. "Appendix A: Workshop Agenda." Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press, 2008.
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Improving the Quality of Cancer Clinical Trials: Workshop Summary
Appendix A
Workshop Agenda
National Cancer Policy Forum
Workshop on Improving the Quality of Cancer Clinical Trials
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Improving the Quality of Cancer Clinical Trials: Workshop Summary
Appendix A
Workshop Agenda
National Cancer Policy Forum
Workshop on Improving the Quality of Cancer Clinical Trials
The Keck Center of The National Academies
Room 100
500 Fifth Street, NW
Washington, DC 20001
Agenda
October 4–5, 2007
Day 1: October 4, 2007
WELCOME AND OPENING REMARKS
8:00 am – 8:15 am
John Mendelsohn, M.D., MD Anderson Cancer Center
SESSION 1: NEW CLINICAL TRIAL DESIGNS
8:15 am – 10:45 am
Exploratory INDs and Phase 0 Trials
8:15 am – 9:45 am
Moderator: James Doroshow, M.D., NCI
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David Jacobson-Kram, Ph.D., FDA
“Overview of the Exploratory IND: Differences in the Traditional IND”
George Mills, M.D., Parexel International Corporation
“Molecular Imaging and Nanotechnology: Strategic Implementation of the 2006 Exploratory IND Guidance”
James Doroshow, M.D., NCI
“Phase 0 Clinical Trials in Cancer Drug Development: From Concept to Practice”
Adaptive Trial Designs
9:45 am – 10:45 am
Moderator: John Wagner, M.D., Ph.D., Merck
Don Berry, Ph.D., MD Anderson Cancer Center
“Adaptive Designs for Cancer Trials”
Susan Ellenberg, Ph.D., University of Pennsylvania
“Adaptive Designs in Cancer Trials: Consensus and Debate”
BREAK
10:45 am – 11:00 am
SESSION 1 RESUMES
11:00 am – 12:30 pm
Targeting Multiple Pathways with Multiple Drugs
11:00 am – 12:00 pm
Moderator: Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center
Janet E. Dancey, M.D., NCI
“Strategies to Develop Combinations of Investigational Agents”
Joe Gray, Ph.D., UCSF Comprehensive Cancer Center
“Modeling Molecular Heterogeneity to Enhance Multidrug Clinical Trial Design”
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Preclinical Model Systems
12:00 pm – 12:30 pm
Ken Anderson, M.D., Dana-Farber Cancer Institute
“Translation from Preclinical Model Systems to the Bedside in Multiple Myeloma”
LUNCH BREAK
12:30 pm – 1:15 pm
SESSION II: MOLECULAR IMAGING
1:15 pm – 3:15 pm
Moderators: Hedvig Hricak, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center, and David Piwnica-Worms, M.D., Ph.D., Washington University School of Medicine
Introduction and Mission Statement
Hedvig Hricak, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center
Lawrence Schwartz, M.D., Memorial Sloan-Kettering Cancer Center
“Imaging Studies That Facilitate Clinical Trials Today”
Steven Larson, M.D., Memorial Sloan-Kettering Cancer Center
“Molecular Imaging: Biomarkers for Oncology”
John Gore, Ph.D., Vanderbilt University
“Imaging Biomarkers on the Near Horizon”
David Piwnica-Worms, M.D., Ph.D., Washington University School of Medicine
“Molecular Imaging Strategies in Drug Development”
Panel Discussion
Tim McCarthy, Ph.D., Pfizer
Jeff Evelhoch, Ph.D., Amgen, Inc.
Jerry Collins, Ph.D., NCI
BREAK
3:15 pm – 3:30 pm
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BREAKOUT DISCUSSIONS: CASE STUDIES OF CLINICAL TRIAL DESIGNS
3:30 pm – 5:30 pm
Phase 0 Trials
Moderator/Reporter: Giulio Draetta , M.D., Ph.D., Merck
James Doroshow, M.D., NCI
Invited Discussant: Richard Schilsky, M.D., University of Chicago
Adaptive Trial Design
Moderator/Reporter: John Wagner, M.D., Ph.D., Merck
Lung Cancer Personalized Therapy
Jack Lee, Ph.D., MD Anderson Cancer Center
“Design for Targeted Therapies in Lung Cancer: Statistical Considerations”
Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center
“Toward Personalized Therapy for Lung Cancer”
Invited Discussant: Rick Chappell, Ph.D., University of Wisconsin
“Comments on the Controversy Over Response-Adaptive Randomization”
Imaging
Moderators/Reporters: David Piwnica-Worms, M.D., Ph.D., Washington University School of Medicine, and Hedvig Hricak, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center
Tim McCarthy, Ph.D., Pfizer
Jeff Evelhoch, Ph.D., Amgen, Inc.
“Incorporating Imaging Biomarkers in Phase I Oncology Trials”
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Use of Proteomics/Genomics to Assign Therapy in Lung Cancer
Moderator/Reporter: John Mendelsohn, M.D., MD Anderson Cancer Center
Proteomics and Lung Cancer Prediction (EGFR)
David Carbone, M.D., Ph.D., Vanderbilt University
“Molecular Signatures to Guide Selection of Lung Cancer Patient Therapy”
Use of Genomics to Assign Therapy in Lung Cancer (genetic targets for Iressa and Tarceva)
William Pao, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center
Mark Kris, M.D., Memorial Sloan-Kettering Cancer Center
“The Lung Cancer Oncogenome Group: Bedside to Bench and Beyond”
Use of Genetics/Genomics to Assign Therapy
Moderator/Reporter: Pierre Massion, M.D., Vanderbilt University
Breast Cancer Personalized Therapy: The TAILORx Trial
Joseph Sparano, M.D., Albert Einstein Comprehensive Cancer Center
“Rationale for and Design of TAILORx”
Steven Shak, M.D., Genomic Health
“The 21 Gene Oncotype DX Assay and the NCI-Sponsored TAILORx”
Using Genetic and Genomic Technologies in Design and Execution of Cancer Clinical Trials
Raju Kucherlapati, Ph.D., Harvard Partners Center for Genetics and Genomics
Invited Discussant: David Chang, M.D., Ph.D., Amgen, Inc.
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ADJOURN DAY 1
5:30 pm
Day 2: October 5, 2007
WELCOME AND OPENING REMARKS
8:00 am – 8:15 am
Hal Moses, M.D., Vanderbilt University
SESSION III: SCREENING FOR PREDICTIVE MARKERS
8:15 am – 10:15 am
Moderator: George Mills, M.D., Parexel International Corporation
Pierre Massion, M.D., Vanderbilt University
“Are Genomics and Proteomics Biomarkers Ready for Prime Time?”
James Heath, Ph.D., California Institute of Technology
“Lowering the Cost of In Vitro Diagnostics Measurements Associated with Clinical Trials by a Factor of 10 (or more)”
Daniel Sullivan, M.D., Duke University
“Is There a Role for Imaging as a Predictive Biomarker?”
Daniel Von Hoff, M.D., Translational Genomics Research Institute
“Improving a Patient’s Chance of Benefiting from Early Clinical Trials”
BREAK
10:15 am –10:30 am
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SESSION IV: COLLABORATIONS AMONG ACADEMIA, PHARMA, BIOTECH, AND GOVERNMENT
10:30 am – 12:30 pm
Moderator: John Mendelsohn, M.D., MD Anderson Cancer Center
Robert Comis, M.D., Coalition of National Cancer Cooperative Groups
“The Public Sector Perspective”
Kevin Schulman, M.D., Duke University Medical School
“Cost of Clinical Trials”
Gwen Fyfe, M.D., Genentech
“The Industry Perspective”
LUNCH BREAK
12:30 pm – 1:15 pm
SESSION V: REGULATORY ISSUES
1:15 pm – 3:15 pm
Moderator: Janet Woodcock, M.D., FDA
Susan Jerian, M.D., OncoRD, Inc.
“The Interplay of Laws, Regulations, and Policies: Moving Cancer Therapeutics Development Out of the Quagmire”
Ellen Stovall, National Coalition for Cancer Survivorship
“Clinical Trial Design, Drug Development, and Policy Issues of Importance to Cancer Advocates”
Janet Woodcock, M.D., FDA
“Issues in Cancer Drug Development of the Future”
Steven Gutman, M.D., FDA
“Regulation of Biomarkers”
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REPORTS FROM THE CASE STUDY DISCUSSION GROUPS
3:15 pm – 4:15 pm
Giulio Draetta, M.D., Ph.D., Merck Research Laboratories
“Phase 0 Trials”
Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center
“Adaptive Trial Design”
David Pinwica-Worms, M.D., Ph.D., Washington University
School of Medicine, and Hedvig Hricak, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center
“Imaging”
John Mendelsohn, M.D., MD Anderson Cancer Center
“Use of Proteomics/Genomics to Assign Therapy in Lung Cancer”
Pierre Massion, M.D., Vanderbilt University
“Use of Genetics/Genomics to Assign Therapy”
WRAP-UP/SUMMARY
4:15 pm – 4:30 pm
John Mendelsohn, M.D., MD Anderson Cancer Center, and Hal Moses, M.D., Vanderbilt-Ingram Cancer Center
ADJOURN DAY 2
4:30 pm
