Interview with Paul McCabe, COO of VLE Therapeutics
Interviewer: Paul, what have you been up to? For the last seven months? Tell us what's been going on?
PAUL: Yeah, so not much. We just decided to build a GMP capability, to go from concept to reality – and do it in seven months. I had an interesting conversation with someone and he said, ‘Seven months, in my world, that’s how long would it take to get through the review committees to make a decision. You guys built it in that time.’ So I thought that was cool. It just told me how we operate here in APC and VLE, and really taught me about the team of people that we have – and the ambition, the drive, the energy that we have here to deliver. And that underpins our business model, and our culture.
Interviewer: Could you tell me a little how you’re building the team and what ideas drive that?
PAUL: As we started to build our team here at VLE, what was at the forefront of my mind was, ‘How do we bring people in, who are willing to try things who, you know, didn't have to follow the standard path that everyone takes?’ That innovative environment here at APC was a key element of why I came and joined and it’s certainly part of how I want VLE to grow and to take off the same way.
And I love the fact that in our sector, that the work that we do, has a meaningful impact on people. And I know, it sounds a bit cheesy to a lot of people, but I actually believe, when you see patients, when you see the impact you’ve had, and think that you’ve been part of that positive impact it really drives you. Looking at APC and coming here to build VLE, that patient focus in the organization, that’s a real key element here.
Interviewer: So we’re creating VLE and building this team to have a purpose and mission. Will we end up as a CDMO? Or another kind of manufacturing organization?
PAUL: I would say, during my time in industry, I’ve worked with multiple of the large multinational biopharma companies, and you know, I’ve worked with many CDMOs.
There’s a huge gap in the market for companies like us. Scientifically-led GMP manufacturing, I think that's something that doesn't exist in the market, to my mind.
You know, patients, they need speed, they need improvements to their medicines. APC with the mile deep process development expertise and analysis – and VLE with the science-led manufacturing, I think, can deliver on that challenge. My experience with 50, 60, 70 CDMOs of my time is that they just don’t offer that. And that’s why I use the term science-led, because it really is our process of development scientists and engineers, leading the knowledge transfer into GMP manufacturing that just doesn’t exist in other companies. And I think it’s doing something different to the marketplace, compared to anybody else.
Interviewer: So when you say that science-led manufacturing isn’t available anywhere else do you mean in the CDMO world or in the innovator world, or both?
PAUL: I mean, in both. GMP manufacturing teams tend to be left to figure things out themselves. And that always leads to delays – so there’s time, there’s cost and there’s risk, because you know, you’re sort of going off documents from teams you’re not connected to and hoping that they’re accurate when you’re understanding the tacit knowledge. And in most cases, something doesn’t work, you need another batch, you didn’t understand what something meant, you’ve got to try something new. You’re set back another six months and that just adds time and risk and effort.
A manufacturing CDMO, their job is for a pharma company to give them the recipe and they’ll make it. That’s it. Transactional. It’s not about refining the development of your product.
If you look at what we’re doing here at APC and VLE, the product development team and the GMP team are five feet away from each other. That just doesn’t exist elsewhere. I think that’s what’s different. Tech transfer actually means knowledge transfer. So it’s the transfer of knowledge from those scientists and those engineers down the hall, to the team who are making it. It’s not just on a piece of paper that’s been written three years ago by an R&D team. To me, that’s not what's in the marketplace today. I think that’s why we’re different.
Interviewer: APC is working on a medicine at the moment, and the team have developed a phenomenal process, the highest titer in the world for a medicine of that type - which ultimately means that at VLE you’re going to run fewer batches. That might have a negative business impact. What are your thoughts on that?
PAUL: Our business model is not to be a capacity house. It’s not about filling those tanks every day and trying to maximize every square foot of our real estate, every minute. Our model is how we support clients with their medicines and how we get them to patients.
It’s about a longer term process with Clients. It’s not about the short term, transactional, make-six-batches-and-we’re-done way of doing things. It’s like, how do we help them through Phase 1? How do we help them with the CMC roadmap. How do we move them into Phase 2, and how do we get them to the point where they can launch commercially. To be part of that success story, you have to lengthen your relationship with the Client, as opposed to just a short, sharp shock of capacity.
Interview conducted by Des O’Grady, CCO of APC & VLE Therapeutics