Gene Therapy Manufacturing Hurdle: Sponsors Unwilling To Share ‘Secret Sauce’
US FDA’s Peter Marks says companies are not exchanging information about adenoviral factors, which is probably slowing down the field. He describes NIH's plans for a bespoke gene therapy consortium for vector generation and continued efforts for regulatory harmonization.
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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.
US FDA Exploring Consortium To Develop Treatments For ‘Economically Infeasible’ Cancer Indications
The FDA could partner with industry, academia and advocacy groups to speed development of novel treatments for cancers that are not commercially viable.
Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?
CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.