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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:00 PM - Apr 10, 2019 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Biostatistics Industry and Regulator Forum

Session 4: Advancing Patient Focused Drug Development

Session Chair(s)

Laura Lee  Johnson, PhD

Laura Lee Johnson, PhD

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER

FDA, United States

Brenda  Crowe, PhD

Brenda Crowe, PhD

Associate Vice President, Statistics

Eli Lilly and Company, United States

Mouna  Akacha, PhD

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)

Pujita  Vaidya, MPH

FDA Patient-Focused Drug Development – Advancing the Science of Patient Input

Pujita Vaidya, MPH

Sanofi, United States

North America Lead, Regulatory Science and Policy

Martin  Ho, PhD, MS

Patient Preference Information for Regulatory Considerations

Martin Ho, PhD, MS

Google, United States

Head of Biostatistics

Elizabeth  Bush, MHS

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

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