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Gene therapy’s next chapter: manufacturing and regulatory innovation

ARTICLE | Product Development

FDA’s Marks, CEOs outline strategies to accelerate development

By Lauren Martz, Executive Director, Biopharma Intelligence

January 16, 2024 10:18 PM UTC

The business model for gene therapies in rare disease is still broken, but a series of FDA initiatives and shifts in strategic priorities at biotechs may be the solutions that extend the reach of these products to more indications and draw in more pharmas.

Peter Marks, director of FDA’s Center for Biologics Evaluation and Review (CBER), outlined several projects designed to incentivize gene therapy development for rare diseases and accelerate the approval process at the Alliance for Regenerative Medicine’s Cell & Gene Therapy State of the Industry briefing during last week’s J.P. Morgan Healthcare Conference.  …