Check out Dr. George Macgrath Lexitas CEO on The Clinical Trials Guru

Transcript:

Hey, Guru nation. Welcome back to another episode we try to cover all different topics of our lovely clinical research industry, ranging from tech vendors to sites to career seekers to CROs and sponsors today we’ve got an interesting story. We’ve got actually very interesting. I don’t think we’ve ever had a guest like you on before. So we have Dr. George McGrath. He is the CEO of Lexa toss pharma services which we’re going to get into and also at the same time, a practicing ophthalmologist which I have a lot of respect for ophthalmology. This is an area of research that I admittedly know very little about. I tried to dabble in it with a pie. Unfortunately, he retired right when we were about to get a study never worked out. But Dr. McGrath has a really interesting story about how he became a CEO of Lexa toss because prior to that, besides just private practice, you were principal investigator, right? I’m assuming for studies. 

Yeah. Yeah, it was. So I’ve been a principal investigator on number of studies in ophthalmology. But, but I also was working on the sponsor side so I was working for a company called Whovian which is a cdmo. Tradition traditionally, but they were developing their own proprietary products and so I was responsible with a group of people have taken their internal intellectual property and and progressing it into the clinic. And so that’s how I actually got acquainted. With us. 

So how do you go from Okay, so as a PA, you were doing were you doing like clinical trials for Lexus as an investigator? 

No, so I did. So it did so my story is a little bit more nuanced than that. So I came out of came out of training, and I went to a an equity analyst firm. So I was an equity analyst for a firm on wall street called Edison investment research and, and from there, I jumped into the sponsor side because I was evaluating a product for hoodia at the time and doing some research on it, like equity research on it. And so that’s how I got into the sponsor side. I’ve sort of done the PII work on the side whenever I’ve been interested in studies. So within my practice, so 

as a prep clinician, you you do occasionally do research studies, but you primarily do your private practice. How do you How did you have time to become an analyst? 

Well, at this point, it’s one day a week, so it’s it’s it’s really curtailed. So it was a Yeah. So so it’s very, very much 

cool. I would have been down as an ophthalmologist, which I believe he said he is so you’re the doctor, medical doctor, and then you probably have a number of optometrists working under you in which you’re delegating a lot of your tasks to them. It’s kind of like a PA and an MD and general practitioner kind of situation, I would assume sounds about right doctor. 

Yeah, it is. It’s the relationship between optometry and Ophthalmology is interesting. So optometrist or are, are very good at had glasses refractions contact lenses and primary eye care and so they actually make great great eye doctors. And while ophthalmologist are more surgical based, right, and so that’s sort of where they play. And 

but uh, sorry, enough kilometers around here an optometrist is not a medical doctor, though. You’re 

correct. Yes, that’s correct. That’s the difference is that my training is medical school, followed by four years of Ophthalmology residency, or one year of internship three years of residency. Whereas an optometrist does four years about tonometry school and doesn’t do medical school. Yeah, so it is it’s a so it ends up being a pretty good it’s analogous to physician extender in the relationship and they they do good research, right. So they do they in ophthalmology, clinical trials. Certainly for anterior segment trials like eyedrops and things like that for dry eye and nurture for keratitis and some of the other things in contact lens trials and and different things like that. They’re fantastic. Investigators and then for other trials are fantastic sub investigators. Right. So kind of to your point Chris, where they get the they get delegated a lot of the a lot of the activities of the trial under the ophthalmologist 

Dr. McGrath has still curious so you know you do the med school you do the residency you do private practice. Where did you when did you decide to become an equity analyst? 

It’s so hard to so I did a master’s in economics from Hopkins while I was in really between kind of the end of residency before fellowship. And so when I did that, that’s when I got introduced to the field and learn the trade. So that’s that’s how I got into that. So when I came out of fellowship, I pretty quickly was part time and then it’s it’s dwindled down more and more as that. As I’ve progressed in the industry. 

And how did the CEO position come about with Lexa toss? 

Yeah, so Lex Das was my service provider for about six years at Whovians. We ran a number of trials with Lex das when I was a sponsor side and so we were doing work with with a minocycline product for meibomian gland dysfunction and ocular rosacea. And in that we were also doing an ivermectin project for these mites called Demodex that can get on your eyelids and in so worked with them for a while, and then it came time were hoping it would be it was the end of the lifecycle for those projects and coding and so they were looking to license them out and things like that. And so it was a natural time for me to make a move. And so the folks that next to us were nice enough to hire me as chief medical officer to start with and then they promoted me about six months and to see 

and this is a CRO they’re a niche ophthalmology CRO 

it’s an Alexa to us is a niche ophthalmology, only CRO we’re about 200 people based out of the Raleigh Durham area and we we run really global trials in ophthalmology, anything from retina like a lot of what we do is diabetic eye disease, age related macular degeneration. Cataract surgery is a big thing we do dry eye, you know, contact lenses, things like that. 

And I’m always surprised. Again, I have like the least amount of experience probably of all therapeutic areas in ophthalmology for my career and probably Chris as well. There’s always seems to be a lot of studies and ophthalmology, and they’re rather lucrative actually compared to most therapeutic indications. And I guess that could lead into a broader discussion of why is that the case? And how does that how does the ophthalmology kind of maybe forecast growth for the rest of the clinical research industry? Or does it 

sets good? So it’s a good point, right? So you’re exactly right and it is a it is a bigger market than you would expect. Right. So I think, you know, the best I can tell it’s about a it’s somewhere between 1.5 and $2 billion outsourced CRO services market, in ophthalmology. So I think it’s I think it’s rather I think it’s rather big considering it’s a niche area. And it can it and certainly, to your point the cost per patient in ophthalmology, according to some of the industry. Research is higher than most so it is more expensive to develop an ophthalmology than it isn’t others. And and really, and really, whether or not it’s a bellwether for the market overall is really an interesting question right? And I think that that’s, I honestly think that that it I think that ophthalmology likely is indicative as a leading indicator for which way the market is going, because it can be lucrative for sponsors, but it also is one of the first things to decrease when the markets go down. Right. So in the in the current market that we’re in, I think what you’re seeing is sort of back to the basics for a lot of the biotechs a lot of a lot of the VC community a lot of the a lot of the investment community later stage. And and I think that what that means to me is that it’s doubling down on oncology. It’s doubling down on you know, diabetes, other types of indications, which are much larger and more and more in the wheelhouse of large pharma companies, right. And so, and then the count on the counter side of that, what you’ve seen is the withdrawal of some big pharma companies from ophthalmology. So Novartis kind of exited ophthalmology a few months ago and, and others have have similarly sort of cut back on ophthalmology sets. I think that whenever the market is turning south, it it the the overall industry focuses on the core basics of oncology diabetes, you know, hypertension, other things like that. And when the market is expanding, they start to look into areas like ophthalmology where you might get an outsized return, but it’s a little bit off off the beaten path. 

I see. So you think like to compare it to like, let’s say stocks since senior equity analysts do would it be like Ophthalmology is like a growth sector and then maybe the diabetes obesity they’re like the industrials like the the stocks that gives dividends rather than huge gains. 

I think that’s exactly right. With the one caveat to the GLP. One that that was done was has a has just like a wonder if 

we’ve got any studies in my site here on a human clinical trials. I work with a doctor that loves obesity. He specializes in diabetes and obesity and he’s obsessed now with the getting these kind of trials so it’s keeping us busy Christmas and Christmas negotiating one right now. He says the budget looks decent. I think I haven’t looked at it. 

Yeah. I’ll tell you. It’s it’s you know how the specialty equipment that’s required in Ophthalmology is probably what makes it tough for for, for doctors who aren’t truly in the area to jump in. Right. And it’s, it’s not just a slit lamp and outfitting an ophthalmic exam Lane are we’ve gotten really big on imaging in our studies, and that’s a and all of that is Specialty Imaging. It’s not MRIs or anything like that. It’s all 

in imaging, everything and, and ophthalmology, 

like 100%. 

How does AI play a role in this? Do you think that I mean, across any therapeutic area, you’re going to have central assessments, right central readers, whether it’s for X rays or MRIs for osteoarthritis or Alzheimer’s. You’re studying to see EGS and other wearables in and major depressive disorder and CNS indications. ophthalmology has always been about imaging. I mean, those are like the primary endpoints, right? Usually. 

Absolutely. Yeah, I think certainly, imaging has always been central up until the appellate approval earlier this year. Companies that always had to fall back on a functional endpoint like vision or something like that. For Lux Turner, or the gene therapy that was approved. It was amazed where the patients had to walk through without stumbling on blocks with the lights turned down low. And it is brutal. It’s we’ve actually even the University of Pennsylvania is doing some work on a virtual reality aspect of that, where you actually put on Oculus headset and do that rather than actually in real life tripping over blocks, which I think is much more humane. It’s it’s a it’s a good it’s a good development. It’s, it’s coming out of Japan, that we’re following in wartime. But back to your question about AI and imaging. We, you know, because a palace was approved on an imaging endpoint which was the first time that’s happened in ophthalmology. It’s been a little bit game on for imaging as the primary endpoint for our trials and so people are really doubling down on the imaging now, and and to hit on the AI aspect of it. I think that I mean, there’s two there’s two aspects of this, right? So imaging and Ophthalmology is becoming higher resolution more, you know, more precise, there’s, there’s advances in the actual technology where people are using adaptive optics and things like that and getting down to resolution you know, right now the octa axial resolution is like seven microns. So it’s it’s incredible the detail you can see. And then you’ve got the other aspect, which is the software side where AI plays plays a part. And just like in any indication, you know, the role of AI right now is to pick out patterns in the data that humans can’t see. Right. So that’s, that’s really what we’re doing with it right now. We are we’re using it to, to basically, you know, to basically feed in all of the pretreatment images, and then look at the images, post treatment and more patients who are a success and mark the ones who are a failure and ask the computer if they can help pick out the patients at baseline that are most likely to have a PayPal response. So though, at Lexington, there’s a lot of people doing a lot of great work on this but at Lexa toss, what we’ve done is basically phase one of the project where we where we train the computer to look at images of an eye and tell whether or not the patient has diabetic macular edema, so type of diabetes in the eye and they can do that with a night literally at 99% specificity and a 96% sensitivity. So it’s pretty accurate 

as a physician as 

AI, yeah. So for this it is so this is a pretty simple thing. So physicians can look at it and you can tell, you can tell on it. Honestly, it’s pretty much 100% It’s pretty obvious. So that’s phase one of the project that we’ve been working on Phase two is to see if we can extrapolate it like I was talking about to a trial where we say okay, these are these are all diabetic macular edema patients, okay, which ones respond, which ones don’t, how do we, how do we tell? So that’s that’s honestly what we’re working on right now. 

And the algorithms are kind of what our that’s a new thing. I’ve noticed Chris, we have a depression study, and they’re using algorithms based on brainwaves to drop people out. Like the algorithms are the final filter after the humans run the IE criteria. The last thing is, must pass the algorithm check brainwaves. And like you said, Doctor there they’re looking at the pattern. So we’re seeing this across the different therapeutic areas, but seems like ophthalmology has been leading the way as somebody as a CEO of a CRO I mean, Chris and I have these discussions all the time with the sites and at what point you know, all the big CROs all the five letter ones, three letter ones. They started out being enabling sponsors, right they enabled sponsors to do more. They enabled sponsors to do trials and not have to worry about monitoring. And over the decades, that’s evolved into more complex trials. And it’s almost as if many of these heroes have an incentive to increase the complexity net reduce it as a CEO of a niche, ophthalmology only CRO. Do you see the role of the CRO changing? Like it used to be just about monitoring. Now that’s almost like an afterthought compared to all the techie guys are rolling out. 

Yeah. So I think that it’s a what is I think what the industry is changing to at least enough homology is, is that our job has been is has more from just being an extension of monitoring and an extension of project management, to actually being the operators who figured out how to truly execute these trials. Because, as they I think the pendulum swung a little bit too far in the complexity because what we’re preaching now is, is more of a simplicity because enrollment rates went down right so as the complexity went up and coat and as we had COVID and people will staff and things like that. There’s been a big, there’s been a big across the board, not just optimality but everywhere. It’s been there been problems with enrollment rates, and so we spend honestly a lot of our time right now thinking about how we improve enrollment rates and, and that and, and that goes to a couple of things, right, that number one is it goes to complexity of the trial, because it just becomes too difficult to do at some point. And the investigators just don’t want to do it. Right. No, pick a trial. It’s easier. And then it comes to it comes to staffing and sites and so making sure that the sites that that lost a lot of staff during the Great resignation are actually getting those people back and then training them right so when they bring in their people training them, and we’ve actually got some good case studies of that where we had investigators who’ve come to us and said hey, we’re interested in research, but we’ve never done anything. It’s kind of intimidating. And we we send some of our people to sort of to the site to train their people and and they enroll in they have great data quality and things like that. So So I think there’s a shift in the industry towards towards getting trials done in a cost efficient time efficient manner, at this point that, that that’s a little bit different than just trying to ramp up the complexity and trying to ramp up to monitoring visits and things like that. 

And at the same time, and I know Chris has been dying to ask the CEO of a CRO some questions but at the same time an interesting observation I have had and been having with tech vendors, especially the ones I respect is there are there’s been a shift from tech vendors who making products more site centric. So you know, in the past everything was patient centric, and it sounds good, but it’s very difficult to achieve. But site centric is a little more achievable. However, it’s very tough to build a business model on that because it requires user base and user growth and premium sort of growth. But I see the tech companies as slowly inching into CRO territory, at least territory that used to be zero. I mean, CROs were supposed to be site centric, at some point, and then sometime along the timelines that shifted to where they’re no longer site centric, don’t ever say it, but they’re the ones you know, acquiring these vendors and then forcing them on the site when the sites don’t want them. What are your thoughts on this like as a CEO of a CRO do you view these companies as allies or are you just trying to innovate internally or how do you 

Yeah, so I would say that our this is very precious because I just had I just literally had a call about this right before like yesterday, so so this is this is on top of my mind. And then I’ll tell you that example and then I’ll get into our sort of philosophy that example is that we’ve got a new a new technology machine that is evaluating the primary endpoint and one of our studies and and that’s been rolled out by a small company that basically that is a tech company right there. They’re basically a hardware company. And so the cool thing is to partner we’re with them where they say, Hey, we can provide your tech right we know how to do that. You guys know how to handle the sites and you guys know how to roll this out and operationalize it. How can we work together to get this to get this this hardware into into the sites and get it get it up and running without without upsetting sites you know, without without causing undue stress and site says it gives a fantastic conversation we had and I think it’s a great model. In general, it looks to us we’re site centric, right so we are doing our best to protect the trials protect the investigators and we don’t we honestly, will, will use tack when it’s needed and wanted, but we are not trying to push anything out that the sites don’t want. So if we’re getting pushed back from the sites, we, we, we basically that that’s that’s what rules today. Because I think to your point, I think the first step from our side, the first step towards being patient centric is to be sites centric, right? If we can make the site’s functioning well and happy and enabling them then they’re the ones that are seeing the patients so I think that ain’t that that’s our philosophy. So we developed we deploy tack when needed, but we certainly don’t we only do it when it’s needed by the site’s 

I mean, so many things I can ask what do you think about sponsors? Trying to squeeze in more and more exploratory endpoints at the cost of increasing study complexity, what is your role as a CRO as far as advising them? To do that or not to do that? In different situations? 

Yeah, it’s a balance, right? I mean, you want them to, you know, and rightfully so if these patients are giving up their time and are willing to enroll in the trial, you want to get as much data about the drug as you can. But, but I view our role as being the meeting where the mediator right where they the, where my job is to allow the scientist at the sponsor to decide the whole laundry list of what they’d like to have. And, and then I come back back and I say, Well, this then yeah, there’s reasonable, and then XY and Z is not reasonable to do. And, and you know, we’ll do it if they want to, and we’ve done things like separating visits into two days and stuff like that, so that you can get all these exploratory endpoints done, but my job is to counsel them that that the more they add, the harder it becomes on the patients the harder it becomes on the sites. The lower the enrollment rates become. And, and and then you honestly worry about at some point, when you add too many things you wonder about whether or not you’re, you’re sort of overloading the data from a quality perspective, right. If it becomes too too complex, you end up getting a lot of deviations and stuff like that. So 

yeah, these flash threes are one slash twos are getting out of hand. 

Like that’s something we’ve seen a lot of is that’s something we see a lot of is is is basically the one slash to where it seems like a real trend in the industry is to do your ask dose escalation, then immediately go out into a into an expansion cohort. So 

it’s in the same study and switch whenever you feel like it. I’m dealing with one of these right now. Chris, 

follow up question that you probably already know the answer those damn because you do these every day, but I don’t. I would assume some of the audience doesn’t really answer this as well. So in terms of complexity, I would assume the push for more complex trials is a combination of both FDA and the sponsor, but which is primarily responsible for the more complex trials is that the requirements of the the FDA or is it the sponsor being greedy in terms of data? 

So I can speak I can speak for ophthalmology, because I’m familiar with the ethnology department there, which I think is it may or may not be a little bit unique. But from my perspective, the FDA ophthalmic division is, is quite. It’s quite clear and concise about what they want. They’ve they’ve done a great job of putting out some guidances and they’ve done a great job of telling people exactly what the path is to prove efficacy. And, and they don’t, you know, to get them to validate a new endpoint is quite a hurdle, right? It’s been done and done very recently by pelisse. But, but it has to have very, very clear rationale. So So I think most of the complexity increase that we see in clinical trials is secondary to sponsors trying to learn more and more about their drug, right, just trying to understand their drug better, and it’s a reasonable thing for them to be doing and it’s our job to sort of, you know, at times just not to push back that’s not the right word, but at times to, to just alert them to what the real world consequences are of some of these situations. 

So a dozen years ago used to be relatively simple to recruit patients promote studies, regardless of area. And now it’s become very difficult in almost all areas of research. Now, what I hear you telling me is that sponsors are the main, I guess, problem in this area, in terms of making complex to recruit patients, at least from a site level. So is that economically is that beneficial to sponsors in terms of, yes, we’re making this more difficult but the data we’re able to gather is making us help is helping us determine which studies are which which new drugs which I P really will probably be successful and which will not at an early point. I mean, what’s what’s the rationale behind the complexity if it’s economically not beneficial? And again, maybe it is in terms of pursuing an IP, right if you can’t get patients it’s very costly for a study. 

Right? Yeah. And the number of studies that you know, I was I was shot this obviously doesn’t happen for us. We finish all the studies we start but I was shocked to see a statistic about the number of studies actually don’t ever finish because they can’t enroll. But, but to to your question, so I don’t think that the method is a little bit more nuanced. I don’t think sponsors their primary reason why enrollment has gotten out of hand. I think the primary reason why enrollment has gotten tougher, has been has been a lot around the macroeconomic and an environment of everything that happened with COVID. Right. So I think that the I think that what we saw were a lot of our keys sites, lost a lot of personnel. And so we had great PIs that were trying to train new study coordinators from scratch, you know, and I think that that really, really slowed everything down. On top of that you had a backlog of patients that had to work through the system. So all the patients who didn’t go get eye care during COVID You know, rightfully so. We’re now we’re now getting back into the system. And so you had sites that had more patience, less staff, and I think that that drove a lot of it. And you you pile on the complexity issue that you were talking that we were just talking about and you’ve got like a recipe for for a not great enrollment rate. It’s I think it’s a little bit of all of those. 

And I’ll add on top of that. Now, not only are studies getting harder, not only our sites and ciros more short staffed and moreover work than ever. Maybe the a bit of a recession here. We’ll change that a little bit. But there’s still such a backlog. But on top of all of this, throw in the push for D and I now so studies now need to enroll minority patients as well. We’re in the past we couldn’t get anyone forget about what their background was now they want a certain percentage to fit or to check the DNI boxes so it makes it even, like exponentially tougher. It’s almost impossible to pull us off all of these things simultaneously. 

Yeah, and we’ve we’ve been lucky because we’ve always sort of we’ve we’ve always done a pretty good job with D and I with in ophthalmology because we we naturally have have gone to nationwide sites that that have had a good number of underrepresented men, you know, people population. And so so that’s something that that we are in we are very much more cognizant of for the reasons that you described. It’s it’s, you know, we now we now include that with a thought process and and in some cases have plans around that for for larger trials to ensure that we get there and so it does add another level of complexity, but luckily enough myology we’ve been it hasn’t really changed much of what we’ve done because we’ve we’ve sort of naturally gotten a diverse group of people. So what about 

how do you do that with the community based sites? We do. 

Yeah, we do. We do mostly community community based sites. So we do we do almost all private practices for ophthalmology and and then we’ve selected practices that are in different areas of the United States. So we look at where the site distribution is, you know, we make sure that they’re both sites and the Carolinas, you know, Minnesota, you know, California kind of spread out like that, you know, all over the place. So, it ends up being representative. I do think it’s important. I think it’s only fair to the people that that at the end of the day, the drug is gets tested and all different people populations before it gets approved, so that we know, but it adds complexity, but it’s I think it’s an important thing. 

What about decentralized clinical trials every three years there seems to be a new buzz. And it’s been DCT until care access. fiasco, but yesterday there was new FDA guidance on DCT Do you think yeah, it works in ophthalmology or that doesn’t work for you because 

it’s a little tougher for us. There’s one company out there is doing a good job. It’s called 2020 on site they have they have some buses that go around they’re fully equipped but but decent research 

on a bus also. 

So it’s so they’re so they’re, they’re doing a good job and and they’re catering to a lot of pelvic exams for other indications. So that’s, that’s a real nice, right is when you’re working in a different therapeutic area, as we know a lot of the immunotherapies and things like that are called side effects with the eyes and so getting those eye exams is is a good service for some of those other those other trials, 

that’s actually like maps and basically like this whole wave of immunotherapy and monoclonal antibodies, UV rays a good point like vision is one of the primary safety concerns for most of these new studies that we have for you. I mean, that’s just gonna keep these ophthalmology clinics busier. 

Yeah, and it’s and it’s hard because again, it’s it’s a whole to your point earlier, it’s a whole new level of complexity because the you’re trying to run an oncology and fusion trial, and then you try to add in ophthalmology on top of that, and just finding the site that’s near, you know, contracting with them getting everything set up is is a pain and so 2020 on site has a great offering for that where they just literally pull the Optometry Clinic up into the infusion center parking lot, and they can get it done. 

They’re nationwide. These guys are nationwide. Yeah, they 

are nationwide. Yeah. Um, I 

need one for we don’t do ophthalmology studies, but increasingly we need eye exams as one of our assessments. If you think about it, Chris and everyone else listening, the vision changes blurry vision. I mean, that’s like 80% of all drugs have that listed on their labels, right. If you watch commercials, you don’t even need to work in our industry. You listen to the side effects afterwards. You almost always hear something about vision. 

Yeah. Like everybody does. Now. They look at screens all day phone screens. Blurry vision, too. So yeah. 

Yeah. So for us for ophthalmic centric trials. DCT is tough. We, you know, there are some because it’s so imaging based and because it’s so the equipment is so nuanced, it becomes difficult to dissociate that from the site. So that we you know, there’s some forays into that but nothing that’s been transformational yet. So 

you guys still you’re a CRO that’s, I imagine constantly seeking sites, rescue sites, whatever you need need to be are you finding a lack of qualified sites? Do you need research naive ophthalmologist doing studies? 

Yeah, so I think so. So I think what’s, what’s happening with what’s happening in Ophthalmology is that the number of sheer volume of trials has gone up dramatically. And I don’t think that the number of ophthalmologists conducting research has gone up commensurately with it. So I think what you have now is, is is really a is really a research base of a PIs PI’s have a lot on their plate. I mean, it’s not uncommon for me to talk to some of our PIs and they have 1520 active protocols at the time, right that they’re rolling. And so it’s good for Alexa, tell us because one of our core, one of our core advantages why people come to us is because we we work with them to make sure their protocols get to the top right. We are really sensitive with our relationship with the investigators. So they do enroll our trials first and we are very sensitive to the complexity of the trial and all the other aspects of it so that it is at the top of that pile. And I think that I think that that will only be alleviated when there are more sites out there that are doing research. And so I think that I think that that is a real core thing to, to getting enrollment rates back to what they were in 2019. 

Personally, I have any ophthalmology sites in our network? 

No, I don’t think we do. 

I almost had a PA here but he retired and Arizona, 

just FYI. If you ever are looking for sites I’m not sure I would have to ask our our coordinator of clients. If we have any ophthalmologists, I would assume we do. I’m just not aware. 

I appreciate that. We’ll definitely reach out we’re always we try to cast a wide net for sure. So yep. 

Yeah, especially if there could be DCT elements. Well, I mean, the ophthalmologists that had here did everything had all the equipment he was just old and retired and then the now we have an optometrist and they have a lot of our sponsors. They have like safety eye exam assessments. They prefer ophthalmologists, but they’ll accept an optometrist if they have the right equipment. So these guys do they have like the Optos and all that latest stuff. Yeah. So we’ve been they’ve just been so busy. We’re like, booked out until July it it’s in our patients do and it’s made right now for those watching. 

And I think it’s completely reasonable for for optometrists to do that, you know, I think that if, if it’s just an eye exam, you know, the optometrist or can be trained and are very skilled so, so they’re good. I think if you’re to your point earlier in the podcast that you if you get into more systemic, holistic, medical doctor type things and you need then you need the ophthalmologists. For sure. 

You think that you’re still a practicing physician ophthalmologist? Do you think that’s an advantage when it comes to site selection? Or, like, get on the phone with doctors and have just Doctor Doctor talk on your site? 

100% Yeah, so I thought to the investigators all the time. I sort of know what the investors gonna say because I’ve been in their shoes. So whenever I see a protocol or talk to a sponsor, I sort of sort of have a good feeling for how this how the trial is. Going to enroll, how it’s gonna go. And it’s pretty straightforward to validate that because, you know, I’m, I am a peer tool rather than 

a medical monitor, also the CEO and medical monitor. 

I used to do that when we were smaller. I’ve gotten away from that. It’s going to grow. So we’ve, we’ve actually hired a number of other we’ve hired a number of other couple of couple ophthalmologists and optometrists to handle most of that now. 

Yeah, would you guys ever we have a lot of a large segment of our audience that are career seekers, a lot of IMGs international medical graduates. And I’ve heard other zeros have hired IMGs provided they have enough research experience to be medical monitors. Is that something you guys have thought about doing or have done? 

Yeah, that’s something we’ve done before and it’s in actually multiple different roles, both with medical monitoring and more of like a strategy consulting type role, too. So some were open to you know. Yeah, 

absolutely. That’s cool. Especially now things are getting more global. Like, I can’t be as in most countries, most developed countries. And you know, who’s to say that they’re their medical monitor, if it’s a doctor in New Mexico, and it’s a global study, why not have him be the medical monitor for us sites to like, it just makes sense. 

100% Yeah, 

you’re just an FYI. Again, I asked Julie, we have two ophthalmologists in our network. There 

you go crystal services short. If you are a site looking for studies, we help we help you negotiate your budgets we put you in touch with people like Dr. McGrath. So yeah, if you need to new sites that are probably not in your network, Doctor. Let us know we’ve got him. 

Now we appreciate that. Absolutely. 

Chris, anything else that you’d love to ask? 

No, I, the things that I’m interested in were answered and I appreciate it. 

Sure, I think niche zeros are going to become increasingly important if that is getting more complex. And I think the bigger zeros that we all know by name are going to have to evolve into tech companies over the next decade, and 

yeah, that’s interesting. I I fully see what you’re saying with the with you know, I do think that we are uniquely positioned for more complex ophthalmic trials. You know that it may it’s one thing for a big CRO to pull off a straight forward, you know, contact lens trial or something like that, but some of the more complex that really involve the thought or are probably better than the CRO. And then the big car is going to a tech company. They’re really interesting idea that I think you’re probably you’re onto something there too. I just think 

that tech is really a double edged sword. I mean, for many trials that makes that site level and many trials for many trials, it makes things much more difficult. As opposed to using. 

Yeah, the bad ones that are forced on us, but the site centric ones that I’ve played with the sponsors of this podcast, you might as well name them first to trail Creo and annatto. For now. Those are sites centric, heck, ish. type of companies, I mean, who of them consider themselves full on tech companies? Barista trowel, and, and I don’t and then creos eSource de reg. Those are all like, site focused. I use them every day. They make my life easier, and no one forced me to use those or like I voluntarily chose to use this. I think the difference is a lot of these heroes they acquire these tech companies and then they kind of make them fit what they needed to do not what the sites 

so here’s an example of tech that no side care cares for. Ie pros. 

Oh, yeah. Yeah, exactly. 

I mean, there’s just tech and there’s very similar texts as well that just are not not site centric or do sites care to work with at all right? Yeah. 

Probably got you agree with that. You guys, do you present ophthalmology? 

We don’t do e pros. Now we do. We do pros but naughty bros. So 

the patient has a visit you guys keep the questions. Limited exactly they have is I think that’s the best way to go about it. 

Absolutely. 

Yeah, exactly. It’s, you know, we’ve mastered methodologies never had, you know, we have some we actually have some good patient reported outcome questionnaires, but, but they’ve never taken off as sort of as sort of essential to trials. So there hadn’t been that big of a push to get all that extra, more complex data that the pros would purportedly get you. 

See, oh, thank you so much for coming on, doctor. I mean, love to connect with other people in the industry that are like minded and niche. You guys are niche. We respect that. And we do have two sites in our network that apparently do fit the bill for probably what you’re looking for. Well, we can get those names out to you. But thank you so much for coming. Out. If people want to get a hold of you. Where can they go? 

Yeah, so selects. test.com is our website. LinkedIn is good way. So it’s, we should be pretty easy to get ahold of and we welcome any conversations. You have 

a LinkedIn profile for yourself or Yeah, we have 

one for myself and certainly one for lifestyle. 

I’ll put Dr. McGrath, LinkedIn underneath this video. You guys go connect with him. Thank you so much for coming on. Chris. Thank you for CO hosting. And letting us know how much you hate pros. Like Subscribe, comment, share, guys. Bye bye.