TL39: How to promote/advocate the statistics leadership in pharmaceutical development: chemistry, manufacturing and control (CMC) area?
*Sutan Wu, CDER/FDA 


"In pharmaceutical industry, the importance and functions of statistician in pharmaceutical development area is generally less emphasized compared to clinical development. However, with the rapid development of biotech and biopharmaceutical industry, and the implementations of modern and sophisticated manufacturing, process and control techniques, the demand of the statistical application such as modern study designs, predictive modeling, and data mining becomes higher and higher.

Therefore, in this roundtable, we are going to discuss how statisticians can utilize this stat in-strong-need trend and provide more statistical leadership in decision making and strategy planning in CMC area.

We are going to discuss the following issues:

1) What are the challenges/difficulties the statistician face in pharmaceutical development and how to conquer/solve these challenges/difficulties? 2) How to implement and emphasize Quality by Design, Process validation and Process monitoring in practice? 3) How to promote/educate modern statistics such as data mining techniques in a more interactive way given a multi-discipline environment? 4) How to improve/promote data visualization in decision making and strategy planning? "