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EXTENDING THE SPECTRUM OF

PRECOMPETITIVE
COLLABORATION
IN ONCOLOGY RESEARCH

Margie Patlak, Sharyl J. Nass, and Erin Balogh

WORKSHOP SUMMARY

National Cancer Policy Forum

Board on Health Care Services
Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

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.

International Standard Book Number-13: 978-0-309-15654-7

International Standard Book Number-10: 0-309-15654-8

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 2010 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

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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 pre-
competitive collaboration in oncology research: Workshop summary. Washington, DC: The
National Academies Press.

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

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 man-
date 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.
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M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

WORKSHOP PLANNING COMMITTEE

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

 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.

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

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, 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

 Institute of Medicine forums and roundtables do not issue, review, or approve indi-

vidual documents. The responsibility for the published workshop summary rests with the
workshop rapporteurs and the institution.

vi

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

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

vii

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

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
ix

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

 REVIEWERS

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.

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

Contents

Introduction, 1
Current Driving Forces for Collaboration, 2
Increasing Complexity and Data, 3
Patient Variability, 10
Declining Research and Development Budgets, 12
Collaboration-Enabling Technology, 13
Benefits of Collaborating, 13
Synergy of Cross-discipline/Cross-institution Collaborations, 14
Improved Validity, 16
Closing Knowledge Gaps and Exploiting Unused Data, 22
Increase the Size of the Value Pie, 23
Shorten Drug Development Time Lines and Improve Efficiency
and Cost-Effectiveness, 23
Win–Win Situation, 30
Challenges to Collaborating, 30
Standards and Interoperability, 31
Legal Issues, 33
FDA Regulatory Issues, 34
Culture Change That Encourages Sharing, 36
Time and Commitment, 42
What to Share, 43
Bioinformatics Resources and Standards, 44
Biomarker Data and Standards, 45
xi

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

xii CONTENTS

The Biomarkers Consortium, 45

I-SPY 2 TRIAL, 49
Disease Characterization and Models, 54
Clinical Methods and Contracts, 54
Information on Failed Compounds or Those on the Market, 55
Types of Precompetitive Collaborations, 60
Lessons Learned, 66
Set Goals and Devise Game Plan, 66
Involve All Stakeholders Early, 67
Involve the Right People, 68
Actively Manage Collaborations, 70
Invoke a Trusted Third Party, 71
Address Legal Issues, 71
Provide Rewards and Incentives, 72
Standards and Quality Control, 74
Next Steps, 74
Seek Public Support for Collaborations, 74
Establish Collaboration Standards and Incentives, 75
Publicize Collaboration Success Stories and Management Plans, 75
Develop Innovative Business Models, 76
Summary, 79
References, 80

ACRONYMS 85

GLOSSARY 87

APPENDIXES
A Workshop Agenda 91
B Polling Results 95

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

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

xiii

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

xiv BOXES, FIGURES, AND TABLES

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

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

Workshop Summary

Introduction
Despite spending more time and money in developing novel thera-
peutics, the success rate for new pharmacologic treatments has been poor.
Although the research and development (R&D) 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 (Booth
and Zemmel, 2004; Munos, 2009). 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 collabo-
ration 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 mar-
keting 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

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

 PRECOMPETITIVE COLLABORATION IN ONCOLOGY RESEARCH

challenges managed to foster a culture of collaboration. At the same time,

regulatory issues, the need for standardization, and intellectual property
(IP) concerns must be confronted if the current models for drug develop-
ment 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 (IOM) held a workshop titled Extending the Spectrum of Pre-
competitive Collaboration in Oncology Research on February 9 and 10,
2010, in Washington, DC. At the workshop, speakers addressed:

• Current driving forces for precompetitive collaborations;

• Benefits of such collaborations;
• Challenges to collaborating;
• Types of precompetitive collaborations and what can be shared;
• Precompetitive collaboration examples;
• Lessons learned and best practices formulated from these examples
of collaboration; and
• Next steps that could facilitate more precompetitive collaborations
in oncology drug development.

This document is a summary of the workshop proceedings. The views

expressed in this summary are those of the speakers and discussants, as
attributed to them, and are not the consensus views of the workshop par-
ticipants or members of the National Cancer Policy Forum.
Building on the National Cancer Policy Forum’s workshop, the
IOM’s Roundtable on Translating Genomic-Based Research for Health
held a related workshop on precompetitive collaboration July 22, 2010,
titled Establishing Precompetitive Collaborations to Stimulate Genomics
Driven Drug Development. A published summary of that workshop is also
planned.

Current Driving Forces for Collaboration

John Wagner, vice president of clinical pharmacology at Merck &
Co., began the workshop by pointing out that the notion of precompeti-
tive collaboration is not new, nor is it limited to biomedical applications.
A precompetitive collaboration launched by the semiconductor industry

Copyright © National Academy of Sciences. All rights reserved.

Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary

WORKSHOP SUMMARY 

in the 1980s (SEMATECH) boosted the global competitiveness of U.S.

companies within this industry (see Box 1). The software industry is also
known for its precompetitive collaborations, which Stephen Weber defined
as “competitors sharing early stages of research that benefit all,” in his book
The Success of Open Source (Weber, 2004).
But Wagner said a number of factors are currently driving precompeti-
tive collaborations in biomedicine, most notably the standard drug develop-
ment model does not appear to be working very effectively. He presented
a slide showing that the new molecular entity output per dollar spent on
research and development has been declining since 1970 (see Figure 1).
In addition, he cited a 2004 analysis of the success rates of compounds
­making it from first-in-human trials to registration during a 10-year period
(1991–2000) for 10 large pharmaceutical companies. The average success
rate for all therapeutic areas is approximately 11 percent; in oncology, the
probability of graduating from the drug development pipeline and making
it to market is only 5 percent (Kola and Landis, 2004). “This tees up the
issue of the need for different models of doing research and development,
including precompetitive collaborations,” Wagner said.
Several speakers expanded on the shortcomings of current approaches
to drug development, suggesting that alternative approaches will be
required. Many of the speakers proposed precompetitive collaborations as
an approach worthy of careful consideration. Many factors have made the
standard model for developing drugs inadequate, they pointed out, includ-
ing the growing complexity of research and far-ranging and uneven distri-
bution of knowledge, patient variability that contributes to the uncertainty
and low success rate, increasing emphasis on comparative effectiveness and
evidence-based medicine, the increasingly long and expensive time lines of
drug development, and declining research and development budgets.

Increasing Complexity and Data

Many speakers noted the growing complexity of basic and clinical
research in oncology, much of which hinges on deciphering the intricate net-
works of molecular pathways involved in the formation and progression of
various cancers, as well as predicting patients’ likely responses to treatments
aimed at the targets within those networks. The increasing need to integrate

 SEMATECH stands for SEmiconductor MAnufacturing TECHnology (http://www.

sematech.org/).

Copyright © National Academy of Sciences. All rights reserved.

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