This week I am talking to Doug Miller, PhD, Chief Technology Officer for SmartTab (@veloce_smarttab) a company developing an advanced platform of ingestible capsules for oral drug delivery of biologics and targeted medications.
Doug started out in avionics but quickly found himself in the world of healthcare focused on drugs and drug delivery mechanisms. At SmartTab they are rethinking the process of how we deliver medication to people with a range of novel solutions that can target delivery in a specific part of the body’s gut and offering novel ways to deliver injectables in tablet form that normally cannot be ingested because the molecules would be digested by our bodies.
Their technology is autonomously carrying a range of sensors that allow the location of the pill to be determined with sufficient accuracy to allow targeted location-based therapies. These onboard sensors are powered by a lithium battery and the whole unit is designed to withstand the hostile environment of our gut that is designed to dissolve and breakdown the food we ingest
We review the technology and how they can determine the location and the process of delivering targeted therapy to a specific location which ends with a command issued by the onboard processor to:
Listen in to hear the challenges of overcoming safety concerns associated with ingesting technology of any kind, and the challenge of dealing with the corrosive acidic environment in the body’s GI system. As Doug points out it is not just protecting the technology and device but also confirming the delivery of therapy.
Listen live at 4:00 AM, 12:00 Noon or 8:00 PM ET, Monday through Friday for the next week at HealthcareNOW Radio. After that, you can listen on demand (See podcast information below.) Join the conversation on Twitter at #TheIncrementalist.
Listen along on HealthcareNowRadio or on SoundCloud
Raw Transcript
Nick van Terheyden
And today, I’m delighted to be joined by Doug Miller. He’s the chief technology officer for smart tab. Doug, thanks for joining me today
Doug Miller
are very welcome. Thank you for inviting me.
Nick van Terheyden
So as I do with all my guests, tell us a little bit about your background and how you arrived at this point in your career.
Doug Miller
Well, I began my career, really, I, I didn’t intend on going into the medical field. As I was studying for my engineering degree, I really had expected to go into avionics. But during my senior year, I got involved with a medical Project at the University. And I’ve been in it ever since I moved from there to leading a research lab at one of the premier medical schools in the United States of Washington University, School of Medicine in St. Louis. And the technology that we developed there. Eventually, we spun that off into a startup company. Later on, left that company and joined a large global medical device company continued to develop wireless implantable devices. And after spending close to 10 years, and that large company decided that I really preferred the environment of the small startups, giving you a chance to really develop new ideas. And so move back to a startup company, and then to another and then on to where we’re at now at Smart tabs. So that’s kind of been my history. I spent some time in my previous startup company, also managing drug manufacturing, as and as well as the medical devices that we were working with. And so that was where I got my pharmaceutical experience, before coming to smart tab and beginning to develop a drug delivery systems.
Nick van Terheyden
So interesting background, avionics, you know, engineering technology, it sort of reminds me a little bit of Fantastic Voyage, as you know, we’re going to explore as we dive into a smart tab, you know, the miniaturization of technology, you know, the potential to essentially put things into the body. Help us understand what smart tab is, and what it is that you do before we dive into the details.
Doug Miller
Sure. So smart tab is a platform technology, which means that we’ve got a line of various capsules that we’ve developed, and each capsule serves a particular purpose. So even though the capsules are perhaps 70 to 80%, common in their components. Each one has specific tasks that they are designed to excel at. So there’s one that we refer to as target tab, where the purpose of that capsule is to deliver the drug very precisely to a specific airy, area of the the GI tract. So for things like IBD colon cancer, things like this, where you want the drug to be delivered precisely on site. Then another variant is inject tab. And this capsule is designed to handle large molecules, biologics, medications that can’t be typically taken orally because the enzymes and acids of the GI tract will break them down before they reach the bloodstream. So this capsule is designed to deliver an injection into the stomach wall, penetrating through the mucosal lining where those enzymes and acids are produced, and delivering the medication into the muscular layer of the stomach. The intent here is to help with patients who have difficulty bringing themselves to do self injection and focus groups that we’ve spoken with. We found that if it’s a regimen that requires very frequent injections, such as diabetes, where it’s several a day, patients typically get used to that but if they’re only taking it once a week or so, like Enbrel or humera they never take it often enough that they get comfortable with delivering that self injection. And so what we found was there was a lot of non compliance there. And so the idea here is to try to provide these patients with an alternative that will overcome that anxiety and allow them to take their medication on time. A third version of our capsule, we refer to as multi tab. And the intent there is to deliver scheduled doses with a single capsule. So things like antibiotics, for instance, where you’re supposed to take the capsules on a prescribed prescribed timeframe that a single capsule will deliver those at the prescribed time, and ensure that you take the entire regimen rather than stopping partway through, because you may not feel like you needed any more. So again, really looking at compliance. So that’s kind of an overview of what the smart tab platform is. Now, we have some other versions that we are currently thinking of as well. So there’s perhaps half a dozen capsule versions that we currently have in our pipeline that we’re developing. But as I said, trying to address very specific issues with drug delivery.
Nick van Terheyden
So, you know, interesting concepts. I think, you know, if I pull this together, it’s the miniaturization of drug delivery that people can swallow this is, when we talk a tab in this particular instance, we’re talking tablet. First of all, just give us a sense of the size of this, I mean, what kind of a size because as you’re talking, I’m thinking, you know, probably larger than you might expect, just because you got to get a lot of stuff in but it sounds like you’ve cracked some of the the miniaturization of this.
Doug Miller
Certainly, we’re currently working with a capsule design that is a triple aught capsule, which is the industry standard nomenclature for defining capsule sizes. So this is a capsule that is commonly administered, it’s typically provided for whole supplements or multivitamin, something where there’s fairly large volumes, and we are currently working with the largest largest size, we do have plans to reduce that size. Right now, the manufacturing route resources that we have available to us would make it a little bit difficult to miniaturize it to the double lot size, which that’s a capsule that is fairly common. Trying to think of something that would be a good example of a double up perhaps something like a Tylenol.
Nick van Terheyden
So essentially, you’re talking tablets and people are currently swallowing exactly, you know, a size that, you know, and to be clear, there’s a whole spectrum of people, I certainly live with somebody that says anything smaller than the tiniest grain of dust catches in the back of their throat. But you know, that aside, we’re talking something that’s in use in in general, pharmacology, it’s a sort of standard size. So you’ve you’ve miniaturize that. That’s a bunch of technical issues around this that, you know, for example, you talked about delivering at a specific location. So the first thing that comes to mind when you say that is, well, first of all, how do you know you’re there? One, two, once you’re there, how do you deliver it? What’s the sort of mechanism to say, Okay, I’m exposing it. And with all of that must come some power element of this, how are you developing and delivering the power to be able to deliver that assuming that’s the way that it works?
Doug Miller
Certainly. Well, I guess let me begin with kind of from the power and so these capsules are designed to not dissolve as a typical capsule or tablet would. They are designed to remain intact as they go through the GI tract, and they eventually pass out of the body. They are self powered. So there is a small lithium battery in the capsule. And then there’s a small circuit, which has a microprocessor. And this microprocessor besides being connected to the release mechanism is also connected to various sensors that are included within the capsule. And these sensors are I monitor the position of the capsule through various means I have to be a little bit careful about what I default here. But let me let suffice it to say that there’s a variety of sensors that monitor various aspects as it’s going through the GI tract. And the microprocessor collects all of that data, runs an algorithm on it, and determines what the position of the capsule is.
Nick van Terheyden
So is this fully autonomous, this is something that doesn’t require externalities that are controlling this.
Doug Miller
Yes, it is when we first started with this target tab was our first try. And we did have external components with that capsule that helped it with itself location. And we determined when in talking to patients that having them learn how to use these external components really was not ideal. We really needed this to be what they were used to in taking a capsule, which is you just get a glass of water and you swallow and they don’t have to do anything else. So we develop systems so that it doesn’t have to remain on a charger or be activated before it is swallowed. It detects the act of being swallowed and causes the capsule two microprocessor to wake up and start running its algorithm monitoring its sensors. And once the microprocessor is determined that it has met all of the requirements for releasing the medication, whether it’s the injectable, or the targeted or the multi dose, then it triggers the release mechanism, which opens the capsule, payload bay, essentially, there’s doors in the side of the capsule on target tab that are opened and allow the drug to be washed out by the fluids and the GI tract.
Nick van Terheyden
Open the payload doors how?
Doug Miller
That’s right.
Nick van Terheyden
What a fantastic analogy. I like it. So, you know, essentially, technology that creates autonomy, I think, you know, smart in terms of how that helps some of the problems that you described, you know, the challenge of compliance challenge of people remembering, you know, I think people go into this patients that is with, you know, positive intentions. It’s not that they sort of need to diverse from the recommended schedule for drugs and so forth. And, you know, as you rightly point out, the challenge of injectables is pretty significant. And it’s easy for anybody that doesn’t have to take an injectable on any regular basis to say, Well, that would not be difficult, but you only have to talk to a diabetic that is dealing with that to know how significant that is. As you think about some of that technology. So you talk about some things that, you know, from my perspective, I would think, from a safety standpoint, obviously have to be covered from a clearance standpoint, we’ve got you know, previous instances of swallowable tabs, we’ve certainly seen that going back a significant period for cameras even correct. With, you know, swallowable capsules that will take images going through what are the concerns? And you know, how have you engineered this to sort of navigate
Doug Miller
So the capsule has to be able to traverse through the GI tract, which is a relatively hostile environment, very corrosive, and it needs to remain intact while it’s going through that environment. And not being only not being broken down by it, but not being affected in a way that would prevent it from functioning as it’s intended to. So from a safety perspective, what we’re looking at as a capsule that is sealed against these corrosive elements, and that has self monitoring systems on board, that are constantly checking to see that everything is working as its intended. The one of the concerns that’s often brought up is safety as far as the dosing, but since these are single dose capsules, with the exception of multi tab, that the dosing is only a single dose. So there, it’s not like there’s a large reservoir of medication that could be released all at once. So that’s another way that we’re dealing with the safety aspect of it. One of the concerns is whether the patient will be able to tell whether or not their dose was administered to them or not, if the capsule just passed on through without ever releasing the medication. So this is part of it that we’re looking at bringing out a little bit further. But we want to be able to provide feedback to the patient that everything is working properly, that their medication has been delivered. So eventually, we’re looking at adding in features like two way communication with a smartphone, for instance. So an app can tell you, yes, your dose was administered at 10:42pm. So these are cut some of the aspects that we’re using there to maintain safety. And then just very thorough testing of the systems using systems that are for the most part proven components. So really, all the components that we’ve pulled together to make the capsule are things that are already in use in miniaturized electronics today. So we’re not bringing in something that is real cutting edge technology, where there’s going to be concerns about whether it’s been fully vetted or not. We’re using things that already are widely used. We’re just putting them together in a different manner and having a little bit different function to those components so that each of the components are already well validated.
Nick van Terheyden
So for those of you just joining, I’m Dr. Nick the incrementalist today I’m talking to Doug Miller, he’s the Chief Technology Officer for smart tab. We were just talking about the safety, management and how you’re ensuring that you know, what enters the body is, you know, safe from a perspective of both, you know, the actual delivery, but you know, you bring up some interesting points, well, did it actually deliver so confirmation of that? You know, I think the multi tab aspect to that, you know, obviously loading appropriately and considering whatever the total dose is, you know, obviously a clear track to be able to make sure that this delivers an appropriately safe mechanism. I think the injectables is an area that, you know, there must be a lot of people listening, certainly anybody that has a regular schedule for injectables, that will be hearing this and saying, Gosh, wouldn’t that be great? You know, I’m wondering about diabetics, because obviously for some of those, there’s a variability and you know, you would need to have some capacity to control what that was to preclude doing that yourself because that’s a titrated kind of aspect and we’ve even got some control mechanisms with artificial pancreas is that a providing feedback to pumps and so For them, maybe this is one of the ways where you don’t have an external something but you’ve potentially swallow a pill each day that sort of communicates and goes on. I mean, there are some, you know, tremendous, exciting opportunities. The question I have is, where are you on the development timeline? Where is this product? What’s the sort of status of it?
Doug Miller
Well, the target tab, design has been tested in preclinical studies in animals, that was a successful test, we were able to deliver the drugs to the entry of the colon, the cecum. Following those preclinical tests, our discussions with pharmaceutical companies, it became clear that the there was a very strong interest in the injectable, which we just really had on the design drawing board at that time. And so because there was the target tab is a bit more of a niche market, because it’s really targeting the colon, there’s only a few diseases, that that’s going to be something that is going to be desirable for. Whereas inject tab, there’s a pretty broad range of disease conditions, medications that are delivered for those. And those medications, actually, at this point in time, are at the top of the pharmaceutical production levels, the most prescribed drugs, right now. Many of them are the injectable, so there was a strong push to for us to move forward with the inject tab. So we’ve been working on that pretty pretty much entirely for the last year or two. And targeting, getting that into a preclinical study later on this year. Once we’ve proven that, as we did with target tab, I think that there will probably be a pretty quick push to get that into clinical studies with particular drugs, and to try to get it onto the market. So where we’re at right now is finalizing the design, doing all of the testing that needs to be done in order to take this into a preclinical study and getting capsules manufactured, that are the final design and are ready for delivering doses to the stomach wall. So that’s where we’re at right now.
Nick van Terheyden
So I mean, it feels like this is I don’t know, from an approval standpoint, but you’re certainly on the path through this, obviously, tremendous interest, you know, high value, high utilization of drugs with, you know, significant challenges. What do you think the timeline is? And I know, you know, there’s a lot of variables, but where do you think you are on the timeline that people might be able to see this in their future?
Doug Miller
Well, that’s an interesting question. We’ve been in discussions with the FDA about the approval path. It turns out that what we thought was going to be our approval path the FDA is has not agreed with, they’ve pointed us a different direction. That pathway actually may be a little bit faster from a regulatory perspective, we thought we would have to go through a two phase approval process where we would get the device cleared through a 510 K, and then get the each drug cleared separately with the device. But the FDA is point is to something where we would basically be jumping past the five or a device approval and go straight to approval with each individual drug, and they would just evaluate the delivery system at the same time. Given that and where we think that will be with our preclinical studies. We’re anticipating that we may be able to get our first approval in 2024.
Nick van Terheyden
Well, that’s exciting. I mean, I know that there must be a lot of folks listening to this going. This is, you know, tremendous potential. We see it across a number of areas and I think, you know, there’s even some possible undiscovered opportunities beyond the injectables, I think the multidose is certainly it makes for an interesting solution to a problem that, you know, ultimately is really about memory and the challenges of people remembering, but hey, if I can just take the one pill. I mean, you see patients saying I’d rather take that antibiotic that’s once a day than the one that’s four times a day. Right. You know, there’s, I think, tremendous potential. This is obviously a very exciting time. You know, I look forward to seeing where this is going to go where the opportunities lie, unfortunately, as we do each and every week, we’ve run out of time, and it just remains for me to thank you for joining me on the show. Doug, thanks for being here being on the show.
Doug Miller
Well, thank you very much for having me.
