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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CBER director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.
Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.
As the first company with two approved chimeric antigen receptor T-cell therapies, Gilead’s Kite subsidiary has set a precedent by keeping the pricing the same as its first approved CAR-T, Yescarta.