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'“Success would be … if not exponential, at least some logarithmic progression towards more and more gene therapies being approved,” he said. The agency has approved 12 gene therapies to date, according to Marks, five of which came in 2022.
To get there, Marks and CBER have a four-poin plant: improve manufacturing through new research, clarify the use of the accelerated approval pathway for gene therapies, coordinate regulatory decisions with other regulators and launch an Operation Warp Speed for rare diseases. Easy, right?'
