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Overview

As a direct and sole result of the outbreak of the coronavirus disease (COVID-19) and due to circumstances beyond our control, DIA has decided to change the format of the upcoming DIA/FDA Biostatistics Industry and Regulator from "face-to-face" (in-person) to entirely virtual.

For more information, please review the list of Frequently Asked Questions


Forum: May 27-29

The DIA/FDA Biostatistics Industry and Regulator Forum is focused on statistical thinking to inform policy, regulation, development, and review of medical products in the context of the current scientific and regulatory environments including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics. Each session will be co-chaired by an FDA/Industry team working side-by-side with today’s experts to present a 360-degree perspective of statistical design, analysis, and methodological approaches to building evidence for pharmaceutical, biologic and biosimilar, combination product and device development, and approval.

The forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs, biologics, and combination products. This unique forum advances the dialogue between industry, regulatory agencies, and academia.

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 completion of this forum, the participant should be able to:
  • Describe the challenges and opportunities in applying Complex Innovative Designs and the role of simulation
  • Identify the opportunities and challenges arising in patient-focused drug development
  • Discuss the role that statisticians play in patient-focused drug development
  • Explain how patient preferences and clinical outcome assessments can inform and influence regulatory submissions
  • Discuss the unique challenges in the assessment of complex generics from statistical, clinical, and regulatory perspectives
  • Identify GDUFA II enhancements for complex generics
  • Describe the most common designs using Master Protocols and their utility in solving clinical development challenges
  • Identify the operational challenges and considerations in executing Master Protocols
  • Discuss the pros, cons, and common mistakes for Master Protocol designs through a panel discussion
  • Discuss the estimand challenges and opportunities arising in oncology drug development
  • 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
  • Identify what has changed in the role of the statistician
  • Describe opportunities for drug development based on advancements in new technologies and data analytics
  • Identify common clinical issues that arise when characterizing the safety and benefit-risk of a pharmaceutical product
  • Apply good statistical practice for safety-related topics

Program Committee

  • Karen Lynn Price, PhD
    Karen Lynn Price, PhD Research Fellow, Statistical Innovation Center/Design Hub
    Eli Lilly and Company, United States
  • Mat  Soukup, PhD
    Mat Soukup, PhD Deputy Director, Division of Biometrics VII, OB, OTS CDER
    FDA, United States
  • Mouna  Akacha, PhD
    Mouna Akacha, PhD Group Head of Statistical Methodology
    Novartis Pharma AG, Switzerland
  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Senior Research Advisor, Global Statistical Sciences
    Eli Lilly and Company, United States
  • Jonathan  Haddad, MPH
    Jonathan Haddad, MPH HIV Disease Area Head, Clinical Statistics
    GlaxoSmithKline, 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
  • Cristiana  Mayer, DrSc, PhD
    Cristiana Mayer, DrSc, PhD Director, Statistics and Decision Sciences
    Janssen Research & Development, LLC, United States
  • Lei  Nie, PhD
    Lei Nie, PhD Associate Director of Biometrics II, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Frank W. Rockhold, PhD, MSc
    Frank W. Rockhold, PhD, MSc Professor of Biostatistics
    Duke Clinical Research Institute, Duke University Medical Center, United States
  • William  Wang, PhD
    William Wang, PhD Executive Director, Clinical Safety Statistics, BARDS
    Merck Research Laboratories, United States
  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER
    FDA, United States
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Additional Information

Biostatistics Industry Resource Kit


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