Getting to know... James Kusena

In this team interview, we get to know MFX's VP Operations, James Kusena.

What is your role and what do you do at MFX? 

So, my role is Vice President of Operations at MicrofluidX. And what do I do is a very good question. I do a wide range of things - I basically think I do a little bit of everything and nothing at the same time.  Fundamentally my role is about aligning the different departments and making sure we are working towards the unified goals that we have as a company.  Making sure that we've got the processes in order to do that and facilitating the different departments with whatever they need in order to achieve their objectives towards the unified goals.  So providing operational support  would be a good summation - and that can range from procurement support to quality to facilities and even aspects of HR and general office life.

And then there are other sides of the role which span a broad range of areas and activities such as: overseeing learning & development, accounting and working with the CFO,  looking after the quality and regulatory aspects of the company and working with external contractors and consultants for various projects.

In addition, because of my background and previous role in the company I also consult on R&D activities specifically on the bioprocessing side of things.

So yeah, a real mix of things!

Tell us a bit about your background and how you got into this varied role.

So my background prior to coming to MicrofluidX was academic and entrepreneurial - I spent time doing process development for cell therapy at Loughborough University.

I guess my background has really always been very kind of dualistic in its approach and the work that I've done. Even my undergrad had a very science focused aspect and then a business aspect to my studies.  At undergrad I did Medicinal Chemistry with International Business and then although my PhD and research then focused on Cell Therapy process development, it had a business angle and it was essentially how do you optimize what was an academic protocol into something that can be manufactured as a commercial product.

There was a lot of work looking at differentiation of PSCs in the lab, but I was also looking at what needs to happen for cell therapies to become products that are adopted and actually used.   Looking at them from the perspective of good clinical data and what does the health technology assessment pathway look like, what does commercialization look like, and what do the health economics look like in terms of actually getting adopted and reimbursed.

I think it's always really important to consider not just the science, but that the science also has to be impactful to the patients and the people that can benefit from it.

So yes, it's always been very much dualistic, and I've also been involved in a number of other things that are more entrepreneurial, starting smaller businesses, doing a range of different things as well, like organising conferences, founding working groups etc. 

That broad background must have proven really useful in the early startup phase of MicrofluidX - you were actually employee number 3  - how has the company evolved since then?

Being employee number three with employees number one and number two being the two co-founders was a very interesting dynamic.

But actually it was very complimentary because we all had very different skill sets and backgrounds and knowledge bases, which essentially complemented what we needed at the beginning.

Cesare had the microfluidics and the material and the fabrication background. I had the bioprocessing and cell and gene therapy background with that knowledge of what the output of the technology needed to look like. And then Antoine really brought the broad overview and bigger picture thinking of the direction of the company, the strategy, and was very good at understanding the critical things we needed to achieve.

So that was quite a good balance. And then as we grew, essentially, it was bringing in people that had the skills to complement the departments that had been set up.  Bringing  in people with the expertise we needed to develop the technology and grow the company. And that is really how we’ve grown the team - trying to figure out what skills and knowledge and expertise  we need and bringing those specific people in.

And I think we've actually been quite good at hiring from a fairly diverse range of people with very fairly diverse experience - and harnessing the transferable aspects of their skills, but also the very specific technical aspects of their background experience as well.

What do you enjoy about working here the most?

I would probably say the thing I enjoy most about working at MicrofluidX is how resourceful and innovative people are.

I think it's been amazing to come in at the very beginning and seeing something being just an idea to seeing it actually be fully fledged into a technology platform.  The level of commitment, tenacity and general perseverance that the team has has really gotten us through some of the key pivotal milestones that we've had to encounter.  So that's been one of the best things  - the people and the challenge of the work is very interesting.

On that - as I've gone through different roles in the company, the dynamic nature of being in a startup also excites me - no single day is the same and each day is quite different, which is really suited to my personality. As you can see from my background, I'd like to have my hands in different things and be involved in different things at the same time.

And thats great too - because I can be spending one hour looking at data, the next hour I'm looking at what efficient processes that we can be using within the company. And then the next meeting, we're talking about something more strategic and visionary! Its great!

So that's a really great segway into going into something a little bit more technical now. Our bioreactors are very different to conventional cell culture tools.  Seeing how you know so much about them - can you explain what are the big differences between cell culture that's done in these microfluidic controlled bioreactors and standard cell culture?

So, the key difference in using microfluidic principles in the bioreactors really means that the cell environment that the cells are exposed to is well-designed and well-thought through.

So with that it brings you better control, better reproducibility and also enhanced process efficiencies for certain unit operations.  You can really tailor the bioreactor to achieve what you want it to do.

You can have a higher level of control around increasing volumes, decreasing volumes, playing with surface areas and channels, etc. That can really allow you to fine-tune and have a bioreactor that is going to be specific for exactly what you need.

Plus the microfluidic principles mean that it's very amenable to automation, that then gives you the ability to look at different feeding regimes through perfusion for instance, and generally have control over a wider range of things than you would be able to with some of the  standard static tools.

And also the way that these bioreactors in particular have been designed has always been to allow for the integration of analytics  and imaging, which are the building blocks of being able to understand what is going on within your culture system to be able to ultimately control it. The premise is not just good process control, but also simple integration of good process monitoring as well.

I think you may have answered a little bit in my next question already but what does the future of cell and gene therapy look like to you?

I think there's two aspects to that. Again, with kind of my dualistic hat on, I think if I tackle it from a general perspective, I think the future of cell and gene therapy is very exciting.

I think we're going to be seeing more approvals  - when you look at the approvals the pipeline is still very CAR-T heavy.  It will be exciting to see more clinical data come out for different types of cells or even CAR-T's being used for different indications that are outside the oncology space.

But,  and I think within the industry as well, there's a real big drive to explore other indications as well,  which is necessary to show that this can be a self-sustaining industry. It's not just a pet project. It's something that is actually scalable and has the opportunity to have a big impact on medicine.

And for that we need innovation.  I think there is an appetite to invest in better technologies for quality control, for manufacturing, for process development.  From a technical perspective, I think the future is really at a point where we are hopefully going to see more specialized tools. 

I think historically, Cell and Gene Therapy has had to do a lot of repurposing of legacy technologies from the biologics or antibody manufacturing processes and we try to work with the best that we can. But now we have companies,  like MicrofluidX, which are there to really service this industry and understand what the industry needs.  Then we can have the tools that fit and really provide solutions to the challenges that developers face with these complex medicines.  

But I think whats really exciting is there's many different companies, not just MicrofluidX, that are coming up with different technologies, and I don't think it's a winner takes all sort of industry because there's such different needs for different therapy developers that there's enough space for everyone.

And I think that makes for a more collaborative industry. I really hope that we see more of that collaboration so we can put a peg in the ground to say cell and gene therapy is here to stay.

Lets talk a bit about this intersection of engineering and biology  - both elements have very different ways of thinking - how do you think taking more of these engineering approaches into biology is going to help solve some of those challenges that we see in cell and gene therapy?

I think it will work very well. I'm biased to say that because I did my PhD at the Center of Biological Engineering which was focused on engineering to address challenges in biology and its pursuits.

So, it is very much ingrained into me that the two work well together. But I think it's really because you've got a marriage of very different disciplines, when they intersect and, you know, in that Venn diagram, there's that sweet spot where you're able to use engineering principles to help remove some, not all, but some of that variability that you get with biological processes and actually create systems, processes, whether that's for process development or manufacturing, that are more robust.

Essentially, when we start to think of the principles of quality by design, that's a very engineering way of thinking and also a more pharmaceutical way of thinking, which isn't necessarily there when it comes to early cell and gene therapies.

But when you start to think about using those engineering principles from the get-go, thinking with the end of mind,  as you go through the  processes of asking: what do you need to measure? What do you need to achieve? What does that mean for my process and how it needs to look.  It becomes very exciting. So I think that intersection will really help with our challenges around manufacturing, process development, analytics etc.

I think its going to be really interesting. So for example, when we think of  the analytics needs we have, these are hardcore engineering challenges.  Whether it's miniaturizing spectrometers to measure in situ or you're using different types of holographic imaging or lasers or whatever it is that you're going to use to probe the cells and more and more commonly now doing it in a non-invasive way. These engineering challenges at the core of them  have to interact with the biology in a complementary way and still provide you with very valuable information.

And I think that's where we're finding a lot of interest within this industry and I see a lot of the technology companies that we see coming out now fundamentally have a strong engineering background and then they bring in those biology teams to help drive the science together.

So I think that's a different way in comparison to the tools that we've had before.

Well, we've covered you and your career and the company. What about the real you, James? What are you passionate about? What do you enjoy doing when you're not working?

So I am passionate about people. I am passionate about empowering people and people having a fair starting point and platform to try and achieve what they want to do, whether that's professionally or personally.

In my spare time, I do a lot of mentoring for different groups of people from people within the engineering space, within biology, general undergrads, PhD students and even some  postdocs as well. And I also do a lot of coaching in my own capacity, so I coach mainly around the areas of professional and personal development with a focus on self-awareness, resilience and personal growth.

So that really is looking at getting people to have a better understanding of themselves to understand what they want to achieve and providing them with necessary tools for that journey, and being that critical friend along the way to their goals. So I guess that's a lot of what I do in my own spare time.

But in addition to that, I am very passionate about being active and living a very healthy lifestyle. So I'm actually a qualified yoga instructor.  I did my training in Bali about four years ago. And I, not often, but do sometimes teach some classes and obviously, practice on my own daily as well.  That helps me to keep a very balanced mind. So I take a very mindfulness based approach to the way in which I work, both in my professional and personal life as well. 

I can also  be a bit of an adrenaline junkie.  I have done some very high bungee jumping and I like to travel,  hike and run as well. I tried to do a half marathon this year, but fainted due to the heat halfway through it. So that's a challenge I'm going to be doing again in slightly cooler weather this year.

But yeah, just being active, being outdoors is one of the main things that I enjoy, as well as cooking. I'm a big fan of cooking as well - food is life!

To learn about the people behind MicrofluidX and what we're working on, head to our website