Planning the Lifecycle of Safety Evaluation Brenda Crowe

Planning the Lifecycle of Safety Evaluation Brenda Crowe, Ph. D Eli Lilly and Company www. diahome. org

Conference Program Committee • • • Brenda Crowe, Ph. D, Lilly (Co-chair) Wanju Dai, MD, Dr. PH, sanofi-aventis (Co-chair) Gerald Dal Pan, MD, MHS, FDA Henry “Skip” Francis, MD, FDA Paul Huckle, MD, Glaxo. Smith. Kline Robert O’Neill, Ph. D, FDA Manfred Oster, MD, sanofi-aventis George Rochester, Ph. D, RAC, FDA Amy Xia, Ph. D, Amgen Program Advisors • Walt Offen, Ph. D, Lilly • Steve Snapinn, Ph. D, Lilly www. diahome. org

Conference Co-chairpersons In addition to the program committee: • Howard Chazin, MD, MBA, FDA • Eileen King, Ph. D, Procter & Gamble • Judith Racoosin, MD, MPH, FDA • James Hung, Ph. D, FDA • Henry Hsu, Ph. D, MPH, FDA • Jesse Berlin, Sc. D, Johnson & Johnson • Sandra Kweder, MD, FDA www. diahome. org

Special Thanks • Constance Burnett, DIA • Jessica Kusma, DIA • Debra Michaels, DIA www. diahome. org

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. www. diahome. org

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 www. diahome. org

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 Metaanalysis • 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 www. diahome. org

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

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Stop Now!! Please You’re killing me! -1 minute www. diahome. org