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

  1. Exploratory INDs and Phase 0 Trials

8:15 am – 9:45 am

Moderator: James Doroshow, M.D., NCI



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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 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 

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 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS 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” B) 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 C) 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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 APPENDIX A D) 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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 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS BReakouT discussions: case sTudies of clinical TRial designs 3:30 pm – 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 “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. “Incorporating Imaging Biomarkers in Phase I Oncology Trials”

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 APPENDIX A 4) 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” 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 “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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0 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 – 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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 APPENDIX A 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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 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