IAM2226 – CEO Specializes in Developing Unique Solutions in the Pharmaceutical Industry

Title: Transcript - Mon, 02 Sep 2024 12:08:13 GMT

Date: Mon, 02 Sep 2024 12:08:13 GMT, Duration: [00:16:53.44]

[00:00:00.44] - Kyle Flanigan

And what we do is we partner with those, what we call the original inventors or the inventors, and we help them walk through that process so they have their AP, what we call their API. Then we help them get that into a formulation. We help it into a stable formulation. There's a lot of QC and R and D just on the testing alone for how do you quantify what it is? How do you know what the safe solution is, what the safe version is? And then it goes to clinical trial.

[00:00:32.03] - Intro

Are you ready to hear business stories and learn effective ways to build relationships, generate sales, and level up your business from awesome CEO's, entrepreneurs and founders without listening to a long, long, long interview? If so, you've come to the right place. Gresh values your time and is ready to share with you the valuable info you're in search of. This is the I am CEO podcast.

[00:01:03.61] - Gresham Harkless

hello, hello.

[00:01:04.14] - Gresham Harkless

This is Gretch from the I am CEO podcast, and I have a very special guest on the show today. I have Doctor Kyle Flanagan. Doctor Kyle, excited to have you on the show.

[00:01:12.90] - Kyle Flanigan

Hey, gresh, thanks. Always good to be chatting with another bison.

[00:01:16.93] - Gresham Harkless

Yes, absolutely. It's always a welcome home experience when you meet and get to connect with another bison. So I'm super excited, of course, about that with Doctor Kyle, but excited even more about all the awesome things that he's doing. So before we jumped into the interview, I want to read a little bit more about Doctor Kyle so you can hear about some of those awesome things. And Doctor Kyle Flanagan is the co founder and CEO of US Specialty Formulations, a biotech firm, certified cGMP, manufacturer of sterile, injectable, topical and specialty pharmaceuticals. One of the few black pharma PhDs, Doctor Kyle provides robust solutions and services for formation, scale up technology, contingency planning, supply chain issues, quality systems implementation, and new facility design. Graduated of Howard University with a B's in chemistry and an MS and PhD in materials science and engineering from the university of Washington. And one of the awesome things I found out about Doctor Kyle when I was preparing for this is that his entrepreneurial story is really a generational story where I think it came from your paternal grandparents that kind of raised you to kind of be an entrepreneur. So I thought that was super awesome to kind of read. And I think one of the things, I guess the lightning, that light at the end of the tunnel during COVID was that there were so many things that were created or started. And I think he has a really phenomenal Covid pivot story that I think we'll probably delve into. So, Doctor Kyle, excited to have you on the show. You ready to speak to the IMcl community?

[00:02:43.84] - Kyle Flanigan

Sure. Happy to share my story and other things.

[00:02:47.25] - Gresham Harkless

Awesome. Well, let's get it started then. So, I know I alluded to it a little bit, so let's rewind the clock, hear a little bit more on how you got started. What I call your CEO story.

[00:02:55.87] - Kyle Flanigan

Yeah. So let's see. My co founder and I both have daughters in gymnastics. Back in 2011, 2012, we started, we were sitting there watching, watching our daughters do death defying things on the various bits of apparatus. And we started talking about our past experiences and what we would do if we were in control. The classic story. While we were sitting there, we said, hey, you know what? We can actually do this ourselves. We don't need to do this for other people anymore. So we founded a company in 2013. And as you mentioned in the introduction, we started off as a contract manufacturer and then combined it with some other things. Our skills. We have extensive background in clean rooms and advanced technology and really cool stuff like that. It was just a natural flow. One thing led to another. It started off with two guys in a clean room, then three guys in a clean room, and we've grown. Now we're in a 42,000 square foot facility. And we started our phase one build out and all these great things. But we get to see really cool projects, really early stage things, long before the public would see most things. And it's just really exciting and fun because unlike normal big Pharma, we're never really working on the same thing one day after another. It's not a. It's not a what? I don't want to. Drudge is not the right word. But, you know, it's. It's. It's always different. And that's really exciting and cool. Back to the COVID story. So we took one of our technologies, which is pretty awesome, and it was for a strep vaccine. Everyone gets strep throat. There currently is no vaccine for that. So we were working on this. We're trying to figure out how to bring it to clinical to, into our clinical trial phase. And Covid hit. So during that time, everyone was on lockdown, including the medical industry and the clinical industry. Right? Unless it was a COVID vaccine, nothing was getting run in a clinic. So we were sitting around talking. We said, well, we pretty much are already set up and ready to go. We can just pivot this technology into, from our strep vaccine into our COVID vaccine. And what's really cool about the COVID vaccine, which we thought would be awesome. We thought everyone would want this. There's no way anyone wouldn't. It's an oral vaccine, so you don't have to get stabbed with a needle. You don't have to undergo any other kind of weird ways of getting a vaccine administered to you through the nose or through the ear or something like that. Literally, all you have to do is drink about ten mils of liquid. So not even enough, like in a slurp of a cup or something, just enough to kind of wet your mouth and throat, and then, you know, 14 days later, you're vaccinated. So we finished up the formulation. We got, you know, all the preclinical stuff that you have to do. And we ran this vaccine. We got it out the door in about the same amount of time. Pfizer got their stuff out the door. Why? That's incredible. Our company only has at that point, we had twelve people in the company. You know, Pfizer has how many thousands of people, right? So we were able to generate this and get our. Get our test samples made and get it into a clinic in about eight months, which is really impressive for a company our size. We ran our clinical trial in New Zealand. Great results, awesome results. So what's really cool about it is it showed, you know, we could go really fast, too, that this oral vaccine, which people were saying could never be done or hadn't been done. We get asked that question all the time, why does yours work when theirs didn't? I'd like to say because we're better.

[00:06:49.31] - Gresham Harkless

Nice. I appreciate you so much in sharing that.

[00:06:51.68] - Kyle Flanigan

So I know you touched on a.

[00:06:53.72] - Gresham Harkless

Little bit, but I wanted to drill down a little bit more to hear a little bit more on how you're working with and serving your clients. Could you take us through exactly how you're making that impact there?

[00:07:00.62] - Kyle Flanigan

Yeah. So what we do, I mentioned half the business is contract manufacturing. So really it's kind of, a client or customer will come to us with a formulation, say they've invented a new solution to our new molecule, or discovered a new molecule, and they want to, hey, we can use this to cure or help treat x disease. X. Well, many times there's a lot of people who invent a lot of things, and they have lots of cool ideas. But again, pharmaceuticals are highly regulated. There's a lot that you have to do to bring something to, through the commercialization path into the market. And what we do is we partner with those. What we call the original inventors or the inventors, and we help them walk through that process so they have their, what we call their API, then we help them get that into a formulation, we help it into a stable formulation. There's a lot of QC and R and D just on the testing alone for how do you quantify what it is? How do you know what the safe solution, what the safe version is? And then it goes to clinical trials. So we work with them through that preclinical process, then the clinical trials, and then going all the way into the. Into the. Into the formulation aspect. Sorry. Into the commercialization and scale up aspect. Prior to us purchasing our new building and our new facility, we would get up to about, you know, the phase one we could handle up to the phase one side, which is if you think about its, you know, a couple hundred vials of the new stuff, and then we've done all this work. But usually, because we were so small, we'd have to hand it off to effectively our competitors because they had much larger facilities and could work with the client all the way up to that point. And now with this new. With this facility, we can actually continue on, you know, the formulation. We can continue on through the formulation and approval process. We've added purification, fermentation and purification capabilities. So really, with the larger footprint, we have more people and can do more, can complete more of the operations around that whole scale up and approval process that's needed for drugs in the US. We also do us drugs, but we also ship things overseas as well. So it's, again, back to. It's a lot of different projects that our teams work on, and we seem to be developing the global, global footprint and global impact.

[00:09:38.61] - Gresham Harkless

Absolutely. Do you feel like that's part of your secret sauce? It could be for yourself most or the combination of the business, but do you feel like being able to maybe ask those questions, be able to say that there can be a different way and be able to blaze those trails? Do you feel like that's part of your secret sauce? What sets you, your organization apart and makes you unique?

[00:09:59.37] - Kyle Flanigan

Yeah, I think, you know, that definitely comes from my just inner character. I was having a discussion with my old, my graduate advisor a while ago, and one of the things, you know, he said, hey, Kyle, you know, one of the things I've always liked about you is you're not afraid to try stuff that no one else would actually. You'll go down a route that no one else will go down, and, you know, you may or may not have good results but it doesn't stop you from giving it a shot and seeing what happened to. And, you know, for us, I think it's the. That it's not a question of can it be done right most of the time. Most of the things that, the challenges that we have, they're not, they're not basic science problems. Like, you know, we're not. We're not trying to figure out how to split a split yet another neutron. It's an engine for us. It's. Well, that's an engineering problem, too, but we're just a. Most of them are just engineering problems. So it's a, how do we do this? So a customer comes to us and say, hey, I want this, this and this. So it's a, how do we do that? Or, hey, wouldn't it be great if there's a compound that did this? Okay, how would we go about finding that? And what would be a stable solution that's actually pharmaceutical manufacturable? Right. Those are the kinds of discussions that we like to have. You know, a lot of our customers, even when they don't select us as their partner to work with on a certain thing, usually it's because we're too small. But in most cases, they come back and say, hey, you guys are the most knowledgeable of all the companies we've talked to. You guys really were on top of this, and you know what it is. And you had. We had good discussions and thoughts about what was possible, not just us telling you what to do.

[00:11:46.91] - Gresham Harkless

Absolutely. Absolutely. So I wanted to switch gears a little bit, and I want to ask you for what I call a co hack. So this could be like an apple book or even a habit that you have, but what's something you lean on that makes you more effective and efficient?

[00:11:59.29] - Kyle Flanigan

Kind of two things is, where possible, demand. Demand. I don't want to say perfection, but it's close, right? If you can make it perfect or fill out the form perfectly or do whatever, you write the document as perfect as you can make it do it. You know, if it's so, always strive for perfection. The second part is, and I think is don't put things off for later. You know, you're in a meeting, you got ten things to do. You're sitting there, you know, in my case, you're running the meeting or talking to people or whatever, and someone gives you an ardental. An action required, right? You got to do some action. Just take care of it. Then don't say, okay, I'll do it later, and put it off and now you got, by the end of the day, you got 200 things to do and, you know, you're trying to remember what they are. You have to go through all the notes and it's just slow. So I found the most effective. People just take care of those activities when they come up. If it's, hey, send a note to sudden such, remind them about whatever it is. All right, one moment. Done. It's off your brain. It's on to the next person.

[00:13:13.50] - Gresham Harkless

Awesome. Would you consider that to be a little bit more what I would like to call a co nugget? So that could be like a word of wisdom or piece of advice or something you would tell your younger business self if you were to hop into a time machine. But is it that understanding that in order to create that innovation, to really increase the likelihood of that happening, you have to have that really active mentality of going to the next thing? The next thing, next thing. And really start to have that as part of your culture? Do you think that's part of your CI.

[00:13:38.88] - Kyle Flanigan

You do. You do. And that fits in with the how do I do that? Right. There's lots of ideas. There's tons of opportunity out there, and some are outside of your sphere, some aren't. But the next thing is to recognize the opportunity. How does it fit into what I'm doing or what my goals are, what the company goals are? And then how do I do it? And then, even if you don't know the full roadmap, but begin to chart a chart your course and begin to start navigating through it, or find someone who knows how to navigate. Right. Find someone who's done it before and ask them.

[00:14:17.61] - Gresham Harkless

Awesome, awesome, awesome. So now I want to ask you one of my absolute favorite questions, which is the definition of what it means to be a CEO. And you might have already touched on this, but we're hoping to have different quote unquote CEO's on this show. So Doctor Kyle, what does being a CEO mean to you?

[00:14:29.54] - Kyle Flanigan

A leader and a communicator. Right. Here's what our team is about. Here's how we're going. Here's what we are doing, here's how we're going to get there. And throughout that process, you have to communicate that to everyone, whether it's the people, your sponsors, external to the company, your employees, or at least the key people within your organization, have to understand those basic things. And then, you know, I would almost say an enabler, right? In the good sense. But really it's established the goals and establish the goals, the how, and then the methods and tools to get there. And really, you know, and then a coach, right?

[00:15:20.58] - Gresham Harkless

Doctor Kyle, truly appreciate that definition. Of course, I appreciate your time even more. So what I wanted to do now was pass you the mic, so to speak, just to see if there's anything additional that you can let our readers and listeners know. And of course how best people can get a hold of you and your team will find out all the awesome things that you all are doing.

[00:15:35.75] - Kyle Flanigan

If anyone wants to learn more about us or has contract manufacturing needs that they may have, www.ussfgmp.com is our website. And if you want to learn about that cool vaccine, which you know, it is paradigm shifting, it is going to change the way people are vaccinated. It's going to change what you could be vaccinated for. There's a lot. It's very powerful. Then it would be kinder. It's. We call it the kinder vaccine because you drink it, you're not, you know, getting a needle, but kinder. Kyndr.com perfect. Perfect, perfect.

[00:16:14.33] - Gresham Harkless

Well, to make it even easier, of course we're gonna have the links and information, the show notes as well too, so that everybody can follow up with you, your team find about all the awesome things that you're doing and I hope you have a phenomenal day.

[00:16:23.20] - Kyle Flanigan

Thanks. You too.

[00:16:24.19] - Intro

Thank you for listening to the Imceo podcast powered by CB Nation and Blue 16 Media. Tune in next time and visit us at Imceo Co ImcEO is not just a phrase, it's a community. Don't forget to schedule your complimentary digital marketing consultation at Blue sixteenmedia.com. this has been the imceo podcast with Gresham Harklis Junior. Thank you for listening.