Accelerating Medical Research with Bioaccess CEO Julio Martinez-Clark

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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Chapters

• 0:00 Introduction to BioAccess and Julio Martinez-Clark
• 9:56 The Journey and Mission of BioAccess
• 18:30 Accelerating Clinical Trials: The Speed Factor
• 25:41 Navigating Regulations Across Different Countries
• 31:00 AI Applications in Clinical Research
• 42:20 Adapting to the Healthcare Industry
• 47:28 Benefits of Participating in Clinical Trials

Transcript

Speaker 1: 0:10

Hello and welcome to Live Parkinson's Live an Exceptional Life. I'm your host, chris Kustenbader, and I've been living an exceptional life with Parkinson's for the past 15 years. The purpose of this podcast is to help as many people as possible living with Parkinson's to lead a great quality of life. Now, today we're diving into a topic Parkinson's to lead a great quality of life. Now, today we're diving into a topic that's absolutely crucial for the future of healthcare, especially for conditions like Parkinson's. And to guide us through this vital conversation, we have an extraordinary guest. Joining us is Julio Martinez-Clark, the insightful CEO of BioAccess.

Speaker 1: 0:41

Julio is a true visionary in the world of global clinical trials, with deep expertise in medtech and biopharma. His company, bioaccess, is on a mission to accelerate medical innovation by focusing on bringing clinical research to emerging markets in regions like Latin America, eastern Europe and Australia. What makes BioAccess so impactful? It's our commitment to speed, cost-effectiveness and leveraging unparalleled regional expertise to get life-changing treatments to patients faster. Today, we'll explore how his work is not only transforming clinical trials, but also how cutting-edge technologies, particularly AI, are playing a pivotal role in this exciting evolution. Ai are playing a pivotal role in this exciting evolution. So get ready for a fascinating discussion on how we can truly live an exceptional life by understanding the very pathways that bring us new hope and therapies. So let's welcome Julio Martinez-Clark. Thank you for joining us. For those of you that may not be familiar with you, can you give us a little bit of a background on bioaccess and its core mission in clinical research?

Speaker 2: 1:44

Thank you, chris, for that very nice introduction. I feel honored, privileged to have that introduction. It's truly a pleasure to be here with you and share with the audience the journey that we've had at BioAccess and the breakthrough research that we are doing in different countries around the world. So, as a matter of introduction, I was born and raised in Colombia, south America. I moved to the US about 40-something years. I now live in Miami and that's the base of our company and the journey the bioaccess journey, really started with my brother, pedro.

Speaker 2: 2:24

He trained at Harvard as a cardiologist and then as an interventional cardiologist and then moved to Miami to become a professor at the University of Miami. And he met his mentor, dr William O'Neill, who is considered one of the top authorities in the world in interventional cardiology, and they worked together for many years and that work included advising many US medical device startups that were developing advanced cardiovascular technologies or devices and they traveled with them around the world doing trials, first in human trials, and they quickly realized that the CRO industry was very fragmented but there was really no CRO in the world dedicated to first-in-human clinical trials, at least for medical devices, at that time. Now we have expanded to other areas biopharma, radiopharma but medical device has been our focus for many, many years. Because we saw the opportunity. We saw a problem in the industry that needed to be addressed and Dr Roneo and Pedro came up with the idea to create a company outside of the university ecosystem. Because we really started inside the university. It was a small desk in the international patient department. You know a lot of international patients, especially from Latin America, traveling to Miami to receive advanced medical care at the University of Miami Hospital and that small desk was doing the work of a CRO. It wasn't really set up for that. So that's why Dr O'Neill and Petro decided to create BioAccess and then I took the leadership role in the company.

Speaker 2: 4:02

I got my MBA in Boston. I got my degree in electrical engineering in Colombia. I worked for a couple of global telecom and networking companies Lucent, nortel. I did business all over the world in Europe, in North South America. I was kind of a good fit for what Pedro and O'Neill wanted to build and fast track. Almost 20 years later, bioaccess is now the leading first-in-human contract research organization specifically helping startups, which is a unique niche because a larger pharma has different needs than a small startup of three people and just a few million dollars in the bank. With a breakthrough technology, you have to become a company. Bioaccess, the CRO, has to adapt to the needs of this clientele. So we consider ourselves a startup. We consider ourselves very nimble, very adaptable, very dynamic. We're a small team of about 40 people, but we have a global reach that can help these startups bring these innovations to market.

Speaker 1: 5:04

Yeah, so you have a strong focus on really accelerating clinical trials. Can you explain how you do it and what sets you apart from a lot of the other companies? Because I've worked years ago in clinical research, monitoring studies and things and a lot of times it was a slow, tedious process but you've been able to do it a lot faster in terms of patient recruitment and other things. So can you talk a little bit about that? Absolutely.

Speaker 2: 5:30

Chris. What happens is that the nature of our clientele demands that we deliver speed. That's really what we sell. We sell speed, we promise and we deliver speed. Speed, we promise and we deliver speed. Because if you understand the nature of the startup community, you're going to quickly realize that speed is of the utmost importance for these companies. And the reason is this when, when people talk about clinical trials, cros, they usually refer regular people on the streets. They usually refer to big pharma and medtech companies.

Speaker 2: 6:33

The journey of a medical device or biopharma or radiopharma startup usually starts at a university. They have research labs that produce intellectual property, a patent for a new molecule, for a new medical device, etc. So this patent needs to be developed right, because innovation does not mean anything if it doesn't translate into a commercial product that benefits humanity and impacts lives. So a patent does nothing in a drawer in an office in a university. So the university is always seeking entrepreneurs who can tap into the potential of the innovation and can build, have the leadership skills to build a team around it, can raise funds and can develop the innovation to the point where it is ready to be tested in humans right Before it gets tested in humans, it needs to go through preclinical lab testing, animal testing, cadaver testing and, of course, the big moment, the pivotal moment, is when they test or they validate the safety and efficacy of the innovation in a live patient, a live human. And that's really a pivotal moment of value creation for the company and the evaluation of the company increases dramatically if the results of that first in human trials are good.

Speaker 2: 8:08

Because the only purpose of these companies I mean these are investors. Right, everybody's for the money, of course. Everybody wants to benefit humanity, everybody have noble means, everybody wants to impact people's or patients' lives, but they all want to make some good money. So they invest money and time and resources in the startup and they have the hope of selling the startup to a larger buyer, right Like Medtronic, boston Scientific, or Merck or Pfizer in the case of Pharma. So that's really the cycle of innovation.

Speaker 2: 8:43

That's how the big players get fed with newer technologies, newer products and remain competitive in the market. So that's the cycle of innovation. So, if you analyze the needs of these startups, they have investors breathing on their neck, they have investors demanding results, they have business plans and they have timelines assigned to those business plans. So those milestones need to happen in certain dates, and that's why time is of the essence for these companies. They need to have a patient on a table for the device to get implanted and tested as soon as possible, so that they know if the device works or not, they know if they have to make changes to their prototype and if so, they have to raise more funds and continue their journey. Time is of the essence because they need to get acquired eventually and investors have to get their money back.

Speaker 1: 9:36

Would you be involved in all three phases? So phase one, two and three clinical trials for these startup companies then no, we get involved on.

Speaker 2: 9:44

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 market knows about us and you have a lot more competitors in later phases. So we prefer to navigate in a blue ocean where we have no competition because we have become so laser focused on first in humans that we have become probably the best in the world on this specific niche. So, yeah, usually we get involved in first in human trials and and the way we we make them happen faster is by looking at countries that have friendly regulations to get them approved faster and also doing a very diligent job in finding those investigators inside those countries that have the patient recruitment potential to complete the trials faster so you're able to leverage in your background 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 help you with your studies. Is that correct? Is that what helps you with the speed aspect?

Speaker 2: 10:52

The database is more of investigators, not necessarily patients. Investigators who can tell us if they can recruit patients fast enough or at the pace that we need for the study. We have developed a very large database. We have a large network of connections all over Latin America, australia, eastern Europe and as soon as I receive a study within hours, I can know where to go, what hospital has the patients, what investigators is 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 recruited and then the results are compiled, and then you can go back 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 60 days, in El Salvador also in about 60 days, in Chile also in about 60 days. This is record Globally speaking. This is record times within the Latin American region. We can do the same in Serbia, in the Balkans. I mean fast approvals in those countries as well, australia as well, even though there's a new proposed law that may change that. But we can get studies approved within 60 days and patients probably recruit a month later, because you know it takes time to get them come to the site, sign the informed consent and all that. But probably 90 days after submission 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 US as a patient and it was a year and a half. Well, the one study was a six-month double-blind placebo-controlled trial and then it went to open-label, which was another year and a half, so it was a long phase three clinical trial. So it sounds like the model you're using. Is it something that can be applied or expanded beyond the countries that you're typically in, or is it the regulatory environment that can really slow you down?

Speaker 2: 13:09

That's a very interesting question, chris. There are many factors why trials take too long in the United States for sites to activate, to get activated patients recruited, and all that. There are many factors. One factor is that in the United States, that there are many factors. One factor is that in the United States the way the healthcare system works is that we have this consolidation in the hospital systems. We have large hospital systems.

Speaker 2: 13:34

You have very few independent small hospitals. Right, you have HCA and all these big players that have HCA. I think I was reading the other week it has 184 hospitals across the United States, 2,000 locations including those 185 hospitals. So imagine you're trying to set up a meeting inside HCA, inside the hospital system, for a trial, hca inside the hospital system for a trial. So it will take you 20 phone calls, 20 emails to probably land one day before a meeting and then the meeting happens and then the bureaucracy, and then you have to talk to XYZ person and then the other person, then another meeting just to set up the study, not to mention the IRB approval process, because these institutions are risk-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 something risky studies, not to mention forcing humans. They don't want to get in forcing humans at all right, because of the reputational damage 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. The other factor is the FDA. It's uncertain, and this is the word that my clients have used. The uncertainty at the FDA level is just unbearable for a startup. You need to give investors certainty. By this date I'm going to have this milestone. If you don't have that certainty at the FDA, especially now with the political environment, the layoffs et cetera, then it takes too long to 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, $3 million in the bank they need to go overseas to find quicker ways to get sites activated and patients treated.

Speaker 1: 15:28

Okay, Well, with Parkinson's there's really people take medication, but then there's also the medical device piece where people get the deep brain stimulation surgery. Is there a difference in speed in terms of testing a compound for a new medication versus a medical device when you're doing it in these other countries?

Speaker 2: 15:49

Not really. Not really, although the regulations are a lot more stringent for molecules, for new drugs, than devices, because devices are kind of newer. So the regulation, the pace of updating regulations, is not the same as the pace of the industry. So usually you find countries that have very, very strong regulations for pharma, for molecules, but not so much for medical devices. So it's usually a little quicker to do a medical device study approved. But in general I wouldn't say that's the case. I mean, for example, in Panama, in Salvador, there's really no distinction, there's very little red tape, keeping quality and ethical standards. I mean the fact that the regulator approved faster doesn't mean that it's not a quality or ethical study. This is very, very important because our job is to deliver quality data and ethical data.

Speaker 2: 16:51

We wouldn't be in business if we were involved in countries with regulators that are not really doing their homework right and where sites are not following international ICI-GCP standards. So to answer your question more specifically, I will say that it doesn't make much difference. Sometimes, depending on the country, medical device studies are approved a little quicker. But no, I mean it's. And also it's also important to understand that in these countries, on top of the regulator being efficient. For example, if I pick up the phone and I call El Salvador, the regulator is going to answer the call. They're going to have a meeting with me because they want to bring trials to the country. It's not like in the US. You have to apply for a pre-sub meeting and wait until that happens. Probably the meeting is six months out. That doesn't happen in El Salvador. So that's one thing.

Speaker 2: 17:43

The other thing is that patients in Latin America are developing economies because of the way the health care system works, where on paper they have the right to access the system and be treated with dignity but in reality that's not the case and offer that participation to the patient. The patient will gladly say yes because they will receive an immediate benefit, which is access to the system. They're going to have all the blood tests that they haven't had done in five years. They're going to be able to access a specialist for their condition, a cardiologist, a neurologist, who is somebody they haven't been able to see in five years because the system makes it difficult for them to access these cardiologists or these specialists. So they're already receiving an immediate benefit. So they want to participate faster in these trials?

Speaker 1: 18:33

Do the startup companies that you work with? Do they request a specific region that you test this in, or are you free to go in order for the speed aspect? Maybe you have a better relationship in Latin America than you do in Australia, so do they give you the freedom to decide where to find the study investigator and run the study?

Speaker 2: 18:52

Yes, they give us the freedom, chris. However, if you look at these three areas in the world, there's really no compelling reason, except the one that I'm going to mention in a minute, why you will go that far to Eastern Europe or Australia and deal with the time difference, the flight times and the different cultures. If you have great options in Latin America where the flight time is short I mean from Miami, you're two and a half hours from most countries, same time zone and similar culture. So what we do is we offer options. But if you tell me, julio, yes, panama is great, salvador is great, dominican Republic is great, colombia is great, what you offer in Latin America is great.

Speaker 2: 19:44

But I love Dr Smith in Macedonia or in Australia. He went to school with me. I think he's the best candidate to lead the study. Sure, then we can set up the study in Australia If you have a compelling reason to go to Australia and have Dr Smith as your investigator. That happens a lot. Yesterday I had a call with a company, a US company, that wanted to do a study in the Dominican Republic and they have a willing and able investigator already identified in the Dominican Republic, probably somebody who they knew from the industry, or they went to school, with whatever reason. Sometimes the sponsor comes to me with a specific country in mind.

Speaker 1: 20:24

Now okay, is it your organization or the sponsor? Because most times when you're running a study, there's always some type of clinical research associate or something that goes and monitors the study and looks at the study paperwork to make sure that the protocol is being followed. Is that part of your group or is that part of the sponsorship group?

Speaker 2: 20:46

Yes, it's usually part of our group. That's a service that we provide. However, sometimes the sponsor wants to have a separate group. That happens occasionally but it's not that common. But it's usually our group because we're independent. We are in the middle between the sponsor and the site so we can carry out all these activities independently, without any vested interest.

Speaker 1: 21:11

Now, do you have people? Are they in the particular countries that you deal with, the people that work for you, the clinical research associates, or do they just happen that they travel when the study is set up?

Speaker 2: 21:21

A little bit of both. A little bit of both. Yes, no-transcript. Until the day of the implantation of the devices, until the day we're ready to implant the devices, dealing with the sponsor, having weekly meetings with the sponsor, he or she knows the protocol by heart. So it doesn't make any sense if we are ready to implant the device in the case of medical devices, if we're ready to implant devices.

Speaker 2: 22:15

The implantation of a medical device on a first human trial is a big big deal. The first patient is a big deal. So the ceo of the company travels from the States, the biomed engineer who designed the study or designed the device, and three more people, the proctor. Usually they have a proctor, a medical advisor from a top university or hospital in the United States John Hopkins, et cetera. They all travel together. So usually the team coming from the US is about five people, is about five people. And then we have our project manager. The physician that I just mentioned also travel with them to the hospital to be in the OR when the implantation happens, because he's the best individual to lead the process, the project. So it doesn't make any sense to have somebody local who has no clue about what's going on with the study. He or she is not going to keep up with the study or going to be updated with the study just by reading 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 know you also do a quality job. So at the end, at the conclusion of the study, how long does it take you to be able to take from when the study is initiated at the investigative site? They get the data and it's summarized and you get it back to the startup company so that they know is this a viable option to continue moving forward.

Speaker 2: 23:36

Well, the data is updated, Chris, to the electronic data capture platform in real time. In real time I mean the moment the first patient gets in, that data is uploaded, the CRF, the case report form, is electronic. We don't use paper anymore. I mean the study coordinators, hate paper, investigators, hate paper. So yeah, it's real time data. So as we go along recruiting patients, the database gets updated and the sponsor can do all the biostat analysis that they desire and they know exactly 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 big buzzword, not only in society, but also in healthcare. Is that something that you implement as part of your process for setting up a scheduling and setting up a study? Is there any AI used in that process?

Speaker 2: 24:36

Well, as you said, it's a word that is widely used now in the industry, but I would say that depending on where in the industry you look into, you're gonna have kind of different applications. In the CRO industry is inside our company. We are using AI to analyze documents. That's something that is bringing superpowers to our project managers, for example with translations. Now before we had a doctor, a physician, sitting in a computer for I don't know how many days, just comparing the english original version of the protocol to the spanish original version. Now that's done with a. So it's speeding up our process of putting together the right documents for studies before submission, writing letters to sponsors, to regulators. I mean, that's something that we are now doing with AI, so it's helping us a lot as a serial.

Speaker 2: 25:40

On the hospital side, I've seen applications where imagine you a large hospital in Colombia and they are running 50 different studies how do you know when a patient comes in in the regular consult of the hospital, not in the research department?

Speaker 2: 25:59

How do you know that that's a good candidate for the research department to be recruited department to be recruited right? So you use AI tools to match the inclusion and exclusion criteria with what is in the EMR electronic medical record of the regular activity of the hospital. So that's something that, with humans, is almost impossible to do, because you have to be on top of all the nurses, on top of everybody in the hospital, all the specialists. Hey, dr Smith, remember that we have this trial, and if you have 50 trials, he's not, she's not going to remember that, or the nurse is not going to remember that. So, with AI getting into the EMR and matching the daily activity of the hospital with what the research department is doing, then you're going to have alerts, you're going to have flags immediately at the research department. Listen, there's a person that just came through the emergency department. He's a good candidate for this XYZ study that you're running.

Speaker 1: 26:54

So do you have good applications, somebody that's like an AI specialist that sits in, you know, because a lot of it's prompts, so you have to put in 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 that right now with our research department. We have research department or a research site in Miami. My brother runs a very large medical practice cardiovascular practice and we're doing exactly that.

Speaker 2: 27:23

The other application, chris, that is worth mentioning here for the audience is patient recruitment. You know is a challenge in every clinical trial and our job is to make that faster and faster. So with AI we can now take a very complex clinical protocol right of 100 pages that's usually the length of our clinical protocol, as you know. You can now reduce that to an infographic that you can use in three different ways. Now you can explain the study in simple language to the study coordinator, that is, the head of the feasibility department of the hospital, because every time there is a new study it usually lands in the feasibility inbox of the research department and that individual is not a physician. Even if he or she is a physician and the study is in oncology and he's a general practitioner, he or she is not going to understand the complexity of the oncology study. Right, that individual needs to be fed with simple language information so that he or she, in the feasibility analysis of the study, can understand the scope of the study and can guide the study to the right investigator and say with certainty, yes, we can recruit patients, we have this type of patients. But if he or she doesn't understand the study, then the studies aren't going to get evaluated for feasibility at that site and that's a waste of resources, that's a waste of time and it's really bad that that's happened, because that hospital may have the patients, it's just that he or she didn't understand the study. So that's one barrier that we have noticed and we're working to create these documents very simple language documents for feasibility personnel.

Speaker 2: 29:08

The other area is investigators. Investigators are busy, specialists are busy, so you have to give them simple information. Don't give them a 100-page protocol. They're not going to read it. They have families, they have a job, whatever. So just give them an infographic with more technical information, more clinical information than the first individual that I just mentioned, right? And the other stakeholder is patients. When you're going to recruit patients, you give them a 50-page informed consent document. What patient is going to be able to understand that Illegalese, right? So, yeah, it's difficult. So just give them an infographic, very simple language, that any seven-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 new technologies and new breakthroughs that are coming out? I mean, you guys do such a great job with speed and you're able to deliver on specific timelines, but how do you, you know, because change is constant. Things are always changing, so how do you manage to? I mean, when do you have the time to sit and say, okay, let me see. I got to look down the road six months 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 is more 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 day long and I read a lot. When I socialize, I am usually with industry peers or clients, or my brother, pedro, who is a physician, so I'm always kind of in the loop. I read at least probably 10 newsletters every day. Ai mostly now are AI newsletters, of course, on top of the news and stuff. But I don't watch news, I just receive a summary of the news and, of course, many newsletters that keep me on top of AI developments, regulatory developments and also talking to a sponsor, I talk to CEOs of medical device biopharma companies almost on a daily basis. So I also have a podcast. So on the podcast I interview leaders of the industry and they teach me so much. So I'm always kind of on the loop. It's just an organic thing. It's not that I force it, just organic.

Speaker 1: 31:32

I'm fascinated. You talked about being an electrical engineer and then getting your MBA. Was it difficult to make that transition 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 word challenging, because I like to say that what you get from schooling, whatever schooling you have, is the ability to learn and adapt that's really what you learn and to synthesize and put together information and come to conclusions. So I came from the telecom and networking industry. I was clueless about the clinical research and the medicine industry or healthcare industry in general, and when my brother approached me about this opportunity, I said yes, because first it was my brother.

Speaker 2: 32:38

The 2000 bubble bust or dot-com bubble bust crisis, where a lot of dot-com companies went bust, I was part of it. I mean, my industry was part of it. I was working for losing at that time and the layoffs were terrible, so I had no job. I was in an industry where there was really not many opportunities for somebody like me, so I had to adapt and my brother came along with this opportunity. I'm like interesting, why not? So I had to learn everything from scratch and it was challenging. I had to search online and that's really the genesis of my podcast, because I was getting from clients usually the same questions and I was doing a lot of research online. I couldn't find information online about the clinical research industry. I didn't even know how to put together a proposal for a clinical trial. I didn't even know what a clinical trial agreement was, so I had to research all that online. And we're talking about almost 15, 20 years ago, where the internet wasn't as developed as it is now. Now we charge GPT, you find everything so easily, but before it was more difficult. So how do you create a proposal for a CRO, proposal for a new study, if you've never done it before? Imagine 20 years ago. So it was kind of a hit and miss, try and error. We made mistakes, but we learned from those mistakes and that's what makes us better now.

Speaker 2: 34:03

And going back to how my blog and my podcast got started and how I got started writing articles, because I saw all those questions from my clients, I couldn't find answers. Because I saw all those questions 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 certain topics. And then I came across a publication called Medivice Online and the chief editor found me on LinkedIn and he liked what I was posting on LinkedIn and he's like Julio, you seem to like writing. Can you write an article for us as a guest columnist? I'm like sure, yeah, what a challenge. Nice, that's a great honor to be invited, and I put together my first article and since then I've written like 25 articles so, and that gives me a lot of visibility.

Speaker 2: 34:55

But one day I was writing one article about the UMDR and I couldn't find anything about the topic. I mean very little information about the topic. Chris and I was forced to interview over 40 people. So I just created a LinkedIn campaign to send messages to to people in the medical device industry to invite them for a 20-minute interview. And that was a transformative moment because I was able to speak with all these leaders and I was able to learn so much from them.

Speaker 2: 35:25

And I realized, chris, that people have so much knowledge and information and experience in their heads that is nowhere to be found. So how do you make it available to newer founders or newer CEOs or to the industry, so that the listeners or readers don't make the same mistakes? Because if already somebody made a mistake, why are you going to repeat the same mistake if you already know how to navigate those waters right? Or are you going to get through those waters if somebody told you already that there's a better way? So that's really the genesis of my podcast. I decided to create a platform where I could speak with people all day long, and that's what I do now.

Speaker 1: 36:04

So your podcast is Global Trial Accelerators correct, and so I know the people in the Parkinson's community are always looking for resources and information. That would be a good source to go to to listen and to learn, because a lot of times I think people are hesitant to participate in clinical trials because they're unsure of what the process is, and you know and yes you know they're so, I think, listening to your podcast, but also do you have any recommendations for people that are listening to help ease their mind about participating in clinical trials?

Speaker 2: 36:41

Well, I would say that participating in clinical trials, it has different connotations. The first connotation is your individual benefit. Benefit, of course, you're going to be able to have access to a new therapy that is research. Because if you're attracted to the clinical trial, it's because you're running out of options, right, commercially available options, so you have to look for experimental options. That's one thing, and you're going to receive a benefit. The other benefit, or the other bigger thing, is helping humanity, helping research advance, helping healthcare advance and helping your fellow, your neighbor, right. So it's a beautiful thing thinking about clinical research in that aspect. If I participate in a trial, I'm helping humanity, I'm helping millions of people that are 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 always inherent 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 review processes until it gets to that point. And you know, that's what I wanted if you could talk a little bit briefly about that, so that people understand that they just don't say, oh, we have this 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 things like that.

Speaker 2: 38:11

Yes, yes, yes. Well, first of all, let's speak about something that happens before that, which is also very important. I've been in the industry for over 20 years and I speak with investors all the time, with my clients and all that, and one issue that always is a topic of conversation is funding how to get funding? Because these are startups, they need to raise money millions of dollars. So I usually hear Chris that for every 100 pitches that investors receive, they fund one. All right, I'm an investor, I get 100 people pitching their startup to me and I invest in only one. That's. That's a big ratio, right? So meaning that the selection process right off the bat from the money funding side is very stringent. They have to make sure it complies with a long checkbox, long list of boxes to check, right. So they have to make sure there is a good regulatory pathway. They have to make sure animal trials are good, that you presume it's not going to harm humans, because if I'm an investor and I'm going to invest one, two or three million dollars in a company, I better don't harm anybody because I'm going to lose my money. So there is a big first filter and then the second filter is all right, that one company that got funded, that one company is going to get reviewed by a committee that has been trained in international ICH, gcp, good clinical practice guidelines, which are guidelines that are issued by the World Health Organization, not any organization in the corner. I mean. This is the World Health Organization that ensures that everybody follows these international guidelines for clinical research.

Speaker 2: 40:13

So that ethical review board has certain requirements the number of individuals, the background of the individuals. Every individual has to have a different background so that everybody can look at the trial from a different perspective. So the review process is very, very stringent. So after that is, of course, the investigator. The investigator also is not going to get involved in a trial where he or she thinks that it's going to be a reputational damage for him, for his hospital. So everybody benefits from having stringent reviews on clinical trials. So if an investigational drug or device gets to a human, many, many people have gone through that and it's very likely it's going to be it's not going to harm you. I mean because this is very important, chris. One thing is safety, another thing is efficacy. One thing is safety, another thing is efficacy. So the most important thing that the review board wants to see is that the investigational product is presumed or is very likely to be safe. It's not going to harm you If it'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 it doesn'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 in clinical trials and it's been. It was a good experience, one of the ones I did that at the drug actually went to mark, got approved and went to market. So it's. It gives you a good feeling that you're you're helping people. And the thing I really like about what you and your company are doing is speed. Is your model something that could be applied globally, expanded and applied globally to get to speed up clinical research in general? I mean, maybe that's too broad of a question, maybe.

Speaker 2: 42:07

But yes, that's more a political question. I think. Yes, I mean, I think by us being involved in this industry, chris, we can give regulators a lot of advice in regards as to what other countries are doing, what best practices really have a global perspective. Just an employee of the regulatory agency or somebody who has a decision power, but just within your jurisdiction, you don't really have this global perspective. So I think we can contribute a lot to create new laws or new regulations to speed up clinical trials. So yeah, I mean, but it's not something that you can ask a lot. I haven't had the country of Germany ask me, julio, based on your experience, what can we do better 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 see happening?

Speaker 2: 43:08

Yes, yes, there are a few changes that I'm seeing. One change that I'm seeing and that is related to the question that you just asked, is there is a new global site certification and individual accreditation for clinical research. It's been around for about five years now. It's an organization out of the UK. It's called the International Accrediting Organization for Clinical Research and they're doing an extraordinary job accrediting organization for clinical research and they're doing an extraordinary job. They were created by, they were created by the industry for the industry, meaning IQVIA, cnu, health Park Cell.

Speaker 2: 43:45

All these big CROs push these to happen, first in the UK, in the national health system of the UK, so that all these sites of the NHS were certified in clinical research excellence. That work led this organization to become global now and now is available in many over 40 countries. So slowly it's getting to more and more sites and that is reassuring for patients. That, because before this there was nothing like this. If you think about it, there's really no seal of quality for a clinical research site and this organization in England was the first to come up with with this quality certification, again created by the industry for the industry. That's's a big change.

Speaker 2: 44:35

The second change is AI. As you said, ai is going to transform everything we do as CROs, as research sites, as hospitals do when they recruit patients, with these innovations that I just mentioned. So I think it's going to transform the way research is done. Also, remote monitoring, I mean now we have all these tools to have the patient not to come to the hospital unless it is an implantable device. But you can do many diagnostic images. You can monitor heart rate and other biomarkers remotely. You don't have to bring the patient physically into the hospital anymore.

Speaker 1: 45:17

Is there things in terms of clinical research in the next five years that you see as breakthrough, or things that might help improve people's lives?

Speaker 2: 45:30

Yes, the fact that there is now an international organization to certify the excellence in clinical research for sites. That started in the UK and is now globally available. It's called the International Accrediting Organization for Clinical Research to ensure that research sites comply with global standards and was created by the industry for the industry. So that's a big move in the industry. The second trend that I see is AI is getting everywhere in the industry. So that's a big move in the industry. The second trend that I see is AI is getting everywhere in the industry. As we said, it's getting into the CRO business, it's getting into the site operation, it's getting into patient-facing material so that we can recruit and screen and recruit patients faster.

Speaker 2: 46:12

And the third area that I see is, countries are understanding that attracting clinical research brings so many more benefits than they previously thought, right?

Speaker 2: 46:26

I've seen a lot of countries, especially in Latin America, enacting new laws because they recognize that clinical research is a catalyzer for science, technology and innovation local in the country.

Speaker 2: 46:38

Because the analogy is like if you bring Messi to play soccer with the local team in El Salvador, the local team in El Salvador will eventually become one of the best in the world, right? Because you can have this transfer of knowledge from somebody who is the best in the world to the local players. So the same thing happens with clinical research. Clinical research is really innovation in a nutshell. I mean, you bring these trials, you bring new ways of doing things, new therapies, new methods and you get this transfer of knowledge to the local investigators, and that elevates communities and brings money because you hire people with higher salaries, with PhDs. So it benefits everybody, not to mention the benefit to the patient. Because also, countries save money because the patient treatment is being paid by the sponsor, not by the health care system. So it's a win-win for everybody in 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's what the channel is all about what would you, in terms of either participating in clinical trials or, if they want to get more information, what's the best from your perspective? What's the best way to go about that?

Speaker 2: 47:58

Yes, I think with the new tools that we have now with AI. For example, the other day I just discovered a new tool inside Perplexity. It's called Task Task. You can now set up an agent within Perplexity to give you updates on whatever you want. So if I am a Parkinson's patient, if I'm always looking for trials or new therapy for whatever I have, I could probably just set up an agent Find me every week or every month or every quarter, find me new clinical trials for this specific condition. You just specify what you need and you're going to receive an alert. You're going to have somebody doing research, a high IQ person, which is really an AI agent, high IQ agent doing the research that for a human is almost impossible to do, for even a specialist, even your doctor is not going to be able to do the level of research that an AI agent is able to do now. And that's a tool that is available to everybody Perplexity task.

Speaker 1: 49:13

Great. So can you provide a little bit of information about your podcast, your blog and your LinkedIn, where people might be able to get in touch with you or just follow you and learn more about BioAccess and the great things 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 bioaccess clinical trials or julio martinez clark. You're gonna find me online very easily because I am on a lot of podcasts. I produce my own podcast, I write a lot of articles and my podcast is global trial acceler. You're going to be able to find it on YouTube, on Spotify, apple, et cetera, and LinkedIn, of course. I'm very, very active on LinkedIn. I have over 30,000 followers. I post three, five times a day something new. So, yeah, just do Julio Martinez Clark on LinkedIn.

Speaker 1: 50:15

Great. Well, it's been great. I really appreciate you being on today. You're doing fabulous work in terms of speed and helping to push drugs and devices to the market, and you should be commended for that. It's a great thing that you're doing and helping people across the world so is there anything else?

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 time you spent today.

Speaker 2: 50:44

Absolutely Final words. I just want to say that I am privileged to be in this industry because of the change that I can make. I've been in procedures with investigational medical devices in Latin America where we implant a device on a patient and we change that patient's and he or her life, her family members' lives, just because of what we did, and that's the most important reward. Seeing somebody's face, somebody walk when he or she couldn't walk for years because of the back pain or whatever, and seeing that transformation in their lives and their family members' lives is just it makes you cry sometimes. So, yeah, I love this industry.

Speaker 1: 51:32

Yeah, it's definitely a ripple effect. It doesn't affect just one person, it affects their family, and it goes on and on. So you know, thank you for doing what you're doing. And one thing that I wanted to touch, just as we close here, that you mentioned is never stop learning. I mean, you talked about learning. You know, you didn't know anything about clinical research, but you took the time to learn. You didn't know anything about clinical 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.

Speaker 2: 52:03

you know, stay on to learn new things. Yes, exactly, Exactly. Especially now, Chris, that things are happening so fast. I think the pace of news and events and technology evolution that we're having in June 18th 2025. It's just too much. So our lives are becoming very busy. Yes, yes, with all this information. So you have to be, correctly, as you said, a good learner, but you also have to filter information. You have to learn how to filter information, 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 and you're doing great things.

Speaker 2: 52:43

My pleasure, Chris. Thank you for having me.