Biography
Dr. Likun Wang
Dr. Likun Wang
Jiangsu Hengrui Medical Co. Ltd., China
Title: A Quality-by-Design Approach for Drug Stability Prediction and Packaging Selection
Abstract: 
Stability is an important feather for both drug substance and drug product as both safety and efficacy of drug product can be influenced by stability behavior. However, current acceleratedstability testing recommend by ICH is not able to predict long-term stability while taking considerably long time, i.e. 3 or 6 months. In this presentation a quality-by-design approach for drug stabilityprediction and packaging selection was presented. Moisture-sensitivity corrected Arrihnius equation was used to model the degradation kinetics while the water sorption behavior of drug substance/product is measured by a dynamic vapor sorption (DVS) system.Moisture vapor transmissionrate (MVTR) of different packaging materials, i.e. PVC, Aclar, were measured and Monte-Carlo simulation was used to estimate the confidence intervalof predicted degradant(s). Samples were stressed under combination conditions of different temperature, relative humidity for different time. Shorter stressing time was used for more aggressive stressing conditions in order to reach isoconverstion state as much as possible. Impurity was then quantified by HPLC and activation energy (Ea), moisturesensitivity term (B) can be obtained by surface-fitting experimental data into modifiedArrihniusequation. Drug substance/product stability as a function of packaging materials and storage conditions can be predicted reliably by the model. Case studies of using accelerated stability assessment program (ASAP) for stability prediction of different solid-state forms and drug product are also given.
Biography: 
EDUCATION
Ph.D., Pharmaceutical Processing Technology, April 2011, National University of Singapore, Singapore
B.E., Biomedical Engineering (Medical Devices), June 2006, Zhejiang University, China

EXPERIENCE
Director, Nanjing R&D Site, JiangSu HengRui Medical Co. Ltd. Sept 2015 ~ Present (leading ~20 scientists)
Plan & build Nanjing R&D site: recruited and built NME, Generics and Biopharmaceutics R&D teams for Nanjing R&D
Responsible for SM NME preformulation & early development (10-15 NMEs per year)
Responsible for SM generics formulation innovation & biopharmaceutics support (5-10 projects per year)
Talent recruitment & R&D team building 
External Innovation & Collaboration with Universities & Research Institutes