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Overview

Conference: April 6-8

The 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, combination, and other medical products. As an open forum to discuss timely topics of mutual theoretical and practical interest to statisticians and clinical trialists, 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.

While we prepare for the 2022 DIA/FDA Biostatistics Industry and Regulator Forum check out our 2021 Program.

Program Committee

  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Senior Research Advisor, Global Statistical Sciences
    Eli Lilly and Company, United States
  • Fairouz  Makhlouf, PhD
    Fairouz Makhlouf, PhD Mathematical Statisticain, CDER
    FDA, United States
  • Satrajit  Roychoudhury, PhD
    Satrajit Roychoudhury, PhD Senior Director, Biostatistics
    Pfizer Inc, United States
  • Yuan-Li  Shen, DrPH
    Yuan-Li Shen, DrPH Deputy Division Director (Acting), Division of Biometrics V, OB, OTS, CDER
    FDA, United States
  • Ruthie  Davi, PhD, MS
    Ruthie Davi, PhD, MS Vice President, Data Science and Statistician
    Medidata, a Dassault Systèmes company, United States
  • Mallorie  Fiero, PhD
    Mallorie Fiero, PhD Lead Mathematical Statistician, CDER
    FDA, United States
  • Lisa  Hampson, PhD
    Lisa Hampson, PhD Director
    Statistical Methodology & Consulting, Novartis Pharma AG, Switzerland
  • Lisa Renee Bailey Iacona, PhD, MPH
    Lisa Renee Bailey Iacona, PhD, MPH Vice President, Oncology Biometrics
    AstraZeneca Pharmaceuticals LP, United States
  • Shiowjen  Lee, PhD
    Shiowjen Lee, PhD Deputy Director, Division of Biostatistics, OBE, CBER
    FDA, United States
  • Lisa  Lupinacci, PhD, MS
    Lisa Lupinacci, PhD, MS Vice President, Late Development Statistics
    Merck and Co., Inc., United States
  • Judith  Maro, PhD, MS
    Judith Maro, PhD, MS Assistant Professor, Department of Population Medicine
    Harvard Pilgrim Health Care Institute, United States
  • Venkat  Sethuraman, PhD, MBA
    Venkat Sethuraman, PhD, MBA Senior Vice President, Global Biometrics and Data Sciences
    Bristol Myers Squibb, United States
  • Li  Wang, PhD
    Li Wang, PhD Senior Director, Statistical Innovation
    Abbvie , United States
  • Yueqin  Zhao, PhD
    Yueqin Zhao, PhD Staff Fellow, OB, OTS, CDER
    FDA, 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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