Timothy J. Watson, Pfizer Inc, Groton, CT, Kevin Fitzpatrick, CMC Regulatory Affairs, AbbVie, North Chicago, IL, Anita Lalloo, Merck & Co., Inc., West Point, PA, Pablo Rolandi, Digital Integration and Predictive Technologies, Amgen Inc, Cambridge, MA, Billie Kline, Chemical and Materials Engineering, Vertex Pharmaceuticals, Boston, MA, Thomas D. Roper, Chemical and Life Science Engineering, Virginia Commonwealth University, Richmond, VA and Sharmista Chatterjee, FDA/CDER/OPQ/OPF, Silver Spring, MD