Rossana García, CEO of Gradocell, participated in the round table ‘Regulation and clinical trials with advanced therapy medicinal product’, organized in the framework of the 38th Symposium of AEFI.
During her speech, he assured that in recent years 290 clinical trials were requested with products classified as advanced therapies in Europe. Of these investigations, 19 received marketing authorization recommendations and 10 were authorized. In addition, she pointed out, at the end of 2017 only 6 drugs of this type continue on the market, which shows, she said, “that the bottleneck in regenerative medicine is real”.
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