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Business & Regulation Trends & Forecasts, Advanced Medicine

ISCT 2022: Post-Conference Reflections

Absence makes the heart grow fonder. You don’t know what you’ve got until it’s gone. Both cliches, but both proven very true by COVID-19. Delara Motlagh, General Manager for Cell Therapy Technologies at Terumo Blood and Cell Technologies, would likely agree that, though meeting and working online has incredible upsides, it simply cannot capture the magic of a real-world meetup. Here, we speak to Motlagh about her experience returning as in-person attendee to the International Society for Cell & Gene Therapy (ISCT) annual meeting for 2022. Issues were debated, ideas were shared, and lessons were learned. Close your eyes, and picture yourself standing by the refreshments, cup in hand, networking…

In one sentence, how would you describe ISCT 2022?
 

Fundamentally, it was a forum where folks shared their news on advancements in the industry and discussed the challenges facing cell and gene therapy – with a focus on commercializing the therapies and figuring out how we can treat more patients.

And was it a success?
 

It was a huge success! The organizers took a risk in planning the conference as an in-person event, but the turnout was great and everyone was delighted to be together once again. It really augmented the learning and the sharing.

Having gone through two consecutive years of virtual communication, we were able to appreciate how much more you can get done in person –  in everything from intricate networking to the simple act of shaking hands. There’s just no virtual substitute for it.

Aside from the shock and joy, what was new this year?
 

This year, we saw a particular focus on all the different elements that we need to commercialize our therapies. ISCT has always dealt with this topic, but this time around there was a special emphasis on really translating this talk into practical steps. Perhaps this was because everyone has been sitting on their ideas and redirecting efforts for the past two years. We saw more collaborations than usual, and I think you could tell that people have been very busy.

There was a lot of talk around automation – enough that I would say it was a key theme of the event. There was also a huge focus on the quality versus quantity of the cells that we use, which then naturally feeds into questions regarding the tools that developers will use. It was all about asking how we use the various innovations in the field to support the broader ecosystem for developing and manufacturing advanced therapies at scale.

In quality versus quantity, do you have to make some hard tradeoff decisions?
 

Yes, there are tradeoffs. For example, suppose you’re trying to grow a cell. A cell is a living thing, and just like you and I, it gets tired. So if we’re trying to reproduce a huge number of copies of that cell, it will eventually become exhausted. A cell that’s exhausted might not be as beneficial when you try to use it for therapy. The next factor to consider is the duration. If your company is trying to rack up one billion cells, it will fall a few days behind the company shooting for one million cells. The final product will look different, too.

So, to manage the tradeoff here we have to take care of those cells and make sure that we don’t exhaust them, and then we need to select the critical few that are really giving us the greatest benefits. Then we need to factor in the time that it takes to actually get that therapy back to the patient who will desperately be waiting for it.

Is automation the magic solution here?
 

Automation solves important problems. It can allow you to control the system enough to select the cells that you really want without damaging them. Automated solutions allow you to replicate your ideal microenvironment and make processes highly reproducible. All of this speeds up and standardizes the number of days needed to get that product out. It de-risks the process. Remember that a simple mistake at any point can prevent the therapy reaching the patient, so mitigating risks is crucial.

What were some of the most interesting conversations you had at ISCT?
 

There were many interesting discussions! For me, some of the most engaging among those were the conversations that turned to companies such as Novartis, whose goal is to begin with a process that can run for up to two weeks, and condense it down to just a few days.

Conversations around process testing were key here; if the testing process eats up one week then it does you no favors. Testing and validating the various parameters in the process upfront is the answer.

Another pain point we explored is the moment of collection. For all the intricacy that follows, the entire process begins with a single drop of blood. Here, standardization is the panacea. The industry is crying out for it. Standardizing the incoming product wouldn’t just benefit companies and their material-hungry pipelines – it would also ensure a better experience for patients and donors.

If you look at the ecosystem in cell and gene therapy today, you’ll see it’s already quite strained.

What changes are you expecting to see in the short, medium, and long term?
 

Ultimately we’re all here because we want to save lives, and I think the biggest hope for the industry is exactly that. These life-saving drugs have the potential to become the standard of care. The question is, how do we make that happen?

If you look at the ecosystem in cell and gene therapy today, you’ll see it’s already quite strained. We have only a limited number of centers able to deliver these therapies and every company in play is racing to accelerate their products’ pathway to the market.

The problem of “access” very often boils down to the hard problem of “cost,” and rightly so, because these are expensive therapies. Yet, if we analyze the cost, we see that it’s not the therapy itself that’s so expensive – it’s all of the different elements that go into delivering it to the patient.

How does the rise in patient headcount track against the progress of the field?
 

25,000 patients will be treated this year across all the clinical trials and commercial products. When that number hits 100,000 in the next few years, how are we going to manage?

Two factors are driving that rise in patient numbers: more trials, and a lot more commercial products. And there are two main bottlenecks: the limited number of treatment centers and our capacity to manufacture and make the drugs.

Despite these bottlenecks, we have some reasons to be hopeful. Not only do we have the means to make existing treatment centers more efficient, but we also know that there are many new entrants to the field, offering a range of different services models and opening up new sites of care. With regards to the production bottleneck, there is an opportunity for companies to have a strong presence in hospital and manufacturing settings, help with collection, and offer support to staff in optimizing their processes. If everyone does their bit, there is hope.

What is the worldwide distribution of the existing centers?
 

Distribution is definitely global, but it is also true that the lion’s share of development is in the US. If we look at the global footprint of the biotech companies driving the field, we can see that they have purposely spread themselves across various geographic regions. And that’s no accident – they’ve done it because they’re trying to treat the world.

The most concentrated areas of development outside of the US are in Europe and the Asia Pacific region. China, in particular, is demonstrating a very heavy focus on CAR T therapies. In each region, the infrastructure takes a slightly different form – and that’s really interesting. Different geographies face different challenges. Pre-pandemic, I was at a conference in Shanghai and saw several representatives from the UK’s Cell and Gene Catapult setting up collaborations with some of the centers in China, helping the centers to set up for treating people within their own province or municipality.

We are also seeing efforts to bring advanced therapies to developing countries, which will raise new questions, such as how to bring the right technologies at the right level.

What else can be done to speed the cell and gene field along on its journey?
 

The regulators are a factor that cannot be ignored. At our end, we can do all we can to accelerate manufacturing and boost access, but all of these different products must ultimately gain approval. Right now, over half of all running trials are either stalled or delayed because of CMC – chemistry manufacturing controls. CMC catches many people off guard.

Automation can help – but so will making sure that you really understand the ins and outs of your process. In that particular area, regulators are putting pressure on developers to define critical quality attributes (CQAs) and characterize their process. That said, there have been a lot of open discussions. 

Quite simply, it’s difficult for regulators to help manage living drugs. We have a history of small molecules and biologics that operate under very tight parameters. But in advanced therapy that level of standardization does not – and cannot – apply. This is personalized medicine – your cells are different from mine, so how do you govern that process? It’s a key challenge, and it comes up in every single cell therapy meeting. If you want to hear a passionate plea from a researcher or a developer, ask them about their CMC package!

In recent years, what has caught you off-guard?
 

I’d be remiss if I didn’t mention the pandemic. It threw all of us – and we’re still recovering from the supply chain challenges it triggered. We’ve been forced to reflect; how do you get the right products to the right people, and how are you moving these precious cells around the world?

But despite the chaos and crisis, I’ve been really impressed by our industry’s resilience. The trials went on, and, at a time of unprecedented global uncertainty, we saw massive investment and lean-in on streamlining processes.

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About the Author
Angus Stewart

Associate Editor of The Medicine Maker

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