I’d like to begin sharing my lessons learned with the community–a “practical” approach that I have been developing while working in the trenches of the Biotechnology industry. For now, I call it “Lean & Agile DOE for QbD.” As a researcher-for-life, I observed what worked and what did not....

How much does it cost to develop a new drug? The answer, of course, depends on which product and which company we are dealing with. However, a Forbes journalist, Herper (2013) attempted to answer this question at a high level based on a study done by Dimasi (2003). As with...

QbDWorks is a resource website dedicated to Quality by Design for Biotech, Pharmaceutical and Medical Devices. Hello, I’m Sun Kim, PhD. I’ve been working inside (and outside) the Biotech, Medical Device field for 10 years with the goal of innovating how we develop products (drug, therapy, medical device, equipment, and service...