AIFA President Nisticò discusses pharmaceutical innovation and drug authorization

Robert Nisticò, President of the Italian Medicines Agency (AIFA), highlighted the rapid advancements in scientific research and the development of increasingly targeted therapies. In a recent interview, Nisticò noted that innovation is shifting focus from merely treating symptoms to addressing the underlying biological processes of diseases.

Key advancements mentioned include gene therapy, genomic editing, and CAR-T cell therapies, which engineer a patient's own lymphocytes to recognize and attack tumor cells. These sophisticated treatments aim to improve both disease progression and patient quality of life.

Regarding the regulatory process, Nisticò explained that drug authorization begins at the European level through the European Medicines Agency (EMA) based on a benefit-risk assessment. Following EMA approval, individual member states, such as Italy, conduct further evaluations regarding the sustainability of the treatments within their respective national health services.