July 2, 2025 • 53 mins
Are you living with Parkinson's and eager to understand how new treatments get from research labs to patients? Or perhaps you're simply fascinated by the future of medicine? In this groundbreaking episode, we sit down with Julio Martinez-Clark, the visionary CEO of Bioaccess, a leader in accelerating clinical trials and medtech innovation globally.
Julio reveals how Bioaccess is revolutionizing the speed and cost-effectiveness of medical device and biopharma studies, particularly in strategic emerging markets like Latin America, Eastern Europe, and Australia. Discover how their unique regional expertise is helping to bring life-changing therapies to market faster, ultimately benefiting conditions like Parkinson's.
In this episode, you'll learn:
- How Bioaccess is tackling the traditional challenges of lengthy and expensive clinical trials.
- The strategic advantages of conducting clinical research in emerging markets for faster patient recruitment and streamlined regulatory approval.
- The transformative power of AI in healthcare: how artificial intelligence is being deployed by Bioaccess to optimize everything from patient identification to data analysis and trial design.
- The ethical considerations and exciting future potential of AI in advancing medical innovation and delivering new treatments.
- Julio's insights on global health impact and fostering equitable access to cutting-edge medical technologies.
This conversation is a must-listen for anyone invested in the future of healthcare, from patients and caregivers seeking hope to medical professionals and innovators driving change. Join us to explore how accelerated clinical development is paving the way for a healthier, more exceptional life.
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Disclaimer: This podcast is for educational purposes only is not intended to treat or diagnose Parkinson's Disease. Please ensure that you are following the treatment plan developed by your doctor. Please ensure before starting anything new you get approval from your doctor. The information being provided is based on my own personal experiences and does not guarantee that it will benefit everyone.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:10):
Hello and welcome to Live Parkinson's Live an
Exceptional Life.
I'm your host, chrisKustenbader, and I've been
living an exceptional life withParkinson's for the past 15
years.
The purpose of this podcast isto help as many people as
possible living with Parkinson'sto lead a great quality of life
.
Now, today we're diving into atopic Parkinson's to lead a
great quality of life.
Now, today we're diving into atopic that's absolutely crucial
for the future of healthcare,especially for conditions like
(00:31):
Parkinson's.
And to guide us through thisvital conversation, we have an
extraordinary guest.
Joining us is JulioMartinez-Clark, the insightful
CEO of BioAccess.
Julio is a true visionary in theworld of global clinical trials
, with deep expertise in medtechand biopharma.
His company, bioaccess, is on amission to accelerate medical
(00:51):
innovation by focusing onbringing clinical research to
emerging markets in regions likeLatin America, eastern Europe
and Australia.
What makes BioAccess soimpactful?
It's our commitment to speed,cost-effectiveness and
leveraging unparalleled regionalexpertise to get life-changing
(01:11):
treatments to patients faster.
Today, we'll explore how hiswork is not only transforming
clinical trials, but also howcutting-edge technologies,
particularly AI, are playing apivotal role in this exciting
evolution.
Ai are playing a pivotal rolein this exciting evolution.
So get ready for a fascinatingdiscussion on how we can truly
live an exceptional life byunderstanding the very pathways
that bring us new hope andtherapies.
(01:32):
So let's welcome JulioMartinez-Clark.
Thank you for joining us.
For those of you that may notbe familiar with you, can you
give us a little bit of abackground on bioaccess and its
core mission in clinicalresearch?
Speaker 2 (01:44):
Thank you, chris, for that very nice introduction.
I feel honored, privileged tohave that introduction.
It's truly a pleasure to behere with you and share with the
audience the journey that we'vehad at BioAccess and the
breakthrough research that weare doing in different countries
(02:04):
around the world.
So, as a matter of introduction, I was born and raised in
Colombia, south America.
I moved to the US about40-something years.
I now live in Miami and that'sthe base of our company and the
journey the bioaccess journey,really started with my brother,
pedro.
(02:24):
He trained at Harvard as acardiologist and then as an
interventional cardiologist andthen moved to Miami to become a
professor at the University ofMiami.
And he met his mentor, drWilliam O'Neill, who is
considered one of the topauthorities in the world in
interventional cardiology, andthey worked together for many
(02:45):
years and that work includedadvising many US medical device
startups that were developingadvanced cardiovascular
technologies or devices and theytraveled with them around the
world doing trials, first inhuman trials, and they quickly
realized that the CRO industrywas very fragmented but there
(03:08):
was really no CRO in the worlddedicated to first-in-human
clinical trials, at least formedical devices, at that time.
Now we have expanded to otherareas biopharma, radiopharma but
medical device has been ourfocus for many, many years.
Because we saw the opportunity.
We saw a problem in theindustry that needed to be
(03:28):
addressed and Dr Roneo and Pedrocame up with the idea to create
a company outside of theuniversity ecosystem.
Because we really startedinside the university.
It was a small desk in theinternational patient department
.
You know a lot of internationalpatients, especially from Latin
America, traveling to Miami toreceive advanced medical care at
the University of MiamiHospital and that small desk was
(03:50):
doing the work of a CRO.
It wasn't really set up forthat.
So that's why Dr O'Neill andPetro decided to create
BioAccess and then I took theleadership role in the company.
I got my MBA in Boston.
I got my degree in electricalengineering in Colombia.
I worked for a couple of globaltelecom and networking
(04:10):
companies Lucent, nortel.
I did business all over theworld in Europe, in North South
America.
I was kind of a good fit forwhat Pedro and O'Neill wanted to
build and fast track.
Almost 20 years later,bioaccess is now the leading
first-in-human contract researchorganization specifically
(04:30):
helping startups, which is aunique niche because a larger
pharma has different needs thana small startup of three people
and just a few million dollarsin the bank.
With a breakthrough technology,you have to become a company.
Bioaccess, the CRO, has toadapt to the needs of this
clientele.
So we consider ourselves astartup.
(04:52):
We consider ourselves verynimble, very adaptable, very
dynamic.
We're a small team of about 40people, but we have a global
reach that can help thesestartups bring these innovations
to market.
Speaker 1 (05:04):
Yeah, so you have a strong focus on really
accelerating clinical trials.
Can you explain how you do itand what sets you apart from a
lot of the other companies?
Because I've worked years agoin clinical research, monitoring
studies and things and a lot oftimes it was a slow, tedious
process but you've been able todo it a lot faster in terms of
(05:25):
patient recruitment and otherthings.
So can you talk a little bitabout that?
Absolutely.
Speaker 2 (05:30):
Chris.
What happens is that the natureof our clientele demands that
we deliver speed.
That's really what we sell.
We sell speed, we promise andwe deliver speed.
Speed, we promise and wedeliver speed.
Because if you understand thenature of the startup community,
(05:50):
you're going to quickly realizethat speed is of the utmost
importance for these companies.
And the reason is this when,when people talk about clinical
trials, cros, they usually referregular people on the streets.
They usually refer to bigpharma and medtech companies.
(06:33):
The journey of a medical deviceor biopharma or radiopharma
startup usually starts at auniversity.
They have research labs thatproduce intellectual property, a
patent for a new molecule, fora new medical device, etc.
So this patent needs to bedeveloped right, because
(06:56):
innovation does not meananything if it doesn't translate
into a commercial product thatbenefits humanity and impacts
lives.
So a patent does nothing in adrawer in an office in a
university.
So the university is alwaysseeking entrepreneurs who can
(07:18):
tap into the potential of theinnovation and can build, have
the leadership skills to build ateam around it, can raise funds
and can develop the innovationto the point where it is ready
to be tested in humans rightBefore it gets tested in humans,
it needs to go throughpreclinical lab testing, animal
(07:42):
testing, cadaver testing and, ofcourse, the big moment, the
pivotal moment, is when theytest or they validate the safety
and efficacy of the innovationin a live patient, a live human.
And that's really a pivotalmoment of value creation for the
company and the evaluation ofthe company increases
(08:03):
dramatically if the results ofthat first in human trials are
good.
Because the only purpose ofthese companies I mean these are
investors.
Right, everybody's for themoney, of course.
Everybody wants to benefithumanity, everybody have noble
means, everybody wants to impactpeople's or patients' lives,
(08:24):
but they all want to make somegood money.
So they invest money and timeand resources in the startup and
they have the hope of sellingthe startup to a larger buyer,
right Like Medtronic, bostonScientific, or Merck or Pfizer
in the case of Pharma.
So that's really the cycle ofinnovation.
That's how the big players getfed with newer technologies,
(08:48):
newer products and remaincompetitive in the market.
So that's the cycle ofinnovation.
So, if you analyze the needs ofthese startups, they have
investors breathing on theirneck, they have investors
demanding results, they havebusiness plans and they have
timelines assigned to thosebusiness plans.
So those milestones need tohappen in certain dates, and
(09:11):
that's why time is of theessence for these companies.
They need to have a patient ona table for the device to get
implanted and tested as soon aspossible, so that they know if
the device works or not, theyknow if they have to make
changes to their prototype andif so, they have to raise more
funds and continue their journey.
Time is of the essence becausethey need to get acquired
(09:32):
eventually and investors have toget their money back.
Speaker 1 (09:36):
Would you be involved in all three phases?
So phase one, two and threeclinical trials for these
startup companies then no, weget involved on.
Speaker 2 (09:44):
Usually we get involved in phase one.
Of course we can do phase two,we can do phase three, but
that's not really how the marketknows about us and you have a
lot more competitors in laterphases.
So we prefer to navigate in ablue ocean where we have no
competition because we havebecome so laser focused on first
(10:07):
in humans that we have becomeprobably the best in the world
on this specific niche.
So, yeah, usually we getinvolved in first in human
trials and and the way we wemake them happen faster is by
looking at countries that havefriendly regulations to get them
approved faster and also doinga very diligent job in finding
(10:29):
those investigators inside thosecountries that have the patient
recruitment potential tocomplete the trials faster so
you're able to leverage in yourbackground in Latin America,
eastern Europe and Australia.
Speaker 1 (10:41):
So you've got probably a great database of
patients to pull from to helpyou with your studies.
Is that correct?
Is that what helps you with thespeed aspect?
Speaker 2 (10:52):
The database is more of investigators, not
necessarily patients.
Investigators who can tell usif they can recruit patients
fast enough or at the pace thatwe need for the study.
We have developed a very largedatabase.
We have a large network ofconnections all over Latin
America, australia, easternEurope and as soon as I receive
(11:14):
a study within hours, I can knowwhere to go, what hospital has
the patients, what investigatorsis willing and able to lead the
study, would you say.
Speaker 1 (11:24):
it typically takes from when you are presented with
the study till it's recruitedand then the results are
compiled, and then you can goback to the company and say
here's what the results are.
Speaker 2 (11:36):
Yeah, Really depends on the country and depends on
what the company is looking for.
On the best case scenario,chris, we can get a site
activated in Panama in about 60days, in El Salvador also in
about 60 days, in Chile also inabout 60 days.
This is record Globallyspeaking.
(11:58):
This is record times within theLatin American region.
We can do the same in Serbia,in the Balkans.
I mean fast approvals in thosecountries as well, australia as
well, even though there's a newproposed law that may change
that.
But we can get studies approvedwithin 60 days and patients
probably recruit a month later,because you know it takes time
(12:20):
to get them come to the site,sign the informed consent and
all that.
But probably 90 days aftersubmission to the IRB we should
have our first patient.
Speaker 1 (12:30):
Yeah, that's exciting because typically the
traditional model is it's slow,it takes a long time to set up
and, being on both sides of it,I participated in a number of
clinical trials here in the USas a patient and it was a year
and a half.
Well, the one study was asix-month double-blind
placebo-controlled trial andthen it went to open-label,
(12:51):
which was another year and ahalf, so it was a long phase
three clinical trial.
So it sounds like the modelyou're using.
Is it something that can beapplied or expanded beyond the
countries that you're typicallyin, or is it the regulatory
environment that can really slowyou down?
Speaker 2 (13:09):
That's a very interesting question, chris.
There are many factors whytrials take too long in the
United States for sites toactivate, to get activated
patients recruited, and all that.
There are many factors.
One factor is that in theUnited States, that there are
many factors.
One factor is that in theUnited States the way the
healthcare system works is thatwe have this consolidation in
(13:30):
the hospital systems.
We have large hospital systems.
You have very few independentsmall hospitals.
Right, you have HCA and allthese big players that have HCA.
I think I was reading the otherweek it has 184 hospitals
across the United States, 2,000locations including those 185
(13:55):
hospitals.
So imagine you're trying to setup a meeting inside HCA, inside
the hospital system, for atrial, hca inside the hospital
system for a trial.
So it will take you 20 phonecalls, 20 emails to probably
land one day before a meetingand then the meeting happens and
(14:16):
then the bureaucracy, and thenyou have to talk to XYZ person
and then the other person, thenanother meeting just to set up
the study, not to mention theIRB approval process, because
these institutions arerisk-averse.
Speaker 1 (14:26):
Right, that's true.
Speaker 2 (14:27):
They don't want to get into studies where a patient
may be harmed or somethingrisky studies, not to mention
forcing humans.
They don't want to get inforcing humans at all right,
because of the reputationaldamage and the PR damage.
So I've experienced that myself, so I know exactly what I'm
talking about.
One is the aside.
So that's one factor right.
(14:47):
The other factor is the FDA.
It's uncertain, and this is theword that my clients have used.
The uncertainty at the FDAlevel is just unbearable for a
startup.
You need to give investorscertainty.
By this date I'm going to havethis milestone.
If you don't have thatcertainty at the FDA, especially
now with the politicalenvironment, the layoffs et
(15:09):
cetera, then it takes too longto get a study approved in the
United States.
So that's why companies,especially startup companies
biopharma, medtech, radiopharma,surgical companies, startup
companies, three people, $3million in the bank they need to
go overseas to find quickerways to get sites activated and
patients treated.
Speaker 1 (15:28):
Okay, Well, with Parkinson's there's really
people take medication, but thenthere's also the medical device
piece where people get the deepbrain stimulation surgery.
Is there a difference in speedin terms of testing a compound
for a new medication versus amedical device when you're doing
(15:48):
it in these other countries?
Speaker 2 (15:49):
Not really.
Not really, although theregulations are a lot more
stringent for molecules, for newdrugs, than devices, because
devices are kind of newer.
So the regulation, the pace ofupdating regulations, is not the
same as the pace of theindustry.
So usually you find countriesthat have very, very strong
(16:13):
regulations for pharma, formolecules, but not so much for
medical devices.
So it's usually a littlequicker to do a medical device
study approved.
But in general I wouldn't saythat's the case.
I mean, for example, in Panama,in Salvador, there's really no
distinction, there's very littlered tape, keeping quality and
(16:35):
ethical standards.
I mean the fact that theregulator approved faster
doesn't mean that it's not aquality or ethical study.
This is very, very importantbecause our job is to deliver
quality data and ethical data.
We wouldn't be in business if wewere involved in countries with
regulators that are not reallydoing their homework right and
(16:58):
where sites are not followinginternational ICI-GCP standards.
So to answer your question morespecifically, I will say that
it doesn't make much difference.
Sometimes, depending on thecountry, medical device studies
are approved a little quicker.
But no, I mean it's.
And also it's also important tounderstand that in these
countries, on top of theregulator being efficient.
(17:21):
For example, if I pick up thephone and I call El Salvador,
the regulator is going to answerthe call.
They're going to have a meetingwith me because they want to
bring trials to the country.
It's not like in the US.
You have to apply for a pre-submeeting and wait until that
happens.
Probably the meeting is sixmonths out.
That doesn't happen in ElSalvador.
So that's one thing.
(17:43):
The other thing is that patientsin Latin America are developing
economies because of the waythe health care system works,
where on paper they have theright to access the system and
be treated with dignity but inreality that's not the case and
offer that participation to thepatient.
(18:04):
The patient will gladly say yesbecause they will receive an
immediate benefit, which isaccess to the system.
They're going to have all theblood tests that they haven't
had done in five years.
They're going to be able toaccess a specialist for their
condition, a cardiologist, aneurologist, who is somebody
they haven't been able to see infive years because the system
makes it difficult for them toaccess these cardiologists or
(18:27):
these specialists.
So they're already receiving animmediate benefit.
So they want to participatefaster in these trials?
Speaker 1 (18:33):
Do the startup companies that you work with?
Do they request a specificregion that you test this in, or
are you free to go in order forthe speed aspect?
Maybe you have a betterrelationship in Latin America
than you do in Australia, so dothey give you the freedom to
decide where to find the studyinvestigator and run the study?
Speaker 2 (18:52):
Yes, they give us the freedom, chris.
However, if you look at thesethree areas in the world,
there's really no compellingreason, except the one that I'm
going to mention in a minute,why you will go that far to
Eastern Europe or Australia anddeal with the time difference,
(19:13):
the flight times and thedifferent cultures.
If you have great options inLatin America where the flight
time is short I mean from Miami,you're two and a half hours
from most countries, same timezone and similar culture.
So what we do is we offeroptions.
(19:35):
But if you tell me, julio, yes,panama is great, salvador is
great, dominican Republic isgreat, colombia is great, what
you offer in Latin America isgreat.
But I love Dr Smith in Macedoniaor in Australia.
He went to school with me.
I think he's the best candidateto lead the study.
(19:56):
Sure, then we can set up thestudy in Australia If you have a
compelling reason to go toAustralia and have Dr Smith as
your investigator.
That happens a lot.
Yesterday I had a call with acompany, a US company, that
wanted to do a study in theDominican Republic and they have
a willing and able investigatoralready identified in the
Dominican Republic, probablysomebody who they knew from the
(20:17):
industry, or they went to school, with whatever reason.
Sometimes the sponsor comes tome with a specific country in
mind.
Speaker 1 (20:24):
Now okay, is it your organization or the sponsor?
Because most times when you'rerunning a study, there's always
some type of clinical researchassociate or something that goes
and monitors the study andlooks at the study paperwork to
make sure that the protocol isbeing followed.
Is that part of your group oris that part of the sponsorship
(20:45):
group?
Speaker 2 (20:46):
Yes, it's usually part of our group.
That's a service that weprovide.
However, sometimes the sponsorwants to have a separate group.
That happens occasionally butit's not that common.
But it's usually our groupbecause we're independent.
We are in the middle betweenthe sponsor and the site so we
(21:06):
can carry out all theseactivities independently,
without any vested interest.
Speaker 1 (21:11):
Now, do you have people?
Are they in the particularcountries that you deal with,
the people that work for you,the clinical research associates
, or do they just happen thatthey travel when the study is
set up?
Speaker 2 (21:21):
A little bit of both.
A little bit of both.
Yes, no-transcript.
(21:52):
Until the day of theimplantation of the devices,
until the day we're ready toimplant the devices, dealing
with the sponsor, having weeklymeetings with the sponsor, he or
she knows the protocol by heart.
So it doesn't make any sense ifwe are ready to implant the
device in the case of medicaldevices, if we're ready to
(22:14):
implant devices.
The implantation of a medicaldevice on a first human trial is
a big big deal.
The first patient is a big deal.
So the ceo of the companytravels from the States, the
biomed engineer who designed thestudy or designed the device,
and three more people, theproctor.
Usually they have a proctor, amedical advisor from a top
university or hospital in theUnited States John Hopkins, et
(22:37):
cetera.
They all travel together.
So usually the team coming fromthe US is about five people, is
about five people.
And then we have our projectmanager.
The physician that I justmentioned also travel with them
to the hospital to be in the ORwhen the implantation happens,
because he's the best individualto lead the process, the
(22:57):
project.
So it doesn't make any sense tohave somebody local who has no
clue about what's going on withthe study.
He or she is not going to keepup with the study or going to be
updated with the study just byreading something three days
prior to the implantation.
Speaker 1 (23:11):
So really, depending on the situation Now in terms of
speed is important and I knowyou also do a quality job.
So at the end, at theconclusion of the study, how
long does it take you to be ableto take from when the study is
initiated at the investigativesite?
They get the data and it'ssummarized and you get it back
to the startup company so thatthey know is this a viable
(23:34):
option to continue movingforward.
Speaker 2 (23:36):
Well, the data is updated, Chris, to the
electronic data capture platformin real time.
In real time I mean the momentthe first patient gets in, that
data is uploaded, the CRF, thecase report form, is electronic.
We don't use paper anymore.
I mean the study coordinators,hate paper, investigators, hate
(23:56):
paper.
So yeah, it's real time data.
So as we go along recruitingpatients, the database gets
updated and the sponsor can doall the biostat analysis that
they desire and they knowexactly if the trial is going in
the right direction or not.
Speaker 1 (24:15):
I just want to switch gears a little bit now.
Ai is always it's the bigbuzzword, not only in society,
but also in healthcare.
Is that something that youimplement as part of your
process for setting up ascheduling and setting up a
study?
Is there any AI used in thatprocess?
Speaker 2 (24:36):
Well, as you said, it's a word that is widely used
now in the industry, but I wouldsay that depending on where in
the industry you look into,you're gonna have kind of
different applications.
In the CRO industry is insideour company.
(24:58):
We are using AI to analyzedocuments.
That's something that isbringing superpowers to our
project managers, for examplewith translations.
Now before we had a doctor, aphysician, sitting in a computer
for I don't know how many days,just comparing the english
(25:18):
original version of the protocolto the spanish original version
.
Now that's done with a.
So it's speeding up our processof putting together the right
documents for studies beforesubmission, writing letters to
sponsors, to regulators.
I mean, that's something thatwe are now doing with AI, so
it's helping us a lot as aserial.
(25:40):
On the hospital side, I've seenapplications where imagine you a
large hospital in Colombia andthey are running 50 different
studies how do you know when apatient comes in in the regular
consult of the hospital, not inthe research department?
How do you know that that's agood candidate for the research
(26:01):
department to be recruiteddepartment to be recruited right
?
So you use AI tools to matchthe inclusion and exclusion
criteria with what is in the EMRelectronic medical record of
the regular activity of thehospital.
So that's something that, withhumans, is almost impossible to
do, because you have to be ontop of all the nurses, on top of
(26:21):
everybody in the hospital, allthe specialists.
Hey, dr Smith, remember that wehave this trial, and if you
have 50 trials, he's not, she'snot going to remember that, or
the nurse is not going toremember that.
So, with AI getting into theEMR and matching the daily
activity of the hospital withwhat the research department is
doing, then you're going to havealerts, you're going to have
(26:42):
flags immediately at theresearch department.
Listen, there's a person thatjust came through the emergency
department.
He's a good candidate for thisXYZ study that you're running.
Speaker 1 (26:54):
So do you have good applications, somebody that's
like an AI specialist that sitsin, you know, because a lot of
it's prompts, so you have to putin specific prompts to get out
the specific data you want.
So is it?
It's now an agent.
Speaker 2 (27:07):
It's now an agent.
You can build an agent for that.
That's science fiction.
Yes, we're working on thatright now with our research
department.
We have research department ora research site in Miami.
My brother runs a very largemedical practice cardiovascular
practice and we're doing exactlythat.
The other application, chris,that is worth mentioning here
for the audience is patientrecruitment.
(27:28):
You know is a challenge inevery clinical trial and our job
is to make that faster andfaster.
So with AI we can now take avery complex clinical protocol
right of 100 pages that'susually the length of our
clinical protocol, as you know.
You can now reduce that to aninfographic that you can use in
(27:54):
three different ways.
Now you can explain the studyin simple language to the study
coordinator, that is, the headof the feasibility department of
the hospital, because everytime there is a new study it
usually lands in the feasibilityinbox of the research
department and that individualis not a physician.
(28:15):
Even if he or she is aphysician and the study is in
oncology and he's a generalpractitioner, he or she is not
going to understand thecomplexity of the oncology study
.
Right, that individual needs tobe fed with simple language
information so that he or she,in the feasibility analysis of
the study, can understand thescope of the study and can guide
(28:37):
the study to the rightinvestigator and say with
certainty, yes, we can recruitpatients, we have this type of
patients.
But if he or she doesn'tunderstand the study, then the
studies aren't going to getevaluated for feasibility at
that site and that's a waste ofresources, that's a waste of
time and it's really bad thatthat's happened, because that
hospital may have the patients,it's just that he or she didn't
(28:59):
understand the study.
So that's one barrier that wehave noticed and we're working
to create these documents verysimple language documents for
feasibility personnel.
The other area is investigators.
Investigators are busy,specialists are busy, so you
have to give them simpleinformation.
Don't give them a 100-pageprotocol.
They're not going to read it.
(29:19):
They have families, they have ajob, whatever.
So just give them aninfographic with more technical
information, more clinicalinformation than the first
individual that I just mentioned, right?
And the other stakeholder ispatients.
When you're going to recruitpatients, you give them a
50-page informed consentdocument.
(29:40):
What patient is going to beable to understand that
Illegalese, right?
So, yeah, it's difficult.
So just give them aninfographic, very simple
language, that anyseven-year-old can understand.
Speaker 1 (29:54):
I find it's really interesting as the CEO, how do
you stay ahead of all the newtechnologies and new
breakthroughs that are comingout?
I mean, you guys do such agreat job with speed and you're
able to deliver on specifictimelines, but how do you, you
know, because change is constant.
Things are always changing, sohow do you manage to?
(30:16):
I mean, when do you have thetime to sit and say, okay, let
me see.
I got to look down the road sixmonths or a year to see what's
happening, If that makes sense.
Speaker 2 (30:26):
Yes, it makes sense, Chris.
Great question, and this ismore a personal comment.
I don't watch sports.
I don't watch TV.
I don't watch TV.
I read.
I read a lot.
I just talk to people all daylong and I read a lot.
When I socialize, I am usuallywith industry peers or clients,
(30:47):
or my brother, pedro, who is aphysician, so I'm always kind of
in the loop.
I read at least probably 10newsletters every day.
Ai mostly now are AInewsletters, of course, on top
of the news and stuff.
But I don't watch news, I justreceive a summary of the news
and, of course, many newslettersthat keep me on top of AI
(31:09):
developments, regulatorydevelopments and also talking to
a sponsor, I talk to CEOs ofmedical device biopharma
companies almost on a dailybasis.
So I also have a podcast.
So on the podcast I interviewleaders of the industry and they
teach me so much.
So I'm always kind of on theloop.
It's just an organic thing.
(31:30):
It's not that I force it, justorganic.
Speaker 1 (31:32):
I'm fascinated.
You talked about being anelectrical engineer and then
getting your MBA.
Was it difficult to make thattransition to managing and
overseeing a clinical research?
Speaker 2 (31:46):
group.
Yes, yes, it was.
I wouldn't say difficult.
I would probably use the wordchallenging, because I like to
say that what you get fromschooling, whatever schooling
you have, is the ability tolearn and adapt that's really
what you learn and to synthesizeand put together information
(32:08):
and come to conclusions.
So I came from the telecom andnetworking industry.
I was clueless about theclinical research and the
medicine industry or healthcareindustry in general, and when my
brother approached me aboutthis opportunity, I said yes,
because first it was my brother.
(32:38):
The 2000 bubble bust or dot-combubble bust crisis, where a lot
of dot-com companies went bust,I was part of it.
I mean, my industry was part ofit.
I was working for losing atthat time and the layoffs were
terrible, so I had no job.
I was in an industry wherethere was really not many
opportunities for somebody likeme, so I had to adapt and my
brother came along with thisopportunity.
(32:59):
I'm like interesting, why not?
So I had to learn everythingfrom scratch and it was
challenging.
I had to search online andthat's really the genesis of my
podcast, because I was gettingfrom clients usually the same
questions and I was doing a lotof research online.
I couldn't find informationonline about the clinical
(33:21):
research industry.
I didn't even know how to puttogether a proposal for a
clinical trial.
I didn't even know what aclinical trial agreement was, so
I had to research all thatonline.
And we're talking about almost15, 20 years ago, where the
internet wasn't as developed asit is now.
Now we charge GPT, you findeverything so easily, but before
(33:43):
it was more difficult.
So how do you create a proposalfor a CRO, proposal for a new
study, if you've never done itbefore?
Imagine 20 years ago.
So it was kind of a hit andmiss, try and error.
We made mistakes, but welearned from those mistakes and
that's what makes us better now.
(34:03):
And going back to how my blogand my podcast got started and
how I got started writingarticles, because I saw all
those questions from my clients,I couldn't find answers.
Because I saw all thosequestions from my clients, I
couldn't find answers.
Whatever answers I could find,I would put them on a blog, on
the website, the company website, and then FAQs more specific to
(34:24):
certain topics.
And then I came across apublication called Medivice
Online and the chief editorfound me on LinkedIn and he
liked what I was posting onLinkedIn and he's like Julio,
you seem to like writing.
Can you write an article for usas a guest columnist?
I'm like sure, yeah, what achallenge.
(34:48):
Nice, that's a great honor tobe invited, and I put together
my first article and since thenI've written like 25 articles so
, and that gives me a lot ofvisibility.
But one day I was writing onearticle about the UMDR and I
couldn't find anything about thetopic.
I mean very little informationabout the topic.
Chris and I was forced tointerview over 40 people.
So I just created a LinkedIncampaign to send messages to to
(35:13):
people in the medical deviceindustry to invite them for a
20-minute interview.
And that was a transformativemoment because I was able to
speak with all these leaders andI was able to learn so much
from them.
And I realized, chris, thatpeople have so much knowledge
and information and experiencein their heads that is nowhere
(35:33):
to be found.
So how do you make it availableto newer founders or newer CEOs
or to the industry, so that thelisteners or readers don't make
the same mistakes?
Because if already somebodymade a mistake, why are you
going to repeat the same mistakeif you already know how to
navigate those waters right?
Or are you going to get throughthose waters if somebody told
(35:54):
you already that there's abetter way?
So that's really the genesis ofmy podcast.
I decided to create a platformwhere I could speak with people
all day long, and that's what Ido now.
Speaker 1 (36:04):
So your podcast is Global Trial Accelerators
correct, and so I know thepeople in the Parkinson's
community are always looking forresources and information.
That would be a good source togo to to listen and to learn,
because a lot of times I thinkpeople are hesitant to
participate in clinical trialsbecause they're unsure of what
the process is, and you know andyes you know they're so, I
(36:30):
think, listening to your podcast, but also do you have any
recommendations for people thatare listening to help ease their
mind about participating inclinical trials?
Speaker 2 (36:41):
Well, I would say that participating in clinical
trials, it has differentconnotations.
The first connotation is yourindividual benefit.
Benefit, of course, you'regoing to be able to have access
to a new therapy that isresearch.
Because if you're attracted tothe clinical trial, it's because
(37:04):
you're running out of options,right, commercially available
options, so you have to look forexperimental options.
That's one thing, and you'regoing to receive a benefit.
The other benefit, or the otherbigger thing, is helping
humanity, helping researchadvance, helping healthcare
advance and helping your fellow,your neighbor, right.
So it's a beautiful thingthinking about clinical research
(37:26):
in that aspect.
If I participate in a trial,I'm helping humanity, I'm
helping millions of people thatare going to benefit from this
therapy, and I'm also benefiting, so everybody wins.
Speaker 1 (37:38):
There are, you know.
Of course, there's alwaysinherent risks in anything, and
there are some in, you know,clinical trials.
It's a new, you know new,molecule, but there's also, you
know, pretty stringent reviewprocesses until it gets to that
point.
And you know, that's what Iwanted if you could talk a
(37:58):
little bit briefly about that,so that people understand that
they just don't say, oh, we havethis molecule, let's just go
run and test it on people.
Can you talk a little bit about, maybe, like the IRB?
No, no, right, IRBs and thingslike that.
Speaker 2 (38:11):
Yes, yes, yes.
Well, first of all, let's speakabout something that happens
before that, which is also veryimportant.
I've been in the industry forover 20 years and I speak with
investors all the time, with myclients and all that, and one
issue that always is a topic ofconversation is funding how to
(38:33):
get funding?
Because these are startups,they need to raise money
millions of dollars.
So I usually hear Chris thatfor every 100 pitches that
investors receive, they fund one.
All right, I'm an investor, Iget 100 people pitching their
(38:56):
startup to me and I invest inonly one.
That's.
That's a big ratio, right?
So meaning that the selectionprocess right off the bat from
the money funding side is verystringent.
They have to make sure itcomplies with a long checkbox,
(39:17):
long list of boxes to check,right.
So they have to make sure thereis a good regulatory pathway.
They have to make sure animaltrials are good, that you
presume it's not going to harmhumans, because if I'm an
investor and I'm going to investone, two or three million
dollars in a company, I betterdon't harm anybody because I'm
(39:39):
going to lose my money.
So there is a big first filterand then the second filter is
all right, that one company thatgot funded, that one company is
going to get reviewed by acommittee that has been trained
in international ICH, gcp, goodclinical practice guidelines,
which are guidelines that areissued by the World Health
(40:03):
Organization, not anyorganization in the corner.
I mean.
This is the World HealthOrganization that ensures that
everybody follows theseinternational guidelines for
clinical research.
So that ethical review board hascertain requirements the number
of individuals, the backgroundof the individuals.
Every individual has to have adifferent background so that
(40:24):
everybody can look at the trialfrom a different perspective.
So the review process is very,very stringent.
So after that is, of course,the investigator.
The investigator also is notgoing to get involved in a trial
where he or she thinks thatit's going to be a reputational
damage for him, for his hospital.
So everybody benefits fromhaving stringent reviews on
(40:49):
clinical trials.
So if an investigational drugor device gets to a human, many,
many people have gone throughthat and it's very likely it's
going to be it's not going toharm you.
I mean because this is veryimportant, chris.
One thing is safety, anotherthing is efficacy.
One thing is safety, anotherthing is efficacy.
So the most important thingthat the review board wants to
(41:12):
see is that the investigationalproduct is presumed or is very
likely to be safe.
It's not going to harm you Ifit's not effective, that's a
different story, right?
Speaker 1 (41:25):
Right, because it's not always efficacious.
It might be safe, but itdoesn't give them the end point
that they're looking for.
Speaker 2 (41:32):
Exactly, yeah, exactly.
Speaker 1 (41:34):
Well, that's a that's a really good perspective,
because I participated inclinical trials and it's been.
It was a good experience, oneof the ones I did that at the
drug actually went to mark, gotapproved and went to market.
So it's.
It gives you a good feelingthat you're you're helping
people.
And the thing I really likeabout what you and your company
are doing is speed.
Is your model something thatcould be applied globally,
(41:59):
expanded and applied globally toget to speed up clinical
research in general?
I mean, maybe that's too broadof a question, maybe.
Speaker 2 (42:07):
But yes, that's more a political question.
I think.
Yes, I mean, I think by usbeing involved in this industry,
chris, we can give regulators alot of advice in regards as to
what other countries are doing,what best practices really have
(42:33):
a global perspective.
Just an employee of theregulatory agency or somebody
who has a decision power, butjust within your jurisdiction,
you don't really have thisglobal perspective.
So I think we can contribute alot to create new laws or new
regulations to speed up clinicaltrials.
So yeah, I mean, but it's notsomething that you can ask a lot
(42:54):
.
I haven't had the country ofGermany ask me, julio, based on
your experience, what can we dobetter here in Germany?
I hope it happens.
Speaker 1 (43:02):
In terms of clinical research, where do you see
progress or what do you seehappening?
Speaker 2 (43:08):
Yes, yes, there are a few changes that I'm seeing.
One change that I'm seeing andthat is related to the question
that you just asked, is there isa new global site certification
and individual accreditationfor clinical research.
It's been around for about fiveyears now.
It's an organization out of theUK.
(43:28):
It's called the InternationalAccrediting Organization for
Clinical Research and they'redoing an extraordinary job
accrediting organization forclinical research and they're
doing an extraordinary job.
They were created by, they werecreated by the industry for the
industry, meaning IQVIA, cnu,health Park Cell.
All these big CROs push these tohappen, first in the UK, in the
(43:50):
national health system of theUK, so that all these sites of
the NHS were certified inclinical research excellence.
That work led this organizationto become global now and now is
available in many over 40countries.
So slowly it's getting to moreand more sites and that is
(44:13):
reassuring for patients.
That, because before this therewas nothing like this.
If you think about it, there'sreally no seal of quality for a
clinical research site and thisorganization in England was the
first to come up with with thisquality certification, again
created by the industry for theindustry.
That's's a big change.
(44:35):
The second change is AI.
As you said, ai is going totransform everything we do as
CROs, as research sites, ashospitals do when they recruit
patients, with these innovationsthat I just mentioned.
So I think it's going totransform the way research is
done.
Also, remote monitoring, I meannow we have all these tools to
(44:57):
have the patient not to come tothe hospital unless it is an
implantable device.
But you can do many diagnosticimages.
You can monitor heart rate andother biomarkers remotely.
You don't have to bring thepatient physically into the
hospital anymore.
Speaker 1 (45:17):
Is there things in terms of clinical research in
the next five years that you seeas breakthrough, or things that
might help improve people'slives?
Speaker 2 (45:30):
Yes, the fact that there is now an international
organization to certify theexcellence in clinical research
for sites.
That started in the UK and isnow globally available.
It's called the InternationalAccrediting Organization for
Clinical Research to ensure thatresearch sites comply with
global standards and was createdby the industry for the
(45:51):
industry.
So that's a big move in theindustry.
The second trend that I see isAI is getting everywhere in the
industry.
So that's a big move in theindustry.
The second trend that I see isAI is getting everywhere in the
industry.
As we said, it's getting intothe CRO business, it's getting
into the site operation, it'sgetting into patient-facing
material so that we can recruitand screen and recruit patients
(46:11):
faster.
And the third area that I see is, countries are understanding
that attracting clinicalresearch brings so many more
benefits than they previouslythought, right?
I've seen a lot of countries,especially in Latin America,
enacting new laws because theyrecognize that clinical research
(46:33):
is a catalyzer for science,technology and innovation local
in the country.
Because the analogy is like ifyou bring Messi to play soccer
with the local team in ElSalvador, the local team in El
Salvador will eventually becomeone of the best in the world,
right?
Because you can have thistransfer of knowledge from
(46:54):
somebody who is the best in theworld to the local players.
So the same thing happens withclinical research.
Clinical research is reallyinnovation in a nutshell.
I mean, you bring these trials,you bring new ways of doing
things, new therapies, newmethods and you get this
transfer of knowledge to thelocal investigators, and that
(47:14):
elevates communities and bringsmoney because you hire people
with higher salaries, with PhDs.
So it benefits everybody, notto mention the benefit to the
patient.
Because also, countries savemoney because the patient
treatment is being paid by thesponsor, not by the health care
system.
(47:34):
So it's a win-win for everybodyin the ecosystem in every
country.
So, yeah, that's what I see,okay.
Speaker 1 (47:40):
So if you could leave people that are listening that
have Parkinson's because that'swhat the channel is all about
what would you, in terms ofeither participating in clinical
trials or, if they want to getmore information, what's the
best from your perspective?
What's the best way to go aboutthat?
Speaker 2 (47:58):
Yes, I think with the new tools that we have now with
AI.
For example, the other day Ijust discovered a new tool
inside Perplexity.
It's called Task Task.
You can now set up an agentwithin Perplexity to give you
(48:19):
updates on whatever you want.
So if I am a Parkinson'spatient, if I'm always looking
for trials or new therapy forwhatever I have, I could
probably just set up an agentFind me every week or every
month or every quarter, find menew clinical trials for this
specific condition.
You just specify what you needand you're going to receive an
(48:42):
alert.
You're going to have somebodydoing research, a high IQ person
, which is really an AI agent,high IQ agent doing the research
that for a human is almostimpossible to do, for even a
specialist, even your doctor isnot going to be able to do the
(49:02):
level of research that an AIagent is able to do now.
And that's a tool that isavailable to everybody
Perplexity task.
Speaker 1 (49:13):
Great.
So can you provide a little bitof information about your
podcast, your blog and yourLinkedIn, where people might be
able to get in touch with you orjust follow you and learn more
about BioAccess and the greatthings that you're doing?
Speaker 2 (49:28):
Yes, chris, our website is
bioaccesslaforlatinamericacom.
Bioaccesslaforlatinamericacom,bioaccess la for latinamericacom
.
We are easily findable online.
Just do a search for bioaccessclinical trials or julio
martinez clark.
You're gonna find me onlinevery easily because I am on a
lot of podcasts.
(49:48):
I produce my own podcast, Iwrite a lot of articles and my
podcast is global trial acceler.
You're going to be able to findit on YouTube, on Spotify,
apple, et cetera, and LinkedIn,of course.
I'm very, very active onLinkedIn.
I have over 30,000 followers.
I post three, five times a daysomething new.
(50:09):
So, yeah, just do JulioMartinez Clark on LinkedIn.
Speaker 1 (50:15):
Great.
Well, it's been great.
I really appreciate you beingon today.
You're doing fabulous work interms of speed and helping to
push drugs and devices to themarket, and you should be
commended for that.
It's a great thing that you'redoing and helping people across
the world so is there anythingelse?
Speaker 2 (50:35):
Thank you for those words.
Speaker 1 (50:37):
Is there anything else that you'd like to leave us
with before we go?
I really appreciate the timeyou spent today.
Speaker 2 (50:44):
Absolutely Final words.
I just want to say that I amprivileged to be in this
industry because of the changethat I can make.
I've been in procedures withinvestigational medical devices
in Latin America where weimplant a device on a patient
and we change that patient's andhe or her life, her family
(51:08):
members' lives, just because ofwhat we did, and that's the most
important reward.
Seeing somebody's face,somebody walk when he or she
couldn't walk for years becauseof the back pain or whatever,
and seeing that transformationin their lives and their family
members' lives is just it makesyou cry sometimes.
(51:29):
So, yeah, I love this industry.
Speaker 1 (51:32):
Yeah, it's definitely a ripple effect.
It doesn't affect just oneperson, it affects their family,
and it goes on and on.
So you know, thank you fordoing what you're doing.
And one thing that I wanted totouch, just as we close here,
that you mentioned is never stoplearning.
I mean, you talked aboutlearning.
You know, you didn't knowanything about clinical research
(51:53):
, but you took the time to learn.
You didn't know anything aboutclinical research, but you took
the time to learn.
Speaker 2 (52:01):
So you know be a lifelong learner, and you know
always you know, try to.
you know, stay on to learn newthings.
Yes, exactly, Exactly.
Especially now, Chris, thatthings are happening so fast.
I think the pace of news andevents and technology evolution
that we're having in June 18th2025.
It's just too much.
(52:22):
So our lives are becoming verybusy.
Yes, yes, with all thisinformation.
So you have to be, correctly,as you said, a good learner, but
you also have to filterinformation.
You have to learn how to filterinformation, so that's another
skill that we all need to learn.
Speaker 1 (52:38):
Well, again, thank you for your time.
I really appreciate it.
I know you're a busy person andyou're doing great things.
Speaker 2 (52:43):
My pleasure, Chris.
Thank you for having me.
Hello and welcome to Live Parkinson's Live an
Exceptional Life.
I'm your host, chrisKustenbader, and I've been
living an exceptional life withParkinson's for the past 15
years.
The purpose of this podcast isto help as many people as
possible living with Parkinson'sto lead a great quality of life
.
Now, today we're diving into atopic Parkinson's to lead a
great quality of life.
Now, today we're diving into atopic that's absolutely crucial
for the future of healthcare,especially for conditions like
(00:31):
Parkinson's.
And to guide us through thisvital conversation, we have an
extraordinary guest.
Joining us is JulioMartinez-Clark, the insightful
CEO of BioAccess.
Julio is a true visionary in theworld of global clinical trials
, with deep expertise in medtechand biopharma.
His company, bioaccess, is on amission to accelerate medical
(00:51):
innovation by focusing onbringing clinical research to
emerging markets in regions likeLatin America, eastern Europe
and Australia.
What makes BioAccess soimpactful?
It's our commitment to speed,cost-effectiveness and
leveraging unparalleled regionalexpertise to get life-changing
(01:11):
treatments to patients faster.
Today, we'll explore how hiswork is not only transforming
clinical trials, but also howcutting-edge technologies,
particularly AI, are playing apivotal role in this exciting
evolution.
Ai are playing a pivotal rolein this exciting evolution.
So get ready for a fascinatingdiscussion on how we can truly
live an exceptional life byunderstanding the very pathways
that bring us new hope andtherapies.
(01:32):
So let's welcome JulioMartinez-Clark.
Thank you for joining us.
For those of you that may notbe familiar with you, can you
give us a little bit of abackground on bioaccess and its
core mission in clinicalresearch?
Speaker 2 (01:44):
Thank you, chris, for that very nice introduction.
I feel honored, privileged tohave that introduction.
It's truly a pleasure to behere with you and share with the
audience the journey that we'vehad at BioAccess and the
breakthrough research that weare doing in different countries
(02:04):
around the world.
So, as a matter of introduction, I was born and raised in
Colombia, south America.
I moved to the US about40-something years.
I now live in Miami and that'sthe base of our company and the
journey the bioaccess journey,really started with my brother,
pedro.
(02:24):
He trained at Harvard as acardiologist and then as an
interventional cardiologist andthen moved to Miami to become a
professor at the University ofMiami.
And he met his mentor, drWilliam O'Neill, who is
considered one of the topauthorities in the world in
interventional cardiology, andthey worked together for many
(02:45):
years and that work includedadvising many US medical device
startups that were developingadvanced cardiovascular
technologies or devices and theytraveled with them around the
world doing trials, first inhuman trials, and they quickly
realized that the CRO industrywas very fragmented but there
(03:08):
was really no CRO in the worlddedicated to first-in-human
clinical trials, at least formedical devices, at that time.
Now we have expanded to otherareas biopharma, radiopharma but
medical device has been ourfocus for many, many years.
Because we saw the opportunity.
We saw a problem in theindustry that needed to be
(03:28):
addressed and Dr Roneo and Pedrocame up with the idea to create
a company outside of theuniversity ecosystem.
Because we really startedinside the university.
It was a small desk in theinternational patient department
.
You know a lot of internationalpatients, especially from Latin
America, traveling to Miami toreceive advanced medical care at
the University of MiamiHospital and that small desk was
(03:50):
doing the work of a CRO.
It wasn't really set up forthat.
So that's why Dr O'Neill andPetro decided to create
BioAccess and then I took theleadership role in the company.
I got my MBA in Boston.
I got my degree in electricalengineering in Colombia.
I worked for a couple of globaltelecom and networking
(04:10):
companies Lucent, nortel.
I did business all over theworld in Europe, in North South
America.
I was kind of a good fit forwhat Pedro and O'Neill wanted to
build and fast track.
Almost 20 years later,bioaccess is now the leading
first-in-human contract researchorganization specifically
(04:30):
helping startups, which is aunique niche because a larger
pharma has different needs thana small startup of three people
and just a few million dollarsin the bank.
With a breakthrough technology,you have to become a company.
Bioaccess, the CRO, has toadapt to the needs of this
clientele.
So we consider ourselves astartup.
(04:52):
We consider ourselves verynimble, very adaptable, very
dynamic.
We're a small team of about 40people, but we have a global
reach that can help thesestartups bring these innovations
to market.
Speaker 1 (05:04):
Yeah, so you have a strong focus on really
accelerating clinical trials.
Can you explain how you do itand what sets you apart from a
lot of the other companies?
Because I've worked years agoin clinical research, monitoring
studies and things and a lot oftimes it was a slow, tedious
process but you've been able todo it a lot faster in terms of
(05:25):
patient recruitment and otherthings.
So can you talk a little bitabout that?
Absolutely.
Speaker 2 (05:30):
Chris.
What happens is that the natureof our clientele demands that
we deliver speed.
That's really what we sell.
We sell speed, we promise andwe deliver speed.
Speed, we promise and wedeliver speed.
Because if you understand thenature of the startup community,
(05:50):
you're going to quickly realizethat speed is of the utmost
importance for these companies.
And the reason is this when,when people talk about clinical
trials, cros, they usually referregular people on the streets.
They usually refer to bigpharma and medtech companies.
(06:33):
The journey of a medical deviceor biopharma or radiopharma
startup usually starts at auniversity.
They have research labs thatproduce intellectual property, a
patent for a new molecule, fora new medical device, etc.
So this patent needs to bedeveloped right, because
(06:56):
innovation does not meananything if it doesn't translate
into a commercial product thatbenefits humanity and impacts
lives.
So a patent does nothing in adrawer in an office in a
university.
So the university is alwaysseeking entrepreneurs who can
(07:18):
tap into the potential of theinnovation and can build, have
the leadership skills to build ateam around it, can raise funds
and can develop the innovationto the point where it is ready
to be tested in humans rightBefore it gets tested in humans,
it needs to go throughpreclinical lab testing, animal
(07:42):
testing, cadaver testing and, ofcourse, the big moment, the
pivotal moment, is when theytest or they validate the safety
and efficacy of the innovationin a live patient, a live human.
And that's really a pivotalmoment of value creation for the
company and the evaluation ofthe company increases
(08:03):
dramatically if the results ofthat first in human trials are
good.
Because the only purpose ofthese companies I mean these are
investors.
Right, everybody's for themoney, of course.
Everybody wants to benefithumanity, everybody have noble
means, everybody wants to impactpeople's or patients' lives,
(08:24):
but they all want to make somegood money.
So they invest money and timeand resources in the startup and
they have the hope of sellingthe startup to a larger buyer,
right Like Medtronic, bostonScientific, or Merck or Pfizer
in the case of Pharma.
So that's really the cycle ofinnovation.
That's how the big players getfed with newer technologies,
(08:48):
newer products and remaincompetitive in the market.
So that's the cycle ofinnovation.
So, if you analyze the needs ofthese startups, they have
investors breathing on theirneck, they have investors
demanding results, they havebusiness plans and they have
timelines assigned to thosebusiness plans.
So those milestones need tohappen in certain dates, and
(09:11):
that's why time is of theessence for these companies.
They need to have a patient ona table for the device to get
implanted and tested as soon aspossible, so that they know if
the device works or not, theyknow if they have to make
changes to their prototype andif so, they have to raise more
funds and continue their journey.
Time is of the essence becausethey need to get acquired
(09:32):
eventually and investors have toget their money back.
Speaker 1 (09:36):
Would you be involved in all three phases?
So phase one, two and threeclinical trials for these
startup companies then no, weget involved on.
Speaker 2 (09:44):
Usually we get involved in phase one.
Of course we can do phase two,we can do phase three, but
that's not really how the marketknows about us and you have a
lot more competitors in laterphases.
So we prefer to navigate in ablue ocean where we have no
competition because we havebecome so laser focused on first
(10:07):
in humans that we have becomeprobably the best in the world
on this specific niche.
So, yeah, usually we getinvolved in first in human
trials and and the way we wemake them happen faster is by
looking at countries that havefriendly regulations to get them
approved faster and also doinga very diligent job in finding
(10:29):
those investigators inside thosecountries that have the patient
recruitment potential tocomplete the trials faster so
you're able to leverage in yourbackground in Latin America,
eastern Europe and Australia.
Speaker 1 (10:41):
So you've got probably a great database of
patients to pull from to helpyou with your studies.
Is that correct?
Is that what helps you with thespeed aspect?
Speaker 2 (10:52):
The database is more of investigators, not
necessarily patients.
Investigators who can tell usif they can recruit patients
fast enough or at the pace thatwe need for the study.
We have developed a very largedatabase.
We have a large network ofconnections all over Latin
America, australia, easternEurope and as soon as I receive
(11:14):
a study within hours, I can knowwhere to go, what hospital has
the patients, what investigatorsis willing and able to lead the
study, would you say.
Speaker 1 (11:24):
it typically takes from when you are presented with
the study till it's recruitedand then the results are
compiled, and then you can goback to the company and say
here's what the results are.
Speaker 2 (11:36):
Yeah, Really depends on the country and depends on
what the company is looking for.
On the best case scenario,chris, we can get a site
activated in Panama in about 60days, in El Salvador also in
about 60 days, in Chile also inabout 60 days.
This is record Globallyspeaking.
(11:58):
This is record times within theLatin American region.
We can do the same in Serbia,in the Balkans.
I mean fast approvals in thosecountries as well, australia as
well, even though there's a newproposed law that may change
that.
But we can get studies approvedwithin 60 days and patients
probably recruit a month later,because you know it takes time
(12:20):
to get them come to the site,sign the informed consent and
all that.
But probably 90 days aftersubmission to the IRB we should
have our first patient.
Speaker 1 (12:30):
Yeah, that's exciting because typically the
traditional model is it's slow,it takes a long time to set up
and, being on both sides of it,I participated in a number of
clinical trials here in the USas a patient and it was a year
and a half.
Well, the one study was asix-month double-blind
placebo-controlled trial andthen it went to open-label,
(12:51):
which was another year and ahalf, so it was a long phase
three clinical trial.
So it sounds like the modelyou're using.
Is it something that can beapplied or expanded beyond the
countries that you're typicallyin, or is it the regulatory
environment that can really slowyou down?
Speaker 2 (13:09):
That's a very interesting question, chris.
There are many factors whytrials take too long in the
United States for sites toactivate, to get activated
patients recruited, and all that.
There are many factors.
One factor is that in theUnited States, that there are
many factors.
One factor is that in theUnited States the way the
healthcare system works is thatwe have this consolidation in
(13:30):
the hospital systems.
We have large hospital systems.
You have very few independentsmall hospitals.
Right, you have HCA and allthese big players that have HCA.
I think I was reading the otherweek it has 184 hospitals
across the United States, 2,000locations including those 185
(13:55):
hospitals.
So imagine you're trying to setup a meeting inside HCA, inside
the hospital system, for atrial, hca inside the hospital
system for a trial.
So it will take you 20 phonecalls, 20 emails to probably
land one day before a meetingand then the meeting happens and
(14:16):
then the bureaucracy, and thenyou have to talk to XYZ person
and then the other person, thenanother meeting just to set up
the study, not to mention theIRB approval process, because
these institutions arerisk-averse.
Speaker 1 (14:26):
Right, that's true.
Speaker 2 (14:27):
They don't want to get into studies where a patient
may be harmed or somethingrisky studies, not to mention
forcing humans.
They don't want to get inforcing humans at all right,
because of the reputationaldamage and the PR damage.
So I've experienced that myself, so I know exactly what I'm
talking about.
One is the aside.
So that's one factor right.
(14:47):
The other factor is the FDA.
It's uncertain, and this is theword that my clients have used.
The uncertainty at the FDAlevel is just unbearable for a
startup.
You need to give investorscertainty.
By this date I'm going to havethis milestone.
If you don't have thatcertainty at the FDA, especially
now with the politicalenvironment, the layoffs et
(15:09):
cetera, then it takes too longto get a study approved in the
United States.
So that's why companies,especially startup companies
biopharma, medtech, radiopharma,surgical companies, startup
companies, three people, $3million in the bank they need to
go overseas to find quickerways to get sites activated and
patients treated.
Speaker 1 (15:28):
Okay, Well, with Parkinson's there's really
people take medication, but thenthere's also the medical device
piece where people get the deepbrain stimulation surgery.
Is there a difference in speedin terms of testing a compound
for a new medication versus amedical device when you're doing
(15:48):
it in these other countries?
Speaker 2 (15:49):
Not really.
Not really, although theregulations are a lot more
stringent for molecules, for newdrugs, than devices, because
devices are kind of newer.
So the regulation, the pace ofupdating regulations, is not the
same as the pace of theindustry.
So usually you find countriesthat have very, very strong
(16:13):
regulations for pharma, formolecules, but not so much for
medical devices.
So it's usually a littlequicker to do a medical device
study approved.
But in general I wouldn't saythat's the case.
I mean, for example, in Panama,in Salvador, there's really no
distinction, there's very littlered tape, keeping quality and
(16:35):
ethical standards.
I mean the fact that theregulator approved faster
doesn't mean that it's not aquality or ethical study.
This is very, very importantbecause our job is to deliver
quality data and ethical data.
We wouldn't be in business if wewere involved in countries with
regulators that are not reallydoing their homework right and
(16:58):
where sites are not followinginternational ICI-GCP standards.
So to answer your question morespecifically, I will say that
it doesn't make much difference.
Sometimes, depending on thecountry, medical device studies
are approved a little quicker.
But no, I mean it's.
And also it's also important tounderstand that in these
countries, on top of theregulator being efficient.
(17:21):
For example, if I pick up thephone and I call El Salvador,
the regulator is going to answerthe call.
They're going to have a meetingwith me because they want to
bring trials to the country.
It's not like in the US.
You have to apply for a pre-submeeting and wait until that
happens.
Probably the meeting is sixmonths out.
That doesn't happen in ElSalvador.
So that's one thing.
(17:43):
The other thing is that patientsin Latin America are developing
economies because of the waythe health care system works,
where on paper they have theright to access the system and
be treated with dignity but inreality that's not the case and
offer that participation to thepatient.
(18:04):
The patient will gladly say yesbecause they will receive an
immediate benefit, which isaccess to the system.
They're going to have all theblood tests that they haven't
had done in five years.
They're going to be able toaccess a specialist for their
condition, a cardiologist, aneurologist, who is somebody
they haven't been able to see infive years because the system
makes it difficult for them toaccess these cardiologists or
(18:27):
these specialists.
So they're already receiving animmediate benefit.
So they want to participatefaster in these trials?
Speaker 1 (18:33):
Do the startup companies that you work with?
Do they request a specificregion that you test this in, or
are you free to go in order forthe speed aspect?
Maybe you have a betterrelationship in Latin America
than you do in Australia, so dothey give you the freedom to
decide where to find the studyinvestigator and run the study?
Speaker 2 (18:52):
Yes, they give us the freedom, chris.
However, if you look at thesethree areas in the world,
there's really no compellingreason, except the one that I'm
going to mention in a minute,why you will go that far to
Eastern Europe or Australia anddeal with the time difference,
(19:13):
the flight times and thedifferent cultures.
If you have great options inLatin America where the flight
time is short I mean from Miami,you're two and a half hours
from most countries, same timezone and similar culture.
So what we do is we offeroptions.
(19:35):
But if you tell me, julio, yes,panama is great, salvador is
great, dominican Republic isgreat, colombia is great, what
you offer in Latin America isgreat.
But I love Dr Smith in Macedoniaor in Australia.
He went to school with me.
I think he's the best candidateto lead the study.
(19:56):
Sure, then we can set up thestudy in Australia If you have a
compelling reason to go toAustralia and have Dr Smith as
your investigator.
That happens a lot.
Yesterday I had a call with acompany, a US company, that
wanted to do a study in theDominican Republic and they have
a willing and able investigatoralready identified in the
Dominican Republic, probablysomebody who they knew from the
(20:17):
industry, or they went to school, with whatever reason.
Sometimes the sponsor comes tome with a specific country in
mind.
Speaker 1 (20:24):
Now okay, is it your organization or the sponsor?
Because most times when you'rerunning a study, there's always
some type of clinical researchassociate or something that goes
and monitors the study andlooks at the study paperwork to
make sure that the protocol isbeing followed.
Is that part of your group oris that part of the sponsorship
(20:45):
group?
Speaker 2 (20:46):
Yes, it's usually part of our group.
That's a service that weprovide.
However, sometimes the sponsorwants to have a separate group.
That happens occasionally butit's not that common.
But it's usually our groupbecause we're independent.
We are in the middle betweenthe sponsor and the site so we
(21:06):
can carry out all theseactivities independently,
without any vested interest.
Speaker 1 (21:11):
Now, do you have people?
Are they in the particularcountries that you deal with,
the people that work for you,the clinical research associates
, or do they just happen thatthey travel when the study is
set up?
Speaker 2 (21:21):
A little bit of both.
A little bit of both.
Yes, no-transcript.
(21:52):
Until the day of theimplantation of the devices,
until the day we're ready toimplant the devices, dealing
with the sponsor, having weeklymeetings with the sponsor, he or
she knows the protocol by heart.
So it doesn't make any sense ifwe are ready to implant the
device in the case of medicaldevices, if we're ready to
(22:14):
implant devices.
The implantation of a medicaldevice on a first human trial is
a big big deal.
The first patient is a big deal.
So the ceo of the companytravels from the States, the
biomed engineer who designed thestudy or designed the device,
and three more people, theproctor.
Usually they have a proctor, amedical advisor from a top
university or hospital in theUnited States John Hopkins, et
(22:37):
cetera.
They all travel together.
So usually the team coming fromthe US is about five people, is
about five people.
And then we have our projectmanager.
The physician that I justmentioned also travel with them
to the hospital to be in the ORwhen the implantation happens,
because he's the best individualto lead the process, the
(22:57):
project.
So it doesn't make any sense tohave somebody local who has no
clue about what's going on withthe study.
He or she is not going to keepup with the study or going to be
updated with the study just byreading something three days
prior to the implantation.
Speaker 1 (23:11):
So really, depending on the situation Now in terms of
speed is important and I knowyou also do a quality job.
So at the end, at theconclusion of the study, how
long does it take you to be ableto take from when the study is
initiated at the investigativesite?
They get the data and it'ssummarized and you get it back
to the startup company so thatthey know is this a viable
(23:34):
option to continue movingforward.
Speaker 2 (23:36):
Well, the data is updated, Chris, to the
electronic data capture platformin real time.
In real time I mean the momentthe first patient gets in, that
data is uploaded, the CRF, thecase report form, is electronic.
We don't use paper anymore.
I mean the study coordinators,hate paper, investigators, hate
(23:56):
paper.
So yeah, it's real time data.
So as we go along recruitingpatients, the database gets
updated and the sponsor can doall the biostat analysis that
they desire and they knowexactly if the trial is going in
the right direction or not.
Speaker 1 (24:15):
I just want to switch gears a little bit now.
Ai is always it's the bigbuzzword, not only in society,
but also in healthcare.
Is that something that youimplement as part of your
process for setting up ascheduling and setting up a
study?
Is there any AI used in thatprocess?
Speaker 2 (24:36):
Well, as you said, it's a word that is widely used
now in the industry, but I wouldsay that depending on where in
the industry you look into,you're gonna have kind of
different applications.
In the CRO industry is insideour company.
(24:58):
We are using AI to analyzedocuments.
That's something that isbringing superpowers to our
project managers, for examplewith translations.
Now before we had a doctor, aphysician, sitting in a computer
for I don't know how many days,just comparing the english
(25:18):
original version of the protocolto the spanish original version
.
Now that's done with a.
So it's speeding up our processof putting together the right
documents for studies beforesubmission, writing letters to
sponsors, to regulators.
I mean, that's something thatwe are now doing with AI, so
it's helping us a lot as aserial.
(25:40):
On the hospital side, I've seenapplications where imagine you a
large hospital in Colombia andthey are running 50 different
studies how do you know when apatient comes in in the regular
consult of the hospital, not inthe research department?
How do you know that that's agood candidate for the research
(26:01):
department to be recruiteddepartment to be recruited right
?
So you use AI tools to matchthe inclusion and exclusion
criteria with what is in the EMRelectronic medical record of
the regular activity of thehospital.
So that's something that, withhumans, is almost impossible to
do, because you have to be ontop of all the nurses, on top of
(26:21):
everybody in the hospital, allthe specialists.
Hey, dr Smith, remember that wehave this trial, and if you
have 50 trials, he's not, she'snot going to remember that, or
the nurse is not going toremember that.
So, with AI getting into theEMR and matching the daily
activity of the hospital withwhat the research department is
doing, then you're going to havealerts, you're going to have
(26:42):
flags immediately at theresearch department.
Listen, there's a person thatjust came through the emergency
department.
He's a good candidate for thisXYZ study that you're running.
Speaker 1 (26:54):
So do you have good applications, somebody that's
like an AI specialist that sitsin, you know, because a lot of
it's prompts, so you have to putin specific prompts to get out
the specific data you want.
So is it?
It's now an agent.
Speaker 2 (27:07):
It's now an agent.
You can build an agent for that.
That's science fiction.
Yes, we're working on thatright now with our research
department.
We have research department ora research site in Miami.
My brother runs a very largemedical practice cardiovascular
practice and we're doing exactlythat.
The other application, chris,that is worth mentioning here
for the audience is patientrecruitment.
(27:28):
You know is a challenge inevery clinical trial and our job
is to make that faster andfaster.
So with AI we can now take avery complex clinical protocol
right of 100 pages that'susually the length of our
clinical protocol, as you know.
You can now reduce that to aninfographic that you can use in
(27:54):
three different ways.
Now you can explain the studyin simple language to the study
coordinator, that is, the headof the feasibility department of
the hospital, because everytime there is a new study it
usually lands in the feasibilityinbox of the research
department and that individualis not a physician.
(28:15):
Even if he or she is aphysician and the study is in
oncology and he's a generalpractitioner, he or she is not
going to understand thecomplexity of the oncology study
.
Right, that individual needs tobe fed with simple language
information so that he or she,in the feasibility analysis of
the study, can understand thescope of the study and can guide
(28:37):
the study to the rightinvestigator and say with
certainty, yes, we can recruitpatients, we have this type of
patients.
But if he or she doesn'tunderstand the study, then the
studies aren't going to getevaluated for feasibility at
that site and that's a waste ofresources, that's a waste of
time and it's really bad thatthat's happened, because that
hospital may have the patients,it's just that he or she didn't
(28:59):
understand the study.
So that's one barrier that wehave noticed and we're working
to create these documents verysimple language documents for
feasibility personnel.
The other area is investigators.
Investigators are busy,specialists are busy, so you
have to give them simpleinformation.
Don't give them a 100-pageprotocol.
They're not going to read it.
(29:19):
They have families, they have ajob, whatever.
So just give them aninfographic with more technical
information, more clinicalinformation than the first
individual that I just mentioned, right?
And the other stakeholder ispatients.
When you're going to recruitpatients, you give them a
50-page informed consentdocument.
(29:40):
What patient is going to beable to understand that
Illegalese, right?
So, yeah, it's difficult.
So just give them aninfographic, very simple
language, that anyseven-year-old can understand.
Speaker 1 (29:54):
I find it's really interesting as the CEO, how do
you stay ahead of all the newtechnologies and new
breakthroughs that are comingout?
I mean, you guys do such agreat job with speed and you're
able to deliver on specifictimelines, but how do you, you
know, because change is constant.
Things are always changing, sohow do you manage to?
(30:16):
I mean, when do you have thetime to sit and say, okay, let
me see.
I got to look down the road sixmonths or a year to see what's
happening, If that makes sense.
Speaker 2 (30:26):
Yes, it makes sense, Chris.
Great question, and this ismore a personal comment.
I don't watch sports.
I don't watch TV.
I don't watch TV.
I read.
I read a lot.
I just talk to people all daylong and I read a lot.
When I socialize, I am usuallywith industry peers or clients,
(30:47):
or my brother, pedro, who is aphysician, so I'm always kind of
in the loop.
I read at least probably 10newsletters every day.
Ai mostly now are AInewsletters, of course, on top
of the news and stuff.
But I don't watch news, I justreceive a summary of the news
and, of course, many newslettersthat keep me on top of AI
(31:09):
developments, regulatorydevelopments and also talking to
a sponsor, I talk to CEOs ofmedical device biopharma
companies almost on a dailybasis.
So I also have a podcast.
So on the podcast I interviewleaders of the industry and they
teach me so much.
So I'm always kind of on theloop.
It's just an organic thing.
(31:30):
It's not that I force it, justorganic.
Speaker 1 (31:32):
I'm fascinated.
You talked about being anelectrical engineer and then
getting your MBA.
Was it difficult to make thattransition to managing and
overseeing a clinical research?
Speaker 2 (31:46):
group.
Yes, yes, it was.
I wouldn't say difficult.
I would probably use the wordchallenging, because I like to
say that what you get fromschooling, whatever schooling
you have, is the ability tolearn and adapt that's really
what you learn and to synthesizeand put together information
(32:08):
and come to conclusions.
So I came from the telecom andnetworking industry.
I was clueless about theclinical research and the
medicine industry or healthcareindustry in general, and when my
brother approached me aboutthis opportunity, I said yes,
because first it was my brother.
(32:38):
The 2000 bubble bust or dot-combubble bust crisis, where a lot
of dot-com companies went bust,I was part of it.
I mean, my industry was part ofit.
I was working for losing atthat time and the layoffs were
terrible, so I had no job.
I was in an industry wherethere was really not many
opportunities for somebody likeme, so I had to adapt and my
brother came along with thisopportunity.
(32:59):
I'm like interesting, why not?
So I had to learn everythingfrom scratch and it was
challenging.
I had to search online andthat's really the genesis of my
podcast, because I was gettingfrom clients usually the same
questions and I was doing a lotof research online.
I couldn't find informationonline about the clinical
(33:21):
research industry.
I didn't even know how to puttogether a proposal for a
clinical trial.
I didn't even know what aclinical trial agreement was, so
I had to research all thatonline.
And we're talking about almost15, 20 years ago, where the
internet wasn't as developed asit is now.
Now we charge GPT, you findeverything so easily, but before
(33:43):
it was more difficult.
So how do you create a proposalfor a CRO, proposal for a new
study, if you've never done itbefore?
Imagine 20 years ago.
So it was kind of a hit andmiss, try and error.
We made mistakes, but welearned from those mistakes and
that's what makes us better now.
(34:03):
And going back to how my blogand my podcast got started and
how I got started writingarticles, because I saw all
those questions from my clients,I couldn't find answers.
Because I saw all thosequestions from my clients, I
couldn't find answers.
Whatever answers I could find,I would put them on a blog, on
the website, the company website, and then FAQs more specific to
(34:24):
certain topics.
And then I came across apublication called Medivice
Online and the chief editorfound me on LinkedIn and he
liked what I was posting onLinkedIn and he's like Julio,
you seem to like writing.
Can you write an article for usas a guest columnist?
I'm like sure, yeah, what achallenge.
(34:48):
Nice, that's a great honor tobe invited, and I put together
my first article and since thenI've written like 25 articles so
, and that gives me a lot ofvisibility.
But one day I was writing onearticle about the UMDR and I
couldn't find anything about thetopic.
I mean very little informationabout the topic.
Chris and I was forced tointerview over 40 people.
So I just created a LinkedIncampaign to send messages to to
(35:13):
people in the medical deviceindustry to invite them for a
20-minute interview.
And that was a transformativemoment because I was able to
speak with all these leaders andI was able to learn so much
from them.
And I realized, chris, thatpeople have so much knowledge
and information and experiencein their heads that is nowhere
(35:33):
to be found.
So how do you make it availableto newer founders or newer CEOs
or to the industry, so that thelisteners or readers don't make
the same mistakes?
Because if already somebodymade a mistake, why are you
going to repeat the same mistakeif you already know how to
navigate those waters right?
Or are you going to get throughthose waters if somebody told
(35:54):
you already that there's abetter way?
So that's really the genesis ofmy podcast.
I decided to create a platformwhere I could speak with people
all day long, and that's what Ido now.
Speaker 1 (36:04):
So your podcast is Global Trial Accelerators
correct, and so I know thepeople in the Parkinson's
community are always looking forresources and information.
That would be a good source togo to to listen and to learn,
because a lot of times I thinkpeople are hesitant to
participate in clinical trialsbecause they're unsure of what
the process is, and you know andyes you know they're so, I
(36:30):
think, listening to your podcast, but also do you have any
recommendations for people thatare listening to help ease their
mind about participating inclinical trials?
Speaker 2 (36:41):
Well, I would say that participating in clinical
trials, it has differentconnotations.
The first connotation is yourindividual benefit.
Benefit, of course, you'regoing to be able to have access
to a new therapy that isresearch.
Because if you're attracted tothe clinical trial, it's because
(37:04):
you're running out of options,right, commercially available
options, so you have to look forexperimental options.
That's one thing, and you'regoing to receive a benefit.
The other benefit, or the otherbigger thing, is helping
humanity, helping researchadvance, helping healthcare
advance and helping your fellow,your neighbor, right.
So it's a beautiful thingthinking about clinical research
(37:26):
in that aspect.
If I participate in a trial,I'm helping humanity, I'm
helping millions of people thatare going to benefit from this
therapy, and I'm also benefiting, so everybody wins.
Speaker 1 (37:38):
There are, you know.
Of course, there's alwaysinherent risks in anything, and
there are some in, you know,clinical trials.
It's a new, you know new,molecule, but there's also, you
know, pretty stringent reviewprocesses until it gets to that
point.
And you know, that's what Iwanted if you could talk a
(37:58):
little bit briefly about that,so that people understand that
they just don't say, oh, we havethis molecule, let's just go
run and test it on people.
Can you talk a little bit about, maybe, like the IRB?
No, no, right, IRBs and thingslike that.
Speaker 2 (38:11):
Yes, yes, yes.
Well, first of all, let's speakabout something that happens
before that, which is also veryimportant.
I've been in the industry forover 20 years and I speak with
investors all the time, with myclients and all that, and one
issue that always is a topic ofconversation is funding how to
(38:33):
get funding?
Because these are startups,they need to raise money
millions of dollars.
So I usually hear Chris thatfor every 100 pitches that
investors receive, they fund one.
All right, I'm an investor, Iget 100 people pitching their
(38:56):
startup to me and I invest inonly one.
That's.
That's a big ratio, right?
So meaning that the selectionprocess right off the bat from
the money funding side is verystringent.
They have to make sure itcomplies with a long checkbox,
(39:17):
long list of boxes to check,right.
So they have to make sure thereis a good regulatory pathway.
They have to make sure animaltrials are good, that you
presume it's not going to harmhumans, because if I'm an
investor and I'm going to investone, two or three million
dollars in a company, I betterdon't harm anybody because I'm
(39:39):
going to lose my money.
So there is a big first filterand then the second filter is
all right, that one company thatgot funded, that one company is
going to get reviewed by acommittee that has been trained
in international ICH, gcp, goodclinical practice guidelines,
which are guidelines that areissued by the World Health
(40:03):
Organization, not anyorganization in the corner.
I mean.
This is the World HealthOrganization that ensures that
everybody follows theseinternational guidelines for
clinical research.
So that ethical review board hascertain requirements the number
of individuals, the backgroundof the individuals.
Every individual has to have adifferent background so that
(40:24):
everybody can look at the trialfrom a different perspective.
So the review process is very,very stringent.
So after that is, of course,the investigator.
The investigator also is notgoing to get involved in a trial
where he or she thinks thatit's going to be a reputational
damage for him, for his hospital.
So everybody benefits fromhaving stringent reviews on
(40:49):
clinical trials.
So if an investigational drugor device gets to a human, many,
many people have gone throughthat and it's very likely it's
going to be it's not going toharm you.
I mean because this is veryimportant, chris.
One thing is safety, anotherthing is efficacy.
One thing is safety, anotherthing is efficacy.
So the most important thingthat the review board wants to
(41:12):
see is that the investigationalproduct is presumed or is very
likely to be safe.
It's not going to harm you Ifit's not effective, that's a
different story, right?
Speaker 1 (41:25):
Right, because it's not always efficacious.
It might be safe, but itdoesn't give them the end point
that they're looking for.
Speaker 2 (41:32):
Exactly, yeah, exactly.
Speaker 1 (41:34):
Well, that's a that's a really good perspective,
because I participated inclinical trials and it's been.
It was a good experience, oneof the ones I did that at the
drug actually went to mark, gotapproved and went to market.
So it's.
It gives you a good feelingthat you're you're helping
people.
And the thing I really likeabout what you and your company
are doing is speed.
Is your model something thatcould be applied globally,
(41:59):
expanded and applied globally toget to speed up clinical
research in general?
I mean, maybe that's too broadof a question, maybe.
Speaker 2 (42:07):
But yes, that's more a political question.
I think.
Yes, I mean, I think by usbeing involved in this industry,
chris, we can give regulators alot of advice in regards as to
what other countries are doing,what best practices really have
(42:33):
a global perspective.
Just an employee of theregulatory agency or somebody
who has a decision power, butjust within your jurisdiction,
you don't really have thisglobal perspective.
So I think we can contribute alot to create new laws or new
regulations to speed up clinicaltrials.
So yeah, I mean, but it's notsomething that you can ask a lot
(42:54):
.
I haven't had the country ofGermany ask me, julio, based on
your experience, what can we dobetter here in Germany?
I hope it happens.
Speaker 1 (43:02):
In terms of clinical research, where do you see
progress or what do you seehappening?
Speaker 2 (43:08):
Yes, yes, there are a few changes that I'm seeing.
One change that I'm seeing andthat is related to the question
that you just asked, is there isa new global site certification
and individual accreditationfor clinical research.
It's been around for about fiveyears now.
It's an organization out of theUK.
(43:28):
It's called the InternationalAccrediting Organization for
Clinical Research and they'redoing an extraordinary job
accrediting organization forclinical research and they're
doing an extraordinary job.
They were created by, they werecreated by the industry for the
industry, meaning IQVIA, cnu,health Park Cell.
All these big CROs push these tohappen, first in the UK, in the
(43:50):
national health system of theUK, so that all these sites of
the NHS were certified inclinical research excellence.
That work led this organizationto become global now and now is
available in many over 40countries.
So slowly it's getting to moreand more sites and that is
(44:13):
reassuring for patients.
That, because before this therewas nothing like this.
If you think about it, there'sreally no seal of quality for a
clinical research site and thisorganization in England was the
first to come up with with thisquality certification, again
created by the industry for theindustry.
That's's a big change.
(44:35):
The second change is AI.
As you said, ai is going totransform everything we do as
CROs, as research sites, ashospitals do when they recruit
patients, with these innovationsthat I just mentioned.
So I think it's going totransform the way research is
done.
Also, remote monitoring, I meannow we have all these tools to
(44:57):
have the patient not to come tothe hospital unless it is an
implantable device.
But you can do many diagnosticimages.
You can monitor heart rate andother biomarkers remotely.
You don't have to bring thepatient physically into the
hospital anymore.
Speaker 1 (45:17):
Is there things in terms of clinical research in
the next five years that you seeas breakthrough, or things that
might help improve people'slives?
Speaker 2 (45:30):
Yes, the fact that there is now an international
organization to certify theexcellence in clinical research
for sites.
That started in the UK and isnow globally available.
It's called the InternationalAccrediting Organization for
Clinical Research to ensure thatresearch sites comply with
global standards and was createdby the industry for the
(45:51):
industry.
So that's a big move in theindustry.
The second trend that I see isAI is getting everywhere in the
industry.
So that's a big move in theindustry.
The second trend that I see isAI is getting everywhere in the
industry.
As we said, it's getting intothe CRO business, it's getting
into the site operation, it'sgetting into patient-facing
material so that we can recruitand screen and recruit patients
(46:11):
faster.
And the third area that I see is, countries are understanding
that attracting clinicalresearch brings so many more
benefits than they previouslythought, right?
I've seen a lot of countries,especially in Latin America,
enacting new laws because theyrecognize that clinical research
(46:33):
is a catalyzer for science,technology and innovation local
in the country.
Because the analogy is like ifyou bring Messi to play soccer
with the local team in ElSalvador, the local team in El
Salvador will eventually becomeone of the best in the world,
right?
Because you can have thistransfer of knowledge from
(46:54):
somebody who is the best in theworld to the local players.
So the same thing happens withclinical research.
Clinical research is reallyinnovation in a nutshell.
I mean, you bring these trials,you bring new ways of doing
things, new therapies, newmethods and you get this
transfer of knowledge to thelocal investigators, and that
(47:14):
elevates communities and bringsmoney because you hire people
with higher salaries, with PhDs.
So it benefits everybody, notto mention the benefit to the
patient.
Because also, countries savemoney because the patient
treatment is being paid by thesponsor, not by the health care
system.
(47:34):
So it's a win-win for everybodyin the ecosystem in every
country.
So, yeah, that's what I see,okay.
Speaker 1 (47:40):
So if you could leave people that are listening that
have Parkinson's because that'swhat the channel is all about
what would you, in terms ofeither participating in clinical
trials or, if they want to getmore information, what's the
best from your perspective?
What's the best way to go aboutthat?
Speaker 2 (47:58):
Yes, I think with the new tools that we have now with
AI.
For example, the other day Ijust discovered a new tool
inside Perplexity.
It's called Task Task.
You can now set up an agentwithin Perplexity to give you
(48:19):
updates on whatever you want.
So if I am a Parkinson'spatient, if I'm always looking
for trials or new therapy forwhatever I have, I could
probably just set up an agentFind me every week or every
month or every quarter, find menew clinical trials for this
specific condition.
You just specify what you needand you're going to receive an
(48:42):
alert.
You're going to have somebodydoing research, a high IQ person
, which is really an AI agent,high IQ agent doing the research
that for a human is almostimpossible to do, for even a
specialist, even your doctor isnot going to be able to do the
(49:02):
level of research that an AIagent is able to do now.
And that's a tool that isavailable to everybody
Perplexity task.
Speaker 1 (49:13):
Great.
So can you provide a little bitof information about your
podcast, your blog and yourLinkedIn, where people might be
able to get in touch with you orjust follow you and learn more
about BioAccess and the greatthings that you're doing?
Speaker 2 (49:28):
Yes, chris, our website is
bioaccesslaforlatinamericacom.
Bioaccesslaforlatinamericacom,bioaccess la for latinamericacom
.
We are easily findable online.
Just do a search for bioaccessclinical trials or julio
martinez clark.
You're gonna find me onlinevery easily because I am on a
lot of podcasts.
(49:48):
I produce my own podcast, Iwrite a lot of articles and my
podcast is global trial acceler.
You're going to be able to findit on YouTube, on Spotify,
apple, et cetera, and LinkedIn,of course.
I'm very, very active onLinkedIn.
I have over 30,000 followers.
I post three, five times a daysomething new.
(50:09):
So, yeah, just do JulioMartinez Clark on LinkedIn.
Speaker 1 (50:15):
Great.
Well, it's been great.
I really appreciate you beingon today.
You're doing fabulous work interms of speed and helping to
push drugs and devices to themarket, and you should be
commended for that.
It's a great thing that you'redoing and helping people across
the world so is there anythingelse?
Speaker 2 (50:35):
Thank you for those words.
Speaker 1 (50:37):
Is there anything else that you'd like to leave us
with before we go?
I really appreciate the timeyou spent today.
Speaker 2 (50:44):
Absolutely Final words.
I just want to say that I amprivileged to be in this
industry because of the changethat I can make.
I've been in procedures withinvestigational medical devices
in Latin America where weimplant a device on a patient
and we change that patient's andhe or her life, her family
(51:08):
members' lives, just because ofwhat we did, and that's the most
important reward.
Seeing somebody's face,somebody walk when he or she
couldn't walk for years becauseof the back pain or whatever,
and seeing that transformationin their lives and their family
members' lives is just it makesyou cry sometimes.
(51:29):
So, yeah, I love this industry.
Speaker 1 (51:32):
Yeah, it's definitely a ripple effect.
It doesn't affect just oneperson, it affects their family,
and it goes on and on.
So you know, thank you fordoing what you're doing.
And one thing that I wanted totouch, just as we close here,
that you mentioned is never stoplearning.
I mean, you talked aboutlearning.
You know, you didn't knowanything about clinical research
(51:53):
, but you took the time to learn.
You didn't know anything aboutclinical research, but you took
the time to learn.
Speaker 2 (52:01):
So you know be a lifelong learner, and you know
always you know, try to.
you know, stay on to learn newthings.
Yes, exactly, Exactly.
Especially now, Chris, thatthings are happening so fast.
I think the pace of news andevents and technology evolution
that we're having in June 18th2025.
It's just too much.
(52:22):
So our lives are becoming verybusy.
Yes, yes, with all thisinformation.
So you have to be, correctly,as you said, a good learner, but
you also have to filterinformation.
You have to learn how to filterinformation, so that's another
skill that we all need to learn.
Speaker 1 (52:38):
Well, again, thank you for your time.
I really appreciate it.
I know you're a busy person andyou're doing great things.
Speaker 2 (52:43):
My pleasure, Chris.
Thank you for having me.
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