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Co-sponsored with the FDA!

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.

Now in its thirteenth year, 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.

Preconference Short Courses

On-Demand Complimentary Webinar

Structured Exploration of Clinical Trial Data
Gain an overview of a structured approach for safely applying these more advanced methods, discuss their application in practice, and explore how they can be used to guide scientific research.

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Continuing Education

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Who should attend?

Professionals involved in:

  • Biostatistics
  • Pharmaceutical Development
  • Clinical Pharmacology
  • Health Economy
  • Epidemiology
  • Regulatory
  • Academia
  • Government

Learning objectives

At the completion of this conference, the participant should be able to:
  • Describe the challenges and opportunities in applying CID 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

  • Jingyu (Julia)  Luan, PhD
    Jingyu (Julia) Luan, PhD Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D
    AstraZeneca, United States
  • Cristiana  Mayer, DrSc, PhD
    Cristiana Mayer, DrSc, PhD Head of Biostatistics
    Johnson & Johnson Vision, United States
  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Associate Vice President, Statistics
    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 Associate Director Statistical Methodology
    Novartis, Switzerland
  • Min  Lin, MD, PhD
    Min Lin, MD, PhD Statistical Science Director
    Astrazeneca, United States
  • Karen Lynn Price, PhD
    Karen Lynn Price, PhD Senior Research Fellow, Statistical Innovation Center/Design Hub
    Eli Lilly and Company, 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 President
    Merck & Co, Inc, United States
  • Amy  Xia, PhD
    Amy Xia, PhD Vice President, Center for Design and Analysis
    Amgen Inc., United States
  • Mouna  Akacha, PhD
    Mouna Akacha, PhD Group Head of Statistical Methodology
    Novartis Pharma AG, Switzerland
  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Director, Data Analytics
    Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
  • Dionne  Price, PhD
    Dionne Price, PhD Deputy Director, Office of Biostatistics, OTS, CDER
    FDA, United States
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On-Demand Complimentary Webinar

Structured Exploration of Clinical Trial Data

Preconference Short Courses

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