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Planning the Lifecycle of Safety Evaluation

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

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Planning the Lifecycle of Safety Evaluation

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

  2. 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

  3. 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

  4. Special Thanks • Constance Burnett, DIA • Jessica Kusma, DIA • Debra Michaels, DIA

  5. 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.

  6. 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

  7. 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

  8. 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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  12. Stop Now!! Please -1 minute You’re killing me!

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