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Benefit-Risk Assessment to Support the FDA’s Decision on Vaccines for SARS-CoV-2

Hong Yang, PhD – FDA/CBER/OBPV ### 1991148###Presenting Author###Biologist###FDA/CBER/OBPV###
Presenting Author: Hong Yang, PhD – FDA/CBER/OBPV
###
Benzodiazepine use early in pregnancy and risk of congenital malformations

Ayesha C. Sujan, PhD (she/her/hers) – Stanford University ### 1991327###Presenting Author###Postdoctoral scholar###Stanford University###
Presenting Author: Ayesha C. Sujan, PhD (she/her/hers) – Stanford University
### she/her/hers @@@ Brian T. Bateman, MD, MSc – Department of Anesthesiology, Perioperative and Pain Medicine, Department of Epidemiology and Population Health, Stanford University School of Medicine ### 1088175###Co-Author######Department of Anesthesiology, Perioperative and Pain Medicine, Department of Epidemiology and Population Health, Stanford University School of Medicine###
Co-Author: Brian T. Bateman, MD, MSc – Department of Anesthesiology, Perioperative and Pain Medicine, Department of Epidemiology and Population Health, Stanford University School of Medicine
### @@@ Loreen Straub, MD MS – Brigham and Women's Hospital/Harvard Medical School ### 1062604###Co-Author###Research Fellow###Brigham and Women's Hospital/Harvard Medical School###
Co-Author: Loreen Straub, MD MS – Brigham and Women's Hospital/Harvard Medical School
### @@@ Sonia Hernandez-Diaz, MD, DPH, FISPE – Harvard University ### 1093997###Co-Author###Professor of Epidemiology###Harvard University###
Co-Author: Sonia Hernandez-Diaz, MD, DPH, FISPE – Harvard University
### @@@ Yanmin Zhu, MS, PhD – Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA ### 1063282###Co-Author###Instructor in Medicine###Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA###
Co-Author: Yanmin Zhu, MS, PhD – Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA
### @@@ Gregory Brill – Brigham and Women's Hospital ### 1655926###Co-Author###Programmer###Brigham and Women's Hospital###
Co-Author: Gregory Brill – Brigham and Women's Hospital
### @@@ Krista F. Huybrechts, MS, PhD, FISPE – Brigham and Women's Hospital, Harvard Medical School ### 1359931###Co-Author######Brigham and Women's Hospital, Harvard Medical School###
Co-Author: Krista F. Huybrechts, MS, PhD, FISPE – Brigham and Women's Hospital, Harvard Medical School
###
Beyond the Beaver Tail in Clinical Epidemiology

Vincent Lo Re, III, MD, MSCE (he/him/his) – Perelman School of Medicine at the University of Pennsylvania ### 1359970###Co-Moderator###Associate Professor of Medicine and Epidemiology###Perelman School of Medicine at the University of Pennsylvania###
Co-Moderator: Vincent Lo Re, III, MD, MSCE (he/him/his) – Perelman School of Medicine at the University of Pennsylvania
### he/him/his @@@ Patrice Verpillat, MD, MPH, PhD – European Medicines Agency ### 1409656###Co-Moderator###Head of Real World Evidence###European Medicines Agency###
Co-Moderator: Patrice Verpillat, MD, MPH, PhD – European Medicines Agency
###
Bias Introduced by COVID-19 Related Healthcare Disruptions in Safety and Effectiveness Studies: Proposing Methodological Solutions

Kieran J. Rothnie, PhD – GSK ### 1062865###Lead Speaker###Director Epidemiology###GSK###
Lead Speaker: Kieran J. Rothnie, PhD – GSK
### @@@ Mei Sheng Duh, MPH, ScD (she/her/hers) – Analysis Group, Inc., Boston, MA, USA ### 1359083###Speaker###Chief Epidemiologist and Managing Principal###Analysis Group, Inc., Boston, MA, USA###
Speaker: Mei Sheng Duh, MPH, ScD (she/her/hers) – Analysis Group, Inc., Boston, MA, USA
### she/her/hers @@@ Catherine Cohet, PhD (she/her/hers) – European Medicines Agency ### 1655442###Speaker###Pharmacoepidemiology/RWE Senior Specialist###European Medicines Agency###
Speaker: Catherine Cohet, PhD (she/her/hers) – European Medicines Agency
### she/her/hers @@@ Melissa Van Dyke, PhD, MPH – GSK ### 1657832###Speaker###Senior Director and Head, Research Epidemiology###GSK###
Speaker: Melissa Van Dyke, PhD, MPH – GSK
### @@@ Marianne Cunnington, PhD (she/her/hers) – Analysis Group, Inc ### 1991261###Speaker###Vice President###Analysis Group, Inc###
Speaker: Marianne Cunnington, PhD (she/her/hers) – Analysis Group, Inc
### she/her/hers @@@ Ian Douglas, PhD – London School of Hygiene & Tropical Medicine, London ### 1358165###Speaker###Professor###London School of Hygiene & Tropical Medicine, London###
Speaker: Ian Douglas, PhD – London School of Hygiene & Tropical Medicine, London
###
Brain Metastasis Prediction in Patients with Metastatic Breast Cancer using a U.S. Nationwide Clinico-genomic Database

Yunru (Claire) Huang, MB, MS, PhD (she/her/hers) – Genentech, Inc. ### 1991304###Presenting Author###Real World Data Scientist ###Genentech, Inc.###
Presenting Author: Yunru (Claire) Huang, MB, MS, PhD (she/her/hers) – Genentech, Inc.
### she/her/hers @@@ Tianyi Sun – Genentech, Inc. ### 1991305###Co-Author######Genentech, Inc.###
Co-Author: Tianyi Sun – Genentech, Inc.
### @@@ Thibaut Sanglier – F. Hoffmann-La Roche Ltd ### 1991215###Co-Author###Senior Principal Data Scientist###F. Hoffmann-La Roche Ltd###
Co-Author: Thibaut Sanglier – F. Hoffmann-La Roche Ltd
### @@@ Chiara Lambertini – F. Hoffmann-La Roche Ltd ### 1991307###Co-Author######F. Hoffmann-La Roche Ltd###
Co-Author: Chiara Lambertini – F. Hoffmann-La Roche Ltd
### @@@ Adam Knott – F. Hoffmann-La Roche Ltd ### 1991309###Co-Author######F. Hoffmann-La Roche Ltd###
Co-Author: Adam Knott – F. Hoffmann-La Roche Ltd
### @@@ Yolande Du Toit – Genentech, Inc. ### 1991310###Co-Author######Genentech, Inc.###
Co-Author: Yolande Du Toit – Genentech, Inc.
### @@@ Raf Poppe – F. Hoffmann-La Roche Ltd ### 1991311###Co-Author######F. Hoffmann-La Roche Ltd###
Co-Author: Raf Poppe – F. Hoffmann-La Roche Ltd
### @@@ Eleonora Restuccia – F. Hoffmann-La Roche Ltd ### 1991308###Co-Author######F. Hoffmann-La Roche Ltd###
Co-Author: Eleonora Restuccia – F. Hoffmann-La Roche Ltd
### @@@ Sanne de Haas – F. Hoffmann-La Roche Ltd ### 1991312###Co-Author######F. Hoffmann-La Roche Ltd###
Co-Author: Sanne de Haas – F. Hoffmann-La Roche Ltd
### @@@ Patricia Luhn – Genentech, Inc. ### 1358236###Co-Author######Genentech, Inc.###
Co-Author: Patricia Luhn – Genentech, Inc.
###
Brainstorm NS Treatments/Exposure

Ian Douglas, PhD – London School of Hygiene & Tropical Medicine, London ### 1358165###Co-Moderator###Professor###London School of Hygiene & Tropical Medicine, London###
Co-Moderator: Ian Douglas, PhD – London School of Hygiene & Tropical Medicine, London
### @@@ Kristian B. Filion, PhD (he/him/his) – McGill University ### 1062622###Co-Moderator###Associate Professor###McGill University###
Co-Moderator: Kristian B. Filion, PhD (he/him/his) – McGill University
### he/him/his
Breast Cancer Cohort Comparison among four real-world databases

Xinyue Liu, PhD – Merck & Co. Inc. ### 1358694###Presenting Author###Epidemiologist###Merck & Co. Inc.###
Presenting Author: Xinyue Liu, PhD – Merck & Co. Inc.
### @@@ Golnoosh Alipour Haris, MS, PharmD – Center for Drug Evaluation & Safety and the Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL ### 1659947###Co-Author######Center for Drug Evaluation & Safety and the Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL###
Co-Author: Golnoosh Alipour Haris, MS, PharmD – Center for Drug Evaluation & Safety and the Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL
### @@@ Changxia Shao – Merck & Co., Inc. ### 1658775###Co-Author######Merck & Co., Inc.###
Co-Author: Changxia Shao – Merck & Co., Inc.
### @@@ Mehmet Burcu, PhD, MS (he/him/his) – Merck & Co., Inc., Rahway, NJ, United States ### 1088178###Co-Author###Sr. Director###Merck & Co., Inc., Rahway, NJ, United States###
Co-Author: Mehmet Burcu, PhD, MS (he/him/his) – Merck & Co., Inc., Rahway, NJ, United States
### he/him/his @@@ Edward A. Bortnichak, Ph.D., M.P.H., MBE – Merck & Co. Inc. ### 1358697###Co-Author###Executive Director, Epidemiology###Merck & Co. Inc.###
Co-Author: Edward A. Bortnichak, Ph.D., M.P.H., MBE – Merck & Co. Inc.
### @@@ Sarah Markt – Merck & Co. Inc. ### 1991282###Co-Author######Merck & Co. Inc.###
Co-Author: Sarah Markt – Merck & Co. Inc.
### @@@ Thao Vo – Merck & Co. Inc. ### 1991283###Co-Author######Merck & Co. Inc.###
Co-Author: Thao Vo – Merck & Co. Inc.
### @@@ Chu-Ling Yu – Merck & Co. Inc ### 1991284###Co-Author###Principal Scientist, Epidemiology###Merck & Co. Inc###
Co-Author: Chu-Ling Yu – Merck & Co. Inc
###
Building Consensus on RWE Evaluation: Standardized Tool for Assessing Validity in RWE Studies of Medication Safety and Effectiveness

Katsiaryna Bykov, PharmD, ScD – Brigham and Women's Hospital and Harvard Medical School ### 1655839###Lead Speaker###Assistant Professor###Brigham and Women's Hospital and Harvard Medical School###
Lead Speaker: Katsiaryna Bykov, PharmD, ScD – Brigham and Women's Hospital and Harvard Medical School
### @@@ Jessica M. Franklin, PhD (she/her/hers) – Optum Epidemiology ### 1359343###Speaker###Principal Consultant, Real-World Evidence###Optum Epidemiology###
Speaker: Jessica M. Franklin, PhD (she/her/hers) – Optum Epidemiology
### she/her/hers @@@ Cynthia J. Girman, DrPH FISPE – CERobs Consulting, LLC ### 1088317###Speaker###Founder and President###CERobs Consulting, LLC###
Speaker: Cynthia J. Girman, DrPH FISPE – CERobs Consulting, LLC
### @@@ Jennifer L. Lund, PhD, FISPE (she/her/hers) – Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill ### 1062592###Speaker###Associate Professor###Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill###
Speaker: Jennifer L. Lund, PhD, FISPE (she/her/hers) – Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
### she/her/hers @@@ Elisabetta Patorno, MD, MPH, DrPH (she/her/hers) – Division of Pharmacoepidemiology, Dept. of Medicine, Brigham & Women’s Hospital, Harvard Medical School ### 1360380###Speaker###Associate Professor of Medicine###Division of Pharmacoepidemiology, Dept. of Medicine, Brigham & Women’s Hospital, Harvard Medical School###
Speaker: Elisabetta Patorno, MD, MPH, DrPH (she/her/hers) – Division of Pharmacoepidemiology, Dept. of Medicine, Brigham & Women’s Hospital, Harvard Medical School
### she/her/hers