Solving Challenges in the Biopharmaceutical Space

We’re talking to Loe Cameron, a professional in the life sciences industry and a member of the Ignition Cross-Industry Collective. We’re discussing overcoming the pushback against adopting a new software platform, solving automation challenges, introducing new automation solutions into the biopharmaceutical space, creating solutions for the business side with Ignition, and finding wins that everyone can agree on.

“We’re looking for platforms that are really flexible and allow us to do all the different weird and wonderful things that our customers ask for and Ignition has not shown us any barriers.” – Loe

Bio:

Loe Cameron is Sr. Director of Analytics & Controls at Pall Corporation, leading development and strategy for the backbone of Industry 4.0 including process analytical technologies (PAT), instrumentation and automation. She has a B.S. in Bioengineering and 17 years of biotechnology experience in both technical and business roles.

Episode Transcript:

00:29
Don: First I'll welcome you. Thanks for being here. And open with a question that allows you to educate those of us who don't understand life sciences. To people outside of your industry, explain a little bit the work that you do.

00:43
Loe: Well, I have to admit I'm not very good at explaining it because I often go into way too much detail, but I'll try and give a quick overview. My background is I'm a bioprocess engineer. So I was an end-user of automated products. I was the person on the floor using automated bioreactors to try to develop bioprocesses, and in doing that I developed quite a passion for how those interfaces worked and how we put recipes on those devices, and how we made them play together in order to develop our processes. Eventually ended up working for an equipment manufacturer where that was a challenge that we needed to solve, and so ended up working my way through the company until that was my challenge to solve.

01:23
Loe: So now I lead a team of engineers who are working across the entire bioprocessing manufacturing train. So everything from the bioreactors all the way down to what we call final formulation and finish, which is taking the drug product and putting it into a vial. There's automation challenges across that entire bioprocess train. So we solve those automation challenges, and sometimes those automation challenges involve automation programming platforms and sometimes they're, how do we get data out of the process? So we think about what analytical instruments do we need to put into the process, as well. So we do everything.

02:00
Don: Okay. Good. That's a good introduction. You did it pretty succinctly.

02:04
Loe: Well, I've had a lot of practice. Maybe I'll get better even in the future.

02:06
Don: As you go forward. This is good practice then, good.

02:08
Loe: Yes, yes.

02:10
Don: So now let's bring in Ignition a little bit. How did you first get introduced to Ignition, along with these professional challenges?

02:18
Loe: It was a little bit random actually. I was walking through a contract engineering firm's kind of engineering floor and they were showing us their facility and some of the things that they were working on. I just walked past an interface and I was teasing them for spending so much time on a test rig, because it was a beautiful interface and they were just using it to run some of their test equipment and pull some data out and it looked better than some of the commercialized software I had seen out there. And they said, "We didn't spend any time on that. It took us about five minutes to throw that together."

02:52
Loe: I, of course, had to know more. I found out that it was Ignition and that kind of started me down the rabbit hole of learning more about Ignition and kind of discovering that it was something that could solve a lot of our problems as well.

03:04
Don: Okay. So what was a little bit of that down-the-rabbit-hole experience? The discovery process with the platform? How did you learn to interact with it? Did you use Inductive University? The manual? The forum? What was the process?

03:17
Loe: Well we definitely used your website very, very heavily. And before we did any programming in the platform, we — and when I say “we,” it was myself and a couple other engineers who know far more about software than I do — came to ICC. We hadn't used the software at all yet, other than downloading it and kind of barely playing with it, but our goal was really information-gathering, to speak to other people who were using it more fully than we were.

03:45
Loe: We were overwhelmed by how positive people were about the platform, because you go to other software platform events and you hear a lot of complaints because people are using it to solve problems and then they're finding problems as well. It was just a completely different culture around ICC. It was a completely different environment.

04:06
Loe: We even asked on the last day, there was kind of a roundtable discussion as one of the events and we asked, we've heard all these positive things and everybody is so happy, what's the negative thing? And people said, ‘Well, the negative thing is that it's so flexible that you have to decide what to do.’ That something we've actually really realized in our own use of it is, that can be a challenge to decide what to do. But if that's the worst thing someone can say about your platform, you're doing pretty good.

04:36
Don: Then we're okay.

04:37
Loe: Yeah, you're doing pretty good. But after that, definitely, I haven't spent much time on Inductive University because I'm more of a managerial role and more of a strategic role, and less the nuts and bolts. But certainly my engineers have been on Inductive University and have utilized it heavily. I don't know if any of them have used the manual or the forum much, but Inductive University has been a really valuable tool.

04:59
Don: Okay. So this may or may not be a question that works for you from what you just said about the role that you play inside your company, and maybe it's come from the other engineers when you decide to build out a solution with it, but what are your favorite things about working with Ignition?

05:14
Loe: So I have a lot of favorite things, even though I'm not the person who is actually doing the programming, I do have a lot of challenges on the business side that Ignition solves for me. So one of the big things is we're looking for platforms that are really flexible and allow us to do all the different weird and wonderful things that our internal customers and our external customers ask for, and Ignition has really not shown us any barriers in that way so far.

05:41
The other one is when I look at deploying the resources that I have towards all of the business problems we're trying to solve, I need to be able to do that efficiently and Ignition really allows me to do that. When I compare the cost of developing a new solution in other automation platforms, with Ignition I can do more with the same amount of money, which means my final product is much more robust, it's much more beautiful to work with, a really nice user experience, and that provides significant value. So those are my favorite things, that I can just do more.

06:14
Don: Sure. Sure, that's great. I have to ask you this because it's one thing that always interests me. I have seen over the last 15 years of the evolution, or the last 10 since the Ignition platform was actually introduced, a lot of folks become relatively evangelistic, I would say excited about it because of its flexibility. That's certainly one of the goals our CEO and developers had in putting Ignition out there.

06:33
Loe: Yeah, you can see it with your community.

06:36
Don: And we love that. I mean, just the experience you guys had when you went to the conference, we can't tell people what to say. They're going to say what their experience is. If they got complaints, believe me, engineers and integrators will tell you what's wrong. They're not shy about it, these men and women share their opinions. So that's good for us. But what I'm interested in is, has it shaped, inspired, influenced in any way your own professional career opportunities or development in your field?

07:03
Loe: Sure. I mean, Ignition, it's solved a ton of problems for us and it's been exactly what we needed for the projects that we've applied it to, but it hasn't been without its challenges. But the challenges don't really come from the software itself. They come from the fact that you're very new in our industry.

07:21
Loe: Within the biopharmaceutical space, Ignition doesn't have a name yet. Hopefully that will change and I think it's on the cusp of changing now, but that creates some significant professional challenges for the people that are trying to bring it into their organization, and I certainly felt those. But it gave me a good chance to grow, learning how to build consensus, learning how to make strong business cases and how to really share the advantages of something in the face of a lot of opposition.

07:50
Loe: And then, also, how to grab low-hanging fruit. So one of the early things that we did with Ignition was we found areas where we were less likely to face resistance, things that the business cared about enough that if we fixed it, it would be an impact but not so much that they wanted to control exactly how things were being done. So we specifically looked for those opportunities to apply Ignition in kind of specific instances and then be very, very loud about what we have just done and show people how it had changed things.

08:21
Loe: Then you can kind of snowball that success to bigger and bigger projects as the resistance becomes lower. But that's something that I didn't know how to do before Ignition. I was mostly used to being a subject-matter expert in bioprocessing and saying, "Let's go this direction," everyone says, "Okay, we'll go that direction." The amount of pushback I got on Ignition was brand new to me. So it's a growth experience for sure.

08:44
Don: Well that's actually good, and it actually brings up an interesting point that I've certainly experienced with the folks that I get a chance to talk to on Inductive Conversations is that, well, of course, Ignition is still part of a young company, Inductive Automation, so we're only 15-plus years old. Ignition is only a decade (old), and it's entering all sorts of industries that have incumbent players that are vertically focused on only that industry and have long histories.

09:09
Don: So when you start changing a value proposition, you start bringing in a platform that isn't just for that industry but does ease the challenges of that industry, the people who are the first movers, and I've heard it jokingly said the settlers get the land and the pioneers get the arrows. If you're a pioneer, you end up having challenges.

09:31
Loe: Yeah, that's true.

09:32
Don: So I think it's really something to see, the challenges you face, they aren't the technical capabilities of the product. It's the adoption and acceptability on the business and corporate side and industry side.

09:43
Loe: And that resistance doesn't come from nowhere. I don't want to be too hard on the people that pushed back when I was pitching Ignition because I think they had some really fair points. We have very few suppliers on the automation side in the bioprocessing space that really only serve us. We're a relatively niche industry for all of the major automation suppliers, and worse than that we're a niche industry with really specific, fussy needs. So we need a lot but we're a small slice of their market, and that's the worst possible kind of customer to be.

10:15
Loe: I was really impressed with Ignition when we first started engaging with you guys, we hadn't spent anything. We had spent only the time to come out to your office and we had downloaded the software for free, and we had a big idea of what we were going to try and do. The amount of support that we got back from you when we hadn't put any investment in yet was really impressive and completely different than anything we had seen with any of our other automation providers.

10:42
Loe: So I think knowing that automation is an area where we're such a niche business and knowing that we're unlikely to get support from vendors, people were right to push back on going to yet another vendor that was new and fresh. But you really solved that concern for me and from very early on I felt the support.

11:00
Don: Actually you make a really good point, and I appreciate the fact that that's been the experience because that's our goal. But we're also a company that has our challenges as we've grown extremely rapidly to try and make sure we don't lose that touch with being a broad platform that's an industrial application platform that doesn't serve just one industry. And to be honest with you, a life-sciences pharmaceutical has been exactly what you said, extremely demanding with low-potential volume relative to other industries.

11:32
Don: So when you look at where's the low-hanging fruit, I think our folks have done a pretty good job from your experience of focusing on your needs so you could at least go forward. And you could increase the adoption by doing what I think is a very good strategy: Find places to have wins that everybody agrees with. Find some common ground before you take on places where people have legitimate hesitation to make a change.

11:57
Loe: Yeah, and we really see that momentum starting to build. The other issue with the biopharmaceutical industry is that we're really secretive. So it can be really hard to find out who else is doing what you're doing. But we have heard here and there about some of the other people in the space using Ignition and using it in GMP applications, which are the most regulated applications that we automate. That's really encouraging.

12:24
Loe: It's only going to increase, and then we'll start to see some of that resistance to adoption fall. Because you fix a lot of the problems that we have in the biopharmaceutical space and you fix them really cleverly. So I'm really excited to see where it goes. We're trying to do brand-new things. We're moving towards continuous biomanufacturing, we're moving towards kind of the paradigm of real-time release where when that vial comes off of the end of the manufacturing train we can put it directly on a truck and ship it to customers. It's already qualified, it's already validated.

12:54
Loe: That requires us to do things we've never done with automation before. It requires us to be making very complex measurements in real time and having our unit ops work together in ways they never have before, and we need new automation solutions to make that happen.

13:09
Don: You just hit on the question I was going to ask you next, so that's actually perfect.

13:14
Loe: Didn't mean to steal your thunder.

13:15
Don: Yes, it's okay. The thunder was supposed to be yours anyway, so that's good. Think about it though, when you think of your industry and are there any other places you see opportunities? Because it is so highly regulated, it is so demanding, and automation is being used in unique ways there in order to accelerate that innovation. Any other comments you want to make about where you see it going industry-wise, but maybe more specifically, because I've seen you guys accelerated, your company has just grown in your use of Ignition.

13:45
Don: So maybe it could be specific and a little general at the same time. Where is the innovation opportunity there? What have you seen happen in your own area in the last year? And what's the next year or so look like?

13;55
Loe: Well I think the FDA has been really clear in where they want to see the industry go in terms of the technologies that are put into biomanufacturing. They want to see us measuring the processes more completely. They want to make sure that we're having that robustness where the process is run the same way every time, and there's some initiatives around that. One is called PAT, so that's process analytical technologies and that's when you're bringing all of your analytical equipment directly into the manufacturing space and hooking it to your manufacturing train. So you're not waiting two weeks to get analytical results, or even days, you're getting it in real time.

14:31
Loe: Once you're getting that information in real time, then you have to think about how to process it in real time and then you're talking about model-based process control. And so that's really where I think we're going. The issue is that, and the reason that people aren't adopting these FDA regulations more quickly, is it's not easy. Many of these analytical pieces of equipment are created by small start-ups or they're very new and someone needs to tie it all together.

14:57
Loe: So there's opportunities there for automation platforms that can be very flexible. How can we pull in all of this analytical information? How can we control all these unit ops in a coordinated and orchestrated manner? Those are new challenges that I think Ignition can help us solve.

15:12
Don: That's great. So as we come to the end of our time I really wanted to say thank you very much for taking the time to join us here at Inductive Conversations. Is there any final thing you want to say to, I guess I would say kind of a general audience, which probably has people in your vertical but also generally speaking, before we end off here?

15:32
Loe: Just that I can't wait to see where it all goes. You guys have been very receptive to listening to us, even though we are kind of a niche market for you and a relatively demanding one at that. And I just can't wait to see where Ignition is going. I can't wait for our first application on 8, I'm really excited about that. Yeah, just can't wait.

15:55
Don: That's good. Well thanks again for you being a take-time-out-of-a-busy-schedule person to join us here on Inductive Conversations with Inductive Automation.

16:00
Loe: No problem.

16:05
Don: Have a great day.

16:06
Loe: Thanks, you too.