Robert G. Baum, Ph.D.: From 2002 through February 2011, Dr. Baum was Executive Director of Global Regulatory CMC Policy for Pfizer Global Research and Development. Previously, he headed Analytical Research and Development at Pharmacia in Skokie, Illinois where his responsibilities included the direction of overall methods and specifications development, stability evaluation of new chemical entities and clinical dosage forms, and the characterization of non-clinical dosage forms used in GLP toxicology studies. He received a Ph.D. in Chemistry from Michigan State University and did post-doctoral research at the University of Alberta. Dr. Baum has been a member of the PhRMA Technical Leadership Committee, and he is currently the ICH Quality Lead for PHRMA, where he has been involved in the development of ICH guidelines on Method Validation, Impurities in Drug Products, Photostability Testing, the Common Technical Document, and Pharmaceutical Development. Additionally, he has co-chaired ICH discussions on the development of an overall ICH Quality Strategy, and he is currently a member of the ICH Q8, Q9, Q10 Implementation Working Group.