National Academies Press: OpenBook

Evolution of Translational Omics: Lessons Learned and the Path Forward (2012)

Chapter: Appendix F: Information Gathering Sessionsand Speakers

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Suggested Citation:"Appendix F: Information Gathering Sessionsand Speakers." Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. doi: 10.17226/13297.
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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

Suggested Citation:"Appendix F: Information Gathering Sessionsand Speakers." Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. doi: 10.17226/13297.
×

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

Suggested Citation:"Appendix F: Information Gathering Sessionsand Speakers." Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. doi: 10.17226/13297.
×

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

Suggested Citation:"Appendix F: Information Gathering Sessionsand Speakers." Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. doi: 10.17226/13297.
×

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Suggested Citation:"Appendix F: Information Gathering Sessionsand Speakers." Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. doi: 10.17226/13297.
×
Page 319
Suggested Citation:"Appendix F: Information Gathering Sessionsand Speakers." Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. doi: 10.17226/13297.
×
Page 320
Suggested Citation:"Appendix F: Information Gathering Sessionsand Speakers." Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. doi: 10.17226/13297.
×
Page 321
Suggested Citation:"Appendix F: Information Gathering Sessionsand Speakers." Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. doi: 10.17226/13297.
×
Page 322
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Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

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