Planning the Lifecycle of Safety Evaluation Brenda Crowe, PhD Eli Lilly and Company

Conference Program Committee Brenda Crowe, PhD, Lilly (Co-chair) Wanju Dai, MD, DrPH, sanofi-aventis (Co-chair) Gerald Dal Pan, MD, MHS, FDA Henry “Skip” Francis, MD, FDA Paul Huckle, MD, GlaxoSmithKline Robert O’Neill, PhD, FDA Manfred Oster, MD, sanofi-aventis George Rochester, PhD, RAC, FDA Amy Xia, PhD, Amgen Program Advisors Walt Offen, PhD, Lilly Steve Snapinn, PhD, Lilly

Conference Co-chairpersons In addition to the program committee: Howard Chazin, MD, MBA, FDA Eileen King, PhD, Procter & Gamble Judith Racoosin, MD, MPH, FDA James Hung, PhD, FDA Henry Hsu, PhD, MPH, FDA Jesse Berlin, ScD, Johnson & Johnson Sandra Kweder, MD, FDA

Special Thanks Constance Burnett, DIA Jessica Kusma, DIA Debra Michaels, DIA

Conference Goals Stimulate discussion among FDA and industry participants regarding proactive planning of safety evaluation throughout the lifecycle of drug development. Includes planning for data collection, evaluation (including data monitoring committees), integration, analysis (including meta-analysis) and reporting.

Program Outline—Day 1 9:10 – 10:30: Challenges and Opportunities to Improve Premarketing Safety Planning, Evaluation and Reporting 11:00 – noon, 1:30 – 2:30: Combining Safety Data at a Development Program Level—Data Collection and Study Design: Dirt Road Vs. Super Highway 2:30 – 3:45: How to Improve Safety Data Analysis and Presentation 4:15 – 5:30: Safety Boundaries for Data Monitoring Committees 5:30 - 6:30: Reception

Program Outline—Day 2 8:30 – 8:40: Welcome and Keynote Introduction 8:40 – 9:30: Keynote Presentation (Janet Woodcock) 9:30 – 10:30: Introduction and Overview of Meta-analysis 11:00 – 12:30: Concurrent sessions (Meta-analysis of 1. Rare Events and 2. Observational Data) 1:45 – 3:00: Regulatory Decision Making Based on Meta-analysis Results 3:30 – 4:30: Lessons Learned and Path Forward Panel 4:35: Conference adjourned

Time Session chairs: Please synchronize your watches: It is now: ….9:0X am Very important: We need to stick to allotted time

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