Amid ongoing difficulties in the development and approval of gene therapies, US and EU regulatory leaders have said they want to help biopharma to reduce the hold-ups and surprises which have plagued the sector - though the industry may well reflect that this is a two-way street.
Speaking at a cell and gene therapy conference, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration and the European Medicines Agency’s head of advanced therapies, Ana Hidalgo-Simon, said regulators and industry needed to work
