LONDON It was a love-in to celebrate the 20th anniversary of the EMA and the start of centralized approvals across Europe, but Elias Zerhouni, president of global R&D at Sanofi SA, pulled few punches in his keynote address, calling for greater consistency, increased speed and a more science-based approach to regulation.
"If we don't work together, we will hit the iceberg, which is the rising tide of disease, particularly chronic disease," Zerhouni said, as he itemized what the industry needs from the EMA over the next five years.
The industry's success in securing investment and delivering new treatments is circumscribed by the regulatory systems under which it operates. "We, as innovators, have to make decisions on investments that are increasingly large," Zerhouni said.
Divergence in regulatory policy and lack of synchronization is making it harder and harder to justify paying for large-scale trials. One example from