Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said his top concern for gene therapy’s future is manufacturing, and how companies will scale up production to match scientific advances. “When the cost of goods are very high, they help justify when people charge astronomical prices,” Marks said in a recent interview with BioPharma Dive. “If we can help see cost of goods and ability to manufacture reproducibly improve, I think that’ll be a big thing. That’s something we’re working on but something that keeps me up at night.” The FDA aims to finalize six draft guidance documents by the end of 2019 related to gene therapy, including some that will address specific manufacturing issues, Marks said. Learn More