Program

(updated 6-10-13)

2013 Workshop Brochure

AGENDA
 
Thursday, May 23
Snyder Auditorium, Kresge G1
8:00-8:30 Registration & Breakfast
Session I – Opening Remarks & Keynote Discussion
8:30-8:35 Victor DeGruttola, Harvard School of Public Health
Opening Remarks/Introductions
8:35-9:15 KEYNOTE: Marc A. Pfeffer, Brigham & Women’s Hospital
Negative Influences on the Integrity of Randomized Clinical Trials
9:15-9:25 Discussant: Robert T. O’Neill, Food & Drug Administration
9:25-9:30 Questions & Discussion
SESSION II – Translational statistics in cardiovascular-diabetes clinical studies
Session Chair: Masahiro Takeuchi, Kitasato University
9:30-9:50 John M. Lachin, The George Washington University
Statistical Practice and Challenges in Chronic Disease Clinical Trials – Diabetes and Cardiovascular Diseases
9:50-10:10 Brian Claggett, Harvard School of Public Health &
Hicham Skali, Brigham & Women’s Hospital
Clinical and Statistical Perspectives on Personalized Medicine
10:10-10:30 Toshio Miyata, Ministry of Health, Labour, and Welfare
Japan policy of pharmaceutical innovation and regulatory science
10:30-10:45 BREAK
SESSION III – Where is the bottleneck for utilizing the new methodology in clinical development?
Session Chair: Yoshiaki Uyama, Pharmaceuticals & Medical Devices Agency
10:45-11:45 Panel Discussion: Paul Gallo, Novartis
Marc de Somer, Alkermes Inc.
Yangchun Du, Alkermes Inc.
Caroline Morgan, Cytel Inc.
Norman Stockbridge, Food & Drug Administration
11:45-12:45 LUNCH
SESSION IV – Modernizing oncology trials: challenges and technical developments
Session Chair: Jerald Schindler, Merck
12:45-1:05 Keith Goodman, Cancer Research And Biostatistics
The Automatic Clinical Trial: Leveraging the Electronic Medical Record in Multi-site Cancer Clinical Trials
1:05-1:25 William T. Barry, Dana-Farber Cancer Institute
Adaptive trial designs with integral biomarkers:  innovation versus feasibility
1:25-1:45 Lorenzo Trippa, Dana-Farber Cancer Institute
Optimal Bayesian Designs and Frequentist Constraints
1:45-1:55 Discussant: Brian Alexander, Dana-Farber Cancer Institute
1:55-2:05 Discussant: John J. Crowley, Cancer Research And Biostatistics
2:05-2:15 Questions & Discussion
SESSION V – Infectious disease research: new statistical
methods to address global challenges         
Session Chair: Victor DeGruttola, Harvard School of Public Health 
2:15-2:25 Victor DeGruttola, Harvard School of Public Health
Introduction
2:25-2:45 Pamela Shaw, National Institute of Allergy and Infectious Diseases (NIAID)
A randomized delayed start trial of linezolid in patients with extensively drug-resistant tuberculosis
2:45-3:05 Ivan S.F. Chan, Merck
Assessing Immune Correlates of Protection in Vaccine Studies
3:05-3:15 Questions & Discussion
3:15-3:30 BREAK
SESSION VI – The FDA Sentinel Initiative – New Data, New Methods:  What have we learned after three years?        
Session Chair: Marcia Testa, Harvard School of Public Health
3:30-3:40 Marcia Testa, Harvard School of Public Health
Introduction
3:40-4:00 Aloka Chakravarty, Food and Drug Administration
An Overview of Quantitative Safety Evaluation at the Center for Drug Evaluation and Research, United States Food and Drug Administration
4:00-4:20 Richard Platt, Harvard Pilgrim Health Care Institute/Harvard Medical School
FDA’s Mini-Sentinel Program to Evaluate the Safety of Marketed Medical Products: Progress and Direction
4:20-4:40 Sebastian Schneeweiss, Brigham & Women’s Hospital
Safety Surveillance using Mini-Sentinel Assessment, Methods and Data in Practice
4:40-5:00 Questions & Discussion
5:00-6:00 RECEPTION, FXB Atrium
Friday, May 24      
Snyder Auditorium, Kresge G1
8:00-8:30 Registration & Breakfast
SESSION VII – Case Studies               
Session Chair: James Ware, Harvard School of Public Health
8:30-9:00 James Ware, Harvard School of Public Health
Reflections on Thursday’s Program
9:00-9:25 Hajime Uno, Dana-Farber Cancer Institute
Non-proportional Hazards
9:25-9:50 James Ware, Harvard School of Public Health
Composite Endpoints
9:50-10:30 Group Discussion of Opportunities for Innovation in Trial Methodologies
10:30 Adjourn
Marvin Zelen Leadership Award in Statistical Science
11:00-12:00 John J. Crowley, Cancer Research And Biostatistics
A Brief History of Survival Analysis   
12:00-1:00 Luncheon Reception, Sebastian’s Café, Kresge 1st Floor