SELECT * FROM sessions where years='2017' and sequence=122
December 4-8, 2017 at Atlantic City, New Jersey
The 73rd Deming Conference on Applied Statistics
Sponsored by Metropolitan Section, ASQ and Biopharmaceutical Section, ASA

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Benefit–Risk Assessment and Utility of Real World Evidence in Medical Product Development and Life Cycle Management

Speaker(s): Dr. Weili He, Abbvie
Dr. Qi Jiang, Amgen.
Moderator: Alfred H. Balch

Dr. Weili He is the head of Global Medical Affairs Statistics, Data and Statistical Sciences at AbbVie. Prior to joining AbbVie, Weili worked in Clinical Biostatistics at Merck & Co., Inc. for over 20 years. Her research interests include survival and longitudinal data modeling, missing data imputation, cancer Phase I & II designs, repeated categorical data modeling, surrogate marker evaluations, adaptive design methodologies and implementations, methods for benefit-risk assessment, and methods utilizing real world evidence to augment clinical research and HTA assessment. Dr. He has published extensively in the areas of adaptive designs and benefit-risk evaluations, and is the author of more than 50 peer-reviewed publications in statistical and medical journals. She is also an editor of the book, “Practical Considerations for Adaptive Trial Design and Implementation”, published by Springer in 2014, and the book, “Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments”, published by CRC Press in 2016. She has also been involved in many professional activities and services, including serving as co-chair of the QSPI Benefit-Risk working group since 2013, co-chair of the DIA ADSWG KOL lecture series from 2012-2016, co-lead of the DIA ADSWG Best Practice Subteam from 2014-2016, Associate Editor for the journal of Statistics in Biopharmaceutical Research (SBR) since 2014, and co-chair of the 2017 ASA Biopharmaceutical Regulatory-Industry workshop. In her current role at AbbVie, Weili has been extensively involved in strategic and methodologic research in real world data and real world evidence.

Dr. Qi Jiang is an Executive Director of Global Biostatistical Science at Amgen. In this role, she is biostatistical therapeutic area head for oncology and hematology and is the lead of the Center of Excellence for Safety and Benefit-Risk. In addition, Qi provides oversight to Amgen’s biostatistical efforts in Asia Pacific. Before joining Amgen, Qi worked at the Harvard School of Public Health, Merck, and Novartis. Qi has many years of clinical trial experience across a broad spectrum of therapeutic areas and has authored over 70 peer-reviewed publications on method development, study design, and data analysis and reporting. In addition, Qi is an editor of the book “Quantitative Evaluation of Safety in Drug Development” published in 2014, and an editor of the book “Benefit-Risk Assessment Methods in Medical Product Development” published in 2016. Qi is also a co-lead of American Statistical Association Biopharmaceutical Section Safety Working Group and a co-lead of the Quantitative Sciences in the Pharmaceutical Industry (QSPI) Benefit-Risk working group. Qi is an Associate Editor for Statistics in Biopharmaceutical Research and is a Fellow of the American Statistical Association.

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