In-depth articles and expert analysis from pharmaceutical leaders, exploring advances in life sciences, drug development and the trends shaping healthcare innovation.
ADC manufacturing is becoming more complex as payloads, conjugation, lyophilisation, containment, and scale-up reshape CMC strategy and commercial readiness.
FDA Expedited IND Pilot Targets Faster First-In-Human Trials
The FDA’s Expedited IND Pilot introduces rolling review and sponsor-QRI partnerships to accelerate Phase I first-in-human trials while retaining regulatory oversight.