Platform designations: FDA's new cell and gene therapy super office director sees potential
FDA’s Nicole Verdun has high expectations for a new designation that could be crucial for cell and gene therapy sponsors.
There’s “a lot of opportunity” for what will be known as a platform designation. Verdun, head of the FDA’s newly created super office, known as the Office of Therapeutic Products, said at the American Society of Cell and Gene Therapy’s policy conference on Monday that it could be specifically beneficial to gene therapies that might use the same AAV backbone and be from the same sponsor, allowing the agency to move more than one therapy forward within a shortened period of time.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.