Quality Grind Podcast

Navigating Cell & Gene Therapy: Setting the Stage for Success

• MEDVACON Life Sciences • Season 1 • Episode 22

Share episode

Send us a text

Welcome to The Grind! Hosts Joe Toscano and Mike Kent caught up with special guest Ray Kaczmarek in San Diego for an insightful discussion highlighting the complexities and dynamic nature of Cell and Gene Therapy.

In this episode, the first in a 4-part series, Ray shares his experiences from military service to multiple C-suite roles during his 25-year career in both pharma and biotech, emphasizing the importance of strong leadership, strategic planning, and team collaboration. Ray also unveils some of his unique strategies for navigating the challenges and opportunities of this rapidly evolving Life Sciences landscape that set the stage for his success.

And stay tuned for Part 2, where the focus will shift to accelerating the development process, here on The Quality Grind Podcast, presented by Medvacon.

Contact MEDVACON:

  • Message us at @MedvaconLifeSciences on LinkedIn
  • Visit our website at www.medvacon.com/contact
  • Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

Ep 22 CGT Part 1 - Ray Kaczmarek

[00:00:00] 

Ray Kaczmarek: There's no one size that fits all in gene therapy anymore because it really depends on what the mechanisms of action and delivery are.

Again, genius protein chemistry here coming out. The output is where the genius is. It's then somebody's figured out how we can make it happen in there. And then that's the delivery mechanism that everybody's trying to figure out. It's how do I get it in there?

Jessica Taylor: This is the Quality Grind Podcast presented by Medvacon. Conversations that go beyond compliance. Sharing insights geared toward helping you navigate the everyday grind of regulated life science industries. Here are your hosts, Joe Toscano and Mike Kent.

Mike Kent: Welcome back to The Grind, everyone! Joe and Mike back with you today, along with a very special guest. Ray Kaczmarek was kind enough to join us onsite in San Diego [00:01:00] to talk about his journey into and through the Cell & Gene Therapy space. And as he pointed out in the tee-up, this dynamic facet of life sciences is rapidly evolving, with the science and technology being as exciting as they are unknown.

So during this four-part series with Ray, he'll share his experiences and perspective on both the challenges and opportunities of trying to engineer this bullet train down the set of rails as they're being laid out in front of it. 

After serving his country in the United States Army, Ray has navigated a career of more than 25 years in the pharmaceutical and biotechnology industries, many of which have been spent in senior leadership positions as a C-suite executive and or board member for multiple organizations. 

I think our listeners and viewers are in for a tremendous ride over the next couple of [00:02:00] hours, aren't they, Joe?

Joe Toscano: Yeah, absolutely. Ray, the biggest thing is, I think a great place to start is, we've had the opportunity to work together, I think it's going on nine years, which it's hard to believe it's been nine years. And we've worked at a number of different companies together in regards to us supporting you and your organizations as your career has continued to progress.

What we're thankful for is having somebody of your experience and caliber and being an executive in the industry, sharing this perspective. But I think for people listening, it would be great for them to understand kind of how you got started with the pharmaceutical industry, how your career's progressed.

Ray Kaczmarek: Thank you. I appreciate the opportunity to be on The Grind. And yeah, it has been nine years. Yeah, but they've been a good nine years. 

Joe Toscano: They've been a, been good nine years. 

Ray Kaczmarek: But yeah. So my background's pretty simple. I've been in basically pharma or biotech for the last 25 years. Why biotech, why pharma? Well, it was, [00:03:00] it's difficult for me to say other than when I was coming out of the United States Army, I knew I wanted to be in something that was a little more scripted and regulated. It made it easier for me in the transition to figure out how do my skills there in the military potentially correlate to corporate America.

And a lot of things that were going on at the time and it made sense. And then just lo and behold, I'm in the middle of nowhere in Kansas, and Abbott Laboratories is wide open. It's the first place that's willing to hire a vet. And I go out there and I got a PhD in manufacturing in about the first 12 months.

So what I basically, what I can tell you is once I got into pharma, I knew it was something that I wanted to do. Always been in Operations and Manufacturing. I've worked through those parts of it, through the supply chain and understanding that. Over the last 10 years I've been building out, just the background of understanding the commercial sales opportunities, how it works, how it ties back both on a services based organizations and [00:04:00] then a therapeutic space, from the early stage development and taking your drug all the way through. 

Like I say, and having to be on both sides of the fence and look at different types of things from a vaccine or a small molecule to an mRNA product or a viral vector product. Yeah, they're all different, but they actually are all the same. Because there's a lot of things that you'll always have and all these companies. And it's going to be about how you set your systems up and what fits that type of company, its DNA, the product and the product life cycle. 

Then more importantly, the people that you have. Not everybody has the same tools in the shed, but that's okay. It's just you gotta use the ones you have the best way. And part of my job as I grew up in this organization and what makes me successful is I look at the organization and the people we have and try to make them effective. And, it's okay. They may not know everything they need to know, but how do you allow them to get smarter? You [00:05:00] have to accept the fact that we do not know everything and we do reserve the right to get smarter. And I stole that from one of my old supply chain heads. Okay. 

Mike Kent: It's a great thing, right? To get smarter. We'll quote you on that, and then you can relay the credits on. Yeah. 

Ray Kaczmarek: Yeah. I give, I'll give it back to her. 

But you know, the reality is we reserve the right to get smarter. But that is so true today in Cell and Gene Therapy. As we start looking at who you have, you may have an expert that came out of a lab, early phase development, but has no idea of what really is a PPQ, what really is a commercialized product. They have an understanding because they're super intelligent. They can read regulations, they can read guidance, they can do it. But until you actually go and do it and have to schedule it, have to get the data, the interface, the turnaround time of your testing, put all that [00:06:00] together and then analyze it and say, yeah, it was good. It's a completely different beast than I'm in early phase, phase one, phase two, doing my characterizations saying this is what it looks like, and submitting that in for a clinical trial. And don't get me wrong, those are very difficult things to do. This is just different. Right? 

So as you start looking at it, there's just phases within the company. And those things drive different types of phases on the company's design as well as the types of people you have and how they grow. 

So you know, you know, 25 years doing it, being in that, developing everything from, like I say, operations, supply, taking things through, learning about commercial sales organizations, building those things, doing the executive portions of it, managing, running companies, now creating business relationships and driving things in that manner, and then being a partner at one point in time with a therapeutic company. 

And now what I'm currently doing is I'm a therapeutic company looking for good partners. 

Mike Kent: Okay. 

Ray Kaczmarek: [00:07:00] So, that all comes around in a big circle. 

And I think the nice thing about our industry and what I've found in our industry is you can make very good friends. And you also have the same thing, you know where people are really strong, don't be afraid to call them. Right. And if you have a good relationship, hopefully they're not afraid to call you. Right. So, that's sort of how I think about things.

Joe Toscano: No, and I appreciate the background. And even before we jump into this, first of all, I've been a beneficiary of some of the stories from your service, and from us and everyone, thank you for your service to the country and the time that you spent. 

Mike Kent: Very much, very much. 

Joe Toscano: I know you dedicated a good portion of your life to that. So we're all very appreciative and thank you for watching out for all of us. 

Ray Kaczmarek: Truly appreciative. And then, I can say I'm here today because I was surrounded by good people. And whether it was early in my life, going through college, definitely in the military.

And then when I look at my career, it's here because I'm surrounded by [00:08:00] good people. It's never one person getting there. It's always a team and an effort. And then it's, so it's looking for people who like to collaborate, and then, and I think that's what makes this type of business for me fun.

It's funny because I'm the most socially awkward person and my partner, she, she'll remind me of that all the time. But I do like to have deep relationships with people and really understand what motivates them. 

I think when we start talking about what we're going to with Cell and Gene Therapy, the motivation sometimes is truly the science. And the science is amazing. I can do something that no one else can do. And you can see it early on. You can see it early in the clinical trial. You can see the output, but now you have to figure out how to make it and deliver it, and that's really where the complexity comes in. And that's where everybody's like, how are we gonna do this? And how is this designed? So, that's where we're seeing the evolution of things coming. 

But it's all a team and it's all a team with very smart people. [00:09:00] They really have a passion for what they do. And it's a little, like I say, it's a little different. I'm not just coming in to punch a button. A lot of people are coming in to learn a process that's new for the first time and they really don't quite know how it's going to work, because they haven't tried it with that gene, they don't know how it expresses, they don't know how it'll deliver. They don't know if it'll even tear it up or it can even transfer it, or you can even maintain potency. 

So, there's a lot of different things that go into it. But one of the key things is teaming, because there's never one person in the room that knows everything.

Joe Toscano: Oh, I can't agree with you more. It's a group of people that get you there. 

From the time that we've started working together, one of the things that I think you do really well, and I think it's something that I, it would be great for you to speak a little bit about. Because you know, from an outsider's view, you usually have brought us in when there's been aspects where we could be of assistance or we could bring people to bear with expertise that could, you know, further along your team or correct issues if there's anything there that we could provide some input and help with. 

But one of the things I always admired was that you have a good ability [00:10:00] of cutting through a lot of the red tape, to be polite, and being really direct in terms of your approach with people understanding what needs to be done with some clarity. And, that's kind of a rare thing in a lot of different areas within the life science industry.

A lot of people aren't that aggressive with an approach. And I mean that in the best possible way because I think it saves a lot of time and it helps people get focused where they need to be. And I've seen you rearrange things in a manner, in a very quick way, where you've gotten much better results that they've struggled with before you got there.

So can you talk a little bit about, from a leadership perspective, coming into an organization, which I've seen you do multiple times, what's your approach? How do you turn it around? How do you work with the senior leadership and the board that you're reporting to, and then your frontline employees that need to get it done every day? 

Ray Kaczmarek: Yeah. There's a variety of ways. 

Joe Toscano: We can spend the whole podcast on this. 

Mike Kent: That smile telling a thousand [00:11:00] stories just in itself. Yeah. 

Ray Kaczmarek: As, as you think about it, I can tell you I learn a lot through failure and I learn a lot through self-reflection. One of the key things I think of being a leader in this type of an environment, and especially in cell and gene, is you gotta have some thick skin. You gotta learn what the word no means, which is, I try to get a different way. But the reality is, you're gonna hear a lot of nos. You're gonna have a lot of naysaying because people don't quite understand things. But your job is really to understand what is the key issue that we're communicating and how we're communicating and doing it. 

I can tell you early in my career, some of it was just, it's a little bit more, I drive it, I make it very easy. Follow the map, do that. As I've gotten into it now I'm looking for leaders that can do that because I just can't replicate all that all the time. So now I'm looking to develop those types of people and I'm looking at the next level up, and now I'm looking at people more strategy around how I'm gonna get these leaders, bring them [00:12:00] in, build systems from the beginning and think about, okay, today this is okay, but tomorrow it won't be. Well, they have to have a plan to improve that. And I have an expectation that people will do that. We'll talk about that. That's when we say, when we do budgeting, I need to know, how's it, the end-state needs to be here. 

So looking at it at different levels when I come in does drive leadership styles a little bit. Some things are gonna be a lot more directive when you come in and it's a group that has a lot of compliance issues.

I'd like to tell you, you want to be as, as friendly as you possibly can because you want people to be comfortable and talk to you. But you also have to draw a very, very strong hard line. If it's not right, it's not right. So let's just discuss how we can make it right. 

Joe Toscano: And it doesn't get better with age. 

Ray Kaczmarek: No. Yeah, and that's what's actually, that's the thing. Yeah, the recall gets much larger. 

Mike Kent: The stakes are higher. They're much higher. 

Ray Kaczmarek: Certainly. Yeah. 

So if you're thinking about from a [00:13:00] leadership style, a lot of times it still is partnering. 

It's, it's... you're not coming in looking at people going, okay, so you just got a consent decree and we're trying to look at how we're running this part of an operation and none of you know what you're doing. Well, if you take that approach, I can guarantee you get zero information.

Joe Toscano: Absolutely. 

Ray Kaczmarek: But if you start understanding, okay, what processes are the problem? Where are you struggling with understanding? And just go and watch and listen, sit down with them at lunch, you will find out in the first 30 days, probably 90% of the problems right away. Then usually it starts to draw back to processes, discipline, and training.

Okay. 

And once we start asking the questions of who wants to be there, there's your first 30% that's either there or they're not. And most of the time they self-volunteer because they tell you very quickly that they don't want to have discipline, they don't want to do the training. And they're not gonna follow your batch record. Well... 

Joe Toscano: Which are all critical.

Ray Kaczmarek: All critical. But you know, but it's [00:14:00] not personal. I know it's very difficult when you say those things to somebody. It's not personal. No, this is not a job that you want to, you're gonna be a part of, because this is, you just don't have these characteristics, and let's help you find something else to do.

But the flip side of it is also find those people who are so passionate about those things. And part of that is you have to temper the passion because they're stepping on other people, and get them to understand that, okay, you understand where we want to be. How do we communicate, how to get everybody thinking the same way? And now you guys are collaborating, right? You're, it's not, I'm not threatening you and I'm not doing coercion. At that point, the team breaks down. When they collaborate, they build. 

So it is, it's putting some of those types of things in place. And if you think about, it doesn't matter what level you come in on, you really are doing the same things. You're coming in and evaluating the people that are there. You're trying to understand exactly what you think you have in front of you versus what you [00:15:00] actually have in front of you. And then is the right team there? Is the people there that you have capable? Have they been given the op, the right authorities, the things they need to do?

And then the other part of it is, you're gonna have gaps. And do you have a network? Do you have a consultant group? Do you have whatever it's gotta be to come in and help you start filling that out, to start putting the right people in the right leadership positions on the bus. 

The most successful leaders that I've seen, and there's times where I've struggled to get people through the door, and that's where I've struggled in some of the changes that I've needed to make, is the ones that can get those leaders through the door and identify the leaders that are already there that they can collaborate and still build that organization. 

And you see change very quick. Or more importantly, it's not so much you need change, you just need to accelerate, and it's focused. The focus now comes and they are running with scissors. But if they got their hands on it to point down, they're not run running one scissors hand pointed up. Sure. So [00:16:00] we're being a little safer about it, but at least you know, we're, we've got focus on where we're going and how we're gonna get there. Yep.

So, that's what I keep looking at. That's pretty much the way I see it is if you can't get the team on the bus, it's gonna be very hard to get where you want to be. But if you can't identify the seats on the bus and playing on the team, that's the biggest issue that most people don't take the time to do in that first 30 to 45 days, is understand what you got. Understand what you need... 

Mike Kent: Where the gaps are... 

Ray Kaczmarek: Where the gaps will definitely be. 

Joe Toscano: And you also need a willingness to solve the problem. A lot of people are like, well, you know, if I don't pay attention to this, sometimes it'll be somebody else's issue. But what people don't understand is by not addressing it, "it's not an issue", as we said, it doesn't get better over, over time. You, all you do is you delay that progress and you, it actually costs a lot more money to take care of it later than it would've if you took it or earlier in the process.

Ray Kaczmarek: I, I guarantee. One of the things we, as we were [00:17:00] chatting on the side prior to, we were talking about, okay, what are some different things that go on in Cell & Gene Therapy? And how does this happen? Some groups will be like, well, I got a competitive advantage, but I want to save money and I just want to do the bare minimum and go from A to B to C. You can't. You can until all of a sudden you're in phase two with a pivotal and somebody goes, oh my gosh, this drug works. And you don't have any qualified methods. You haven't qualified all the raw materials the right way. You haven't got the system and process locks. You don't have a scalable process platform yet. 

I mean, you got there because you figured out how to get there, because funding is limited. Those things are true. I only have so many people I can have, I only have so much to get through my clinical trial. I've gotta get X number of patients through. I could still be a rare indication where I don't have large patient pools to begin with. I may only be treating 15 to 20 patients. But again, that's still a lot of money to make that, right? 

 Well, you got another group will be like, well, [00:18:00] what's a competitive advantage if I think I have a platform? Qualify your methods early. Qualify, validate, run them through. You have comparability of all your steps. That's an interesting, strategic way of addressing stuff, right? Sure. And it's also something a little different because not everybody says, we'll put a lot more emphasis on getting our methods right and understanding what we're testing and doing that early. But if you have a platform or you feel you have a platform, you're starting to run through it. That's one of the things I would tell you that's a competitive advantage as soon as you can lock that in, because that allows the Operations guy to have some sort of opportunity later to do things. 

So now it's back to leadership. So when you come into an organization and you're assessing what some of the needs are, well, where are these people at in their thought process and where are we at in a development company versus a commercial company? And now it's the same thing. Once you assess what it is, it's really [00:19:00] simple. A lot of them can be accelerated by just making one or two changes in the strategy, bringing one or two of the right people in. And the next thing you know where exactly where we want be.

Mike Kent: So if I'm hearing you correctly, kind of putting it all together, you need to know what the bus looks like. Yeah. You need to know who's on the bus, who's been on the bus, but more importantly, what type of people, what skills, what characteristics, what mindset do I need in each one of the seats on the bus? Because each seat has a specific role, opportunity, objective, and expected outcomes. And then the driver of the bus has to know who's behind them. That's right. And that's how things get started thrown down the road. 

Ray Kaczmarek: When I look at a lot of the earlier development companies there, as they start to transition, one of the things to try to understand is when does your bus get bigger? [00:20:00] When do I need... 

Joe Toscano: When do I go from a short bus to a big bus? 

Ray Kaczmarek: That's right. When do I need three seats instead of this one? 

Joe & Mike: Sure. 

Ray Kaczmarek: And when does my job really need to start splitting up, and growing that out, right? And that's a very difficult thing to, to 

to actually do. 

Some people, oh yeah, I get this, I get that. When you're short on funding because you're trying to get these things through, you want to minimize the number of people you're bringing in as full-time employees, right? Which means you gotta think about how you're gonna manage different aspects, whether it's a contract manufacturer or whether it's consultants, advisors, bringing in different board members, KOLs, whatever you're bringing in to get expertise to feed the machine per se, right?

They may have seats, but they just may be a rotating seat, right? And that's part of the strategy. But the more important thing is when does it actually need to expand? Okay? And it's not really at this phase, it really has to be at the, when these things start to occur. And it could be at that phase, it [00:21:00] could be a little earlier, it could be a little later, but the reality is and say, okay, as soon as I hit phase two, I need to hire 20 more people. Most likely not. It's when you get to the next segment of development, or when I get to this next level of advancement of where I'm going to do process lock and everything else. I may not need full-time equivalents for 20, I might need three or four because they need to carry the program through. 

But I'm probably gonna have 17 to 20 people working throughout different types of things, between contract manufacturers, consultants, advisors, whatever I'm bringing in. Even going back to the individuals that you may have got the technology from, and solving those issues. 

That roadmap is difficult. It's, it is difficult to find, but the reality is, as you start sitting back and thinking about it, your people will tell you. You'll see it in the performance, you'll feel it in the stress. And you'll also see it as when you're looking at the workload as it's coming, it's coming. That big iceberg's there, you see the peak. So, and [00:22:00] alarms there, you can, you start predicting it. You can see when you need it. 

Mike Kent: Well, we're off to a tremendous start in our conversation with Ray Kaczmarek around Cell and Gene Therapy. To this point, we've focused on the people elements: characteristics of effective leadership, ways to strategize and evaluate what your team needs to be successful based on their performance, mindset, and where you are along your development path.

In part two, we'll dive into what that development process should look like, as well as strategies to both accelerate the journey and strengthen the case you're making for your potential blockbuster new product. Here's a hint: it may involve ensuring those dreaded concepts of good documentation and highly integrous data. You know - good science! 

So join us for part two of Cell and Gene Therapy with Ray [00:23:00] Kaczmarek next time here on The Grind.

Joe Toscano: If Medvacon can help you and your organization, we're happy to do so. We specialize in the following areas: Quality and Compliance, Validation and Qualification Services, Project Management, Tech Transfers, General and Specialized Training Programs, Engineering Services, and Talent Acquisition. If you have general questions as well, feel free to give us a call at any time.

We can easily be reached at 833 633 8226 or via our website at www.medvacon.com. Thanks so much, and we look forward to speaking with you. 

Jessica Taylor: Thank you for listening to the Quality Grind Podcast presented by Medvacon. To learn more or to hear additional episodes, visit us at www.medvacon.com.