Scientific leaps forward have opened the floodgates of interest and investment in gene therapy. With the advent of safe and effective gene therapy vectors, such as Adeno Associated Virus (AAV) vectors, the US Food and Drug Administration has seen a “surge” in gene therapy products in early development, as noted by Center for Biologics Evaluation and Review Director Peter Marks and then-FDA Commissioner Scott Gottlieb last year.
Scientific Wave Pushes CBER Into Brighter Light
What are US regulators doing to prepare for adequate review of the upcoming wave of gene therapy applications, and what other actions could CBER take to ensure it is able to facilitate the expected onslaught of breakthroughs in this field? Consultant Nancy Bradish Myers weighs in.
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