POSITIONING

SYNTHETIC
BIOLOGY

TO MEET THE CHALLENGES
OF THE 21ST CENTURY

SUMMARY REPORT OF A SIX ACADEMIES SYMPOSIUM SERIES

Stephanie Joyce, Anne-Marie Mazza, and Steven Kendall, Rapporteurs

Committee on Science, Technology, and Law
Policy and Global Affairs

Board on Life Sciences
Division on Earth and Life Studies

National Academy of Engineering

NATIONAL RESEARCH COUNCIL AND
NATIONAL ACADEMY OF ENGINEERING
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

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Stephanie Joyce, Anne-Marie Mazza, and St p M teven Kendall, Rapporteurs , mmittee on Science, Technol Com logy, and Law w Policy and Global Aff fairs Board on Life Scienc o ces Division on Earth and Life Studies E e National Aca ademy of Eng gineering

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW 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 Insti- tute 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/Grant No. 2011-3-04 between the National Acad- emy of Sciences and the Alfred P. Sloan Foundation. Any opinions, findings, conclu- sions, 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: 978-0-309-22583-0 International Standard Book Number-10: 0-309-22583-3 Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334- 3313; http://www.nap.edu. Copyright 2013 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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The Na ational Academy of Sciences is a private, nonp s profit, self-perpe etuating society of y distingu uished scholars engaged in scie entific and engin neering research dedicated to the h, furthera ance of science and technology and to their use for the general welfare. Upon the a authorit of the charter granted to it by the Congress in 1863, the Acade ty emy has a mand date that req quires it to advis the federal go se overnment on sc cientific and tech hnical matters. D Dr. Ralph J. Cicerone is preesident of the Na ational Academy of Sciences. y The Nattional Academy of Engineering was establishe in 1964, unde the charter of the y ed er Nationa Academy of Sciences, as a pa al S arallel organizat tion of outstandi engineers. It is ing t autonom mous in its adm ministration and in the selection of its members sharing with t i s, the Nationa Academy of Sciences the res al S sponsibility for advising the feederal governmeent. The Naational Academy of Engineerin also sponsors engineering p y ng s programs aimed at d meeting national needs, encourages edu g ucation and reseearch, and recoggnizes the super rior achievements of engine eers. Dr. C. D. (D Dan) Mote, Jr., is president of t National Aca the ad- emy of Engineering. The Insstitute of Mediccine was established in 1970 by t National Ac the cademy of Scienc ces to secur the services of eminent memb of appropri ate professions in the examinati re o bers ion of polic matters pertai cy ining to the hea of the publi The Institute acts under the re- alth ic. sponsibility given to the National Acad e demy of Sciences by its congress s sional charter to be an adviser to the federal government and, upon its ow initiative, to identify issues of a wn o medical care, research, and education. Dr. Harvey V. Fi l D ineberg is presid dent of the Institu ute of Mediicine. The National Research Council was organized by the National Acade h o e emy of Sciences in s 1916 to associate the broad community of science and technology w the Academy o b y d with y’s purpose of furthering knowledge and advising the fe es ederal governme Functioning in ent. g accordaance with genera policies deter al rmined by the A Academy, the Co ouncil has become the prin ncipal operating agency of both the National Aca a t ademy of Scienc and the Natio ces on- al Acaddemy of Enginee ering in providin services to th government, t public, and t ng he the the scientifi and engineer ic ring communitie The Council is administere jointly by bo es. l ed oth Academ mies and the Insstitute of Mediccine. Dr. Ralph J. Cicerone and Dr. C. D. (Da d an) Mote, Jr are chair and vice chair, respe r., ectively, of the N National Researc Council. ch www.nation nal-academies.o org

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PLANNING COMMITTEE ON SIX PARTY SYMPOSIA ON SYNTHETIC BIOLOGY Drew Endy (Chair), Assistant Professor, Bioengineering, Stanford University and President, The BioBricks Foundation Michael Elowitz, Howard Hughes Medical Institute Investigator and Associate Professor of Biology, Bioengineering, and Applied Physics, California Institute of Technology Richard Johnson, Chief Executive Officer, GlobalHelix LLC and Counsel and Senior Partner (retired), Arnold & Porter, LLP Wendell Lim, Professor of Cellular and Molecular Pharmacology, University of California, San Francisco Pamela Silver, Professor of Systems Biology, Harvard Medical School Staff Anne-Marie Mazza, Director, Committee on Science, Technology, and Law, National Academy of Sciences Jo Husbands, Scholar/Senior Project Director, Board on Life Sciences, National Academy of Sciences Proctor Reid, Director, Program Office, National Academy of Engineering Steven Kendall, Associate Program Officer, Committee on Science, Technology, and Law, National Academy of Sciences v

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CHINA SYMPOSIUM PLANNING GROUP Guo-Ping Zhao, Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences Jian-Dong Jiang, Institute of Materia Medica, Chinese Academy of Medical Sciences Xuan Li, Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences Zhongjun Qin, Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences Haihan Xu, Chinese Academy of Engineering Chen Yang, Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences Zhihua Zhou, Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences Staff Guo-Rong Fa, Shanghai Institutes of Biological Sciences, Chinese Academy of Sciences vi

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UNITED KINGDOM SYMPOSIUM PLANNING GROUP Richard I. Kitney, Imperial College London Peter Leadlay, University of Cambridge Staff Shafiq Ahmed, The Royal Academy of Engineering Jessica Bland, The Royal Society Nick Green, The Royal Society Shane Mchugh, The Royal Academy of Engineering Hayaatun Sillem, The Royal Academy of Engineering Rapela Zaman, The Royal Society vii

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COMMITTEE ON SCIENCE, TECHNOLOGY, AND LAW David Korn (IOM), (Co-chair), Massachusetts General Hospital and Harvard Medical School Richard A. Meserve (NAE), (Co-chair), Carnegie Institution for Science and Senior Of Counsel, Covington & Burling LLP Barbara E. Bierer, Harvard Medical School and Brigham and Women’s Hospital Elizabeth H. Blackburn (NAS/IOM), University of California, San Francisco John Burris, Burroughs Wellcome Fund Claude Canizares (NAS), Massachusetts Institute of Technology Arturo Casadevall, Albert Einstein College of Medicine Joe S. Cecil, Federal Judicial Center Rochelle Cooper Dreyfuss, New York University School of Law Harry T. Edwards, U.S. Court of Appeals for the District of Columbia Circuit Drew Endy, Stanford University and The BioBricks Foundation Marcus Feldman (NAS), Stanford University Jeremy Fogel, The Federal Judicial Center Alice P. Gast (NAE), Lehigh University Benjamin W. Heineman, Jr., Harvard Law School and Harvard Kennedy School of Government D. Brock Hornby, U.S. District Court, District of Maine Wallace Loh, University of Maryland, College Park Margaret Marshall, Massachusetts Supreme Judicial Court (retired) Alan B. Morrison, George Washington University Law School Cherry Murray (NAS/NAE), Harvard University Roberta Ness (IOM), University of Texas School of Public Health Harriet Rabb, Rockefeller University David Relman (IOM), Stanford University and VA Palo Alto Health Care System Richard Revesz, New York University School of Law David S. Tatel, U.S. Court of Appeals for the District of Columbia Circuit Staff Anne-Marie Mazza, Director Steven Kendall, Associate Program Officer viii

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BOARD ON LIFE SCIENCES Jo Handelsman (NAS/IOM), (Chair), Yale University Vicki L. Chandler (NAS), Gordon and Betty Moore Foundation Sean Eddy, Janelia Farm Research Campus Sarah C.R. Elgin, Washington University David R. Franz, Midwest Research Institute Louis J. Gross, University of Tennessee Richard A. Johnson, GlobalHelix LLC and Arnold & Porter, LLP Judith Kimble (NAS), University of Wisconsin, Madison Cato T. Laurencin (NAE/IOM), University of Connecticut Health Center Alan I. Leshner (IOM), American Association for the Advancement of Science Bernard Lo (IOM), University of California, San Francisco Karen E. Nelson, J. Craig Venter Institute Robert M. Nerem (NAE/IOM), Georgia Institute of Technology, Atlanta, Georgia Camille Parmesan, University of Texas, Austin Alison G. Power, Cornell University Margaret Riley, University of Massachusetts, Amherst Bruce W. Stillman (IOM), Cold Spring Harbor Laboratory Janice C. Weeks, University of Oregon Cynthia Wolberger, Johns Hopkins University School of Medicine Mary Woolley (IOM), Research!America Staff Frances E. Sharples, Director Jo L. Husbands, Scholar/Senior Project Director Jay B. Labov, Senior Scientist/Program Director for Biology Education Katherine W. Bowman, Senior Program Officer Marilee K. Shelton-Davenport, Senior Program Officer India Hook-Barnard, Program Officer Keegan Sawyer, Program Officer Bethelhem M. Banjaw, Financial Associate Carl-Gustav Anderson, Program Associate Orin Luke, Senior Program Assistant Sayyeda Ayesha Ahmed, Senior Program Assistant ix

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COUNCIL OF THE NATIONAL ACADEMY OF ENGINEERING Officers Charles O. Holliday, Jr. (NAE), (Chair), Bank of America Charles M. Vest (NAE), (President), President, National Academy of Engineering Maxine L. Savitz (NAE), (Vice President), Honeywell Inc. (retired) Thomas F. Budinger (NAE/IOM), (Home Secretary), University of California, Berkeley and E. O. Lawrence Berkeley National Laboratory Venkatesh (Venky) Narayanamurti (NAE), (Foreign Secretary), Harvard School of Engineering and Applied Science and Harvard Kennedy School C.D. (Dan) Mote, Jr. (NAE), (Treasurer), University of Maryland Councillors Linda M. Abriola (NAE), Tufts University School of Engineering Alice M. Agogino (NAE), University of California, Berkeley Corale L. Brierley (NAE), Brierley Consultancy LLC Paul Citron (NAE), Medtronic, Inc. (retired) Ruth A. David (NAE), ANSER (Analytic Services Inc.) Charles Elachi (NAE), Jet Propulsion Laboratory and California Institute of Technology Paul R. Gray (NAE), University of California, Berkeley Richard A. Meserve (NAE), Carnegie Institution for Science Julia M. Phillips (NAE), Sandia National Laboratories Arnold F. Stancell (NAE), Mobil Oil (retired) and Georgia Institute of Technology (emeritus) Richard H. Truly (NAE), United States Navy (retired) and National Renewable Energy Laboratory (retired) Ex Officio Ralph J. Cicerone (NAS), President, National Academy of Sciences x

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Acknowledgments We would like to acknowledge the contributions of the following individ- uals who made presentations at the symposia: Anita L. Allen, University of Pennsylvania Law School; Luke Alphey, Oxitec Ltd. and University of Oxford; Rifat Atun, Global Fund to Fight AIDS, Tuberculosis, and Malaria; Roel Bo- venberg, DSM, Netherlands; Patrick Boyle, Harvard University; Yizhi Patrick Cai, Johns Hopkins University School of Medicine; Peter Carr, Massachusetts Institute of Technology; Lionel Clarke, Shell Global Solutions; Rochelle Cooper Dreyfuss, New York University School of Law; Alexandra Daisy-Ginsberg, De- signer, Artist, and Writer; Ben Davis, University of Oxford; Maitreya Dunham, University of Washington; Ioannis Economidis, EU-US Task Force on Biotech- nology Research; Robert Edwards, Food and Environment Research Agency; Kirstin Eley, TMO Renewables Ltd.; Michael Elowitz, California Institute of Technology; Drew Endy, Stanford University and The Biobricks Foundation; Da-ming Fan, Chinese Academy of Engineering; Nita Farahany, Vanderbilt University Law School; James Field, Imperial College London; Ian Fothering- ham, Ingenza; Paul Freemont, Imperial College London; Paul Gemmill, Bio- technology and Biological Sciences Research Council, U.K.; Saul Griffith, En- gineer and Entrepreneur; Jaydee Hanson, International Center for Technology Assessment; Karmella Haynes, Arizona State University; Wei Huang, University of Sheffield; Farren Isaacs, Yale University School of Medicine; Mitsuhiro Itaya, Keio University; Sheila Jasanoff, Harvard University; Michael Jewett, North- western University; Gerardo Jiménez-Sanchez, Organisation for Economic Co- operation and Development; Nigel Jones, Linklaters LLP; Richard Jones, Uni- versity of Sheffield; Linda Kahl, Synthetic Biology Engineering Research Center (SynBERC) and Stanford University; Nikki Kapp, Pennsylvania State Universi- ty; Jason Kelly, Ginkgo BioWorks; François Képès, Centre Nacionale de Re- cherche Scientifique; Daniel Kevles, Yale University; Richard I. Kitney, Imperi- al College London; Thrane Kreiner, Santa Clara University; Peter Leadlay, University of Cambridge; Thomas Lee, Defense Advance Projects Research Agency; Mark Lemley, Stanford University; Jing-hai Li, Chinese Academy of Sciences; Chen Liao, University of Science and Technology of China; Hai-Yan Liu, University of Science and Technology of China; Duo Liu, Tianjin Universi- xi

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xii Acknowledgments ty; Chenli Liu, Gangzhou Institute of Advanced Technology; Meagan Lizarazo, iGEM Foundation; Heather Lowrie, University of Edinburgh; John McCarthy, University of Warwick; Jason Micklefield, University of Manchester; Gautam Mukunda, Harvard University; Carlos Olguin, Autodesk; Qi Ou-yang, Peking University; John Perkins, Department of Business, Innovation, & Skills (U.K. Government); Todd Peterson, Life Technologies Corporation; George Poste, Complex Adaptive Systems Initiative and Arizona State University; Zhong-jun Qin, Shanghai Institutes for Biological Sciences; Renzong Qiu, Chinese Acade- my of Social Sciences Institute of Philosophy; Arti Rai, Duke University; Sohi Rastegar, National Science Foundation; Cesar Rodriguez, Genome Compiler Corporation; Nikolas Rose, King’s College London; François Roure, French High Council for Industry, Energy, and Technologies; Marc Salit, National In- stitute of Standards and Technology; Christopher Schoene, Imperial College London; Daniel P. Schrag, Harvard University; Reshma Shetty, Gingko Bio- Works; Darlene Solomon, Agilent Technologies; Gregory Stephanopoulos, Mas- sachusetts Institute of Technology; David Uffindell, Department of Business, Innovation, & Skills (U.K. Government); Charles Vest, National Academy of Engineering; William Wakeham, Royal Academy of Engineering; Barry L. Wanner, Purdue University; Robert Wells, Organisation for Economic Co- operation and Development; David Willetts, U.K. Government; Jeffrey Tze Fei Wong, Hong Kong University of Science and Technology; Jetta Wong, U.S. House of Representatives; Liang Wu, DSM, Netherlands; Youli Xiao, Shanghai Institutes for Biological Sciences; Huanming Yang, Beijing Genomics Institute; Sheng-li Yang, Shanghai Institutes for Biological Sciences; Edward You, Fed- eral Bureau of Investigation; Joy Zhang, London School of Economics; Wei- wen Zhang, Tianjin University; Hao-qian Zhang, Peking University; Xian-en Zhang, Ministry of Science and Technology of China; Weiwen Zhang, Tianjin University; Guo-ping Zhao, Shanghai Institutes for Biological Sciences; Hui- min Zhao, University of Illinois at Urbana-Champaign; Lishan Zhao, Amyris, Inc.; Jindong Zhao, Institute for Hydrobiology (Chinese Academy of Sciences); Zhihua Zhou, Shanghai Institutes for Biological Sciences; Laurie Zoloth, Northwestern University; and Gordon Zong, Shanghai Institutes for Biological Sciences. We would also like to thank session moderators Roel Bovenberg, DSM, Netherlands; Rob Carlson Biodesic; Zi-xin Deng, Shanghai Jiao Tong Universi- ty; Drew Endy, Stanford University and The Biobricks Foundation; Richard Johnson, GlobalHelix LLC; Richard I. Kitney, Imperial College London; Peter Leadlay, University of Cambridge; Jonathan Margolis U.S. Department of State; Jonathan Moreno, University of Pennsylvania; Megan Palmer, Synthetic Biology Engineering Research Center (SynBERC) and Stanford University; Aristides Patrinos, Synthetic Genomics; David Rejeski, Woodrow Wilson International Center for Scholars; Pamela Silver, Harvard Medical School; Huanming Yang, Beijing Genomics Institute; Ying-jin Yuan, Tianjin University; and Guo-ping Zhao, Shanghai Institutes for Biological Sciences.

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Acknowledgments xiii This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures ap- proved by the National Academies’ 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 quality and objectivity. 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: Arti Rai, Duke University; Markus Schmidt, Biofaction; and Terrence Taylor, International Council for the Life Sciences. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the content of the report, nor did they see the final draft before its release. Responsibility for the final content of this report rests entirely with the rapporteurs and the institution.

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Contents 1 INTRODUCTION ................................................................................................. 1 2 SYNTHETIC BIOLOGY: SCIENCE AND TECHNOLOGY FOR THE NEW MILLENNIUM ......................................................................... 7 Building on a Heritage of Biological Discovery, 8 Synthetic Biology and Converging Scientific Disciplines, 9 What Makes Synthetic Biology Special?, 10 3 STRATEGIES FOR ADVANCING SYNTHETIC BIOLOGY ....................... 17 China, 17 United Kingdom, 19 United States, 21 Organisation for Economic Co-operation and Development, 23 4 OPPORTUNITIES AND CHALLENGES EMERGING VIA A NETWORKED WORLD ................................................................................ 25 Challenges for Synthetic Biology, 28 Technical Challenges, 28 Regulatory Challenges, 33 Intellectual Property Issues, 34 Inclusiveness, 36 Preparing for a Networked World, 38 APPENDIXES A LONDON SYMPOSIUM AGENDA .................................................................. 43 B SHANGHAI SYMPOSIUM AGENDA .............................................................. 49 C WASHINGTON, DC SYMPOSIUM AGENDA ............................................... 55 BOXES 2-1 DNA and Biological Parts, 9 2-2 Synthetic Biology Tools and Technology Timeline, 11 2-3 The International Genetically Engineered Machine (iGEM) Competition, 15 3-1 Strategic Targets for Synthetic Biology in China, 19 3-2 Publicly Funded Synthetic Biology Research in the United States, 22 4-1 The Commercialization of Synthetic Biology: Amyris, Inc., 26 4-2 Cooperative Arrangements for Discussions about Benefits and Risks, 29 4-3 What Can We Expect from Synthetic Biology?, 30 xv

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