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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.


Welcome Remarks and Session 1: Challenges with Global Development and Satisfying Regulatory Requirements

Session Chair(s)

Mouna  Akacha, PhD

Mouna Akacha, PhD

  • Group Head of Statistical Methodology
  • Novartis Pharma AG, Switzerland
Aloka  Chakravarty, PhD

Aloka Chakravarty, PhD

  • Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER
  • FDA, United States
In this session we will provide an overview of the changes in the regulatory landscape driven by the development of various ICH guidance documents (E8, E9, E11, E17, E19, E20). The key statistical challenges and opportunities that are in scope of the ICH guidelines will be discussed. Furthermore, the link and the overlap of some of the guidelines will be highlighted and the role of the Bayesian framework in these developments will be discussed.
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Recognize the various ICH documents and their impact on drug development
  • Identify issues and challenges in global drug development
  • Engage in meaningful discussions with multidisciplinary team on estimands, Bayesian framework and other key statistical concepts

Speaker(s)

Aloka  Chakravarty, PhD

Statistical Issues in ICH Guidances: Beyond E9

Aloka Chakravarty, PhD

  • Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER
  • FDA, United States
Mark S. Levenson, PhD

Panelist

Mark S. Levenson, PhD

  • Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
  • FDA, United States
Gregory  Levin, PhD

Panelist

Gregory Levin, PhD

  • Deputy Director, DBIII, OB, OTS, CDER
  • FDA, United States
John  Scott, PhD, MA

Panelist

John Scott, PhD, MA

  • Director, Division of Biostatistics, OBE, CBER
  • FDA, United States
Frank  Bretz, PhD

Panelist

Frank Bretz, PhD

  • Distinguished Quantitative Research Scientist
  • Novartis Pharma AG, Switzerland
Andrew  Thomson, PhD, MA, MS

Panelist

Andrew Thomson, PhD, MA, MS

  • Statistician, Methodology Taskforce
  • European Medicines Agency, Netherlands
Greg  Ball, PhD

Panelist

Greg Ball, PhD

  • Senior Principal Biostatistician
  • Merck & Co., Inc., United States

Contact us

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Additional Information

Biostatistics Industry Resource Kit