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Overview

Conference: November 14-15

The aim of this forum is to bring together data-minded professionals from regulatory agencies, pharmaceutical, device and biotechnology industries, and data organizations to discuss the growing role and applicability of data science in drug development as well as the integration and regulatory challenges and considerations of data science. This forum offers a platform for experts in regulatory science, clinical development, and data science to deliver deep-dive relevant perspectives and to share pertinent case examples of data science application. It will provide the opportunity to collaborate in breakout rooms with cross industry and regulatory colleagues and explore new ideas and applications, common research questions, and topics relevant to the development process and business needs.

Program Committee

  • Joan  Buenconsejo, PhD, MPH
    Joan Buenconsejo, PhD, MPH Head of Cardiovascular and Early Development Biostatistics
    Bristol Myers Squibb, United States
  • Pritibha  Singh, MBA, MSc
    Pritibha Singh, MBA, MSc Global Program Associate Director, Oncology Hematology Development
    Novartis AG, Switzerland
  • Ruthie  Davi, PhD, MS
    Ruthie Davi, PhD, MS Vice President, Data Science and Statistician
    Medidata, a Dassault Systèmes company, United States
  • Nan  Shao, PhD
    Nan Shao, PhD CVP, Global Head of Analytics Strategy
    Parexel International, United States
  • Steve  Wilson, PhD
    Steve Wilson, PhD Senior Staff Fellow, OB, OTS, CDER
    FDA, United States
  • Jingjing  Ye, PhD
    Jingjing Ye, PhD Executive Director, Global Head of Data Science & Operational Excellence (DSOE)
    Global Statistics and Data Science (GSDS), BeiGene USA, United States
  • Jessica  Federer, MPH
    Jessica Federer, MPH Partner
    Boston Millennia Partners, United States
  • Jerald  Schindler, DrPH
    Jerald Schindler, DrPH Vice President, Biostatistics
    Alkermes Pharmaceticals, United States
  • Rebecca  Taha, PhD, MBA
    Rebecca Taha, PhD, MBA Statistical Consulting Director
    ICON Biotech Solutions, United States
  • Chava  Zibman, PhD
    Chava Zibman, PhD Mathematical Statistician, CDRH
    FDA, United States
  • Representative Invited
    Representative Invited DIA, United States
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