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Overview

Call for Poster Abstracts
Guidelines | Submit
Deadline: Monday, February 12


Short Courses: April 23
Forum: April 23-25
The Biostatistics Industry and Regulator Forum is a collaboration by DIA and FDA. We have focused this event 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 twelfth 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.


Highlights

  • In-depth discussions on new and revised guidances
  • Town Hall: An open discussion lead by an expert panel of leaders from industry and regulatory agencies
  • Each session is co-chaired by an Industry-FDA team
  • Two interactive half day Short Courses tor even more indepth knowledge-sharing
  • Poster Presentations from researchers across the statistics field
  • Luncheon Round Table Discussions on cutting-edge topics with key thought leaders
  • DIA Statistics Open Community Meeting

Who should attend?

Professionals involved in:

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

Program Committee

  • Cristiana  Mayer, PhD
    Cristiana Mayer, PhD Scientific Director, Statistical Modeling and Methodology, SDS
    Janssen Research and Development LLC, United States
  • Dionne  Price, PhD
    Dionne Price, PhD Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Mouna  Akacha, PhD
    Mouna Akacha, PhD Statistical Methodologist
    Novartis Pharma AG, Switzerland
  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Acting Deputy Director, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Jonathan  Haddad, MPH
    Jonathan Haddad, MPH Director, Clinical Statistics
    GlaxoSmithKline, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Lead Mathematical Statistician, Office of Translational Science, CDER
    FDA, United States
  • Pandurang M Kulkarni, PhD
    Pandurang M Kulkarni, PhD Vice President, Global Biometrics & Advanced Analytics
    Eli Lilly and Company, United States
  • Jingyu  Luan, PhD
    Jingyu Luan, PhD Lead Mathematical Statistician
    FDA, United States
  • Karen Lynn Price, PhD, MA
    Karen Lynn Price, PhD, MA Senior Research Advisor
    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
  • Amy  Xia, PhD
    Amy Xia, PhD Executive Director, Biostatistics
    Amgen, Inc., United States
  • Lisa M. LaVange, PhD
    Lisa M. LaVange, PhD Director, Office of Biostatistics, Office of Translational Sciences, CDER
    FDA, United States
  • Nevine  Zariffa
    Nevine Zariffa Vice President and Head Biometrics & Information Sciences
    Astrazeneca Pharmaceuticals, United States
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Contact us

Registration Questions?

Send Email
+1.215.442.6100


Call for Abstracts

Guidelines | Submit

Submission Deadline: February 12


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