Episode’s Transcript

Julio Martinez-Clark (00:04):

Hello. Welcome to another episode of the Latin MedTech Leaders Podcast, a conversation with leaders in the MedTech industry who have succeeded in Latin America. Subscribe on popular podcast platforms like Apple, Spotify, and others. Well, today we have Miriam Serrano as our guest. She is the founder and executive director of the Association of Clinical Research Specialist Professionals, AAIC and Mexico. Miriam, welcome to the podcast,

Miriam Serrano (00:45):

Julio. The pleasure is mine. I truly appreciate the opportunity to participate in this important forum and contribute to the dissemination of what clinical research is in Latin America, particularly in Mexico. The performance was absolutely outstanding and truly remarkable, showcasing an exceptional level of skill and dedication. It was without a doubt,

Julio Martinez-Clark (01:07):

Miriam, well, let's start by talking a little about you, your background, your past, your education, your personal and professional life, and then we'll get into more specific questions about clinical research in Mexico.

Miriam Serrano (01:22):

Well, Julio, I am a pharmacist by original training, and I studied a master's degree in sciences with a specialty in clinical research. I am the daughter of a pediatrician father and an anthropologist mother. And I believe that in the end, these two perspectives greatly influenced my personal life, of course, and my professional life in both the short and long term. Now, I will tell you why after having ventured into the pharmaceutical industry, always in the field of clinical research along the way, I realized that health regulation is truly my passion. And last year I finished my law degree.

Julio Martinez-Clark (01:58):

Impressive.

Miriam Serrano (01:59):

I finally studied a specialty in health law, and I am currently pursuing a master's degree in corporate law. So I believe I have managed to combine the best of two great fields, life sciences on one hand and on the other, everything related to health law, which is something I love.

Julio Martinez-Clark (02:18):

I love. Well, tell us a bit about how you came to found the Association of Clinical Research Specialists, professionals, AAIC in Mexico, how the genesis of the association was in

Miriam Serrano (02:31):

Mexico. There had already been associations for years that at the time brought together medical directors who back in the eighties were responsible for all areas within pharma pharmaco vigilance on one side, regulatory affairs, clinical research, and medical affairs. And little by little, as you know very well, all these areas started to specialize and sub-specialize. And a single association that addressed the issues of medical directors became somewhat insufficient to cover, cover the entire complexity of the topics. Thus, we saw the birth of associations dedicated to pharmacovigilance associations dedicated to medical affairs, and as a group of friends, we really saw the need to create an association dedicated to pharmaceutical clinical research.

Julio Martinez-Clark (03:15):

Excellent. In what year was it founded?

Miriam Serrano (03:18):

May, 2012, Marx 12th anniversary this year.

Julio Martinez-Clark (03:21):

2012. 12 years. Fantastic. That's great. It's quite mature. No PA then.

Miriam Serrano (03:26):

It has been a long journey, you know, a complex journey, but persistence seems to me to be the key to keeping our clear objective of bringing together all of us who are dedicated to this, contributing to the profession, professionalization and spreading the value that clinical research brings.

Julio Martinez-Clark (03:47):

Of course, yes. Well, let's talk a bit about the challenges you see in Mexico regarding clinical research, the opportunities, and now let's talk a bit more about the work and achievements of the association. How is it, let's say, trying to solve those challenges and taking advantage of those opportunities? Mexico?

Miriam Serrano (04:11):

Of course, Julio, Mexico is an interesting country. I believe that to some extent it manages to combine the best of both worlds, the developed world and the developing world. Speaking of the population of the country's own epidemiology, we have a very high prevalence incidence of chronic metabolic and oncological diseases, which as you know today continue to be the primary targets for the development of new medications and medical devices. We are truly a country with a very large population. We are more than 125 million undergoing a full demographic and epidemiological transition, increasingly younger. And we are also developing disease is typical of developed countries. In this sense, we are an attractive country because we manage to have the population targeted by new developments. We must also recognize that we are geographically privileged in the sense of being very close to North America, which greatly facilitates logistics as you know very well for the shipment to central laboratories and the supply of various inputs associated with research. We are a country that has great health institutions with first class doctors and cutting edge medical equipment, which also allows us to participate in complex clinical studies. This is not so much due to the population, but rather the availability of specialists and specialized equipment, which may not be as easily accessible in other regions. So I would say that this diversity places us as a strategic location for the pharmaceutical and medical device industry.

Julio Martinez-Clark (06:03):

Yes, yes, completely. Mexico is a privileged country, as you rightly said, Miriam and I feel and have always said, Mexico in my opinion, is the perfect country in Latin America for research, thanks to its geographical proximity to where medical innovation is produced in the USA and the hospital infrastructure, the population density, the size of the country. I mean, it makes it perfect, but Well, now we have already talked about, let's say it, well, we talked a little about the challenges. What do you see in Mexico that makes things difficult at this moment? And then let's talk about how your association is working to contribute, improve, or solve those challenges.

Miriam Serrano (06:51):

Of course. Look, I think it's no secret to anyone, right? The National Regulatory Authority has faced a series of fundamental changes that have directly impacted above all competitiveness. You know that in clinical research, time is gold. We really need to be countries that manage to have everything ready to start recruitment in the shortest possible time. Sadly, in Mexico, we have gone from record times where in six months we managed to go from receiving a protocol to starting the first center to sadly exceeding a year and a half in this process. So these have been times of change, mainly regulatory challenges, long approval times in committees, and even longer authorization times by our regulatory authority. We are at a historic moment, almost more than a couple of years ago, we became active members of the International Council for Harmonization of technical requirements for pharmaceuticals, for human use, ICH, through the Federal Commission for the Protection against Sanitary Risks. And it has been a real challenge you send to implement a work plan that allows us in the medium to long term to ensure full implementation of the ICH guidelines. So I would say that the challenges are mainly normative and regulatory. Precisely

Julio Martinez-Clark (08:14):

Perfect. And I also see other challenges, correct me if I'm wrong, but let's talk a little bit about the healthcare system in Mexico. Let's talk about the IMSS. Let's talk, well, people say that in Mexico there are five healthcare systems. Let's talk a little about that so the audience understands how the healthcare system works in Mexico, where the public and private patients are, please.

Miriam Serrano (08:44):

Sure. Excellent question. And what you heard is a reality. Sadly, Mexico does not have an integrated health system in Mexico. The right to health protection is still tied to having a job, to being an active worker, so that all those who do not have formal employment, do not have access to public health services and have to seek alternatives. Often private clinics, which obviously make healthcare more expensive in this regard, I think you have said it very precisely. Speaking of clinical research centers in Mexico, we have two large worlds that coexist July. On one hand, we have large public institutions that concentrate the population, but the demand for health services is overwhelming and exceeded. The medical staff does not have time to dedicate to clinical research activities. We have these places that have specialist doctors, that have a world of patients that have high tech equipment, and what they lack is the time to invest and dedicate themselves to pharmaceutical clinical research, which as you know, is not something that can be done in spare moments or between consultations. On the other hand, we have private research centers where they have the time and trained personnel to dedicate to these complex activities, but what they lack are patients, right?

Julio Martinez-Clark (10:13):

Yes, yes, indeed. Yes, yes.

Miriam Serrano (10:16):

We live between these two extremes. Trying to reach a balance that in real life becomes very complicated. The first centers to become operational are the private ones, as they do not have to get involved in so many complex institutional and administrative processes. They are not the first to start, but they have the lowest volume of patients. The public centers, which are the ones with the patient population, are the last to arrive in the recruitment race. And well, we had to overcome several administrative complexities along the way, and although they are already the ones with the patients, many times globally, time surpasses us and when they're ready, well, the sample size and the goal have already been <crosstalk>.

Julio Martinez-Clark (11:00):

It's already already very late. That that is good. So what percentage would you say of the population is in the public system and in the private system, let's say? I don't know.

Miriam Serrano (11:10):

Sure. Generally speaking, 80% of the population has access to public institutions and 20% has access to private institutions, right? That's approximately the proportion. And

Julio Martinez-Clark (11:22):

How, how, how do you get access to private institutions because you have a job and you pay extra thousand to be able to go to the private one. Is that how it works?

Miriam Serrano (11:33):

Very well. I would also need to differentiate between private medicine and private medicine. There are of course, large tertiary hospitals, which are very expensive and can be accessed precisely by acquiring a major medical expenses insurance. Many jobs, especially those in multinational companies, offer benefits such as medical expense insurance for the worker and their immediate family. But we must also recognize that there is another sector of private medicine, which is that of the informal worker, the man who sells at a food stall. Yes. Right, of course. And that does not have, let's say, access, they really don't have it. Exactly. They don't have access to that public healthcare, but neither to that private healthcare, which depends on medical expense insurance. And so they turn to a type of private clinics adjacent to pharmacies, usually providing only primary care. And interestingly, an ecosystem has developed in a fragile balance July, because these people who do not have access to social security, let's say to the social security who do not have access to high specialty private medicine, what they have left is to go to those clinics adjacent to pharmacies where they can surely get a general practitioner consultation for $10.

Miriam Serrano (12:56):

But the moment that patient needs specialized care, that's where we are in trouble, because they definitely would no longer have access to that specialized medicine in economic terms.

Julio Martinez-Clark (13:06):

They have to go into debt, et cetera, borrow money from family, friends, or get gifted money, et cetera. Yes, I understand now. That's

Miriam Serrano (13:14):

Right. A familiar and social situation ultimately very complex.

Julio Martinez-Clark (13:19):

But then, is this the way I am trying to understand the way a public patient from the public system could move to the private sector? Aman,

Miriam Serrano (13:29):

I tell you that these private research centers, which perhaps in the USA, are known as site management organizations, establishments, that actually invite doctors who work in those public institutions and have access to patients. And then they say, well, let's do this protocol. But instead of doing it at the National Institute of X,

Julio Martinez-Clark (13:52):

Yes,

Miriam Serrano (13:53):

We do it at this private research center.

Julio Martinez-Clark (13:56):

Okay, okay. I mean, it depends on creating a network of referring doctors who refer patients.

Miriam Serrano (14:05):

Exactly. And

Julio Martinez-Clark (14:07):

How interesting.

Miriam Serrano (14:08):

Don't know if it's a common problem in Latin America, but the professional jealousy of doctors can influence them. Yes. Not to refer the patient. I think this leads me to directly talk about another challenge. Doctors in Mexico, specialist doctors often listen and participate in research activities, but very academic research, which does not adhere to the same standards as research aimed at developing and bringing a new health product to the market. So these are doctors who, yes, maybe decide to pursue a postgraduate degree, a master's in science, a doctorate in science, and who take a lot of courses in research methodology, biostatistics, bioethics. But in reality, this regulatory part, which is so important in clinical research, which aims to knock on the door of the FDA, the EMA or any regulatory authority, needs to demonstrate full compliance with international standards, good clinical practices and local regulations specific to clinical research. All of this is something unknown to a doctor. These are not topics covered by the undergraduate curriculum and sadly neither by the curriculum of medical specialties or postgraduate programs. Julio. Then in reality, the reason a specialist doctor ends up participating in clinical studies sponsored by the pharmaceutical industry is usually because they hear about it, they are given a hand, and it is the pharmaceutical industry that ends up training them in what should be a common standard for conducting research on human beings.

Julio Martinez-Clark (16:06):

Well, Miriam, let's talk a bit about your association. How you are mitigating these problems or challenges, how you are trying to solve them, and what is your vision for the association in the next three to five years?

Miriam Serrano (16:21):

Of course. Thank you. Julio. A pH was born with the objective of contributing to the professionalization of human resources in research centers, in research ethics committees in the pharmaceutical industry itself, CROs, and even in regulatory authorities. It has been a complex issue throughout this decade, a bit more of breaking ground, opening forums to start linking, getting to know each other, understanding the needs, what the industry needs from a researcher, what a researcher needs from the industry, what we need from a committee, what we need from the authority open, these communication channels that allow all actors to be effectively and efficiently linked. We have achieved this through various spaces. Traditionally, we have an annual event where we bring everyone together and try to open agendas that allow us to stay very updated on topics, very local issues, perhaps regional, but always looking at how the world is in global terms.

Miriam Serrano (17:31):

So we have annual events, we have monthly academic sessions, we have periodic courses that we open twice a year, very dedicated to particular topics, bioethics, health regulation, contracts in clinical research courses to develop people who work in the areas of quality assurance, pharmacovigilance. The intention is always to provide continuous training, recognizing the absence of this training. Since our initial stages of education, Julio, we have also launched initiatives like a podcast, which aims to make it attractive to anyone, not just to gather experts, but to make known outside our network, which is relatively small compared to other sectors, the value of research in contributing and bringing health solutions to society. So we have indeed sought to go beyond our own collaboration network and bring clinical research closer to the general public.

Julio Martinez-Clark (18:33):

Very good response. Let's talk a little about MIF. How do you work with MIF? Because I see that they are quite relevant in Mexico. They are very well structured and are also moving in the direction of promoting clinical research in the country. Do you work in concert? Like how is the relationship? Of course,

Miriam Serrano (18:53):

There are several associations with which we have a very close collaboration. The Mexican Association of Pharmaceutical Innovation Industries is one of them. amif. Amif brings together the innovative and pharmaceutical industry. Epic Socio does not group companies. We group individuals, professionals, however, we have an exact individuals. However, we have a common agenda. So we have close work. We have tried to support in meetings, in forums, organized by MIIF and conversely in APEC forums, bringing MIF, always being able to present the perspective, the vision of the industrial sector. And that is critical. It is critical. So of course we have spaces for exchange and collaboration where what we seek is to create synergy. There is me, the National Chamber of the pharmaceutical industry, which in addition to the transnational innovation industry also includes the national industry. We collaborate with other professional associations such as the Mexican Association of Pharmacovigilance, the Mexican Association of Health Regulation Professionals, the Difa Des of Mexico, the equivalent of COTA in Argentina and Akram in Mexico. And always looking for areas of convergence where we are very aware that we can build synergies. It's not the same to knock on a regulatory agency's door 10 times as it is to knock with the voice of 10 associations. So we really seek to close ranks and have common objectives. While each of us may differ in certain aspects, setting a common agenda will truly allow us to have a voice that is more audible to the authorities.

Julio Martinez-Clark (20:45):

Now that you mention authorities, look, it is a very relevant and important topic in this chain of actors. How do you see the attitude of the Mexican government to bring foreign investment into clinical research? Do they see the potential? How has the response been? Very

Miriam Serrano (21:03):

Well, very well. July. This administration has not been easy. Like many other countries in Latin America, we transitioned to a government with a different ideology, right? This change in administration touched very sensitive areas regarding what this government private sector collaboration means. I would say that it practically took us four years, four years from 2018 to 2022 to find spaces for dialogue with the Usan authority. Again, we had a very positive momentum, practically. Well, I have been working in the sector for more than 20 years, and it was the first time in 2018 that I saw the door closed on us. They closed the door on us. Thanks to these joint collaborative efforts, thanks to everyone's insistence on a common front, we have gradually managed to make the relevance visible, haven't we from the private sector, the relevance of clinical research for the health of the population.

Miriam Serrano (22:08):

And I would tell you that since our incorporation, I insist through the Federal Commission for the protection against sanitary risk, aish, we have seen much greater openness from the current administration. Recently, at the end of last year, digitalization, which is one of the greatest achievements of the current administration reached clinical trials. We have enormous expectations. The current commissioner has promised a significant reduction in protocol authorization times, which is something we are eagerly needing. July, we went from authorization times of 60 days or two months to more than six months. So this has hit the sector, the industry very hard. And now we are very positive that the incorporation of the electronic platform for the submission of research protocols will help us bounce back and regain the position

Julio Martinez-Clark (23:01):

We had agreed, yes, a

Miriam Serrano (23:02):

Few years ago.

Julio Martinez-Clark (23:03):

Six months at the regulatory agency is definitely unacceptable. It is possible. It

Miriam Serrano (23:09):

Leaves us out, it leaves us out.

Julio Martinez-Clark (23:10):

And well, you see that perhaps for medical devices, that regulatory time of six months might be a bit faster. Since suddenly the whole conversation revolves around medications. It

Miriam Serrano (23:23):

Has always been like this. Right? July, I had the opportunity. I started my clinical research career in medical devices.

Julio Martinez-Clark (23:31):

Okay, that's great. Sadly,

Miriam Serrano (23:33):

At the regulatory level in Mexico, there is no difference. There

Julio Martinez-Clark (23:36):

Is no difference. There

Miriam Serrano (23:37):

Is no difference.

Julio Martinez-Clark (23:38):

It goes through the same desk, the same office,

Miriam Serrano (23:41):

The same line. You queue up with your ticket in the same place. Right? And certainly you know very well that the development of a medical device follows a very different path than that of a drug. And that is poorly understood by the committees, poorly understood by the regulatory authority, and it can even complicate the authorization of a device protocol due to this lack of knowhow of expertise in this very special subtype of health supplies.

Julio Martinez-Clark (24:11):

If you have a pharmaceutical chemist evaluating a biomedical device, I believe the skills are not, and their training to truly understand the mechanism of action, the mechanics, the software,

Miriam Serrano (24:25):

It's a different mindset that needs to be

Julio Martinez-Clark (24:26):

Adopted. Yes. Another chip

Miriam Serrano (24:28):

To evaluate a device project, the Federal Sanitary Risk Protection Commission has areas dedicated to medical devices, sanitary registration, technical aspects, and surveillance. Is there a lack of an area of experts in medical devices for definitive clinical research?

Julio Martinez-Clark (24:45):

Well, Miriam, we are almost at the end of the episode. Could you share some words to give light or hope to these foreign companies that want to see Mexico as a clinical research destination? Because as we mentioned earlier, it might be the perfect country in Latin America to do it since it is close to the USA and has that cultural, historical affinity, et cetera. So before we conclude, do you have anything to say? We

Miriam Serrano (25:15):

Have the patients, we have the specialist doctors, and we have already started resumed a dialogue with the regulatory authority that will create a much more favorable atmosphere for conducting clinical studies. So that 2024 will be a year where we will once again see fertile ground in all aspects for conducting clinical studies in Mexico,

Julio Martinez-Clark (25:39):

July. Excellent, Miriam. Well, Miriam, thank you so much for your participation in our interview on the Latin Med Tech Leaders podcast. I appreciate your wisdom and that you shared with the audience everything you know about clinical research in Mexico, and I hope to see you again very soon.

Miriam Serrano (25:58):

The annual event, the grand annual event of AP is always in May around International Clinical Trials Day, which you know is May 20th, and this year it will be on May 22nd and 23rd, research land 2024. So I hope to be able to count on your attendance and that of many of your listeners.

Julio Martinez-Clark (26:17):

Of course. Absolutely. Well, goodbye.

Miriam Serrano (26:20):

Thank you for the opportunity