According to an analysis, 11 pharmaceutical companies led by Pfizer and Novartis have earmarked a combined $2 billion to invest in gene therapy manufacturing since 2018, as reported by the Financial Post.
The news source said that Pfizer has allocated $600 million to build its own gene therapy manufacturing plants, while the full scope of Novartis' $500-million plan, revealed by the company's gene therapy chief, has not been previously disclosed.
Bob Smith, who heads Pfizer's global gene therapy business, acknowledged that drugmakers take a "leap of faith" when they make big capital investment outlays for treatments before they have been approved, or even produced data demonstrating a benefit in some cases.
Meanwhile, David Lennon, president of Novartis' AveXis unit, noted "there's so little capacity and capability at contract manufacturers for the novel gene therapy processes being developed...We need internal manufacturing capabilities in the long term."
However, the FDA is keeping a close eye on standards, amid a probe of alleged data manipulation for Novartis' gene therapy Zolgensma by former executives at its AveXis unit. They allegedly altered data to cover up discrepancies after AveXis had switched its method for measuring Zolgensma's potency in animal studies.
The news sources cites four industry executives as saying the FDA has stressed in recent meetings the need for continuity in production processes all the way from the development of a drug to its commercialization. The FDA is finalizing new guidelines for gene therapy manufacturing, expected at the end of the year.
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