Episode 87: Top Strategies for Growing Biotech Companies – How to Thrive Amid Industry Shifts in 2025

Want to grow your company without losing your mind or your margins? Tune in as Katrina Rogers spills the secrets, minus the consulting fee. You're listening to Bio from the Bayou, empowering biotech leaders with the tools, assets, and expertise to improve healthcare outcomes.

Each episode provides insights and information to expand your network, advance your product line, and help your company thrive.

Serving the entire Gulf South, but recorded in the heart of New Orleans. Welcome back to Bio from the Bayou. I'm your host, Dr. Elaine Hamm, the executive in residence at Tulane School of Medicine. And today we have a guest, and our guest is Katrina Rogers. She is the founder and CEO of an aptly named company, Katrina Rogers Consulting, a firm that helps medicine and medical device companies decrease the cost and the time to bring their new therapies to market. So she is also a member of the Bullpen, of which Tulane and my own company is a member. So welcome to the show, Katrina.

Well, thanks, Elaine, and I appreciate the invitation that you and James extended to me. Absolutely.

Well, you have an amazing 25 years of experience discovering, developing, manufacturing medical technologies. But before we get into that piece of it, can you gimme a little rundown of what your experience in the field has really been?

Okay. Well, I got my start with an analytical chemistry degree at the University of Washington in Seattle. That's a lens through which I look at a lot of the work. I'm always about, can you measure it? Is there something that we can measure here?

I love that. That's honestly my hardest class in chemistry. I have a chemistry minor and I was like, oh, this is— that was almost the class that killed me.

Analytical?

Yeah, analytical.

Yeah.

I took a lot of quantitative analysis classes and I was like, oh, it was a good reminder of why I did not want to become a chemist because it's really hard and detail-oriented.

So. Very much so. Very much so. So after I left the University of Washington, I went to Pfizer Central Research. And leveraged that analytical chemistry degree to work in a wide variety of discovery and development roles for a bunch of project teams and on special project teams from the lens of drug metabolism, for which measuring is a significant component, right? Drug metabolism is about measuring the effect of the body on the drug.

Yep.

After I left Pfizer, I came back and worked to Seattle and worked at a contract research organization and added pharmacology as well as working in drug metabolism, ended up as a technical director for pharmacology and metabolism. metabolism with that group, and then took a dive into the quality roles at a sterile fill finish manufacturing organization, which is here in my hometown of Spokane, Washington. I feel like understanding quality and having a quality perspective is a nice match to the analytical chemistry. It's, a lot of it is about really thinking about what are the structures under which we can operate.

Love it. Bringing quality to quantity. Well, in pharmacology, I'm honestly, I'm knee deep in that right now. We have My multiple sclerosis company is at that stage where we're really trying to figure out, like, how do we translate it from the preclinical side and get this into the clinic? And then having a really solid pharmacology person on your team is such an important piece of really understanding that sometimes very large step when you go from the mice all the way up to the humans, there's lots of big leaps that have to be made.

Yeah. Well, and you have to think about safety pharmacology as well as on-target pharmacology too.

Absolutely. Well, let's talk about something I'm sure our listeners are concerned about, because I'm concerned about it myself, just being in the industry. Like, what do you feel like are some of the most significant challenges that we are really facing in 2025? Well, that's a loaded question.

Yeah, it is a super loaded question because there's lots of things we could talk about. I think what we are seeing is some significant shifts to the landscape about how we operate for medicine and medical devices. In the past, since World War II, a significant fraction of the early innovation space has been supported by and funded by both the research universities, which are themselves supported by the federal government, as well as the federal government working to support innovation in sectors that it thinks is important for our communities. Those structures appear to be changing. I think there's a widespread agreement that changes were appropriate or necessary, but there's a great disagreement about the kinds of changes. I think there are going to be secondary or knock-on effects that people are not paying attention to that are going to be a challenge. And I think there's a significant— we are already seeing a significant drain from the United States to other countries, which is going to create an economic challenge for us. And we know that our companies are already struggling to find top talent. If that top talent doesn't feel welcome and goes to other countries, then that's only going to make the talent problem even bigger.

Especially for early-stage companies where it's always, I mean, we're in the riskiest stage of our company being an early-stage company, but also in our stage of development, either devices or in drugs. I mean, we have very high hurdles to overcome, usually operating at the 10% chance of succeeding kind of range. And so as a company looks forward, and I've been thinking about this a lot for my own, we just had a board meeting this week and we're thinking about the regulatory side of filing our IND and having a pre-IND meeting and all of the sort of Typically sort of box-checking moments, and we know the process typically of like what we need to do. But given all of the changes and the layoffs that are occurring within the FDA, what would you advise a small company that is trying to, that's in a preclinical stage, wanting to go into the clinic, what would you advise them to think about over the next maybe 6 months to a year?

I think that for everybody who is working in this space, the relationship is going to be key. The FDA provides a number of ways for companies to engage early and often and to begin to have conversations with review teams and with— to understand the thinking and provide, here is the science base that we are— under which we are operating, and get feedback, as well as educate reviewers about your science. So that's one of the things we hear from the reviewers all the time is that they want to follow the science. But they need your help to do it.

Yeah.

And so that's where your key opinion leaders come in. That's where your publications come in. All of these things where the regulators are just— think about them as if they were also your investors. What they're going to commit to you is being able to approve your new therapy.

Right.

If you do a good job of working with them, if you do a good job of the relationship, you'll have very consistent information, which is great milestones for your actual fiscal investors. And then also it gives you a lot more confidence moving forward. You have good space to talk about it when you inevitably have problems. Because let's face it, when you get to the stage of actually commercializing the drug product, you are going to have challenges. You're going to have challenges in the clinic, and you want to be able to have authentic conversations to negotiate how you're going to get out of those challenges.

I like the lens you mentioned of treating them as investors. And I think about that, that struck me because anytime I talk to my investors, I never want to waste their time. And I always want to be extremely concise and transparent as well. It's a balance. And so, one of the things I think now probably a good commodity at the FDA is time and making sure that you're not going to waste their time because time is very valuable when you have a labor shortage.

So, I mean, any advice on how to balance that line of giving the right sort of concise I would say that this is where you should do your homework, that you should think about what are the drivers behind their challenges? What is it that they're facing? How can you help them achieve their goals? Because that's— I mean, mutually, what you're both trying to do is achieve a set of goals that are common. We want new medicines. They want to approve the best new medicines. They've been given the mandate by Congress to do that work in a timely fashion.

Yeah.

So, I think that's where you should start. So always thinking about what is the specific, what are the specific outcomes I'm trying to achieve with this conversation, making sure that you're completely clear and upfront with that. That also you make sure to ask some time to say, what else do you want to hear? What other pieces are we missing and that we should be bringing to the meeting?

Well, switching gears just a little bit as we talk about labor and workforce, talent is a challenge, always has been, of just making sure that you have the right people around the table. How can companies in this current climate really help to attract and keep talent in what can be a really challenging and competitive environment?

I think new companies should be really thoughtful about how they set up their talent structures. I think there is definitely a role for post-secondary education and postgraduate education in our field. However, there is a significant role played by the skilled technical workforce. In fact, that the skilled and low-skilled technical workforces make up more than 60% of the employment in our industry. And so you want to be thinking about your individual roles. What is absolutely mandatory in terms of degree or ticket punching, as it were, for the role? What's within the scope of someone's experience?

Yeah.

So great example here is I have worked in the past with an organization. They were looking for a new head of quality operations, and they had some candidates who had a 2-year degree and 15 years of shop floor experience, 15 years of manufacturing experience.

Which is everything.

The job description was written for someone with a bachelor's degree. Yep. And so if your systems, and unfortunately, especially in CGMP, but in many employment systems, you must meet the criteria for the, under the job description in order to be accessible to the job. They were not getting candidates with bachelor's degrees that had nearly the experience that this other person was. The line managers were just wringing their hands saying, we want to hire this other person, but we've given ourselves handcuffs. So don't do that because actually changing job descriptions is a job in and of itself.

Truly. It really is an underappreciated, undervalued piece of our labor workforce. I had a great appreciation for this when I worked at a previous company. Where honestly, one of our best-paid scientists was someone that had a high school education, but she had been in, at the bench and in an animal facility for over 35 years. And her skills and her knowledge were just incredibly valuable, more so than any PhD I've ever worked with. I honestly said that my whole job was to make Debbie happy, because I never wanted her to leave, because she was that valuable. It really was a good lesson for me of just like, PhDs are wonderful, but that at-the-bench skill set is so important, and it's a hard piece that we And one thing that our listeners may know, I'm also in Oklahoma in addition to New Orleans. The state of Oklahoma had gotten a Build Back Better grant specifically for biomanufacturing, and part of that grant was actually spent to help train up 2-year programs of people that can come in without the bachelor's degree and the PhD to go into biomanufacturing and serve as a technical workforce. Yeah, Yeah, and I think that's a really important point. the state of Florida has an excellent framework for that as well.

They've been working on it for many years. I am a board member for the Biotechnology Aptitude and Competency Exam, the BASE.

I was like, it has to be an acronym.

Yeah. So let me say that again, because it's a little goofy. So I'm a board member for the Biotechnology Aptitude and Competency Exam, which is a national board. The base. This is an exam that verifies the knowledge, skills, and abilities necessary for an entry-level biotechnology professional in multiple types of roles. It is accessible to students at junior colleges as well as coming out of high school.

Yeah.

And essentially requires some specialized prep, but these young people are able to pass this exam It's a great marker of preparedness for this work. When I talk to people, they're always afraid of, well, what is the FDA going to say? And I'm like, the FDA regulations, the CGMP regulations say you need a combination of education, training, and experience to do your role. When you start out, nobody has any experience.

Right.

And smart people have a bunch of different kinds of education. So how do you solve the problem? You solve it with training. And there's no CGMP plant on the planet that will let anybody, even if you have 50 postgraduate degrees, touch anything until you've been through their training program. This is a risk category that is relatively easily addressed. My thought is, let's get some good shots on goal here. Let's get some people in who have shown some basic proficiency.

Yeah.

And let them work.

I love that. Touching on sort of like the standard piece that you mentioned, that we're having to hit certain standards, that's really such an important piece to life science in every sort of stage of development. What are some best practices that you would recommend, given that you're both quality management, but also quantity too? What do you recommend for companies to maintain standards in scaling their operations?

Well, the first thing, and something that I think young companies struggle with or forget to do Is set up a documentation system and follow it.

Ooh, yeah.

You do not need an eQMS. You do not need a formal QMS to begin with, but you do need to have some way to understand what you knew when. That's the intellectual property and then reproducibility of your experiments. Some way to be able to say, these are all the things that we knew when. Here's where we noticed that when you have a deviation or something happens, you've got this body of knowledge that you could go back. And say, has this ever happened before? Is there something that we know already that we can do? And then ultimately, you will want to have some kind of document, formal documentation system if you're in a regulated industry. And so, then you're just building towards it. Then you're building towards the SOPs. And people forget this, that you need a process for finance. You need a process for— I mean, if you can't handle your accounts payable and your accounts receivable, you're already in Absolutely.

I think Ian's laughing because we had it over the last summer. We called it the summer of SOPs because James and I were like, we need SOPs for everything we do. Yeah. So, that's what a lot of our office did. And you love an SOP, don't you, Ian? He's nodding. He loves it when I bring him in on the podcast. I do. I do. SOPs, honestly, they really, they really help getting everybody on the same page about everything. Absolutely. And if you lose a critical member of your team for whatever reason, heck, even my wine bar has an SOP, which we've had to utilize this week because the person that runs our payroll is out of town. And so, we have a nice little SOP for us to go by when we, because our staff needs to be paid this week. And so, we have an SOP documented to help figure that piece out because that documentation piece, whether you're a wine bar or a drug development company, it comes into play and it's a boring part. I love an SOP. I love operations. At the same time, a lot of people find them very tedious, but boy, they can really serve as just an amazing foundation for a company.

So true. And they don't have to be complicated. A checklist of steps and links to where you can find the stuff, just that knowledge management alone will get you right down the road.

The links of where to find it. That's such an overlooked piece of like, that's another thing we preach in our office is like Box is everything to us. We have a centralized process of where we keep all of the things. We have nice backup systems to make sure that we don't lose that knowledge. Same thing in a pharma company too, of just, you wanna make sure you can locate it. And it turns out all those times you were supposed to be writing in your lab notebook, you should really be writing in your lab notebook and documenting and making sure that those things that you don't think about are taken care of.

Well, and it turns out that paper systems are not only often the easiest to operate, but they could be from a regulatory standpoint, a lot easier to operate for, especially for a small company, an electronic system. If it needs validation, if it needs revalidation and qualification, that can require a lot of hours of time that if you just had a simple, straightforward paper and PDF system, you'd probably be in better shape.

Yeah, absolutely. I tend to use ChatGPT sometimes to even help think through. I have sometimes a little bit convoluted process of creating my SOPs. I'm like, can you make this simpler and make it so that anybody can read it, not just me? So, and that's been a helpful sort of zoom out, like you're making this too complicated, Ham. Well, what's one last piece of advice you would offer our listeners to help them really navigate the complexities of our industry and grow and thrive in this year?

I would say don't lose hope is my advice at this point. Yeah, there will be opportunities. There already are opportunities. And in fact, this kind of disruption can create some better space for innovation, and that innovation can come from you. I think For the founders, especially if you have an innovative business model, if you can demonstrate why your business model will work and will produce good outcomes, you'll be rewarded. I think I would offer a challenge to investors that you've been telling us for years that you want to have a chance to help support the early stages of innovation in our industry. I'm like, time to put your money where your mouth is, folks. I would encourage us to challenge each other. about what is a good way for us to be moving forward and what are good, stable ways for us to build trust networks and to move forward out of this.

Yeah, and despite the chaos, good science, smart people, and good processes will have a place in this world, so.

They certainly will.

Thank you so much for talking with us, Katrina. Hopefully some of this advice was helpful to our listeners, and if they need more, if they're thirsty for more, they can always reach out to you at Katrina Rogers Consulting, and we'll add all the information that we talked about today In our show notes, as always. And yeah, thank you so much. We really appreciate it.

I love the opportunity. I really appreciate the invitation, and I'm really looking forward to catching up with everyone at Bio on the Bayou in October.

Absolutely. It would be great, great to catch up in person with a cocktail in hand. Thanks, everyone.

Thanks for joining us for Bio from the Bayou, and we hope you'll join us again to never miss the latest.

updates in biotech, hit the subscribe button now.

We'll catch you on our next episode of Bio from the Bayou.