ESTABLISHING PRECOMPETITIVE COLLABORATIONS TO STIMULATE GENOMICS-DRIVEN PRODUCT DEVELOPMENT

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Establishing PrEcomPEtitivE collaborations to stimulatE gEnomics-DrivEn ProDuct DEvEloPmEnt Workshop summary Steve Olson and Adam C. Berger, Rapporteurs Roundtable on Translating Genomic-Based Research for Health Board on Health Sciences Policy

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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 project was supported by contracts between the National Academy of Sciences and the American College of Medical Genetics (unnumbered contract); American Medi- cal Association (unnumbered contract); American Nurses Association (unnumbered contract); Blue Cross and Blue Shield Association (unnumbered contract); Centers for Disease Control and Prevention (Contract No. 200-2005-13434); College of Ameri- can Pathologists (unnumbered contract); Department of the Air Force (Contract No. FA7014-10-P-0072); Department of Veterans Affairs (Contract No. V101(93) P-2238); Eli Lilly and Company (unnumbered contract); Genetic Alliance (unnumbered contract); Health Resources and Services Administration; Johnson & Johnson (unnumbered con- tract); Kaiser Permanente (unnumbered contract); National Cancer Institute (Contract No. N01-OD-4-2139, TO#189); National Heart, Lung, and Blood Institute (Contract No. N01-OD-4-2139, TO#189); National Human Genome Research Institute (Con- tract No. N01-OD-4-2139, TO#189); National Institute of Child Health and Human Development (Contract No. N01-OD-4-2139, TO#189); National Society of Genetic Counselors (unnumbered contract); Pfizer Inc. (Contract No. 140-N-1818071); and the Secretary’s Advisory Committee on Genetics, Health, and Society (Contract No. N01-OD-4-2139, TO#189). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13: 978-0-309-16182-4 International Standard Book Number-10: 0-309-16182-7 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. Establishing Precompetitive Col- laborations to Stimulate Genomics-Driven Product Development: 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 Acad- emy 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles 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 Insti- tute 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 Sci- ences 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 Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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PLANNING COMMITTEE* STEPHEN ECk, Vice President, Translational Medicine & Pharmacogenomics, Eli Lilly and Company, Indianapolis, IN GEOFFREy GINSbuRG, Director, Center for Genomic Medicine, Institute for Genomic Sciences & Policy, Duke University, Durham, NC GARRy NEIL, Corporate Vice President, Corporate Office of Science and Technology, Johnson & Johnson, New Brunswick, NJ AIDAN POWER, Vice President and Global Head of Molecular Medicine, Pfizer Inc., New London, CT LAuRA LyMAN RODRIGuEZ, Senior Advisor to the Director for Research Policy, National Human Genome Research Institute, Bethesda, MD kEvIN A. SCHuLMAN, Professor of Medicine and Business Administration; Director, Center for Clinical and Genetic Economics; Associate Director, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC SHARON TERRy, President and Chief Executive Officer, Genetic Alliance, Washington, DC MARTHA TuRNER, Assistant Director, American Nurses Association Center for Ethics and Human Rights, Silver Spring, MD IOM Staff ADAM C. bERGER, Project Director ALEx REPACE, Senior Project Assistant * Institute of Medicine (IOM) 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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ROuNDTAbLE ON TRANSLATING GENOMIC- bASED RESEARCH FOR HEALTH* WyLIE buRkE (Chair), Professor and Chair, Department of Bioethics and Humanities, University of Washington, Seattle NAOMI ARONSON, Executive Director, Technology Evaluation Center, Blue Cross and Blue Shield Association, Chicago, IL bRuCE bLuMbERG, Co-chief of Medical Genetics, Kaiser Permanente, and Institutional Director of Graduate Medical Education, Northern California Kaiser Permanente, The Permanente Medical Group, Oakland, CA DENISE E. bONDS, Medical Officer, Division of Prevention and Population Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD C. THOMAS CASkEy, Director and Chief Executive Officer, The George & Cynthia Mitchell Distinguished Chair in Neurosciences, Executive Vice President of Molecular Medicine and Genetics, University of Texas Health Science Center at Houston STEPHEN ECk, Vice President, Translational Medicine & Pharmacogenomics, Eli Lilly and Company, Indianapolis, IN CATHy FOMOuS, Secretary’s Advisory Committee on Genetics, Health and Society; Office of Biotechnology Activities, Office of Science Policy, National Institutes of Health, Rockville, MD ANDREW N. FREEDMAN, Branch Chief, Clinical and Translational Epidemiology Branch, Epidemiology and Genetics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD GEOFFREy GINSbuRG, Director, Center for Genomic Medicine, Institute for Genomic Sciences & Policy, Duke University, Durham, NC R. RODNEy HOWELL, Special Assistant to the Director, National Institute of Child Health and Human Development, Bethesda, MD SHARON kARDIA, Professor and Chair of Epidemiology; Director, Public Health Genetics Program; Director, Life Science and Society Program; Co-director, Center for Genomics & Public Health, University of Michigan School of Public Health, Ann Arbor * IOM 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. vi

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MOHAMED kHAN, American Medical Association Representative; Leader of Radiation Oncology, Vancouver Cancer Centre, Vancouver, BC MuIN kHOuRy, Director, National Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA DEbRA LEONARD, College of American Pathologists Representative; Professor and Vice Chair for Laboratory Medicine, Director of the Clinical Laboratories, Weill Cornell Medical Center of Cornell University, New York, NY MICHELE LLOyD-PuRyEAR, Chief, Genetic Services Branch, Health Resources and Services Administration, Rockville, MD ELIZAbETH MANSFIELD, Director of the Personalized Medicine Staff, Office of In Vitro Diagnostic Devices, Food and Drug Administration, Silver Spring, MD GARRy NEIL, Corporate Vice President, Corporate Office of Science and Technology, Johnson & Johnson, New Brunswick, NJ RObERT L. NuSSbAuM, Chief, Division of Medical Genetics, Department of Medicine and Institute of Human Genetics, University of California-San Francisco School of Medicine AIDAN POWER, Vice President and Global Head of Molecular Medicine, Pfizer Inc., New London, CT RONALD PRZyGODZkI, Associate Director for Genomic Medicine, Biomedical Laboratory Research and Development, Department of Veterans Affairs, Washington, DC LAuRA LyMAN RODRIGuEZ, Senior Advisor to the Director for Research Policy, National Human Genome Research Institute, Bethesda, MD ALLEN D. ROSES, Jefferson-Pilot Professor of Neurobiology and Genetics; Professor of Medicine (Neurology); Director, Deane Drug Discovery Institute; Senior Scholar, Fuqua School of Business, R. David Thomas Executive Training Center, Duke University, Durham, NC kEvIN A. SCHuLMAN, Professor of Medicine and Business Administration; Director, Center for Clinical and Genetic Economics; Associate Director, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC SHARON TERRy, President and Chief Executive Officer, Genetic Alliance, Washington, DC MARTHA TuRNER, Assistant Director, American Nurses Association Center for Ethics and Human Rights, Silver Spring, MD MICHAEL S. WATSON, Executive Director, American College of Medical Genetics, Bethesda, MD vii

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DANIEL WATTENDORF, Deputy Chief, Medical Innovations, Department of the Air Force; Program Manager, DARPA/Defense Sciences Office, Arlington, VA CATHERINE A. WICkLuND, Past President, National Society of Genetic Counselors; Director, Graduate Program in Genetic Counseling; Assistant Professor, Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL IOM Staff ADAM C. bERGER, Project Director CLAIRE GIAMMARIA, Research Associate ALEx REPACE, Senior Project Assistant ANDREW POPE, Director, Board on Health Sciences Policy viii

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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 and Medicine, Director of International Medical Services, University of California, San Francisco School of Medicine, San Francisco, CA Stephen H. Friend, President and CEO, Sage Bionetworks, Seattle, WA victoria M. Pratt, Chief Director, Molecular Genetics, Quest Diagnostics Nichols Institute, Chantilly, VA John Wagner, Vice President, Clinical Pharmacology, Merck & Co., Inc., Rahway, NJ Although the reviewers listed above have provided many constructive comments and suggestions, they did not endorse the final draft of the report before its release. The review of this report was overseen by Melvin Worth. ix

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x REVIEWERS 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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Acknowledgments The support of the sponsors of the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health was crucial to the planning and conduct of the workshop “Establishing Precompetitive Col- laborations to Stimulate Genomics-Driven Drug Development.” Federal sponsors are the Centers for Disease Control and Prevention; Department of the Air Force; Department of Veterans Affairs; Health Resources and Services Administration; National Cancer Institute; National Heart, Lung, and Blood Institute; National Human Genome Research Institute; National Institute for Child Health and Human Development; and the Secretary’s Advisory Committee on Genetics, Health, and Society. Non-federal spon- sorship was provided by the American College of Medical Genetics, the American Medical Association, the American Nurses Association, Blue Cross and Blue Shield Association, the College of American Pathologists, Eli Lilly and Company, Genetic Alliance, Johnson & Johnson, Kaiser Per- manente, the National Society of Genetic Counselors, and Pfizer Inc. The Roundtable wishes to express its gratitude to the expert speakers whose presentations helped outline a framework for establishing precom- petitive collaborations. The Roundtable also wishes to thank the mem- bers of the planning committee for their work in developing an excellent workshop agenda. Planning committee members were Stephen Eck, Geoff Ginsburg, Garry Neil, Aidan Power, Laura Lyman Rodriguez, Kevin A. Schulman, Sharon Terry, and Martha Turner. xi

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Contents AbbREvIATIONS AND ACRONyMS xv 1 INTRODuCTION 1 Expanded Use of Precompetitive Collaborations, 3 Identifying New Approaches to Precompetitive Collaboration, 3 The Potential for Precompetitive Sharing of Biobanked Specimens, 6 2 A LESSON AbOuT PRECOMPETITIvE COLLAbORATION 9 The SEMATECH Experience, 9 Lessons from SEMATECH, 11 3 REQuISITES FOR SuCCESSFuL PRECOMPETITIvE COLLAbORATION 13 Requisites from the Pharmaceutical Industry, 13 Requisites from Diagnostic Companies, 15 Requisites from Academia, 16 4 FRAMEWORkS FOR COLLAbORATION 21 Public–Private Partnerships with NIH or Government, 21 Advancing Technological Achievements Through Collaboration, 24 Open Access Partnerships, 26 Access to Large-Scale Data Networks, 28 xiii

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xiv CONTENTS 5 THE uSE OF bIOSPECIMENS IN PRECOMPETITIvE COLLAbORATIONS 31 Standards for Biospecimen Quality, 32 Linking Health Outcomes Data to Biorepository Samples, 35 Sustaining Access to Biospecimens, 38 Creating a National Virtual Biospecimen Bank, 40 Clinical and Genetic Data Access in the Pharmaceutical Industry, 42 6 ETHICAL CHALLENGES IN THE uSE OF bIOSPECIMENS 45 Discussion, 47 7 TOWARD DEvELOPING A CuLTuRAL, LEGAL, AND bEHAvIORAL FRAMEWORk FOR PRECOMPETITIvE COLLAbORATION 49 Facing the Problems, 49 Drawing the Line Between Precompetitive and Competitive Efforts, 51 Moving Forward, 52 Sharing Biospecimens and Data, 52 Final Thoughts, 53 REFERENCES 55 APPENDIxES A WORKSHOP AGENDA 57 B SPEAKER BIOGRAPHICAL SKETCHES 63 FIGuRES 1-1 Normalized new molecular entity output per dollar expended, 4 3-1 Model for industry-academic collaboration, 18 4-1 New molecular entity approvals, 23 4-2 Model for precompetitive chemistry, 27 4-3 Integration of genotypic, gene expression, and trait data, 28 5-1 Changes in gene expression over time after intrasurgical ischemia, 33 5-2 Community engagement strategy, 37 5-3 UK DNA Banking Network advanced management of annotation, 39 TAbLE 1-1 Biospecimen Storage in the United States, 1999, 7

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Abbreviations and Acronyms CaHUB Cancer Human Biobank CEO chief executive officer CHEP Community Health Engagement Program (Indiana) CTSA Clinical, Translational, and Science Awards CTSI Indiana Clinical and Translational Sciences Institute DMPK drug metabolism and pharmacokinetics FDA Food and Drug Administration IMI Innovative Medicines Initiative IOM Institute of Medicine IP intellectual property NCI National Cancer Institute NIH National Institutes of Health PI principal investigator R&D research and development UCSF University of California, San Francisco UDBN UK DNA Banking Network xv

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