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Improving the Quality of Cancer Clinical Trials Workshop Summary (2008) / Chapter Skim
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Appendix A: Workshop Agenda
Pages 115-122

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From page 115...
... 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 A) Exploratory INDs and Phase 0 Trials 8:15 am – 9:45 am Moderator: James Doroshow, M.D., NCI 115
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From page 116...
... 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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From page 117...
... Jerry Collins, Ph.D., NCI Break 3:15 pm – 3:30 pm
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From page 118...
... 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" 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.
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From page 119...
... 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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From page 120...
... " 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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From page 121...
... APPENDIX A 121 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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From page 122...
... 122 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS 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
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Key Terms

  • clinical trials
  • anderson cancer
  • cancer clinical
  • lung cancer
  • vanderbilt university

  • assign therapy
  • clinical trial
  • adaptive trial
  • cancer personalized
  • trial design

  • personalized therapy
  • roy herbst
  • tailorx trial
  • cancer oncogenome
  • breast cancer

  • comprehensive cancer
  • partners center
  • kettering cancer
  • daniel von
  • genomics research

  • multiple pathways
  • joe gray
  • targeting multiple
  • targeted therapies
  • gene oncotype

  • multiple drugs
  • jack lee
  • harvard partners
  • ucsf comprehensive
  • raju kucherlapati


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