Invited Session 3: Panel Discussion-Decentralized Clinical Trial Design and Real-World Evidence in Oncology Research

Chair: Jie Chen, ECR Global

Jie Chen Dr. Jie Chen is Chief Scientific Officer at ECR Global. Before joining ECR Global, Jie was Senior Vice President and head of Biometrics at Overland Pharma (2020-2021) and a distinguished Scientist in the Biostatistics and Research Decision Sciences at Merck Research Laboratories (US) (2017-2020). He also worked as a senior global group head and/or biometrics head in several multi-national biopharmaceutical companies including Novartis, AstraZeneca, and Merck Serono.

Jie has over 28 years of experience in biopharmaceutical R&D and has been invited to give short courses at JSM, ASA Regulatory-Industry Statistics Workshops, and EMA statistics symposium and delivered invited / keynote speeches at national or international conferences. Jie currently is a co-chair for the phase3 project of the American Statistical Association (ASA) BIOP Real-World Evidence Scientific Working Group (SWG). Jie has co-authored a book on Medical Product Safety Evaluation: Biological Models and Statistical Methods (with Heyse and Lai) and published over 50 papers in peer-reviewed statistical journals. He is an elected Fellow of the ASA and a visiting member of the Center for Innovative Study Design, Stanford University.

Jie received a medical degree from Shanghai First College of Medicine (now Fudan University School of Public Health) and a Ph.D. in statistics from Temple University, Philadelphia.

Co-Chair: Ying Lu, Stanford University

Ying Lu Ying Lu, Ph.D., is Professor in the Department of Biomedical Data Science, and by courtesy in the Department of Radiology and Departement of Health Research and Policy, Stanford University. He is the Co-Director of the Stanford Center for Innovative Study Design and the Biostatistics Core of the Stanford Cancer Institute. Before his current position, he was the director of VA Cooperative Studies Program Palo Alto Coordinating Center (2009-2016) and a Professor of Biostatistics and Radiology at the University of California, San Francisco (1994-2009). His research areas are biostatistics methodology and applications in clinical trials, statistical evaluation of medical diagnostic tests, and medical decision making. He serves as the biostatistical associate Editor for JCO Precision Oncology and co-editor of the Cancer Research Section of the New England Journal of Statistics and Data Science. Dr. Lu is an elected fellow of the American Association for the Advancement of Science and the American Statistical Association. Dr. Lu initiated the Stat4Onc Annual Symposium with Dr. Ji and Dr. Kummar in 2017 and is the PI of the R13 NCI grant for this conference.

Panelist: Jing Zhao, Merck

Jing Zhao Dr. Jing Zhao is an Executive Director of Late Stage Development Statistics, Women Cancer Section Head of Oncology including Breast and GYN cancer, Biostatistics and Research Decision Sciences in Merck Research Laboratories. The Division provides industry-leading quantitative, analytical and statistical expertise to support Global Clinical Development in MRL. She graduated from University of Pennsylvania with a Ph.D. in Biostatistics and immediately joined Merck late stage development statistics. During her 18 years in Pharmaceutical Industry mainly with Merck, she has been the lead statistician in many therapeutic areas including HIV/AIDS, Anti-fungal, HCV and Oncology and has multiple successful filings endorsed by corresponding world-wide approvals for Isentress, Daklinza, Lynparza, Lenvima and Keytruda. She has led the statistical group and helped product development team develop the broad strategy for Oncology women cancer program, establishing Keytruda as part of the new standard of care. She supervises both GYN and Breast statistical teams in Merck Oncology. Her current research interests include Bayesian adaptive design, Biomarker enrichment strategy and Group Sequential Design in application of Oncology trials. Dr. Zhao has authored or co-authored more than 40+ clinical, statistical and scientific peer-reviewed publications and over 50+ scientific conference presentations, with expertise in Bayesian statistics.

Panelist: Hana Lee, FDA

Hana Lee Hana Lee, PhD, is a Senior Statistical Reviewer of the Office of Biostatistics (OB) in the CDER, FDA. She leads and oversees various FDA-funded projects intended to support development of the agency’s RWE program including multiple projects to develop causal inference framework for conducting non-randomized studies, to enhance analytic capacity using machine learning-based methods, and to implement sensitivity analysis for RWE studies to support regulatory decision-making. She is currently a co-lead of the RWE scientific working group of the American Statistical Association (ASA) Biopharmaceutical Section, which is a CDER-FDA public private partnership involving scientists from FDA, academia, and industry to advance the understanding of RWD/E to support regulatory decision-making.

Panelist: Weili He, AbbVie

Weili He Dr. Weili He has over 25 years of experience working in the biopharmaceutical industry. She is currently a Distinguished Research Fellow and head of Medical Affairs and Health Technology Assessment statistics at AbbVie. She has a PhD in Biostatistics. Weili’s areas of expertise span across clinical trials, real-world studies and evidence generations, statistical methodologies in clinical trials, observational research, innovative adaptive designs, and benefit-risk assessment. She is the lead or co-author of more than 60 peer-reviewed publications in statistics or medical journals and lead editor of three books on adaptive design, benefit-risk assessment, and RWE (to be published in April or May 2023), respectively. She is the co-founder and co-chair of the American Statistical Association (ASA) Biopharmaceutical Section (BIOP) Real-world Evidence Scientific Working Group from 2018 to 2022. Weili is the BIOP Chair-Elect, Chair, and Past Chair from 2020-2022. She is also an Associate Editor of Statistics in Biopharmaceutical Research since 2014, and an elected Fellow of ASA since 2018.

Panelist: Sammi Tang, Servier Pharmaceuticals

Sammi Tang Dr. Rui (Sammi) Tang is a leading expert of biostatistics in the biotech/pharmaceutical industry and she is currently the VP, Global Head of Biometric of Oncology at Servier Pharmaceuticals. Prior to join Servier she was the Biostatistics Therapeutic Area Head for multiple teams at Shire Pharmaceuticals including oncology, Transplants, Ophthalmology and prematurity neonates. Sammi’s research interests are primarily in the area of adaptive clinical trial design and statistical issues in precision medicine. She has authored more than 40 articles in peer-reviewed scientific journals on methodology, study design, data analysis and reporting and is a co-inventor of several patents. Sammi is co-founder of DahShu which is a 501(c)(3) non-profit organization, founded to promote research and education of 5000 members. She is leading teams in the DIA (Drug Information Association) Innovative design scientific working group of oncology drug development and small population working group for rare disease statistical methodology development.