With welcome scientific breakthroughs catalyzing cell and gene therapy (CGT) development, more companies than ever before are now preparing to commercialize advanced medicinal products. Many firms behind the science of CGTs are emerging biotechs that do not have sales and marketing weight of large pharma. Despite this, the road to CGT market access is not insurmountable for a smaller company; ask the right questions in the planning phases of the clinical design and finding the right patients is a great beginning to a what could be a fruitful journey to the patient.
This coming year, 13 new cell or gene therapies could be approved in the US, Europe or both. 2022 was a record year for the approval of never-before-authorized gene therapies,...
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