By Kumar Dhanasekharan, Ph.D.
In drug development, you need to balance speed-to-market with mitigating critical risks impacting scale-up and operation during GMP manufacturing. Achieving that balance can be difficult as the industry looks to shorten timelines. Risk management principles, when applied correctly, will moderate speed to prevent catastrophic failures. There are three key principles that must be applied early in drug development to meet both requirements of speed and risk control successfully — simplicity, efficiency, and effectiveness (SEE).