Scott Gottlieb: The Future Of The CGT Regulatory Paradigm

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

When I transitioned from the biosimilar industry into the cell and gene therapy (CGT) space, the irony of such a transition wasn’t lost on me. I was making a leap from one end of the innovation and patient access spectrum to the other.

On the one hand, biosimilars are a celebration of what is possible when we know the analytical and clinical profile of a molecule so well that we can replicate it, manufacture it at a large scale, and sell it at a discount. Such a development expands patient access and frees up healthcare funds to cover innovative treatments — including CGT treatments.