20 Years of Excellence in Life Sciences
Memorable Quotes:
"Despite facing numerous challenges, we never lost sight of our goals and remained committed to our vision." - Stephen M. Perry
"Our success is a testament to the dedication and hard work of our team members." - Sarah, Co-Founder of Kymanox
"We're proud of the positive impact we've had on our industry and the communities we serve." - Stephen M. Perry
"As we celebrate 20 years in business, we're excited for the opportunities that lie ahead." - Sarah, Co-Founder of Kymanox
"At Kymanox, we don't just solve problems; we empower solutions." - Stephen M. Perry
"Our journey is not just about milestones; it's about the people who make each step possible." - Sarah, Co-Founder of Kymanox
Transcript:
Cee Cee Huffman - 00:00:04: Welcome to The Factor, a global medical device podcast series powered by Kymanox Today, we have a very special episode. As Kymanox is celebrating 20 years of business, we're talking to founders Stephen and Sarah Perry, as well as some of the key early employees. Get ready for a walk down memory lane as they reflect on the early days, successes and failures, and what it's been like to grow from a bootstrap idea to a 300-person company. I'm Cee Cee Huffman, your co-host for today's episode. I had the chance to go into the studio at Kymanox headquarters in RTP, North Carolina, and meet the team. First up is Stephen and Sarah Perry, founders of Kymanox. Stephen's background is in chemical engineering, where he has worked in the biopharma industry. It was there that he developed a passion for sciences and felt he could offer a unique service model for improvements.
Stephen Perry - 00:00:57: Kymanox actually was born out of frustration. After working all those years in life science, I really realized that There was a lot of bureaucracy, a lot of red tape, and the modern medicines that needed to get into the patient's hands was really being slowed down with extra expense, scheduled delays that are all very preventable. And so that's really what triggered me to start Kymanox.
Cee Cee Huffman - 00:01:24: And Sarah leveraged her background in finance and education to support building the team and early processes at Kymanox.
Sarah Perry - 00:01:32: So we actually interestingly started the very first employees, I think one and two were interns. My background was in higher education. And so I like to think at least that that played a small part in picking up some college students. We were close to Northwestern University, so we had access to some really high caliber students. And again, with the ideal knowledge transfer, it worked really well because they were young and eager to learn. And then it kind of just grew from there. I mean, I started at some point helping out on non-technical things. That's not my background at all. And then as the work became more and more interesting and complex, we were able to pull people over from larger companies. Some of the first hires of professionals actually came from Abbott, where Stephen had some contacts there. And then the financials, I think, you know, like most companies, it was slow to start, but it's really ramped up. And really exceeded, I think, any expectations. That at least I know for sure I had going into it. Stephen had pretty high expectations, but he's even exceeded, I think, his own expectations from the very beginning.
Stephen Perry - 00:02:37: Yeah, and I think we started out in our house, and we had two spare bedrooms. Those were the first two offices. Soon after that, we went over and we were in downtown Highland Park, which is in the state of Illinois. Just north of Chicago. And we got a really cute office above the pancake shop. We were right next to a famous Hollywood producer. So we felt like we were pretty cool. And of course, it was a 110 year old building. So nothing really worked in the building. It was kind of a good startup vibe. And then we expanded here to Research Triangle Park, North Carolina, and had a really humble office. Basically, 1,200 square feet is very humble beginnings. And I think that's a great way to start your company.
Sarah Perry - 00:03:23: Yeah, everything was bootstrapped, right? There was no... Influx of cash from anyone.
Stephen Perry - 00:03:29: Yeah, and I think that's an interesting thing. A lot of companies that start now, they understand that finance is the key to speed. And we did everything, tapping our savings accounts and just bootstrapping, using revenue from the company to invest back in the company.
Cee Cee Huffman - 00:03:45:And what was your vision for the company at that time? And how has that changed over the long term?
Stephen Perry - 00:03:53: Yeah, so the one thing is the vision really hasn't changed at all. We kind of have a cool vision statement. So right now it's dot, dot, dot because patients deserve better. And I think that sums it up very, very well. But, If you go back to the very beginning, our original corporate why or our corporate vision statement, it was basically the exact same thing. It was just a lot more wordy. So we basically, and this is one of the beauty of starting your own company, if it has a core foundation of... Purpose. Your company can last and you can get people behind it. And so that really has been unchanging all these years.
Sarah Perry - 00:04:36: If I might add just one quick thing, I think also from the beginning, Stephen's goal was to get to a point where he could be a force for good within the industry. And that's why the growth. Is a point of focus as well. Because if you're three people, there's only so much you can do. The broader reach that you have, the more you're able to influence how things are done and make sure that... Priorities are kept straight.
Cee Cee Huffman - 00:05:05: You've mentioned a few of the challenges of starting Kymanox but can you discuss some of the challenges you faced over the last 20 years?
Stephen Perry - 00:05:14: Sure. I think the biggest one, if you go back to the beginning, is just making payroll. So if you're in a bootstrap situation, you're managing cash, you have these people who believe in your vision and the purpose of the company. They've entrusted their future and their career development into the organization, and they expect a paycheck, and they expect to be paid on time. That money's got to be there, and that's got to flow. So I'd say payroll has been a challenge in the early years of Kymanox and now we're very strong financial backers behind Kymanox We have Westview Capital Partners, and then we have a really top-grade chief financial officer. His name is Tony Perry, no relation to Stephen and Sarah Perry. And that was just one challenge, but it's a big one. And it's something that literally for 17 years, I would stay up at night making sure we always had payroll secured.
Sarah Perry - 00:06:11: Yeah, and I would, not to just echo exactly what Stephen said, but also my background, as I mentioned, is higher education, specifically student financial aid. So I'm very familiar with some of the struggles and the emotions around finance from an exterior perspective. And so I will say yes, there were many sleepless nights, I think, on both of our parts. Employees have committed to be there and work for you. So you have this very overwhelming responsibility to ensure that they are financially whole. And that their needs are always met. And again, that can become a little bit of an emotional thing. That you want to make sure that people feel appreciated and understand that they are important. And that they are key in a lot of times, especially in a work situation, that comes through financially. And so that has been a big thing. And it maybe isn't the first thing that comes to mind, but I would say. That that was important.
Stephen Perry - 00:07:08: Yeah, and sometimes that meant taking a 401k loan, which you're really not supposed to be doing, hopefully. It also meant taking a second mortgage on your house, selling the brand new car that you just bought that you spent the last five years trying to pick out. Those kinds of things. The other thing, I think it was a challenge was when we were small, we were such a tight knit group. People wanted to stay at Kymanox but they had other opportunities outside of Kymanox And so when those people left, and they gave their professional two-week notice. Very traumatizing to the business. And it was like almost, it almost like, why, why are we doing this? Now, at 300 kind of global team members, people can kind of go in and out of the organization. We can have a turnover rate of less than 10%, which is phenomenal. But that still means that like 30 people can kind of move through the Kymanox doors every year and be really strong. So in those early years, any departures were really tough on the organization. And now that former struggle is almost, we're almost cheerleading to see people that have spent a few years at Kymanox and then take on a double promotion and are going to go work at one of our clients. And we get to kind of change roles with each other.
Cee Cee Huffman - 00:08:19: Fortunately, in the more recent years, Kymanox has expanded and grown, acquiring four companies. Can you talk to your reasoning behind these decisions and how you manage the process?
Stephen Perry - 00:08:30: Yeah, so there's a little known fact. It's actually six companies in the entire span of Kymanox. There's two M&A deals that happened very early in the organization. We picked up a company called Freedom Labs, and we also picked up a company called GMP Pence. Of course, these are way back in the archives, and you'll have to Google those things to find them. Recently, we decided that... Using other people's money was going to be a faster way to achieve our long-term ambitious goals. So bootstrapping was very noble, and we loved being fiscally responsible. But we realized it was a slow way to go. So when we did our recapitalization of the company in the summer of 2021, we did a tuck-in, and that was NUMA Engineering. And what it was is we took three other founders who had been working on that company for multiple years, and they had grown out a book of business. They had developed procedures. They developed a brand. They had really unique skill sets. They had a laboratory. And we could have simply invested money to build that ourselves. But it would have taken us about the same amount of time. So that acquisition in particular was like buying time. Another two acquisitions, we acquired a company in Germany and Switzerland. We thought about investing in our Luckenberg office, which we've now kind of closed down. And it was just a way to buy time. Instead of doing it organically, we could do it with merger acquisition and really just hyperspace to the future. And then we already were growing our human factors business organically. But we said, what do we want to do for the future and how fast we want to get there? And it turns out that most of the Kymanox people, they like to go fast. And so using capital, we were able to acquire Agilis. And now we are probably the second largest or even maybe the largest human factors organization in the world. And it's phenomenal. And we just wouldn't have been able to get there so quickly without finance.
Cee Cee Huffman - 00:10:38: Sarah, you decided to step away as an active leader at Kymanox in 2021. What was it like to transition away?
Sarah Perry - 00:10:46: Ooh, that's a good question. It was harder, I think, than I thought. We have a lot going on at home. And so that was really the crux of the decision, was to be able to focus on some of the things that we had in our personal lives. That quite honestly had been neglected for the focus on Kymanox. Not that it was like all consuming, but it was a big part of both of our lives. And so that allowed me to kind of manage the home. Um. So it has been nice for me to have a more singular focus at home. But I mostly, I do miss kind of the mental stimulation. I miss a lot of the connections that I have here. I miss seeing people. And honestly, I miss some of the connection with Stephen. Not connection, maybe, but that was like an additional thing that we had in common as well. So I would say, so those are some of the things that I miss. But I do still have the opportunity to come back and say hi and visit and participate in things like this. So it's been good overall. But, you know, definitely, you know, there are some things that I miss. But I do have a lot that I'm focused on.
Cee Cee Huffman - 00:11:54: Stephen, can you speak to your leadership journey now as a leader of a global company with 300 employees worldwide?
Stephen Perry - 00:12:01: Yeah, so one day I woke up and Kymanox is a global organization. Really, the last few years have been about empowerment. And it's like, how can I transfer my previous skills that I had? How can I transfer that? And then how can I really empower people to be the best versions of themselves in a really dynamic organization? And it's not even down to the employee level. It's really the other leaders in the company. So it's really I'm working on other leaders who are trying to do what I was doing just a couple of years ago. And what's phenomenal about Kymanox is some of our directors now at Kymanox have a lot more responsibility and a lot more impact to the industry than I had as CEO of Kymanox just a few years ago. So that's been a real blessing to see how the company has grown and then how we've dispersed decision making and leadership within the organization.
Cee Cee Huffman - 00:12:58: Why is empathy important to you as a leadership skill?
Stephen Perry - 00:13:03: Empathy is so important. I think the first thing you have to do if you're going to communicate with someone, you have to have a base understanding of where that person's at. And as a leader, you have to meet someone not where you're at. You have to meet them where they're at. And I think empathy helps you achieve that and then ultimately allows for clear, meaningful communication to occur. Once you have that. Possibilities are endless.
Cee Cee Huffman - 00:13:31: How do you stay on current industry trends as a leader?
Stephen Perry - 00:13:35: So I think like everybody else, I use Google Alerts. I look at multiple international news feeds. And I go to where I think the Democrats are getting their news. And I go there. I go to where the Republicans are getting their news. I go there. I go to where the independents are going to get their news. I really try to get orthogonal inputs in the digital space. But possibly the best thing is networking with other professionals that are maybe even not in the industry, but they're tangential to the industry. And so that I can get a better understanding of what the macroeconomic and socioeconomic and global geopolitical issues of the day that ultimately impact our business. So that's actually a big part of my job is understanding what current affairs are, where the opportunities are, what the trends are, both positive and negative. And it ultimately means a lot of reading, a lot of phone calls. And now that the pandemic's over, a lot of face-to-face meetings with people that I respect.
Cee Cee Huffman - 00:14:36: One of your personal motivators is wellness. How do you promote this lifestyle within such a large organization?
Stephen Perry - 00:14:43: So you just lead by example. For us, we want to make sure we give people a flexible work environment. So that's probably the number one thing you can do. If you tell people that they have to be in this cubicle on these days, these hours. You really are not. Potentially allowing them to accommodate their work into their life and vice versa. So really the wellness is kind of based on trust. And then you have to give people an opportunity to practice some of the things that you think are good practices. So make sure people have an opportunity for movement. So that might be taking some calls while you're walking around in the hallways or even outside. And if you put all those three things together, foundation of sleep, and movement throughout the day that you hopefully can be intentional with, and then feeding your body, not based on how you feel, but how you want to fuel your body, I think that's a recipe for wellness.
Cee Cee Huffman - 00:15:41: Speaking of caring, Sarah, what was the reasoning behind starting the program Kymanox Cares?
Sarah Perry - 00:15:15: So I think it had just been on my heart for a while that we needed to do something, especially as we were becoming more and more successful. And so at a town hall, I kind of just threw it out there without a whole lot of forethought or planning about the specifics of it. And I wasn't sure what would come of it. But before the meeting even was over, I had three different employees email me and say, I'm really interested. I'd love to meet with you. How can we take this forward? And so from that initial group. I kind of met with them and then, and then. Put it into a more official email. And sent that out and we started a group and we just started having meetings and kind of navigating where our heads were at. It had to be kind of a grassroots effort. It had to be everybody. Who wanted to be involved had some reason to be involved. So it really started with getting an understanding of what people really wanted to support and where they wanted to put time and energy and effort. And, um, So really, I kind of, you know, put it out there at the beginning, led the first, you know, six to 12 months worth of meetings. And then there were some natural leaders within the company that kind of rose to the top and really wanted to take it and run with it. And that was really the most appropriate way for it to grow was for other employees to kind of, take that and run with it. And I was still a big... A relatively... Involved party until I kind of left the company officially. So it was just really something that had been in. In my head and in my heart. For a while that we wanted to continue with. And then, like I said, these other employees really took the ball and ran with it. And it's incredible what is going on today with Kymanox Cares.
Cee Cee Huffman - 00:17:35: What is one of your favorite memories at Kymanox over the last 20 years? Stephen, we'll start with you.
Stephen Perry - 00:17:42: I think the memories are really packaged in the Kymanox annual meetings. So that's kind of like our punctuation, our exclamation point at the end of a year to really celebrate. And it kind of normally falls in the summertime. And by summer, we kind of know how our fiscal year is going to end. Our fiscal year ends September 30th. So it's a great way to kind of just inventory all the wins. And we've just had so many different people come as guest speakers. We've had different employees present. It's also a chance where we get to do recognition for our employees. And I would just say the best memories are probably the party that happens afterwards or sometimes before, depending on the agenda. And people really letting loose, having fun, and really enjoying their colleagues and the whole Kymanox experience. And really celebrating all the success that we have as a team. So those are probably... And that's, you know, we've got 19 of those and we'll have a 20th one coming up this summer. That for me, that's, those are my best memories.
Sarah Perry - 00:18:48: I would agree. I think the annual meeting is huge for this, really for the same reasons that Stephen said. There's it's it's a time where everybody's in the same place at the same time for the most part. It's also interesting to look back at some of the early ones. There's like three of us. And then, you know, look, look what it's become now. And even the venues and the events. I mean, it's been it's so different now than when we started, when we were so much smaller. And, you know. Less financially able to do what we can now. Another thing that I've enjoyed. Is the Christmas parties. So for several years, we hosted actually the Christmas party at our home, which was really fun and very intimate in a regard. And our kids loved it. I mean, every year. They would get out all the Christmas decorations, and they really put a lot of time and energy and thought into getting everything decorated. And they were so excited to meet everybody. And so that was also a fun thing for me. So I guess it kind of comes down to these out-of-work gatherings where you really get to – not understand – get to know the people that you're working with and that you're on this kind of journey with Kymanox together. I always learn something new about people and come to appreciate them just that much more when you understand where they're coming from and some of their personal story, too.
Stephen Perry - 00:19:45: So kind of the whole time spent growing. So every one of these annual meetings, it's like we're a different company every time we get together. And so that just like as a proud founder, not just the CEO, but the founder, just to see the organization grow every year. And then how my role has changed as a leader. So at the beginning, there was a lot of lecturing from Steven, right? And a lot of updates, like I was the CFO and I was the COO and I was the CEO. So all the updates were kind of coming from me. And my talking time was, I was probably talking more than half the time in the meeting. And then now I kind of just show up, I give an inspirational speech and then I get to watch all the people do all this amazing work that's now been delegated throughout the entire organization.
Cee Cee Huffman - 00:20:50: What do you see on the horizon for Kymanox over the next 20 years? Sarah, we'll start with you for this one.
Sarah Perry - 00:20:56: Oh, wow. Gosh, that's, I don't know. I'll probably go short and sweet with this one, but I think it's just going to continue to grow, probably not quite the trajectory it's been at just because we have. You know, grown so much, I feel like, relatively quickly already. But I just see Kymanox continuing to do this great work. And just growing and growing and doing more and more within the industry. And ideally, kind of setting a standard where... Patients aren't forgotten about. It can be easy, I think, to get caught up with your spreadsheet or your formula or your whatever it is. More minutely that you're working on individually. And I think that's something that has been really important to Stephen is keeping that. More global outlook. Like, what are we actually doing in the end? So I would love to see, as we grow, some of that influence other companies as well, where we're helping them.
Stephen Perry - 00:21:57: Yeah, and right now we're in the fourth era of Kymanox and it's called the professionalization area. So we're trying to professionalize the business. So this includes having a professional CPA finance person be your chief financial officer and having a dedicated finance office, for example. We now have dedicated HR leader with an HR office. Our talent acquisition, we have a talent acquisition manager who just, their only job is to bring in amazing talent into the organization. So we've professionalized the business. We're not done yet, so we have a little bit more work there. But once we're done professionalizing the business, it's going to be about scaling. And scaling is going to be growing what we've got, but also making sure that we're in all the different markets where we can have an impact. So I think we're going to expand in Europe, but Asia Pacific is going to be an area. South America will be an area. There's plenty of parts around the world where Kymanox doesn't have a physical presence that we're going to change that over 20 years. The other thing is, Kymanox has kind of been like the best kept secret in life science. And people kind of come to us through the good old boy network and referrals. And sometimes it's former employees that are really engaging Kymanox . And what I'm looking forward to is having an opportunity where Kymanox is on the forefront of everyone's mind in the boardroom when they're thinking about this next big program that's going to go into development and say, hey, we're not going to just call Kymanox because if we get in trouble, we're going to call Kymanox early and partner with this organization. Just like if you were going to have a really big project and you needed to transform, let's say, the central government's IT systems, you call Accenture. And everyone just knows, okay, you're going to call that company. That's, I think, in 20 years, we want to be right in that space where people think of us first and they think of us as the market leader.
Cee Cee Huffman - 00:23:49: What is the value differentiator for people to partner with Kymanox?
Stephen Perry - 00:23:53: Yeah, I wish I could say it's our intellectual property, these fancy software programs that we have, that we, you know... We have the algorithms that make everything work and that we just have the proven past performance, but it's really our dynamic people. And it's the interconnectedness of our people. And our people are really special. So most of the people at Kymanox are what we call T-shaped professionals. So that horizontal part of the T, that's kind of demonstrating how broad of interests they have. And the vertical part of the T, that's kind of like... Their ability to drill down on a topic, having the intellectual smarts to do so, but also the grit and discipline to stay with a subject matter and then become a subject matter expert across a variety of things. So we have a lot of these T-shaped professionals. They're very versatile. Now imagine talent stacking those into a team and then putting that together for a program that's trying to take something from the bench all the way to the patient. And it's really differentiating. So we're a people-based business. I think even with the advent of machine learning and AI and all the modernization that we're doing with our computer systems and our core IT infrastructure, it's really going to be the people delivering everything and putting these very special people in very... Well-curated teams, that's where the magic happens. And that's where I think Kymanox is differentiated. And that's why I think people come to Kymanox why they stay with Kymanox and then why we kind of outperform expectations.
Cee Cee Huffman - 00:25:40: Thank you, Stephen and Sarah, for sharing your Kymanox story. Next, Stephen sits down with employees that have been with him since the early years. First up is Mitchel Kevern. He's been with Kymanox for almost 12 years. Mitchel begins discussing his recent move from project management into regulatory affairs.
Mitchel Kevern - 00:25:59: Well, Stephen and I were chatting one time about my professional development and where I would go next. And I had a desire to be really closer to serving the patients.
Stephen Perry - 00:26:10: Yeah. Mitchel, do you remember some of the early submission work that we worked together on? Do you want to talk a little bit about that story?
Mitchel Kevern - 00:26:21: Absolutely. Yeah. .. was a product I touched just about every piece of, from drug, device, to packaging. I even wrote one of their early inventory management SOPs for the product. So I had become an expert on this product and still may be one of the people who knows more about it than anybody else in the world. But I had the opportunity to write some of the early device documentation. So when the opportunity came up for us to write their 32R section for their BLA. And I'd say this is one of the things that Kymanox sells at most is we kind of coupled together a couple of members of the team, expert in regulatory, and really hit it out of the park product. Ended up getting approved and being on the market and serving on orphan and orphan indication. So it really, really meant a lot to get it out there in the market. And I think it was my first product approval. So that was exciting.
Stephen Perry - 00:27:09: Yeah, and if you remember, after those two marketed products made it through FDA approval, so we got to also see kind of a startup go all the way through their full vision realization to be acquired by a big pharma company. And we got to see the impact on all of our colleagues that we were supporting at the time. And so I think, Mitchel, now that we have the Kymanox hyper-virtual model, I mean, I think I'm hoping we get to live that out many, many more times over the next 20 years in Kymanox future.
Mitchel Kevern - 00:27:46: Absolutely. I think that's one of the special things about Kymanox We can bolt on what our client needs at the right time and then switch it around when the environment changes.
Stephen Perry - 00:27:55: Yeah, so Mitchel, I'm a big fan of you being in our regulatory affairs group. I think you're a real differentiated person, a really special talent. And one of the reasons I think you're special is your engineering background. And you have two, you know, you have your undergrad engineering, but you also have your master's in engineering management. Could you talk a little bit about how your engineering and engineering management degrees and that background actually gives you an edge in the regulatory affairs practice area?
Mitchel Kevern - 00:28:24: Sure. Yeah, absolutely. So I guess, yeah, starting with my chemical engineering background right now, more than I had in the recent career, I'm working in the science, in the weeds of why this product is effective and needed to convince the FDA about that as well as, yeah, why it works. It works well, why it's reliable enough. So the engineering, tactical education is absolutely critical in that, which is one of the reasons I've really enjoyed the switch to regulatory. From the engineering management side, being able to advise on regulatory strategy. So seeing long term all the pieces fit together and and knowing how predecessor relationships work, key milestones, reporting on those, just really ensuring success of a program. I think that that background in project management that I got from my engineering program, engineering management program. Really, it's been, yeah, instrumental in being able to succeed in this new role. And then now as Kymanox grows, I'm also able to use that project management experience in our internal group to ensure that, yeah, we're organized in our portfolio of work and have the, our project managers have the regulatory specific tools that they need for all of our projects to succeed.
Stephen Perry - 00:29:48: Yeah, and now we have a lot of tools that are getting quite sophisticated. We're also trying to put machine learning and AI into those tools to really help us do our job better and faster. The other thing, Mitchel, and we've had this conversation before, but I feel like the chemical engineering background and then the master's of engineering management. It gives you like this really strong base in science and all the technical sides of things so that you can really understand the molecule and how the molecule interacts with the manufacturing process and then how ultimately the molecule interacts with the patient. And because we have that deep understanding as chemical engineers, I think it gives us better context to really interpret what the rules and regulations are that the FDA is trying to enforce and hopefully find the best regulatory roadmap and pathway to product approval. The other thing, Mitchel, and we've had this conversation before, but I feel like the chemical engineering background and then the master's of engineering management. It gives you like this really strong base in science and all the technical sides of things so that you can really understand the molecule and how the molecule interacts with the manufacturing process and then how ultimately the molecule interacts with the patient. And because we have that deep understanding as chemical engineers, I think it gives us better context to really interpret what the rules and regulations are that the FDA is trying to enforce and hopefully find the best regulatory roadmap and pathway to product approval. And I think rather than just memorizing the regulations, which is, I think, a part of being a great regulatory professional, I think having contextualized understanding of the product itself and the ultimate benefit to the patient, as well as the risks to the patient, I think that's really what differentiates Kymanox And I think we're one of the few organizations in the world that has half of the regulatory senior advisors with that type of degree.
Mitchel Kevern - 00:31:10: Completely agree. Yeah, it's been instrumental in multiple of the recent projects that I've had. We have to convince FDA how these specific analyses will demonstrate that our product is equivalent to whatever else is on the market. So we can we can get approved and get whatever necessary bio waivers we need to ensure that our product gets gets approved quickly enough and gets those patients sooner, sooner rather than later.
Stephen Perry - 00:31:41: Yeah, and I think our team on the regulatory side, we're really good at anticipating the data that the FDA is going to need in order to make a decision. And at the end of the day, FDA, it's two things. One, it's a science-based organization, and then its charter is to protect the human health of the American population. And so if you put those two things together, if we can anticipate all the data that's going to be necessary for the FDA to make a good, sound decision, we can prescribe all the studies, get those studies summarized, and have a submission that's complete right first time that gets reviewed. Maybe you get a couple of questions, but it goes all the way to approval in one swoop rather than having to find out that you're missing data and you have to go back and do studies and you get delays in your programs. So. Mitchel, the reason I started Kymanox is so that that doesn't happen. So please continue to do your amazing work in the regulatory group and help our clients bring these products from bench to patient right first time.
Cee Cee Huffman - 00:32:51: Thanks, Mitchel . Next up is Akshay Nadkarni. His path to Kymanox reflects his academic curiosity and hands-on interests. With a background in biomedical engineering, he studied drug delivery mechanisms, later transitioning to focus on downstream process development of biologics during his master's. Finishing his master's. He started at Kymanox in 2014.
Akshay Nadkarni - 00:33:15: When I graduated, Kymanox was probably about eight people, ten people. I mean, much, much smaller company than it is today. But I could already see the types of work that Kymanox was doing then and kind of giving me that opportunity to explore regulatory quality, participating in audits, things like that. And I thought, you know, this is a great place for me to just look at all aspects of product development. So that was what originally brought me to Kymanox in 2014. Why I left, and I think that was probably around 2016, I think Kymanox. That version of Kymanox we specialize in very specific areas when we help clients, but we never got to see the full picture from start to finish. We would get brought in to help develop a column lifecycle protocol and execute that, but then we would never see anything beyond that or help audit a supplier, but then never really see how that supplier's material got used in the overall production of the med device. So I left to go work at actually one of Kymanox partners at the time. We had helped qualify some process equipment and then ultimately manufactured GLP Tox material. I really wanted to see what happened to that product after GLP-TOX, when it went into the clinic and how it performed there. So I kind of wanted to get that experience a little bit. What brought me back was I realized that Kymanox as they grew larger from 10 people to 30 people, 60 people, now over 200 people, Kymanox now offers that too. If you look at the work we're doing with similar companies, we are starting at the very beginning with concept and helping them all the way through to commercialization. There's really no need to go outside of Kymanox to get that experience anymore. You get to see from start to finish the entire product development cycle, which I think is really cool.
Stephen Perry - 00:35:02: Yeah, I think Akshay got to see all the eras of Kymanox The Kymanox 1.0 era, the 2.0 era, 3.0, and then now we're in the fourth era, the Kymanox 4.0. He's really been a part of all of those eras. It's nice to have someone other than Kevin Brown who knows what it's like to evolve as a business. And then just recently at JP Morgan, we rolled out our hyper-virtual model. So, it's these amazing companies that have spectacular intellectual property. They're well-backed by VCs, or they're going to be well-backed by VCs and already well-funded from the seed capital standpoint. Then they're completely powered by Kymanox It's the three guys in a molecule and then Kymanox behind the curtain doing everything. Those are going to be clients that are potentially going to have 10-year relationships. We're going to be able to see from, you know, the earliest preclinical work, all the way to post-market support on these clients. Akshay's an enabler in there. He's now running our project management office. Akshay, do you want to talk a little bit about the different jobs you've had at Kymanox
Akshay Nadkarni - 00:36:15: Yeah. I think I started as a process engineer. Again, really in my specialty zone of downstream process development. I think I moved into med device and combo product development. After that as more of an engineer in that space. And we helped develop a lot of meter dose. Device aids and things like that. And then transitioned more into the PMO. Even under the PMO, you get to participate both on a project management standpoint and a technical standpoint in so many different types of work. I've been the tech lead on a post-market complaints program. I've helped install and qualify spray-dried biologics processing equipment into a new facility. It's really a lot of different hats, I would say, over the years.
Stephen Perry - 00:37:01: Yeah, and it's just to see you. I'm sure as an executive, your technical chops have always just been phenomenal. But now to see you take some of the business learnings and then incorporate the business into the technical, can you talk a little bit about that journey?
Akshay Nadkarni - 00:37:16: Yeah. I think as Kymanox grows, I remember how we used to do things when we were eight or ten people. Our entire resourcing, looking at utilization, finance review, that was all a weekly staff meeting that lasted about an hour. And now, given the size and scale that we are, we have tons of different interconnected systems. But I think the real value in how you use those systems is, do we actually take a step back, look at the data that we're generating on a regular basis, and then make decisions based on the data, not just based on how we may feel about something or partial information? So really, my role is kind of also involved as part of the PMO in developing processes that take a look at that data and then facilitate those decisions with other key stakeholders within the company. So we can point to things like project intake team as one of those processes that have worked really well. That's our process for building RMT objects based on proposals in Salesforce and then allocating them with the best people for those roles. We're starting to kind of spin off similar processes like that that look at projects we've recently closed out. What are we doing with the lessons learned and client feedback that we're getting from those? How do we take that data, analyze it, and then influence future projects that we use? So there are a few other examples that we're trying to kick off similar to that later this year that I think will really help how the company does business overall.
Stephen Perry - 00:38:39: Yeah, and it's great to see you interfacing with our chief operations officer, our finance team, all of our technical functional leads, and just really putting that all together and make it work in harmony. As well as our account managers and business development professionals on the sales side of the organization. Everything kind of like all roads go to the PMO pretty much. And so having somebody who really understands Kymanox at its core is a phenomenal advantage to the business.
Akshay Nadkarni - 00:39:12: Yeah, and I think that's the key, right? Like all aspects of the company need to communicate with each other for things to work as efficiently as possible. And I think everyone's really great in that they're always open, they're always willing to communicate and kind of hear that feedback or take things into account when somebody's coming to them and telling them, like, hey, this is what we're hearing from the clients. Can we maybe tweak our sales approach to go this way? And I think that's always been a really productive conversation. We've seen a lot of rewards from that, too. So, yeah, I know it's a really interesting role, and I'm glad to kind of be able to have the opportunity to contribute in that manner.
Stephen Perry - 00:39:46: Yeah, and Akshay's one of those T-shaped professionals that we talked about earlier, and he could really be leading development, for example. He could be leading the CMC group. He could be leading the project manager office, which is what his current role is. And then we've learned he's phenomenal with sales. I mean, so if he's in front of a client describing how we're going to pull together the solution architecture to solve a client's problem, he's really gifted in that area. So it's really great to see all the opportunities that Akshay has, but then also leverage those opportunities in his current role by bringing people together. And I think what separates us from being a high-performing organization that is bringing drugs through the development process very quickly and right first time is we have our functions, and we have our swim lanes, and people stay in their swim lanes, but we're talking to each other. And if you think about project management, as a profession, it's almost 75% communication.
Akshay Nadkarni - 00:40:21: Yeah. And that's really the trick, right? As we scale up, those same conversations that we were having in 2014 when we were a 10-person company around the table, how do we recreate that but now at a company of 200 people or 300 people or 500 people as we continue to grow? So putting those systems in place is really something I'm excited to keep working on over the next few months.
Cee Cee Huffman - 00:41:09: Thank you, Akshay. Next up is Kevin Brown, Vice President of Accounts. Kevin, who has been with Kymanox for over 15 years, started out in a different industry. He and Stephen's paths have crossed since college.
Kevin Brown - 00:41:24: I started out in the IT consulting business. So I was a software developer for a consulting firm for several years. Right after college, Stephen and I actually attended college together, and that's how we know each other. And Stephen... About four years into Kymanox. Decided that he wanted to look at an IT angle and look at maybe developing some software to help the industry. And so we decided we would collaborate on a software platform. So we built something prior to me being a full-time employee, and that was called ChimaPro. And it was a software to support projects for Kymanox and our clients. And it was an online platform where people could upload. Files that pertain to a project and it was like, you know, SSL secured and really, really cool for the time. Cause this was back what, 2004 or five, something like that. 2006 maybe. So yeah. So it was still kind of the infancy of sharing stuff online.
Stephen Perry - 00:42:31: Yeah, and that's when SharePoint was coming out. And so SharePoint was like a highly configurable system. You almost needed like a whole department of IT people to like manage your SharePoint site. So it's definitely not user-friendly. So the nickname was HoardPoint, like you're hoarding your files because no one can actually share the files. And then there was a company called ShareFile. That started up right around the same time. And so we felt like this was going to be like, you know, Mark Zuckerberg story again, right? Where, you know, we're we're going to be the next Facebook. And this is like when Facebook was starting off. This is when LinkedIn was starting up and we felt like. We were like the two guys in Silicon Valley in the garage, but we were in the Chicago suburbs.
Kevin Brown - 00:43:13: Yeah, so we got together, we put that software out there, did pretty well, and then we got to the point where we were like, okay, maybe I'll come on full-time. So that was December 1st, 2008 was my first day, and it actually, as we were mentioning earlier, we were worried about insurance because my twins were due. My wife was having twins, and that was...Right around the same time I was going to start for Kymanox So we, we decided, okay, we're going to like overlap my, my, um, exit time from my previous job and, and my, uh, start date for Kymanox And it turned out that, uh, I went in and, you know, told my boss I was going to quit from the old job and he was really great about it. And, um, and then I, you know, we said, okay, well, this will be my first day at Kymanox you know, just to make sure we could overlap the insurance coverage well. And then, uh, my wife calls and says, oh, I'm going to the hospital. I've got like a swollen foot and they want me to come in and make, take a look at it. And then she wound up having the twins that day. So my first day at Kymanox was also the birth date of my twins. So it was, uh, it was pretty crazy, but, um, Yeah, I've done a lot at Kymanox since then. Did a lot of IT work for several years, got involved in software consulting in the biotech space as far as helping our clients with validating their software. Then I transitioned from there into more project management, got my project management professional certification. Did that for several years and then kind of went back to my roots, which was my degree was in management information systems, which is really like using computers to manage your business. And at the time, we were growing enough where Stephen said to me, hey, we're having trouble with this new software that we're trying to implement for running the business, which was NetSuite. And can you take a look at this and see if you can make this work? So that's where I wound up in. Kind of managing that, doing more accounting stuff, which was a little different.
Stephen Perry - 00:45:19: That was like when you were general manager.
Kevin Brown - 00:45:21: Yeah. And then I went into the general manager job, did that for a while. And then after that, transitioned into account management. And just by virtue of the fact that I had met so many of our clients and I knew a lot of them pretty well. And so it just made a lot of sense for me to look at account management as the next step in my career. So yeah, over the last 15 years, those have been kind of a few of the stops that I've made with Kymanox And it's been very rewarding to see the company grow and expand and getting to do lots of different things here.
Stephen Perry - 00:45:55: Yeah, and I think Kevin came in as a Vice President. And even today, 20 years of all this growth, we have very few people at the VP level at Kymanox. And he's really like a business partner. And then even one of the things when we were starting the company, we said, we need to explain what this Kymanox is. It means ideal knowledge transfer. Well, what is ideal knowledge transfer? So we created a step-by-step procedure called a SOP, standard operating procedure. We created a theory and background presentation like in PowerPoint that really went. For one particular topic into great depths to really understand all the scientific and engineering and history behind things. And then a video, an illustration video. And what we wanted to do is like manufacturing some really cool biologic, right? That would be cool. And it turns out like all of that was proprietary. We couldn't borrow clients' information. So literally Kevin was at my house when we were videotaping us making popcorn. And so the drug was popcorn. And we made that the manufacturing process. And to this day, you can go to the Kymanox website or you can go to YouTube and watch this video. And Kevin's literally in the background and helped with the editing of the video and things like that.
Kevin Brown - 00:47:10: I remember that well.
Stephen Perry - 00:47:11: And that was before you were an employee, but you got this. And that was even before Kymanox even had our website.
Kevin Brown - 00:47:15: Yeah, I think we were picking the name at one point, too, around the same time. And you were like, hey, what do you think about these three? But I don't even remember what the other two were. Do you remember the other two names?
Stephen Perry - 00:47:24: Oh, yeah.
Kevin Brown - 00:47:28: So it's pretty funny to think back then. Yeah, it's been a long time.
Stephen Perry - 00:47:32: Yeah.
Cee Cee Huffman - 00:47:38: Thanks, Kevin. Finally, we have Michelle Frakes, Senior Director of Business Solutions and Marketing. Michelle has been with Kymanox for almost six years, starting in the early years of hypergrowth as a process engineer and then expanding her talents into business development and marketing.
Michelle Frakes - 00:47:55: I started at Kymanox in April of 2018. Kymanox was a little over 40. People large at the time. And I started as a senior process engineer. Um, However, I have one of those personalities where I like to do multiple things and wear multiple hats. So when the opportunity came about where they needed more sales support, I jumped in. And sent an email to Stephen and said, hey, I'd love to support this area. I really enjoy marketing. I really enjoy sales. Is there some availability? And he happily allowed me to pursue that path and sort of paved my way within the company.
Stephen Perry - 00:48:35: Yeah, and I remember just having someone with that PhD-level engineering background who had meticulous attention to detail to look at our information sheets. So these information sheets are these little two-sided summaries of all of our core capabilities and stepwise going through every capability, updating the old ones to a new format, but then also refreshing all the language. And then because I was in charge, there were a lot of missing info sheets. And so Michelle would grab myself and a subject matter expert, and we would sit in a room for hours and decide what content would go in there. And Michelle used her artistic mind as well as her technical mind and her communication. Michelle's actually a phenomenal project manager amongst her other amazing talents. And having that all kind of come together in one product. And I think we're still using those info sheets to this day.
Michelle Frakes - 00:49:36: We are. We are. And it has expanded since then. So it started with some information sheets, and then it rolled into proposals, working with proposals, working on our CRM system and stuff like that, and it's sort of evolved over the years. And so now I have a small team under me. Which Stephen has supported the growth of, and also improved my management and leadership. So it's been a nice journey and ride to see how the company has grown as well as my career has been able to grow. Within a growing company.
Stephen Perry - 00:50:05: Yeah. So I'm a little bit of a perfectionist. That's probably one of the things that maybe holds me back as a leader. So having Michelle at my side and being able to hand over things that needed to be hand over, like proposal writing, to actually hand it over and watch someone do it better than you could do it. And so that was like a really freeing thing for me as a leader to have someone like Michelle at my side. And I could delegate to Michelle and know that it was going to get done faster, better, and with certainly more artistic flair than I could ever dream of.
Michelle Frakes - 00:50:23: And it's been fun to be able to develop a department and develop a team. So that kind of fits with what the company needs as well as maybe. My vision for my own growth and where I want to go with my career. So it's nice to be able to work with a company that allows you to kind of spread your wings a little bit. And broaden your own expertise and things like that. So Stephen's been very supportive of that. And I've seen it not only within my group, but in other groups as well.
Stephen Perry - 00:51:08: Yeah, and Michelle, I think when I interviewed her, she was at another company that was a really great technology company, but she wasn't even working full-time. She's a busy mom. And so to me, to get behind a working mom and kind of get her back into a full-time, like high-performance role, that was something that I was really excited about. I feel like sometimes moms who are returning to the workforce full-time, full-force, they're kind of a forgotten part of the workforce. And so Michelle basically has paved the way for so many moms at Kymanox because not only is she a fantastic wife and mother to her children, but she's a fantastic executor of work and is now doing quite a bit of leadership. Originally, it was leadership on projects, but now it's leading people. And leading a lot of core functions at Kymanox and then paving the way for all of our working moms at Kymanox which is quite a few now.
Michelle Frakes - 00:52:07: Yeah, and I have a couple, you know. Seeing several people come through with new children and stuff like that. And it's great to see them be able to work. And be able to raise their children and not always have to step aside and stuff like that. So it's nice to be in a company that supports that environment.
Stephen Perry - 00:52:25: Yeah, and I think we talked about flexibility being key for success at Kymanox So Michelle lived just down the road from me in the Cary Apex area, which is a popular suburban area here in the Raleigh-Durham area. And then her family situation required her to move to Charlotte, which is a decent ways away. And the company made that accommodation with no issues. And then she adapted her work style, her communication style, to be mostly remote. And it worked out, certainly, I think, really, really well for everyone. And I think I'm proud to be able to offer that flexibility and then see our people just execute it flawlessly.
Michelle Frakes - 00:53:05: Yeah, it's nice to be able to work remote, be there for the children and stuff like that, still be able to. Be a career mom, not only to be a model for my children, but for the people I'm working with as well. And it's been fun. It's been fun. I enjoy being there at home. To see the children when they're there and stuff like that. I do miss out on a lot of the office environment, so I do try to come back a lot. Once a month. To meet with my team and meet with the leaders here and stuff like that. Because I don't want to lose those connections, which you can only get in person. I like the flexibility. Makes it for a more enjoyable day.
Stephen Perry - 00:53:44: Yeah, and I think for other leaders out there, you can offer that flexibility, but you can also maintain very high performance. So just because we have flexible work times and work hours and you can take unlimited vacation and you can start your day at 10 AM. If you don't have a critical client meeting before then, but it doesn't mean we're not working hard. We work our butts off and we are signing up for stretch goals almost all the time. And I think Michelle really exemplifies that. I mean, her life is as busy as anyone at Kymanox But she finds time to work on deliverables, hit deadlines, help other people hit deadlines. So I think like a message for everyone out there is you can offer amazing flexibility and still harvest the best performance in the industry.
Michelle Frakes - 00:54:31: Thank you. Thank you, Stephen. And I have one goal left that I'm still going to do before I leave here, and it's one of my favorite memories of Kymanox to ring the gong, and I'm going to ring the gong one day.
Stephen Perry - 00:54:41: Yes, yes.
Michelle Frakes - 00:54:43: I think that was one of my first memories when I came in through the door. I was like, why is there a gong here? I love to see that it's still here. And that you can still hear it being rung when somebody makes a great accomplishment or a big sale. Or meets a big goal.
Stephen Perry - 00:54:58: Yeah, and I think Michelle appreciates those things. So it's like we have these, in our boardroom, we have this giant handmade Chinese wind gong and we ring it for two reasons. One is to celebrate the winds in life. If you don't celebrate right away too, you may never celebrate it. So it's like, hey, did something amazing happen? Is it your first day at work? Did you just have a baby? Did you just close on your first house? Okay, let's bring the gong. And it can be for personal reasons or for professional reasons. Sometimes we have someone get their first million dollar scope of work sold. And so that's a great reason to ring the gong. But it's also there to remind us that we're in the West. Sometimes we're trapped in Western thinking and the gong is an Asian, it's an Eastern thinking process. Inside the Japanese boardroom, they make decisions based on 100 year outcomes to the business, which is why it takes them a long time to deliberate. The Chinese, they actually make decisions based on the impact to the seventh generation, that's almost 250 years. I think like in America, like with these publicly traded companies, it's like they make decisions based on the impact to next quarter. So it's a reminder to celebrate the wins, but also to think long-term.
Cee Cee Huffman - 00:56:15: Thank you, Michelle, and thank you everyone who participated. We hope you enjoyed this look back at the last 20 years of Kymanox But before we go, I had to ask Stephen, how did you come up with the name Kymanox.
Stephen Perry - 00:56:28: So Kymanox is an interesting name. I think my dad gave me a hard time. He says it sounds like a drug to treat dysentery. And what it was is I wanted to have a unique name that when you Googled it, it was the only instance in the entire world. At the time, I was studying Greek philosophy. And so I was really into these Greek philosophers. And I was studying a little bit of the Greek language. So I came up with two words that really meant ideal knowledge transfer, which is what the company was really going to be about. That was going to be what the corporate DNA was. You can think of ideal knowledge transfer as It's basically like teaching and learning. And so the two words are kaima or Kyma, and that means wave in Greek. And then the other word is Gnosis, and that means knowledge. So in Greek, it means wave knowledge. And then I've kind of modernized it. So I took Gnosis, turned it into Knox, made it look more like a cool biotech company name. And what was beautiful is that domain name was available. And even today, 20 years later, you can Google Kymanox, and the only thing that pops up is our company.
Cee Cee Huffman - 00:57:50: All right, everyone. Thanks for tuning in. For more information on what Kymanox offers, visit kymanox.com. . This episode was edited and produced by EarFluence. I'm Cee Cee Huffman , and we'll talk to you again soon on The Factor.
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