March 29, 2023
Published on Endpoints News
A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.
That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.
BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.
Endpoints: What made you want to take the CEO role at BioCina?
Womack: The most satisfying thing in my career today was being able to help build out AGC Biologics from what began as CMC Biologics. And then ultimately, three CDMOs we combined to create AGC Biologics and then make that a major global player in the industry… To take the scale of what CMC was at one point and then ultimately build out to AGC Biologics, which again included a couple of other small CMDOs and then really build something great on the global stage of the industry was exhilarating and was incredibly satisfying. And that’s the opportunity here, and to do it even better from everything learned.
It’s a tremendous opportunity to create that kind of growth trajectory, and we will do that. And that’s one part of it. Another part of it is the starting point. The facility is gorgeous. It’s in a great city, in an amazing country, with significant economic benefits for clients to come to Australia in this industry. Our quality or regulatory record of the facility is elite. We have really strong talent, technical and operational talent, and just a very prideful, hardworking, and driven team here across the board. We have all of the ingredients to build out this foundation and then really grow this out so that we become an even far more attractive CDMO for the market. We’ll add modalities, we’ll add facilities, we’ll add capacity, but job one is to earn the trust of the global market that BioCina is a CDMO that you can rely on in terms of quality and delivery.
Endpoints: What about Australia made you take the position?
Womack: It’s an amazing place. If you’re going to put pins on the map and choose where you might do something like this, this is a great place to do it. I’m an adventurer.
How will you leverage your experience in the CEO role at BioCina?
Womack: I know exactly how every core component of the business, I know how it should look. I know how it should operate. I know the right thinking behind getting those areas to operate properly and at a high level, whether it’s the supply chain, business development, process development, or production. I know exactly how those should look when they’re right and when they’re operating the way they need to form a quality standpoint, an execution standpoint, and a client satisfaction standpoint. So, I take that from the combination of all of those CMDO experiences, not only the things we did well but the mistakes we made and the learnings from that. So, it’s a recipe and a playbook for how to do all those things right and day by day, step by step. That’s what we’re going to do, and we started on my first day with my new team.
What are your growth plans for BioCina?
Womack: I have a five-year vision and timeline with major milestones in it that I introduced on my first day here with the whole organization, and in terms of adding modalities, will add mammalian (modalities). It’s possible we’ll go into gene therapy, but that’s not certain that I’ll want to do that. But mammalian (cell manufacturing) for sure will be the first modality will add. We will add fill-finish around the same time as adding mammalian. We will add microbial capacity, we will add plasmid capacity, and we will become capable in the next year or so (to do) large-scale mRNA GMP programs. We’re near the first wave of that in terms of CDMO suppliers. That’s one of the things we’re mostly on the leading edge about is the work that the organization had done prior to my joining with small-scale mRNA and including some grants from the Australian government. We have small-scale mRNA we will build that out, including, with some additional grants, large-scale mRNA.
We will add one or more facilities, where we’ll put those to be determined. I have some definite ideas about what part of the world those might be, but we will for sure add one or more facilities, and we’ll add a significant amount of capacity after we ensure our foundation is really strong to grow from.
How does the CDMO market in Australia compare to that of the US or Europe?
Womack: I’ll compare in a couple of ways. In terms of where it is right now versus some of the more mature regions of the world, the US, for example. It obviously doesn’t have the breadth and robustness and volume, if you will, that some of those other markets have, it wouldn’t, given when it started and so on. Having said that, that sort of makes it even more exciting to me to now be a part of it because it didn’t just start, but it’s still in maybe its first or second phase of development and evolution. And it’s only going to grow.
In Australia and New Zealand, they’re not messing around. The governments are not messing around about wanting to help with investment and incentives. The economic incentives are significant for CDMO clients to choose a trusted CDMO in Australia for their programs. I started to feel them competitively before I joined BioCina started about two years ago to be hearing from clients.
What are some of the biggest challenges that BioCina faces right now?
Womack: If you’re a US client, it’s more convenient if you’re an innovator in Texas to go to a CDMO in California or Seattle or whatnot. It’s obviously considerably more convenient. We have to do a lot of things more virtually, I mean, everyone’s doing so much virtually these days, but we have to do even more virtually with potential clients, but these days, that’s not so difficult. But is it a bigger lift to convince a potential client to travel this far if it’s farther for them than to travel to somewhere in the US or Europe to check us out and tour our facility? Yes, but that just means we have to be good at showing folks our strengths and why we’re worth traveling over to look at when they get really serious about us.
And not everyone in the industry knows… BioCina, (it) has been over a year yet, but not everyone knows BioCina (we are) 24 months into existence. So, there are still a lot of folks in the industry that don’t know about us.
Because we’re so far away from a lot of other parts of the world, attracting the talent I’ll want to bring in and add to the great team I inherited, it’s not as easy to find the right talent in this industry, no matter where you are, but it might be a bigger lift to track folks to come over here unless they’re adventurers like me. But each of those three things is overcomeable. There’s no doubt.