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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



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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

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

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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 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. 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

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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. v

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

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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

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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 ix

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x 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.

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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

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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

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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 xiii

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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