Kresge Building, Snyder Auditorium
677 Huntington Avenue - Boston, Massachusetts

THURSDAY		MAY 29th, 2008
8:00 a.m.		Registration and Continental Breakfast
Session I - Overview and Keynote Lecture Session Chair: Marcello Pagano
8:45 a.m. - 9:00 a.m.		Welcome / Introduction	Louise Ryan, Harvard School of Public Health & Tom Capezzi, Schering-Plough Research Institute
9:00 a.m. - 9:45 a.m.		Challenges in Synthesizing Information to Resolve Medical and Public Health Controversies	Colin B. Begg, Memorial Sloan-Kettering Cancer Center
Session II - Combining Trials and Observational Data Session Chair: David Harrington
9:45 a.m. - 10:15 a.m.		International Early Lung Cancer Action Program: Background	Claudia Henschke & David Yankelevitz, Weill-Cornell Medical Center of New York-Presbyterian Hospital
10:15 a.m. - 10:45 a.m.		Epidemiological Perspective	David Ransohoff, Lineberger Comprehensive Cancer Center, University of North Carolina
10:45 a.m. - 11:00 a.m.		Break
11:00 a.m. - 11:30 a.m.		Combing Trials and Observational Data: Bayesian Perspective	Donald A. Berry, M.D. Anderson Cancer Center, University of Texas
11:30 a.m. - 12:00 p.m.		Research on Screening for a Cancer: Theses, Antitheses, Syntheses	Olli S. Miettinen, McGill University, Montreal
12:00 p.m. - 12:30 p.m.		Panel Discussion
12:30 p.m. - 1:30 p.m.		Lunch
Session III - Recent Data Driven Safety Decisions Session Chair: Lee-Jen Wei
1:30 p.m. - 2:00 p.m.		The Story of Avandia from an FDA Statistical Reviewer Perspective	Joy Mele, Food and Drug Administration
2:00 p.m. - 2:30 p.m.		Losing a Medication from a Patient's Perspective	Marcello Pagano, Harvard School of Public Health
2:30 p.m. - 3:00 p.m.		Discussion
3:00 p.m. - 3:15 p.m.		Break
Session IV - Synthesizing Information Session Chair: Tianxi Cai
3:15 p.m. - 3:30 p.m.		Introduction	Tianxi Cai, Harvard School of Public Health
3:30 p.m. - 4:00 p.m.		Meta-Analyses of Randomized Trials Should Use Individual Patient Data	Marc Buyse, International Institute for Drug Development, Universiteit Hasselt, Belgium
4:00 p.m. - 4:30 p.m.		Meta-Analysis for Drug Safety Assessment	Michael Stoto, Harvard School of Public Health and Georgetown University
4:30 p.m. - 5:00 p.m.		Case Studies of the Use of Meta-Analyses of Drug Safety Questions in the Regulatory Setting	Jesse Berlin, Johnson & Johnson
5:00 p.m. - 5:30 p.m.		Discussion
Following Discussion		Reception	Sebastian's Cafe located in the School of Public Health

FRIDAY		MAY 30th, 2008
8:00 a.m.		Continental Breakfast
Session V - Risk and Benefit Session Chair: Scott Evans
8:30 a.m. - 9:00 a.m.		Risk, Reputation and R&D...Is Data Enough?	David Slavin, Imperial College London
9:00 a.m. - 9:30 a.m.		Evidentiary Standards for the Acceptance of New Technologies and Diagnostics	Stephen Williams, Decisionability, Inc.
9:30 a.m. - 10:00 a.m.		Quantitative Issues in Assessing Risks and Benefits of Medical Interventions	John Powers, National Institutes of Health
10:00 a.m. - 10:30 a.m.		Industry Perspective	Marty Huber, Schering-Plough Research Institute
10:30 a.m. - 11:00 a.m.		Break