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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
