EPISODE 39: JAMES SAPIRSTEIN, PRESIDENT AND CEO AT AZURRX BIOPHARMA

Episode’s transcript

Julio Martinez: 0:00

Welcome to the Latin MedTech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform. Apple Podcast, Spotify, Google Podcast. Amazon Music is teacher. Tune in iHeart Radio, Pandora or Deezer . Welcome back to the La MedTech Leaders Podcast. Today our guest is James Saperstein . Hey, James. Great to have you here today. Welcome to the show.

James Sapirstein: 0:29

Thanks for having me. Gracia . <laugh>

Julio Martinez: 0:32

<laugh>. All right , listeners. Uh , James has served over 30 years, 35 years in the pharmaceutical industry. He's currently the president and CEO of Azure RX Biopharma, a publicly traded company on nasdaq. He has been part of almost 12 dozen drug product launches and is specifically either led or has been a key member of several HIV product launches into different new classes of therapeutics. At the time, James is a board member or board director for bio, the leading biopharma industry organization, promoting public policy and networking in the healthcare space where he sits on both the health section and emerging companies section governing , uh, boards. Mr. Stein received an MBA from Fort Lee Dickinson University in 1997, and a Bachelor of Science in Pharmacy from Rutgers University in 1984. I hope I pronounced your name and the names of these institutions correctly. <laugh>. Alright , James, it's truly a privilege to have you here on the show. I'm sure listeners will get a lot out of our conversation. So, just to get started here, the first question that I usually ask my guest , uh, James or Javier, as was your initial <laugh> name , uh, when you were born and raised in Argentina. What's your link to Latin America personally and professionally? How is your journey to the region?

James Sapirstein: 2:03

Interesting question. So , uh, yes, I was born in Buenos Aires Aina. My , my real name is <inaudible> . I came here when I was young and like most immigrants in the sixties, we maintained our Spanish at home. So I , I still speak it, although very simplistic Spanish as opposed to , uh, people speak it every day . Then , uh, I went into the pharmaceutical industry , uh, worked at Eli Lilly and then went to Hoff La Roche , uh, had a lot of different jobs at LER Roche from sales, sales, marketing, sales training. And then at that time, someone approached me and , uh, uh, we had just started , uh, the very first specialty sales force with a fellow named Dan O'Day. Actually, Dan O'Day is now the CEO of Gilead. Uh, Dan and I, I started at biotech Specialty Salesforce together where I felt a tap on my shoulder, literally a tap. And it was a guy who was the head of, or the president of Latin America for , uh, Roche. And he said to me, I'm looking for someone who's young, someone who can speak the language, someone who has sales and marketing experience. I cannot tell you what the job is, but I need you to move to Basel, Switzerland, which is where our home office is, and I would like you to , um, to take the job. So , uh, I consulted with a lot of people. Uh , you know , it's hard, you know, they tell you they want you to take a job. I was 31 years old at the time and , uh, negotiated a whole lot of things. So my base at the time, I had an apartment in Basel , but my ba base was in Mexico City, is there for six months. And the job itself, what unbeknownst to me was that Roche was acquiring a company called Tex or Tex , which at that time was the largest pharmaceutical company in Mexico and one of the largest pharmaceutical companies in all of Latin America. And my job was to help train marketing managers and help choose the, through the integration process, who was going to stay and who was going to go. So I , I spent a lot of time in country in all the countries, every country, but Bolivia and Guyana, where we had , uh, businesses , uh, got myself a visa to in Brazil. And so for the next two years, I spent , uh, traveling all over Latin America, both , uh, integrating , uh, the companies, but also we became choirs of other companies as well. When I came back , uh, from Switzerland to Hoff , Roche in Nutley, New Jersey, that also was a new company, but I had the <inaudible> , I had the flavor for the international job, which I really, really liked. Uh , it was enjoyable, even though at Roche they offered me , uh, to become general manager of Costa Rica, farmer manager of Argentina. I wanted to come back to the United States. It's where I grew up. So I went over to Bristol Myers Squibb to work for a young woman named Christine . Very same job I had at Roche. After being at Roche for 10 years, I went to Bristol Myers Squibb to do very much the same thing. We were in acquisition mode that we acquired at that time, the largest pharmaceutical company in Peru , uh, the second largest company in Columbia . So , uh, yeah, I have a whole network of , uh, great people all over , uh, Latin America.

Julio Martinez: 5:23

Wow. You must be a wealth of knowledge about all things related to pharmaceuticals in Latin America. Fascinating story. Javier or James, can I call you Javier? Is that fine?

James Sapirstein: 5:34

<laugh> .

Julio Martinez: 5:35

Okay, perfect . Javier , um, what major trends do you see in Latin America that are relevant to our discussion today? I mean, trends, I mean, any epi , theological, political, economic that are driving the business of pharmaceuticals or medical technologies in Latin America?

James Sapirstein: 5:53

Wow, that's a loaded question. Um, what hasn't changed? Let's just talk about first, what has not changed. When I used to review , uh, performance with all the general managers in country , uh, we always had a line at the bottom of the p and l, which it was different depending on the general manager you worked with. It was either miscellaneous distribution costs , whatever it was. Uh, I , I always called it kickbacks money that had to be paid to the wholesalers and to certain distributors to make sure that your products are being used. Unfortunately, that has not changed. It's different in the United States. In the United States, obviously that's a very larger piece of the p and l, but it drives market share. Uh, the more you invest in that line, it'll drive sales, it'll drive opportunity for your company. In Latin America, it's a given. If you don't participate, you're out. Uh, so, and if you participate at a large level, it doesn't mean what it's going to impact, what kinda impact you'd have on , on your product. So that needs to be changed. I think the distribution models continue to change depending on the country. Some countries like Brazil, the wholesaler still controls a lot of power as opposed to the individual manufacturer. Places like Argentina and Columbia, you still have the local , uh, family owned companies that still wield a lot of power, a lot of market share. It's very hard. It's very hard to introduce new innovative products because price point is a problem. When you're a private company, family owned company, you're balancing very mature product lines versus innovation, you know, who's gonna pay for it. They're not used to investing both on a marketing perspective and a clinical perspective on new and innovative products. Therefore, the price points are lower. The profit margins are , are smaller. There's been years where the private market has expanded, and that's when all the multinationals jump in. They're starting to see the private markets expand, and they take a big breath and say, oh , finally the private market's gonna expand into the middle class . But it's like an accordion in Latin America, depending on political power and the political winds , the market , uh, expand and, and deflate at the same time. So, sorry, I'm giving you a long-winded answer, but the current trend right now with kind of a leftist governments, both , uh, the leftist and right rights, you know, both in , um, Brazil and Argentina and Mexico, some of the larger markets you're seeing at deflation of the markets until that improves.

Julio Martinez: 8:27

Yeah, agree. All right . Um, Javier, what do you think about the region as a place to conduct research for pharmaceutical companies or medical device companies and also to sell , uh, products? I mean, is there an opportunity in Latin America to commercialize technologies and pharmaceuticals?

James Sapirstein: 8:45

Y you know, one , that's exactly where the opportunity is. Uh, quite frankly , um, I think the doctors and the clinical staff in , in Latin America is as good as anything you'll find anywhere in the world, including the United States. I mean, certainly in the United States, you're gonna have some outstanding medical centers like Mass General and Stanford that can't really re be reproduced anywhere in the world. But when you're looking at the other primary and secondary institutions, phase one centers, phase two centers, I , I have to say the ones that I've seen in Brazil, Columbia, Argentina, are second to none. They're very good. Uh , their G-M-P-G-L-P facilities are excellent on the med tech side. Their ability, for instance, in wound care wound infections, I find that , uh, Latino doctors and and their staff are , are far more adventurous in combination , uh, therapies and ways to treat people. 'cause they have to be, quite frankly, they have to be much more adventurous. And I see you , you see some terrific outcomes, especially on the surgical front. Wound cares burns, things of that sort. On the MedTech side, I think second to none in my company, we're currently doing studies , uh, in Asia, Eastern Europe, United States. I'm new. I'm , I'm only been CEO of this company for eight months. But I've challenged my staff. Uh , we're actually today closing on a round of 13 and a half million. So we're going to be flush again. And I'm encouraging my staff to start going back into Argentina, Brazil, Mexico, Columbia, Columbia's got some of the best , uh, GI hospitals in the world that we need to go back and look there.

Julio Martinez: 10:29

Awesome. Awesome. Fantastic. Hopefully we can collaborate somehow in Columbia . <laugh>. All right , Javier, moving along here. In what specific countries, well, you kind of answered this, but what specific country you've had the most experience in Latin America in the past, and now what are you doing today in Latin America?

James Sapirstein: 10:47

I wish I could tell you I'm doing a lot right now. Uh , but I'm not, my last company, controvert that I ran, we were running clinical studies in , in Argentina and Columbia. Uh, we were an infectious disease company back then that we were doing virology programs. So , um, very friendly with the infectious disease people in Columbia. They , they're antimicrobial units, again, are second to none, very well educated. Many of the doctors, quite frankly, are educated in the states. So they have some great contacts. So we were conducting multidisciplinary cohorts , uh, both phase two , uh, and in phase three as well with very good results. Columbia , I think is probably where I'd go, or Mexico at this point. Their regulatory departments are a little less political than we see right now in Argentina and Brazil. Obviously, Brazil and Argentina is where you have a , a very large amount of patients and excellent doctors who can do work very quickly . But going through the regulatory authorities and waiting a year sometimes just to be seen is , is very difficult.

Julio Martinez: 11:53

Yeah. The issue is time and predictability. You need predictability, you need that. If you submit document A, B, and C in 30 days, in 60 days, you're gonna get approval. I mean, it is , they're not gonna come back to ask you for things that they didn't, including the list of requirements. So that's an issue that Columbia has become , uh, really good at that. And BMA has become a lot more predictable and the approval time has decreased , uh, a lot. I mean, the evaluation time, the approval time is another story, but , uh, the evaluation time, at least they meet every so often . The medical device division meets every 30 days. The pharmaceutical division also meets every 30 days. So there's still two different committees, but you have time efficiencies and predictability. Alright , so moving along here, Javier. Uh , what about regulatory approvals in Latin America? What experience have you had with pharmaceuticals or other technologies with covered priests in Mexico and Visa and Brazil, edema, Columbia , et cetera ?

James Sapirstein: 12:49

Yeah, so my experience is old, to be honest. Uh , it dates my , the last product launch I did that I was part of was in 2002 with Gilead. Uh , I used to be in the AIDS field, so it's old and it wasn't very good. There was a lot of theft of IP back then. I understand it's improved quite a bit , uh, in Columbia for sure. It's improved Mexico, it's also improved. But , uh, Brazil is still a , a very, very bad culprit in terms of stealing IP as is Argentina. You know, they say they're getting better. We certainly have not seen a , a lot of evidence of that. So what you see in commercially is a lot of delayed launches. And , um, you know, again, the market's a private market. You know, you , you go through distributors and you're able, you get approval, but then you distribute, you know, to cash paid patients or people with good , uh, private access. But I wish I could give you a better answer, but my experience is old.

Julio Martinez: 13:45

That's fine, that's fine. But you're bringing up a very good point. The fact that a lot of these countries in Latin America are now members of the OECD makes things a lot easier. You know, they're now following international policies and international best practices on how to do business. They have become more business friendly. A particular event that is happening in the region is the Pacific Alliance, you know, Mexico, Colombia , Peru, and Chile. And these four countries are now considered the most forward looking economies in the region. They are all ECD countries. Brazil is still far in the process. Uh, so, so that makes a difference.

James Sapirstein: 14:21

Yeah. And if I can give you an example, I'm chairman of a board of a company called Mariza . Mariza was started in Brazil, basically , uh, some very large investors that they, not Brazil , sorry, Chile. In Chile, they farm krill. Krill is what the , you know , the whales eat . Uh , and we use it for wound care. We also use it for , uh, cardiovascular use for arteriosclerotic patients to , to take some of the clots after, out after they've been scoped. We are doing a merger right now with another company here in the United States, and we have some Chilean investors. And we're looking at some other products that we have. Unfortunately, when we started the company in Chile, we did a lot of our clinical trials in Brazil. And that was four or five years ago. And I'm telling you, we can't even get our data, not because of the doctors, but because of the, or the hospitals, but because of the regulatory fee people, it becomes a bit of a problem. So for me, you know, when I travel , although I haven't been to Chile since January, but when I traveled to Chile to talk to my investors who were very, very frustrated, I explained to them, look, you know, before I joined the company, you made this decision to do your work in Latin America. And you know, we're paying the consequences right now. So the issue is we've gotta put some formal project management, formal regulatory procedures to make sure that we're following the way America and the Western Europe does clinical trials. And that's not always necessarily the , the case unless you are doing a trial. Multinational. Yeah,

Julio Martinez: 15:53

Yeah. Uh , multicenter, yeah , international. Uh, but , uh, you are also bringing up another point that is , uh, something that I remember from our initial introductory call where we discussed the podcast that you are acquiring or you are involved with a Chilean company that has developed some technologies. I , I wanna get a little , uh, more details on that because I am particularly interested in seeing home grown companies in Latin America and life sciences, which is not very common. Um, so can you elaborate a little bit on that? I mean, what spots have you seen life science innovation happening in Latin America? Because most of the innovation in the region is imported innovation, right? And gets adapted to local markets , but very few initiatives, or there's really not an ecosystem in the top economies in Latin America to really foster world class medical innovation. So can you elaborate a little bit on that?

James Sapirstein: 16:53

Sure. Uh , that's a great question. And you're right. Most of the products that Latinos have seen for the last 50 years have been me too products or older products that are introduced into the country. You very rarely see , uh, NCE as we call it, a new chemical entity that comes out in our company, Zyme . We have this product, you know, made from krill. Uh , you basically, you wash it, you purify, you grind it up into powder and it helps eat up basically fat and other cholesterol items and other particles that you find in arterial sclerosis. So you could do cardiac bypass surgery, you could do angioplasty, and you sprinkle this powder in and it helps clear away some of the old clots. We are in the middle of acquiring a company where we , uh, have a grafting product as well for people who have bypass surgery, helps improve their healing with graft. So we have complimentary products. We have two other companies in Chile that, that , I can't really tell you their names because they're private and I don't own them , but we're trying very hard to acquire them . One of 'em , believe it or not, takes uh , toxins from mussels in the Pacific Ocean Farms, muscle Farms, you know, like clams, you know, and , uh, they take these toxins, they purify them , and it works a lot like bot like, you know, what you see in Botox, except it's not injectable, it's cream, but you have to apply more often. But it also, it helps restore collagen. Um, it's a very, very interesting company. I like these guys. Unfortunately, they can't get out of their own way. They , they don't really, because they don't have the right ecosystem. They keep spending money 'cause they have money. But farming things out and trying to make a deal with Allergan, for instance, the United States , uh, they don't have enough data yet. They really need probably to join a company like ours. And , you know, 'cause we've developed, I've been in this business 37 years developing drugs and just getting it done the right way and then, you know, they can get it done. So there's some very interesting , uh, marine science going on in Chile with some of these scientists and some of the universities in , uh, Brazil and Argentina. Obviously, there's always been a great deal of virology study that's been going on just because of the tropical, you know , diseases. And right now with dengue, dengue is , uh, used to be in the jungles. It's, it's all over the cities right now. So there's a lot of new research going on with Dengue and we're starting to see new chemical entities being formed for dengue. So big pharma in the United States has a lot of interest in partnering with some of the universities in Brazil and Argentina for dengue. Wow.

Julio Martinez: 19:37

What about Mexico? Have you seen anything? Mexico, Columbia ?

James Sapirstein: 19:41

I can't say that I've seen it. I'm not gonna say it doesn't exist. I don't know. I just haven't been privy to it.

Julio Martinez: 19:47

Okay. Hmm . Fascinating. All right . I mean, I'm really happy to hear that, that there's innovation happening in the region. It's not that common <laugh>. Alright , moving along here. Uh , Javier, what do you think about the issue of corruption and bribery in Latin America, in the life science business when you're commercializing medical products? Can you say something about that? Have you heard an experience?

James Sapirstein: 20:11

Sure. Well, yeah. So I was alluding to that earlier on in the p and l line. You know, something you don't see in the United States or Europe when you're reviewing a business plan is you've got 10%, 12%, 20% that comes off the top line that goes right to corruption. And you know, it's a lot. I mean, so when you're looking at a gross margin for a product at 60% and you need 60% in order to survive. So let , lemme give you an example. When I was at , uh, Myers and Roche, I , I managed international organization, Latin America being included. So you'd want the general managers in country to launch a product and say it was an antibiotic. And you're looking at Columbia , and Columbia has five, six antibiotics with Bristol Myers Squibb already . And the general manager says, well, my cost of goods is so low with these antibiotics, and you have this great new antibiotic that's come by, but my cost of goods is, you know, 40% as opposed to 2%. And then I've gotta fit a 60% margin. So already I'm down to my 60% margin because of my cost of goods. Now I've got a 15% differential that I've gotta pay in corruption costs . I'm down to, you know, 45% and everything else is 70 or 80%. Why would I make my salespeople, why would they want to get paid on something they're not gonna make any money off of? So, James, you're in charge. I get this, but I'd rather not launch this new drug because we're actually gonna lose money. That's a problem. So that's where I think the governments don't really understand where corruption really affects the general public that think they're doing the right thing. You know, because part of the corruption is, you know, they have to feed the cops, they have to feed this, everyone has to get a taste, so to say. The problem becomes that the pharma companies, the MedTech companies cannot launch the products because big pharma is not gonna say to Columbia, to Mexico, oh, that's okay, I'm gonna lower your cost of goods because you've got a special case. No, no. This is what the cost of goods is for everybody and you've gotta pay it country man, if , if you don't want to, that's up to you, you're gonna be less profitable and you're not gonna have the newest products. And that's a decision we make. You mentioned earlier on, I'm a bio, I'm , I'm a lobbyist as well with bio, the organization, the international represents the, the pharmaceutical industry. And so is this issue with presidential politics in the United States with Bernie Sanders will say, oh, you know, we'll just go to Canada. Everyone says, we'll just go to Canada. What people don't understand, and the lay public should understand is pharmaceutical companies control pricing all over the world. We also control distribution all over the world. It's not like the Canadian GM could say, okay, I'll supply the United States at all my product at a cheaper price, because headquarters in New Jersey will say, well, we're not giving you any more product. So I don't think people understand that you're basically just hurting the local economy. So price points, yes. We'll work with Columbia. I know I would, I used to have these cost of good projects to try to lower cost of goods for some of the local, but for the most part, Latin American countries do not launch products on time because they just can't afford to because of corruption.

Julio Martinez: 23:47

Yeah. Interesting. You are also mentioning a bio, the organization that you are a board of directors. Um , and I'd like to talk a little bit about that because , uh, I, my background is more in med tech and I'm very familiar with the work of Advate , which I'm sure you know who they are and that they have a Latin American chapter. They have , uh, local country chapters and all that. Is there something similar happening with bio , um, in the pharmaceutical side? Sure.

James Sapirstein: 24:20

Okay . Absolutely. Well, we just had our meeting in June. We have our, our international meeting every June. Unfortunately it was virtual this year. Normally we have 30, 25 to 30,000 attendees. We've got a very big floor. Uh , I know you're Columbian , but , so there's always , uh, bio Columbia is always very well represented. They have a very large booth. Uh, they usually, we have a big Latin American pavilion where , uh, you know , the Colombians hang out with the Brazilians and the Argentines, and they're all there. There's most definitely , uh, a biotech unit in Columbia that represents all the pharmaceutical companies and biotech companies in Columbia . And there's , uh, we are, I wanna say, over 95 countries around the world.

Julio Martinez: 25:05

Wow. Fascinating, huh ? Excellent. Excellent. All right , so moving along here. Um, Javier, we're close to the end of the show. I know you're a busy person. So a fun question here. I mean, is Latin Latin America a a nice place or a fun place to do business? I mean, what do you think about the people, the culture, the way people do business and behave general ? Know ?

James Sapirstein: 25:26

Wow . So I'm gonna say something very controversial, but if I wouldn't say it, then I wouldn't be Argentina. Okay. 'cause the old joke is, you know, when you're from Argentina, the , the highest point to jump off of is an Argentine's ego. So what I'll say, yeah, I learned that in Colombia that my Colombian friends told me that. So to me, I've always categorized it this way. You , I spent probably 14, 15 years working in Latin America. And I say this from north to south, from Mexico down to, you know , Fugo . And in Mexico, they tend to over promise and under deliver . And in Chile and Argentina, they tend to under promise and over deliver , and all the other countries are kind of in between . And it's a shame, it's a shame because everyone tends to categorize Latin America as this, this one en en encompassed unit. And it's not, it's, every country has a different way of , of doing business. I find, you know, the corruption in Brazil, for instance, is second to none. Mexico is close. Uh , I don't see Columbia being very corrupt, to be honest with you, Venezuela, for sure. 20 years ago, Venezuela wasn't corrupt at all. Chile is probably the , the country that's most like the United States, believe it or not, the way they do business. Argentina, excellent medicine, they just can't get out of their own way. 'cause they have such a socialistic way of looking at everything. So you have, you know, Chile, a Columbia that's trying very hard to be a capitalist organization, Mexico, who is a true capitalist society, but so corrupt and so run by criminals. It's crazy. And Brazil is just so big that it's, you know, again, very corrupt and the corruption takes over. So is it a fun place? I I it's a very unique place to work. It's challenging , uh, the people. I love Latinos. I mean, it's just the passion, the , the ability to learn. Everybody works really, really hard. Uh, they really want to be successful. What I tell , you know, because I'm pretty American. So what I tell my cousins is the problem is that you're all so emotional and you vote in , in America, the reason Trump keeps winning all the time is Americans vote with their wallets in Argentina, Columbia , Puerto Rico. People vote with their emotions, and people really need to start thinking about the future and forget about the emotions. You know, the passion's gonna be there. People need to think about what's right and what's, what's the right thing to do for the country. If you look at Argentina, the one I'm , I guess I'm most expert in, like mockery , who was the president, they didn't give this guy a chance. I mean, he had ideas within a year, you know , the whole Congress went against him , and then he fails at two and a half, three years, he's failing. And people wonder why . And now we're back to a left wing socialist, you know, and people are gonna be without jobs again. So, and you know , people and all the people who have dollars start leaving. And all the Brazilians now are coming to Florida. They're all over the place here. So, you know, we have to get back to basics. And, and that's my feeling. I think it's a great place to work. Latin America makes me very sad because collectively, when you look at all the natural resources that they have that they're selling, for instance, Bolivia, selling all its lithium to China, the fact that no one's thinking about what to do with those natural resources and human resources and combining them and getting together, like Merkel Sur was a great idea. The Pacific program you talked about now, great idea. They just have to stay with it for a long period of time.

Julio Martinez: 29:15

Agree, agree . Beautiful answer. I I love it, <laugh>. I totally love it because you're being very honest and it's a great and accurate description of the dynamics of the region. And hopefully Pacific Alliance will take off. I mean, it has taken off, I mean, it started 2010 and I see increasing activity. And eventually for pharmaceuticals, they will create a single regulatory environment where if you get approval in one country, it's gonna be recognized in other countries. Uh, they have a lot, a lot of work to do with Chile, for example, for medical devices, because they're free, they're open, they don't really have a regulatory approval process except for very basic class one , uh, low risk , uh, products. But eventually , uh, the Pacific Alliance will change how Latin America is perceived because it's really the most serious initiative to unify , uh, the region, or at least starting with four countries. So that's great. And the OECD is doing a great job. I think.

James Sapirstein: 30:15

Look , you , you're gonna laugh at me, but you know , I've got Colombian friends that I , I've told them , if you think about all the effort in the drug wars that were made in the nineties, if the government just would've taken some of these people who've done a great job in the jungle in their laboratories and taught them how to make anesthesia, think about it and supply the whole world with topical, you know, cocaine derived anesthesia, and they're given the money back to them. And think about that. Columbia could have led the world in , in production of anesthesia, just fruit for thought. People have to think, how do you work together? You know, <laugh> . Yeah . Yeah,

Julio Martinez: 30:54

Yeah, yeah. All right . Um, Javier , before we sign out for today , uh, do you have any final thoughts , uh, mores of wisdom or other museums for our listeners? In other words, what would you say to the CEO of a biotech or early stage biotech or MedTech company that is just starting to look at places to do research or to sell other products after their commercial in , in the US or Europe? So what would be your worth of advice to the CEO of one of these companies?

James Sapirstein: 31:25

That's a wonderful question. Um, because I've seen a lot of mistakes made by local CEOs. They tend to want to partner with big companies. Uh , don't ever think, you know, just because it's America, it's great, and you need to go to big companies and partner within bio. There's some very good organizations that you can find that you can help you. There's some good people that can help you. I would tell 'em be careful trusting Americans, because , uh, they're not always looking out for your own good. Uh, and that's big, big companies. So I would tell 'em be very, very careful. And then the other thing is be careful to listen just to your local people too, who tell you, no, we've got this. Right. Sometimes pride gets in the way of , of really examining the problem with smaller companies in Latin America is they don't realize the amount of work that has to be done because they don't have the experience. So they need to really import people and bring people in from the United States that can help 'em. I think when you look at China, that's what they've done really, really well. They've put their people in this university systems in the United States, and then they take them out , uh, with great experience. And I think that's really what Latin America , uh, from a government perspective, if they are serious about building up a very profitable business venture for, for their countries, that's what they should do. There's some great universities here that could exchange students and then bring 'em back to your country. I know when I was chairman of Bio NJ I've created an entrepreneurship program with fellows, and we've done just that. We're up , we've got seven fellows because it's still fairly new. But I , that's what I would say. If you've got money to invest in a company, send some people out, learn from the United States, Europe, bring them back, and then start your company.

Julio Martinez: 33:14

Okay? But that's from the perspective of local innovation, fostering local innovation, biotech or MedTech companies that are homegrown in the region. But what about foreign companies that are looking at Latin America? Um , uh, MedTech or biotech?

James Sapirstein: 33:29

<laugh> . Yeah, that's <laugh> . Get yourself a good interpreter. Um, I'll tell you when I , I've been in that situation just a quick, you know, look, my English is fairly perfect. I don't have an accent. Um, I can't tell you how many times I've been in meetings where everyone thinks I'm the gringo, right? Gringo, I don't understand the word of Spanish. I'm listening to everything they say, and they're just not translating at all correctly, if you know what I mean. And then I'll just, I'll listen to it for about half an hour and I'll tell 'em in Spanish, okay, this is what we're gonna do. 'cause you know, you didn't , you didn't tell my boss everything you were supposed to say. But in any case , um, yeah, I think there's some great opportunities. Um, just, I think IP is important. When you're a big company, make sure that you've got and understand all the IP laws in country. 'cause the problem with Latin America is those laws change too often. In the US the IP laws change maybe every 10 years. And Brazil, they change every eight months it seems like. So you have to be ready for , for that. So that, that's the big question mark.

Julio Martinez: 34:34

All right . Excellent. All right . Javier, thank you so much for being in the show. I mean, I really enjoy our conversation, I'm sure listeners did as well. So I look forward to exploring collaboration opportunities in Latin America with your company. Okay .

James Sapirstein: 34:46

Oh , pleasure . Thank you. Bye bye-Bye.

Julio Martinez: 34:48

Thank you.