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Short Course: March 16, 2023 | Virtual

Short Course: March 21, 2023 | Virtual

Short Course: March 23, 2023 | Virtual

Forum: March 29-31, 2023 | Virtual

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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Who should attend?

  • Meeting Designed For

    • Access & Value
    • Clinical Development & Operations
    • Clinical Safety & Pharmacovigilance
    • Data & Data Standards
    • Preclinical & Early Phase Research
    • Regulatory
    • Quality Assurance / Control & CMC
    • Statistics
  • Learning Objectives

    At the conclusion of this activity, participants should be able to:
    • Discuss approaches to collecting novel types of data for evidence generation and analytic methods needed to power new approaches to data
    • Identify and discuss issues relevant to applying the ICH E9(R1) framework to complex innovative trials
    • Identify key updates for each user fee program, including launching the Rare Disease Endpoint Advancement (RDEA) Pilot program under PDUFA VII
    • Recognize the purpose of the Comparative Clinical Endpoint Studies in Biosimilar Development Program and apply Bayesian designs for biosimilar product development
    • Summarize and apply principles of ICH E11A draft guidance to pediatric drug development
    • Discuss updates in FDA’s Project Optimus and ongoing development of dose optimization guidance and recognize approaches to develop a composite endpoint to select an optimal dose
    • Describe the current use of ML in analysis of safety data by the pharmaceutical industry and regulatory agencies and identify areas of potential future applications and methods development
    • Explain strengths of the estimand framework for jointly assessing efficacy and safety of a treatment and identify challenges in joint assessment of efficacy and safety
    • Describe the general ideas of various methods to borrow information from external data and discuss potential applications in regulatory clinical trials
    • Recognize statistical methods leveraged in the analysis of RWD and describe innovative approaches of combining RWD and clinical trial data in decision making
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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 Executive Director, Statistical Research and Innovation
      Pfizer, Inc., United States
    • Anup  Amatya, PhD
      Anup Amatya, PhD Lead Mathematical Statistician
      FDA, United States
    • Hye Soo  Cho, MS
      Hye Soo Cho, MS Statistician
      FDA, United States
    • Mallorie  Fiero, PhD
      Mallorie Fiero, PhD Master Mathematical Statistician, CDER
      FDA, United States
    • Shanti V Gomatam, PhD, MS, MSc
      Shanti V Gomatam, PhD, MS, MSc Mathematical Statistician
      FDA, United States
    • Lisa  Hampson, PhD
      Lisa Hampson, PhD Senior Director, Advanced Methodology & Data Science
      Novartis Pharma AG, Switzerland
    • Karen  Higgins, PhD
      Karen Higgins, PhD Supervisory Mathematical Statistician
      FDA, United States
    • Dalong Patrick Huang, PhD
      Dalong Patrick Huang, PhD Lead 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, PhD
      Xiang Ling, PhD Statistician
      FDA, United States
    • Jerald  Schindler, DrPH
      Jerald Schindler, DrPH Vice President, Enterprise Biostatistics
      Medtronic, 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
    • 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, PhD
      Yun Wang, PhD Deputy Division Director
      FDA, United States
    • Lisa  Wruck, PhD
      Lisa Wruck, PhD Associate Professor of Biostatistics and Bioinformatics
      Duke School of Medicine, United States
    • Representative Invited
      Representative Invited DIA, 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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