Changing the Game for Drug Delivery with Robert Niichel, CEO of SmartTab

Transcript

Changing the Game for Drug Delivery with Robert Niichel, CEO of SmartTab

[00:00:15] Kelly Stanton: Hi, everyone. Thanks for turning into from lab to launch today. If you haven't already please subscribe, rate the podcast and share with your network. We'd absolutely love that. I'm Kelly from Qualio and I'm your host. Today we're talking to Robert Niichel the CEO of SmartTab, SmartTab is creating ingestible capsules for drug delivery of biologics and targeted medications.

Think of a pill you take that tells medications where to deliver their remedy. It's pretty cool. It's like an Uber driver GPS for drug therapy. So Robert comes to us with 20 years, more than 20 years of experience in the industry pharmaceutical high-tech holds numerous patents in pharma delivery systems.

Hopefully we'll, we'll get a chance to talk about that here a little bit today. 

 welcome. It's great to meet you. 

[00:01:03] Robert Niichel: Thank 

[00:01:03] Kelly Stanton: you for having me. You bet. We'd love to hear what was the catalyst to launching SmartTab? 

[00:01:09] Robert Niichel: Yeah. Great question. So you have to go back a little bit, maybe about 10, 12 years.

My background is in the pharmaceutical space. About 10 years ago, I started a company called Nano Pharmaceutical Technologies with the idea to bring pharmaceutical types of technologies, to sports, nutrition, consumer healthcare, and then as an extension of that the next step was to blend in wireless technology, digital technology to delivery systems. So to that end SmartTab was really started as a mechanism, as an adjustable capsule that has electronics onboard has a small battery on board. You swallow it, it moves to a certain place in the GI tract, and then it releases the active ingredient based upon a signal.

Sent in from perhaps a iPhone or an iWatch. So really the catalyst was taking my career, my experience one step further. You know, you look all around and you see cell phones and you see I-phones and other types of iWatches and computers. But if you go into a pharmacy, it looks pretty much the same as it did 50, 60 years ago.

So the thinking was, if we could expand in that direction with technology, that would be pretty grand. We would have better patient outcomes. We would be able to tie into some of these other platforms. So really it's, you know, like a lot of people do. When they started a company, they have an idea.

That's maybe an extension of what they're currently doing or something better than they're currently doing. And then they'd look to implement that. So that's how it all started with SmarTab 

[00:02:47] Kelly Stanton: Nice. Yeah. I was reading a little bit on the website about the benefits technology, right? So targeted drug delivery. Tell us a little bit about that. 

[00:02:56] Robert Niichel: Yeah. So what are the key things is this is very much patient focused. So we contain a lot of data. We obtained from patients. We'll have these networking sessions, we'll have focus groups with people, we'll get them together. And maybe one of them for example, is from Crohn's disease.

Today. People will perhaps have to self-inject with a syringe and a needle into their arm or leg once a week. You know, categorically people would like to see that go away. And if you could replace a syringe and needle with a capsule, that would be very exciting. So really the key here is that.

That's where we start, how can we make these lives better for patients and then working back from there. Okay. Now we need a capsule that will have these types of characteristics. Then we've moved backwards from that to how do we develop it? How often do you have to take it? What types of drugs can be used?

And from there we really move forward in focusing on how this can make a better outcome for the patients. 

[00:03:53] Kelly Stanton: That's exciting. as I was reading some of the benefits there and the trying to get, I know there's a lot of innovation going on around drug delivery because somethings are very effective, in the dish on the bench.

In that very targeted sort of, situation. But as soon as you put it into your body, you've got all these other processes that come into play. It gets digested before it gets there, or you have to take so much of it to get therapeutic levels you know, to a place where it actually works, but now it's toxic because of the volume you have to take.

So that's, that's pretty exciting. We noticed that you're running an equity crowdfunding campaign. Why did you choose that route for funding? 

[00:04:30] Robert Niichel: Oh yeah, exactly. So, today before the equity crowdfunding, we've been pretty much self-funded myself, some individual investors we've raised about $4 million.

We were actually approached by start engine a few months ago. And they were like, you can do crowd funding campaign. And we looked at it as one of our shorter term goals over the next year is to get listed on the London stock exchange. So we're moving in that direction to get that done. So for some type of intermediate finance team, we thought, well, this could be interesting because it would expand our investor base who gives more publicity.

So then when we do go on one of the exchanges, we will have more visibility and it has done that to a large extent. We will need to raise, you know, larger capital typically than crowd funding will provide, but it seemed to be a good intermediate step. So kind of branching into, you know, moving outside.

Of just our individual investors to get more a public platform. So that was really kind of a intermediate step sets the stage to get listed on one of the exchanges. And then from there, we'll continue moving forward, raising capital. 

[00:05:41] Kelly Stanton: Oh, that's exciting. Has it been w has it been easy, challenging, different than things you've experienced in the past?

It's kind of a unique approach, I think, to drug delivery, you know, fundraising. Yeah. 

[00:05:52] Robert Niichel: It's, it's been fine. It's been good. You know, you are looking at a different platform. It does give us exposure to many types of people. It does get our name out there. It really has generated, continue to generate a lot of buzz around our technology, what we're doing, you know, it helps us on that path.

Yeah, kind of one step at a time to get listed on one of the exchanges. So it has been, it has been good and it will continue to, I believe the funding round goes through perhaps March or April. So we'll continue to push forward on that get that wrapped up, get it closed, and then continue on the path to get listed on most likely the London stock exchange.

[00:06:33] Kelly Stanton: Nice. That's exciting. Where do you see SmartTab or this tech being in the next five, 10 years? 

[00:06:41] Robert Niichel: Yeah. So, you know, the vision is in three years or less, we will have our first product on the market. So that means we'll move through FDA approvals. They'll have a specific drug that will be approved as well.

So a physician could prescribe this who would then go to the pharmacy. You would go into the pharmacy, pick up your bottle of spark tabs. Take it home. And then you take them as this prescription has laid out. So you're not talking about a long time here, like 5, 10, 15 years. This is a shorter term. This is real, you know, we've spent the last four or five years developing the technology working out.

But it it's ready to go. We've completed one successful preclinical animal trial. Last year, there was an, a pig model with our target tab. We're getting ready to go into a new trial this spring. Most likely insulin with the inject tab. And then from there, we file with the FDA we're working with the FDA now.

There are some pre-submission meetings that we're working through. So as we file later, next year, we know the roadmap to getting approval. So this is not. Like an idea or something like, perhaps it was five years ago, this is a real deal. It's been reduced to practice. We, we have filed several patents around it.

I believe we have three or four issued patents to date. So the next two or three years we'll be finishing up the approvals and getting the product to market. So to answer your question in five years, you should be able to go to the pharmacy and they have maybe five, six different drugs that are approved with our technology.

Hope. Hopefully. 

[00:08:21] Kelly Stanton: That's really exciting. Wow. Especially the insulin piece too. That's that's a game changer. There's a whole group of people that would like to stop injecting themselves. I'm sure. 

[00:08:32] Robert Niichel: Yeah. It's a significant, I mean, you look at some of these drugs where you have to self-inject daily. So for insulin, a lot of people have to get a Bazell amount in the morning.

So if you could take a pill to obtain that in the morning and these poor people with Crohn's, I mean, there are a lot of young people that are being diagnosed with Crohn's. 20 years ago, they would prescribe maybe some steroids or this and that. And if it didn't work, they would go right to some type of a biologic.

If it didn't, you know, the other things didn't work. So first today you go right to a biologic it's like, guess what? You're going to have to self-inject once a week for the rest of your life. That's daunting. I mean, that's a, that's a big thing to look at spot, but if you could take a capsule once a week um, the other thing I'd like to touch on is you mentioned this with, you know, the toxicity levels or whatever.

There's does have applications longer term for something like infusions that you take an infusion typically go into the hospital clinic once a month. Well, the reason they do it once a month and they give you this huge bolus of the drug. You're not going to get people to go into the hospital once a day and get an infusion.

So they spread it out. As far as they can. You get your infusion the first three, four days you feel sick, then you feel okay for a couple of weeks. And then the last week, whereas. Then you get to go back in and get stabbed. So you sit there for another 30, 60 minutes with the infusion, but if you had a device like ours to, we could titrate in the amounts, maybe take a capsule every day or two or three days.

That would be huge in the progress of. You know, getting rid of infusions, you would still deliver the same amount over the course of a month. It would just be spread out so many applications and you know, many drugs that this could certainly improve people's lives. 

[00:10:17] Kelly Stanton: Wow. Wow. Yeah. Changing delivery. Oh man.

That's, that's always one of the biggest challenges in, in, in the drug development, any, any time. And like we talked about before, right. But you know what your bioavailability looks like and how does that adjust? And so also I think a huge opportunity with targeted delivery to reduce overall amount. You'd have to take in the long-term too, right.

Because you're not having to digest it before you can uptake or filter half of it through your kidneys before. Right. 

[00:10:49] Robert Niichel: Yeah, exactly. And many of the, many of the new drugs today are biologics. You know, they do have to be deployed with a syringe in a needle 30 years ago, small molecules, you know, they were kind of paving the way and then you got to generics and a lot of the generics were small molecules, but today they're bigger.

Molecules are big. Drugs are big markets, they work great. That's just a little painful and problematic to deploy them to the patient. 

[00:11:17] Kelly Stanton: Yeah, definitely. And it, and it often has to be injected directly into, you know, the locations. Wow. That's that is so exciting. One of the things we also love to hear about with founders and entrepreneurs is how you balance product development and quality in your, in your startup.

So how do you approach product velocity and quality? Those are very often viewed as opposing forces. What's your take on that? 

[00:11:44] Robert Niichel: Fortunately, we're in the. Kind of the grand plan of the FDA. So when we really look at what we're developing, it's really a two prong path, if you will. So on one side, we're developing the products.

Certainly keep it in mind, know the design controls, quality, all the things that we need to have to put together to file with the FDA. So that's one path, a lot of products. That's your, your path, you just developed the product. You have internal quality control systems and you go to market here. Not only do we have to build a product and have all those controls in place, but we have to file with the FDA.

The FDA is like building a product itself. It's, it's a heavy lift. It's a big task. There is a pretty good line of sight. Don't what a company needs to do with that. So we have these two paths. So as we pursue product development, The quality controls have to be in check because those need to be submitted with the FDA.

So then we're working through the pre sub meetings and then as we complete more trials, we'll have our filings, we'll have the FDA approvals and then everything we do has to match what we need to file with the FDA. Audits. Everything needs to be under a GMP environment, which is, is another part to that.

So it's almost like the quality, the quality controls are built in that this is what we have to do, and we just seek to get those in place early. And then as we expand you just budget for those activities, I mean, it does add to the cost. But it's necessary if we're bringing a product like this to market.

[00:13:22] Kelly Stanton: Absolutely. It's a, it's definitely an it in my experience costs you less if you do it upfront than if you try to shoehorn it into the place later. So that's good 

[00:13:34] Robert Niichel: to hear. Good to hear. 

[00:13:37] Kelly Stanton: If you could go back and tell yourself something at the start of SmartTab, what would you say? 

[00:13:44] Robert Niichel: Well, that's a really good question.

So going back to the start I think maybe, you know, just have a good line of sight with the one thing that I've learned in, you know, the innovation in this space, you know, it's exciting. You're getting some early chatter in the space, but just be aware that. We have to get this pretty far along before pharma companies, larger pharma companies are going to want to perhaps be strategic partners.

Now we do have some strategic partners, some in the U S some not, but I've been a little. Not surprised, but it's been interesting that, you know, pharmaceutical companies are very conservative. They want to see things get to a certain point before. They're interesting. And that, that depends from company to company, but.

That would be one thing. Just be ready to make sure that you have things far enough along you sometimes you hear like, oh, this company came up with an idea. They got some patents, they got bought by a big company. You really have to get down the path that, yes, this is a viable product. We have clinical studies, just, we have FDA approval.

We're ready to commercialize. Maybe we even have a pilot facility that'd be ready for that. And you know that then companies are very excited. Pharmaceutical companies will pay up in terms of a purchase price. If that's the path the company wants to go later. So they're very willing, you know, they have a lot of capital right now to let things get further along and then come in and purchase a company.

So maybe that's just something that. You know, these are not, you know, overnight projects or, you know, get it to market quick. These are, these are big targets. Now having said all that I would say the people in our team though, that this is, you know, this is truly a mission we've had prior successes and we've done some really cool things in the past.

So then it is so much about, you know, cover the idea or some patents and then getting sold or bought quick. This is a mission to get it tomorrow. To make sure this is successful, do something that really changes patient's outcome for the better. And we're willing to put the time in to, to do that.

So from that perspective, it's very exciting that we can work on something that will, will have a huge impact on virtually billions and billions of people. Once this is in the market. 

[00:16:05] Kelly Stanton: That is exciting. That is exciting. And of course, you know, being a, being a quality professional, I always love to hear that qualities in that.

I do think it makes you more attractive for those partnerships in the long run, too, because if you're developing things and applying. Some GMP principles to how you do your development, how you document your efforts. They, they, I feel like they just take you more seriously as opposed to, you know, Hey, we just have this idea and here's our patent in this.

Great. So that's exciting. That's exciting. Is there anything else that you that you want to share with our audience or chat about? 

[00:16:40] Robert Niichel: We can just, you know, to comment that, you know, again, we are pretty far along. We had a call this morning with a company talking about the, what is a pilot scale look like?

Like how do we, we already have a GMP facility. We already have some of these capsule filling machines. So, you know, Thing to build the capsule, et cetera on the bench. But to actually now we're looking at pilot production, how do you build out 50,000 of these capsules? So we already have some of that equipment.

We already have the GMP facility. So my point is that we're pretty far down the path. You will see this. Three to five years. And you know, we're very excited about that. You know, five, six years ago, it was kind of an idea, not really many companies working on this, but now there are some companies out there that, you know, there are working on things, not as advanced as we are, but you know, you're getting some early chatter to you know, five, 10 years.

You will see this widely deployed. In the market in pharmacies, but you know, the point is that we're pretty far along and we will be doing more clinical studies, FDA submissions. And so then you're, you know, you're talking 2, 3, 3 years. You'll see our first products in the market. And then you can say, I remember that guy talked to him on a cold snowy day and Franktown Colorado.

My internet won't work, but here they are 

[00:18:01] Kelly Stanton: here. It is. It's exciting. That is awesome. And it's, I love, I love what I do. This is why, because we, and quality in general, you know, we really, we believe in, in these innovation and, and just changing people's lives. And it's really exciting. I also love that you're right in my backyard.

That's so awesome. Well, I guess to wrap it up where can people find you in the company if they want to follow along or get 

[00:18:28] Robert Niichel: into. Yeah. So our webpage is SmartTab.co CEO, not, not com. So SmartTab dot C O that's our webpage, you know, I'm on LinkedIn Robert dot initial I'm on LinkedIn and Sasha, our main marketing person.

He can probably send you. More contacts. And then, you know, a lot of good publicity. I mean, like I said, some of our team just attended the Arab health this last week, we're going to, there's a Vive conference in March in Miami, Florida. There's a south by Southwest conference in Austin, late March.

We'll be attending. I'm actually going to be a speaker there, one out of 45 companies that were chosen across the globe to present. So we're out there and I think if you, oh, here's another cool thing. We have one of the TV stations coming in next Tuesday to film a documentary for one of the local TV stations here in Denver.

So we'll be able to probably add that to our list of Assets as well. So a lot of exciting things going on right now, and we're happy to be part of Denver. You know, Denver is starting to really get built out as a hub. You know, you see health is making great gains in this space. A lot of cool technology companies are starting to come out of Denver.

So we're really looking to expand, you know, get our pilot stuff, wrapped up, build a larger manufacturing facility and, and keep our home right here in Denver caller. 

[00:19:56] Kelly Stanton: Nice. That's exciting. Awesome. All right. Well, thanks so much for your time today, Bob. I really appreciate it. What an exciting technology. 

We'll definitely be keeping an eye 

[00:20:06] Robert Niichel: on that one. 

[00:20:07] Kelly Stanton: All right. Well, thanks a bunch, Bob has been a real pleasure. 

[00:20:10] Robert Niichel: Thank you, Kelly.