In accordance with the watchwords, “speed” and “creation/maximation of product value,” the Drug Development and Regulatory Science Division has not only worked to make our processes based on conventional methodologies more efficient as possible, but has also changed our approach and overhauled our development process from square one. At the same time, we always place “science” at the top of our decision-making list as we absolutely need to get the science right. Even if we emphasize speed and proceed with testing using different methods from the previous ones, we still need to be strict and objective in considering data and to make sure that what we are doing is scientifically persuasive in terms of efficacy and safety to make a go/no go determination. We are therefore sparing no effort in our action to voraciously gather and analyze past cases and latest scientific knowledge, think through them thoroughly, and hold extensive discussions before reaching well thought-out decisions.