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DIA/FDA Biostatistics Industry and Regulator Forum
Welcome Remarks and Session 1: Challenges with Global Development and Satisfying Regulatory Requirements
Session Chair(s)
Mouna Akacha, PhD
- Group Head of Statistical Methodology
- Novartis Pharma AG, Switzerland
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)
Statistical Issues in ICH Guidances: Beyond E9
Aloka Chakravarty, PhD
- Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER
- FDA, United States
Panelist
Mark S. Levenson, PhD
- Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
- FDA, United States
Panelist
Gregory Levin, PhD
- Deputy Director, DBIII, OB, OTS, CDER
- FDA, United States
Panelist
John Scott, PhD, MA
- Director, Division of Biostatistics, OBE, CBER
- FDA, United States
Panelist
Frank Bretz, PhD
- Distinguished Quantitative Research Scientist
- Novartis Pharma AG, Switzerland
Panelist
Andrew Thomson, PhD, MA, MS
- Statistician, Methodology Taskforce
- European Medicines Agency, Netherlands
Panelist
Greg Ball, PhD
- Senior Principal Biostatistician
- Merck & Co., Inc., United States
