Planning the Lifecycle of Safety
Evaluation
Brenda Crowe, PhD
Eli Lilly and Company
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Conference Program Committee
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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
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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
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Special Thanks
• Constance Burnett, DIA
• Jessica Kusma, DIA
• Debra Michaels, DIA
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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.
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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
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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
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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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5
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Stop Now!!
Please
You’re killing me!
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