In nearly all industries, there has been a general shift away from on-site construction to prefabricated solutions. Specifically, the requirement in the biopharmaceutical industry to address speed to market and lower the total cost of ownership for facilities has accelerated this movement. More recently, the impact of COVID on our society has placed a strain on how we operate while also creating an immense need for additional capacity.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.