Lessons from the first generation of cell and gene oncology trials

Advances in cell and gene science are paving the way for transformative cancer treatments, but there are still many complexities in delivering clinical trials for these therapies. ICON’s Tamie Joeckel and Brandon Fletcher take us through best-practice approaches to CGT studies and discuss what the future could hold for this exciting area.

Cell and gene therapies (CGTs) might be showing amazing promise in tackling cancers that were previously thought almost-untreatable, but their novelty and complexity mean the industry is still working out how best to run trials for these therapies – which have some key differences from ‘traditional’ studies.

ICON was one of the first CROs of scale managing CGT trials, and Tamie Joeckel, the company’s global business lead for their cell & gene therapy center of excellence, says they have learnt from first-hand experience what does and does not work.

“When we first started working in the earliest CAR-T programmes, there was definitely an overall lack of awareness of how these trials are different from traditional studies,” she says. “We were literally learning alongside our sponsors.

“As research in the area has grown, we do see more discussions and participate with various organizations on the work around defining standards – but there are still gaps.”

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