Sally Choe, Ph.D., Senior Director, at PAREXEL Consulting, provides expert consulting on issues ranging from drug discovery and development process to the regulatory review and approval, and pertinent regulations and guidances focused in US and Japan regions. She has extensive government and pharmaceutical industry experience, including designing and reviewing of clinical trials in the areas of clinical pharmacology, biopharmaceutics relating to In Vivo-In Vitro Correlation (IVIVC) and Biopharmaceutics Classification System (BCS), and efficacy/safety to support global registration of new drug candidates. Before joining PAREXEL, Dr. Choe was a team leader in the Office of Clinical Pharmacology at the Food and Drug Administration.