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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.

Content Preview Webinar

Statistical Considerations for Platform Studies: Case Examples
February 26 | 11:00AM-12:00PM
Discuss unique statistical opportunities and issues that arise when planning/executing innovative trial designs via case examples.

Register Today.

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.

Register Today.

Who should attend?

Professionals involved in:

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

Program Committee

  • Jingyu (Julia)  Luan, PhD
    Jingyu (Julia) Luan, PhD Deputy Division Director (Acting), OB, OTS, CDER
    FDA, United States
  • Cristiana  Mayer, DrSc, PhD
    Cristiana Mayer, DrSc, PhD Director, Statistics and Decision Sciences
    Janssen R&D, Johnson and Johnson, United States
  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Senior Research Advisor, Global Statistical Sciences
    Eli Lilly and Company, United States
  • Jonathan  Haddad, MPH
    Jonathan Haddad, MPH Director, Biostatistics
    GlaxoSmithKline, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Lead Mathematical Statistician,Div.of BiometricsVII,Office of Biostatistics,OTS
    FDA, United States
  • Karen Lynn Price, PhD, MA
    Karen Lynn Price, PhD, MA Senior Research Advisor, Statistical Innovation Center
    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 Executive Director, Clinical Safety Statistics, BARDS
    Merck Research Laboratories, United States
  • Amy  Xia, PhD
    Amy Xia, PhD Vice President, Biostatistics, Design & Innovation
    Amgen Inc., United States
  • Mouna  Akacha, PhD
    Mouna Akacha, PhD Statistical Methodologist
    Novartis Pharma AG, Switzerland
  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER
    FDA, United States
  • Dionne  Price, PhD
    Dionne Price, PhD Acting 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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