2008 ASCO–NCI–EORTC Annual Meeting on Molecular Markers in Cancer
From Hypothesis to Product: ASCO-NCI-EORTC Diagnostic Development Tutorial
DRAFT PROGRAM AGENDA
Wednesday, October 29, 2008
Materials Pick Up
7:30 AM – 8:30 AM
Continental breakfast provided
Welcome
8:30 AM – 8:45 AM
- General Session I: Overview, General Principles & Clinical Scenarios
8:30 AM – 10:30 AM
Chair: Nils Brünner, MD, DMSc – University of Copenhagen
- Overview of the Learning Objectives and Tutorial Schedule
Richard L. Schilsky, MD – University of Chicago
The Elements of Successful Marker Development: General Overview of Process
Sheila Taube, PhD – National Cancer Institute
Statistical Presentations
9:30 AM – 10:30 AM
- Biomarker Based Trial Design
Gary M. Clark, PhD - Array BioPharma
Development of statistically robust and clinically meaningful multiplex markers
Lisa McShane, PhD – National Cancer Institute
- Break 10:30 AM – 10:45 AM
- General Session I: Overview, General Principles & Clinical Scenarios (continued)
10:45 AM – 12:00 PM
- Introduction of the Clinical Scenarios and Assignment to Working Groups
Richard L. Schilsky, MD – University of Chicago
(Please see below for working group breakout session faculty)
Breakout Session 1: Circulating Tumor Cells
Breakout Session 2: RTK Inhibitor
- Break for Lunch
12:00 PM – 12:45 PM
Box lunch provided
- General Session II: Regulatory Issues & Working Breakout Sessions
12:45 PM – 3:00 PM
Chair: Sheila Taube, PhD – National Cancer Institute
- Regulatory Issues: The Standardization Imperative
Fred Sweep, PhD – Radboud University Nijmegen Medical Centre
Regulatory Issues: United States
Robert L. Becker, Jr. MD, PhD - FDA/CDRH
Regulatory Issues: Europe
TBD
Success Stories: Circulating Tumor Cells
Daniel F. Hayes, MD – University of Michigan Health System
Success Stories: Oncotype Dx
Steven Shak, MD – Genomic Health
- Break
3:00 PM – 3:15 PM
- General Session II: Regulatory Issues & Working Breakout Sessions (continued)
3:15 PM – 5:00 PM
- Breakout Sessions: Circulating Tumor Cells
Breakout Sessions: RTK Inhibitor
- Dinner & Discussion of Problems and Questions
5:00 PM – 6:30 PM
Buffet dinner provided
- General Session II: Regulatory Issues & Working Breakout Sessions (continued)
6:30 PM – 9:00 PM
- Breakout Sessions: Circulating Tumor Cells
Breakout Sessions: RTK Inhibitor
Thursday, October 30, 2008
Continental Breakfast Provided
7:00 AM – 7:30 AM
Breakout Regroup
7:30 AM – 9:00 AM
- General Session III: Presentations: Critiques of Development Plans
9:00 AM – 10:20 AM
Chair: Gary M. Clark, PhD - Array BioPharma
- Presentations of Development Plans Part 1
- Break
10:20 AM – 10:35 AM
- General Session III: Presentations: Critiques of Development Plans (continued)
10:35 AM – 11:55 AM
- Presentations of Development Plans Part 2
Course Critique and Evaluation
11:55 PM – 12:15 PM
Gary M. Clark, PhD - Array BioPharma
Wrap–Up
12:15 PM – 12:45 PM
Nils Brünner, MD, DMSc – University of Copenhagen
Adjourn
12:45 PM
Boxed lunches will be provided for participants as they leave the tutorial
Working Group Breakout Session Faculty
Statisticians:
Susan G. Hilesenbeck, PhD – Lester and Sue Smith Breast Center at Baylor College of Medicine
Gary M. Clark, PhD – Array BioPharma
Lisa McShane, PhD – National Cancer Institute
Jan Bogaerts, ScD – European Organisation for Research and Treatment of Cancer
Clinicians:
Richard L. Schilsky, MD – University of Chicago
Nils Brünner, MD, DMSc – University of Copenhagen
Daniel F. Hayes, MD – University of Michigan Health System
Steven Shak, MD – Genomic Health
Nadia Harbeck, MD, PhD – Inter Disciplinary Breast Center, Technische Universitaet Muenchen
Lab Scientists:
Robert L. Becker, Jr. MD, PhD - FDA/CDRH
Fred Sweep, PhD – Radboud University Nijmegen Medical Centre
Sheila Taube, PhD – National Cancer Institute
Manfred Schmitt, MD – Inter Disciplinary Breast Center, Technische Universitaet Muenchen
Tracy G. Lively, PhD – National Cancer Institute
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