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Overview

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.

Attend the DIA/FDA 2021 Biostatistics Industry and Regulator Forum and join leading edge discussions: statistical analyses in COVID-19 interrupted trials and therapeutic/vaccine trials, RWE and its use in regulatory decision making pre-marketing, approaches to the incorporation of external controls – applicability and methods, the FDA RCT DUPLICATE project, enhancing diversity in clinical trial populations, and so much more!

Who should attend?

Professionals from industry, academia, and government involved in all phases of the medical product lifecycle who are interested in the application of statistics to advance biopharmaceutical development and accessibility including:
  • Biostatisticians
  • Bioinformaticists, Medical Informaticists
  • Mathematical Statisticians
  • Regulatory Scientists
  • Clinical Pharmacologists
  • Clinical Trial Design and Clinical Trial Optimization Specialists
  • Clinical Research Physicians
  • Epidemiologists
  • Health Economists
  • Clinical Operations

Learning objectives

At the conclusion of this activity, participants should be able to:
  • Describe the challenges and opportunities in applying Complex Innovative Designs
  • Explain the use of RWE to support regulatory submissions
  • Apply the FDA guidance to enhance diversity and inclusion in clinical trials
  • Apply lessons learned from the COVID-19 pandemic to enhance statistical leadership, collaboration, and study design in drug development
  • Identify the operational challenges and considerations in executing Master Protocol
  • Describe the most common designs using Master Protocols and their utility in solving clinical development challenges
  • Evaluate the differences among stakeholder views on clinically meaningful estimands
  • Apply the estimand framework to the learner’s own clinical investigations
  • Describe the collaboration of statistical science with data science in drug development

Program Committee

  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Senior Research Advisor, Global Statistical Sciences
    Eli Lilly and Company, United States
  • Yuan-Li  Shen, DrPH
    Yuan-Li Shen, DrPH Deputy Division Director (Acting), Division of Biometrics V, OB, OTS, CDER
    FDA, United States
  • Mouna  Akacha, PhD
    Mouna Akacha, PhD Group Head of Statistical Methodology
    Novartis Pharma AG, Switzerland
  • Ruthie  Davi, PhD, MS
    Ruthie Davi, PhD, MS Vice President, Data Science and Statistician
    Acorn AI, A Medidata Company, United States
  • Mallorie  Fiero, PhD
    Mallorie Fiero, PhD Mathematical Statistician, CDER
    FDA, United States
  • Renee  Iacona, PhD
    Renee Iacona, PhD Vice President, Oncology & Immuno-Oncology
    AstraZeneca Pharmaceuticals LP, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Biostatistician, Division of Biostatistics and Study Methodology
    Children’s Research Institute at Children’s National Medical Center , 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
  • Fairouz  Makhlouf, PhD
    Fairouz Makhlouf, PhD Mathematical Statisticain, CDER
    FDA, United States
  • Erik  Pulkstenis, PhD
    Erik Pulkstenis, PhD Vice President, Data and Statistical Sciences
    Abbvie, United States
  • Venkat  Sethuraman
    Venkat Sethuraman Senior Vice President, Biometrics and Data Sciences
    Bristol Myers Squibb, United States
  • Judith  Maro, PhD, MS
    Judith Maro, PhD, MS Assistant Professor, Department of Population Medicine
    Harvard Pilgrim Health Care Institute, United States
  • Meiyu  Shen, PhD
    Meiyu Shen, PhD Expert Mathematical Statistician, Office of Translational Sciences, CDER
    FDA, United States
  • Ram  Tiwari, PhD
    Ram Tiwari, PhD Head of Statistical Methodology
    Bristol Myres Squibb , United States
  • Stella C. Grosser, PhD
    Stella C. Grosser, PhD Division Director, Office of Biostatistics, OTS, CDER
    FDA, United States
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