2217 - The Race Against Time for Medical Device Startups with bioaccess® CEO Julio Martinez-Clark

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1:05With us right now is Julio Martinez-Clark. Julio, you are the CEO of BioAccess. You're found on the web at BioAccessLA. And then you have your personal website, which is JulioMartinezClark.com. Both of those links to our friend that's listening right now, we have linked in your show notes. You just kind of click around. You'll find where that's it. Julio, it's great to have you. Thank you, Josh. Likewise. Yeah. Well, hey, before we get going, by the way, you and I were talking beforehand. You live in Miami, and you're now up here. You took the Brightline train. So Florida not too long ago installed a semi, not high speed, but high-ish speed train that goes direct from Miami to Orlando.

1:54And it's kind of funny. It's high speed compared to Amtrak, by the way. What's that again? It's high speed compared to Amtrak. Oh, yeah, yeah, no doubt, no doubt. um well julio before we get going in that um you know aside from writing the bright line and visiting family here in orlando uh what have you been doing for fun lately or what are you geeking out on well i'm geeking out on perfecting my paella actually oh all right what's the secret to a great paella aside from getting really good non-frozen seafood that's my you know you just have to pay the extra money, get it fresh. But what are your tips?

2:33Get a bigger pan. Oh, just get more? Get more. Yes. You know why? Because if you make more pahella, more people will come and more fun you're going to have. You know, I love that because that feels like such a Latin kind of piece of advice. I love it. I love it. Well, let's talk about the work that you do. Tell me about BioAccess and LA. And by the way, LA is not Los Angeles, it's Latin America. But what is BioAccess? Well, Josh, BioAccess is the first contract research organization ever to help US medical device startups with their early phase clinical trials in Latin America. The problem in the industry, the medical innovation industry, is that when startups try to develop a technology or molecule, I mean, call it medtech or biotech startup, they face a lot of challenges in the United States when they are ready to test the safety and efficacy of their innovations in the United States.

3:49As you know, what's happening in the political arena with the FDA, the layoffs, the delays that is costing through the industry, the high cost associated with conducting the files in the U.S., the reluctance of patients to participate in high-risk files if they don't have to, makes, not to mention the delays in the large hospital systems in the country. Oh, yeah. Trying to get meetings with investigators and IRB approvals, all that, and it's conducting these trials in the U.S. very, very challenging. It is. It's unpredictable. So these companies are pretty much forced to go overseas to explore conducting these trials in Eastern Europe, in Australia, and more recently in Latin America.

4:40Yeah, yeah. So, David, do you mind, or I'm sorry, Julio, do you mind talking just a bit more about how expensive and time-consuming, for someone, like, they're hearing you say, oh, it's costly and it's expensive if you want to do trials in the United States. Do you mind illustrating that a little bit? People have no idea. So, for example, like I heard, I've been following the news on, you know, GLP-1s and Eli Lilly. People are saying, oh, it's, you know, it's so awful that the medicine is so expensive. And I'm like, oh, I know it is awful. But one thing you have to take into consideration is just how insanely expensive it is to bring something to market like a drug.

5:24Do you mind kind of? Yeah. Do you mind explaining that world for someone who doesn't know? Well, this is a fascinating world that very few people are familiar with only joining the industry. And it really starts with universities in the U.S. where research happens. I mean, universities get these grants from the U.S. government, from NIH. And by the way, the US government is the government that invests the most amount of money and resources in biomedical research in the world just to remain competitive. And because the US is an innovation machine. So as universities come out with these innovative molecules and devices, and they license the intellectual property, the patents, to third parties, which are usually entrepreneurs, people who identify the opportunity, the patents, and they see the potential of the innovation to make an impact in the healthcare system.

6:36They contract, of course, a licensing agreement with the university, and then they set up a company, usually Delaware. They raise funds,$2,$3,$5 million or whatever is needed, to get the innovation to a certain point, certain milestones with that money, which usually includes an animal study, all the way from lab testing to an animal study. and sometimes a person's human study. So they put together a world-class team of people experience in developing medical innovations. And they start just working on the development of the device, of the male molecule, going through the different phases. And they do their animal studies, which are absolutely needed.

7:32And then they move on to the human testing phase, which is where a company like us will come in and will help these companies find the right hospitals around the world with the right patient population. Are there any, what would be the, I guess, are there concerns? And I guess my question is, why do we have to do so much work within the United States that where it's so much more expensive, why aren't we doing more trials overseas? I guess there might be some concern over quality or quality control or just oversight and making sure that everything is adhering to United States standards. Do you mind talking on that?

8:19Yes. The key word here, Josh, is that the FDA wants to see a trial that is representative of the U.S. population. That's the main message. And that involves the right diversity. I mean, you cannot really go through a country like, like, and do a trial because it's not really representative of the U.S. population because it's not as diverse society as we are in the U.S. And they have different healthcare systems, they have different standards of care. You need to have these trials done in places where things are pretty similar to the United States. That's kind of the main reason why trials don't go overseas more.

9:08And you usually negotiate with the FDA a percentage of your clinical data that will come from sites, research sites in the United States and sites from outside of the United States. So usually that split, that percentage is 70, 30, 60, 40. I mean, 60 % of the clinical data or the site will be in the United States and 40 % of the site and the clinical data will come from overseas. So that's a negotiation that you do with the FDA based on the technology or the molecule based on many things. But that's something that you agree with the FPA-T that is helping you with the development, regulatory pathway of your device or molecule.

10:01Yeah. And by the way, I shouldn't say so. Obviously, you're doing a lot of trials in Latin America, but you also do work in Eastern Europe and Australia. Yes. All of which, all of which have significantly faster processes in terms of speed to market. And Julio, for someone who's a med tech, speed to market is pretty darn critical. Do you mind maybe sharing a little bit about why speed is so important? And again, we need safety, obviously. However, in some cases, people are suffering and dying because available technology is not available to them. I'm just such a big fan. I truly believe that technology can solve many of the world's ills as long as we're doing research and development at a brisk enough pace.

11:01Yes, yes. Well, the name of the game in this industry, Josh, is speed, as you correctly said, time. So it's important to understand the context of these companies, these startups. They, as I said, they usually start at a university and they're kind of a spin-off. And the startup is no more than three, five people in general. And they have investors breathing on their neck for results. That's one thing. The other thing is that these startups are created with one single purpose, which is to get acquired or to be sold to a larger company, Metronic, Bossos & Titi, Johnson & Johnson. So the development is done in such a way that the startup is already thinking, is starting with the end in mind.

11:59They know that Metronic needs a product like this or Pfizer needs a molecule in their portfolio. So they do the development based on the feedback that they get from the larger players. They're usually called strategists. Okay? So the strategic will tell the startup, listen, I love what you're doing. I want you to show me that you did a person-human trial with five patients, with a six-month follow-up, for example. And if you do that, you're delisiting the investment. So I can buy you out because we already went through the risky phase of validating the safety and efficacy of the technology. So I don't have to do that.

12:49But a good price for your company. So that's usually how it works. So there's a time element involved in all these. It's a business plan that starts from the moment they signed the contract with the university to license the technology. So they already have some milestones. They already know how much money they need. And they already know when they're going to sell the company to mature. That's why time is effective. Okay. So to our friends that are listening, Julio, who should be reaching out? In fact, I have a couple of really good introductions I'll make to you after the show, folks I've had on this podcast.

13:26Who should be reaching out and building a relationship with you? Anybody who is developing any medical technology or any new biopharmaceutical drug that is interested in speed of approval, who needs to validate the safety and efficacy of the innovation tomorrow. That's where I found it. All right. And what do they do? And by the way, you've got a couple of websites. Obviously, there's bioaccessla.com. And then there's your personal website. And Julio, what would you recommend next steps be for our friend that's listening to our conversation? Just go through our website. There's a great blog section where they can learn about the different regulatory approval timelines and processes in different countries around the world.

14:19There's an option to stay to a meeting with us. and I'll be the person to attend that meeting initially. The initial conversations I usually handle with potentially new clients. And also I am widely available on LinkedIn. I'm very active on social media, LinkedIn more specifically. I have over 30 ,000 followers. So just Google my name or just put it into LinkedIn search and kind of find it. Excellent. All right. Right. So Julio Martinez-Clark, that's your website, JulioMartinezClark.com, for those who want to connect with you personally. To our friends that are listening to this podcast very intentionally because you're searching it out and you wanted to learn a little bit more about bioaccess, you just simply go to BioAccessLA.com, click on Book a Meeting.

15:10Julio, great conversation. Please do enjoy the rest of your time with your family here in Orlando. Absolutely, Josh. I will.

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