Gene Therapies Make A Mark In US FDA Expedited Review Programs
More than 20 gene therapies are being developed with increased interaction under FDA’s breakthrough and regenerative medicine programs.
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FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.
As the pipeline and market for novel cell and gene therapies expands, it is time for drug developers to address other critical aspects in the logistical chain – and for these complex therapies a lot of those issues relate to manufacturing. Looking at specific cases, In Vivo has underlined the main manufacturing challenges facing cell and gene therapy developers, and highlighted methods and approaches being used to generate solutions.