Should cell- and gene-therapy developers engage with regulatory authorities?

This article concerns engaging with regulatory authorities by those developing novel cell- or gene-therapy-based treatments. From the view of regulators, the aim of engaging so is to improve the quality of development such that the correct decision can later be made by the regulator, whether at clinical trial application or on licensing the product for market access. The aim is to influence development such that products may come to market more quickly, to allow patients to benefit. Whereas larger organizations typically retain specialist regulatory staff, smaller organizations may be less aware of regulators’ expectations. This article seeks to make those in this space aware of the idea to engage with regulatory authorities. The primary focus is seeking advice in Europe but the concepts may have application in other regulatory territories.

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