How Can Biopharma Companies Effectively Maintain Quality And Manage Risk While Rapidly Scaling Up Operations?

IT’S ALL IN THE SETUP. YOUR FOUNDATION NEEDS TO INCLUDE, MINIMALLY, THREE AREAS: 1) a robust quality system/process ownership 2) an understanding of your quality data and 3) an engaged quality risk culture. These three elements cannot be implemented as afterthoughts. If you need to scale up, and do not have control of your processes and data, you should reevaluate the objectives and overall scale-up strategy. Failing to first bring systems and processes to a state of control and attempting to move in an exponential manner will quickly bring to surface quality gaps and materialization of risks. For risk engagement, you must recognize the importance of risk identification and focus on the risks that matter.

JASON URBAN, PH.D. is executive director, R&D quality risk management, governance, and analytics at Gilead Sciences.