Fernandes (00:35.008)

All right, thank you for the invitation. It's going to be a pleasure to have this talk.

Julio Martinez-Clark (00:39.847)

Excellent, Paolo. All right, Paolo, let's get started with your journey to the clinical trial world. How is it that you got involved in this industry?

Paulo Fernandes (00:52.654)

Okay, that's a very interesting question. At least, I think it allows for sharing a little bit more on what are the pathways for professionals from Latin America to join the field, right? So I started working for a CRO nearly 20 years ago. And at that time, the main pathway for getting started was as a research assistant.

and then as a CRA. So I had a good opportunity to be working on the field for seven years monitoring clinical trials, visiting investigators, talking directly to side staff, which I just feel it was a very good opportunity and actually helped me to prepare to take over management and working with the clients on coordinating clinical trials in the region.

Julio Martinez-Clark (01:53.095)

Excellent. You've had an outstanding career based on your resume. You work for PPD, Covens, IQVIA. I mean, that's extraordinary to be involved with international CROs like that. And also, you gain a lot of training, corporate training, which is fantastic, and a worldview of clinical research, right?

Paulo Fernandes (02:19.904)

Yes, that's for sure. I you mentioned these three companies very, and I had very good experiences there, right? In terms of corporate training, the drive for quality execution, the contact with the investigators. So all of these three companies take it and took it, all of these very seriously. And there were like a lot of support to the staff, you know.

Julio Martinez-Clark (02:34.344)

Yes.

Paulo Fernandes (02:50.198)

I can tell you I had the opportunity to have very good mentors throughout my career, people who really helped me to understand the industry and also the importance of working very closely to sites. But yeah, definitely very good training, very quality oriented, which I just feel supported and continue to support the good track record our region has in the clinical trial landscape.

Latin America is a very good region for placing clinical trials, with a strong track record of delivering to really big and important trials globally.

Julio Martinez-Clark (03:31.389)

Excellent. Okay. So my second question is about trends. What trends do you see happening in Latin America and or Brazil that are making Latin America a great place to do clinical trials right now? Political trends, economic trends, social trends, disease trends. What do you see happening?

Paulo Fernandes (03:56.098)

Well, another very good question is it gives the opportunity to share a little bit more about how seriously a good part of our countries are taking clinical trials in the past few years, right? So we are a good region with good and a strong record of delivery in global trials. But what we have been able to see in the latest few years is the...

enhancement on the practices from the regulators, right? And this not only in terms of the quality of the assessments. We have, for example, in Brazil, a very strong regulatory authority which is called Anvisa, which is an ICH member, with very well known for the quality of the assessments they conduct. In this

was really exposed during COVID -19, right? As Brazil had the opportunity to take part in the development of global products. But we also have like UNMAT in Argentina following the same path, being a member of ICH. And even a few years back, the regulatory reform in Argentina,

which led to more competitive timelines for the assessment of clinical trials. The trend followed by Brazil this year with the clinical research law, the new clinical research law, which in the end of the day is aimed to help the ecosystem to be more predictable and also to improve the competitiveness of the timelines in Brazil. So I always like to say, Latin America,

is very strong as a whole, as a region, as you place your trial in several countries and get access to a diverse population, but also to a right mix of investigators who are able to deliver to recruitment, to the recruitment needed for the studies at good quality, and now with more competitive timelines when we compare to other countries around the globe.

Julio Martinez-Clark (06:17.299)

Yes. Well, let's get back to your background because you're bringing up the issue of the new law in Brazil. And that's a topic that I really want to address in this episode. But you were the president of the board of directors of the Brazilian Association of Clinical Research Organization, which is a big deal for somebody to lead such an organization in

such an important country like Brazil. So you were in that capacity, you were involved in helping the regulator and the government draft the law. Is that correct?

Paulo Fernandes (06:59.374)

Yes, well, definitely it was, at least for me, a big deal, something really important that definitely marked my career. I had the opportunity of working as a volunteer inside our local clinical research organizations association, which is called Abracro, and I spent 10 years there as a volunteer. So I started working on discussion groups.

Julio Martinez-Clark (07:24.373)

Hmm, great.

Paulo Fernandes (07:29.26)

Then coordinating a commission, got involved with the board of directors and spent nearly four years leading the board of directors for the association where I had the opportunity to get involved on the discussions about the new law. Of course, it wasn't something done only by me. It started with very good people who were actually visionaries in the past.

by creating an association to support the improvement of the ecosystem, right? So these guys, definitely deserve the merit and it ended up with allowing the association to get involved in the discussions, to discuss with regulators, with the government about the sector, the view of the sector about what should be improved, the needs, the global trends.

how to be competitive, keeping high ethical standards and the quality. So it was really an amazing journey. And to get to a place where I had the opportunity to see the bill being approved, it was really amazing. We spent nearly 10 to 11 years working on that. Not only AbraCro, but other associations, investigators.

Julio Martinez-Clark (08:51.197)

Wow, really?

Paulo Fernandes (08:56.29)

people really concerned about doing high quality research, but also about improving the level of opportunity for the population. Because in the end of the day, although it's not the primary objective, clinical research can also mean access to the population, Especially in a region where we have still a lot of disparity, social and economical disparity within the population.

So yes, it was an amazing journey, like 11 years working for that and supporting it and representing the sector, Very big responsibility, which I mean, I'm really proud about the fact I had the chance of contributing, of adding two or three blocks to the wall.

Julio Martinez-Clark (09:45.077)

Fantastic. Congratulations. I mean, that's an amazing accomplishment. All right, so let's talk a little bit about the law, what new changes it brings to the ecosystem in Brazil. How will it make Brazil a more competitive country for clinical trials? Because in my experience, and I come from the medical device clinical trial world, as you

Medical device companies, least medical device startups, don't usually think about Brazil as a place to do first in human early disability proof of concept clinical trials. go to other countries that are more friendly to these type of studies where you can get them started anywhere between 30 and 90 days, which is kind of the timeline that these companies are looking for.

Is Brazil going to be now an innovator of these companies and also pharmaceutical companies that want faster approvals?

Paulo Fernandes (10:46.752)

No doubt, I do think that's gonna change. Brazil, the compelling offer that I like to discuss and to show about Brazil relates to the ability to recruit, to recruit fast and now in a more competitive timelines landscape. So the law itself may propose some changes.

to the total timelines for the regulatory authority evaluation. So now we are talking about nearly like 100 days, 120 days for this assessment. And also something that it was very characteristic about Brazil in the past relates to the fact we used to have two ethical approvals. One from a local ethics committee, another one

from the National Ethics Committee. Now with the law, that's going to be one ethical approval. Local Ethical Ethics Committees will be able to assess and approve the studies, which we expect added to the new timelines for the regulatory authority to put ourselves in a more competitive position in terms of timelines.

So this and the population aspect and also the fact Brazil is a very relevant market in terms of selling of these products. All of the three conditions will definitely put Brazil in the map for the medical device companies. And for pharma, mean, we have a very good

track record with phase three trials, right? That's gonna only get even better. Yeah, with better timelines, the population aspect, the fact that our people here, most of them live in cities, which make research more accessible for them. All of these together will support Brazil to become

Julio Martinez-Clark (12:48.115)

Better. Easier, yeah.

Paulo Fernandes (13:10.506)

is supporting already Brazil to become more competitive in the global ecosystem for clinical research, either for drugs, but also for devices.

Julio Martinez-Clark (13:17.191)

Excellent. Yes, yes. All right, so let me see if I understood correctly. So the first step is IRB or ethics committee approval. And that takes around what?

Paulo Fernandes (13:33.486)

90 days.

Julio Martinez-Clark (13:34.965)

90 days. I mean, it's a private IRB inside the hospital or can also be a central IRB.

Paulo Fernandes (13:36.426)

Yes. No, it's not private, but it's inside the hospital or associated to the institution proposing the research, which can be a private practice, right? But we used to have two approvals, the local IRB and the central. And now that's going to be just one.

Julio Martinez-Clark (13:54.889)

Yes.

Julio Martinez-Clark (13:59.829)

Just one, the local IRB or Earth's Committee. And that takes about 90 days.

Paulo Fernandes (14:02.412)

Yes. Yes.

Yes, that's gonna take about 90 days.

Julio Martinez-Clark (14:08.99)

And then you have to go to UNDISA, the National Regulatory Agency, and they evaluate the study and take how much?

Paulo Fernandes (14:21.71)

they will have the maximum of 120 days. Yes.

Julio Martinez-Clark (14:27.957)

maximum 120 days. So we're looking at 90 days at the local IRB or ethics committee and then 120 day tops at AMVISA.

Paulo Fernandes (14:38.888)

Yes, yes, we expect taking into account administrative staff contract and the approvals to be able to activate sites with like, depending on the trial, four months, five months, something like that. There will be of course, and they are there and everywhere is just the same, very complex studies which need more assessments or

Julio Martinez-Clark (15:07.445)

Sure, yeah.

Paulo Fernandes (15:08.238)

which have more multiple rounds of assessment, but that's not the case. It's going to be really more competitive. We are talking about like 160 days to have sites activated. That's going to be

Julio Martinez-Clark (15:24.851)

Yes, yes. All right. Good, Excellent. OK, so let's talk a little bit, about the health care system in Brazil. Why is it good for clinical research? Let's talk about the public system, the private system. Are public hospitals friendly to clinical trials? I understand that a large percentage of the population is probably in the public system. Can we do trials there or not?

or we have to move those patients to private hospitals. How does it work?

Paulo Fernandes (15:59.47)

That's very interesting to share. Brazil has nearly 200 million people, right? 80 % of these people use the national healthcare system. 80 %? Yes, exactly.

Julio Martinez-Clark (16:22.613)

80 % of the 200 million people are in the public health care system.

Paulo Fernandes (16:27.998)

in the public health care system. This is most probably one of the biggest and largest networks of public hospitals and primary care, ambulatory outpatient clinics that we can see around the globe. So this makes the access to medical care widespread all around the country.

Julio Martinez-Clark (16:46.153)

Yes, agree.

Paulo Fernandes (16:57.698)

with nearly, with the majority of the population being able to enter in a public health care institution and get treated. So that's one of the most important things about the infrastructure in Brazil and one of the things that makes it a very good place to recruit for large trials. We can recruit population from north to south and this

is very like the network is already there, it's like a network by design. Of course, each of the states, institutions, they have their own rules, but the majority of the states in Brazil are served by institutions maintained by the federal government. And all of these are part of a network, and very often these are also connected to the medical schools. That's where we see

Julio Martinez-Clark (17:53.885)

Okay.

Paulo Fernandes (17:55.438)

a lot of the research, a good volume of clinical research happening. So it's all there, you know. It's very interesting when we take a deeper look and see that we have 27 states in Brazil. And these medical schools is where very often research is happening. The same investigators who are professors in the medical schools, they also very

treat patients in the private healthcare system, the other 20 million, 30 million people, either in hospitals or through their private practices. So these investigators, they have access to the entire population, to the entire country population. So this makes Brazil a very interesting location because when we implement a trial, we can go...

for the patients where they are. We can map using data, for example, from Datasus, which is the electronic system kept by the federal government about healthcare. And we can identify incidents and prevalence of diseases and go and try to maximize the...

performance, the possibility of allowing patients to get access to trials, to clinical trials. So that's very interesting about our local healthcare infrastructure.

Julio Martinez-Clark (19:33.077)

That's fantastic. Yes, I've heard about the data source that you're referring to. In the United States, they call it a claims database. Columbia also has a very good one, and I heard about the Brazilian one, because it covers, as you said, 80 % of population. So you can do a lot of good epidemiology research on it and locate where patients are.

Paulo Fernandes (19:54.006)

And there are exactly, and there are companies already taking advantage of it. And it's worth saying that all of these within the GDPR regulations, know, no individualized patient data is accessed. So all of these focused on implementing the clinical trials where they are most needed and where actually participants can be found, which works.

Julio Martinez-Clark (20:09.885)

Yes, of course.

Paulo Fernandes (20:24.563)

for the good either of the participants but also of the research, the purposes of the research and also it helps the health care system. In end of the day, when you are getting treated under a clinical trial, you are actually saving public resources.

Julio Martinez-Clark (20:44.209)

Absolutely. That's a good point. Now that you're talking about saving money, let's talk about cost. Is Brazil a cost competitive country for drinker trials?

Paulo Fernandes (20:55.202)

Definitely, no doubt. There are several factors which contribute to this view, but one of them relates to the fact we have very well -formed healthcare staff and a lot of people choosing careers such as medicine, but not only. Like we have nurses, pharmacists, biomedical doctors. So we do have people with good academic level.

economics for the global development landscape very often are based on dollars, right? And we do have a very competitive and positive economic landscape for the execution of clinical trials here. The cost of healthcare in Brazil is still lower

cost of health care in other places around the globe. One of the things is mainly related to the public health care system, know, so the way it's structured it also helps this cost relation.

Julio Martinez-Clark (22:10.311)

Excellent, Paulo. think this covers most of the topics that listeners want to learn about when choosing a destination for clinical trials, at least for medical device clinical trials. Is there anything you want to add to your discussion, to your comments?

Paulo Fernandes (22:31.608)

Well, I always like to invite people who actually do not know Latin America or don't have detailed information about it to get in touch, to contact people like ourselves, who can actually help them to navigate through the nuances of the region, and also to reaffirm that this is a very good region for execution and also creation of clinical trials which can contribute to the global development landscape, you know.

Julio Martinez-Clark (22:44.521)

Yes.

Paulo Fernandes (23:00.726)

It's just a matter of ask the right questions and go to the people who can actually support things in each of the countries. We do have very good investigators and a very strong track record of delivery. So all of this is what I think it makes Latin America really, if not a new frontier, the next frontier for clinical development, know, a growing market

Julio Martinez-Clark (23:13.865)

Yes.

Julio Martinez-Clark (23:24.597)

Mm -hmm. Yes.

Paulo Fernandes (23:30.09)

also local pharmaceutical companies starting to propose innovations. So it's a very interesting and positive moment for Latin America as a region.

Julio Martinez-Clark (23:41.491)

I totally agree. And to add to that comment, I think there is a movement of many governments in Latin America to one, join ICH. Mexico, by the way, is also an ICH member. I think they joined last year. So now we have three countries, as far as I understand, there are members, which is a big deal for Latin America because it took us a while as a region to join that club. And also,

Paulo Fernandes (23:58.636)

Yes, that's right.

Julio Martinez-Clark (24:11.645)

the fact that countries are issuing new laws for clinical trials. They are now aware of the fact that that brings a lot of benefit to the patients, to the healthcare system, cost savings and other things, innovation, et cetera, and also foreign investment, which is badly needed in our country. That brings jobs, high paying jobs. So I applaud.

the new era, this new way of thinking of the Latin American government. Also Colombia is thinking about a new law. Panama has a law, Paraguay has a law, Mexico is making very, very good changes based on this new thinking. So Argentina did it in 2017, something like that. So yeah, things are looking great for Latin America to attract more clinical trials.

Paulo Fernandes (25:08.23)

I agree.

Julio Martinez-Clark (25:09.855)

All right, Paulo, thank you so much. appreciate your involvement with the lifetime medic leaders podcast. I look forward to our future conversations.

Paulo Fernandes (25:18.936)

Thank you Julio, very good opportunity to be with.