FDA official Dr. Peter Marks approved a gene therapy that failed trial.

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Dr. Peter Marks, a top FDA official, who overruled three teams and two top directors to approve gene therapy that failed trial: "Being able to move from one gene therapy to another without having to reinvent all of the information that's necessary about the manufacturing process, the toxicology process and it may really help us to do some regulatory streamlining which is really necessary if you want to get through hundreds of rare diseases. Because to go back and do the same toxicology, the same manufacturing information over and over again is expensive, time consuming and it really does slow down the throughput for the process."
Source: Thermo Fisher Scientific