Larisa Wu, PhD
Associate Director for Science and Communication
Office of New Drug Products (ONDP)/Office of Pharmaceutical Quality (OPQ)/Center for Drug
Evaluation and Research (CDER)/US FDA
United States of America
This presentation will talk about FDA’s efforts to modernize quality assessment and enhance submission format. FDA’s Knowledge-aided Assessment and Structured Application (KASA) initiative is a creative regulatory approach developed as a data-based platform that captures and manages knowledge during the lifecycle of a drug product. Although currently KASA primarily serves as an assessment tool, knowledge-aided assessment (KA) will be greatly enhanced when applicants will submit structured applications (SA) with standardized data aligned with the assessment system. New initiatives such as revision of ICH M4Q guideline and pharmaceutical quality electronic data standards are intended to modernize regulatory submissions to be structured and standardized, which can significantly reduce the data management burden in KA. These long-term efforts will bring the quality assessment into the 21st Century by eliminating the need for transcription; increasing access to information; enabling analytics; streamlining regulatory review; facilitating surveillance of pharmaceutical product quality; increasing consistency and efficiency in regulatory decision-making and actions; and improving communication with industry.
About the speaker:
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.