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David McCall, Senior Editor of BioInsights and former founding Project Director for Phacilitate, reflects on two decades of working within the advanced therapies industry as Phacilitate celebrates 20 years of operating in the field.
To start with, could you please introduce yourself and describe your connection to Phacilitate?
I’m David McCall, Senior Editor of BioInsights these days, commissioning for and editing Cell & Gene Therapy Insights and Nucleic Acid Insights. However, 23 years ago this Spring, I became the first Project Director for Phacilitate.
Could you tell me more about your experience with Phacilitate over your time here?
I kind of found my way into the events business by accident before Phacilitate was founded in September 2001. We started off exclusively in vaccines and high-level pharma R&D strategy and expanded from there. Our first event was the European Vaccine Forum, which launched in Paris in April 2002.
The Cell and Gene Therapy Forum, as it was then called, launched in January 2005, and really gave Phacilitate a big boost at the time. From the second edition onwards, I oversaw researching and writing the agendas, but it really was ‘all hands to the pump’. In those days, there were only 4 of us in the office, growing to 6 or 7 before Clarion Events bought the company in 2010.
I subsequently ran the division as Portfolio Director for Clarion for 3 years. I then took a step back to return to my first love, which was research and the content side of things, so I carried on for a few more years working specifically on the cell and gene therapy side of the portfolio.
I moved to New Zealand in 2017 and carried on working for Phacilitate for about another 6 months before calling it a day in March 2018.
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What was the industry demand for Phacilitate to exist at the point of launch? What was the subsequent demand for the change in direction towards cell and gene therapies?
Nicola [McCall – Phacilitate’s Founder] was very motivated to start Phacilitate by the desire to make sure that every aspect of our offering was excellent. There were no areas that left our hands and went into others who didn’t share this same commitment, which we felt would have diluted the quality of what we wanted to do. We set out with this vision of, ‘we’re going to be the absolute best events company there is, we’re going to do everything with real excellence’, and a big part of that was making everything we did very personalized. We decided we were not going to do a lot of events, but that we’d concentrate on delivering a handful of events really well. We had a small, tight-knit team that really bought in to what we were doing. It was something of a family business, so we naturally had the tight team ethic, and we just strived to be at the top of our profession – I can’t really put it in any other way. That was the real driving force behind why Nicola went out on her own with Phacilitate.
We began working on the Cell and Gene Therapy Forum in 2004 after Dr Chris Holloway, who we knew through the vaccines world, came to us and said “I think it’s time that there was something in the regenerative medicine events space for the industry. There are a few association events here and there, but they’re all very academic. There’s nothing that’s really commercially focused at all in the world”. So, the Cell and Gene Therapy Forum was launched to be that very first event for the industry.
I’m sticking my neck out here, but I’m reasonably confident in saying that the term ‘cell and gene therapy’ was actually coined by Phacilitate. I don’t think my memory is playing tricks on me because we really agonized over it. For months, we researched and researched with people working in the field, and at that time, cell therapy and gene therapy were two quite different areas.
The poster children of the space at the time were adult stem cell therapies and tissue engineered products, which these days are mainly in the realm of academia and are somewhat neglected by industry and investors, at least relatively speaking. It was the opposite then. The very few products that were on the market were tissue engineered products, for the most part. Genzyme’s Carticel had just received its approval, which was a really big deal and served as an important catalyst to us in getting started because it was regarded as the first major product to achieve commercialization.
On the gene therapy and viral vectors side, however, it was a very difficult time. Gene therapy was kind of a dirty word, to be honest. It was still quite soon after the death of Jesse Gelsinger, which was a hugely significant event for the field, and a lot of people working in the space were busy pretending they weren’t in gene therapy at all. Certainly, the cell therapy and tissue engineered product people with whom we were discussing our plans didn’t want anything to do with it, and so the idea that we would call this the ‘Cell and Gene Therapy Forum’ was of real concern to a lot of people.
It was also something of a happy accident that we started to use that term, because we weren’t to know then that the two areas would converge as they did. Things like CAR-T cell therapies were still way off in the distance – out of sight at that point. Until CAR-T cell therapy started to take shape, the two fields remained quite separate.
Nevertheless, there was clearly a need for an industry event. There was a relative handful of biotechs in the space, but the number was growing. There wasn’t a lot of funding, there was a little bit of big pharma interest, and a very nascent tool and service provider sector. But it was just starting to take shape, and that’s what encouraged us to go ahead. So, we made the decision to take the plunge, and the first event took place at The Ritz-Carlton Hotel in Washington, DC in January 2005.
It’s interesting you’ve raised that, as I am also aware that Phacilitate worked with the industry to coin the term, ‘advanced therapies’.
I remember thinking at the time of the name change that it was a bold move. I would talk to American people in particular, and they would tend to regard ‘advanced therapies’ as a very European term because of ATMPs. But I think you kind of predicted and in fact, drove what would happen there with the widespread acknowledgement and acceptance of ’advanced therapies’ as a term to describe the field as a whole.
What did that first event look like? What was on those early agendas?
I remember the first event well. It was a very successful event for us!
It was a 3-day standalone event. We had around 200 attendees in total and 15–20 exhibitors, which were big numbers for us in those days! The expo was pretty basic – we gave exhibitors some space, a table and a couple of chairs, and that was about it. Usually, they brought just a little bit of signage with them and a few brochures. There were no tech demonstrations, no shell scheme, not even any curtains separating them at that first event. At conference reception, we had an enormous tablecloth spread over a few trestle tables made out the biggest bit of cloth we could find, which was actually a piece of parachute material with the Phacilitate logo on it.
Initially, we simply weren’t set up to do bigger events than that because we were just so focused, firstly, on quite senior-level events, which automatically narrowed the field somewhat, and secondly, on keeping the quality very high – particularly of the interactive elements of the event such as receptions and dinners. We placed great importance on creating an environment where senior-level people could feel comfortable networking, learning, and benchmarking.
Do you remember who the KOLs at the time were? Who would you perhaps have seen as a big win or a big success to get into a plenary or onto the agenda as a whole?
There were some familiar names from today on the panel for the first event. Scott Burger, Alan Boyd, Gary du Moulin… all people who might well be speaking at your event in January 2024, and all of whom I still work with today myself.
In terms of agenda content, at a high level, it didn’t look so very different to now. There were some similar umbrella topics that you’ll be talking about in Miami, I’m sure. For some reason, the one that always stands out in my memory is manufacturing scale-up – we had a big focus on scale-up in the first agenda. Obviously, 20 years later, that’s still a challenge that is yet to be solved, which continues to be good news for those of us in events and in publishing!
Financing was huge. It was a totally different scenario then, though – it was enormously difficult to get VCs to come and speak, and that remained the case for the next 10 years and more. It’s much easier now, but my goodness me, it was hard to put together a financing panel, and forget about getting a Wall Street analyst to turn up! They really weren’t yet aware of the space in any real sense.
Pharma speakers were also very difficult to confirm. There were very few big pharma companies that were active in the space, like GSK and Johnson & Johnson, but they kept their cards close to their chests and rarely sent speakers to meetings. And most of the other big pharma and big biotech companies just kept a watching brief. This certainly made things tricky for me because for the first decade at least, getting big pharma and investors to the event was my number one priority.
It is interesting how things go full circle. In the first agenda, we had quite a lot of coverage of in vivo gene therapy for cancer – an area that went quiet for a long time, but which is now resurfacing with in vivo CAR-T cell therapy.
Check out this year’s agenda >>
What key industry milestones stand out to you from the past 20 years?
The growth and evolution of the tools and services space has been of vital importance to the development of the field as a whole, as has the sea change in both investors’ and big pharma/big biotech’s willingness to get involved in cell and gene therapy. For the latter, I’d pick out the acquisition of Kite Pharma by Gilead Sciences in 2017 as being a particularly significant milestone.
However, right from the start of Phacilitate, we tended to regard the commercialization of products as the biggest milestones, because that’s what drives everything. It’s what gets pharma and investors fully involved, ultimately. It creates regulatory precedent that allows other products to follow, and it also gets the regulators innovating with their guidance.
In terms of product approvals, Carticel was huge at the time, as I’ve mentioned. There were also 2 gene therapies that were approved in China in 2003, just before the Cell and Gene Therapy Forum started. That was really big news at the time, too.
The next big commercial milestone was probably the approval of Dendreon’s Provenge in early 2010 – the first dendritic cell therapy. It’s not entirely happy, the commercial story of Provenge, but it’s a really significant one. It brought to the fore all sorts of issues around the manufacturing and supply chain for centrally manufactured autologous cell therapies, and helped pave the way towards addressing a lot of the issues that Kymriah and the other commercial CAR-Ts have since faced.
Strimvelis was also an important commercialization in Europe, in 2016, and then we come to the CAR-Ts, with Kymriah’s approval in 2017.
More recently, AAV-driven in vivo gene therapies like Zolgensma and Luxturna have been hitting the market, and bringing us right up to date, it was great to see Vertex and CRISPR Therapeutics’ Casgevy gaining approval just a few weeks ago. As the first gene edited therapy to reach the market, it became the latest in a long line of game-changing advanced therapy commercializations.
How did the advanced therapies industry evolve from starting that first event to the final event that you worked on with Phacilitate, and beyond?
As I’ve mentioned, it was a struggle for industry in the early days. For the first decade of this century in particular, it was a struggle for money, it was a struggle for big pharma’s attention – and it was a struggle for our event.
It makes me chuckle now, but as the person who had to write the conference agenda every year, I kept having to come up with a different way of saying ‘on the cusp’, in the context of an impending commercial breakthrough that would really reshape the field and drive exponential growth. The thesaurus came in very handy! That had to be the theme every year because it felt closer every year, but it was still not quite there. That ‘standing on the brink’ feeling went on for years. Then, the big breakthrough finally occurred, and it was the approval of Kymriah that delivered it.
For Phacilitate, everything changed overnight. I believe that was the year that we basically went from a 500-person event to a 1,000+-person event, which is a big thing in the events context. And at the same time, the tool and service provider sector was growing immeasurably in size and sophistication. So, the expo really started to grow, too. I remember when we hit 50 exhibitors for the first time, we couldn’t quite believe it – the rest is history, I guess!
Have you kept up with Phacilitate since leaving?
Yes, absolutely – I certainly keep an eye on Phacilitate whenever I can. I’ve got some good old friends there, and it’s very near to my heart and always will be.
I notice from watching videos of the recent events a very high level of professionalism, and the presentation of the events is amazing! They look so slick.
I think what really stands out for me now, and what I really like, are the community-building and the support efforts that Phacilitate undertakes. Things like the ongoing support for the Emily Whitehead Foundation, and Women in Advanced Therapies. I think those sorts of things are tremendously important, and they are in the old Phacilitate spirit, as I see it, of being a really positive force for the community you serve. I love that.
What memories of ‘unexpected moments’ do you have from Phacilitate events?
There was the final Washington event, when it snowed and snowed and lots of people couldn’t get into DC. But despite that, it turned out to be a really good event for the people who were there. The circumstances created a sort of siege mentality, and there were some really good discussions as a result.
That reminds me of one of the European versions of the event, in Berlin, where we had a power cut in the middle of the afternoon session – all the lights went out during a presentation, and everyone was left sitting there literally in the dark. I think we found some candles, and we just had this impromptu candle-lit roundtable – a bit like sitting round a campfire. It was absolutely brilliant!
One thing I was especially nervous about was introducing the boat party when we moved to Miami, just because we’d had a really terrible boat party experience at the second ever event in Baltimore. We hired a boat on which we were going to have a dinner and reception for about 150 people. It was the first time we’d done anything like that, so we were very excited about it – and it sold out, too. Unfortunately, it turned out this boat was usually employed as a teenagers’ party venue, and it hadn’t been cleaned very well since its last voyage… It was a bit smelly, the food was inedible, the bathrooms were unbearable, and it was just an awful evening. But again, that was another one where people came up to us afterwards to tell us they’d a great time! All they did was laugh about how terrible it was and did some good networking while they were at it. That reaction was definitely unexpected! Actually, all of my ‘unexpected moments’ appear to relate to things going catastrophically wrong, but working out in the end!
Take a look at the networking events we have planned for this year’s Advanced Therapies Week >>
What memories from Phacilitate events have had a lasting impact for you?
The lasting impact for me is just meeting the people in this space, growing up in the space. I was in my mid-20s when I started and I’m 50 next year. I’ve obviously left events, but I’m still working in cell and gene therapy with Elisa Manzotti, Nicola, and the rest of the team at BioInsights – I’ve never left it and have no plans to do so. That’s down to just how much I enjoy being part of this endeavor and working with the people who are involved in it. I’m still surprised and amazed every day by what I read and hear about what’s going on in this space, and how quickly it’s moving forward. It was exciting to be a part of from day 1. It’s been a privilege for me to work and grow up in cell and gene therapy.
As we approach our 20-year anniversary, do you have any final comments or anything you’d like to say to the team or the industry?
Yes, to potential attendees, I’d say that if you haven’t been to a Phacilitate event before, go, because they’re fantastic!
What I would say to the Phacilitate team as you look ahead to your 20th anniversary is, go hard! Your company was founded as one that would always strive to be a cut above, to go the extra mile, and to make a difference. I think those are values that can only be upheld by a very tight-knit, motivated, and positive team, which was always central to the core identity of Phacilitate. I do know that under Kim, that continues, which is very gratifying to me.
