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Business & Regulation Profession, Advanced Medicine, Trends & Forecasts, COVID-19

Change is the Only Constant

Across your career, what changes have you seen in cell and gene therapy?
 

The first is the annual increase in approvals. Back in 2013, at the start of my career, there were six approvals worldwide. Now, there are 23 FDA-approved therapies, and 40 worldwide. The FDA’s Peter Marks predicted that we’ll be seeing 10 approvals per year by 2025 – a prospect that is hugely exciting to this industry; after all, more approvals mean more proof-of-concepts. For example, we hit a landmark in 2016 with Novartis’ CAR T approval. Since then, we’ve seen a sustained and ongoing increase in investment, and that is a result of the therapy becoming “real.” 

The second change I’d point to is innovation. Automation, decentralized manufacturing, gene editing, viral vectors… the new technologies just keep coming! This innovation is driven by a surge in new biotech companies and technology providers – in this industry, they are second-to-none. At Phacilitate, we have to refresh our database of companies every six months to keep up with the rate of the new arrivals. Of course, it’s a great problem to have, and it’s exactly what we want to see in an immature industry progressing through the innovation stage of its development.

I had found a real passion inside myself. Most of all, I enjoyed working with patient advocates – hearing their stories about the victories that cell and gene was scoring against rare diseases and cancers.

Third, I’ll highlight the ever-increasing number of mergers and acquisitions across the industry. Take Charles River, which has acquired six companies in the last three years, helping the company advance towards its goal of becoming an end-to-end development service for cell and gene therapy research. Now we’re seeing more companies copy that strategy.

How much of your expertise have you gained on the job?
 

I didn’t come to Phacilitate from a scientific background. At that time I was a graduate who didn’t know what she wanted to do with her life, but after just eight weeks of research into the industry to help create the agendas for Phacilitate’s shows, I was sold. I had found a real passion inside myself. Most of all, I enjoyed working with patient advocates – hearing their stories about the victories that cell and gene therapies were scoring against rare diseases and cancers.

One really formative moment at that stage in my life was seeing cell and gene leader Sven Kili talk at an event at University College London. He was there to talk about Pippi, a toddler with third degree burns who had a great deal of her pain and difficulty alleviated by a cell therapy. It was a really emotional talk that profoundly affected my later career choices.

Is an unconventional career path a hindrance in this field?
 

I don’t think so. This is an innovative field subject to constant change, and that means there are many potential points of entry, and so many opportunities for upskilling and reskilling.

There’s a huge amount of goodwill out there, and in my career I’ve seen it through my mentors, advisors, and colleagues.

Typically, new hires enter via the academic route, the research route, or through industry. People not only jump from academia to industry and vice versa, but also from branch to branch – from manufacturing to clinical, for example. My first piece of advice would be a simple reminder that you don’t have to stay in your lane. You can move around, and you can learn across many parts of this industry, because it’s so innovative. Change is a constant.

This industry is also really friendly. There’s a huge amount of goodwill out there, and in my career I’ve seen it through my mentors, advisors, and colleagues. The friendlies are everywhere! Armed with that reassuring knowledge, my advice to every young professional would be: don’t be shy! Share your ideas, be creative, and build a network. You never know; one of your ideas could be the game changer that sends the industry surging forward! 

How do you feel about diversity in this field?
 

Diversity, equity, and inclusion are inseparable, and too important to ignore. Together, they form a vital aspect of developing the workforces of today, and of the future. It is the leaders who should be considered responsible for creating an inclusive workplace culture. It can take work, but it’s work that pays off by creating a fully engaged and highly productive workforce in an industry where retaining talent – or even attracting it in the first place – is getting harder.

Diversity brings other benefits, too. Without achieving diversity of thought – which diversity of background and identity can amplify greatly – you will cap your company’s level of innovation. We’ve seen this very dynamic in Phacilitate during our brainstorming sessions. Different people see problems through different lenses, and from different angles. In business, this kind of plurality is an excellent multiplier for boosting problem solving, creativity, and collaboration.

One dimension of diversity that’s very close to my heart is women in science, women in cell and gene therapy, and women in leadership. I really want to see more women holding executive roles. In cell and gene therapy, we are very lucky to have some very incredible women in leadership positions, including Claudia Zylberberg, Jacqueline Barry, Janet Lambert, and Queenie Jang.

According to a report from the Biotechnology Innovation Organization, 47 percent of the people working in biotech companies are women, but only 31 percent of biotechs’ executive team members are women, and for CEO positions the number shrinks to 23 percent. Although these are biotech numbers rather than specifically cell and gene numbers, I do think they tell us there’s still a lot of work to do.

Without achieving diversity of thought – which diversity of background and identity can amplify greatly – you will cap your company’s level of innovation.

And that’s why I launched a specialist group within Phacilitate called Women in Advanced Therapies. The group launched a mentorship program where we take a class of 20 women every year and match them into a six month mentorship. These mentors are invited by Phacilitate based on the mentees’ needs, though people can also apply to become mentors for us. Most of these women then continue these mentor–mentee relationships well beyond the end of the program. Beyond the mentorship, we also run roundtables on topics such as work-life balance, self-advocating, and creating networks. We’ve noticed that “being the only woman at the executive table” is a recurring theme in these discussions. 

Has our time in lockdown cast the “offline” world in a new light?
 

The pandemic certainly highlighted the human need for face-to-face interaction. Our customers generally agree that virtual events do not have the same impact as “the real thing.” At the Miami show we ran in 2020, two months before many countries went into lockdown, attendees told us they had become frustrated and bored with traveling to event after event. But after the first wave of the pandemic, they found the prospect of meeting in person a little more valuable. 

Real-world meetups may not be essential in every instance, but I think we’ve learned that we suffer when they are ruled out entirely. Handshakes, bustling gatherings, chance encounters, and random conversations over drinks and dinner are worthwhile life experiences in themselves, but they also grease the wheel. It can be really hard to do business without them.

There’s a need to create events that will make people think, “I really must make sure to attend next year, too.”

Of course, digital events will not fly out the window. Digital accessibility is wonderful – it can eliminate expensive, carbon-hungry transcontinental travel, and it can open doors for the less mobile. I expect virtual–live hybrid events to persist in the long term, and I expect that every organizer in the field will have their own take on that hybridity. Livestreaming and recorded sessions are excellent ways to allow for virtual attendance during and after the live event, and of course almost everyone with an internet connection is now at least a novice in the world of Zoom or Teams – two programs that transitioned from “strange and new” to the fabric of our everyday lives incredibly quickly. At Phacilitate, our customers now expect some form of virtual accessibility in all of our events, so the onus is on us to provide that – be it through streaming, recording, or Zoom rooms.

We need a diverse range of people, so it does us no good to only reach out to the most privileged candidates

Our online events are becoming more popular, however, I’m sure few of us expect a rush back to a pre-pandemic state of affairs. Despite the newfound value people seem to be seeing in live events, they also have become more choosy. Event attendance has decreased. Now, this may simply be because event marketing budgets have got tighter since the pandemic, but I think this is actually about more than numbers. For so long, event organizers have seen their attendees as numbers and not humans. Now that humans have realized that event attendance need not be arbitrary or mandatory, the organizers will need to think about what they can do to make their events really incredible experiences flush with memorable moments. There’s a need to create events that will make people think, “I really must attend next year, too.”

What will workforce development look like in a post-COVID-19 world?
 

Workforce development is a major challenge for our industry. In fact, I would say that it’s the biggest challenge that we face today in advanced therapies. At the core of the problem, we have a knowledge and skills gap, particularly in the technical workforce. From bioprocessing and manufacturing to pure cell and gene science, the roles grossly outnumber the candidates.

Curriculums – and advanced therapy’s absence from them – is one side of the problem. There are many young scientists who don’t even know that the cell and gene therapy world exists until they become postgraduates. And that’s precisely why we need to get into not just the UK’s red brick universities or America’s Ivy League, but into as many universities as possible. As I said, we need a diverse range of people, so it does us no good to only reach out to the most privileged candidates.

Besides hiring, we also need to look at upskilling, training, and talent retention –which also links to my point about diversity, as we can benefit massively from bringing in people from other sectors of the sciences, and upskilling them into the roles we need to fill. Long before hiring, it couldn’t hurt to try and bring an awareness of cell and gene therapy into schools. If advanced therapy is to be a medicine of the future, then let’s make sure it’s a future that children can imagine themselves contributing to.

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About the Author
Angus Stewart

Associate Editor of The Medicine Maker

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