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Nanotechnology and Oncology WORKSHOP SUMMARY Margie Patlak and Christine Micheel, Rapporteurs National Cancer Policy Forum Board on Health Care Services
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Gov- erning Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engi- neering, and the Institute of Medicine. This study was supported by Contract Nos. HHSN261200900003C and 200-2005- 13434 TO #1, between the National Academy of Sciences and the National Cancer Institute and the Centers for Disease Control and Prevention, respectively. This study was also supported by the American Association for Cancer Research, American Cancer Society, the American Society of Clinical Oncology, the Associa- tion of American Cancer Institutes, C-Change, the CEO Roundtable on Cancer, Novartis Oncology, and the Oncology Nursing Society. Any opinions, ﬁndings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reﬂect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-16321-7 International Standard Book Number-10: 0-309-16321-8 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2011 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2011. Nanotechnology and oncology: Workshop summary. Washington, DC: The National Academies Press.
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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.
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The National Academy of Sciences is a private, nonproﬁt, self-perpetuating society of distinguished scholars engaged in scientiﬁc and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal govern- ment on scientiﬁc and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in pro- viding services to the government, the public, and the scientiﬁc and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org
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PLANNING COMMITTEE ON POLICY ISSUES IN NANOTECHNOLOGY AND ONCOLOGY* EDWARD BENZ (Chair), President, Dana Farber Cancer Institute ANNA BARKER, Deputy Director of the National Cancer Institute, retired September 2010 STEVEN CURLEY, Professor of Surgical Oncology, MD Anderson Cancer Center MAURO FERRARI, President, Chief Executive Ofﬁcer, and Director of the Methodist Hospital Research Institute PIOTR GRODZINSKI, Director, Nanotechnology for Cancer Programs, National Cancer Institute JOHN MENDELSOHN, President, University of Texas, MD Anderson Cancer Center JOHN NIEDERHUBER, Adjunct Investigator and Former Director, National Cancer Institute RALPH WEISSLEDER, Professor, Harvard Medical School and Director, Center for Molecular Imaging Research Study Staff CHRISTINE MICHEEL, Study Director ERIN BALOGH, Associate Program Ofﬁcer MICHAEL PARK, Senior Program Assistant PATRICK BURKE, Financial Associate SHARYL NASS, Director, National Cancer Policy Forum ROGER HERDMAN, Director, Board on Health Care Services * Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. v
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NATIONAL CANCER POLICY FORUM* HAROLD MOSES (Chair), Director Emeritus, Vanderbilt-Ingram Cancer Center, Nashville, TN FRED APPELBAUM, Director, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA PETER B. BACH, Associate Attending Physician, Memorial Sloan- Kettering Cancer Center, New York EDWARD BENZ, JR., President, Dana-Farber Cancer Institute and Director, Harvard Cancer Center, Harvard School of Medicine, Boston, MA THOMAS G. BURISH, Provost, Notre Dame University, South Bend, IN, and Past Chair, American Cancer Society Board of Directors MICHAEL A. CALIGIURI, Director, Ohio State Comprehensive Cancer Center, Columbus, OH, and President, Association of American Cancer Institutes RENZO CANETTA, Vice President, Oncology Global Clinical Research, Bristol-Myers Squibb, Wallingford, CT MICHAELE CHAMBLEE CHRISTIAN, Retired, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Washington, DC WILLIAM DALTON, President, CEO, and Center Director, Mofﬁtt Cancer Center, Tampa, FL, and Chair, AACR Committee on Science Policy and Legislative Affairs ROBERT ERWIN, President, Marti Nelson Cancer Foundation, Davis, CA BETTY R. FERRELL, Research Scientist, City of Hope National Medical Center, Duarte, CA JOSEPH F. FRAUMENI, JR., Director, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD PATRICIA A. GANZ, Professor, University of California, Los Angeles Schools of Medicine & Public Health, Division of Cancer Prevention & Control Research, Jonsson Comprehensive Cancer Center, Los Angeles, CA ROY S. HERBST, Chief of Medical Oncology, Yale Cancer Center, New Haven, CT * Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the work- shop rapporteurs and the institution. vi
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JOHN HOHNEKER, Senior Vice President and Head, Global Development, Integrated Hospital Care, Novartis Pharma AG, Basel Switzerland THOMAS J. KEAN, Executive Director, C-Change, Washington, DC DOUGLAS R. LOWY, Deputy Director, National Cancer Institute, Bethesda, MD JOHN MENDELSOHN, President, MD Anderson Cancer Center, Houston, TX MARTIN J. MURPHY, Chief Executive Ofﬁcer, CEO Roundtable on Cancer, Durham, NC BRENDA NEVIDJON, Clinical Professor and Specialty Director, Nursing & Healthcare Leadership, Duke University School of Nursing, Durham, NC, and Past President, Oncology Nursing Society JOHN NIEDERHUBER, Adjunct Investigator and Former Director, National Cancer Institute DAVID R. PARKINSON, President and CEO, Nodality, Inc., San Francisco, CA SCOTT RAMSEY, Full Member, Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA LISA C. RICHARDSON, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, Atlanta, GA JOHN A. WAGNER, Vice President, Clinical Pharmacology, Merck and Company, Inc., Rahway, NJ JANET WOODCOCK, Director, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD National Cancer Policy Forum Staff SHARYL NASS, Director, National Cancer Policy Forum LAURA LEVIT, Program Ofﬁcer CHRISTINE MICHEEL, Program Ofﬁcer ERIN BALOGH, Associate Program Ofﬁcer JULIA DOOHER, Christine Mirzayan Science and Technology Policy Graduate Fellow MICHAEL PARK, Senior Program Assistant PATRICK BURKE, Financial Associate SHARON B. MURPHY, Scholar in Residence ROGER HERDMAN, Director, Board on Health Care Services vii
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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its pub- lished report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain conﬁdential to protect the integrity of the process. We wish to thank the following individuals for their review of this report: Joseph M. DeSimone, University of North Carolina at Chapel Hill Sanjiv Sam Gambhir, Stanford University Scott E. McNeil, Nanotechnology Characterization Laboratory and National Cancer Institute Richard C. Pleus, INTERTOX, Inc. Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the ﬁnal draft of the report before its release. The review of this report was over- seen by Melvin Worth. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the ﬁnal content of this report rests entirely with the authors and the institution. ix
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Contents 1 INTRODUCTION 1 What Are Nanotechnology and Nanomedicine?, 3 Physical Properties of Nanomaterials, 5 2 USES OF NANOTECHNOLOGY IN ONCOLOGY AND CANCER RESEARCH 9 Diagnosis and Monitoring, 11 Treatment, 18 Prevention, 21 Nanotechnology in the Clinic, 22 3 RESEARCH AND DEVELOPMENT OF NEW CANCER NANOMEDICINES—CHALLENGES AND SOLUTIONS 25 Basic Biology, 25 Strategies for Improving Nanoparticle Targeting Effectiveness and Efﬁciency, 27 Design Complexity of Nanomaterials for Medical Applications, 29 Transition from the Laboratory to Manufacturing, 29 Bridging Multiple Disciplines, 31 4 RISKS ASSOCIATED WITH NANOTECHNOLOGY 41 Data Collection: Biodistribution and Toxicology, 41 Occupational Safety, 47 Nanomedicine Safety, 48 Risk–Beneﬁt Assessments, 51 xi
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xii CONTENTS 5 STANDARDS AND REGULATION 53 Nanomaterial Deﬁnitions, 53 Nanotechnology Standards, 55 Working with the FDA, 56 Setting Regulatory Policy, 58 Collaboration with and between Regulatory Agencies, 60 6 NANOTECHNOLOGY AND THE PUBLIC 63 7 ADDITIONAL CHALLENGES 65 8 CONCLUDING REMARKS 67 REFERENCES 69 ACRONYMS 73 GLOSSARY 77 APPENDIXES A Agenda 83 B Speaker and Planning Committee Biographies 89