How an Enabling Technology Can Unlock Product Performance
Tim Sullivan is CEO of Zeteo Biomedical, a company dedicated to providing drug and biologic delivery systems. In this episode Tim shares how an enabling technology effects the efficacy of treatment, understanding each stakeholders needs, a systematic approach for gathering stakeholder input, working with pharma companies on combination products, and the future of vaccine administration.
Links from this episode:
Tim Sullivan LinkedIn https://www.linkedin.com/in/timothy-sullivan-67089a/
Zateo Biomedical https://zeteobiomed.com/
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Patrick Kothe Twitter: https://twitter.com/patrickkothe
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome! When we think of the effectiveness of a product, we often focus on the one key technology that drives it. I was reminded of that recently when I went to the wiener dog races with 1000s of others in the small town of Buda, Texas. My wife and I had staked out some great seats for us and our soon to be arriving daughter and her grandkids. I grabbed my trusty cell phone, which I rely on and can't live without, and I texted her. Then I was quickly frustrated because nothing was working. No text, no phone, no internet, no way to communicate. Everybody else at this event was sending pictures and videos, clogging up the cellular network and enabling technology of our mobile devices. Sometimes one technology doesn't work alone, it needs a partner. By the way, we eventually found each other and had a great time. Kids and adults love wiener dog races. Our guest today is Tim Sullivan, CEO of Zeteo Biomedical, a company dedicated to providing drug and biologic delivery systems. Like the mobile phone examples, the tails products enable other products to be administered more effectively. Tim has an interesting background in several different industries, which we're going to hear about in this conversation, but it's based on his curiosity for emerging new trends. In our conversation, we discuss how an enabling technology affects the efficacy of treatment. Understanding each stakeholders needs a systematic approach for gathering stakeholder input, working with pharma companies on combination products, and the future of vaccine administration. Here's our conversation. Tim, as a fellow Wisconsin boy, I was envious of your first job. District Manager for paps Brewing Company was wondering how to land that gig.
Tim Sullivan 02:51
It was the dream job out of college it was beer a car and an expense account. It was at the time Pabst Brewing Company, you know, based in Milwaukee, was the third largest brewer in the country. They were rebuilding their field, district manager, Salesforce sales or sales organization. I was fortunate enough to be included in the interview and landed the job and spent a year in their management training program and then was assigned as a district manager, interestingly enough to northern Wisconsin.
Patrick Kothe 03:30
So was was that great training for you your first job out of college? Tell me about that training,
Tim Sullivan 03:35
I was already pretty well trained in the beer consumption. But it was it was actually an interesting job because it spanned you know, a combination of marketing logistics, we actually were the you know, control the logistics for the distributors. And I had nine distributors in the region that I was the district manager of and we we did quality control, we inspected the warehouses, we put together marketing campaigns, we rode in beer trucks with the drivers and promoted the, you know, the brewery and put on a suit and went into bars and restaurants and learned how to interface with customers.
Patrick Kothe 04:17
So often our first jobs and we learned so much we learned how to get out of bed in the morning and go to work, how to be a part of the team and just all of the things that that you described there, but you moved on from past and, and your career is involved a lot of entrepreneurial activities. Have you been an entrepreneur? For you know, since you were a kid or what what what gave you the entrepreneurial bug?
Tim Sullivan 04:44
I've been innovating, you know, things since Yeah, since I was quite young. I mean it it. I was fortunate in that I had very supportive parents in and I had always had sort of an engineering and science bent. So you know, I had the chemist street lab in my parents basement. And, you know, I built robots out of Erector sets and I launched rockets. I was into all of that sort of stuff. I actually started my first company about two years out of undergrad in 1978, I started an engineering firm. This was after Papst. And we were designing and installing alternative energy systems, solar systems, wind turbines, things like that. And, and that really was my first official foray into, you know, my entrepreneurial endeavors. And I actually took my savings account and put it into the company. So I sort of rolled the dice with what little bit of money I had put away and borrowed some money, and actually, that that industry sort of collapsed in 1980. So I actually had to go through a very challenging sort of experience of being in an industry that essentially fell apart, and it fell apart largely because of politics, and, you know, in the national focus on alternative energy or green energy at that time period. And so I had to figure out how to pivot.
Patrick Kothe 06:10
Carter had the, the solar arrays on top of the White House, and Reagan came in and yank them out.
Tim Sullivan 06:17
Exactly, right. Yeah. And cut the tax credit program that was actually the, you know, one of the death blows to the, you know, to the first generation of solar and wind energy. And that really cratered, the, you know, the oil industry, and that there was a lot of politics involved, you know, I had the unique opportunity to sell a solar system, a solar heating system, to the CEO of northern states power in Minneapolis. But I had to sign a nondisclosure. I couldn't tell anybody. You know, so I couldn't use it as a promotional mechanism. But we actually installed the system on his house. And, you know, because he wanted to see what it was all about.
Patrick Kothe 06:57
So the saying, you know, once bitten twice shy, you, you come out you, you've got a great job working for a big company, you come out and start your own thing, and it dies. So what happened at that point? I mean, did you jump right back into entrepreneurial? Or were you were you shy?
Tim Sullivan 07:16
Well, two things really, I had, as part of that business, I started developing modeling and simulation software to support the design of the design of the systems that we were putting in, because it was actually a fairly technical poll, I mean, we, we started out designing the system, sizing them and calculating the performance of them out in a given environment with a three ring notebook of methods, calculation methods, and a ti 55, hand programmable calculator to design one of these systems and price it out and determine its performance performance was hours and hours and hours. And you had to do that for every potential client. And so I developed software to essentially facilitate that process and make it much faster. And that took me into the software business. And so my next foray, was actually I joined a startup. And it was, you know, in Milwaukee, you know, in the, in the early 80s, there weren't a whole lot of software startups that was not the hotbed of software, but I happen to land in one. And we developed a mainframe based software package for automating the legislative process and state legislatures.
Patrick Kothe 08:30
What other industries have you really been involved with?
Tim Sullivan 08:35
Well, so about every 10 or 12 years, I tend to, you know, throw myself into something, you know, new and part of it is I like the challenge of it. Part of it is sort of insatiable curiosity about, you know, learning new things. And my focus has always been on looking at innovating in areas where there's not much innovation or where innovation can make a huge significant advancement. So the software company that I joined was a good example of that. I mean, you know, they were, they were doing state governments were doing Bill drafting and build tracking. You know, on very rudimentary, you know, IBM Selectric typewriters in those days and word processors had sort of come out, but there wasn't anybody that had put together a comprehensive system. And that was why I got involved in that. And I obviously didn't create that technology, but it was a small startup, you know, that was very early on. That was doing it and I was drawn into it. And actually, they brought me in as the bizdev guy, right. So I had the western half of the United States and over a three year period, you know, we automated 10 or 12 state legislatures, including Texas, which is in part how I got here,
Patrick Kothe 09:51
moving from from there. How did you get involved in the medical space?
Tim Sullivan 09:57
Early 80s and early 90s I stayed in the software industry. But I took a short break. In 1985 1987, I went back to graduate school and I went to the University of Houston Clear Lake in something called studies of the Future program, which was a Master's of Science Program at the time, u h, was the preeminent graduate program and future studies in the world, they had attracted a tier one faculty, and I was very much interested in, in acquiring better skills to sort of, you know, understand the future and where things were going, because I had been involved in innovating technology, a couple of on a couple of cycles. And, quite frankly, you know, the, the collapse of the energy into the industry, the solar industry, caught me by surprise, I wasn't paying attention at the time to the national picture of it. And so when it happened, I was completely taken by surprise. And that tends to happen to a lot of entrepreneurs out there, you know, you get very focused on, you know, the tech or whatever it is that you're doing, and you don't pay attention to the broader landscape of things that could have really significant impact on you. I went back to graduate school, I actually spent some time at the Johnson Space Center doing technology forecasting work as a consultant, and then stayed in the software industry for another, basically about another seven or eight years, did a couple more software startups, we built those up and sold them we sold one to Hewlett Packard, you know, we had several successful exits out of out of those companies. And I got intrigued in in the mid 90s, I actually invested in a drug delivery technology out in in Phoenix, it was a small company that was developing a drug delivery technology, which ultimately became or influenced the development of Nicorette gum, in the mid 90s, I invested as a small private investor in a couple of life science based companies that were actually all drug delivery companies of one type or another. And that's sort of a good example of sort of leaping into a whole new area. As I learned more about it, I began to identify opportunities, where innovation could have huge potential impact. And I'd much prefer, you know, being an innovator, and rolling up my sleeves and getting into it than just being an you know, an investor on the sidelines I've built for being in the fight more so than sitting on the sidelines. And, you know, and just investing in it. And so that's how I launched into life science space,
Patrick Kothe 12:31
you saw some things happening within drug delivery, what were some of the broad things that were going on, that kind of caught your interest at that point?
Tim Sullivan 12:40
Well, there was a, there was a whole variety of, you know, key driving trends, I started tracking the mapping of the human genome, as an example and became quite intrigued with that. There was also in the early 2000s, is when the pharma industry began to undertake direct to consumer advertising and started talking about personalized medicine. You know, that whole concept began to sort of unfold and evolve. There was also emerging at that time, several other sort of key science trends, the early stages of something called patient centric drug device combination products, was beginning to emerge. And there was more focus on the total patient experience in taking a drug or biologic development focus, you know, for decades had been on the drug appropriately. So you know, developing a better drug and more efficacious drug to treat various types of indications. But there wasn't much attention being paid to, how does the patient actually take that drug, especially when they have to, you know, self administer it, that was beginning to shift in you know, 2001 2000 to 2003, which is when I actually started my first medical device company, now called mystic pharmaceuticals, I actually took some things that I learned from the software industry, and I applied them in the drug, the medical device, you know, drug delivery space. And part of the core concept was most of the focus had been around packaging, drugs, and pretty standard stuff, you know, vials and sort of small blisters, it was a solid dosage form, you know, capsules, that sort of thing. The focus that I had was really to build a platform that could be used for a wide variety of different types of drugs and biologics, across different routes of delivery into the body. And the concept of a platform really came from my experience in the software industry. When we developed reusable code library software code libraries, it was the same underlying sort of principle which is, you you build a you know, basic infrastructure that allow As you then to very quickly configure, in this particular case, the device, the packaging technology, you know, you've done 75 or 80% of the engineering, you've de risked it. And now once you know what the drug is, you know what the patient population is. And you know what some of those product specific requirements are, you can do the final configuration and instead of taking a year to to do it, you do it in three months, or four months or five months. And you have a much lower risk of failure running into regulatory issues. And so that's really what I set out to do. And we self funded for a few years and then raised money with mystic and then focused on advancing the development of that platform concept. And and we decided to focus it into basically three different routes of delivery into the body atomic delivery, because there was a huge need for administering atomic drugs, effectively, the patient population tended to be elderly. Those are the folks who suffer from chronic eye disease like glaucoma, or macular degeneration, or dry. And the number one as was sort of finally discovered, oh, about 2008, or 2009, there was a series of a series of clinical trials that were run. And, and what they identified was the number one problem in a filmic direct delivery was compliance, it was a compliance problem, because the elderly patient was not correctly administering the drug into the eye, even though they thought they were. And we sort of saw that coming early on. The other sort of big trend in atomic delivery was the pharmaceutical companies were moving from preserved atomic formulations, which you have to do when you put it in, I grew up bottle, once you crack that I dropped bottle open, it has to be preserved, or it'll get contaminated through the new cycle time, you know, typically, a script and atomic script is a one month script. And that drug has to, you know, be contamination free for that one month period of time, there was the discovery that the preservatives that were being used in atomic products were actually caught causing other types of adverse side effects, particularly for chronic indications where the drug was used every day over a lifetime. So things like glaucoma, and the pharmaceutical companies were beginning to move to preservative free formulations. Well, that required a completely different packaging technology, right? It actually created the movement from reservoir based, I dropped bottles to unit don't single unit of use technology where you know, each drop or each dosage was in a single container, you just use it throw it away. So it was those kinds of things. And we we found those things, essentially, early on, discovered those as part of our market research work, you know, when we evaluated sort of the current landscape of technology out there, and then the needs of key stakeholder groups in the product value chain. For atomic products, we did the same thing. And the other sort of two other key areas of the platform, the device packaging and device platform for nasal delivery. And that's really systemic nasal delivery into the body. So a lot of research was being done at that in the early 2000s. around at that time, administering small molecules into nasally for systemic absorption. And what we discovered was that it bypassed the hepatic system. So it didn't go through, you know, the liver, it went directly into the bloodstream, if you got it, you had a landed in the right place in the nose, you had to have the the droplet size or the particle size sized appropriately, and then it could be systemically absorbed into the bloodstream. And so onset time is very rapid. So one of the early nasal products that was out in the market was a product for migraine. So as a migraine rescue product, you shoot it in your nose, and you know, within five minutes, you've got relief. So we were focused in that area. And then the third area was actually sublingual delivery, which was under the tongue. Also systemic absorption, bypasses and hepatic system as well. In the early days, we actually developed a very robust method. And this came out of my earlier work that I had done in future studies, right, and we use some some of those techniques. And we looked at key stakeholders in the product value chain. So we looked at pharmaceutical manufacturers, we looked at the prescribing physician, because they were involved in that, you know, in the product acquisition and then we looked at the end user, the patient based upon that market research, we developed a set of requirements for each different stakeholder groups and then those served as the design inputs that we use to engineer the platform.
Patrick Kothe 19:53
Every group is going to have different value associated with it or different It needs associated with it. What was the what were some of the big things that were driving? What were the problems? And you mentioned compliances. One, efficacy of the drug, what was what were the real problems that were that were being surfaced that you said, there's, there's a real issue here, and let's apply some technology towards it.
Tim Sullivan 20:21
So those were those tended to be stakeholder, you know, they fell into stakeholder sort of categories. And there were some overlaps. And though so if you start with the end user and the patient and work your way back up the value chain, compliance was a key one, ease of self administration was really a critical one. So if you think about the atomic application, the way that eyedrops are, you know, have been delivered for you know, more than a century isn't an eyedropper bottle, well, you're an elderly person you have and those eyedrop bottles are now down to five milliliters. So they're really tiny, little things. And they don't, they're not very precise, right. So if you squeeze it too hard, you get too much out, if you don't squeeze it enough, you know, nothing comes out of it. And and you have to hold it over your head and aim it in your eye. So what came out of that, in that for that category really well, requirements like ease of self administration, orientation independent operation, so I dropped ball requires gravity, you have to be in a specific physical orientation to use it, our requirement was a device that could be used in any physical orientation, which meant that it couldn't rely on gravity as the motive force. So we had to figure out a way to actually aerosolized and dispense it. We had some rather unique requirements in that when you hold something up to your eye and you push a button, you have a physiological tendency to blink, we had to do two things, we had to figure out a way to mimic the traditional way that people sort of deal with that when they administer an eyedropper, which is they use their fingers to hold their island upper and lower lid open, or they pull down their lower lid, which we did, we actually developed an AI cup that would do that. But the other sort of key thing was to be able to administer the dose out of the device and beat the blink. Right? And in fact, if you think about it, you have to beat half the blink, right? Because you have to get it in there. You know, and in which we did we accomplish that preservative free was sort of another key thing. Ease of carrying it around, you know, people didn't want a big bulky thing, it had to fit in your pocket or your purse and be somewhat discreet when you use it if you're using it out in public. So it was those kinds of factors, you know, that came into play. For the patient requirements. For the physician requirements, they, you know, their big thing was really compliance. In the atomic space preservative free was becoming a, you know, a pretty big deal, they would prefer to administer preservative free formulations. At the manufacturers level, they had requirements like abuse resistant packaging, flexible device configurations, depending upon sort of the the dosing regimen and the new cycle time. aseptic packaging, which is a requirement, if you're doing preservative free formulations for say an atomic product, you have to it has to be packaged aseptically Well, that's a huge that's a sterile, that's a sterile packaging process, which is a very challenging sort of thing to accomplish at scale. Right? And so, and if you think about it, you know, in that sort of a configuration, you're essentially packaging individual eyedrops, right, each one in its own little we, the way that we do it is we package each our drop in a little blister, and that blister goes into a multidose cartridge, and the cartridge drops into the device. So from the end users perspective, they have a device that will last them a couple of days, and then they have to change out the cartridge.
Patrick Kothe 23:53
So let's let's, let's talk a little bit more about about this, this, this customer, the pharma, the pharma company, when we think about drug development, we think about you know, the the molecule what it does and and what it doesn't do and side effects, etc. We don't often think about your how it's ingested into the system. Is that something that the pharma company works on? Or is that independent companies that work on that problem?
Tim Sullivan 24:27
Well, typically, what we see today is that most of the pharma companies, the larger pharma companies have developed enough experience that they incorporate that into the target product profile document, right, which is becoming increasingly more important out there is a way to sort of completely define the product to the end user is cost factors, you know, dosing regimen, it's all of those different aspects of what this product ultimately will be. And when We actually advocate the use of TPPs, as does the FDA, the FDA is, you know, has for a number of years now began looking at that as part of a quality of quality by design aspect. So the larger pharma companies are much more attuned to that the challenge going back, you know, 10, or 15 years was that most of the big pharma companies did not have a lot of expertise on the packaging and device side of things, unless it was standard commodity packaging, which they had been doing for a long time. But novel, you know, new devices, was something that they didn't have a lot of experience with smaller pharma companies and biotechs, don't tend to think much about the packaging and delivery side of it, until way later in the game, they don't have the funds to do it, which is actually, you know, can be quite challenging for them for two reasons. One is that they may make some assumptions about the availability of delivery devices and packaging, that are not valid, you know, though, you know, they push it off into the future, and they say, oh, you know, we'll be able to find that, you know, nasal is a great example of that nasal systemic nasal delivery is a great example of that. There are only four or five companies on the planet, that have precision Metered Dose nasal delivery systems, that really can handle that aspect. But the smaller companies tend to think, oh, there's lots of them out there. And so they don't tend to engage in that aspect of the their product development lifecycle, until later. And oftentimes, they get caught by surprise, when they discover Well, there's only two or three companies that have this tech that can actually deliver this as they as they move from preclinical work into the clinic. The other sort of important aspect about that is that oftentimes, the packaging and delivery tech that can actually advise how they formulate their product, with our technology, as an example, we've had situations where we had a small bio pharma company come to us they have a particular formula formulation of a small molecule or a large molecule. And in this particular example, they were developing a vaccine. And what they discovered about a year into the development was that the vaccine wasn't stable in a liquid form. And so they came to us and we had been talking to them and encouraging them to engage with us. We weren't aware of that until later on, you know, they were they were talking about using our liquid nasal delivery platform. And we by the way, have, we ultimately ended up the tail ultimately ended up building two platforms, one for liquid drugs and biologics, and one for dry powder, drugs and biologics, they use the same base technology, but the configurations are very different for those two things. And that's another, you know, going back to your prior question about well, what are the pharma companies are looking for? Is that flexibility, right, in other words, if they have to pivot, you know, because something's not working with a formulation early stage, you know, we have the capability to support either of those two, you know, formulation structures. In the example, I was just sharing with you, this particular group brought us the, it was a liquid, liquid formulated vaccine wasn't stable in a liquid form, and we actually help them transition to a dry powder form, didn't miss a beat, you know, in the development cycle. I mean, you know, there was relatively minor setbacks. Now, normally, that could potentially set back a development effort, you know, a year or more, right, if you had to do sort of a major change, but because we had the tech, and we were able to catch it early in that particular case, we transition them over to that, and it worked beautifully.
Patrick Kothe 28:52
Bottom line with this Pharmaceuticals is the clinical data that you need, not only depends on the formulation of the molecule, but that it's actually getting in the patient in the appropriate dosage. So some of these things that we're discussing here, if you've got a vial and and somebody has to do something to get that product out of the vial, and then get it into the patient. That's a variable that is not controlled, but it will affect the clinical performance of your product. So even though you've got a great formulation of of a pharmaceutical, if it's not in the patient in the right dose at the right time, your clinical data is going to suffer.
Tim Sullivan 29:38
Exactly, exactly right. And, and that sort of takes you into sort of the next level, which is it's really about precise dosing, consistency of precise dosing and consistency of precise dosing across broad populations, right, because eventually, if the product is successful, and makes it out into the commercial market marketplace, purchase Ecoli a product that is self administered, but not necessarily it can be caregiver administered as well, it's likely you're going to have a broad range of different types of patient populations using that. And essentially, the, the delivery system has to ensure that irrespective of the influence of the end user on how they use the device, the device performs exactly the same way every time with precision and consistent reliability.
Patrick Kothe 30:28
So these issues that that you were you're seeing, were those recognized by the pharma companies or were they just you're kind of going along, hey, we're selling selling x amount of product, you know, we we don't have a problem, because we're still selling x amount of prod product, were they aware that there was there was a problem there, or did that have to come from outside,
Tim Sullivan 30:50
oftentimes, they're not aware of it right away. But you know, with a year or two of, you know, post release experience, they become very much aware of it. So I'll give you sort of a classic example, there was a very effective beta blocker developed called Timo for treating glaucoma, and it worked very well, it was initially packaged in in, you know, traditional eyedrop bottles with a preservative in it. And about two years into the following the commercial release of that, and there's a physics problem with eyedrop bottles, and that the issue is that your eye holds about seven to 10 microliters of fluid in it, you know of a drug in it before one of two things happens, either it flows down your face, right, which everybody is sort of experienced, or it flows down your nasal lacrimal duct into the back of your throat and into your gut, or both. And in this particular case, what they discovered was that being a beta blocker, after about two years of use, a number of people were suffering from adverse cardiac and respiratory side effects, because the beta blocker was because of that overdosing in the eye was was building up in their system and creating adverse side effects. You know, the pharma companies became aware of that the fundamental problem was, it was a function of the packaging and the delivery device, you know, the only way to do that would be to dial down the delivered dose, but I grew up bottles and blow fill seal vials, which are the single use styles that you see a lot of Ophthalmic drugs packaged in, are incapable of doing that, right. Because if you think about the gravity, and our pressure is how the drug comes out of it. And if it's gravity, the size of the drop, has to get to about 40, or 50 microliters, for gravity to break the surface tension and pull it off into the eye. And the alternative is you just squeeze it really hard, you know, and outer comes in in either case, you're overdosing, we saw that problem, because we were actually able to dial in exactly the right amount of emitted dose and deliver that consistently every time. In that particular case, the you know, the pharma company became aware of it, you know, because of the adverse side effects are showing up out in the marketplace. And eventually, that led to the development of sort of the next generation, it was a prostaglandin that sort of came up next, it didn't have those kinds of adverse side effects.
Patrick Kothe 33:07
That's the tail, what you're doing is you're providing a device that's an enabling device for pharmaceuticals. So are you a medical device? Are you part of a pharmaceutical or combination device? How would you describe what you're doing?
Tim Sullivan 33:25
We're unique in that we live in both worlds, right? We live in the pharma slash, you know, biotech world, and in the device world, because we we touch everything, if we have to sort of pick up position in the market, we, you know, we basically say, Look, we're a med device, company, although this is evolving a bit from a regulatory perspective, we actually went to, you know, submitted a request for designation to the FDA early on in our, our evolution, and our devices, because they're mechanical, and not electromechanical. We're basically considered to be class one devices didn't require, you know, a 510 K, would go through the regulatory process with the drug, if it was a small molecule seeder would be the reviewing, you know, agency, but the combination office will be brought in to evaluate it. And if it's a biologic, it would be CBRE, same sort of thing. What's happened in the last 567 years is that the FDA has become much more focused on human factors aspects of it that has sort of raised the bar significantly in the clinical workups that have to be done. And you know, when you have devices that are self administered, the FDA wants to make sure that you know, a patient can effectively use the device there isn't the potential for error, you know, what are the failure? You know, what are the likely failure and so there's a lot more evaluation that goes on on the human factor say it nevertheless, it's still considered a class one device at this point.
Patrick Kothe 35:06
So your class one device, your read registered medical device supplier, you've got your quality system, and you've got your relationship with with the agencies. But when a pharma company goes to utilize your your class one device, now it's a combination device, and that pharmaceutical manufacturer will go and get the regulatory clearance of that combined device.
Tim Sullivan 35:32
That is correct. And, and as it goes through clinical trials and ultimately gets approved. It's the two technologies that together that get approved. So later if they want to go change the device, but you know, put a drug in a different device down the road, it depends upon sort of how how extreme the differences, but there may be a supplemental filing with the FDA, you may have to go back and rerun, you know, some of the clinical work at it, you know, it's very much case dependent on it. But those the two technologies go through together to go through the review process together, and ultimately get approved as a combo, essentially, as a combo product.
Patrick Kothe 36:14
At what point do you generally get involved with the pharma companies is it preclinical is a clinical what phase
Tim Sullivan 36:21
we're skilled at sort of engaging anywhere in the product development lifecycle, and that can be and we prefer to get involved very early on for the some of the reasons that I described before that is that oftentimes we can provide solutions to formulation challenges that they may have, or other types of technical, you know, or marketing challenges. By getting involved early on, we've also extended our platform, both of our platforms, into the animal care space, we can support preclinical studies and things like ferrets and rats and non human primates and, and it's the same base technology, right, the devices are just configured for that particular animal species. And so that gives us that gives our clients our pharma and biotech clients, technology, and most of that work happens in the nasal space. So we haven't talked a whole lot about nasal, but our work in the nasal spaces, systemic nasal delivery, and we actually also diagnosed brain delivery, right, which is delivered through the nose, but the, you know, the deposition site is a much different sort of depth deposition site when you're trying to get drugs into the brain. But we can provide devices and we're doing that now with a number of different clients, with the, you know, the drug or the biologic, you know, configured for nasal administration to a ferret or to a dog or to a a rat. And that gives them that base technology, you know, they get experience with it, they have the advantage of having very precise delivery, right. So they're preclinical data is more solid. And as they transition into humans, it's the same base technology. So all that work you did, typically, early on, you have to do a packaging, evaluation, to make sure that the drug, you know, is compatible, it's contact compatibility study, you know, this drug is going into this primary container system, you know, is everything stable on that, and you typically do that early on, all of that data moves through the progression into the, you know, into the clinical trial, and ultimately, into the documentation, you know, the regulatory submission documentation that has to go in.
Patrick Kothe 38:42
Tim, at this point, you've developed these different platforms, you said, yes, so you've got different platforms, for different routes of administration, and you engage with a pharma company, and you assume you have IP associated with, with these these different platforms, you've got the patents on these different platforms. But at some point in time, you're going to engage with that pharmaceutical company, and there may be some development time with that, or some development that needs to occur with an individual formulation. Right? How do you handle IP from that standpoint? Because there may be some IP that comes out as a result of that?
Tim Sullivan 39:21
Yeah, that's always one of the stickiest you know, questions? Right. So part of the design of our platforms is the ability to modify based upon unique requirements, we've actually engineer that inherent into the design of the platform. And in fact, that was an intention. Right, you know, right from the get go. So there's always a discussion around well, what is you know, modify mean? I mean, is it you know, you change the color, are you changing something significant about it? And there's always a discussion or a debate over who owns that IP. If there is IP, we have evolved agreements. It's fairly rare for it. Now to have an impasse. Early on, there's always a debate about it. But it's fairly rare now, because we try and take a measured approach. And that is that if there's innovation that occurs under a contract, that is directly related to our technology, we retain ownership of that. And, and vice versa, if there's, and sometimes that happens, sometimes we'll come back to the client will make a suggestion about how to change a formulation to make it better. That particular case, if it's specifically related to the formulation, they own it. And then we have that sort of general catch all cat category, which is, you know, if there's joint IP, that doesn't fall into one of those two categories, that joint IP is then co owned, usually, innovation falls into one of the first two categories. So it's pretty clear. The biggest challenge in that though, is that the big pharma companies tend to come into it with a very sort of entrenched perspective of oh, we own it all. Surprise, yeah. And, you know, we have 10s of millions of dollars invested in the development of this technology over the years, we have, you know, 50, some odd global patents on it, you know, so it's very well documented as to, you know, what we've done. And of course, with that sort of in investment, you don't just give it away, you can't, or you won't be in business very long.
Patrick Kothe 41:27
So, Tim, you mentioned vaccines a little bit ago. And I want to dig into that a little bit. Because, you know, obviously, we're just coming through a significant time when vaccines are, are so important. But one of the things that, that I thought about, as we were discussing this is, you know, when vaccines first first came out, they were in a vial, and I think they still are, but but there was debate, you know, you can pull four doses out of this vial, and it may be something a little bit left over. And you know, maybe, maybe we're going to capture some of that and with another vial and use that, and you were kind of discussing about trends and single doses. And we've got self administered drugs, a lot of self administered drugs, we don't do that with vaccines, what's going on? What's the future kind of look like in terms of vaccines,
Tim Sullivan 42:27
COVID drove a number of what I would say are nascent trends going on in the industry. So there's been an evolving trend about trying to move more and more healthcare, into the hands of the patient into the home, a lot of that was revolving around diagnostics, COVID tended to accelerate that in part because it it sort of tore the cover off of, you know, the fairly, although the US has probably got one of the most robust healthcare infrastructures, you know, in the world. We staggered under, you know, the load of trying to deal with a fast moving pandemic event the country did in the healthcare infrastructure, did you know, as was evidenced by, you know, what, you know, what, that first, you know, 1218 months was like, that problem is really significantly complicated in other parts of the world where they don't have that sort of healthcare infrastructure, you know, even to begin with, and much larger populations and much more dispersed populations. And so in the vaccine space, the movement has been towards the next generation of vaccines and I'm talking about not just for COVID, but things like flu and you know, a Num number of the other biosecurity issues that tend to affect global populations towards reducing the burden on the healthcare infrastructure for deployment, you know, of the vaccine, and so that nasal nasal delivery of vaccines and other types of biomedical countermeasures has become one of the sort of key leading areas for that the use of patches, dermal patches is another area but essentially trying to move away from invasive, you know, injectable based products. And right now in the COVID space, there's something on the order of 30 or 35. Next Generation COVID vaccine programs in development around the world, the majority of which are nasal, they're focused on nasal delivery, and some of them are focused on oral solid dosage forms, or other types of orally administered dosage forms. The idea behind that is that whatever the delivery method, or the non invasive delivery method, you have the option to either self administer or caregiver administer. So you can sort of flex between those things. And you have the ability to do rapid deployment. We first learned this in 2010 when we had the h h five and one pandemic flu pandemic, it was relatively short live wasn't anything like COVID. But it scared the healthcare professionals. Because the the morbidity rate for that particular strain of flu was very high, right, it was spreading very rapidly, we didn't have a good vaccine at the time that had to be generated, it was late getting out, you know, lag behind because it was because at that time, the method of making vaccines it takes about using the traditional egg based method for, you know, which has been traditional for things like flu vaccines, you know, it takes about, you know, four to six months to generate that vaccine, and then you got to package it and get it out into the public space. And in that particular case, the vaccine that was developed as an injectable, they had some of it that came out on time, but the large bulk of it ended up coming out after the pandemic waste started to subside, it was put into storage, and a year later, it was thrown away. And that was packaged in glass vials, you know, for injectable use. So it was 240 220 to $240 million. That was basically dumped down the drain strategy going forward is alternative forms of delivery that can be very rapidly deployed that can be self administered, even to the point of a nasal, as I mentioned, is sort of a key behind that even to the point of it shows up at your doorstep, right comes to you in the mail, right? Can you stick it in your nose here in this country, you know, if it's, you know, Africa or India or some of these other nations where that kind of infrastructure doesn't exist, you can deploy it on drones if you need to deploy it in drones, right? And, and you make it very simple for people to you know, you got a little instruction for use cartoon insert, or smartphone based video if that infrastructure exists where somebody can watch it 32nd video and oh, here's how I do this. And what we're finding is that, in the case of COVID, in particular, intranasal vaccines, actually, onset time of the immune response appears to be faster. So if you think about when you got your, your to COVID, injections, took about six weeks to build full systemic immunity, you know, and what we're seeing in, you know, with certain types of vaccines is that you get localized immune response in the upper respiratory tract, which is the route of infection within 24 to 48 hours, and full systemic immunity within a day or two later. So much faster onset, you know, with a nasal and you have the other benefits of things like, you know, self administration, you don't have a sharps disposal problem. I mean, we've got a problem out there with biohazardous sharps waste and repurposing of needles, you know, in some, some places where they're repurposed for abuse.
Patrick Kothe 47:53
That's kind of a fascinating topic, as as we kind of go forward. Because you talked about different geographies and different parts of the world who have have access issues or weather related issues, you're shipping things out and 100 degrees and an error on a truck. What does that do? What does that do? What is it when the formulation is frozen, and then comes back. So there's, there's a lot of work, obviously, that needs to go in there. But the overall concept of speeding up the deployment, there's a lot in there. So I think that that's going to be fascinating to kind of watch that as it evolves.
Tim Sullivan 48:35
As an example, we're working on a COVID vaccine, that's actually a dry powder. So it's room temperature stable, it's packaged as a powder and administered as a powder. nasally. Right. And so we're overcoming a number of those current deficiencies with the current state, you know, cold chain requirements that you know, all of those kinds of things and configuration of this is we actually have the ability to create delivery devices that can be single use disposable, or reloadable devices, and they all use the same cartridge. So you have a lot of flexibility. And because the vaccine is packaged in a primary container, that's not actually the device itself, the device is separate. You can stockpile those much more space efficiently, right, it's a much smaller footprint. And so you know, if you've got to stockpile 100 million doses, or 200 million doses, in that particular packaging, it's much easier to do that. And then sort of the, you know, going back to the example I used about the h5 and one vaccine that they had to dispose of. If you ended up dumping it, you're you're actually not dumping the entire device, you're just dumping the primary container, right. So your inventory rotation costs go down significantly. A tip
Patrick Kothe 49:54
thanks for having a great discussion on a topic that a lot of us don't deal with all the time because it's a form of place where most of us are in medical device, and don't interface on the pharma side. So this has been really a fascinating discussion, I want to kind of close up our conversation because you do a lot, not only within your company, but within the ecosystem within Central Texas, in terms of startup companies, and different groups that are organizations, either either private organizations or government organizations that help to build up the life science community, you've been president of different different groups, you've been on the board of these, these different groups that have a goal of helping alongside others to build out our life science community. So tell me a little bit about why you do that. And whether you think it's important for other people to do it too.
Tim Sullivan 50:57
I've been fortunate in that I sit on an advisory board at Dell Medical School, I'm actually on the board of directors of bio Austin, CT X, and I sit on an advisory board at the bioscience incubator at ACC, the key to success in this industry is really all about collaboration, you know, there's just no one company that can sort of tackle all of these challenges in and of themselves, you know, unless you're a giant multibillion dollar, Pfizer, and even they have to partner. So collaboration is really key. And all of these organizations that I'm involved in, have that as part of their central focus. The other aspect of it is that in order to really build a robust Life Science ecosystem in Central Texas, you have to, you have to coordinate that collaboration and actually provide some, you know, some guidance to it, to have it grow and expand, because that then just self reinforces the success of the the entities that, you know, are involved in, in in that space. So it's, it's absolutely important to get involved in the local, you know, the local ecosystem, wherever you are, in order to support the growth of the industry, the success of life sciences, in general, supports the overall health of the world, you know, the global population, the immediate area that I'm involved in, I'm involved in a couple of different nonprofit organizations that support that. But we reach out, you know, internationally as well, to try and create relationships around the world through a variety of different means. Organizations like the Texas Global Health Initiative is a great example of that they're now based in Switzerland, I really encourage entrepreneurs, you know, that may be part of your listening audience, to expand out into their own local ecosystem, really, not only to help support it, but you'll learn a ton, right? You make new contacts, you make new connections, by doing that, and oftentimes, that can have significant benefits for you know, what you do in your day to day activities.
Patrick Kothe 53:07
My thanks to Tim for opening up an important topic. I hope this conversation has prompted you to consider if your technology is truly standalone, or if other technologies affect its efficacy, a few of my takeaways, first, the importance of stakeholder feedback. And the way Tim described it is identify all the stakeholders, not just a primary, but who are all the stakeholders in there and then systematically gather feedback from each one. There may be overlap, or there may not. But you need to gather it from every single one of those stakeholders. And then you start developing your product based on that feedback. But also keep the conversation going. What happened a couple of years ago may not be what it's what it's like today. The second thing is he got a degree in future studies and a future studies program. I found that to be really fascinating because what it allowed him to do is to provide a framework for identifying trends in an industry and then identifying emerging technologies, or trends and other industries and then put them together and being creative and looking for new approaches, and then looking for areas where innovation can make a significant advancement. So I liked that idea of a formal study in looking at the future. Finally, giving back to your community and some of you are early in your careers and some of you are mid or later in your careers and giving back becomes something that's more important. I encourage each of you to consider giving back into your local community. Because as the saying goes, rising tide lifts all boats, but also it feels great aid to help others come along and in the industry, you end up benefiting from it. But it's really about helping others become more effective. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical advice podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical advice podcast as interviews like today's in help you become a more effective medical device leader. Work hard. Be kind
