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March 29: Short Course
April 1: Short Course
April 6-8: Conference

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.


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Highlights & Features

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Learning objectives

At the conclusion of this activity, participants should be able to:
  • Discuss the use of RWD and methods used to minimize bias and confounding variables
  • Discuss utilizing Bayesian methods to support decision making in drug development and clinical trial design and analysis
  • Describe how the ICH E9(R1) esteemed framework can be used to clarify the impact of decentralized clinical trials on the scientific question(s)
  • Identify statistical issues, safety, and efficacy measures in the design of pediatric Covid-19 vaccine trials and potential statistical solutions to the uncertainty of developing vaccines
  • Evaluate the uses of synthetic controls in the regulatory and nonregulatory spaces

Program Committee

  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Associate Vice President, Statistics
    Eli Lilly and Company, United States
  • 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 Executive Director, Statistical Research and Innovation
    Pfizer, Inc., United States
  • Yuan-Li  Shen, DrPH
    Yuan-Li Shen, DrPH Deputy Division Director, 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 Master Mathematical Statistician, CDER
    FDA, United States
  • Lisa  Hampson, PhD
    Lisa Hampson, PhD Senior Director, Advanced Methodology & Data Science
    Novartis Pharma AG, Switzerland
  • Shiowjen  Lee, PhD
    Shiowjen Lee, PhD Deputy Director, Division of Biostatistics, OBPV, CBER
    FDA, United States
  • Lisa  Lupinacci, PhD, MS
    Lisa Lupinacci, PhD, MS Senior Vice President, Biostatistics and Research Decision Sciences
    Merck and Co., Inc., United States
  • Judith C. Maro, PhD, MS
    Judith C. Maro, PhD, MS Assistant Professor, Department of Population Medicine
    Harvard Medical School; Point 32 Health, United States
  • Venkat  Sethuraman, PhD, MBA, MS
    Venkat Sethuraman, PhD, MBA, MS Senior Vice President, Global Biometrics and Data Sciences
    Bristol Myers Squibb, United States
  • Li  Wang, PhD
    Li Wang, PhD Senior Director, Head of Statistical Innovation
    AbbVie , United States
  • Yueqin  Zhao, PhD
    Yueqin Zhao, PhD Lead Mathematical Statistician, 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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