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: 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

9. 5
minute

10. 1
minute

11. minute

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