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.

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 Institute 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 Academy of Sciences and the Alfred P. Sloan Foundation. 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: 978-0-309-22583-0
International Standard Book Number-10: 0-309-22583-3

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. C. D. (Dan) Mote, Jr., 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. C. D. (Dan) Mote, Jr., are chair and vice chair, respectively, of the National Research Council.

This page intentionally left blank.

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

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

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

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

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

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

Acknowledgments

We would like to acknowledge the contributions of the following individuals 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 Bovenberg, 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, Designer, Artist, and Writer; Ben Davis, University of Oxford; Maitreya Dunham, University of Washington; Ioannis Economidis, EU-US Task Force on Biotechnology 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 Fotheringham, Ingenza; Paul Freemont, Imperial College London; Paul Gemmill, Biotechnology and Biological Sciences Research Council, U.K.; Saul Griffith, Engineer 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, Northwestern University; Gerardo Jiménez-Sanchez, Organisation for Economic Cooperation and Development; Nigel Jones, Linklaters LLP; Richard Jones, University of Sheffield; Linda Kahl, Synthetic Biology Engineering Research Center (SynBERC) and Stanford University; Nikki Kapp, Pennsylvania State University; Jason Kelly, Ginkgo BioWorks; François Képès, Centre Nacionale de Recherche Scientifique; Daniel Kevles, Yale University; Richard I. Kitney, Imperial 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-

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 Academy 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 Institute 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, Massachusetts 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 Cooperation 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, Federal Bureau of Investigation; Joy Zhang, London School of Economics; Weiwen 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; Huimin 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 University; 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.

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 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.

This page intentionally left blank.

Contents

This page intentionally left blank.