So the solution that we've come up with is we call it solid drop. It is a drug delivery system. So I have to choose my words carefully because in the eyes of the FDA, what we've developed is a new drug product. It is not a device. However, it has some similarities there. So it gets a bit blurry. But I will say it is an eye drop that provides sustained release of drugs at the ocular surface. And the way that it does that is liquid installation, just like any other eye drop, that then collects in the space beneath the lower eyelid called the inferior fornix. And there it transitions at body temperature from a liquid to a stable gel. And that gel just stays, it just sits there, and within that gel we have polymer microspheres which are very well characterized, very commonly used. And those allow for release of the drug over about one month, that's our maximum time frame for the glaucoma formulation. And really the unique part of our solution it's not the drug release, lots of people can make glaucoma drugs be released for a month, though I hate to admit it. What is most unique, is that we combine that with a gel, a thermal responsive gel, and just said we're going to treat it the same as an eye drop. It's just going to happen to reside for very long periods of time. And when we first came up with the solution conceptually we were thinking, well if we could ever make this work it would be great. But we never had high hopes for a drop to actually stay put for one month. And so lone behold after some tweaking with our animal studies, we were in fact able to demonstrate that, and that was going back to the uh-huh moment, that was a big one for us. Because it was after 24 hours, when I walked in and I saw that all of the gel drops were still in place exactly where we had put them, that was a big moment for us, where we thought this might actually have some legs and it might actually work. We do not have an original drug that goes inside. So we didn't do any drug discovery in the traditional sense. We are taking drugs that are FDA approved, they're very common place. The drug that we started with is Brimonidine which is about 26% of the topical pharmaceutical market for glaucoma. There is lots of different options, and that's a whole other complication, but really the goal for something like this is never to put anything too experimental in it. That leads to a lot of other regulatory hurdles that we really aren't interested in. It's neither a product nor a technology platform and I say that because it has shades of each, but it's not developed enough to be what I would consider a product, it will be, but it's not there yet. And in terms of a platform, that's a scary word because a lot of people don't believe you when you say it's a platform, you have to really demonstrate that. And so, what I see it as right now is in the future it will be a portfolio of products. And the technology what we're patenting, yes, that's a platform technology but what we're developing those are products. And so I would say it's not a straightforward answer but it's really got a bit of both, but I just would caution people not to over use the word platform because most of the time, if you don't have data to back it up, you will not be believed when you say that. Each of the envisioned products would have very similar components. So they would use the same base materials. It's just the way that we combine and fabricate those materials is going to be different. Just to modulate the drug release for different drugs. So for something like anti-infective, you would want acute use, so two weeks or less. So you want the drug to be coming out at higher levels over shorter periods of time. So you do have to tweak the materials a bit, but the carrier, the gel, our hope right now is that never changes. We want it to always be the same and I kind of harp on this because I think that as scientist we're taught to go after what's new and cool, and the buzz word is sexy. All the time it has to be something that's very exciting but really for this we tried to keep it very translational by going with boring and predictable and things that the less we can change the better. And so that's what we've done and that something that really resonates with potential investors. So the way that it would work for patients, for something like glaucoma, which is chronic use. We would envision the patient actually having the materials, the gel drop in their home, and its room temperature stable. So, I think at some point we'll probably talk about what it would take to turn this into a product, that's where that comes in. But basically the patient would administer this to themselves. It could also be done by a caretaker. Once a month is a lot easier to do than once a day or three times a day for many glaucoma medications. And so it would essentially be administered similar to an eye drop, maybe a slight learning curve there but the goal being that once a month the patient would remove it and put a new one in. And removal is also a unique aspect of this. So it can be flushed out just with room temperature liquid, saline solution or what have you. And that was something really unique to this as well, because most people are trying to design fully degradable solutions. But we had a big issue with that because from a regulatory standpoint, if it's fully degradable, it has to be 100% gone before you can put another dose in, and that leads to a situation where you're not administering the right amount of drug, just before that next dose comes in. And that's a lack of control and the field is called controlled release, and so by having a hard stop and putting a fresh drop in, we know that we're getting the same amount of drug at any period in time. So that makes us very different. The idea of developing a project or a technology into a product is a complex one and it's one that I don't think anyone spends enough time thinking about in those early stages. But it is absolutely critical, and I think that it is a point at which many potential products can fail because there has to be changes to the formulation. It's inevitable, because you do things on the bench just to make it work, in your animal model, in your cell model, whatever it maybe. You do whatever works. You don't really think too much about how you just made that thing that did the job it needed to do. Now we've been at this long enough that we've started to look at the scale up of materials. So very early on we had to address the fact that we could only make one milliliter or less of our gel at a time. That was problematic. So we scaled things up and it worked really well. So we were comfortable with that. Then we had to address things like sterilization. So how we sterilize these materials? How do we actually manufacture them because we're going to be having someone else manufacture this in large quantities. We have to make sure that we get consistent product every single time. And I would say that those are the biggest thing. So stability, shelf storage and stability is something very important. Consistency is of the utmost importance and the ability to properly sterilize it. If you cannot do a terminal sterilization step, which means you've everything, you have it, then you sterilize it, if you can't do that, you need to start with all sterile raw materials. That's a challenge. That is a big challenge. And so, we had to make sure that we could do that. And so, it's not the most exciting project for a graduate student, but we have been able to do some of that here in the university. Where we're limited is, we really can't make any GMP grade material, which is what you need for a clinical trial. And we can't do any GLP studies with any of that material, and so we can begin to collect data on how this should all work. But there comes a point where you have to outsource it, and that's the point that we're at right now. In academic research, we're all very familiar with what the concept of innovation is. It's something that no one has ever thought of, it's so brand new. I mean those are the things that you see on Twitter or whatever, you see a little blurb about it. Scientists say they can do x, y, and z, and people are like wow and then your mum forward you the link and that kind of the end of it. And come to find five, ten years later nothing's ever happened with that little blurb because academic innovation is very different from what is innovative in the real world which is what you can actually do. So it's funny to me, also a little depressing, that something like this technology we're working with has been incredibly difficult to publish our academic paper because we're using materials that are well characterized. They've been around a long time. They're predictable, boring, all of these things. And yet when we take that to a pharmaceutical company, they see it as incredibly innovative because we've taken things that have been around so long. And we've done new things with them and not only are they new but they are things that actually have a shot at working in practice. And so in that sense what's innovative is what you can actually do, what you can sell and what will be bought. It has very little to do with the idea itself, it's the execution. And so they like boring and predictable because that equals safe and consistent and those are important things. And so, it's been quite a process to come to grips with that, and I still get excited by new and sexy technologies. But I have to be willing to also accept that some of the other things we're working on that aren't as exciting to my academic peers or the things that have the best shot at commercialization The process for beginning this commercialization journey at the university it all begins with what's called an invention disclosure. So this is something that we'll hear about, but I think maybe it's not that well understood. You hear all the time as soon as you have an idea or as soon as you get that first piece of data or whatever, go in and file your invention disclosure, but I think some people think it needs to be very well developed. Some people just don't want to be bothered with it. That is something that is very easy and quick to do and it's a necessary step, because you file the invention disclosure. All you're doing is telling the Office of Technology Management Innovation Institute, you're telling them this is my idea, this is where it's at right now, and this is the need it addresses, how it kind of fits into that landscape. And from there, it's kind of done for a little while. They take over at that point, and that's that team aspect I was talking about. So from there what they will do is review all the information you've given them, they'll sit down with you, talk about your innovation, your technology, and understand how it fits in to, at that point it's the patent landscape. So you are talking about patenting a technology. And they will present that information to the technology transfer committee and that committee will decide whether or not it is worth it to pursue a patent. And there's a couple of different things that can happen there. They can say no, and at that point you can patent it yourself [LAUGH]. In my experience that doesn't happen often because a lot of times the things that are worth in invention disclosure are worth patenting. But sometimes what they'll do is they'll differ. They'll say just collect some more date, give it some time and that's helpful too, because it helps guide you in terms of what you need to be doing in order to protect that technology with a patent. Or sometimes they'll say, go ahead and patent it. And that can be because the idea is so good, or if it's related to an idea that's being patented, they may also want to kind of fold that into the mix and add that to the portfolio even if it's not as well developed. And so at that point, the patent will be prepared. You'll get what's called a provisional. You have one year to collect additional data then they'll file the full patent application. And from there you just kind of sit and wait in terms of the patenting. But that's when you can be doing everything else. You can be taking courses like benchtop to bedside and participating in all these programs that will teach you the things you need to do. So that in 18 months time when you start to actually work through the process with the patent and trademark office of formalizing that patent and getting it approved, you're ready to go because you will have investors who want to potentially license that patented technology. And so it's a slow process and I was happily surprised to learn that it's not this big machine that starts rolling without any input from the inventor. They definitely involve us very heavily in the process, and we get to learn a lot but we're not expected to know everything. And that it's a slow roll out. So there's time to adjust, there's time to make changes. You're never really locked into anything, and so it's funny when we get correspondents from the patent office, I always think that that's the end of the road. I'm like, what do we do now? And the lawyers are like, we're not even close to the end of the road. We still have years before we figure this out. So it's a completely different ball game, but it's a necessary one if you want to commercialize stuff, you have to protect it. So if the inventor chooses not to be involved, I think that it still has the potential to linger around a little bit and maybe get picked up by someone. But I think that the odds of success in that scenario are very slim. I think that the highest chance for success is when the inventors are involved to the extent that they're able to be. And I would say that if you want to have investors come in, if you want people to potentially give money to a start-up company or license a technology. One of the first things they'll ask is about how involved the inventors are. Because they know that the critical information for translating this product is in our brains. And so we're a necessary part of the process, you can give it away and try and step away from it. But for me, I think that the odds of success go way down. And also any any fun that you hope to have in the process is gone at that point, so you might as well see it through. And the good news is that at the end of the day we still have our academic jobs. And so there's not actually that much risk for us, and so it's worthwhile to be involved if you really want to see it through to success.
