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  • Sunday, Aug 24th
    3:45 PM - 4:00 PM ET
    2B-02 - Application of Bayesian Detection of potential Risk using Inference on Blinded Safety data (BDRIBS)
    Presenting Author: Julie Rouette, PhD – Global R&D Epidemiology, GSK, Canada
    Co-Author: Luca Grassano, MSc – Global R&D Biostatistics, GSK, Italy
    Co-Author: Alex Spiers, PhD – Global R&D Biostatistics, GSK, United Kingdom
    Co-Author: Matteo Pedone, PhD – Global R&D Biostatistics, GSK, Italy
    Co-Author: Naomi Givens, MSc – Global R&D Biostatistics, GSK, United Kingdom
    Co-Author: Keele Wurst, PhD – Global R&D Epidemiology, GSK, United States
    Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
  • Monday, Aug 25th
    8:30 AM - 8:45 AM ET
    3G-02 - Patterns of Topiramate Use Among Women of Childbearing Potential in the USA (2000-2023)
    Presenting Author: Amir Sarayani, PharmD, MPH, PhD – Global Epidemiology, Johnson & Johnson
    Co-Author: Erica A. Voss, PhD, MPH, PMP – Johnson & Johnson
    Co-Author: Patrick Ryan, PhD – Johnson & Johnson
    Co-Author: Chris Knoll – Johnson & Johnson
    Co-Author: Leslie Killion – Janssen Research & Development, LLC
    Co-Author: Bo Fan, MD/PhD – Johnson & Johnson
    Co-Author: Kourtney J. Davis, PhD, MSPH – Johnson & Johnson
    Co-Author: Melanie H. Jacobson – Johnson & Johnson
    Co-Author: David M. Kern, PhD – Johnson & Johnson
    Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
  • Monday, Aug 25th
    4:15 PM - 4:30 PM ET
    4B-01 - Pregnancy, Lactation, and Fertility Safety Data of FDA-Approved Oncology Therapies: A Systematic Review of Labeling Information (2017–2022)
    Presenting Author: Xin Ye M. Liu, n/a – John Hopkins University
    Co-Author: Jie Yang, PhD – Brigham and Women's Hospital and Harvard Medical School
    Co-Author: Ariel Freedman – Brigham and Women's Hospital and Harvard Medical School
    Co-Author: Krista Huybrechts – Brigham and Women's Hospital and Harvard Medical School
    Co-Author: Sonia Hernández-Díaz – Harvard T.H. Chan School of Public Health
    Co-Author: Yanmin Zhu, MS, PhD – Brigham and Women's Hospital and Harvard Medical School
    Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
  • Monday, Aug 25th
    4:45 PM - 5:00 PM ET
    4B-03 - Leveraging Genetic Evidence to Predict Clinical Trial Success: A Novel Approach to Enhancing Patient Outcomes
    Presenting Author: Jiaxuan Yang – Tsinghua University
    Co-Author: Xinyang Jiang – Tsinghua University
    Co-Author: Xiangyun Mao – Tsinghua University
    Co-Author: Guanqiao Li – Tsinghua University
    Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
  • Monday, Aug 25th
    4:45 PM - 5:00 PM ET
    4E-03 - Real-World Data included in Post-Authorization Measures: A case study of approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024
    Presenting Author: Diogo Almeida – Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal
    Co-Author: Bruno Sepodes – Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal
    Co-Author: Carla Torre – Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal
    Benefit-Risk Assessment, Communication, and Evaluation (BRACE)
  • Monday, Aug 25th
    5:30 PM - 5:45 PM ET
    4E-06 - Patient Experience Data in regulatory decision-making: An analysis of non-interventional studies supporting marketing authorization applications submitted to the European Medicines Agency in 2018-2019
    Presenting Author: Diogo Almeida – Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal
    Co-Author: Denise Umuhire – European Medicines Agency, Amsterdam, The Netherlands
    Co-Author: Carla Jonker – European Medicines Agency, Amsterdam, The Netherlands
    Co-Author: Kelly Plueschke – European Medicines Agency, Amsterdam, The Netherlands
    Co-Author: Rosa Gonzalez-Quevedo – European Medicines Agency, Amsterdam, The Netherlands
    Co-Author: Bruno Sepodes – Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal
    Co-Author: Carla Torre – Faculdade de Farmácia, Universidade de Lisboa, Lisbon, Portugal
    Benefit-Risk Assessment, Communication, and Evaluation (BRACE)