September 6, 2024 • 26 mins
Miriam is a seasoned professional in Health and Law, specializing in Sanitary Regulation and Clinical Research. With over 20 years of experience, she has a track record in planning and executing global, regional, and local clinical development programs, including Bioequivalence studies and Phase I-IV clinical trials. Her expertise spans Clinical Monitoring, Quality Assurance, Budgeting, Contracts & Payments Control, Clinical Trial Supplies, Master File, Pharmacovigilance, and Regulatory Affairs within both pharmaceutical industries and CROs, at national and international levels. She is recognized in the sector as a key opinion leader and a local expert in regulatory matters. Her leadership and active participation in gremial improvement initiatives have been pivotal, building synergies with authorities, academic, and industrial colleagues to further the development and progress of Clinical Research.
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Episode Transcript
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Speaker 1 (00:04):
Hello. Welcome to another episode of the Latin
MedTech Leaders Podcast, aconversation with leaders in
the MedTech industry who havesucceeded in Latin America.
Subscribe on popular podcastplatforms like Apple, Spotify,
and others. Well, today we haveMiriam Serrano as our guest.
(00:31):
She is the founder andexecutive director of the
Association of ClinicalResearch Specialist
Professionals, AAIC and Mexico.
Miriam, welcome to the podcast,
Speaker 2 (00:45):
Julio. The pleasure is mine. I truly appreciate the
opportunity to participate inthis important forum and
contribute to the disseminationof what clinical research is in
Latin America, particularly inMexico. The performance was
absolutely outstanding andtruly remarkable, showcasing an
exceptional level of skill anddedication. It was without a
(01:06):
doubt,
Speaker 1 (01:07):
Miriam, well, let's start by talking a little about
you, your background, yourpast, your education, your
personal and professional life,and then we'll get into more
specific questions aboutclinical research in Mexico.
Speaker 2 (01:22):
Well, Julio, I am a pharmacist by original
training, and I studied amaster's degree in sciences
with a specialty in clinicalresearch. I am the daughter of
a pediatrician father and ananthropologist mother. And I
believe that in the end, thesetwo perspectives greatly
influenced my personal life, ofcourse, and my professional
life in both the short and longterm . Now, I will tell you why
(01:45):
after having ventured into thepharmaceutical industry, always
in the field of clinicalresearch along the way, I
realized that health regulationis truly my passion. And last
year I finished my law degree.
Speaker 1 (01:58):
Impressive.
Speaker 2 (01:59):
I finally studied a specialty in health law, and I
am currently pursuing amaster's degree in corporate
law. So I believe I havemanaged to combine the best of
two great fields, life scienceson one hand and on the other,
everything related to healthlaw, which is something I love.
Speaker 1 (02:18):
I love. Well, tell us a bit about how you came to
found the Association ofClinical Research Specialists,
professionals, AAIC in Mexico,how the genesis of the
association was in
Speaker 2 (02:31):
Mexico. There had already been associations for
years that at the time broughttogether medical directors who
back in the eighties wereresponsible for all areas
within pharma pharmacovigilance on one side,
regulatory affairs, clinicalresearch, and medical affairs.
And little by little, as youknow very well, all these areas
started to specialize andsub-specialize. And a single
(02:54):
association that addressed theissues of medical directors
became somewhat insufficient tocover, cover the entire
complexity of the topics. Thus,we saw the birth of
associations dedicated topharmacovigilance associations
dedicated to medical affairs,and as a group of friends, we
really saw the need to createan association dedicated to
pharmaceutical clinicalresearch.
Speaker 1 (03:15):
Excellent. In what year was it founded?
Speaker 2 (03:18):
May, 2012, Marx 12th anniversary this year.
Speaker 1 (03:21):
2012 . 12 years.
Fantastic. That's great. It'squite mature. No PA then .
Speaker 2 (03:26):
It has been a long journey, you know, a complex
journey, but persistence seemsto me to be the key to keeping
our clear objective of bringingtogether all of us who are
dedicated to this, contributingto the profession,
professionalization andspreading the value that
clinical research brings.
Speaker 1 (03:47):
Of course, yes.
Well, let's talk a bit aboutthe challenges you see in
Mexico regarding clinicalresearch, the opportunities,
and now let's talk a bit moreabout the work and achievements
of the association. How is it,let's say, trying to solve
those challenges and takingadvantage of those
(04:09):
opportunities? Mexico?
Speaker 2 (04:11):
Of course, Julio, Mexico is an interesting
country. I believe that to someextent it manages to combine
the best of both worlds, thedeveloped world and the
developing world. Speaking ofthe population of the country's
own epidemiology, we have avery high prevalence incidence
(04:35):
of chronic metabolic andoncological diseases, which as
you know today continue to bethe primary targets for the
development of new medicationsand medical devices. We are
truly a country with a verylarge population. We are more
than 125 million undergoing afull demographic and
epidemiological transition,increasingly younger. And we
(04:59):
are also developing disease istypical of developed countries.
In this sense, we are anattractive country because we
manage to have the populationtargeted by new developments.
We must also recognize that weare geographically privileged
in the sense of being veryclose to North America , which
(05:21):
greatly facilitates logisticsas you know very well for the
shipment to centrallaboratories and the supply of
various inputs associated withresearch. We are a country that
has great health institutionswith first class doctors and
cutting edge medical equipment,which also allows us to
participate in complex clinicalstudies. This is not so much
(05:45):
due to the population, butrather the availability of
specialists and specializedequipment, which may not be as
easily accessible in otherregions. So I would say that
this diversity places us as astrategic location for the
pharmaceutical and medicaldevice industry.
Speaker 1 (06:03):
Yes, yes, completely. Mexico is a
privileged country, as yourightly said, Miriam and I feel
and have always said, Mexico inmy opinion, is the perfect
country in Latin America forresearch, thanks to its
geographical proximity to wheremedical innovation is produced
in the USA and the hospitalinfrastructure, the population
(06:26):
density, the size of thecountry. I mean, it makes it
perfect, but Well, now we havealready talked about, let's say
it, well, we talked a littleabout the challenges. What do
you see in Mexico that makesthings difficult at this
moment? And then let's talkabout how your association is
working to contribute, improve,or solve those challenges.
Speaker 2 (06:51):
Of course. Look, I think it's no secret to anyone,
right? The National RegulatoryAuthority has faced a series of
fundamental changes that havedirectly impacted above all
competitiveness. You know thatin clinical research, time is
gold. We really need to becountries that manage to have
(07:12):
everything ready to startrecruitment in the shortest
possible time. Sadly, inMexico, we have gone from
record times where in sixmonths we managed to go from
receiving a protocol tostarting the first center to
sadly exceeding a year and ahalf in this process. So these
have been times of change,mainly regulatory challenges,
(07:35):
long approval times incommittees, and even longer
authorization times by ourregulatory authority. We are at
a historic moment, almost morethan a couple of years ago, we
became active members of theInternational Council for
Harmonization of technicalrequirements for
pharmaceuticals, for human use,ICH, through the Federal
Commission for the Protectionagainst Sanitary Risks. And it
(07:58):
has been a real challenge yousend to implement a work plan
that allows us in the medium tolong term to ensure full
implementation of the ICHguidelines. So I would say that
the challenges are mainlynormative and regulatory.
Precisely
Speaker 1 (08:14):
Perfect. And I also see other challenges, correct
me if I'm wrong, but let's talka little bit about the
healthcare system in Mexico.
Let's talk about the IMSS.
Let's talk, well, people saythat in Mexico there are five
healthcare systems. Let's talka little about that so the
(08:35):
audience understands how thehealthcare system works in
Mexico, where the public andprivate patients are, please .
Speaker 2 (08:44):
Sure. Excellent question. And what you heard is
a reality. Sadly, Mexico doesnot have an integrated health
system in Mexico. The right tohealth protection is still tied
to having a job, to being anactive worker, so that all
those who do not have formalemployment, do not have access
(09:05):
to public health services andhave to seek alternatives.
Often private clinics, whichobviously make healthcare more
expensive in this regard, Ithink you have said it very
precisely. Speaking of clinicalresearch centers in Mexico, we
have two large worlds thatcoexist July. On one hand, we
(09:25):
have large public institutionsthat concentrate the
population, but the demand forhealth services is overwhelming
and exceeded. The medical staffdoes not have time to dedicate
to clinical researchactivities. We have these
places that have specialistdoctors, that have a world of
(09:46):
patients that have high techequipment, and what they lack
is the time to invest anddedicate themselves to
pharmaceutical clinicalresearch, which as you know, is
not something that can be donein spare moments or between
consultations. On the otherhand, we have private research
centers where they have thetime and trained personnel to
(10:07):
dedicate to these complexactivities, but what they lack
are patients, right?
Speaker 1 (10:13):
Yes, yes, indeed .
Yes, yes.
Speaker 2 (10:16):
We live between these two extremes. Trying to
reach a balance that in reallife becomes very complicated.
The first centers to becomeoperational are the private
ones, as they do not have toget involved in so many complex
institutional andadministrative processes. They
are not the first to start, butthey have the lowest volume of
(10:37):
patients. The public centers,which are the ones with the
patient population, are thelast to arrive in the
recruitment race. And well, wehad to overcome several
administrative complexitiesalong the way , and although
they are already the ones withthe patients, many times
globally, time surpasses us andwhen they're ready, well, the
(10:57):
sample size and the goal havealready been .
Speaker 1 (11:00):
It's already already very late. That that is good.
So what percentage would yousay of the population is in the
public system and in theprivate system, let's say? I
don't know.
Speaker 2 (11:10):
Sure. Generally speaking, 80% of the population
has access to publicinstitutions and 20% has access
to private institutions, right?
That's approximately theproportion. And
Speaker 1 (11:22):
How, how, how do you get access to private
institutions because you have ajob and you pay extra thousand
to be able to go to the privateone. Is that how it works?
Speaker 2 (11:33):
Very well. I would also need to differentiate
between private medicine andprivate medicine. There are of
course, large tertiaryhospitals, which are very
expensive and can be accessedprecisely by acquiring a major
medical expenses insurance.
Many jobs, especially those inmultinational companies, offer
(11:55):
benefits such as medicalexpense insurance for the
worker and their immediatefamily. But we must also
recognize that there is anothersector of private medicine,
which is that of the informalworker, the man who sells at a
food stall. Yes. Right, ofcourse. And that does not have,
let's say, access, they reallydon't have it. Exactly. They
(12:17):
don't have access to thatpublic healthcare , but neither
to that private healthcare ,which depends on medical
expense insurance. And so theyturn to a type of private
clinics adjacent to pharmacies,usually providing only primary
care. And interestingly, anecosystem has developed in a
fragile balance July, becausethese people who do not have
(12:39):
access to social security,let's say to the social
security who do not have accessto high specialty private
medicine, what they have leftis to go to those clinics
adjacent to pharmacies wherethey can surely get a general
practitioner consultation for$10. But the moment that
patient needs specialized care,that's where we are in trouble,
(13:00):
because they definitely wouldno longer have access to that
specialized medicine ineconomic terms.
Speaker 1 (13:06):
They have to go into debt, et cetera, borrow money
from family, friends, or getgifted money, et cetera. Yes ,
I understand now. That's
Speaker 2 (13:14):
Right. A familiar and social situation ultimately
very complex.
Speaker 1 (13:19):
But then, is this the way I am trying to
understand the way a publicpatient from the public system
could move to the privatesector ? Aman ,
Speaker 2 (13:29):
I tell you that these private research centers,
which perhaps in the USA , areknown as site management
organizations, establishments,that actually invite doctors
who work in those publicinstitutions and have access to
patients. And then they say,well, let's do this protocol.
But instead of doing it at theNational Institute of X,
Speaker 1 (13:52):
Yes,
Speaker 2 (13:53):
We do it at this private research center.
Speaker 1 (13:56):
Okay, okay. I mean, it depends on creating a
network of referring doctorswho refer patients.
Speaker 2 (14:05):
Exactly. And
Speaker 1 (14:07):
How interesting. I
Speaker 2 (14:08):
Don't know if it's a common problem in Latin
America, but the professionaljealousy of doctors can
influence them . Yes . Not torefer the patient. I think this
(14:32):
leads me to directly talk aboutanother challenge. Doctors in
Mexico, specialist doctorsoften listen and participate in
research activities, but veryacademic research, which does
not adhere to the samestandards as research aimed at
developing and bringing a newhealth product to the market.
(14:54):
So these are doctors who, yes,maybe decide to pursue a
postgraduate degree, a master'sin science, a doctorate in
science, and who take a lot ofcourses in research
methodology, biostatistics,bioethics. But in reality, this
regulatory part, which is soimportant in clinical research,
which aims to knock on the doorof the FDA , the EMA or any
(15:19):
regulatory authority, needs todemonstrate full compliance
with international standards,good clinical practices and
local regulations specific toclinical research. All of this
is something unknown to adoctor. These are not topics
covered by the undergraduatecurriculum and sadly neither by
(15:39):
the curriculum of medicalspecialties or postgraduate
programs. Julio. Then inreality, the reason a
specialist doctor ends upparticipating in clinical
studies sponsored by thepharmaceutical industry is
usually because they hear aboutit, they are given a hand, and
it is the pharmaceuticalindustry that ends up training
(16:00):
them in what should be a commonstandard for conducting
research on human beings.
Speaker 1 (16:06):
Well, Miriam, let's talk a bit about your
association. How you aremitigating these problems or
challenges, how you are tryingto solve them, and what is your
vision for the association inthe next three to five years?
Speaker 2 (16:21):
Of course. Thank you. Julio. A pH was born with
the objective of contributingto the professionalization of
human resources in researchcenters, in research ethics
committees in thepharmaceutical industry itself,
CROs, and even in regulatoryauthorities. It has been a
(16:43):
complex issue throughout thisdecade , a bit more of breaking
ground, opening forums to startlinking, getting to know each
other, understanding the needs,what the industry needs from a
researcher, what a researcherneeds from the industry, what
we need from a committee, whatwe need from the authority
(17:04):
open, these communicationchannels that allow all actors
to be effectively andefficiently linked. We have
achieved this through variousspaces. Traditionally, we have
an annual event where we bringeveryone together and try to
open agendas that allow us tostay very updated on topics,
very local issues, perhapsregional, but always looking at
(17:27):
how the world is in globalterms. So we have annual
events, we have monthlyacademic sessions, we have
periodic courses that we opentwice a year, very dedicated to
particular topics , bioethics,health regulation, contracts in
clinical research courses todevelop people who work in the
(17:49):
areas of quality assurance,pharmacovigilance. The
intention is always to providecontinuous training,
recognizing the absence of thistraining. Since our initial
stages of education, Julio, wehave also launched initiatives
like a podcast, which aims tomake it attractive to anyone,
not just to gather experts, butto make known outside our
(18:12):
network, which is relativelysmall compared to other
sectors, the value of researchin contributing and bringing
health solutions to society. Sowe have indeed sought to go
beyond our own collaborationnetwork and bring clinical
research closer to the generalpublic.
Speaker 1 (18:33):
Very good response.
Let's talk a little about MIF .
How do you work with MIF ?
Because I see that they arequite relevant in Mexico. They
are very well structured andare also moving in the
direction of promoting clinicalresearch in the country. Do you
work in concert? Like how isthe relationship? Of course,
Speaker 2 (18:53):
There are several associations with which we have
a very close collaboration. TheMexican Association of
Pharmaceutical InnovationIndustries is one of them. amif
. Amif brings together theinnovative and pharmaceutical
industry. Epic Socio does notgroup companies. We group
individuals, professionals,however, we have an exact
(19:17):
individuals. However, we have acommon agenda. So we have close
work. We have tried to supportin meetings, in forums,
organized by MIIF andconversely in APEC forums,
bringing MIF , always beingable to present the
perspective, the vision of theindustrial sector. And that is
(19:38):
critical. It is critical. So ofcourse we have spaces for
exchange and collaborationwhere what we seek is to create
synergy. There is me , theNational Chamber of the
pharmaceutical industry, whichin addition to the
transnational innovationindustry also includes the
national industry. Wecollaborate with other
(19:59):
professional associations suchas the Mexican Association of
Pharmacovigilance, the MexicanAssociation of Health
Regulation Professionals, theDifa Des of Mexico, the
equivalent of COTA in Argentinaand Akram in Mexico. And always
looking for areas ofconvergence where we are very
(20:19):
aware that we can buildsynergies. It's not the same to
knock on a regulatory agency'sdoor 10 times as it is to knock
with the voice of 10associations. So we really seek
to close ranks and have commonobjectives. While each of us
may differ in certain aspects,setting a common agenda will
(20:40):
truly allow us to have a voicethat is more audible to the
authorities.
Speaker 1 (20:45):
Now that you mention authorities, look, it is a very
relevant and important topic inthis chain of actors. How do
you see the attitude of theMexican government to bring
foreign investment intoclinical research? Do they see
the potential? How has theresponse been? Very
Speaker 2 (21:03):
Well, very well.
July. This administration hasnot been easy. Like many other
countries in Latin America, wetransitioned to a government
with a different ideology,right? This change in
administration touched verysensitive areas regarding what
this government private sectorcollaboration means. I would
(21:25):
say that it practically took usfour years, four years from
2018 to 2022 to find spaces fordialogue with the Usan
authority. Again, we had a verypositive momentum, practically.
Well, I have been working inthe sector for more than 20
years, and it was the firsttime in 2018 that I saw the
(21:47):
door closed on us. They closedthe door on us. Thanks to these
joint collaborative efforts,thanks to everyone's insistence
on a common front, we havegradually managed to make the
relevance visible, haven't wefrom the private sector, the
relevance of clinical researchfor the health of the
population. And I would tellyou that since our
(22:10):
incorporation, I insist throughthe Federal Commission for the
protection against sanitaryrisk, aish , we have seen much
greater openness from thecurrent administration.
Recently, at the end of lastyear, digitalization, which is
one of the greatestachievements of the current
administration reached clinicaltrials. We have enormous
(22:31):
expectations. The currentcommissioner has promised a
significant reduction inprotocol authorization times,
which is something we areeagerly needing. July, we went
from authorization times of 60days or two months to more than
six months. So this has hit thesector, the industry very hard.
(22:52):
And now we are very positivethat the incorporation of the
electronic platform for thesubmission of research
protocols will help us bounceback and regain the position
Speaker 1 (23:01):
We had agreed, yes , a
Speaker 2 (23:02):
Few years ago.
Speaker 1 (23:03):
Six months at the regulatory agency is definitely
unacceptable. It is possible.
It
Speaker 2 (23:09):
Leaves us out, it leaves us out.
Speaker 1 (23:10):
And well , you see that perhaps for medical
devices, that regulatory timeof six months might be a bit
faster. Since suddenly thewhole conversation revolves
around medications. It
Speaker 2 (23:23):
Has always been like this. Right? July, I had the
opportunity. I started myclinical research career in
medical devices.
Speaker 1 (23:31):
Okay, that's great.
Sadly,
Speaker 2 (23:33):
At the regulatory level in Mexico, there is no
difference. There
Speaker 1 (23:36):
Is no difference.
There
Speaker 2 (23:37):
Is no difference.
Speaker 1 (23:38):
It goes through the same desk, the same office,
Speaker 2 (23:41):
The same line. You queue up with your ticket in
the same place. Right? Andcertainly you know very well
that the development of amedical device follows a very
different path than that of adrug. And that is poorly
understood by the committees,poorly understood by the
regulatory authority, and itcan even complicate the
(24:02):
authorization of a deviceprotocol due to this lack of
knowhow of expertise in thisvery special subtype of health
supplies.
Speaker 1 (24:11):
If you have a pharmaceutical chemist
evaluating a biomedical device,I believe the skills are not,
and their training to trulyunderstand the mechanism of
action, the mechanics, thesoftware,
Speaker 2 (24:25):
It's a different mindset that needs to be
Speaker 1 (24:26):
Adopted. Yes .
Another chip
Speaker 2 (24:28):
To evaluate a device project, the Federal Sanitary
Risk Protection Commission hasareas dedicated to medical
devices, sanitary registration,technical aspects, and
surveillance. Is there a lackof an area of experts in
medical devices for definitiveclinical research?
Speaker 1 (24:45):
Well, Miriam, we are almost at the end of the
episode. Could you share somewords to give light or hope to
these foreign companies thatwant to see Mexico as a
clinical research destination?
Because as we mentionedearlier, it might be the
perfect country in LatinAmerica to do it since it is
(25:06):
close to the USA and has thatcultural, historical affinity,
et cetera. So before weconclude, do you have anything
to say? We
Speaker 2 (25:15):
Have the patients, we have the specialist doctors,
and we have already startedresumed a dialogue with the
regulatory authority that willcreate a much more favorable
atmosphere for conductingclinical studies. So that 2024
will be a year where we willonce again see fertile ground
(25:36):
in all aspects for conductingclinical studies in Mexico,
Speaker 1 (25:39):
July . Excellent, Miriam. Well, Miriam, thank you
so much for your participationin our interview on the Latin
Med Tech Leaders podcast. Iappreciate your wisdom and that
you shared with the audienceeverything you know about
clinical research in Mexico,and I hope to see you again
very soon.
Speaker 2 (25:58):
The annual event, the grand annual event of AP is
always in May aroundInternational Clinical Trials
Day, which you know is May20th, and this year it will be
on May 22nd and 23rd, researchland 2024. So I hope to be able
to count on your attendance andthat of many of your listeners.
Speaker 1 (26:17):
Of course.
Absolutely. Well, goodbye .
Speaker 2 (26:20):
Thank you for the opportunity.
Hello. Welcome to another episode of the Latin
MedTech Leaders Podcast, aconversation with leaders in
the MedTech industry who havesucceeded in Latin America.
Subscribe on popular podcastplatforms like Apple, Spotify,
and others. Well, today we haveMiriam Serrano as our guest.
(00:31):
She is the founder andexecutive director of the
Association of ClinicalResearch Specialist
Professionals, AAIC and Mexico.
Miriam, welcome to the podcast,
Speaker 2 (00:45):
Julio. The pleasure is mine. I truly appreciate the
opportunity to participate inthis important forum and
contribute to the disseminationof what clinical research is in
Latin America, particularly inMexico. The performance was
absolutely outstanding andtruly remarkable, showcasing an
exceptional level of skill anddedication. It was without a
(01:06):
doubt,
Speaker 1 (01:07):
Miriam, well, let's start by talking a little about
you, your background, yourpast, your education, your
personal and professional life,and then we'll get into more
specific questions aboutclinical research in Mexico.
Speaker 2 (01:22):
Well, Julio, I am a pharmacist by original
training, and I studied amaster's degree in sciences
with a specialty in clinicalresearch. I am the daughter of
a pediatrician father and ananthropologist mother. And I
believe that in the end, thesetwo perspectives greatly
influenced my personal life, ofcourse, and my professional
life in both the short and longterm . Now, I will tell you why
(01:45):
after having ventured into thepharmaceutical industry, always
in the field of clinicalresearch along the way, I
realized that health regulationis truly my passion. And last
year I finished my law degree.
Speaker 1 (01:58):
Impressive.
Speaker 2 (01:59):
I finally studied a specialty in health law, and I
am currently pursuing amaster's degree in corporate
law. So I believe I havemanaged to combine the best of
two great fields, life scienceson one hand and on the other,
everything related to healthlaw, which is something I love.
Speaker 1 (02:18):
I love. Well, tell us a bit about how you came to
found the Association ofClinical Research Specialists,
professionals, AAIC in Mexico,how the genesis of the
association was in
Speaker 2 (02:31):
Mexico. There had already been associations for
years that at the time broughttogether medical directors who
back in the eighties wereresponsible for all areas
within pharma pharmacovigilance on one side,
regulatory affairs, clinicalresearch, and medical affairs.
And little by little, as youknow very well, all these areas
started to specialize andsub-specialize. And a single
(02:54):
association that addressed theissues of medical directors
became somewhat insufficient tocover, cover the entire
complexity of the topics. Thus,we saw the birth of
associations dedicated topharmacovigilance associations
dedicated to medical affairs,and as a group of friends, we
really saw the need to createan association dedicated to
pharmaceutical clinicalresearch.
Speaker 1 (03:15):
Excellent. In what year was it founded?
Speaker 2 (03:18):
May, 2012, Marx 12th anniversary this year.
Speaker 1 (03:21):
2012 . 12 years.
Fantastic. That's great. It'squite mature. No PA then .
Speaker 2 (03:26):
It has been a long journey, you know, a complex
journey, but persistence seemsto me to be the key to keeping
our clear objective of bringingtogether all of us who are
dedicated to this, contributingto the profession,
professionalization andspreading the value that
clinical research brings.
Speaker 1 (03:47):
Of course, yes.
Well, let's talk a bit aboutthe challenges you see in
Mexico regarding clinicalresearch, the opportunities,
and now let's talk a bit moreabout the work and achievements
of the association. How is it,let's say, trying to solve
those challenges and takingadvantage of those
(04:09):
opportunities? Mexico?
Speaker 2 (04:11):
Of course, Julio, Mexico is an interesting
country. I believe that to someextent it manages to combine
the best of both worlds, thedeveloped world and the
developing world. Speaking ofthe population of the country's
own epidemiology, we have avery high prevalence incidence
(04:35):
of chronic metabolic andoncological diseases, which as
you know today continue to bethe primary targets for the
development of new medicationsand medical devices. We are
truly a country with a verylarge population. We are more
than 125 million undergoing afull demographic and
epidemiological transition,increasingly younger. And we
(04:59):
are also developing disease istypical of developed countries.
In this sense, we are anattractive country because we
manage to have the populationtargeted by new developments.
We must also recognize that weare geographically privileged
in the sense of being veryclose to North America , which
(05:21):
greatly facilitates logisticsas you know very well for the
shipment to centrallaboratories and the supply of
various inputs associated withresearch. We are a country that
has great health institutionswith first class doctors and
cutting edge medical equipment,which also allows us to
participate in complex clinicalstudies. This is not so much
(05:45):
due to the population, butrather the availability of
specialists and specializedequipment, which may not be as
easily accessible in otherregions. So I would say that
this diversity places us as astrategic location for the
pharmaceutical and medicaldevice industry.
Speaker 1 (06:03):
Yes, yes, completely. Mexico is a
privileged country, as yourightly said, Miriam and I feel
and have always said, Mexico inmy opinion, is the perfect
country in Latin America forresearch, thanks to its
geographical proximity to wheremedical innovation is produced
in the USA and the hospitalinfrastructure, the population
(06:26):
density, the size of thecountry. I mean, it makes it
perfect, but Well, now we havealready talked about, let's say
it, well, we talked a littleabout the challenges. What do
you see in Mexico that makesthings difficult at this
moment? And then let's talkabout how your association is
working to contribute, improve,or solve those challenges.
Speaker 2 (06:51):
Of course. Look, I think it's no secret to anyone,
right? The National RegulatoryAuthority has faced a series of
fundamental changes that havedirectly impacted above all
competitiveness. You know thatin clinical research, time is
gold. We really need to becountries that manage to have
(07:12):
everything ready to startrecruitment in the shortest
possible time. Sadly, inMexico, we have gone from
record times where in sixmonths we managed to go from
receiving a protocol tostarting the first center to
sadly exceeding a year and ahalf in this process. So these
have been times of change,mainly regulatory challenges,
(07:35):
long approval times incommittees, and even longer
authorization times by ourregulatory authority. We are at
a historic moment, almost morethan a couple of years ago, we
became active members of theInternational Council for
Harmonization of technicalrequirements for
pharmaceuticals, for human use,ICH, through the Federal
Commission for the Protectionagainst Sanitary Risks. And it
(07:58):
has been a real challenge yousend to implement a work plan
that allows us in the medium tolong term to ensure full
implementation of the ICHguidelines. So I would say that
the challenges are mainlynormative and regulatory.
Precisely
Speaker 1 (08:14):
Perfect. And I also see other challenges, correct
me if I'm wrong, but let's talka little bit about the
healthcare system in Mexico.
Let's talk about the IMSS.
Let's talk, well, people saythat in Mexico there are five
healthcare systems. Let's talka little about that so the
(08:35):
audience understands how thehealthcare system works in
Mexico, where the public andprivate patients are, please .
Speaker 2 (08:44):
Sure. Excellent question. And what you heard is
a reality. Sadly, Mexico doesnot have an integrated health
system in Mexico. The right tohealth protection is still tied
to having a job, to being anactive worker, so that all
those who do not have formalemployment, do not have access
(09:05):
to public health services andhave to seek alternatives.
Often private clinics, whichobviously make healthcare more
expensive in this regard, Ithink you have said it very
precisely. Speaking of clinicalresearch centers in Mexico, we
have two large worlds thatcoexist July. On one hand, we
(09:25):
have large public institutionsthat concentrate the
population, but the demand forhealth services is overwhelming
and exceeded. The medical staffdoes not have time to dedicate
to clinical researchactivities. We have these
places that have specialistdoctors, that have a world of
(09:46):
patients that have high techequipment, and what they lack
is the time to invest anddedicate themselves to
pharmaceutical clinicalresearch, which as you know, is
not something that can be donein spare moments or between
consultations. On the otherhand, we have private research
centers where they have thetime and trained personnel to
(10:07):
dedicate to these complexactivities, but what they lack
are patients, right?
Speaker 1 (10:13):
Yes, yes, indeed .
Yes, yes.
Speaker 2 (10:16):
We live between these two extremes. Trying to
reach a balance that in reallife becomes very complicated.
The first centers to becomeoperational are the private
ones, as they do not have toget involved in so many complex
institutional andadministrative processes. They
are not the first to start, butthey have the lowest volume of
(10:37):
patients. The public centers,which are the ones with the
patient population, are thelast to arrive in the
recruitment race. And well, wehad to overcome several
administrative complexitiesalong the way , and although
they are already the ones withthe patients, many times
globally, time surpasses us andwhen they're ready, well, the
(10:57):
sample size and the goal havealready been
Speaker 1 (11:00):
It's already already very late. That that is good.
So what percentage would yousay of the population is in the
public system and in theprivate system, let's say? I
don't know.
Speaker 2 (11:10):
Sure. Generally speaking, 80% of the population
has access to publicinstitutions and 20% has access
to private institutions, right?
That's approximately theproportion. And
Speaker 1 (11:22):
How, how, how do you get access to private
institutions because you have ajob and you pay extra thousand
to be able to go to the privateone. Is that how it works?
Speaker 2 (11:33):
Very well. I would also need to differentiate
between private medicine andprivate medicine. There are of
course, large tertiaryhospitals, which are very
expensive and can be accessedprecisely by acquiring a major
medical expenses insurance.
Many jobs, especially those inmultinational companies, offer
(11:55):
benefits such as medicalexpense insurance for the
worker and their immediatefamily. But we must also
recognize that there is anothersector of private medicine,
which is that of the informalworker, the man who sells at a
food stall. Yes. Right, ofcourse. And that does not have,
let's say, access, they reallydon't have it. Exactly. They
(12:17):
don't have access to thatpublic healthcare , but neither
to that private healthcare ,which depends on medical
expense insurance. And so theyturn to a type of private
clinics adjacent to pharmacies,usually providing only primary
care. And interestingly, anecosystem has developed in a
fragile balance July, becausethese people who do not have
(12:39):
access to social security,let's say to the social
security who do not have accessto high specialty private
medicine, what they have leftis to go to those clinics
adjacent to pharmacies wherethey can surely get a general
practitioner consultation for$10. But the moment that
patient needs specialized care,that's where we are in trouble,
(13:00):
because they definitely wouldno longer have access to that
specialized medicine ineconomic terms.
Speaker 1 (13:06):
They have to go into debt, et cetera, borrow money
from family, friends, or getgifted money, et cetera. Yes ,
I understand now. That's
Speaker 2 (13:14):
Right. A familiar and social situation ultimately
very complex.
Speaker 1 (13:19):
But then, is this the way I am trying to
understand the way a publicpatient from the public system
could move to the privatesector ? Aman ,
Speaker 2 (13:29):
I tell you that these private research centers,
which perhaps in the USA , areknown as site management
organizations, establishments,that actually invite doctors
who work in those publicinstitutions and have access to
patients. And then they say,well, let's do this protocol.
But instead of doing it at theNational Institute of X,
Speaker 1 (13:52):
Yes,
Speaker 2 (13:53):
We do it at this private research center.
Speaker 1 (13:56):
Okay, okay. I mean, it depends on creating a
network of referring doctorswho refer patients.
Speaker 2 (14:05):
Exactly. And
Speaker 1 (14:07):
How interesting. I
Speaker 2 (14:08):
Don't know if it's a common problem in Latin
America, but the professionaljealousy of doctors can
influence them . Yes . Not torefer the patient. I think this
(14:32):
leads me to directly talk aboutanother challenge. Doctors in
Mexico, specialist doctorsoften listen and participate in
research activities, but veryacademic research, which does
not adhere to the samestandards as research aimed at
developing and bringing a newhealth product to the market.
(14:54):
So these are doctors who, yes,maybe decide to pursue a
postgraduate degree, a master'sin science, a doctorate in
science, and who take a lot ofcourses in research
methodology, biostatistics,bioethics. But in reality, this
regulatory part, which is soimportant in clinical research,
which aims to knock on the doorof the FDA , the EMA or any
(15:19):
regulatory authority, needs todemonstrate full compliance
with international standards,good clinical practices and
local regulations specific toclinical research. All of this
is something unknown to adoctor. These are not topics
covered by the undergraduatecurriculum and sadly neither by
(15:39):
the curriculum of medicalspecialties or postgraduate
programs. Julio. Then inreality, the reason a
specialist doctor ends upparticipating in clinical
studies sponsored by thepharmaceutical industry is
usually because they hear aboutit, they are given a hand, and
it is the pharmaceuticalindustry that ends up training
(16:00):
them in what should be a commonstandard for conducting
research on human beings.
Speaker 1 (16:06):
Well, Miriam, let's talk a bit about your
association. How you aremitigating these problems or
challenges, how you are tryingto solve them, and what is your
vision for the association inthe next three to five years?
Speaker 2 (16:21):
Of course. Thank you. Julio. A pH was born with
the objective of contributingto the professionalization of
human resources in researchcenters, in research ethics
committees in thepharmaceutical industry itself,
CROs, and even in regulatoryauthorities. It has been a
(16:43):
complex issue throughout thisdecade , a bit more of breaking
ground, opening forums to startlinking, getting to know each
other, understanding the needs,what the industry needs from a
researcher, what a researcherneeds from the industry, what
we need from a committee, whatwe need from the authority
(17:04):
open, these communicationchannels that allow all actors
to be effectively andefficiently linked. We have
achieved this through variousspaces. Traditionally, we have
an annual event where we bringeveryone together and try to
open agendas that allow us tostay very updated on topics,
very local issues, perhapsregional, but always looking at
(17:27):
how the world is in globalterms. So we have annual
events, we have monthlyacademic sessions, we have
periodic courses that we opentwice a year, very dedicated to
particular topics , bioethics,health regulation, contracts in
clinical research courses todevelop people who work in the
(17:49):
areas of quality assurance,pharmacovigilance. The
intention is always to providecontinuous training,
recognizing the absence of thistraining. Since our initial
stages of education, Julio, wehave also launched initiatives
like a podcast, which aims tomake it attractive to anyone,
not just to gather experts, butto make known outside our
(18:12):
network, which is relativelysmall compared to other
sectors, the value of researchin contributing and bringing
health solutions to society. Sowe have indeed sought to go
beyond our own collaborationnetwork and bring clinical
research closer to the generalpublic.
Speaker 1 (18:33):
Very good response.
Let's talk a little about MIF .
How do you work with MIF ?
Because I see that they arequite relevant in Mexico. They
are very well structured andare also moving in the
direction of promoting clinicalresearch in the country. Do you
work in concert? Like how isthe relationship? Of course,
Speaker 2 (18:53):
There are several associations with which we have
a very close collaboration. TheMexican Association of
Pharmaceutical InnovationIndustries is one of them. amif
. Amif brings together theinnovative and pharmaceutical
industry. Epic Socio does notgroup companies. We group
individuals, professionals,however, we have an exact
(19:17):
individuals. However, we have acommon agenda. So we have close
work. We have tried to supportin meetings, in forums,
organized by MIIF andconversely in APEC forums,
bringing MIF , always beingable to present the
perspective, the vision of theindustrial sector. And that is
(19:38):
critical. It is critical. So ofcourse we have spaces for
exchange and collaborationwhere what we seek is to create
synergy. There is me , theNational Chamber of the
pharmaceutical industry, whichin addition to the
transnational innovationindustry also includes the
national industry. Wecollaborate with other
(19:59):
professional associations suchas the Mexican Association of
Pharmacovigilance, the MexicanAssociation of Health
Regulation Professionals, theDifa Des of Mexico, the
equivalent of COTA in Argentinaand Akram in Mexico. And always
looking for areas ofconvergence where we are very
(20:19):
aware that we can buildsynergies. It's not the same to
knock on a regulatory agency'sdoor 10 times as it is to knock
with the voice of 10associations. So we really seek
to close ranks and have commonobjectives. While each of us
may differ in certain aspects,setting a common agenda will
(20:40):
truly allow us to have a voicethat is more audible to the
authorities.
Speaker 1 (20:45):
Now that you mention authorities, look, it is a very
relevant and important topic inthis chain of actors. How do
you see the attitude of theMexican government to bring
foreign investment intoclinical research? Do they see
the potential? How has theresponse been? Very
Speaker 2 (21:03):
Well, very well.
July. This administration hasnot been easy. Like many other
countries in Latin America, wetransitioned to a government
with a different ideology,right? This change in
administration touched verysensitive areas regarding what
this government private sectorcollaboration means. I would
(21:25):
say that it practically took usfour years, four years from
2018 to 2022 to find spaces fordialogue with the Usan
authority. Again, we had a verypositive momentum, practically.
Well, I have been working inthe sector for more than 20
years, and it was the firsttime in 2018 that I saw the
(21:47):
door closed on us. They closedthe door on us. Thanks to these
joint collaborative efforts,thanks to everyone's insistence
on a common front, we havegradually managed to make the
relevance visible, haven't wefrom the private sector, the
relevance of clinical researchfor the health of the
population. And I would tellyou that since our
(22:10):
incorporation, I insist throughthe Federal Commission for the
protection against sanitaryrisk, aish , we have seen much
greater openness from thecurrent administration.
Recently, at the end of lastyear, digitalization, which is
one of the greatestachievements of the current
administration reached clinicaltrials. We have enormous
(22:31):
expectations. The currentcommissioner has promised a
significant reduction inprotocol authorization times,
which is something we areeagerly needing. July, we went
from authorization times of 60days or two months to more than
six months. So this has hit thesector, the industry very hard.
(22:52):
And now we are very positivethat the incorporation of the
electronic platform for thesubmission of research
protocols will help us bounceback and regain the position
Speaker 1 (23:01):
We had agreed, yes , a
Speaker 2 (23:02):
Few years ago.
Speaker 1 (23:03):
Six months at the regulatory agency is definitely
unacceptable. It is possible.
It
Speaker 2 (23:09):
Leaves us out, it leaves us out.
Speaker 1 (23:10):
And well , you see that perhaps for medical
devices, that regulatory timeof six months might be a bit
faster. Since suddenly thewhole conversation revolves
around medications. It
Speaker 2 (23:23):
Has always been like this. Right? July, I had the
opportunity. I started myclinical research career in
medical devices.
Speaker 1 (23:31):
Okay, that's great.
Sadly,
Speaker 2 (23:33):
At the regulatory level in Mexico, there is no
difference. There
Speaker 1 (23:36):
Is no difference.
There
Speaker 2 (23:37):
Is no difference.
Speaker 1 (23:38):
It goes through the same desk, the same office,
Speaker 2 (23:41):
The same line. You queue up with your ticket in
the same place. Right? Andcertainly you know very well
that the development of amedical device follows a very
different path than that of adrug. And that is poorly
understood by the committees,poorly understood by the
regulatory authority, and itcan even complicate the
(24:02):
authorization of a deviceprotocol due to this lack of
knowhow of expertise in thisvery special subtype of health
supplies.
Speaker 1 (24:11):
If you have a pharmaceutical chemist
evaluating a biomedical device,I believe the skills are not,
and their training to trulyunderstand the mechanism of
action, the mechanics, thesoftware,
Speaker 2 (24:25):
It's a different mindset that needs to be
Speaker 1 (24:26):
Adopted. Yes .
Another chip
Speaker 2 (24:28):
To evaluate a device project, the Federal Sanitary
Risk Protection Commission hasareas dedicated to medical
devices, sanitary registration,technical aspects, and
surveillance. Is there a lackof an area of experts in
medical devices for definitiveclinical research?
Speaker 1 (24:45):
Well, Miriam, we are almost at the end of the
episode. Could you share somewords to give light or hope to
these foreign companies thatwant to see Mexico as a
clinical research destination?
Because as we mentionedearlier, it might be the
perfect country in LatinAmerica to do it since it is
(25:06):
close to the USA and has thatcultural, historical affinity,
et cetera. So before weconclude, do you have anything
to say? We
Speaker 2 (25:15):
Have the patients, we have the specialist doctors,
and we have already startedresumed a dialogue with the
regulatory authority that willcreate a much more favorable
atmosphere for conductingclinical studies. So that 2024
will be a year where we willonce again see fertile ground
(25:36):
in all aspects for conductingclinical studies in Mexico,
Speaker 1 (25:39):
July . Excellent, Miriam. Well, Miriam, thank you
so much for your participationin our interview on the Latin
Med Tech Leaders podcast. Iappreciate your wisdom and that
you shared with the audienceeverything you know about
clinical research in Mexico,and I hope to see you again
very soon.
Speaker 2 (25:58):
The annual event, the grand annual event of AP is
always in May aroundInternational Clinical Trials
Day, which you know is May20th, and this year it will be
on May 22nd and 23rd, researchland 2024. So I hope to be able
to count on your attendance andthat of many of your listeners.
Speaker 1 (26:17):
Of course.
Absolutely. Well, goodbye .
Speaker 2 (26:20):
Thank you for the opportunity.
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