Authors
Bo Fu
Sr. Director, Astellas, China
Weili He, PhD
Volwiler Distinguished Research Fellow; Head, Global Medical Affairs Statistics, AbbVie, United States
Dr. Weili He is a Senior Director, head of Global Medical Affairs Statistics at AbbVie Inc. Prior to AbbVie, she worked at Merck & Co., Inc. for over 20 years. Weili has published extensively in the areas of adaptive designs (AD), benefit-risk assessment (BRA), and RWE methodology research. Since joining AbbVie in February 2017, Weili has involved extensively in RWD and RWE research for evidence generations. She is the co-founder and co-chair of the ASA Biopharm Section (BIOP) RWE SWG since 2018. The SWG’s efforts in the past 2+ yeas resulted in three peer-review publications in a statistical journal. Weili is also the BIOP Chair 2021, an AE for the journal of the SBR since January 2014, and an elected Fellow of the ASA.
Meredith Smith, PhD, MPA, FISPE
Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States
Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years of experience in health outcomes, drug safety and regulatory policy in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER and is an adjunct professor at the University of Southern California School of Pharmacy. She has been a pioneer in the application of Implementation Science methods within the context of drug development and has published widely in the peer-reviewed literature.
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