Appendix A

Workshop Agenda

New Paradigms in Drug Discovery: How Genomic Data Are Being Used to Revolutionize the Drug Discovery and Development Process—A Workshop

March 21, 2012

20 F Street NW Conference Center
20 F Street, NW
Washington, DC 20001



WORKSHOP OBJECTIVES

•   To examine the impact of and investment in the use of genetic and genomic data in drug development.

•   To discuss how genomic and genetic data have been and will be used in the drug development process to improve aspects such as target identification, clinical trial design, pharmacogenomic approaches, biomarker development, and understanding of disease biology.

•   To investigate the economic drivers, incentives, and models for genomic-based strategies for drug development.



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Appendix A Workshop Agenda New Paradigms in Drug Discovery: How Genomic Data Are Being Used to Revolutionize the Drug Discovery and Development Process-- A Workshop March 21, 2012 20 F Street NW Conference Center 20 F Street, NW Washington, DC 20001 WORKSHOP OBJECTIVES To examine the impact of and investment in the use of genetic and genomic data in drug development. To discuss how genomic and genetic data have been and will be used in the drug development process to improve aspects such as target identification, clinical trial design, pharmacogenomic approaches, biomarker development, and understanding of disease biology. To investigate the economic drivers, incentives, and models for genomic-based strategies for drug development. 59

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60 GENOME-BASED THERAPEUTICS 8:308:35 A.M. WELCOMING REMARKS Wylie Burke, Roundtable Chair Professor and Chair, Department of Bioethics and Humanities, University of Washington 8:358:45 A.M. HARGE TO WORKSHOP SPEAKERS AND C PARTICIPANTS Geoffrey Ginsburg Director, Center for Genomic Medicine, Duke University 8:4510:15 A.M. CURRENT LANDSCAPE Session Moderator: Aidan Power, Pfizer Inc. 8:459:00 A.M.Current Use of Genetic and Genomic Strategies in Drug Development Nicholas Davies Partner, Pharmaceutical and Life Sciences Practice, PwC 9:009:15 A.M.Economic Incentives for Genetic and Genomic Strategies Mark Trusheim Visiting Scientist and Executive-in-Residence, MIT Sloan School of Management; President, Co-Bio Consulting 9:159:30 A.M.Perceived Challenges in Genomic-Based Drug Development Garret A. FitzGerald Professor of Medicine and Pharmacology and McNeil Professor in Translational Medicine and Therapeutics; Associate Dean for Translational Research; Chair, Department of Pharmacology; Director, Institute for Translational Medicine and Therapeutics, University of Pennsylvania School of Medicine

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APPENDIX A 61 9:3010:15 A.M. Discussion with Speakers and Attendees 10:1510:30 A.M. BREAK 10:30 A.M. DRUG DISCOVERY AND DEVELOPMENT: 12:15 P.M. CASE STUDIES OF GENOMICS-BASED DRUG DEVELOPMENT Session Moderator: Michelle Penny, Eli Lilly and Company 10:3010:50 A.M.Development of Crizotinib for Treatment of Non- Small-Cell Lung Cancer Steffan N. Ho Director, Translational Oncology, Pfizer Inc. 10:5011:10 A.M.Use of Genetics to Inform Drug Development of a Novel Treatment for Schizophrenia Laura Nisenbaum Senior Research Advisor, Pharmacogenomics, Translational Medicine and Tailored Therapeutics, Eli Lilly and Company 11:1011:30 A.M.A Genetic Approach to the Treatment of Cystic Fibrosis Peter Mueller Executive Vice President, Global Research and Development; Chief Scientific Officer, Vertex Pharmaceuticals Incorporated 11:30 A.M. Discussion with Speakers and Attendees 12:15 P.M. 12:151:00 P.M. WORKING LUNCH

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62 GENOME-BASED THERAPEUTICS 1:002:15 P.M.UTILITY OF EMERGING GENOMICS TECHNOLOGY IN DRUG DEVELOPMENT Session Moderator: Geoffrey Ginsburg, Duke University 1:001:15 P.M.Large-Scale Whole-Genome Sequencing for Disease Understanding, Drug Development, and Genomic Medicine Radoje Drmanac Co-Founder and Chief Scientific Officer, Complete Genomics 1:151:30 P.M.Clinical Next Generation Sequencing--Value to Drug Developers Gary Palmer Senior Vice President, Medical Affairs and Commercial Development, Foundation Medicine 1:301:45 P.M. Pharma Perspective Jane Fridlyand Senior Statistical Scientist, Genentech 1:452:15 P.M. Discussion with Speakers and Attendees 2:154:15 P.M. EVOLVING PARADIGMS Session Moderator: Sharon Terry, Genetic Alliance 2:152:30 P.M. Foundations and Drug Development Walter Capone Chief Operating Officer, Multiple Myeloma Research Foundation

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APPENDIX A 63 2:302:45 P.M. Genomics and Regulatory Science Michael Pacanowski Team Leader, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 2:453:00 P.M. BREAK 3:003:15 P.M. Repurposing of Drugs Christopher Austin Director of the Division of Pre-Clinical Innovation; Scientific Director, NIH Center for Translational Therapeutics; National Center for Advancing Translational Sciences, National Institutes of Health 3:153:30 P.M.Pharmacy Benefit Management and Pharmacogenomics Felix W. Frueh President, Medco Research Institute 3:304:15 P.M. Discussion with Speakers and Attendees 4:155:30 P.M.LEADING THE STRATEGY FOR PERSONALIZED MEDICINE: PHARMA, GOVERNMENT, ACADEMIA-- HOW DO WE ALL WORK TOGETHER? Session Moderator: Thomas Lehner, National Institute of Mental Health, National Institutes of Health Discussants: Deborah Dunsire President and Chief Executive Officer, Millennium: The Takeda Oncology Company

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64 GENOME-BASED THERAPEUTICS Victor Dzau Chancellor for Health Affairs, Duke University; President and Chief Executive Officer, Duke University Health System Margaret Hamburg Commissioner, U.S. Food and Drug Administration Kathy Hudson Deputy Director for Science, Outreach, and Policy; Acting Deputy Director, National Center for Advancing Translational Sciences, National Institutes of Health 5:305:45 P.M. CONCLUDING REMARKS Geoffrey Ginsburg Director, Center for Genomic Medicine, Duke University 5:45 P.M. ADJOURN