EPISODE 32: GARY GERSHONY, DIRECTOR OF CARDIOVASCULAR RESEARCH, EDUCATION AND TECHNOLOGY AT JOHN MUIR HEALTH

Episode’s transcript

Julio Martinez: 0:04

Welcome to the La MedTech Leaders Podcast. This is a conversation with MedTech leaders who have succeeded in Latin America. Welcome back to the La MedTech Leaders Podcast. Today our guest is Dr. Gary Hanni . Hey, Gary, it's great to have you here today. Welcome to the show,

Gary Gershony: 0:26

Julio. It is a pleasure and an honor to participate. Thank you so much.

Julio Martinez: 0:31

Well, listeners, today we are in for a treat. I feel honored . I'm privileged to have Dr. Hanni on the show today. For the past 20 years, Dr. Hanni has practiced interventional cardiology at the John Muir Cardiovascular Institute in the San Francisco Bay area, where he is currently the director of cardiovascular Research, education and technology and has established a successful TAVR program. Prior to that, Dr. Gar was director of the Cardiac Cath Lab and interventional cardiology at the University of California Davies Medical Center. His research interest include novel devices for complex cardiovascular diseases. He has author over a hundred manuscripts and abstracts and is a regular invited faculty lecturer to the preeminent US and international interventional cardiology meetings. He's the author of 10 issued medical device patents and has been a member of the scientific advisory board or a consultant to numerous medical device companies and venture capital funds in the Bay Area and elsewhere. He is an active early stage MedTech company investor and mentor, a member of the Life Science Angels medical device and digital health committee, and a member of the Band of Angels. Dr. Hanni has also served on the adjunct faculty of the Stanford Biodesign Innovation Program. So I'm really, really looking forward getting to our conversation today. Dr. Hanni has had clinical research and also commercialization experience in Latin America. He has been involved in his research efforts and commercialization efforts in several countries in the region and has a lot to say about his experiences. So I'm really, really looking forward to today's episode. So Gary, the first question that I have for you is, if you could please tell listeners about your journey to Latin America. How is it that a Canadian doctor who trained in the US and ended up doing research and selling devices in Latin America?

Gary Gershony: 2:46

Well, it seems like a natural progression, doesn't it? <laugh> ? I say that a little bit in jest, but in any event, yes, my journey to Latin America was a very interesting and overall extremely enjoyable and pleasurable journey. I was able to meet some extraordinary, highly talented physicians, wonderful business partners, and overall would say that this is a part of the world that offers tremendous benefits to small and larger companies that want to evaluate, investigate innovative new medical device products and ultimately bring them to the market. So my journey started almost by chance in the early 1990s when I, in an honest way , um, as a very busy practicing interventional cardiologist , uh, was experiencing unmet clinical needs. And this was mainly related to the fact that we were having problems in those days with a lot of bleeding from the vascular access sites for our interventional cardiology procedures. And as a result, I actually invented a closure device. This led to the formation of a company called Vascular Solutions, which became a pretty successful company in the US and internationally and developed a number of products beyond vascular closure devices. This was really my early experience with Latin American countries in terms of some clinical research studies. Most of this originated in Brazil , uh, Sao Paulo, but my most recent and most extensive experience occurred after I founded a second medical device company called Angio Score . This was founded in 2003, again, an interventional cardiology company that developed unique scoring balloon catheters to treat complicated blockages and coronary arteries and in peripheral arteries. And all of our early clinical work was done in , uh, Latin America , uh, primarily again in Sao Paolo , uh, with a terrific group at Dante Psi Institute that had been at the forefront of innovation in many cardiovascular products, drug-eluting stents as well, and had the opportunity to go down there on multiple occasions and work with this very talented team that were helpful, both with refining the clinical trial design, achieving outstanding results, perhaps the best we achieved anywhere in the world, including Europe, Germany, and ultimately in the US with their use of the device in clinical trials and ultimately achieving commercialization based on CE mark approval and initiating commercialization both in , uh, Brazil , uh, as well as a number of other countries in Latin America, relatively small company. Uh, our , uh, commercialization efforts were through distributorships and we had the benefit of some excellent local distributors, particularly in smaller countries in Latin America. And then for some of the larger countries, including Brazil, we used international companies that were eager to add our products to their portfolio. And so they served as our sales channel or distributors in some of the larger countries in Latin America.

Julio Martinez: 6:17

Excellent, Gary. So I'm not so sure about how updated you are with the developments economic political boarding of disease trends in Latin America, but do you have any thoughts on that? Do you see any major trends happening in the region that are relevant to our discussion today?

Gary Gershony: 6:37

Maybe just so I understand a little bit more clearly when you're talking about trends, perhaps , uh, in what specific domain so I can try to answer it in a more effective way.

Julio Martinez: 6:49

Well, in the medical domain is certainly one trend that I like to get your thoughts on. Medical and domain meaning prevalence of certain diseases in Latin America. For example, Mexico is famous for being one of the country with the most number of diabetes patients, you know, things of that nature. Political or economical trends , uh, in the region that you read about or you experienced yourself.

Gary Gershony: 7:14

Yeah , so no, thank you very much for the clarification. So there's no doubt that as certain of the Latin American countries are becoming increasingly affluent and perhaps adopting in some ways some of the less desirable lifestyle habits, whether it's European or American. Unfortunately, some of the exports from the United States, I'm embarrassed about , uh, fast food and a number of other things. Clearly the incidents of , uh, diseases that are very prevalent, such industrialized nations are becoming more prevalent in , uh, certain Latin American countries and perhaps a healthier diet that had been in lifestyle and act activity level that had been the norm in many Latin American countries is being replaced by these risky behaviors and lifestyle and leading to more cardiovascular disease and other disease entities, including diabetes. Of course, having said that, these diseases are replacing some other types of diseases perhaps that were more prevalent or more dominant, such as infectious diseases and so on. And with that, the requirement or the need for devices, particularly in the cardiovascular arena is clearly increasing. I think that, you know, it's a mixed picture because on the one hand, it was clear when we were doing our commercialization efforts in Latin America, including in Brazil, that there was certainly a need for , uh, use of more devices, but unfortunately the uh, use per uh, population or per a hundred thousand or per million population was still quite a bit lower than other parts of the world and likely due to economic pressures or economic issues. And, and we did experience both directly and through distributors, the pressure on pricing for certain , uh, newer generation medical devices. So I think that there are conflicting pressures, and that was certainly the case five to 10 years ago. I think that, you know, there may be some improvements in the pricing sensitivity, but I think this is something that , uh, needs to be managed in a more thoughtful way by multinational , uh, corporations or medical device companies that are looking to penetrate the markets in different Latin American countries. It's not to say that this isn't an issue elsewhere, there is no question that for medical device companies, many places in the world are creating economic challenges. Europe is the case as well. Many countries in Europe are very challenging in terms of penetrating the market, but it is a, a balance between the advantages of providing lifesaving and important new therapies to patients around the world to learning more about the , uh, usefulness of these products in a more diverse way, having the benefit of some extraordinary thought leaders around the world, which also pertains to , uh, Latin America, some really terrific people all over Latin America. Uh, so I think that one has to weigh the pros and cons as one does , uh, anywhere else.

Julio Martinez: 10:26

Very well said, Gary. So the next question is usually a question that I ask my guest , but , uh, you kind of touch on the answers to this question in your prior comments, but I'm gonna ask it anyway for the record and in case you also want to add something else. But , um, the question is, what's your overall perception of Latin America as a place to conduct first in human clinical trials or early stage clinical trials or medical devices or to commercialize medical devices? Yeah ,

Gary Gershony: 10:56

I'll start with the first one about clinical trials or early clinical trials. And what I can say is that my experience was it was extraordinarily positive, perhaps the most positive I've had anywhere in the world, including early clinical trials that I conducted in Europe when we were never doing them really in the US until recently. The FDA made it very challenging in the last couple of years, the FDA's tried to facilitate doing first in human trials, it's called the EFS or Early Feasibility Study Program. So we're seeing more of those in the US now. So of course that may be a little bit of a competition to doing early clinical studies in Latin America, but I can honestly say that particularly how fortunate I was to work with certain groups of investigators in Latin America, that the quality of the work , both , uh, in terms of the actual operator , uh, procedures , the data collection, the data analysis, rivaled anything that I experienced anywhere else in the world, including the best, most advanced , uh, facilities in Europe and in the us . So I can wholeheartedly say, and it's not that every site is going to be that way, of course it's not that way in Europe, it's not that way in North America, but I think if one finds the right investigators that are committed to the project and have the resources and infrastructure that one can achieve the highest caliber outcomes and also be very comfortable and appreciative of the quality of the work and research and data collection. And in fact, this kind of data , uh, was at the level and rigor that allowed us to include it in our submissions to the US regulatory agencies, the FDA , which allowed us to move into US clinical trials. So again, like anything else, it's, it's very important to pick the right sites and the right investigators anywhere in the world, but there's no doubt that Latin America has some of the finest places to conduct early clinical research that I've encountered anywhere with regard to commercialization. I think it's country by country and just like , uh, Europe is , uh, you know, very diverse and some countries commercialization is , uh, easier and more lucrative. The same can be said about Latin America and it's changing over time. So I think that having the right kind of distributors to work with and choosing them wisely is the way to proceed. Some distributors are very local country only. Some may be regional, several countries, and some may be more global. And I think one needs to be very thoughtful and strategic about working with the right partners. Like anywhere in the world, you can choose business partners that are not the best and don't deliver on their promises or in which the financial relationship is not optimal. But I think that in Latin America, there's some outstanding and very , uh, capable business partners and one just needs to do the kind of due diligence to ensure that one finds those types of relationships.

Julio Martinez: 14:18

Excellent. Gary, I'm very happy to hear that you have positive thoughts about Latin America. So let's dive into your practical experience conducting research and selling devices in the region. First, in what country specifically have you been involved in Latin America, both for commercialization and clinical research ?

Gary Gershony: 14:40

Yeah, so the clinical research is a big part of , uh, my experience. And I probably have been in Latin America dozens of times, mainly early on for , uh, the clinical research activities. Most of this was in, in Brazil , uh, some of it was in , uh, uh, in Paraguay. I have not had extensive experience personally in other countries, including Columbia , but my understanding is that more and more countries are becoming very facile and very capable in clinical research. And I would not wanna leave your listeners with the impression that there are only several countries in which one is able to do this kind of research. I think that there are many Latin American countries, and I think part of it should be based on personal relationships. Because my experience was so positive in Sao Paulo , Brazil , I kept coming back for many different studies. I think certain countries are , uh, particularly prolific or proficient at doing the earliest first in human trials. There are a number of investigators I understand in Columbia , Paraguay and other countries that are very, very proficient in these most early, very limited numbers of patients where this is the first human experience. There are other countries that can do that well and also can do larger studies and participate in , um, multicenter international trials. And I would include many of my dear colleagues and friends in Sao Paulo at Dante Pasi and other institutions there. So I think when again, needs to tailor the trial to the institution and to the investigators . With regard to commercialization, again, you know, my experience has been in several countries and it's been primarily through my work with distributors. I can say that very positive relationship with the local distributors I had early on in Brazil, working with them to identify the best clinical sites, helping to train their clinical sales reps and uh, to , uh, ensure a smooth rollout of the product. We did encounter challenges with reimbursement. This is not a , a simple issue. And of course we know that each country has their own , uh, health insurance and reimbursement policies and different percentage of patients that have social insurance or government insurance versus private insurance. And all of those nuances are very, very important in terms of understanding how to optimize reimbursement for companies that want to start commercialization in Latin America. I think once again, having the right business partner, having the right distributors that really understand the local issues and reimbursement programs are critical to ensure the best outcome with commercialization efforts in Latin America.

Julio Martinez: 17:42

Excellent, Gary. So Gary, in terms of sales, can you name some countries where you've been actively involved in , uh, through distributors , uh, selling devices like Mexico, Columbia , Peru? I don't know.

Gary Gershony: 17:56

Sure. Uh, again , uh, through our distributorships we sold products in Brazil, in Argentina, Chile, Mexico, and you know, I'm sure that there were sporadic sales in many countries. Those are the ones that are most memorable to me. And of course they reflect the size of the populations and the reimbursement capabilities. Some of the smaller countries and less populous countries , uh, the numbers probably were rolled in to a regional program or a regional distributor. You know, I don't have firsthand recollections of our precise abilities there, but as you would expect, the larger countries with the bigger populations with , uh, since we were talking about cardiovascular interventions, those countries that had more cardiac catheterization laboratories and operating facilities would've been the obvious targets for our commercialization efforts.

Julio Martinez: 18:54

Sure, makes sense. So Gary, any recollection of your experience trying to obtain regulatory approvals in these countries?

Gary Gershony: 19:05

Yes, I have much recollections of that because like anywhere else in the world and when it comes to medical products, particularly as we might call them in the US class three products that are potentially high risk, you know, any cardiovascular interventional products often fall into that category and require very careful, thoughtful regulatory approach in most countries around the world. One of the reasons of course that many companies, including the companies I was involved with, came to Latin America is because at that point in time, and, and certainly still in this point of time, one could find the ideal combination for a company trying to do early clinical trials. And that is the combination of excellent investigators, very good clinical facilities and a regulatory environment that was supportive and facilitated initiation of clinical trials, even if they were the first place in the world to perform these clinical trials. That was the scenario in the past that has changed in a number of countries, and there are many reasons for it. Some of them are political and some of them are perhaps maturation of the regulatory agencies within that country and the competent authorities. But it is true that Latin America did represent that ideal combination, particularly in certain countries and institutions of having optimal facilities and investigators and a very facilitating regulatory environment. And it's not as simple as that anymore, but it is true that it has become more nuanced. And what I mean by that is there are still, and there are a growing number of new entities , uh, that are able to provide that combination of an excellent facility and investigators in a facilitating regulatory environment. I'm aware that Columbia is like that and a number of other countries and some of the countries that dominated these early clinical trials in the past such as Brazil, have developed a regulatory processes that are more cumbersome and more challenging, and unfortunately have made the countries and the investigators there less , uh, able to participate as easily in early clinical trials. And this is not a surprise, we have seen this in other places in the world. Europe was also a very friendly and from a regulatory standpoint with the medical device directives in the past. And many countries in the European Union were very accommodating for doing first in human clinical trials, even places such as Germany that we would certainly consider highly , uh, technologically advanced and with , uh, outstanding clinical investigators had a very , uh, accommodating regulatory approach and allowed doing early clinical trials. And frequently when I did some of my early clinical trials, I would include two centers, a Latin American center and a German center, because they were both outstanding clinically and had easy regulatory environments. And we know that that's changing rapidly in Europe and even in the last year or two with the medical device directive, MDR, many companies now are becoming less inclined to do their early feasibility or first in human trials in Europe because the regulation to become very, very cumbersome and not even that well understood yet. Now, of course, in the era of COVID-19 , many clinical trials are up in the air anyways, and the European Union has essentially put a freeze on MDR so that they're not enacting some of the more challenging regulations immediately, even though they were supposed to go into effect this year. But having said that, the point I was trying to make is that it's not anything necessarily unique to Latin America. Regulatory environments change and in Latin America, countries that used to be very friendly from a early clinical investigation standpoint have become a little more challenging. Other countries have stepped up to the plate with having outstanding , uh, clinical , uh, facilities and investigators and regulatory environments that are more friendly. And , uh, I think I already mentioned Columbia, but there's certainly other countries and I think that it behooves any , uh, multinational or US based medical device company to thoughtfully evaluate specific countries on a case by case basis. I am sure that they will have the ability to find that very attractive combination of strong , uh, clinical facilities, committed investigators, and a regulatory environment that can be supportive and facilitate getting the studies done in a timely fashion.

Julio Martinez: 24:21

Excellent, Gary, thank you for that comprehensive answer. And just outta curiosity , um, since you are in the San Francisco Bay area, which is perhaps the most important and prolific medical device innovation hub in the US or perhaps in the world, what's the overall perception perception about Latin America as a place to conduct early stage medical device trials?

Gary Gershony: 24:46

Well, it's very interesting. I think that the cardiovascular device companies, both the larger companies and the startups have for a while understood perhaps because of personal relationships between investigators in the US and Latin America. Uh, and a number of other reasons. There has been a lot of communication and a lot of cross pollination over several decades. And so I think that whether it's large or small companies, there's almost a , an understanding that there are some terrific people and places to work , uh, in Latin America for early clinical development and , uh, ultimately commercialization. I think in some of the other areas , uh, it's perhaps less well understood, of course in other areas such as orthopedics , uh, for example, which is a common medical device vertical. Many of the products either don't require clinical studies, or if they do, they are generally under the , uh, five 10 K clearance office in the US and can often be done relatively easily in the us So it doesn't really require travel outside of the us . And so I think that where Latin America and particular brings tr tremendous value is for the type of clinical studies that either can't be done in the US because , uh, getting FDA approval , uh, or an IDE for a first in human trial appears to be too difficult , uh, or , uh, a company has decided that they have a , a relationship with a particular investigator who really understands how to do first in human trials very well and very safely. Many American investigators don't know how to do that. They know how to do multicenter clinical trials. They know how to do trials once a product has gone through multiple iterations. Keeping patients safe and doing procedures in a very thoughtful way in a first in human trial is very different than doing it in a later stage clinical trial when a product is almost ready for commercialization. And so I think there is a unique expertise that exists in Latin America for those first in human trials, but again, because those trials tend to be required more for what we call class three products that require PMA approval in the us many companies that have products that either don't require clinical trials obviously, or in which the clinical trials can be done relatively easily locally or in the United States, would not normally seek to do those trials offshore or in Latin America. But having said that, I think that for many of those companies, it is worth educating them on , uh, how useful it can be to have thought leaders from Latin America that are very experienced with early clinical development participate in early clinical trials if they decide that they want to go down that path or that they need more clinical sites or want to , uh, create more , uh, of a diverse group of investigators.

Julio Martinez: 28:13

Excellent, Gary. All right . So let's switch topics a little bit before we , um, sign off for today. Have you experienced any issues first in shipping and importing devices into Latin America, both for clinical research purposes and commercialization purposes? And the second question is about corruption and bribery. Have you experienced any of these in Latin America?

Gary Gershony: 28:39

Yes. Well, thank you for raising those. I'll answer the second question first 'cause it's a little easier. So I think that with bribery and corruption and all of this, I have had the benefit of working in organizations or with companies that was, you know, certainly not part of our or not acceptable behavior for our culture, and we chose , uh, business partners or distributors that had the same feelings, culture and internal controls that we did. And so even though obviously there can be business practices that are not generally considered acceptable by certain norms, I did not personally experience , um, the companies I worked with did not. And I think like anything else, it's who you choose to be your business partners. And I think that can be the case anywhere in the world. It is possible that Latin America might have a reputation that includes some of that. Uh, but it , in my experience, I've seen it to be no different or maybe even better than other parts of the world, whether it's Asia or other countries. So again, this is not something that I would consider a reason to avoid doing business in Latin America. For me, the biggest consideration for a company ought to be, needs to be, other than the humanitarian issue in medical devices, we wanna make sure that great products are available to everyone in the world if they need it. But I think the primary business consideration is really what is the reimbursement and business model gonna be like, and will it , does it make business sense for the company to , uh, have a commercialization effort in Latin America in general or in specific countries? And I think it really needs to be viewed case by case and, you know , uh, details such as transfer prices to distributors and, and all of these things , uh, are important considerations. So I hope that I've answered that question. Uh , and the other question, if you can just rephrase it for me again so I can answer it succinctly , um,

Julio Martinez: 30:50

I've heard from many people, clients and partners in the US that they think that Latin America is a difficult place to do business. And that leads me to a third question that I'm also gonna ask you in regards to these questions they're referring to is about shipping and importing products into Latin America. People think that Latin America is , uh, is the wild west and the importing products, shipping and importing products is a monumental task, is full of corruption and bribery. You have to bribe and , and do a lot of paperwork to get products through costumes and they get stuck in costumes and you lose your money. And, you know, people have all these preconceptions of Latin America. So I just wanna hear your experience or your perception of it.

Gary Gershony: 31:40

Thank you for asking that. And it is true that whether it was during clinical trials or for commercialization, that we have to be mindful of how we imported product. Obviously because Latin America is such a large, we're talking about, you know, a very, very large part of the world, both in terms of geography, a very significant population and many different countries with many different regulations and approaches. It would be as if one wanted to go to the European Union and there was no EU and each country had, you know, many different regulations and customs , uh, approaches and, and uh, and it was that way at one point. And I think for most of us doing business in Europe now, we forget that there were many challenges like that. I think that Latin America is like an EU but with no overriding regulations and consistencies. And so that in of itself is probably the largest challenge, I think there's no doubt about that. So that for each country, one has to be sure that one knows the specific regulations, customs requirements, importation licenses, all of these things are unique. And I am sure that there are also instances or situations where there can be some concerns over product, whether it's for research purposes or for commercialization, getting stuck somewhere and requiring practices that generally would not be acceptable, whether it's bribery, what have you, once again, I think reinforces the importance of being educated about countries making clear decisions about the risk benefit and the advantages, whether they're clinical research or whether they're commercial of entering a specific country because perhaps some countries are just not worth the effort at a particular point in time, and that's a business decision that needs to be made. They're all worth, every country in the world is worth entering to help patients. But you know, obviously we have to have margins. If there's no margin, there's no mission. If there's no operating margin, if there's no , uh, financial profit, then one cannot, you know, succeed as a medical device company of any size. Ultimately those decisions about which country to enter have to be based on that risk benefit analysis. But most important in terms of dealing with some of the nuances of importation challenges , uh, customs really, again , once again, depend on being very thoughtful about which distributor one works with. And overall in our experience, whether it was for clinical trials or whether it was for commercialization, having, and I'm not saying we always picked the right distributor the first time around, but ultimately I think we ended up with distributors that really understood the most efficient pathway for avoiding custom , uh, issues and hassles for understanding any of the regulatory challenges and being able to circumvent them or work through them in a way that allowed us to achieve our goals, whether it was to bring in product for clinical trials or whether it was to have , uh, products shipped for commercialization. And I'm not trying to minimize it, and certainly there are reputations that have occurred because of challenges in the past, but I believe that if it's done in a thoughtful , uh, careful manner and one does make the effort to carefully choose the right business partners, these are all surmountable problems and challenges.

Julio Martinez: 35:44

Alright , Gary, so now that we're talking about issues about the way Latin America behaves or the way the region is, what do you think about the culture and the way people do business in Latin America?

Gary Gershony: 35:59

Are you talking about the apre work in the cath lab? Because if that's what you're asking, there is nowhere I'd rather be than my good friends and colleagues in different Latin American countries going out for a lovely dinner, a social dinner. Yes, you are absolutely correct. Terrific. <laugh> from that standpoint,

Julio Martinez: 36:20

<laugh>, I , I knew it wasn't gonna be a fun question for you because , uh, I usually , uh, hear people saying that , uh, they have a lot of fun in Latin America because just the, the warmth of the people and , and the drinks and, and the fun and, and people are very familiar. They're very, they, they treat you as a friend before they do business with you. And because they all wanna do business with somebody they trust and they're friends with, I mean also in the us but this is a little different in the us people are a little warmer, I will say in Latin America, at least that's what I've been hearing. And , uh, I'm a little biased because I'm also from Latin America, <laugh>,

Gary Gershony: 36:56

I can say without any question, it is likely my favorite place in the world if I find the right program and the right investigators and my favorite place to do business and clinical trials provided the business side and the clinical and regulatory side has done the right way. And so that's why one has to be very thoughtful. But even with those type of high level , very serious people, the ability to then at the end of a long day of work, very long days, we had together to then go out and to take a personal interest in each other, in each other's families. And to have, these are some of my most wonderful and fondest memories. And if I were to do another startup or another medical device company, part of the reason would be because I miss so much. Those.

Julio Martinez: 37:50

Good, I'm really happy to hear that <laugh>. So before we sign off for today , um, do you have any final thoughts , uh, more sorts of wisdom or other musics for our listeners? In other words, Gary, what would you say to the CEO of a small or mid-size medical device company that hasn't looked at Latin America or is just starting to explore the region as a potential place to do either research or to commercialize their products?

Gary Gershony: 38:20

Yes, I think, thank you for that question. Uh, I think that , uh, if, if a particular CEO or leadership team at a medical device company has not previously worked in Latin America, I would say that given the similarity of time zones, which is very helpful in terms of the ability to go and start work and , uh, not have jet lag, given the numerous, extremely capable investigators and clinical programs, given the desire to work collaboratively with many companies smaller and larger, that such a CEO ought to strongly consider a Latin American clinical site or clinical sites as part of their development. And it behooves them to research this to reach out to other , uh, medical device company executives and CEOs to learn their experience. And like anything else in life, although we tend to think that the world is global and , uh, we think in macro ways, this kind of work is , uh, done at a very local level, whether it's in the US or anywhere else. And really knowing where you're going, the capabilities the individuals involved is critically important. And , uh, since most , uh, smaller companies based in the US have familiarity mainly with , uh, the US or English speaking countries, it might be somewhat less comfortable considering other countries, particularly if it's not an English speaking country. I can certainly reassure them that Latin America is worth the effort. It's worth the time and the research to identify top-notch clinical sites and business partners. And they will be greatly rewarded by doing that, I think both from a business standpoint and professionally, and certainly also on a personal level. So I would strongly encourage them to do the investigation and identify , uh, potentially terrific partners in Latin America.

Julio Martinez: 40:35

Well said Gary. Thank you for that. And something that we haven't mentioned before, we , an offer today, we will quickly, is the currency exchange rate in Latin America is extremely favorable. Now for any US company that is looking to do research. Just to give an example, the exchange rate in Columbia has gone up in the past few months, probably since the beginning of the year because the coronavirus pandemic dramatically like over 20% or so, the end of last year, the Colombian peso was 3000 pesos for one US dollar. Now is, is a little over 4,000 pesos. And , and this is not only happening in Columbia , also in other countries in Latin America that , uh, are dependent on oil exports and mineral exports and commodities and things of that nature. So the US dollar being sore strong represents a , a bad , uh, exchange rate for these , uh, countries in , in the region. So it's really advantageous for any US company to explore Latin America just for, I mean, aside for for the other topics that we just discussed, the quality of the investigators of the facilities, et cetera , the time zone , et cetera . Also, the fact that cost savings could be , uh, significant.

Gary Gershony: 41:52

Thank you.

Julio Martinez: 41:55

All right , Gary, thank you so much for your presence today, your participation in the show. In , in the episode. I think , uh, listeners got a lot <laugh> from your experience in , in Latin America, and I like to repeat what I said at the beginning of the episode that I feel , uh, honored and privileged to have you here on our show. And I can't thank you enough, <laugh>.

Gary Gershony: 42:21

Well, Julio, it was a pleasure for me as well and , uh, uh, delighted to do it and really only , uh, a very small way in which I can repay the wonderful experiences I had over many years working with both clinical and business colleagues in Latin America. And , uh, uh, really , uh, hope that others can experience what I did. So thanks again very much and thank you for your invitation.

Julio Martinez: 42:47

Excellent, Gary. And , uh, that's very nice of you to say that , but.