Opportunities and Challenges for Statisticians in Advanced Pharmaceutical Manufacturing

Abstract

Advanced pharmaceutical manufacturing technologies have the potential to make substantial contributions toward reducing waste, cost, and cycle time. However, the steady introduction of advanced manufacturing systems such as continuous manufacturing processes, automated microbioreactors, robotics, etc. create both challenges and opportunities for nonclinical statisticians who support chemistry and manufacturing control (CMC) activities in the pharmaceutical industry. Not only will closer collaboration be essential for optimal utilization of statistical tools, but CMC statisticians may need to acquire new engineering statistical skills as well as some knowledge of how to deal with “big data” issues. It is also expected that the confluence of advanced manufacturing technologies and statistical methods will require input from nonclinical statisticians on some regulatory issues. The purpose of this article is not only to alert CMC statisticians to these opportunities and challenges, but to provide a call-to-action for the industry and academia to better prepare statisticians for careers in modern manufacturing environments.