Innovating Patient-Centric Healthcare: A Conversation with Stephen M. Perry
Memorable Quotes:
"Delivering high volume subcutaneous medicines opens up a whole new world. The shift to home-based therapies enhances patient dignity and removes the anxiety of clinic visits." - Stephen M. Perry
"Kymanox aims to be an end-to-end life science solutions provider, replacing up to 50 traditional suppliers in the ecosystem, fostering a culture of collaboration and interconnectedness." - Stephen M. Perry
"Innovation requires collaboration, hard work, and perseverance. There are no shortcuts. Patients deserve better, and the industry should continue to innovate to meet their needs." - Stephen M. Perry
Transcript:
Announcer - 00:00:03: Welcome to The Factor, a global medical device podcast series powered by Agilis by Kymanox. Today, we're back for part two of our conversation with Stephen M. Perry, founder and CEO of Kymanox, and Shannon Hoste, Vice President of Human Factors Engineering at Agilis by Kymanox. Recently, Stephen delivered the keynote address at the 2023 Universe of Pre-Filled Syringes and Injection Devices Conference. That address? “The Inspiring Evolution of Parenteral Combination Products from 2004 to Today from an Entrepreneurial Perspective and a Peek at What is Coming.” So the thing that Stephen noted in part one is that tracking the evolution of insulin and what innovation is next can offer a glimpse into what is coming. Here's Shannon.
Shannon - 00:00:49: Some of the discussion we're having today builds on your presentation, your keynote. At PDA, you presented on, you know, the history and then also kind of looking forward. What are we what are we seeing and what are the opportunities that lay in front of us? And so I really appreciate some of this discussion here. I think even dives a little bit deeper into the future, the future opportunities that we have.
Stephen - 00:01:15: Yeah, and I think, like you mentioned, that move from the hospital to the home setting you know, moving from an IV formulation to a subcutaneous formulation, that's driving a lot of innovation. It's driving a lot of value for the healthcare system and for patients. And we're seeing more and more high volume subcutaneous medicines be developed. And it's kind of shocking how much you can deliver under the skin. It's, you know, it's almost, you know, people are talking like, okay, two mLs. Can we do it? Okay, can we do five? I mean, there are talks of like 10, 20, you know, if you deliver it slow enough. So that really opens up a whole new world. And what's great is like these cancer patients that have to go to the hospital, they're called like death rooms. That's what the cancer patients call them. And everyone's sitting in a chair and they're getting their chemotherapy infusion. But now you can do that either in the doctor's office in a couple of minutes, or you can theoretically bring that home. And do that around your support system and with your own dignity kind of intact. So that I think I'm really excited about having more and more therapies home. Also like, you take grandma out to the clinic to get her infusion or her medicine and What happens? Oh, Grandma trips on the curb and falls. Or they go into the doctor's office with all these other sick people and they catch a cold or a flu or a Covid-19 or whatever it may be. And it's, it's really adds, like it takes away from the benefit of, of, the medicine administration. So by doing it at home, it creates also just the mental health considerations, the anxiety of going to a clinic or a doctor's office or a hospital. You can remove that. So that whole moving from the hospital to the home is a wonderful revolution. And there's a ton of innovation happening to support that. And I'm
Shannon - 00:03:23: Really excited about that. Yeah, I absolutely agree. If you don't mind, if I digress a little bit, I have a personal story on this front. My mother had a common variable immunodeficiency. So somewhere in her forties, her body stopped producing IgG. So what would happen, and luckily this was diagnosed in the late 80s, early 90s. And so because of the immunology research going on around the AIDS epidemic at the time, you know, they were able to diagnose it. Had it been five, 10 years earlier, they probably would have never been able to identify it. But what she had to do from that point forward was every three weeks she had to go into an infusion clinic and get an IgG infusion, a gamma globulin infusion, because her levels had dropped back down to single digits. And so she would get her infusion and then three weeks later she'd go back in. The challenge is a hospital is the last place you want to be when your immune system is shut down. And then to go back every three weeks in that scenario. And exactly what you said, as she got older, she became more frail. And so now it's January in Ohio and she's going to the clinic and she falls and shears her arm. Right. You know, this journey of hers is, and my support of it. Has really been what's led me in my career direction and why I'm so passionate about this field. But this specific move from clinic to home for those, you know, for post cancer treatments, you know, any immune compromised and people in her situation, if she could move to subcutaneous in-home infusions, just takes out so much risk from her life, right? Her quality of life. And so it's, it's good to see the evolution in there. And I'm, I'm hoping for, for many, many patients you know, we're creating a landscape that is, a higher quality of life.
Stephen - 00:05:28: Yeah, so... Probably well more than 10 years before the Institute of Medicine's report on to air is human, which exposed all these medical error. Deaths happening in the hospital setting, for example, which was really shocking. I knew that. Why? Because I grew up in a household with a life science executive. My dad worked at Abbott and as little as I can remember, my dad would tell me, If you want to die, go to the hospital. So, I mean, I've been trying to get medicine in the home for as long as I can remember. And it's kind of just ingrained in my thinking. And I do think it's true. I think you can really reduce the medical errors and just all the anxiety, all the transportation issues, logistics. I mean, just logistics issues. Because think of how hard it is on the family of the person who's getting the treatment. You kind of have to coordinate with the phone calls. And it's almost like a carpooling situation, right? So you can solve all that with bringing the medicine.
Shannon - 00:06:47: Absolutely. What was your vision for Kymanox back in the beginning?
Stephen - 00:06:51: Yeah. So back then it was meant to be a very different type of company. And it was really born out of frustration. So I kind of saw how big pharma was working, how small biotech was working. I got exposure to genomics. Which is all the cell and gene therapy stuff that we see now today. And I just felt like there was a better way. And so, Shannon, if you've worked with me a little bit, I'm a little bit impetuous. I kind of like to go fast and like, you know, let's just do this. Like, why can't we have these things now today? And pushing the envelope. And I just knew that we probably needed a different way of doing that. And so, Kymanox is really now like this end-to-end A to Z life science solutions provider where probably can replace maybe up to 50 traditional suppliers in the ecosystem. And we don't have our own manufacturing facility. It's not like we're running big clinical trials and things like that. So those parts of the system still need to, kind of exists. But anything related to science, anything related to engineering, anything related to technology, quality and compliance, and anything that requires project and program management, Kymanox has it all under one umbrella and it's to go fast and to do it right the first time and hit both of those things together. And I think that was kind of the big idea and my big passion for starting Kymanox.
Shannon - 00:08:23: Yeah. To make a difference in healthcare. So, we talked about some of the bigger issues we're seeing coming up and some of the challenges in front of us. What are you doing at Kymanox to to prepare to support those?
Stephen - 00:08:40: Yeah, so one is we've got to keep, we have to make sure we maintain a really well-rounded organization, and it's difficult. So we're now a 300-person global company, And the natural progression of a business as it goes, say, above 300 is you start to get specialties. So you have specialists that just focus in on one thing. And that could be what unravels, Kymanox's massive value proposition. So what I'm really passionate about is letting that happen naturally. So let people move into more specialist roles, but have the company be even more interconnected. And so I think the best way that is culture is make sure as a company, as a culture that we feel connected, that we feel like we can just pick up the phone and call anybody and say, Hey, I mean, I've only met this person once, but I'm in a jam and I know this person is the resident expert at Kymanox and that we can move fast. Because if we, if we have to ask permission and move slowly, the entire value proposition at Kymanox kind of goes away. And then I think like turning on these amazing tools, I know AI is a little scary, but I think AI could really allow us to share our knowledge, both not just with inside the organization, but also share our knowledge with our clients in a really, fast, efficient manner. Of course, we will do that in a responsible and very supervised way. So those are the kinds of things I'm thinking about right now. And so we talked about Shannon, the T-shaped professional that really is the hallmark of Kymanox. And this is somebody who's got a really wide range of interests, but has the academic ability, has the grit and determination to be able to study one particular thing and kind of really drill down quickly on a topic and be able to hang with the PhDs on that particular topic. And then once that problem is solved, boom, they're back up again and onto the next thing. And we're still going to require some specialists, but I think I would hope that a majority of the people that we recruit and develop as an organization are these T-shaped professionals, which is you kind of have it all. You're well-rounded, but then when necessary, you can buckle up and drill down on a topic real deep, real fast. Yeah.
Shannon - 00:10:58: Yeah, and I have to say, Stephen, from being Agilis, became part of Kymanox earlier this year on March of 2023. What I'm seeing, as you said, with growth, there comes changes and growing pains. But what I see being a leader of a bit of a specialist group of human factors is, is exactly what you were mentioning. It's the culture of collaboration and the T-shaped individuals. So people that are all dedicated and working towards the common vision, their current why is because patients deserve better. And I see that resonating across the folks that I have a chance to work with at Kymanox. And I think that shared mission and the T-shaped individuals, as you said, builds that culture of collaboration. And I just see that growing with the organization. And I'm excited to see that expand over to the larger group of individuals. I mean, I see that in human factors. I have folks that have and do work on post-market surveillance as well as supporting human factors projects or CMC and regulatory and other areas.
Stephen - 00:12:11: Yeah, and they may get pulled on some hairy design history file that we have to remediate. And they probably could do a great job. So I think the other thing that as a leader of the company, I'm trying to make sure people have the confidence in themselves. So believe in yourself. You got here at Kymanox. You're special. But then believe in the system. The system works. And the system's really... Built on know what you know and know what you don't know. And when you don't know it, don't give up. That's when you ask for help. So that's when the colleagues come in and provide the guidance or the answers as required. And so it's great to see sometimes how we start out with a very specific human factors question from a particular client on a specific project. And then next thing you know, we're doing a particulate matter investigation on their drug substance. It's like, how did we get there? Right. And it's just like the next thing. So I love it when, you know, the CMC and clinical worlds combine. I love it when the science and engineering worlds combine. When the regulatory world gets involved, it's great. And human factors are a great example of a lot of things colliding. And it's usually high consequences because people are trying to get these studies approved so that they can file their submission to get their product reviewed and approved by the FDA or whatever the global regulatory authority is. And it's a lot of things because at the end of the day, the people that you're evaluating are using the product. And it's a culmination of a lot of work.
Shannon - 00:13:53: So I think this... The spirit of collaboration is also the foundation of PDA. As you go to these conferences, you see that cross-disciplinary presentations and conversations. The energy at these conferences, at the pre-filled syringe conference, was amazing. To hear all of the conversations going around. Folks that were specific deep dive, maybe folks that were doing presentations on sustainability. You know, we were then participating in conversations around sustainability, but also human factors and, you know, patient experience and so forth. So it was just exciting to hear that collaboration at PDA and to also see it within Kymanox as a support organization.
Stephen - 00:14:40: Yeah, and what's great is I think PDA kind of gives you a really strong opinion that carries some weight. But it's not the regulatory authority, right? So it's just, it's a... Non-for-profit organization that's trying to just kind of like improve society. And it's very helpful. And so it's kind of like your non-regulating FDA partner. For FDA and EMA partners. That's super important, I think. And I'm so glad we have PDA to collaborate.
Shannon - 00:15:18: Yep. So I wanted to thank you for your time today and see if there's two things. One thing we started talking a little bit about Kymanox and Kymanox history, which is that same 20 years as PDA. And so I hope you'll have a chance to come back on The Factor and we can dive into a little bit more on the Kymanox history and that evolution into the full service provider. And second, I wanted to see if you had any final insights that you wanted to say about the PDA conference specifically.
Stephen - 00:15:49: Yeah, I mean, I think if you haven't been to this conference, this is something you should add to your professional development program. You can obviously... Network with professionals, you can get quite a bit of education. And it's just a great way to step away from your daily work streams and kind of think about some of the big problems that we're facing as an industry and how collectively we're solving them. And then I think one of the takeaways, I think, from my talk was innovation, you just can't take it for granted. You can be smart. You can have a pathway that's already been literally paved for you, and it's still hard. And it just requires a lot of collaboration, a lot of hard work, and there's really no shortcuts. And you're going to fall and stumble along the way. And I think the people who quit and give up, they're not going to see the innovation and the people that persevere. They're going to be rewarded in the long run. And I think we still need a lot of innovation happening in our industry. I think people kind of use the, oh, we're so strongly regulated, we're not going to see a lot of innovation. And I think that's just a lazy excuse. So we still have to innovate. There's a lot of creative regulatory pathways that you have that are quite accelerated that you can take advantage of if you know how to navigate them. And I think Kymanox is an expert at that. And there's plenty of room for innovation in our industry. And I'm just excited to help hopefully bring that in and get to see the fruits of all that effort.
Shannon - 00:17:23: Absolutely. And then hearing the patient stories. And lives changed from the work that we do collaboratively.
Stephen - 00:17:30: That's excellent. Yeah, that's what, I mean, we, you know, I think we all get paid well, we're treated well as employees, but I don't think that's why Shannon, you and I get up in the morning to get out of bed and go to work. Because patients deserve better is kind of what, why we get up. And if, I think if we, I think you, if you and I believe patients were getting everything right, that they needed, we would maybe sleep in a little bit. But nope, we get up early every day because it's a hard, long road. And then some of those patients, like you mentioned in your story, they're our loved ones. And so it's like that's the greatest purpose you can possibly have.
Shannon - 00:18:15: Stephen, thank you so much for joining me today and sharing your insights with the industry. And I look forward to sitting down with you again to discuss 20 years of Kymanox.
Stephen - 00:18:24: Yes. Thanks, Shannon. I look forward to coming back in the future and I hope people got just a little flavor of the keynote talk and all the wonderful ongoings at PDA this year.
Outro - 00:18:38: Thank you so much for listening to or watching this episode. Please subscribe or follow this podcast in whatever app you're using right now, or follow Agilis by Kymanox on LinkedIn for all updates. For more information on what Kymanox offers, visit kymanox.com. This episode was edited and produced by Earfluence. Thanks for listening, and we'll talk to you again soon on The Factor.
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