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Appendix A Workshop Agenda National Cancer Policy Forum Workshop on Improving the Quality of Cancer Clinical Trials The Keck Center of âThe National Academies Room 100 500 Fifth Street, NW Washington, DC 20001 Agenda October 4â5, 2007 Day 1: October 4, 2007 Welcome and Opening Remarks 8:00 am â 8:15 am John Mendelsohn, M.D., MD Anderson Cancer Center Session 1: New Clinical Trial Designs 8:15 am â 10:45 am A) Exploratory INDs and Phase 0 Trials 8:15 am â 9:45 am Moderator: James Doroshow, M.D., NCI 115
116 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS David Jacobson-Kram, Ph.D., FDA âOverview of the Exploratory IND: Differences in the Traditional INDâ George Mills, M.D., Parexel International Corporation âMolecular Imaging and Nanotechnology: Strategic Implementation of the 2006 Exploratory IND Guidanceâ James Doroshow, M.D., NCI âPhase 0 Clinical Trials in Cancer Drug Development: From Concept to Practiceâ B) Adaptive Trial Designs 9:45 am â 10:45 am Moderator: John Wagner, M.D., Ph.D., Merck Don Berry, Ph.D., MD Anderson Cancer Center âAdaptive Designs for Cancer Trialsâ Susan Ellenberg, Ph.D., University of Pennsylvania âAdaptive Designs in Cancer Trials: Consensus and Debateâ Break 10:45 am â 11:00 am Session 1 Resumes 11:00 am â 12:30 pm C) Targeting Multiple Pathways with Multiple Drugs 11:00 am â 12:00 pm Moderator: Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center Janet E. Dancey, M.D., NCI âStrategies to Develop Combinations of Investigational Agentsâ Joe Gray, Ph.D., UCSF Comprehensive Cancer Center âModeling Molecular Heterogeneity to Enhance Multidrug Clinical Trial Designâ
APPENDIX A 117 D) Preclinical Model Systems 12:00 pm â 12:30 pm Ken Anderson, M.D., Dana-Farber Cancer Institute âTranslation from Preclinical Model Systems to the Bedside in Multiple Myelomaâ Lunch Break 12:30 pm â 1:15 pm Session II: Molecular Imaging 1:15 pm â 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 âImaging Studies That Facilitate Clinical Trials Todayâ Steven Larson, M.D., Memorial Sloan-Kettering Cancer Center âMolecular Imaging: Biomarkers for Oncologyâ John Gore, Ph.D., Vanderbilt University âImaging Biomarkers on the Near Horizonâ David Piwnica-Worms, M.D., Ph.D., Washington University School of Medicine âMolecular Imaging Strategies in Drug Developmentâ Panel Discussion Tim McCarthy, Ph.D., Pfizer Jeff Evelhoch, Ph.D., Amgen, Inc. Jerry Collins, Ph.D., NCI Break 3:15 pm â 3:30 pm
118 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS Breakout Discussions: Case Studies of Clinical Trial Designs 3:30 pm â 5:30 pm 1) 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 2) Adaptive Trial Design Moderator/Reporter: John Wagner, M.D., Ph.D., Merck Lung Cancer Personalized Therapy Jack Lee, Ph.D., MD Anderson Cancer Center âDesign for Targeted Therapies in Lung Cancer: Statistical Considerationsâ Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center âToward Personalized Therapy for Lung Cancerâ Invited Discussant: Rick Chappell, Ph.D., University of Wisconsin âComments on the Controversy Over Response-Adaptive Randomizationâ 3) 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. âIncorporating Imaging Biomarkers in Phase I Oncology Trialsâ
APPENDIX A 119 4) se of Proteomics/Genomics to Assign Therapy in Lung U 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 âMolecular Signatures to Guide Selection of Lung Cancer Patient Therapyâ 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 âThe Lung Cancer Oncogenome Group: Bedside to Bench and Beyondâ 5) 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 âRationale for and Design of TAILORxâ Steven Shak, M.D., Genomic Health âThe 21 Gene Oncotype DX Assay and the NCI- Sponsored TAILORxâ 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.
120 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS Adjourn Day 1 5:30 pm Day 2: October 5, 2007 Welcome and Opening Remarks 8:00 am â 8:15 am Hal Moses, M.D., Vanderbilt University Session III: Screening for Predictive Markers 8:15 am â 10:15 am Moderator: George Mills, M.D., Parexel International Corporation Pierre Massion, M.D., Vanderbilt University âAre Genomics and Proteomics Biomarkers Ready for Prime Time?â James Heath, Ph.D., California Institute of Technology âLowering the Cost of In Vitro Diagnostics Measurements Associated with Clinical Trials by a Factor of 10 (or more)â Daniel Sullivan, M.D., Duke University âIs There a Role for Imaging as a Predictive Biomarker?â Daniel Von Hoff, M.D., Translational Genomics Research Institute âImproving a Patientâs Chance of Benefiting from Early Clinical Trialsâ Break 10:15 am â10:30 am
APPENDIX A 121 Session IV: Collaborations Among Academia, Pharma, Biotech, and Government 10:30 am â 12:30 pm Moderator: John Mendelsohn, M.D., MD Anderson Cancer Center Robert Comis, M.D., Coalition of National Cancer Cooperative Groups âThe Public Sector Perspectiveâ Kevin Schulman, M.D., Duke University Medical School âCost of Clinical Trialsâ Gwen Fyfe, M.D., Genentech âThe Industry Perspectiveâ Lunch Break 12:30 pm â 1:15 pm Session V: Regulatory Issues 1:15 pm â 3:15 pm Moderator: Janet Woodcock, M.D., FDA Susan Jerian, M.D., OncoRD, Inc. âThe Interplay of Laws, Regulations, and Policies: Moving Cancer Therapeutics Development Out of the Quagmireâ Ellen Stovall, National Coalition for Cancer Survivorship âClinical Trial Design, Drug Development, and Policy Issues of Importance to Cancer Advocatesâ Janet Woodcock, M.D., FDA âIssues in Cancer Drug Development of the Futureâ Steven Gutman, M.D., FDA âRegulation of Biomarkersâ
122 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS Reports from the Case Study Discussion Groups 3:15 pm â�������� ��������� 4:15 pm Giulio Draetta, M.D., Ph.D., Merck Research Laboratories âPhase 0 Trialsâ Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center âAdaptive Trial Designâ David Pinwica-Worms, M.D., Ph.D., Washington University School of Medicine, and Hedvig Hricak, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center âImagingâ John Mendelsohn, M.D., MD Anderson Cancer Center âUse of Proteomics/Genomics to Assign Therapy in Lung Cancerâ Pierre Massion, M.D., Vanderbilt University âUse of Genetics/Genomics to Assign Therapyâ� Wrap-Up/Summary 4:15 pm â 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