Appendix F

Information Gathering Sessions and Speakers

COMMITTEE MEETING 1 – DECEMBER 20, 2010

ROBERT L. BECKER, JR., Chief Medical Officer, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration

LISA MCSHANE, Mathematical Statistician, Biometric Research Branch, National Cancer Institute

COMMITTEE MEETING 2 – MARCH 30-31, 2011

KEITH BAGGERLY, Associate Professor of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center

NED CALONGE, Chair, Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group, and President and CEO, The Colorado Trust

KATRINA KELNER, Editor, Translational Medicine, and Managing Editor, Research Journals, Science Magazine

VÉRONIQUE KIERMER, Executive Editor and Head of Researcher Services, Nature Publishing Group

SUMITHRA MANDREKAR, Associate Professor of Biostatistics, Division of Biomedical Statistics and Informatics, Mayo Clinic

JOSEPH NEVINS, Barbara Levine University Professor of Breast Cancer Genomics, Institute for Genome Sciences and Policy, Duke University



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Appendix F Information Gathering Sessions and Speakers COMMITTEE MEETING 1 – DECEMBER 20, 2010 ROBERT L. BECKER, JR., Chief Medical Officer, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration LISA McSHANE, Mathematical Statistician, Biometric Research Branch, National Cancer Institute COMMITTEE MEETING 2 – MARCH 30-31, 2011 KEITH BAGGERLY, Associate Professor of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center NED CALONGE, Chair, Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group, and President and CEO, The Colorado Trust KATRINA KELNER, Editor, Translational Medicine, and Managing Editor, Research Journals, Science Magazine VÉRONIQUE KIERMER, Executive Editor and Head of Researcher Services, Nature Publishing Group SUMITHRA MANDREKAR, Associate Professor of Biostatistics, Division of Biomedical Statistics and Informatics, Mayo Clinic JOSEPH NEVINS, Barbara Levine University Professor of Breast Cancer Genomics, Institute for Genome Sciences and Policy, Duke University 319

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320 EVOLUTION OF TRANSLATIONAL OMICS HAROLD PAZ, Chief Executive Officer, Penn State Milton S. Hershey Medical Center, and Senior Vice President for Health Affairs and Dean, College of Medicine, Pennsylvania State University CHARLES PEROU, Professor of Genetics and Pathology, and Member, Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill PETER PRONOVOST, Director, Division of Adult Critical Care Medicine, Director, Quality and Safety Research Group, and Medical Director, Center for Innovations in Quality Patient Care, Johns Hopkins University STEVEN SHAK, Chief Medical Officer, Genomic Health RICHARD SIMON, Chief, Biometric Research Branch, National Cancer Institute LAURA VAN ‘T VEER, Director, Applied Genomics, and Program Leader, Breast Oncology, Helen Diller Family Comprehensive Cancer Center SCOTT ZEGER, Professor of Biostatistics and Vice Provost for Research, Bloomberg School of Public Health, Johns Hopkins University COMMITTEE MEETING 3 – JUNE 30-JULY 1, 2011 LISA McSHANE, Mathematical Statistician, Biometric Research Branch, National Cancer Institute TELECONFERENCE 1 – AUGUST 4, 2011 WILLIAM SELLERS, Vice President and Global Head of Oncology, Novartis Institutes for BioMedical Research TELECONFERENCE 2 – AUGUST 15, 2011 JEFFREY DRAZEN, Editor-in-Chief, New England Journal of Medicine TELECONFERENCE 3 – AUGUST 19, 2011 ALBERTO GUTIERREZ, Director, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration PANEL DISCUSSION WITH DUKE UNIVERSITY FACULTY AND ADMINISTRATION – AUGUST 22, 2011 WILLIAM BARRY, Assistant Professor of Biostatistics and Bioinformatics

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321 APPENDIX F ROBERT CALIFF, Vice Chancellor for Clinical Research and Director, Duke Translational Medicine Institute MICHAEL CUFFE, Vice President for Ambulatory Services, Chief Medical Officer for Duke University Health System JOHN FALLETTA, Professor of Pediatrics and Senior Chair, Institutional Review Board GEOFFREY GINSBURG, Director of Genomic Medicine, Institute for Genome Sciences and Policy MICHAEL KELLEY, Associate Professor of Medicine, Oncology, and Cancer Protocol Review Committee SALLY KORNBLUTH, James B. Duke Professor of Pharmacology and Cancer Biology and Vice Dean for Research, Duke University Medical Center ROSS McKINNEY, Director, Clinical and Translational Research Ethics, Law, and Policy, Professor of Pediatrics, and Director, Trent Center for Bioethics, Humanities, and Medical History

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