Dr. Kyle Flanigan | CEO of US Specialty Formulations | Kinder Vaccines, Commercialization, & Innovation

Dr. Kyle Flanigan is the co-founder and CEO of US Specialty Formulations. In this episode, Dr. Flanigan discusses the importance of providing specialized formulations that aren't typically addressed by larger pharmaceutical companies, shares about the company's focus on developing a unique oral vaccine platform called Kinder, and expresses his passion for leadership and innovation.

Guest links: https://ussfgmp.com/

Charity supported: Equal Justice Initiative

Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.

PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium

EPISODE TRANSCRIPT

Episode 015 - Dr. Kyle Flanigan

Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.

Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Dr. Kyle Flanigan. With more than 25 years of experience, Dr. Kyle Flanigan, co-founder and CEO of US Specialty Formulations, LLC is an expert in pharmaceutical and medical performance materials development stages. He consults with companies providing robust, stable solutions and services for formulation, scale-up technology, contingency planning, supply chain issues, quality systems implementation, and new facility design. He brings this knowledge and guidance to his company's clients and their pharmaceutical and medical developments on the best path to market. Thank you so very much for being here, Kyle. I'm so excited to speak with you today.

Kyle Flanigan: Yes, thanks for having me. It's a pleasure.

Lindsey Dinneen: Yeah, absolutely. I would love, if you wouldn't mind starting out by telling us just a little bit about yourself and your background and how you got to where you are.

Kyle Flanigan: Sure. I'm Kyle Flanigan, CEO of US Specialty Formulations. I'm a co-founder with my business partner, Gary Moorefield. The two of us founded US Specialty Formulations with the idea of being able to provide specialized formulations to the public at large. So formulations that aren't typically picked up by the larger pharmaceutical manufacturing companies. And being able to provide those to, to patients or to doctors who are treating patients with compounds and formulations that they otherwise wouldn't be able to get ahold of. And that's kinda what started US Specialty Formulations.

In addition to that, both of us have deep foundational knowledge in specialty materials processing, pharmaceuticals processing, clean room operations, SOPs, setting up and building groups that work on a variety of different types of technologies like this. So we also looked at how do we further a vaccine project that my co-founder had going. And in doing that, we just, we decided to set up this company and make this service available to other people.

In addition to providing just your standard formulations used to treat certain diseases out there, we also provide a service for producing investigational drugs that new inventors may come to us and ask us to make, to deliver a high quality, clean, sterile high quality product into their investigations so they can continue with their clinical trials. So that's kind of where we are. And then out of that, we developed a vaccine platform, Kinder, which is the oral vaccine platform which we just got into, we just finished up its clinical trial out of New Zealand. And we got some awesome results out of because we adapted the platform from its original intended purpose, which was strep, and into a COVID 19 targeted vaccine.

And this oral vaccine actually shows improvement over the existing mRNA vaccines that are out there as far as protection capability. It operates on a slightly different regime. It's a mucosal vaccine, which is really interesting and part of a new wave of vaccines that are gonna start showing up in the next decade. And also, it's really easy to take. It's so great because this allows treatments without needing to stab someone with a needle. That's as simple as it gets. It's you don't need to have a needle to, to administer a therapeutic.

Lindsey Dinneen: Wow. That is very exciting for somebody like me who hates needles.

Kyle Flanigan: Yes. Both of us. I hate needles. Also, it's, that's part of the reason I got into this was to avoid-- when I was little, getting a battery of boosters and that was such an unpleasant experience. Part of the kinder thought process, and the reason we call it Kinder is because it's a "kinder" way to administer a vaccine. It's a much more pleasant patient experience.

Lindsey Dinneen: Yeah, absolutely. Backing up just a little bit, you mentioned founding the company, but I would love to hear the inception story of, how did you get connected with your co-founder, and then how did you guys come up with " this is what we want to do with our careers"?

Kyle Flanigan: Right. So Gary and I met through our daughters and we're in gymnastics and they're on the same gymnastics team. Anyone listening who is from a gymnastics family will know this very well. And what happens is, the person doing the gymnastics is maybe performing for a whole 30 minutes, maybe 50 minutes total time on the floor. But at a gymnastics event, typically with all the teams and everything out goes on for easily four to six hours. And so Gary had his other company that he was working with, I was employed by another company. But we were both very interested in technology . And so while we sat in the stands trying to be supportive of our daughters as they're doing these crazy death defying moves, to kind of pass the time we would just talk shop sometimes.

And, over the course of a couple of seasons, we recognize that one, we got along, but two, we both had very strong and clear ideas of how to do a variety of things. So that's key. And our vision and our goals kind of align with, "Hey, if I had the ability to do this, this is what I would do and here's how I'd run it." And as we work through those casual conversations, we recognized that we were aligned in kind of our thinking of what we wanted to do with our careers. And an opportunity came up so that I was able to leave what I was doing and devote some time to some business planning, business modeling and things like that. We developed the model and then incept the business in 2013. And bring it up and just begin to build our clean rooms and things like that. We built everything by hand at first. Just the two of us again.

With such intimate knowledge of the space, the operational side, as well as the development side, as well as the business side from our past lives, the two of us were able to do what typically you would expect a high powered team of, 10 to 12 people to do, just to start the company up and running. So we were able to do that, and that was, that's really what started, USSF off in this pharmaceutical space. It's really a cool story. I think our first clean room looked a little-- you could tell it was hand-built-- but it was very functional. It worked very well. Our next set of clean rooms is a lot better, and then our third set that we're still in the planning stages for our expansion, those look much more much more we'll say professionally built.

Lindsey Dinneen: That's amazing.

Kyle Flanigan: It was a good story because, again it's kinda like the two of us had the vision, put a business model together. And we've worked through it and surprisingly from our original business model, the environment and everything else hasn't changed all that much. So our model has held consistent through the test of time over these past what is it, 10 years? 10 years now.

Lindsey Dinneen: Great. Wow. Yeah that's amazing. I love those kinds of stories where it's just a person or a couple of people with big dreams and big goals, and they just set out to do what they know that they were meant to do. And sure, sometimes it looks a little wonky at the beginning, but it works.

Kyle Flanigan: Yes, we were very happy. The first formulation we had for sale was a very celebratory day. I think it was just, I think our first product was saline. We had saline for injection and it was a monumentous day when we got it packed and ready to ship to a customer.

Lindsey Dinneen: Oh, yeah. I can only imagine. That's so exciting. I love those moments. So I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career for you? Now, that's a broad question. So it could be related to your experience in the industry as a whole, or it could be specific to your company. But in general, is there a moment or a series of moments that just said, "yes, this is it."

Kyle Flanigan: Yeah. I think, one of them actually happened fairly recently. We made an investigational drug for a customer. And they used it. And this particular one was made to enhance the survivability of organs during transplant. From that, you know, it's still in development and it's still being going through its processes. But we had to refine the formulation, develop the formulation really quickly to get it available for a-- I think they were going for a compassionate care use, I'm not entirely certain-- but you know, we were able to get the team trained and ready to go and we were able to get this formulation out the door to the customer.

And we received a note later that was forwarded from their CEO to us, and it was, " Hey, you just wanna let the team know that because of your diligence and capability this, this was used and we applied it to an organ. And the surgeon let us know that the organ would not have been viable if not for the additive that you guys supplied to us and the transplant was successful because of what you provided." Otherwise, I think it was a girl of like 17 or something, she would not have made it if it, if they had not used this.

I did not think it would have such a big impact in my thought process, and then after it, as it kind of sunk in what we were able to accomplish. This really is one of the satisfying things about what we do. We were able to successfully get this out. We were able to produce a high quality thing and it saved someone's life. That makes the entire team as you're going through it, it focuses you and allows you to say, "Hey, this is the goal, this is why we do this. This is why this is important." And the results are very tangible at the end.

And that just affirmed that, so it was, it was awesome. But I would say that's the moment that was, you know, a couple years ago, but it let me know that, "okay, you're in the right field. This is what I like doing." You know, putting a team together that can do that. Having, the technology and the bits and parts that all come together to culminate in being able to provide that lifesaving action is really important.

Lindsey Dinneen: Yeah. It is so important. And I can only imagine too, being a father yourself and realizing, you have a daughter too, and that like connection-- yeah-- of, of this is so impactful to somebody. And it could be somebody that you know personally in the future, who knows, but the point is you're making a difference. And that's-- ugh. Yeah. That's a good feeling.

Kyle Flanigan: Right, it's one of the feelings-- when we thought about why does USSF exist? And that's one of the things is we handle a lot of the formulations that the big companies don't handle. For a variety of business reasons, they don't. But really, when it comes down to it, when you're a patient sick and your physician prescribed a certain medication, if that medication's not available, then it's effectively you don't have any healthcare, right? That's the problem. That's one of the reasons USSF is here, is to be able to provide, certain medications or vaccine technology, so that we are able to provide this healthcare when the larger companies have passed on providing for that.

Lindsey Dinneen: Yeah. Yeah. That's great. So growing up, was medicine always of interest to you or chemical formulas or whatever, like was that always of an interest or is that something you kind of developed?

Kyle Flanigan: It was always an interest. It was always, we'll say an ancillary interest. Truth be told, I'm a pilot and I love flying and anything aviation or space related. So I always wanted to go into space to do pharmaceutical research on the space station or zero G or microgravity type stuff. So , chemistry has always been a part of my training and my background. Both my parents are chemists. My dad was big pharma, my mom was analytical lab chemist, so, so it's always been there. My training is as a chemist.

But I think, I always want to do from the beginning is, it's that explore and build kind of drive in me. Go into unchartered territory where I am the first, or only among the very few, that actually have blazed the way down a certain technology path or being able to introduce new things to the market. And I think that drive is one of the things that influenced my spin up into deciding to found effectively a startup, and then grow it into a much larger entity.

And it's not for the faint of heart, right? As we discussed earlier, this is extraordinarily challenging. You need the technology, you need the chemistry chops, you need the science chops. But there's also more, you also need a energy and an underlying drive in order to really do this. It's that goal to explore, create, and bring people up behind me as I keep charting a path. And that's kinda the drive that's pointed me in this direction and laser focused me in this direction.

Lindsey Dinneen: Absolutely. Yeah. And I love your idea that you brought up of exploring and creation and sort of being the first to go into some uncharted territory. I think that's a common theme I've noticed in this industry of people who are curious and they're interested in learning and they're interested in growing not only themselves and their own abilities, but also the industry as a whole, pushing it forward and whatnot.

Kyle Flanigan: I was gonna say it's that, read everything. I think when I was growing up, the net was still-- it wasn't the net that we know now. But, reading The American Scientific or whatever business journals my dad brought home from the office. But just picking up those magazines and devouring them and reading, even though I didn't have the background in training for them, I would still read them and pick up little bits of knowledge here and there. And even today, I think one of the things that separates the kind of people on our team that do really well are those that if they don't know something or there's a meeting where there's some bit of information that they don't know offhand, the behavior that I see that really makes me proud is, they'll just go look it up.

Yeah.

No one goes, "Oh, I dunno," and then move on. No, you've got three or four people go look it up and like, "Oh, okay, here's what it is, now we understand it, let's proceed with this new knowledge." Those are the kinds of people that enable technology to grow rapidly because, to commercialize any technology, it's not a one man show. You might come up with certain things, but once you try to commercialize it or bring it into production or run it through a regulatory process, it becomes a major team effort, and the curious make that effort much easier than if you just have people who just do exactly what they're told all the time. That works for very large kinda sustaining type companies. But for these, the leading edge-- although as they say, the bleeding edge-- of technology, it's those kinds of people that is what's required for companies to be successful.

Lindsey Dinneen: Yeah, absolutely. I'm curious how your own leadership abilities have evolved over time and how would you define leadership or what does it mean to you?

Kyle Flanigan: You know, initially when we first found it, it was the two of us, then three of us, then five, and now we hover around between 13 and 16 at any given time. And I think it's gone from, initially when you first found, you're a doer, a planner, but you're focused on daily ops with a little bit of strategic stuff in there. And now it's shifted with more of a team. What has shifted is into being able to lay out a roadmap for people so that the team leaders understand where we're going.

And, I'm not, and Gary's not focused on, explaining to people how to do a certain task. It's more of a "Here's where we're going, here's the task that you need to accomplish. You guys know how to do it. We've trained you how to do it, or you've got the training on how to do it now, just execute to your training, but here's where we're trying to go." So that's how it's shifted. It's shifted from the tactical to the strategic.

I think for me, a leader is a person who can identify the strategic direction that the team should go. And usually that's getting input from a lot of people, not just in the company, but you know, knowing the lay of the land, right? Being out in the industry, taking in the voice of the customer, all that great stuff, and then saying, "Here's the direction this company should go. Here's what's required for us to go there, and here's what I need each of you to do to get us there." And being able to lay that out. That's kind of the strategic side.

The other side as a leader is to be able to remove roadblocks from your team, meaning reading the team, how does this particular team member operate? What are their buttons? What is preventing them from accelerating and providing that feedback to them. And if it's something that you can address, addressing it. So, removing roadblocks. Again, as I say to my logistics person when he says, " We can't get this our, our supplier doesn't have this anymore." Then it's working with him and saying, "Okay, let's work through this and find some alternates and we'll work through our process for identifying alternates and picking new ones."

That's a basic one, but you know, it could be as simple as, "Hey, my childcare person just quit." Right? "I have no one to babysit my child and so I can't do what we're doing." Okay, let's figure out how you can still do what I need you to do, but also your home stuff is taken care of so that you can focus, you're not worried about that while you're executing your other duties. And I think a leader has to be aware of the different challenges their team members are facing and be able to, one, create an environment to make it pleasurable to work. But two, help them overcome those different things. And so I call it just removing roadblocks, whether that's on the business side or the personal side. What are the roadblocks that I need to assist with?

And sometimes you just can't do anything, right? And you have to say that. But if there's things within your power to, to help with, then I believe a leader should do that. So set the direction strategically. Empower the people to do what you're asking them to do, right? Don't tell someone to do something and then give them no power to do it or authority to do it, right? That's pretty poor leadership. And then remove any roadblocks that are coming, whether it's professional or personal, if you can help with that.

Lindsey Dinneen: Yeah. That's great. Thank you so much for that advice. I think that's really important to have all those components, like you said, because people are multidimensional, so it can't just be one thing that you're trying to help manage, say. So it's not just the strategic side as a good leader, although that's extremely important. But like you said, the roadblock, I really like that analogy of helping someone to do their very best. And that could be through the work. It could be through the personal lives or whatever, but since people, it's all intertwined for us, it's so helpful to have a leader who understands that and can put it all together. So I really like your 360 approach to that for sure.

Kyle Flanigan: Ah, thanks. And again, both Gary and I come from large corporate environments. So we know how not to manage people.

Lindsey Dinneen: Yeah. I hear ya.

Kyle Flanigan: We've both experienced that. Yeah.

Lindsey Dinneen: Yep. That is sometimes not a lesson that you would prefer to learn that way, but it is a good teacher. Yeah, absolutely. Pivoting just a little bit. Just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why?

Kyle Flanigan: Oh, I think, yeah, for me it would be how to commercialize a product. And I say that because a lot of the world, when you hear notes about technology and the challenges associated with just being a human today, right? You'll have people say, "Oh, well someone invented X, Y, and Z." Okay. And then you have a large company, many years ago that will say, "All right, we produced 80 million of these widgets a year, and we're providing them to, to these people to make their lives better." Okay. That's two ends of a very long spectrum. Very few people are familiar with what has to happen between the person in the lab saying, "Yes, I now have a working model of what we're going to ultimately produce" to when you can go buy it on a shelf somewhere, right?

And here's an example. I think, during Covid, a lot of people were saying, "Oh, we're gonna throw all this money at this problem. And we should be able to then have it go away." And it's that in between having something in the lab to having it on a shelf ready to use, that's a very long time period or a very complex period. Not necessarily long, but complex period. In some cases it is actually a fixed amount of time between certain steps in that, that have to occur, and no amount of money that you throw into it is going to speed that up.

So I see this a lot in the investor discussions and other types of discussions with politicians and things where, okay, if you throw a million dollars at a given problem, it doesn't mean it's gonna be fixed tomorrow or in six months. And so teaching that class of what are the things that actually have to happen at the high level. For instance, I talked a lot about teams and building and things like that. If you were to throw up a new facility, you have to staff it. That takes time. You have to find these people. Even then, once you have the people, you have to train them on all the new equipment you put in the facility, right? So all that takes time. And that could be six months, it could be a year. The team has to get comfortable working well together, so they're probably gonna take another eight months before of actually doing it, before everyone knows what each person's supposed to do. So now you're in a, a 24 month time period from someone just throwing a lot of money at something.

So, I would love to teach a, a masterclass on when we say we're gonna commercialize and start up as an entrepreneur or something like that, here's what that involves, right? Here are all the considerations that, that are gonna go into this, and these are the choices you're gonna have to make. Some, you can make early on to make your life easier on the backend. Some, you won't be able to make until the day or the month you actually have to make that decision. Some are instantaneous. But these are the kinds of things that you have to consider while going through.

While I was at grad school, actually took an entrepreneur course. We used Guy Kawasaki's book. But it talks about that, that beginning cycle. How do you pick what you're gonna do? But the commercialization side, I think a lot of people who are in the field, looking at it as industry specific. But I think it could be taught a lot broader. That would be my, my thing.

But how do you, commercialize looking at supply chains? We saw a perfect example of broken supply chains, right? So how do you design for those? And these concepts have been around for a long time. Certain industries are better at it than others, but it's not something that is ubiquitous in the industry. It's not a regular thought process for people. And I think in a masterclass set up, those are the things that, that if they're called out and actually focused on with a little bit more attention on stabilizing, or teaching people these considerations, it'll go a long way to mitigating those scale up risks in the future for all the other really cool inventions and technologies that are out there. But, everyone depends on a supply chain. So that's what I would teach, I would devote some serious time in examples into trying to teach people about that.

Lindsey Dinneen: Yeah, that's a great subject and very important, so that would be a great class to take. What is one thing you wish to be remembered for after you leave this world?

Kyle Flanigan: Yeah, again, we go back to having daughters and things like that, but as I look at them growing up and maturing, I think it's really having left the world, let's say, a better place. And by being in a better place, meaning the human condition is a lot more pleasant than it was when I entered the world. And I contributed to that. So again, vaccinations, you don't need to get stabbed every time you get vaccinated. I just hate needles. But, you know, that goes a long way at making the deliverance of healthcare process more pleasant, and making it more available to people who otherwise would not have access to it in using conventional methods. So I think that is improving the human condition considerably. And enabling a lot better care and opportunities for people throughout the world.

Lindsey Dinneen: Yeah. I love that. Yeah. And I love that you're actually living what you are passionate about and so you're building your legacy as you go. So, final question. What is one thing that makes you smile every time you see or think about it?

Kyle Flanigan: So many things. I'll give you two things I can't decide between them.

Lindsey Dinneen: Sure.

Kyle Flanigan: One is both my daughters are competitive in their sports. So one is a cyclist. And when I see her racing around the track on her bicycle, winning or placing and medaling, I am thoroughly thoroughly proud of that. And the other daughter is a gymnast, like I said. And when I see her out competing and again, medaling and things like that, I'm just immensely proud of their dedication and focus that allows them to do that. And I would say at least I married someone who was able to teach that to them probably. So I smile whenever I think of the two of them.

And then drone drops, drone dropping of medications and essential supplies to the outback, places where there are no roads and things like that. I think that's just awesome. It's the combination of multiple technologies to again, improve people's lives and it's gonna be the start of something. Right now we're talking about little packages, right, for those things. But as the tech gets better and people get more and more comfortable with trusting the robots. Again, that has some science fiction implications, but I think as people get more familiar with the technology and work some of the bugs out of it, more and more things will begin to be employed that way.

And it makes me smile because it is reducing the risk for people living out there and for the delivery people who have to deliver that stuff. You know, all around it's a risk reduction exercise. And it embodies everything I love about technology, aerospace, pharmaceuticals, and drones and logistics. So it's just awesome. So, I do smile when I think about drone dropping of stuff.

Lindsey Dinneen: I love that. What a great answer. So relevant to what you do, but also just such a unique answer. That's fantastic. Kyle, this has been so much fun. I really appreciate you joining me today and sharing your story and your insights. So, thank you just for the time that you spent and we're honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. Thank you for choosing that. And again, just thank you for being here. We wish you continued success as you work to change lives for a better world.

Kyle Flanigan: Okay, thank you. Thanks, Lindsey, for having me. And I appreciate it. I'm honored to always be asked to speak about various topics.

Lindsey Dinneen: Absolutely. Yeah, of course. And thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.

The Leading Difference podcast is brought to you by Velentium.

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