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Overview

Co-sponsored with FDA!

DIA Virtual Conference

The 17th Annual DIA/FDA Biostatistics Industry and Regulator Forum is a unique forum addressing the statistical issues associated with the development and review of therapeutic drugs, biologics, devices, and other medical products. As an open forum to discuss timely topics of mutual theoretical and practical interest to statisticians and clinical trial professionals, this meeting focuses on the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress with the implementation of innovative solutions.

An important purpose of the forum is to advance the dialogue between industry, regulatory agencies, and academia around policy, regulation, development, and review of medical products in the context of today’s scientific and regulatory environments. The program is developed collaboratively by FDA, industry, and academic experts who team up to ensure that each session brings all stakeholder perspectives to the discussion.

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Program Committee

  • Fairouz  Makhlouf, PhD
    Fairouz Makhlouf, PhD Deputy Director, Office of Biostatistics, Office of Translational Science, CDER
    FDA, United States
  • Satrajit  Roychoudhury, PhD
    Satrajit Roychoudhury, PhD Senior Director, Statistical Research and Innovation
    Pfizer, Inc., United States
  • Anup  Amatya
    Anup Amatya Mathematical Statistician
    FDA, United States
  • Hye Soo  Cho
    Hye Soo Cho Statistical Analyst
    FDA, United States
  • Mallorie  Fiero, PhD
    Mallorie Fiero, PhD Lead Mathematical Statistician, CDER
    FDA, United States
  • Shanti V Gomatam, PhD
    Shanti V Gomatam, PhD Mathematical Statistician
    FDA, United States
  • Lisa  Hampson, PhD
    Lisa Hampson, PhD Director, Advanced Methodology & Data Science
    Novartis Pharma AG, Switzerland
  • Karen  Higgins, PhD
    Karen Higgins, PhD Mathematical Statistician
    FDA, United States
  • Dalong Patrick Huang, PhD
    Dalong Patrick Huang, PhD Mathematical Statistician, CDER
    FDA, United States
  • Lisa Renee Bailey Iacona, PhD, MPH
    Lisa Renee Bailey Iacona, PhD, MPH Vice President, Oncology Biometrics
    AstraZeneca Pharmaceuticals LP, United States
  • Xiang  Ling
    Xiang Ling Statistician
    FDA, United States
  • Jerald  Schindler, DrPH
    Jerald Schindler, DrPH Vice President, Enterprise Biostatistics
    Medtronic, United States
  • Venkat  Sethuraman, PhD, MBA
    Venkat Sethuraman, PhD, MBA Senior Vice President, Global Biometrics and Data Sciences
    Bristol Myers Squibb, United States
  • Guoxing  Soon, PhD
    Guoxing Soon, PhD Lead Mathematical Statistician
    FDA, United States
  • Li  Wang, PhD
    Li Wang, PhD Senior Director, Head of Statistical Innovation
    AbbVie , United States
  • Yun  Wang
    Yun Wang Deputy Division Director
    FDA, United States
  • Lisa  Wruck, PhD
    Lisa Wruck, PhD Duke University
    Associate Professor of Biostatistics & Bioinformatics, United States
  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Associate Vice President, Statistics
    Eli Lilly and Company, United States
  • Stella C. Grosser, PhD, MS
    Stella C. Grosser, PhD, MS Division Director, Office of Biostatistics, OTS, CDER
    FDA, United States
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