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Invited Paper Session

Toward a Common Framework for Use of Real-World Evidence in Drug Development

Wed, Aug 7, 10:30 AM - 12:20 PM

Birol EmirOrganizerMichael GaffneyChair

Biopharmaceutical Section

4 Presentations

FDA Framework for Real-World Evidence: Guidance and Recent Examples

10:35 AM - 10:55 AM

Pallavi Mishra-Kalyani (Food and Drug Administration)

Co-authors: Mark Levenson (US Food & Drug Administration)

Enhancing Evidence Generation in Biomedical Research Through Use of a Natural Hermite Distance, with Applications to Case-Control Assignment and Other Trial Designs

10:55 AM - 11:15 AM

Javier Cabrera (Rutgers University)

Statistical lessons from the Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND) initiative combing international real-world evidence to better treat hypertension and type 2 diabetes

11:15 AM - 11:35 AM

Marc Suchard (University of California-Los Angeles)

Targeted Learning and Causal Inference for Generating Real World Evidence in Drug Development

11:35 AM - 11:55 AM

Mark Van Der Laan (UC Berkeley)

Discussant

Demissie Alemayehu (Pfizer)

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