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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

EXTENDING THE SPECTRUM OF PRECOMPETITIVE COLLABORATION IN ONCOLOGY RESEARCH

WORKSHOP SUMMARY

Margie Patlak, Sharyl J. Nass, and Erin Balogh, Rapporteurs

National Cancer Policy Forum

Board on Health Care Services

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

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.

This study was supported by Contract Nos. HHSN261200611002C 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 Cancer Society, the American Society of Clinical Oncology, the Association of American Cancer Institutes, C-Change, and the CEO Roundtable on Cancer. 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.

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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). 2010. Extending the spectrum of precompetitive collaboration in oncology research: Workshop summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

“Knowing is not enough; we must apply.

Willing is not enough; we must do.”

—Goethe

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES


Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

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. 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 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. 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 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

WORKSHOP PLANNING COMMITTEE1

JOHN A. WAGNER (Chair), Vice President,

Clinical Pharmacology, Merck & Co., Inc., Rahway, NJ

ANNA D. BARKER, Deputy Director and Deputy Director for Strategic Scientific Initiatives,

National Cancer Institute, Bethesda, MD

STEPHEN ECK, Vice President,

Translational Medicine and Pharmacogenetics, Eli Lilly and Company, Indianapolis, IN

STEPHEN H. FRIEND, President,

Sage Bionetworks, Seattle, WA

GEOFFREY S. GINSBURG, Director,

Center for Genomic Medicine, Duke Institute for Genome Sciences & Policy and

Professor of Medicine and Pathology,

Duke University Medical Center, Durham, NC

ROY S. HERBST, Professor and Chief,

Section on Thoracic Medical Oncology, Department of Thoracic/Head & Neck Medical Oncology, MD Anderson Cancer Center, Houston, TX

SHARON B. MURPHY, Scholar-in-Residence,

Institute of Medicine, Washington, DC

Study Staff

ERIN BALOGH, Study Director

MICHAEL PARK, Senior Program Assistant

PATRICK BURKE, Financial Associate

SHARYL J. NASS, Director,

National Cancer Policy Forum

ROGER HERDMAN, Director,

Board on Health Care Services

1

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

NATIONAL CANCER POLICY FORUM1

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, Past Chair,

American Cancer Society Board of Directors and

Provost,

Notre Dame University, South Bend, IN

MICHAEL A. CALIGIURI, Director,

Ohio State Comprehensive Cancer Center, Columbus, OH

MICHAELE CHAMBLEE CHRISTIAN, Retired,

Division of Cancer Treatment and Diagnosis, National Cancer Institute, Washington, DC

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,

UCLA Schools of Medicine & Public Health, Division of Cancer Prevention & Control Research, Jonsson Comprehensive Cancer Center, Los Angeles, CA

ROY S. HERBST, Chief,

Thoracic/Head & Neck Medical Oncology, MD Anderson Cancer Center, Houston, TX

THOMAS J. KEAN, Executive Director,

C-Change, Washington, DC

JOHN MENDELSOHN, President,

MD Anderson Cancer Center, Houston, TX

MARTIN J. MURPHY, Chief Executive Officer,

CEO Roundtable on Cancer, Durham, NC

JOHN E. NIEDERHUBER, Director,

National Cancer Institute, Bethesda, MD

1

Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

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 & Co., Inc., Rahway, NJ

JANET WOODCOCK, Deputy Commissioner & Chief Medical Officer,

Food and Drug Administration, Rockville, MD

National Cancer Policy Forum Staff

SHARYL J. NASS, Director,

National Cancer Policy Forum

LAURA LEVIT, Program Officer

CHRISTINE MICHEEL, Program Officer

ERIN BALOGH, Research Associate

ASHLEY McWILLIAMS, Senior Program Assistant

MICHAEL PARK, Senior Program Assistant

PATRICK BURKE, Financial Associate

SHARON B. MURPHY, Scholar-in-Residence

ROGER HERDMAN, Director,

Board on Health Care Services

Page viii Cite
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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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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 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 process. We wish to thank the following individuals for their review of this report:

NEAL H. COHEN, Vice Dean, Professor of Anesthesia and Perioperative Care & Medicine, University of California San Francisco School of Medicine, San Francisco, CA

GREGORY A. CURT, U.S. Medical Science Lead, AstraZeneca-Oncology, Garrett Park, MD

ELLEN V. SIGAL, Chairperson and Founder, Friends of Cancer Research, Arlington, VA

CAROLINE SIGMAN, President and CEO, CCS Associates, Mountain View, CA

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

of the report before its release. The review of this report was overseen 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.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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Boxes, Figures, and Tables

BOXES

1

 

SEMATECH,

 

4

2

 

The Cancer Genome Atlas,

 

18

3

 

Sage Bionetworks,

 

24

4

 

Open Source Drug Discovery,

 

26

5

 

Merck–AstraZeneca Preclinical and Clinical Testing Collaboration,

 

27

6

 

Myelin Repair Foundation’s Accelerated Research Collaboration,

 

32

7

 

Conference on Clinical Cancer Research,

 

38

8

 

Critical Path Institute,

 

40

9

 

Reagan–Udall Foundation,

 

42

10

 

Collaborations Aimed at Improving Bioinformatics and Information Technology,

 

46

11

 

Oncology Biomarker Qualification Initiative,

 

50

12

 

CEO Roundtable on Cancer Life Sciences Consortium,

 

56

13

 

Science Commons,

 

58

14

 

Models of Collaborative Relationships,

 

62

15

 

Multiple Myeloma Research Foundation,

 

65

FIGURES

1

 

30-year decline in new molecular entities per dollar spent on research and development,

 

6

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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2

 

Advances in molecular biology, functional genomics, and genetics have fueled an explosion of data,

 

7

3

 

A network of transcription factors and their mesenchymal gene expression signature targets involved in high-grade glioma,

 

8

4

 

Distributed nature of knowledge,

 

11

5

 

The approach to new intellectual property in the I-SPY 2 TRIAL,

 

53

6

 

The eight models of precompetitive collaboration,

 

62

TABLES

1

 

Value Proposition and Benefit for Partners Involved in the I-SPY 2 TRIAL,

 

55

2

 

Innovation Models,

 

78

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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Despite spending more time and money in developing novel therapeutics, the success rate for new pharmacologic treatments has been poor. Although the research and development expenditures have grown 13 percent each year since 1970 (a 50-fold increase), the number of new drugs approved annually is no greater now than it was 50 years ago. Over the past decade, skyrocketing costs and the complexity of the scientific knowledge upon which to develop new agents have provided incentives for alternative approaches to drug development, if we are to continue to improve clinical care and reduce mortality. These challenges create opportunities for improved collaboration between industry, academia, government, and philanthropic organizations at each stage in new drug development, marketing, and implementation.

Perhaps the most appropriate initial step in addressing the need for collaboration is to consider more precompetitive relationships that allow sharing of scientific information to foster drug development. While these collaborative relationships in basic and preclinical research on drug targets and the early stages of clinical testing are acknowledged to be potentially important drivers for innovation and more rapid marketing of new agents, they also raise a number of concerns that must be addressed. For example, acknowledgment of academic productivity and independence and economic competitiveness must be considered and these challenges managed to foster a culture of collaboration. At the same time, regulatory issues, the need for standardization, and intellectual property concerns must be confronted if the current models for drug development are to be refined to encourage robust participation in precompetitive collaborations.

Recognizing the growing importance of precompetitive collaborations in oncology drug development, as well as the challenges these innovative collaborations pose, the National Cancer Policy Forum of the Institute of Medicine held a workshop on February 9 and 10, 2010. This book is a summary of the workshop proceedings.

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