As many begin to show proof-of-concept in a range of disease indications, cell and gene therapies (CGTs) have quickly become one of the most talked-about areas of development in the pharmaceutical industry. The US Food and Drug Administration (FDA) has now approved more than 30 CGTs and plenty more are currently making their way through clinical trials globally.
Although CGTs have the potential to be breakthrough medications in a vast range of therapeutic areas, there are significant hurdles that must be overcome during the development process — before even considering commercialisation. Therefore, pharmaceutical companies and manufacturers must find ways to mitigate these issues to make such therapies available to patients as quickly as possible.
At Charles River’s recent Cell and Gene Therapy Summit in London, UK, a panel of experts sat down to talk about what companies should be considering when trying to develop and bring a cell and gene therapy to market. During their discussion, all participants unanimously agreed that companies should focus on problem solving early on; one way that CGT companies can approach this, they said, is by developing a clinically sound and simple potency assay.
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