Forum on Synthetic Biology

FORUM ON SYNTHETIC BIOLOGY

Project Scope

CSTL has established a forum for discussions about scientific, technical, ethical, legal, regulatory, security, and other policy issues associated with synthetic biology. The forum will stimulate dialogue about issues of mutual interest to its membership by serving as a venue in which to discuss scientific advances in, challenges and opportunities for, and public policy concerns about synthetic biology. The specific agendas for forum meetings will be determined by the forum membership. It is expected, however, that the forum will begin its consideration of synthetic biology by addressing the near, mid- and far- term technical advances that have potential security and safety aspects and identifying possible strategies to address these aspects during both the development and post-development phases of the emerging technologies. The forum will meet three times in a period of one year with options for two additional years. It may commission papers to inform its discussions and suggest topics for studies, workshops, or other public meetings to be held in conjunction with forum meetings.

ACCOMPLISHMENTS & IMPACT

Since its inception in 2012, the forum has sponsored numerous events in the United Stated and abroad. In 2013, the forum organized a joint meeting with colleagues at Imperial College London entitled Ownership and Sharing: Setting the Patent Framework for Innovation in Synthetic Biology, A Workshop. The meeting’s focus was on ownership and barriers to sharing that might obstruct innovation in synthetic biology. The forum also collaborated with the U.S. Department of State to organize a public briefing at the U.S. State Department entitled The Evolving Nature of Synthetic Biology: A Panel Discussion on Key Science, Policy, and Societal Challenges Facing the International Community.

In 2014, the forum organized a meeting in Palo Alto, CA entitled Understanding Risk Frameworks for Emerging Technologies. Invited speakers spoke about what has been learned from decades of research on risk assessment and management, innovative approaches to addressing emergent risk, the politics of risk, pre-quantitative risk, international approaches to risk, and the risks of synthetic biology. At a second meeting in Washington, DC, the membership discussed the expected impacts and possible benefits of synthetic biology, the place of synthetic biology in the U.S. biotechnology regulatory system, and FDA oversight of synthetic biology. In addition, representatives from federal agencies provided updates on their activities.

In collaboration with the UK Synthetic Biology Leadership Council, the forum sponsored a meeting in October 2014 at Imperial College London to bring together leaders from government, industry, and academia to discuss efforts to create an environment to support investment and innovation in synthetic biology in the United States and United Kingdom. That meeting, entitled Creating an Environment to Support Investment and Innovation in Synthetic Biology, led to a report of the proceedings by the UK Synthetic Biology Leadership Council in January 2015.

In November 2016, the forum convened a workshop to discuss current trends in synthetic biology, including international scientific and technical developments in synthetic biology; possible risks and benefits related to these developments; and legal, regulatory, and policy concerns. A report of the workshop proceedings entitled Making the World Engineerable: Science, Practice, and Policy: Proceedings of a Workshop—in Brief was issued in December 2016.

The forum has played an important role in fostering relationships across government, industry, and academia. It has been particularly successful in fostering the exchange of information amongst its constituent members, in nurturing international relationships, and through its summary reports, documenting for a broad audience the emerging policy landscape for synthetic biology.

	Project Information
PROJECT SCOPE ACCOMPLISHMENTS & IMPACT MEETINGS & EVENTS REPORTS MEMBERS SPONSORS

PROJECT STAFF

Anne-Marie Mazza, Ph.D.
Senior Director, Committee on Science, Technology, and Law
Phone: 202-334-2469
E-mail: amazza@nas.edu

Steven Kendall, Ph.D.
Program Officer, Committee on Science, Technology, and Law
Phone: 202-334-1713
E-mail: skendall@nas.edu

Karolina Konarzewska
Program Coordinator, Committee on Science, Technology, and Law

Meetings & Events

This website contains unedited verbatim presentations made by meeting participants and is not an official report of the National Academies. Opinions and statements included in this material are solely those of the individual authors. They have not been verified as accurate, nor do they necessarily represent the views of other participants, the committee, or the National Academies.

November 16, 2016
Making the Living World Engineerable: Science, Practice, and Policy
Washington, DC

View Agenda

Presentations

*Scott Fahrenkrug - see video at: http://kstp.com/news/gene-editing-supply-medical-research-recombinetics/4315545/
*Kevin Esvelt, "Living Technologies for Ecological Problems"
*Rob Carlson, "Ubiquitous Biological Manufacturing"
*Lionel Clarke, "Policy Levers and Strategies: Making the Living World Engineerable - The UK Approach"
*Jane Calvert, "A Synthetic Biology Roadmap for the UK"
*Laurie Zoloth, "Ethics: Recent Histories and Narratives"
*Jason Delborne, "Engagement as Governance"

View Report of Proceedings
View Roster of Workshop Planning Committee

October 28-29, 2014
Creating an Environment to Support Investment and Innovation in Synthetic Biology
London, England

Agenda
Read UK Synthetic Biology Leadership Council Summary Report of Meeting

September 18-19, 2014
3rd Meeting
Washington, DC

Agenda

Presentations

*Sarah R. Carter, "Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options"
*Thomas M. Connelly, "Synthetic Biology and Advanced Manufacturing - A Chemical Industry Perspective"
*Floyd Romesberg, "Artificial DNA in Living Cells"
*Frank F. Weichold, "FDA Oversight of Synthetic Biology"

March 13, 2014
2nd Meeting: Understanding Risk Frameworks for Emerging Technologies
Palo Alto, CA

Agenda
Video

Presentations

*Lynne P. Cooper, "Pre-Quantitative Risk: The Social Construction of Risk in Project Teams"
"Adam Finkel, "Channeling Synthetic Biology Through 'Solution-Focused Risk Assessment'"
*Stephen Hilgartner, "The Politics of Risk"
*Sheila Jasanoff, "International Approaches to Risk (Understanding Risk Frameworks for Emerging Technologies)"
*Jennifer Kuzma, "Beyond Old Debates: New Systems Risk Analysis (NESRA) in an Action Oriented Approach"
*Andrew D. Maynard, "Innovative Approaches to Emergent Risks"
*Jonathan Wiener, "Learning from Research about Risk Regulation"

October 20-21, 2013
1st Meeting
Washington, DC

Agenda

Presentations

*Linda Chrisey, "Office of Naval Research Synthetic Biology"
*Denver Dale, "Specialized Capital Formation and Deployment to Support Synthetic Biology"
*Philip Dormitzer, "Synthetic Vaccinology at Novartis"
*Antony Evans, "Glowing Plant"
*Theresa Good, "NSF Investments in Synthetic Biology"
*Alicia Jackson, "Engineering Biology"
*Megan Palmer, "Enabling Next Generation Synthetic Biology Leadership"
*Alan Pearson, The Role of USDA-APHIS in the Regulation of Biotechnology in the United States"
*Pablo Rabinowicz, "DOE Office of Biological and Environmental Research (BER) Genomic Science Program: Biosystems Design"
*Marc Salit, "National Institute of Standards and Technology"
*Mark Segal, "EPA Oversight of Synthetic Biology"
*William So, "Synthetic Biology and National Security"

August 16, 2013
The Evolving Nature of Synthetic Biology: A Panel Discussion on Key Science, Policy, and Societal Challenges Facing the International Community
Washington, DC

Agenda
Video

Presentations

*Drew Endy, "What and Why Is Synthetic Biology"
*Richard Johnson, "Synthetic Biology: Ten Policy Reasons It Matters to U.S. Foreign Policy"
*Eleonore Pauwels, "Lost in Translation: Sharing Knowledge on the Technological Frontier"

August 1, 2013
Virtual Meeting

This meeting was closed in its entirety.

July 15-16, 2013
Ownership and Sharing: Setting the Patent Framework for Innovation in Synthetic Biology, A Workshop
London, England

Meeting Summary

Agenda

Presentations

*Robert Wells, Synthetic Biology and the Bioeconomy
*Rob Carlson, The Bioeconomy, IP, and Synthetic Biology
*Rochelle C. Dreyfuss, The Patent Landscape: Recent Decisions from the U.S. Supreme Court
*Linda Kahl, How Synthetic Biology Challenges Current Patenting/Ownership Frameworks
*Joanne Kamens, Addgene: A Unique Non-Profit Biotech
*Drew Endy, From Genetic Engineering to Synthetic Biology
*Lionel Clarke, Synthetic Biology Ownership and Innovation: Industry and Other Perspectives
*Stephen Laderman, Case Study: Agilent Technologies - Freedom to Operate

reports

Summaries of the proceedings of forum activities may be published as NRC reports.

MEMBERSHIP

Co-chairs:

Vicki L. Chandler (NAS)
Dean of Natural Sciences
Minerva Schools at Keck Graduate Institute

Richard M. Murray (NAE)
Thomas E. and Doris Everhart Professor of Control and Dynamical Systems and Bioengineering
California Institute of Technology

Members:

Steven A. Benner
Director
The Foundation for Applied Molecular Evolution (Ffame)

Jef D. Boeke (NAS)
Director
Institute for Systems Genetics
New York University Langone School of Medicine

Rob Carlson
Principal
Biodesic LLC

R. Alta Charo (NAM)
Warren P. Knowles Professor of Law and Bioethics
Department of Medical History and Bioethics
School of Medicine and Public Health
University of Wisconsin-Madison

Laura K. Donohue
Professor of Law
Georgetown University Law Center

Drew Endy
Assistant Professor, Bioengineering
Stanford University
President
The BioBricks Foundation

Richard A. Johnson
Chief Executive Officer
GlobalHelix LLC

Claire Marris
Senior Research Fellow
Department of Social Science, Health and Medicine
Kings College London

Darlene J.S. Solomon
Senior Vice President and Chief Technology Officer
Agilent Technologies

Ex Officio Members:

Linda Chrisey
Program Officer
Office of Naval Research

Genya Dana
Office of the Science and Technology Adviser to the Secretary
U.S. Department of State

Barbara Gerratana
Program Director
National Institute of General Medical Sciences

Marc Salit
Group Leader
National Institute of Standards and Technology

Jessica M. Tucker
Program Director
National Institute of Biomedical Imaging and Bioengineering

Edward You
Supervisory Special Agent
Federal Bureau of Investigation

Project Scope

ACCOMPLISHMENTS & IMPACT

Meetings & Events

reports

MEMBERSHIP

Sponsors