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Planning the Lifecycle of Safety Evaluation

Brenda Crowe, PhD

Eli Lilly and Company

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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

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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 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

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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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5minute

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1minute

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Stop Now!! Please

You’re killing me!