FDA's Marks Sees 'Two Or Three Year Window' To Transform Gene Therapy Environment
Agency has to ‘think creatively’ to make gene therapies commercially viable, CBER director says, suggesting greater use of accelerated approval endpoints and advancing manufacturing technologies. Center is focused on recruiting mid-level career people with manufacturing experience.
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FDA’s Peter Marks says educating academics about CMC would help them understand why it is necessary to do things in a standardized way. He predicts the field will move away from individual manufacturing platforms in the next five to 10 years.
CBER director does not want to hold back potentially beneficial products, but also warned that patients will have difficult treatment decisions to make since an immune response might prevent a patient from receiving another gene therapy using the same vector ever again.
CBER’s director says manufacturing and regulatory issues need to be resolved to ensure the gene therapy sector thrives.