National Academies Press: OpenBook

Making Better Drugs for Children with Cancer (2005)

Chapter: Front Matter

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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Making Better Drugs for Children with Cancer

Committee on Shortening the Time Line for New Cancer Treatments National Cancer Policy Board

Peter C. Adamson, Susan L. Weiner, Joseph V. Simone, and Hellen Gelband, Editors

INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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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 Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Contract No. NO2-CO-01029 between the National Cancer Institute and the National Academy of Sciences. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

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Copyright 2005 by the National Academy of Sciences. All rights reserved.

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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

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 government on scientific and technical matters. Dr. Bruce M. Alberts 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 members, sharing with the National Academy of Sciences the responsibility for advising 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. Wm. A. Wulf 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 providing 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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COMMITTEE ON SHORTENING THE TIME LINE FOR NEW CANCER TREATMENTS

JOSEPH P. NEWHOUSE (Chair), Professor of Health Policy and Management,

Harvard University, Boston, MA

PETER C. ADAMSON, Chief,

Clinical Pharmacology and Therapeutics, Pediatric Oncology, The Children’s Hospital of Philadelphia, Philadelphia, PA

JAMES O. ARMITAGE, Dean,

University of Nebraska College of Medicine, Omaha, NE

JILL BARGONETTI, Associate Professor,

Hunter College Department of Biological Sciences, New York, NY

KATHLEEN M. FOLEY,

Attending Neurologist, Memorial Sloan-Kettering Cancer Center and Professor

of Neurology, Neuroscience & Clinical Pharmacology, Weill Medical College of Cornell University, New York, NY

ALAN M. GARBER, Director,

Center for Health Policy; and Center for Primary Care and Outcomes Research, Stanford University, Stanford, CA

KAREN HERSEY, Senior Intellectual Property

Counsel, Massachusetts Institute of Technology, Cambridge, MA

CARL MORRIS, Professor of Statistics,

Harvard University, Cambridge, MA

RICHARD A. RETTIG, Senior Social Scientist,

RAND Corporation, Alexandria, VA

LOUISE B. RUSSELL, Research Professor of Economics,

Institute for Health, Rutgers University, New Brunswick, NJ

WILLIAM B. SCHULTZ, Partner,

Zuckerman Spaeder LLP, Washington, DC

JOSEPH V. SIMONE, Consultant,

Simone Consulting, Dunwoody, GA

BRUCE W. STILLMAN, Director,

Cold Spring Harbor Laboratory, Cold Spring Harbor, NY

ELLEN STOVALL, Executive Director,

National Coalition for Cancer Survivorship, Silver Spring, MD

SUSAN L. WEINER, President,

Children’s Cause for Cancer Advocacy, Silver Spring, MD

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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National Cancer Policy Board Liaisons

JOHN MENDELSOHN, President,

M.D. Anderson Cancer Center, University of Texas, Houston, TX

DAVID PARKINSON, Vice-President of Oncology,

Amgen, Inc., Thousand Oaks, CA

National Cancer Policy Board Staff

Hellen Gelband, Study Director

Roger C. Herdman, Director, National Cancer Policy Board

Anike Johnson, Administrator

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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NATIONAL CANCER POLICY BOARD

JOSEPH V. SIMONE (Chair),

Simone Consulting, Dunwoody, GA

ELLEN STOVALL (Vice-Chair),

National Coalition for Cancer Survivorship, Silver Spring, MD

BRUCE W. STILLMAN (Vice-Chair),

Cold Spring Harbor Laboratory, Cold Spring Harbor, NY

JILL BARGONETTI,

Hunter College, New York, NY

TIMOTHY EBERLEIN,

Washington University School of Medicine, St. Louis, MO

KATHY GIUSTI,

The Multiple Myeloma Research Foundation, New Canaan, CT

KAREN HERSEY,

Massachusetts Institute of Technology, Cambridge, MA

JIMMIE C. HOLLAND,

Memorial Sloan-Kettering Cancer Center, New York, NY

WILLIAM G. KAELIN,

Harvard Medical School, Boston, MA

WILLIAM W. McGUIRE,

UnitedHealth Group, Minnetonka, MN

JOHN MENDELSOHN,

M.D. Anderson Cancer Center, Houston, TX

KATHLEEN HARDIN MOONEY,

University of Utah College of Nursing, Salt Lake City, UT

PATRICIA A. NOLAN,

Rhode Island Department of Health, Providence, RI

DAVID PARKINSON,

Amgen, Inc., Thousand Oaks, CA

JOHN D. POTTER,

Fred Hutchinson Cancer Research Center, Seattle, WA

LOUISE B. RUSSELL,

Rutgers University, New Brunswick, NJ

THOMAS J. SMITH,

Medical College of Virginia at Virginia Commonwealth University, Richmond, VA

ROBERT C. YOUNG,

Fox Chase Cancer Center, Philadelphia, PA

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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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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 NRC’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 published 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 deliberative process. We wish to thank the following individuals for their review of this report:

William E. Evans, St. Jude Children’s Research Hospital

Michael P. Link, Stanford University School of Medicine

Stuart E. Siegel, Childrens Hospital Los Angeles

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Gilbert Omenn, Harvard Medical School and Leslie Z. Benet, University of California, San Francisco, School of Pharmacy. Appointed by the National Research Council and Institute of Medicine, they were 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 authoring committee and the institution.

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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Acronyms and Abbreviations


ALL

acute lymphocytic leukemia

AML

acute myeloid leukemia

APL

acute promyelocytic leukemia


BPCA

Best Pharmaceuticals for Children Act

BRB

Biological Resources Branch


CF

cystic fibrosis

CNS

central nervous system

COG

Children’s Oncology Group

CTEP

Cancer Therapy Evaluation Program


DDG

Drug Development Group

DES

diethylstilbestrol

DTP

Developmental Therapeutics Program


FDA

Food and Drug Administration

FDAMA

Food and Drug Administration Modernization Act


GMPs

Good Manufacturing Practices


HL

Hodgkin’s lymphoma

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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IND

Investigational New Drug

IOM

Institute of Medicine


MMV

Medicines for Malaria Venture


NCE

new chemical entity

NCI

National Cancer Institute

NHL

non-Hodgkin’s lymphoma

NIH

National Institutes of Health


PhRMA

Pharmaceutical Research and Manufacturers of America

PRB

Pharmaceutical Resources Branch


RAID

Rapid Access to Intervention Development

RAND

Rapid Access to NCI Discovery Resources

R&D

research and development

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2005. Making Better Drugs for Children with Cancer. Washington, DC: The National Academies Press. doi: 10.17226/11259.
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The successes that have been achieved in treating childhood cancers stand as beacons against the less dramatic improvements for adults with cancer. Progress began to accelerate in the 1960s and 1970s, as treatment regimens were built up, primarily by building combinations of chemotherapeutic drugs. However the near absence of research in pediatric cancer drug discovery threatens to halt the progress in childhood cancer treatment achieved during the past four decades. Making Better Drugs for Children with Cancer identifies the major issues to be addressed in developing new agents for childhood cancers, the gaps in research and development, and the steps that have been suggested to move the process forward. This report also makes a new proposal to capitalize on today's science to bring new treatments to children's cancers.

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