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InterContinental San Francisco

Nov 05, 2018 7:00 AM - Nov 06, 2018 3:00 PM

888 Howard Street, San Francisco, CA 94103

Real World Evidence Conference

This conference has reached maximum capacity.

Session 5: Use of RWE in Label Expansion

Session Chair(s)

Paul M. Coplan, DrSc, MBA, MSc, FISPE

Paul M. Coplan, DrSc, MBA, MSc, FISPE

VP, Medical Device Epidemiology & Real-World Data Analytics

Johnson & Johnson, United States

Marni  Hall, PhD, MPH

Marni Hall, PhD, MPH

VP & GM, Global Regulatory Science and Strategy

IQVIA, United States

21st Century Cures Act and the current user fee commitments direct and give FDA the authority to develop a framework for use of real world evidence for indication expansion. This section will discuss the current landscape, examples of when RWE protocols have been accepted by FDA for label expansion, and strategies for more broad application, including the criteria for routine use.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe three criteria in which RWE has been used for label expansion
  • Explain why it will be necessary to employ different assessments for different therapeutic areas
  • Propose one or more pilot projects to advance a framework for use of RWE for label expansion


Peter P. Stein, MD

Use of Real World Evidence to Expand Labels: Expectations, Opportunities, and Challenges: Peter P. Stein, MD

Director, Office of New Drugs, CDER

FDA, United States

Nancy A Dreyer, PhD, MPH, FISPE

Use of RWE in Label Expansion: Nancy A Dreyer, PhD, MPH, FISPE


Dreyer Strategies LLC, United States

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