Andrew Brackin: Hi, I’m Andrew Brackin the co-founder of Vial. Vial is a next generation tech-enabled CRO and we’ve built a practice in retina, and across a number of therapeutic areas. We’re here to really push the field forward and build a better CRO that uses technology and experienced ClinOps leaders to deliver faster execution for sponsors. I’m here with Dr. Veeral Sheth the Director of Clinical Trials from University Retina. How are you, Dr. Sheth?
Dr. Veeral Sheth: Hi, Andrew. I’m doing well, thank you for having me. My name is Veeral Sheth. I’m a retina specialist in the Chicagoland area. We are part of a private practice that’s affiliated with the university locally, the University of Illinois. I’m the Director of Clinical Trials and we run a pretty busy clinical trial site. One of the busiest in the Midwest when it comes to retina research, and so very excited to be here today and have this conversation with you.
Andrew Brackin: Absolutely. Excited to be here as well. My first question for you is obviously, as you said you’re, an extremely busy researcher. When, a new biotech company approaches you and, they have an exciting new asset, what advice do you usually give them if it’s their first in human trial?
Dr. Veeral Sheth: Yeah, no, that’s a great question. And there’s a lot of this going on right now which is really exciting. And so my advice to, these sponsors is generally you’ve gotta run a high quality trial. I mean, you’re really just at the outset of this exciting new technology or medication, it could be a surgical approach. And so you really wanna do everything you can to make sure you succeed and you’ve got something there.
And so I think the key is partnering with people in that space that you trust partnering with people that, that are going to do high quality work. And that’s not just the clinical trial sites, that’s CROs, that’s vendors all the way across the board. And so if you do that’s a great starting point, right? That’s gonna give you the best chances of, doing at least the high quality trial. And hopefully at the end of that, study we, get the results that, that we’re hoping for.
Andrew Brackin: Absolutely. Obviously recruitment is, one of the biggest challenges, especially in retina. What have you seen work in terms of recruitment for the trials you’ve been a part of?
Dr. Veeral Sheth: Yeah, so I think it depends. I think it depends on what diagnoses we’re talking about. So the more common diagnoses, let’s just say, for example, diabetic macular edema, or for us, macular degeneration. Those are patients we see every day. And so we are getting those referrals in, regardless of, if we’re talking to, to physicians about this studies we’re doing. So in those scenarios, I think educating internally is critically important. So educating our physicians that we have, our staff people, anybody that’s interacting with the patients in our clinic, educating them on what the trial is or what trials are available is critically important.
Now on the flip side, if you have diagnoses that are just less common, that we’re not seeing I’ll give you an example. A few years ago, we weren’t seeing a lot of GA being sent to our clinic. So in those scenarios, we have to go outside of our clinic to start educating. So it’s an external education that’s, to referring physicians, that’s potentially to patient groups because for the longest time there were no options for these patients. And so now that we’re starting to explore options in those disease states, we need to make sure that the people that see those patients or that are those patients know about those options.
Andrew Brackin: That’s incredibly interesting. You spoke about internal marketing. How do you prioritize those trials that you’re running and, manage your recruitment goals, given that you’re running a number of studies across maybe similar indications?
Dr. Veeral Sheth: Yeah it’s tough because especially when you are really busy there, you run into a couple of problems. One is there’s potentially competition between studies at your site. And then different studies are in, various life cycles in your organization, right? Some are just starting up. So it’s important to continue that process. Some are in recruitment phase. Those are the ones you really want focus in on and maximize because that’s… you have that, window where you can recruit patients for that study. And then you have pati- you have studies that are later on in their life cycle, you’re just following the patients through the end of the study.
So we really focus in on that middle group. And the way we do that is we have weekly meetings. I think this is one of those things where you have to keep things top of mind with the fellow physicians and also the staff, especially the staff because that’s where the recruitment’s gonna come from. And when you start to see recruitment pick up, you can then start focusing on other trials and making sure you’re focusing those efforts. But we’re humans, right, we can only focus on a few things at a time. And so having those weekly touchpoints is important at our site.[00:05:00]
Andrew Brackin: Yeah, absolutely. Those touchpoints make a lot of sense. And I know that you do a lot of different, trials. So I imagine there’s a lot to catch up on there every week. You’re, obviously a well known figure on the podium and, seeing a lot of innovation in the field. With, all of the recent progress you’ve seen, what’s some of the most exciting research that, that you’ve seen that, that you didn’t expect?
Dr. Veeral Sheth: Yeah. So I think that’s an easy one because I think there’s really two fields where we’re really starting to make progress at, what I think is a, much faster speed than I had expected. So one is gene therapy and that, that’s that broad catch all. But within gene therapy looking at options for, neovascular EMD, as well as GA geographic atrophy has been really, exciting to see how many phase two and phase three studies we have at this moment how quickly we’re seeing kind of results. And that’s, really exciting. That was, if you would’ve asked me three or four years ago, I wouldn’t have thought we’d be this far along in that. And so that’s one place where I’m really excited.
And then more specifically disease states, we’re talking about geographic atrophy. We were in some of those trials four or five years ago, six years ago now with Lampalizumab, for example. And when that didn’t make it through we were really excited about that as a treatment option for GA. We didn’t know where we would go after that. We didn’t know which sponsors would, come through and, continue that work. And to see how many sponsors and how many different pathways we’re exploring right now again, just another thing that I, don’t think I would’ve bet on five years ago. But I’m so happy today that we’re starting to see the fruits of all that labor and that people would, that they continue to follow through with that.
Andrew Brackin: Absolutely. Just digging into the history of retina research has been incredibly interesting. And it’s obviously a field that has seen a transformation in the past 15-20 years and pretty incredible for, patients the, amount of innovations coming down the pipeline. So I think, out of all the fields of medicine I’ve dug into in the last two years, retina feels like incredible amount of innovation. Researchers like yourself are really on the forefront of incredible new innovations for patients that are gonna just deliver so much improvement in life for patients.
Dr. Veeral Sheth: Yeah. Andrew and, I’ll, just add to that. It’s, incredible the boom that’s happened in the last five years. We were busy five years ago but, to see how many different sponsors and how many different disease states we’re looking at now, and how many different ways, I mean, forget, hey, it’s not just EMD and DME anymore. We’re looking at all kinds of things and, different ways of doing it, whether that’s different ways of applying the, medication or different surgical techniques. I mean, so that’s, it’s really exciting because there’s so many different avenues we’re exploring right now.
Andrew Brackin: 100%. We were just at ASRS and I know we met you there and pretty unbelievable the amount of, new biotechs working on, innovation and companies that have been been in a number of fields, of medicine that are now applying their, innovation into retina. So incredibly exciting. Okay. So fast, forwarding say, the year is 2027 we’ve talked about the past what do you think we’ll be talking about in retina research circles is it gene therapies? Is it something else?
Dr. Veeral Sheth: Yeah, no, that’s a great question. I think the easy answer there is gene therapy, right? I mean, I think we’re, in phase two, phase three or approaching phase threes for a lot of these programs right now. Which means that in 2027, we should be talking about hopefully some of these finally coming to market or getting close to that point of FDA approval. And I’m sure at that point we will be, there will be a buzz about that. And, there should be because those are gonna change the, lives of our patients. Right. But I think that if you’re asking me to be a little bit more thinking about moonshots, right-
and where, that buzz with those of us that do phase one phase two early treatments, where are we gonna be looking at that point? My hope, maybe this is like a wishlist but talking about neuro regeneration. Because right now everything we’re doing is really maintaining vision, controlling disease states. But we have yet to figure out… and this is all throughout medicine, right? I mean, our colleagues in neurology have been working on this for a long time with their ALS patients and with MS patients and, Parkinson’s, and you name it, they’re trying to figure out ways of regenerating neural tissue or, reversing nerve loss, spinal cord injury’s another one.
So in our field I, think that… and we’re starting to see this, don’t get me wrong. We’re starting to see certain places start to look at this, some promising results early, early stage results animal models, things [00:10:00] like that. But the hope is that five years from now, when you and I touch base and have this conversation, it’ll be, “Hey can you believe we’re in phase one, phase two clinical studies of treatment options that are actually gonna start to restore vision?” Right?
We recruit for these patients that have GA in these studies. And one of the, biggest pain points still is that patients will say “Hey doc, you’re doing great, but I’m not getting any vision back. I’m not seeing any better.” But we don’t have anything like that at this point. Right. But I’m, my hope is that in 2027, we’ll be talking about some of these options that might be able to bring us into that place. And so that’s again, maybe more of a wishlist, but with how fast things have moved in the last five years, Again, if I go back five years and you told me what we had today, I would be more than surprised and excited. And so I’m hoping that, that, will be the case five years from now as well.
Andrew Brackin: Absolutely. That would be incredibly exciting. The speed of innovation is, unbelievable. And I think if we can continue at, that pace or increase our pace hopefully we’ll have some good, options there. We’ve, always loved speaking to you about clinical trials. I think you’ve built an, incredibly impressive research site that has grown over the last few years. But based on the good work that you and your team do. But I’d love to dig into the challenges. Running a successful research site is, very challenging. And, I think that’s one of the big reasons we’re here. We see the, pain points and the challenges that sponsors and investigators have, and we’re trying to solve some of those problems. So what, where do you see the, greatest challenges in terms of running a research site?
Dr. Veeral Sheth: Yeah. It’s it’s amazing when we run our day to day practice, forget about research for a second, just what we do day to day from a clinical standpoint. It’s pretty straightforward, right? We have a simple set of inputs. That’s what we are putting in our exam notes. And then we have a simple set of outputs. And we just don’t have that in clinical trials, right? The world of clinical trials is so disparate. You have disparate inputs, which leads to disparate outputs. And from my standpoint you think about a clinical trial. Our, we do our best within one clinical trial to standardize everything. But if you look at it at a macro level, there is no standardization to clinical trials, right? So we, have different vendors, we have different ways of documenting. We have different…
So when we do that, it makes it a very inefficient system to run. And just look at collection of payments, for example. There’s different ways those come in and different ways of managing, and it takes a lot of effort and labor to, to manage that and mistakes can be made. And so from my standpoint to answer your question more directly I think standardizing some of these things makes a lot of sense. Having a system that oversees all of it that says, “Look, I know these inputs are going in now correctly, and I know what to expect on the other end.”
I think that’s gonna be something that’s hugely beneficial not, just at the site level, but just in order to push forward and continue to generate really high quality data. If we look at the amount and the number of trials we run, well, we wanna be able to continue to do that and continue to grow as, a trial site, but it becomes more difficult over time because you’re, having to manage each trial so differently. Again, goes back to that, efficiency, right. We wanna create more efficiency. And I think standardizing some of those things would be helpful.
Andrew Brackin: 100%. It, blows me away how much repetitive work there is for research sites across all of these trials. Feels like sometimes you have to reinvent the wheel for each trial and build a brand new process and obviously creates an incredible amount of work on the site and on the research staff on the ground.
Dr. Veeral Sheth: Yeah. Day to day we use one EMR in our clinic. Can you imagine if in my clinic, I told you in the day I’m gonna have you use 10 different EMRs depending on the patients-
Andrew Brackin: [laughs].
Dr. Veeral Sheth: … you saw, right. But that’s what we do. That’s what we-
Andrew Brackin: Yeah.
Dr. Veeral Sheth: … do in clinical trials. Right. So I think that’s, that making those processes more efficient it, seems simple, but we, Over the last decades or so we haven’t been able to figure that out.
Andrew Brackin: With, our new CRO, how do you think we can solve some of those problems? Where do you see Vial making the biggest impact on sites and, where should we focus our time and resources?
Dr. Veeral Sheth: Yeah. So I think there’s a couple ways . I think one is at the CRO level, you’re able to dictate what platforms that are gonna be used. And so I think once you start at that point, that already makes things a little bit easier, right? There’s not that unpredictable kind of, which are we gonna be using this company for, labs or are we gonna be using that company? Because it it does affect our day to day. The second is focusing on high quality trial sites, because your trial at the end of the day is only as good as the sites that [00:15:00] are doing the work. And so I think that’s another barrier that you’re gonna be able to lower. And, I think there’ll be a comfort, not only at the site level, but at the sponsor level, from that standpoint.
Andrew Brackin: Absolutely agree. And I think that’s all the, problems that we’re working on solving right now. The last question I have for you today is you’re obviously, as I said, a prolific investigator but breaking into research is hard. I’ve met many, physicians that want to break into research and, can’t, or have had challenges doing so. It’s that chicken and egg problem, right. Sponsors wanna work with great sites that can recruit and have good quality data and high quality teams, but if you don’t have experience, it’s hard to break in. What advice do you have for your colleagues that want to break into research, but haven’t yet? How did you do it and how do you think they should do it?
Dr. Veeral Sheth: Yeah, that’s a great question. The chicken and the egg problem is a real problem in this space. So I- I’ll start with saying, if you’re gonna do it first, I think it’s, fantastic. Obviously we’re doing it. We love doing it. There’s a reason why we’re doing it. So I, would say first start with doing it for the right reason. You wanna be able to treat your patients with cutting edge technologies. You want to keep yourself intellectually stimulated from that standpoint. I think that these are the right reasons to do it. And doing it the right way is, just as important. Right?
I think the other thing is, when, you say it’s hard for people to start, a trial system you’ve gotta throw a lot of resources at it. And when I say resources, it’s not just financial resources, it’s time. Because at the end of the day, if, when you say you gotta do it the right way, what that ultimately translates to is quality. If you focus on quality that chicken and the egg problem becomes less of a problem. In other words when you’re starting off, if you’ve got people that have experience and that can go from the, PI to the coordinators that’s gonna help, that’s gonna help you get that first trial. And getting that first trial is always the hardest thing to do.
I’ll tell you personally, what we started with was the DRCR network. I love the DRCR network and I’m, always going to be in debt to them because they, helped us get started. They were very good in teaching us . They were helping us learn the trial system for ophthalmology. And then taking that knowledge and moving it forward to other sponsors is how we ended up doing it. So that’s just one way of doing it.
But to your point experience does help. And so getting that experience with, some of these sites, or making sure you focus on phase three later studies later, phase studies, because those are again, easier to start with. And then as you demonstrate quality and demonstrate the ability to recruit, then you’re gonna be able to work on phase two and phase one studies.
Andrew Brackin: That’s great advice. Really enjoyed the conversation today. It was incredibly interesting and I learned a lot and I’m sure our viewers did as well. Thanks so much for the time Dr. Sheth and excited to work with you on a number of trials in the future. I know we have a number of opportunities we’re working on and looking forward to working with you more.
Dr. Veeral Sheth: Thank you for having me.
