R&D

While regulators are “catching up” to the use of artificial intelligence in clinical development, some skepticism remains around the use of AI to generate synthetic patient data, says Alexion’s Nick France.

The first multinational clinical trial approval under the EU’s 70‑day fast-track pilot pathway is expected by the end of April 2026.

The agency offered to drop annual IND fees for sponsors not conducting Phase I trials in the US, but industry still raised several concerns about fee incentives for onshoring clinical development.

The EU remains a major global player in biopharma but needs to act quickly or risk falling further behind its rivals, according to EFPIA.