Dose Finding and Beyond in Biopharmaceutical Development

About

Jingjing Ye is a Fellow of American Statistical Association and is currently an executive director and global head of Data Science and Digital Innovations (DSDI) with Global Statistics and Data Sciences (GSDS) in BeiGene. She leads a global team with diverse background supporting business functions in R&D and outside R&D for their data analytics and technology support. She has over 17 years experience in pharmaceutical industry and US FDA with focus in cancer drug discovery and development. Her statistical and regulatory experience expands full spectrum on patients treatment journey from diagnosis treatment to living with the condition. Her main research interest is the innovative trial designs and analyses related to small populations e.g. pediatric and rare diseases. She received her PhD degree in statistics from University of California Davis and BS in applied mathematics from Peking University. Ding-Geng Chen is a fellow of the American Statistical Association and is currently the executive director and professor in biostatistics at the College of Health Solutions Arizona State University. He is also an extraordinary professor and the SARChI in biostatistics at the University of Pretoria an honorary professor at the University of KwaZulu-Natal South Africa. Dr. Chen has more than 200 referred professional publications and co-authored and co-edited 35 books on clinical trial methodology meta-analysis data science causal inference and public health research. Wen Zhou is an Associate Professor in the Department of Biostatistics at the School of Global Public Health New York University. He is an elected member of International Statistical Institute. His research area includes high dimensional inference statistical genomics and genetics network analysis robust statistics and causal inference. Currently he is serving as the associate editor for Biometrics Journal of Multivariate Analysis Statistica Sinica as well as the Co-editor in chief of the Journal of Biopharmaceutical Statistics. Qiqi Deng is a Director in Clinical Biostatistics at Moderna. Her main research area includes hypothesis testing and modeling in dose finding adaptive design and pragmatic considerations in applying innovative methodology into real clinical studies. She publishes on wide array of statistical topics in her main area and beyond e.g. multiplicity adjustment Bayesian statistics Joseph C. Cappelleri is an executive director of biostatistics at Pfizer Inc his employer since June 1996 and is the recipient of the companys Craig A. Saxton Clinical Development Excellence Award. He has co-authored approximately 1350 external presentations and 650 publications on clinical and methodological topics including on regression discontinuity designs meta- analysis and health measurement scales. Dr. Cappelleri is the lead author of the book Patient-Reported Outcomes: Measurement Implementation and Interpretation and has co-authored or co-edited four other books (Statistical Topics in Health Economics and Outcomes Research Phase II Clinical Development of New Drugs Design and Analysis of Subgroups with Biopharmaceutical Applications A Practical Approach to Quantitative Validation of Patient-Reported Outcomes: A Simulation-Based Guide Using SAS).