Dr. Larisa Wu is the Associate Director for Science and Communication in the Office of New Drug Products (ONDP) at US FDA. Larisa has been with the Agency since 2011, starting her career as a Chemistry Reviewer. Over the years, Larisa contributed significantly to various initiatives that became pivotal to the launch of Office of Pharmaceutical Quality (OPQ), including integrated team-based quality assessment (IQA), risk-based review, and ANDA backlog review and management. After OPQ stood up in 2015, Larisa was a Special Assistant in the OPQ Immediate Office and worked extensively on several FDA, CDER, and OPQ initiatives including: Knowledge-aided Assessment and Structured Application (KASA), Concept of Operations (ConOps) for Inspection of Human Drugs, Process and Facility Integration, OPQ Secondary Assessment, and BARDA-FDA Drug Shortage Program. Most recently, Larisa leads the FDA KASA for NDAs initiative, and serves as the Rapporteur Supporter and Content Manager of the ICH M4Q(R2) Expert Working Group. Larisa received her Ph.D. degree in Bioengineering from University of Utah, followed by a postdoctoral fellowship in Pharmaceutical Sciences at University of Maryland, School of Pharmacy. She also holds an M.S. degree in Chemistry from University of New Orleans and a B.S. degree in Medical Bioengineering from University of Medicine and Pharmacy ‘Grigore T Popa’ Iasi, Romania.