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Improving clinical trials for cell and gene therapies

As Strategic Implementation Manager at Bayer US, Dan Tierno is focused on making clinical trials ‘faster, cheaper and, most importantly, targeting the right populations’. Alongside the Clinical Information and Analytics group he is part of, he works across a range of therapeutics, but predominantly on cell and gene therapies – a space he calls the ‘future for drug development, particularly when you talk about a cure based model’.

Speaking at Biotech Week Boston, he explains the importance of a data-led approach:

‘We're tasked with looking at new technologies, and the implementation of those technologies, to make clinical trials perform faster, as well as to acquire data for us to design more efficient trials in the future…How can we generate real world evidence such that we can get a very keen and rapid understanding of how drugs are affecting patients and take those learnings and adapt them to new clinical trials?’

 

Development of cell and gene therapies

Though Tierno’s focus is firmly on clinical trials, he is clear that this is just one part of a wider process – ‘you see different phases of ramp up, followed by periods of, not stagnation, but digestion’. He explains:

‘If you were to chart the industry's progression in the cell and gene therapy space, you get phases. You get a phase of academic research that really ramps up and generates a lot of excitement. Then from there the adaptation to be able to take those academic discoveries and translate them into industry; to be able to actually create scalable therapeutics. Once you get it to a clinical trial, then it's the regulatory questions that come; the ability to satisfy the regulatory body's knowledge base and their requirements. Then from there, commercialization.’

Throughout this cycle, Tierno is realistic about the balance between business and the desire to help people:

‘Beyond the promise of the therapeutics and the idea of creating cures for people, and beyond the ability to make healthcare less burdensome for the general population, it's our responsibility as scientists, and those who work in every facet of this industry, to do everything we can to make medicines for unmet clinical needs.

It's always a business, naturally, and we have to pay attention to the fact that this industry employs millions of people worldwide - which is also a wonderful benefit of what we do - but first and foremost we're here to make sure we're making the right drugs for the right people the safest and fastest way possible. I see this cell and gene therapeutics space as an amazing opportunity to get to the next frontier of treating patients.’

Watch the full interview above or here.

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