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Session 4: Advancing Patient Focused Drug Development
Session Chair(s)
Laura Lee Johnson, PhD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
FDA, United States
Brenda Crowe, PhD
Associate Vice President, Statistics
Eli Lilly and Company, United States
Mouna Akacha, PhD
Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland
Discuss the opportunities and challenges of patient focused drug development. The different concepts and strategies around ‘patient experience’, ‘patient preference’ and ‘clinical outcome assessment’ will be laid out. Furthermore, the four FDA guidelines that are currently being put together will be briefly discussed. Two case studies illustrating the role of preference studies and clinical outcome assessments in regulatory submissions will be presented.
Learning Objective : At the conclusion of this session, the participant should be able to:- Appreciate the opportunities and challenges arising in patient-focused drug development
- Understand that statisticians have an important role to play
- Appreciate how patient preferences and clinical outcome assessments can inform and influence regulatory submissions
Speaker(s)
FDA Patient-Focused Drug Development – Advancing the Science of Patient Input
Pujita Vaidya, MPH
Sanofi, United States
Director, Regulatory Science and Policy
Patient Preference Information for Regulatory Considerations
Martin Ho, PhD, MS
Google, United States
Head of Biostatistics
Clinical Outcome Assessments and Statistics – An Industry Perspective
Elizabeth Bush, MHS
Eli Lilly and Company, United States
Associate VP and Head, Patient-Focused Endpoints and Measurement