Lindsey Clarke, VP Commercial at MicrofluidX, reflects on two decades of working within the advanced therapies industry as Phacilitate celebrates 20 years of operating in the field.
First of all, could you tell me a little bit about your career over the last 20 years?
In the last 20 years I have transitioned from undergraduate studies (pharmacology), via an immunology PhD and postdoctoral experience in bioengineering, to a variety of commercial/strategic roles within tools and technology companies.
My PhD was undertaken in translational research in rheumatology at UCL and Great Ormond Street Hospital studying biomarkers of vascular inflammation in pediatric vasculitis, and led into a postdoc at Imperial College in bioengineering looking at blood flow and its influence on atherosclerosis.
At this point, I fully realized a career in academia was not for me, and I joined Miltenyi Biotec as a Clinical Account Manager. Initially I was involved in supporting graft engineering approaches utilizing cell selection to modify stem cell transplants, and then I started getting more and more involved in utilizing the technology for novel approaches in cell therapy. I was part of the team that brought the Prodigy onto the market and have been involved in bringing a number of innovative technologies into the space ever since.
It was my time at Miltenyi that kicked off this passion and drive to bring better technologies to make the manufacturing of these therapies easier. I joined Bio-Techne in 2018 initially to build out their European CGT team, and then ended up overseeing their global cell and gene therapy go to market strategy and product marketing team, bringing more closely aligned their broad portfolio of tools for use in the cell and gene therapy space.
I was involved at the beginning of establishing the ScaleReady joint venture, but then decided to join a start-up with the hope of bringing the disruptive innovation that is so needed in this space – I joined Ori Biotech in 2022 and then MicrofluidX in 2023. So back to rheumatology, it feels like my career is coming full circle, as we start to see innovative approaches like CAR-T or gene modified stem cells impacting this area of unmet need that I started out in.
Honestly, I fell into it. I knew I didn’t want to be an academic, so I’d been talking to recruiters and was very adamant I didn’t want to do sales, but I got persuaded to go to a first interview with Miltenyi. I think the words, ‘it will be good practice for you’ were used.
Anyway, don’t you dare tell him, but that was when I met my good friend, mentor and manger for a while, Jason Jones, over coffee and I was just enthralled by all the amazing things that were happening in cell therapy and the potential for what you could do by taking cells outside the body and then culturing them and redirecting them to where they could have the most impact. Fortunately, he offered me the job, and that’s it – I was hooked on CGT.
What changes have you observed from the industry over the last 20 years? What’s changed, what challenges have arisen?
I like to say I got involved in CGT before it was fashionable. The first industry meetings I attended were in basements of university hospitals and the therapies were seen as ‘futuristic’ – we didn’t know if they would even work.
I do remember going to workshops early on and there were very few people who had actually done the ‘getting the therapies into the clinic’ part, but there were a lot of people looking to learn more.
There was a lot of cynicism back then after the early gene therapy failures and these therapies were seen as risky. Mostly, it was in the hands of academics who would take a proof-of-concept trial to clinic and then treat maybe 10–20 patients before moving on to the next trial. Then it all changed in 2012 with the incredible results from CAR-T coming out and big pharma getting involved for the first time. Suddenly, there was a whirlwind of biotech companies appearing as if from nowhere, spinning out from academia and a growing excitement that this stuff really works and has huge potential.
It was really exciting seeing an industry spring up around these amazing therapies. I think we’ve ridden out that wave of initial excitement and are now in the realization stage that even pharma hasn’t been able to resolve the challenges of delivering such complex therapies at the numbers needed to reach their potential. We’ve seen trends in investors looking at therapy developers, then technologies, and now it feels like manufacturing capacity is the big thing to be invested in. I guess now we’re looking at these therapies from a much more holistic viewpoint. Solving one challenge just leads to pushing the bottleneck elsewhere.
From a technology perspective, it’s not been easy to develop the tools that are needed for this field. We’ve seen a number of promising innovations fail as the reality of productization happens, and so we’re sort of stuck still using the tools were a decade ago as they became embedded in the early processes.
What key industry events or milestones have stood out to you over the last 20 years?
Novartis jumping in and partnering with UPenn and then the subsequent race to be first to commercialization with a CAR-T product between them, Kite and Juno. I was watching this all unfold with almost disbelief that the therapies that for years had gotten no further than small first-in-human trials in academia, were now going to be medicines.
Whenever a trial would get a mention in the news/mainstream media, I could say to my mum – ‘that’s what I do’. Especially when it was a UK study that I’d been involved in.
What memories do you have of the first Phacilitate event you ever attended? What year was it?
I think I first attended Phacilitate in 2019, which, thanks to Covid, feels like a lifetime ago. I’d been wanting to attend for years, but I wasn’t senior enough! I then stupidly skipped ATW 2020 – if I’d have known the world was then closing for a year, I’d have definitely rethought that one…
My first Phacilitate event was before the event moved to Miami Beach and was held in the hotel in downtown. I loved the Whole Foods across the street – best conference breakfast venue ever!
Anyway, I was attending with the marketing team I was with at the time, and I’m not sure they had got their heads around it being a B2B exec event. For the booth, they’d sent a giveaway of bags of cotton candy as we were launching CloudZ – an activation reagent product line – Cloudz/Candy Floss/Cotton Candy – there was some link there. Funnily enough, we ended up sending most of them back. No-one wanted to even try it – execs really don’t do sugar, not even to bring back to their kids! A great example of the importance of understanding your audience in marketing!
What ‘unexpected moments’ do you remember from over the past 20 years of Phacilitate events? Do you have any anecdotes or memories that especially stand out from attending our events, that might have surprised or had a lasting impact for you?
Going running on the beach first thing in the morning the past couple of years – you see so many people you recognize from the CGT community. Some you’re like, ‘was that…?’ as you pass each other. It’s brilliant.
What do you expect to see from the industry over the next 20 years?
I think the realization is happening that we need more alignment, standardization, and real collaboration if we are going to solve the big challenges here. As we generate more data and more confidence on the safety of these approaches, we’ll see a broadening of the indications we are treating.
If you could speak to yourself 20 years ago, what would you say? Would you have any advice or pearls of wisdom to share?
That careers aren’t a straight path; you’ll find your niche along the way. If someone suggests you’d be good at something, why not give it a go? They might just have more insight than you do on what you’ll be good at.
What would you say to anyone considering attending Phacilitate’s 2024 Advanced Therapies Week?
Expect to become part of a community, not just attend a conference.
Lee Buckler, SVP Advanced Therapies, Blood Centers of America, Advanced Therapies Network, reflects on two decades of working within the advanced therapies industry as Phacilitate celebrates 20 years of operating in the field.