Rossana García, CEO of Gradocell, was part of the round table on “Regulations and Clinical Trials for Advanced Therapy Medicinal Products,” of the 38th Symposium of AEFI (Spanish Association of Industry Pharmacists).
During her lecture, she explained that, in the last years, in Europe, 290 clinical trials were requested for products classified as advanced therapies. 19 of these research projects were recommended for authorization for commercial use, but only 10 were actually authorized. Moreover, she stated that at the end of 2017, only six of these medicines were still on the market, which shows that, in her words, “the bottleneck in regenerative medicine is real.”
