Accelerating Clinical Trials in Emerging Markets

0:00 Welcome to Doctor Podcast episode #119 and I'm your host as usual, Doctor Robert Sicard, Please like, subscribe, repost, and share this podcast and Doctor podcast so we can have more great guests like we have today. Today we're discussing a very important topic, and that topic is clinical trials required for approval of new drugs and medical devices by the FDA and other regulatory agencies. This is a complex matter and many people don't understand it, but after today, you're all going to be experts on it, I assure you.

0:37 And we're thrilled to have and chat with an expert in this area, Julio Martinez Clark. He's the innovative founder and CEO of Bio Access, which is AUS based contract research organization or CRO dedicated to accelerating first in human early feasibility and pivotal medical device trials in Latin America, Eastern Europe and Australia. With over 15 years of hands on experience, Julio has empowered more than 120 medtech, biopharma and radiopharma companies to generate crucial clinical evidence, streamline regulatory approvals and secure first commercial sales in emerging markets, all while emphasizing faster enrollment cost savings, which are critical, and diverse patient populations, which is also very important and learning more and more about that over the years.

1:38 Beyond his CEO role, Julio serves as President of IAOCRGCSA Americas and the Association for the Advancement of Clinical Research in Columbia, known as Avanzar, where he champions the growth of clinical research infrastructure and ethical standards in the region, which are also very important. He's also a prolific thought leader on this subject. He's a frequent keynote speaker, guest on over 25 different podcasts, including this one and host of the Global Trial Accelerators podcast as well. And he's also a contributing writer for outlets like Med Device Online and Clinical Leader, where he shares insights on medtech innovation and global patient access through his expansive 30,000 member LinkedIn network.

2:30 Now Julio's the work extends to mentoring Latino professionals in biotech via Latinos in Bio, advising on disruptive innovation at Stetson University, and publishing in depth articles on clinical trial landscapes in countries like Argentina, Colombia and El Salvador, making him a go to expert on capital efficient pathways for health tech startups. So, Julio, I could go on and on with your credentials, but I have lots of great questions to ask you. First, I want to thank you for taking the time to join us today to discuss the important topic of clinical trials.

3:11 You are Robert, thanks for having me here. It's a pleasure to share my experience and knowledge with your audience. All right, so let's start first by telling us what is a clinical trial and why are they necessary for the FDA to approve drugs and devices and what do clinical trials accomplish? Well, Robert, very few people really understand what's behind the engine behind medical innovation and the COVID pandemic kind of a put the clinical trial thing on the spotlight. It was in the news and everything.

3:53 And I think it was a breakthrough moment where people in the US and all over the world started really grasping what a clinical trial is, which in essence, for every drug or device that is commercialized in any country around the world, it has to go through certain phases of clinical validation, right? Clinical meaning validation in live humans in patients versus preclinical, preclinical meaning animal and Caterpillar testing or validation. So usually a company, any startup company or or pharma company that is involved in the development of a new medical product, they have to go through all these phases.

4:48 The two big faces are preclinical validation and then clinical validation. And each one of these two big, big buckets, they have their faces, right. You have to do sometimes bench testing, mini animal testing. You choose a model, you choose a rat or a model or you choose a monkey model, whatever fits your your specific product. And you do several of those. And then sometimes you do kind of testing and then you move on to the next big phase, which is the clinical testing or the clinical validation, which means that you have to also go through phase one, which is a small subset of patients where you validate the safety and efficacy of the innovation.

5:42 And then you go to the second phase, which is a larger subset of patients and then the third phase, which is a significantly larger set of patients. That gives you the right to get the commercial clearance if of course the FDA or the Regulatory agency in in the country of choice is satisfied with the results of the study, the, the, the safety and efficacy of the of the study. So that's the definition of clinical trials is basically the validation, the clinical validation in humans safety and efficacy of a drug or a device before it gets put into the market.

6:25 Right now, at each one of those phases, the company that's doing the clinical trials has to provide the FDA with data that they get so that they can move on to the next step. Is that right? Yes, absolutely. Yes, exactly. The, the FDA will set certain requirements on the data, meaning the FDA will tell you something like all right, for me to approve based on the risk classification of these product or the risk profile. I need you to do 300 patients and I need you to do 50% of those patients in the US, 50% you can do outside of the United States or 70308020.

7:10 You kind of negotiate with the FDA that percentage. And the FDA will also impose on you the design of the clinical testing, the clinical trial meaning the amount of subjects, the the amount of sites and as I said, the percentage of the data that that has to come from U.S. hospitals or sites. Right now, we've all heard that clinical trials take a long time and are very expensive. On the average, how long does it take to get a new drug approved starting from the first phase where you check it in the laboratory, do animal testing, and then go on through the three phases of human clinical testing?

7:59 Yes. The numbers that I see in the industry and around the Internet when you read about this topic is usually 10 years and $10 billion. So it's a very expensive proposition for a pharmaceutical company to bet on the success of a drug. Many drugs don't make it, but they still have to invest that money because it's kind of a spray and pray type of thing where you, you, you, you put money into different drugs or different devices hoping that one is gonna really, really make it. So it's gonna just take it out of the stadium.

8:37 Right. And they take many years and and very expensive. Do you know approximately what percentage of pharmaceutical products or drugs eventually get approved? From the starting point, what percentage get approved? Yeah, very small. I think it's around 10% if I remember correctly. Yeah, Yeah. So for most companies, they need to always be researching, well, drug discovery, which is the first phase. They're always looking for the discovery of new drugs. They're always looking for trials for these new drugs to see which one is the one that's going to make it to the market.

9:21 Right. So the pharmaceutical companies are always telling us that it's very expensive to get these drugs approved and that's why they charge so much money for for new drugs. And I guess it, it sounds like they are extremely expensive to get through and with only a 10% approval rate, they've invested huge amounts of money to get one out of 10 drugs approved. Now you mentioned earlier that the clinical trials on humans of phase one through 3 can be done in other countries in addition to the USA. How does the FDA decide what percentage of the the humans that are the drug is being tested on is in the USA versus being done in Latin America or Europe or Australia or other parts of the world?

10:14 Yes. First of all, the USA, I'm sorry, the FDA will look at the profile of the product and determine if the the population that will benefit from this drug is gonna be found in the United States. If the population is not gonna be found in the United States for some XYZ reason because of diversity nowadays you have to follow a diversity plan. And if that diversity plan cannot really be fulfilled in the United States for XYZ reason, then the FDA will be more open to accepting foreign clinical data.

10:57 And also the FDA will look at the the way medicine is practiced in different countries. So if the way the drug is gonna be used or the device it's gonna be used in the US is very particular for the US healthcare system, then the FDA will probably lean more towards a larger percent of the data coming from the US. But if it is gonna be a universal drug or device that can be tested anywhere around the world, of course, the FDA will be more open to, to the possibility of having poor and clinical data.

11:35 And you as as the pharmaceutical company or the medical device company, the sponsor, that's the terminology, the sponsor of the clinical trial, you are very much interested in having a larger percentage of the subjects that participate in clinical trial coming from overseas because overseas is easier, faster and cheaper to do these clinical trials. And that's why about 50% of so Robert of the clinical trials around the world happen outside the United States. Well, that's interesting. By the way, when we say FDA, we're talking about physician and other biochemistry experts and various types of experts at the FDA who review this.

12:22 So they they are experts in the field and they make those decisions. Yeah, that's interesting because, you know, one of the criticisms of clinical trials in in recent years has been that they are not diverse. They were. Most of them used to be done in in white males. Yes. Weren't really tested on females, weren't tested on black patients or brown. Yes. So now there's more emphasis on diversity because sometimes the drugs or devices can work differently on on different types of people. So that's why it's it's important to spread it out all over the world.

13:00 Yes, there is a genetic component on the behavior of a of a drug on, on, on on patients and you need to make sure that the the the effectiveness of the drugs is going to benefit multiple the population in the United States or what is going to be solved. Yeah, right. Yeah. If you only tested on white men, you don't know what the effects are. Exactly and. Other people now I mentioned earlier CRO or contract research organization, can you explain what that is and how you're involved with that? Yes, Robert, the industry, the pharmaceutical medical device industry has a core business which is to come up with new products or molecules or devices.

13:57 So that's really the core business and to sell them, right. So there's a process of research and development and then commercialization. And years ago, about 25 years ago, the big Pharmaceutical industry is called big pharma. They realize that their core business is their core business. I mean, they're not in the business of setting up clinical research clouds around the world. It's a global industry. So their core business is to do research, do drug discovery and research and development, but internal research, meaning Preclinical Research, although that's also outsourced to third parties.

14:47 So what I'm saying is that the industry, call it pharma or device industry, they outsource to third parties what is not really part of their core business. So meaning clinical research. Clinical research, the testing in humans is usually outsourced to third parties, even animal testing. Sometimes they outsource to companies like Charles River Labs, ETC, which are called contract research organization. But for preclinical testing in the case of Charles Rivers Labs, which is the leader in the world.

15:20 However, for clinical testing, there are many companies also called contract research organizations, where the pharmaceutical company, the big pharma company Merrick, Pfizer, Novoris, or in the case of medical devices, Medtronic, Buster Scientific, Johnson and Johnson Striker, They outsource the execution of a clinical trial. Meaning that there are many, many activities that involve setting up a clinical trial. Meaning, for example, you have to find a site around the world or a number of sites around the world where you can test the product, the medical product.

16:07 You have to obtain regulatory approvals for these trials. And before that, of course, you have to translate all these documentation to the local language. And you also have to end regulatory approval, meaning you have to submit for ethical evaluation and approval according to international standards for clinical research to the different ethics committees that are gonna approve the study to be done on their their population in the area of influence. And also you have to go to the Ministry of Health or the Regulatory agency, the FDA's of the other countries.

16:46 For example, in Mexico, the FDA is called CAR Fepris, in Brazil is called and these are in Colombia is called in Dimas. So every country has its own FDA, so to speak. So that study needs also to be approved by those regulatory agencies or Ministry of Health. So and after that approval happens, then somebody needs to manage the study and ensure that it's the research site, the hospital recruits patients and and etcetera, etcetera. And also somebody needs to ensure that the reporting of adverse events happen because nothing is perfect.

17:25 Sometimes there are adverse events, zeroes and non zeroes that need to be reported, etc, etc. So what I'm saying with all these is that there is a set of activities that need to happen for a study to be executed anywhere around the world, even in the United States, right? So if you go outside of the United States, it's even more important to have a third party who helps you with that layer of activities. That is not really your core expertise because you are just the sponsor of the clinical trial, you are the manufacturer, You are not right in the business of finding sites and managing study.

18:04 So going back to my initial comment, Robert, about 25 years ago, the industry realized that this should be a layer, somebody in the middle, a middle layer between the pharmaceutical company or the sponsor of the clinical trial and the research site at the bottom. Meaning that somebody can be like the orchestrator of the execution of the clinical trial, somebody in charge of finding the sites, getting the approvals, importing the investigation approach in the different countries or the logistics related to placing the products in the different hospitals and sites, managing the study, etcetera, etcetera, right.

18:46 So that layer is called the clinical research organization in space or industry. And there are big players and smaller players. There are big players like IQVIA, PPD, Parxel, LabCorp, These are huge multi billion dollar global companies that work for big pharma, right, Hoping big pharma execute trials. And there are also smaller companies like us. We are a kind of a boutique clinical research organization mostly focused on 1st in human trials for medical devices and biopharma. And now we are very excited to also be involved in radio pharmaceutical research.

19:26 So yes, to conclude, it's just the Contra research organization is a multi billion dollar industry that supports the work of of the sponsors of clinical trials in the execution of the clinical trials. Right. So without you, without the CRO that the pharmaceutical or device company would not be able to go from research and development to commercialization. You're you're. Exactly. Yes, yes. And they can't do it because they don't have expertise in that they. Don't have expertise? Exactly. All the expertise, all the talent, all those skills are usually in the CRO layer.

20:03 So tell us about your journey funding bio access in 2010 and how it evolved into a specialized hero with assets like 250 plus audited sites, bilingual teams and a proprietary investigator database across 14 countries. How did how did you get that done? Well, Robert, the origin story is intriguing because it was a combination of factors that were not supposed to happen. I was born and raised in Colombia, South America, and I left the country many years ago. And my brother Pedro, who is 2 years younger than I am, he is a physician.

20:49 He trained at Harvard as interventional cardiologist. He trained at the Beth Israel Medical Center at the Harvard Medical School in Boston, and he was able to get accepted in these prestigious, as you know, you're a physician, this prestigious fellowship program where very few people are chosen out of thousands of people who apply every year. So that put him in a very unique position where very few Latin Americans have ever been in. So he was able to see the world from a different perspective, the the medical work from a different perspective.

21:28 That was easier for a typical Latin American like us. And after he completed his fellowship training in Boston, he moved to Miami and became a professor at the University of Miami. And that's where the pivotal moment really happened because he met his mentor is Doctor William O'Neill. Bill O'Neill. He's considered Robert one of the top authorities in interventional cardiology in the world. So they got along really well. They became really good friends and and colleagues. Even today they they talk almost on a weekly basis.

22:05 And O'Neill, since he was respected a physician, he was hired by many set up companies that were developing advanced cardiovascular technologies, more specifically structural heart devices and that they needed his advice in the preclinical and and clinical validation and also the design of the devices. So O'Neill brought Pedro into that space, into that kind of a activity of advising these companies. And they travel around Latin America doing first in human trials. And they quickly realized, Robert, that there was really nobody helping these companies in the execution of these clinical trials.

22:55 It is first in human trials for advanced cardiovascular devices. They were doing the work in Colombia. They started very small in Colombia and inside the university, they had a University of Miami, they had an international patient office, which just is not really set up to be acroa Contra research organization. It's just an international patient office that helps foreign patients, especially for Latin America, come to the US to receive advanced care. But it was the only thing, the only office that the university had kind of set up for international clinical activities.

23:33 And that office was just a small desk in essence. And they saw the need, because of the demands of clinical work from US start-ups, they saw the need to create something bigger outside of university. And that's really the genesis of Bio Access. They, they, they started doing trials in the cardiovascular space and then Bio Access got started. I took the leadership of the company in 2010. And since then, we've grown the company exponentially to what it is now. And we have also expanded to different therapeutic areas, ophthalmology, oncology, peripheral vascular devices, surgery devices, urology, neurology, etc, etc. Wow, great story.

24:23 It starts by just coincidence and leads to something very huge like this. So why has Latin America emerged as a prime destination for first in human and early feasibility studies in medical devices, especially as compared to hubs like the United States or in Europe, the EU? Well, what happens, Rob, is that the way the system works in the United States is that is expensive to execute these type of trials. Everybody knows that the health care system in the United States is famous for being expensive, right?

24:58 A procedure in the US cost probably triple what it cost in other places around the world. Really. Triple wow. And yeah, yeah, that's why you have a lot of medical tourism. There are a lot of US patients going to Mexico, to Colombia, Dominican Republic for dental care, for plastic surgery and other treatments because they want to save money. Anyway, the point is that in the United States, it's expensive. It's difficult to recruit patients. It takes too long to get these studies approved at the IRB level in the hospital because in the US we have these large hospital systems.

25:46 So you have to navigate the bureaucracy of these systems and have meetings after meetings after meetings to agree to do a study. So that takes a while. And also at the FDA level, it takes a while to get these trials approved because they are very risky. So all these factors, Robert, make these companies explore options overseas where they can activate sites or they can recruit patients faster, easier and cheaper, right? Because remember, these are start-ups, start up companies that start at a university in the United States.

26:24 They are usually a spin off of a university. They raise 2 or $3,000,000. They have three to five team members and they are on a race to produce results because they are investors behind them. They want a return on their investment. So every minute counts for these startups and they're cash strapped. And also it's important to mention to the audience that these startups are created with one single goal, goal in mind, which is to get acquired to be sold to a larger company like Medtronic, Bozo Scientific, Johnson and Johnson, or in the case of pharma, Pfizer, Merck, Nobodys.

27:07 Because that's how the big players get innovation in their portfolio. They remain competitive. So the startup gets get incorporated, usually in Delaware. They get funded, they build a team around the company and they build a beautiful business plan with timelines, very specific timelines and everything and milestones. And they need to do a first in human testing to make sure that their investors are happy because they they need to raise a second round of funding for a lawyer study. They also need to speak with the potential buyers.

27:47 I'll assume as they do a first in human trial, they speak with the potential. It's strategic. That's the word they use in the industry because they're looking for an exit. That's really the terminology in the investment banking world and the M&A world. And they also speak with the FDA once they get the results of the first human trial. So Latin America is just close to the United States, it's geographically speaking, same time, so on pretty much. And you have short flights from Miami, you can be in Colombia, in Panama and Dominican Republic in two, 2 1/2 hours.

28:25 So you have cost savings, meaning that you can do these procedures to implant the devices for way less than the United States, a fraction of what it costs in the United States. And, and also you can get these trials approved really, really quickly in countries like Panama. You can get these trials approved in 15301660 days versus a year or two in the United States. So all these benefits and make startup companies go overseas for first in human research. Wow, that's very interesting. So the startup companies basically are just looking to sell out most of the time to one of the giant companies and so the quicker and cheaper they can get the studies done, the better.

29:14 Makes sense. Now the I always wonder how the FDA monitors all these trials in the USA. That's tough enough 'cause there are probably hundreds or thousands of them going on all at the same time. How does the FDA monitor trials that are going on in Colombia or Chile or Dominican Republic, other countries in Latin America? How do they do that? Or they do, they just rely on the equivalent FDA Regulatory agency in these countries that they're doing the right thing? Well, there is something called ICHGCP that stands for Good Clinical Practice, OK, Good Clinical Practice GCP, meaning that there is a, the, the the World Health Organization manages these guidelines called GCP Good clinical practice that are standard around the world.

30:15 They started about 70 years ago and they have been evolving and that's kind of the standard, universal standard on how to do human research. So most developed countries, most decent countries around the world have adopted these international guidelines. So that's a good thing because now we all speak the same language. So data that is gathered from patients in Peru is the same data, meaning that it was captured following international guidelines as data from Mexico or from South Korea. Cuz everybody follows the same guidelines.

31:00 The FDA will accept any foreign clinical data or domestic data as long as the data was captured following international guidelines, UCP guidelines. So the boarding of proof is on you as the sponsor of the clinical trial to show the FDA that you got your study approved at an IRB that follows international guidelines. The guidelines establish how the members of the IRB are set up, the diversity of the members, the number of members, the training of the members have must have things like that. So it's the only way that the FDA has to ensure that the data is valid.

31:47 But it's impossible for them to inspect or monitor every single site. They trust that the sponsor is doing the right thing because everybody wants to produce quality data for submission purposes, because everybody wants to product the product in the market. Nobody wants a recall, nobody wants to harm patients because that's going to be bad PR reputation for for for the company. Makes sense, and occasionally they do send out monitors to countries. Exactly. Facilities and things like that. But but but but if there is a red flag if there is something sometimes they do random audit.

32:28 But if if there is an indication of something going wrong, they they send out somebody, they just show up by two price. Oh, that's, that's good. And they can compare the data from other countries to the USA data because some of the trials have to be done in the USA. And if there's a huge difference between the results, that probably is also a red flag that something's wrong somewhere. Makes sense. Exactly. Now how does bio access your company? Balance building local research capacity and host countries through training and infrastructure with creating tangible economic values such as job creation or access to $1.2 billion Med tech market for post trial commercialization.

33:18 Yes. Well, first of all, Robert, we have created in the past 1520 years that we've been in business a very large network of investigators as you alluded to in the in the introduction, which is preparatory of course, because it has taken us years and effort to cultivate these relationships with these sites and investigators. So we, we are ambassadors of the International accrediting Organization for clinical Research, which is this organization out of the UK that is promoting global clinical research excellent standards by certifying sites.

34:03 So it is a way for us to ensure that a site is following international guidelines. It has it has the right quality processes internally to carry out a clinical trial. So we suggest that each one of the sites that work with us that they get certified in this international standard because we want to do business with people who know the industry, people who can show their Excellency in, in, in clinical research. And also we train our investigators, actually our sponsors. They want our investigators to be properly trained.

34:44 So many times we bring investigators from those countries to the United States. We get them in a, in a, in an animal lab, on a caliber lab to to do the procedure to simulate the procedure before they actually do the implantation procedure of the investigational device in humans. So it's a complicated process now. Do the giant pharma and device companies Medtronic or Pfizer contact you if if they're about to start a clinical trial? And then, well, our. Set it up. Our clients, Robert, are usually smaller startups.

35:27 We don't really cater to the big companies like the ones you just mentioned. Our niche is a smaller status because we realize Pedro, my brother and Doctor William O'Neill, when they were at the University of Miami, they realized that if I start up calls, one of those big CRO's, IQV, LabCorp, PPD product sale, they don't even answer the phone. They don't reply to emails because they're in a different business. Their clients are big pharma companies, right? They're looking to do global large clouds.

36:05 But if you're a small startup, sometimes it's just one person or three, no more than five with just a couple $1,000,000 in the bank, how can you compete with these larger pharma company? So the CRO industry was was in need of somebody like Bioaccess that specialize in helping smaller companies in their first in human testing or validation. And that's really where we excel in, in those smaller studies. Our studies are 1020 patients, no more than that one to three sites and and that's it. And we, we do a lot of those and we don't do larger studies or anything like that.

36:54 Right now, how much savings do you offer these companies per patient, let's say as compared to if they did all the studies in the USA, how much are are they saving? Yes, usually the numbers that I hear from my sponsors, my clients is around anywhere between 30 and 50% savings, sometimes even more. One time I heard one of my clients that we help with the study in Colombia, He told me this hospital that you guys Bio access connected me with my company with where we're executing this trial is charging me $10,000 per patient for a procedure, for the whole study procedure, all the images before the procedure and all the images after the procedure, all the follow up visits and all that around $10,000 per patient.

37:51 He told me in the United States, this would have cost me probably $50,000. Wow, that's a shocking number. That's a shocking difference, right? Five times. Yes, exactly. Exactly. So savings can be substantial anywhere between 30 to 50 or more in the case of this particular client. And but not only that, Robert, it's, it's also very important to emphasize that when you say time, you're saving money because again, these are startups, they have something called a burn rate, a burn rate, burn rate, meaning that every day they're burning cash, They're not receiving any revenue from anybody.

38:38 They just raise money from investors and they have a runway, they have a year to execute whatever activity they need to execute. And every day they have to pay salaries and fees and that so rent etcetera, etcetera. So the burn rate of these startups is high. So every day that we can save them on the initiation of the study and is a big saving. I mean the faster we can get them a patient on a table on an OR table, the better for them, the more money they save. Right. And the less complaints they have from investors.

39:15 Exactly. Yes. Yes. And the quicker they sell the company to the big buyers, Medtronic, Puzzle, Scientific, etcetera, and the happier everybody is, yeah. Right now, based on your articles in Med Device Online, what makes specific Latin American countries like Colombia, for example, or Argentina particularly strategic for Med tech clinical trials? From a regulatory framework to patient recruitment, How do you decide which countries are best for this? OK, two parts of that answer. The first part is countries in Latin America, Robert, have realized that clinical research brings many benefits to all the stakeholders.

40:03 For example, there's a famous study done by IQVIA, which is the largest CRO in the world. They did that study about five years ago. They concluded that for every patient. One country in Latin America receives about $17,000 in income. It's probably nowadays about $20,000. So imagine $20,000 per patient as as an economic benefit, meaning the salaries that they pay, the fees they pay to the investigator, to the hospital, etcetera. Not to mention the benefit to the patient, because the patient is having fast access or early access to a medical innovation that otherwise they wouldn't have access to because it's not available in the country yet.

40:47 It's not even available in the United States. It's only available in that country, Colombia or Argentina because of the clinical trial that we're bringing to that hospital. So the patients are benefiting from this study and the healthcare system of that country, meaning that usually the healthcare system of these countries is a public system. So is is less money that the government has to pay for the care of the citizens because the sponsor of the clinical trial in the United States is paying out of pocket for the care of that patient, right?

41:26 That's interesting. And also the patient benefits because, and that's one of the reasons why recruitment in the emerging economies is faster and easier than in the developed world because as I said, it's a public health care system. So imagine the inefficiencies of these government run systems, they make you wait too long for appointments to receive treatment, etcetera, etcetera. So if you're invited to clinical trial, it's really your way into the system, it's really your way in to receive advanced care, right?

42:03 So it's a benefit. That's why in emerging economies in Latin America particularly, you don't pay patients to participate in clinical research because they're already benefiting from the trial, they're already being part of the study, so they're having fast access to the system. So it's kind of win, win for everybody. It's a win, win for everybody. Yes, yes, yes. And also the investigator receives a benefit on top of the monetary benefit. Of course he gets paid professional fees, etc, but not only that, he receives advanced knowledge.

42:34 There's a transfer of knowledge from the US investigators who travel to Argentina, Colombia to execute this trial. So it's also when we publish, they co-author papers together, which is great also for everybody involved. Right. That's great. What about you're also working in some Eastern European countries, Serbia, Kosovo, I think, as well as Australia. So you're expanding to other areas, Yes. Why is that? Well, we realize, Robert, that our clients need options. Our clients need options. And what's happening in Europe is that more countries are getting into the EU system or federation, so to speak, or the union, more countries are becoming EU members.

43:31 That's good and bad. Is is not the best for first in human clinical research because as I said, the the name of the game in first in human trials is speed to recruit patients. So when a country in Eastern Europe joins the EU then becomes part of a larger system, becomes more bureaucratic is everything has to go through committees it's just difficult exactly yes, yes. So the, the the border of the EU keeps moving E right. But there are a few countries like in the Balkans where they have the freedom still to do their own thing.

44:19 They haven't joined the EU. So those are countries where we can execute trials really, really quickly because you don't have to go through all these bureaucracy, right? So we, we, that's why we expanded our operation to those countries just to give our clients, especially European clients that option. And Australia particularly is a country that has become famous, Robert, because they give you a very generous tax rebate. In other words, if you come in as a, as a, as a sponsor of a clinical trial and you spent X amount of dollars in a clinical trial, then you're gonna get 43.5% back.

44:58 It's a check from the government. Of course you have to set up an entity, hire an attorney, an accountant, whatever, and then claim that money, that check from the government. And also the currency exchange fluctuation usually benefits companies. So they save probably 50% of what the same trial would have cost somewhere else. So, so yeah, that's why Australia is big, is famous in the first in human world. Right, but it's it's very far away that's. That's the thing exactly, yes. So we want to give our clients options, Eastern Europe, the Balkans or Australia or Latin America.

45:44 However, as you said, there is really no compelling reason if you can have the same benefits of Australia or Eastern Europe right here in in the Americas. If you can go to Panama and get cost savings, fast approvals, good recruitment, why would you go to Australia? Why would you go to Eastern Europe? Yeah, makes sense. Now what key challenges do underrepresented professional face in medtech and biopharma and and how can they overcome them? There's probably some issues with that. Challenge is what do you mean exactly?

46:22 Well, I would assume that maybe there's some hesitation and using hospitals in Latin America or maybe the doctor there that are doing the trials or inserting the medical devices, maybe there's some fear that they're not doing it right or maybe weren't adequately trained to do the procedures. Is that an issue? Usually the issue that I that I hear or the challenge or the obstacle that I get from my clients in the conversation is, is the quality going to be good? Is the FDA going to accept the data?

47:04 The the conversation Robert doesn't really center about the skills of the investigator because the level of education in these countries or training is, is pretty high. It's pretty world class, pretty standard. You'd be surprised. A lot of investigators in South America are trained in the US or Europe, and they go back to their home countries. Many, many of them are training in Spain, not because of the language and the culture. Some of them come to the US, some other ones go to France. So you find some highly trained individuals even in smaller countries is very common to, for example, you go to El Salvador and you speak with a Cuban leader.

47:53 He was probably trained in Colombia, or he was training a larger Latin American, more advanced country economy like Mexico, Argentina, Brazil. So smaller countries usually rely on larger countries for training because they understand that larger countries in Latin America have more advanced infrastructure. So the issue of the quality is solved by following international good Clinical Practice standards or guidelines, as we just mentioned. You as the sponsor have to ensure everybody's properly trained, that you've got your study approved by a legit Institutional Review Board or Ethics Committee board.

48:40 And also you suggest that the site gets certified in this international global standard that I just mentioned from the UK, the international creating organization for clinical research, so that everybody is certain that all these stakeholders have received proper training, have the right as of PS, etcetera. Right. Makes sense because I'm an ophthalmologist. I did a fellowship in cornea disease and I remember half the other fellows that work with me came from Latin America and after and time here they went back to Colombia.

49:25 I remember, yes, Peru, Chile. And so they have the same skills and education that I had and. And sometimes you meet them at conferences. Yeah. Yeah, exactly. So, yeah. Is there a part of a network? Right. And they published scientific papers. With. Yes, exactly. As well. So we're spreading the knowledge. That's great. Looking ahead, what trends in in global clinical trials such as patient diversity, regulatory sprints or tech integration do you see shaping the future for companies like those you work with?

50:03 And how should innovators prepare for that? Well, Robert, the obvious train is artificial intelligence. It's just impossible to have a personal professional conversation in any industry or any setting, human setting without speaking about artificial intelligence because it's gonna be second industrial revolution, probably bigger than that, right? So yes, we in the clinical research organization or contract research organization industry see how our sponsors are using more clinical research for writing the protocols, writing the documents.

50:42 We as a company as ACRO, we translate documentation using artificial intelligence. We generate simple language documents using artificial intelligence so that the patient can understand and inform consent form or document easily because usually large in foreign consent forms of 30 pages. A regular jaw on the street is not gonna be able to understand it if if they don't have high school education. So we also see agents being deployed in the site feasibility activities related to finding sites. You know, to find a site is a very laborious process.

51:27 You have to sign NDA's, you have to send the protocol to 100 sites, you have to receive the completed disability questionnaire form. So it becomes difficult to manage. So you can use intelligent, I mean as a piece of intelligence agents or other AI tools to facilitate that process. And also in larger hospitals, I'm seeing how they can now match the studies that they have going on with the patients that are going through the hospital through the regular consult every day. So if in the electronic medical record you see a patient today and that EMR is connected to these artificial intelligence that is looking for trial participants, it will immediately flag to the consulting or the physician, primary care physician or especially that that's a good candidate for a study.

52:26 But because if if you rely on the humans to remember that 30 studies that your hospital is running is you're never going to recruit a patient. Right. So wow, so AI is going to reduce the cost of this and also improve the the speed. Yes, exactly. Right. And also it might also help in the research and development stage as well. It might find newer drugs or newer devices as well. Makes sense. So this is been very educational and informative for me and I'm sure the audience as well. I want to thank you very much for taking the time to share your knowledge and expertise with us about clinical trials and how that works.

53:19 It's it's been great. Thank you. Thank you Robert for having me here. It was a pleasure to share my experience and knowledge and I hope that the audience really benefited from from our discussion today. I'm sure they have.