Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System

Consensus

Download PDF

Paperback - $66.60
Ebook - $53.99

Request an exam or desk copy

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5–10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology?

Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Additional materials

Press Release

Publication information

230 pages · 7 x 10 · paperback
ISBN Paperback: 0-309-45205-8
ISBN Ebook: 0-309-45206-6
DOI: https://doi.org/10.17226/24605

Suggested citation

National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press.

Import this citation to:

Richard M. Murray

Dr. Richard Murray is Thomas E. and Doris Everhart Professor of Control and Dynamical Systems and Bioengineering at California Institute of Technology. He received his B.S. degree in Electrical Engineering from California Institute of Technology in 1985 and his M.S. and Ph.D. degrees in Electrical Engineering and Computer Sciences from the University of California, Berkeley, in 1988 and 1991, respectively. Professor Murray's research is in the application of feedback and control to mechanical, information, and biological systems. Current projects include integration of control, communications, and computer science in multi-agent systems, information dynamics in networked feedback systems, analysis of insect flight control systems, and biological circuit design. Professor Murray has recently developed a new course at Caltech that is aimed at teaching the principles and tools of control to a broader audience of scientists and engineers, with particular emphasis on applications in biology and computer science. Dr. Murray is co-founder and board member of Synvitrobio, a start-up biotechnology company focused on commercialization of cell-free synthesis methods.

Richard M. Amasino

Richard M. Amasino is a professor with the Department of Biochemistry at the University of Wisconsin–Madison. His work focuses on how plants perceive seasonal cues such as changing day-length and temperature and how they use such cues to determine when to initiate flowering. His most recent focus has been on understanding the biochemical pathway through which perception of winter cold leads to flowering in the spring–a process known as vernalization. Dr. Amasino is also a member of the Great Lakes Bioenergy Research Center, which is one of the three bioenergy research centers established by the U.S. Department of Energy. His work with the center involves studying the biochemical basis of plant biomass accumulation as well as directing the education and outreach program of the center. Dr. Amasino is a Howard Hughes Medical Institute (HHMI) professor, a member of the U.S. National Academy of Sciences, and a fellow of the American Association for the Advancement of Science. His teaching and research have resulted in several national and international awards, including the Alexander von Humboldt Foundation Award in 1999. He has served both as president and chair of the board of trustees of the American Society of Plant Biologists. Dr. Amasino received his BS in biology from Pennsylvania State University and his MS and PhD in biology/biochemistry from Indiana University.

Steven P. Bradbury

In August of 2015, Dr. Bradbury was appointed as a professor of environmental toxicology in the Departments of Natural Resource Ecology and Management and Entomology. He is also a faculty member in Iowa State University's Toxicology Program. From July 2014 through July 2015, Dr. Bradbury served as a visiting professor in the Department of Entomology. Dr. Bradbury is contributing to research, teaching and extension in university-wide toxicology, environmental, agriculture and natural resource science and policy programs. Areas of emphasis include pesticide resistance management; pollination services and monarch butterfly conservation; and sustainable agriculture, including the role of integrated pest management within nested layers of governance. Dr. Bradbury retired from the U.S. Environmental Protection Agency in 2014. During his last 4 years at EPA he was the Director of the Office of Pesticide Programs. In this role he led evaluation of new and existing pesticides, including biotechnology products; integration of federal pesticide registration decisions within related national, state and stakeholder-initiated programs; and addressed management options for emerging, high impact pests, pesticide resistance, and water quality, endangered species and pollinator protection. Prior to joining OPP in 2002, Dr. Bradbury had over 15 years of experience in EPA’s Office of Research and Development leading efforts to advance human health and ecological risk assessments in support of water quality, pesticide and industrial chemical programs. Dr. Bradbury has a BS in Molecular Biology from the University of Wisconsin-Madison and a MS in Entomology (Insecticide Toxicology) and a PhD in Toxicology and Entomology from Iowa State University. He has published over 70 peer-reviewed journal articles and book chapters and has an extensive record of invited presentations at international and national scientific conferences. In 2014, Dr. Bradbury received the Henry A. Wallace Award for Outstanding Leadership to National and International Agriculture from the College of Agriculture and Life Sciences, Iowa State University.

Steven L. Evans

Dr. Steve Evans is currently a Fellow at Dow AgroSciences in Seeds Discovery R&D. He received his B.A. and B.S. degrees in chemistry and microbiology from the University of Mississippi and a Ph.D. in microbial physiology from the University of Mississippi Medical School. He was an NIH postdoctoral fellow at the University of California, Berkeley, and subsequently with the U.S.D.A. in Peoria, Illinois. In 1988 he joined Mycogen Corp., now Dow AgroSciences, where he has been involved in the development of natural and recombinant biopesticides, including several crop traits from the Mycogen pipeline. At the U.S.D.A. and subsequently in industry roles, Evans blends high-resolution chemical analysis with enzymology to research agricultural applications of biotechnology. Evans continues to identify and acquire differentiating biotechnology capabilities. Evans is chair emeritus of the Industrial Advisory Board of the SynBERC synthetic biology consortium and co-chair of the BIO Organization IES synthetic biology sub team.

Barbara J. Evans

Dr. Barbara Evans joined the University of Houston Law Center in 2007. She is George Butler Research Professor and Director of the Center for Biotechnology and Law at UHLC and is an affiliated member of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. She was named a Greenwall Foundation Faculty Scholar in Bioethics for the period 2010-2014 and conducts an active research agenda including projects funded by the National Institutes of Health and Food and Drug Administration. Her research interests include governance, privacy, and financing issues with large health information networks and tissue repositories; regulatory and judicial uses of evidence from large-scale observational studies; and legal barriers to clinical translation of pharmacogenomics. Earlier in her career, she was a partner in the international regulatory practice of a large New York law firm and subsequently advised clients on U.S. privacy, research, and medical device regulatory matters. Prior to joining the University of Houston Law Center, she was a Research Professor of Medicine and Director of the Program in Pharmacogenomics, Ethics, and Public Policy at the Indiana University School of Medicine/Center for Bioethics. She holds an electrical engineering degree from the University of Texas at Austin; M.S. and Ph.D. degrees from Stanford University; a J.D. from Yale Law School; and she completed a post-doctoral Fellowship in Clinical Ethics at the M.D. Anderson Cancer Center.

Farren Isaacs

Dr. Isaacs is an Assistant Professor of Molecular, Cellular and Developmental Biology at Yale University. He received a B.S.E. degree in Bioengineering from the University of Pennsylvania and obtained his PhD from the Biomedical Engineering Department and Bioinformatics Program at Boston University. In his PhD he integrated theory and experiment to study gene regulatory network dynamics and then pioneered the design and development of synthetic RNA components capable of probing and programming cellular function. He then was a research fellow in the Department of Genetics at Harvard Medical School working on genome engineering technologies with George Church. At Harvard, he developed enabling technologies for genome engineering, including MAGE (Multiple Automated Genome Engineering) and CAGE (Conjugative Assembly Genome Engineering). His research is focused on developing foundational genomic and biomolecular engineering technologies with the goal of developing new genetic codes, and engineered cells that serve as factories for chemical, drug and biofuel production. He has recently been named a “rising young star of science” by Genome Technology Magazine, a Beckman Young Investigator by the Arnold and Mabel Beckman Foundation, and recipient of a Young Professor award from DuPont. Dr. Isaacs is also co-founder and CTA of enEvolv, a start-up biotechnology firm aimed at commercializing the MAGE technology he co-invented.

Martha A. Krebs

Martha Krebs is senior scientist in Pennsylvania State University’s College of Engineering and principal investigator and director of the Consortium for Building Energy Innovation at The Navy Yard in Philadelphia. In her most recent previous position, Krebs worked with University of California, Davis faculty and staff to leverage and expand research programs through federal, state and private partnerships. In that role she also has served as science advisor for the California Energy Commission. Before joining UC Davis, she was the Commission’s deputy executive director for research and development (R&D). From 1993 to 2000, Krebs served as assistant secretary and director of the Office of Science at the Department of Energy, responsible for the basic research program that supports the department’s energy, environmental and national security missions. She also advised the Secretary of Energy on the department’s R&D portfolio and the institutional health of its National Laboratories. From 1983 to 1993, Krebs served as an associate director for Planning and Development at the Department of Energy’s Lawrence Berkeley National Laboratory, where she was responsible for strategic planning for research and facilities, technology transfer, and science education and outreach. From 1977 to 1983, she served on the House Committee on Science first as a professional staff member and then as subcommittee staff director, responsible for authorizing the department’s non-nuclear energy technologies and energy science programs. Krebs received her bachelor’s degree and doctorate in physics from the Catholic University of America. She is a fellow of the American Physical Society, the American Association for the Advancement of Science and the Association of Women in Science.

Jennifer Kuzma

Jennifer Kuzma is the Goodnight-NCGSK Foundation Distinguished Professor in Social Sciences and co-director of the Genetic Engineering and Society Center at NC State University. Prior to this position she was a faculty member in science and technology policy at the Humphrey School of Public Affairs, University of Minnesota (2003-2013); study director at the National Academies of Science in Washington DC for genetic engineering and bioterrorism (1999-2003); and a AAAS Risk Policy Fellow at the U.S. Dept. of Agriculture (1997-1999). She has over 100 scholarly publications on emerging technologies and governance; and has been studying genetic engineering and its societal aspects for over 25 years. She discovered that bacteria product isoprene, a precursor to natural rubber, during from her Ph.D. work in biochemistry, and her postdoctoral work in plant molecular biology resulted in a publication in the journal Science. She has held several leadership positions, including the Society for Risk Analysis Council & Secretary, Chair of the Gordon Conference on S&T Policy, the FDA Blood Products Advisory Committee, and the UN WHO-FAO Expert Group for Nanotechnologies in Food and Agriculture. In 2014, she received the Society for Risk Analysis Sigma Xi Distinguished Lecturer Award for recognition of her outstanding contributions to the field of risk analysis. She has been called upon in national media for her expertise on genetic engineering policy issues, including recently in the Washington Post, Scientific American, New York Times, 2015 World’s Fair exhibit, Nature, and National Public Radio.

Mary E. Maxon

Dr. Mary Maxon is the Biosciences Area Principal Deputy at Lawrence Berkeley National Laboratory where she is responsible for developing strategies for the use of biosciences to address national-scale challenges in energy and environment. Previously, she was Assistant Director for Biological Research at the White House Office of Science and Technology Policy (OSTP) in the Executive Office of the President where she developed the National Bioeconomy Blueprint. Before moving to OSTP, Dr. Maxon ran the Marine Microbiology Initiative at the Gordon and Betty Moore Foundation, which supports the application of molecular approaches and comprehensive models to detect and validate environmentally-induced changes in marine microbial ecosystems. Prior to that, Dr. Maxon served as Deputy Vice Chair at the California Institute for Regenerative Medicine, where she drafted the intellectual property policies for California stem cell grantees in the non-profit and for-profit research sectors. Previously, she was Associate Director and Anti-infective Program Leader for Cytokinetics, a biotechnology company in South San Francisco and team leader at Microbia, Inc., based in Cambridge, Massachusetts, where she contributed to the discovery and development of the Precision Engineering technology for production of commercial products using metabolic engineering. Dr. Maxon received her Ph.D. from the University of California, Berkeley in Molecular Cell Biology, and did postdoctoral research in biochemistry and genetics at the University of California, San Francisco.

Raul F. Medina

Dr. Raul F. Medina’s research interests center around the role that ecological factors play in the population genetics of arthropods. Dr. Medina is particularly interested in the incorporation of evolutionary ecology considerations into pest control practices. His laboratory is currently assessing how species interactions at macroscopic (e.g., host-parasite associations) and microscopic (e.g., arthropod microbiomes) levels may affect genetic variation of agricultural pests and arthropod vectors of human disease. Dr. Medina is currently exploring if the same principles governing insect herbivores’ adaptation to their hosts translate in arthropod parasites of animals. Dr. Medina completed his Bachelor in Biology in Lima, Peru at the Universidad Nacional Agraria La Molina. He then obtained a Graduate Certificate in conservation biology from the University of Missouri in Saint Louis. He received his Master and PhD from the University of Maryland working on predation of forest caterpillars and on hymenopteran parasitoid population genetics respectively. Soon after his PhD Dr. Medina started working at Texas A&M where he is currently an Associate Professor.

David Rejeski

Mr. Rejeski directs the Science and Technology Innovation Program (STIP) at the Woodrow Wilson Center, a non-partisan policy research institute in Washington DC. STIP focuses on emerging technologies and the critical choices innovation presents to public policy. Work includes synthetic biology (http://www.synbioproject.org), nanotechnology (http://www.nanotechproject.org), citizen science (http://wilsoncommonslab.org/), additive manufacturing, converging technologies, and the application of computer games to public policy challenges. He is presently a Guest Researcher at the International Institute of Applied Systems Analysis (IIASA) in Austria, a Visiting Scholar at the Environmental Law Institute, and was a Visiting Fellow at Yale University’s School of Forestry and Environmental Studies. Between 1994 and 2000, he worked at the White House Council on Environmental Quality (CEQ) and the Office of Science and Technology Policy (OSTP) on a variety of technology, R&D, and policy initiatives, including the development and implementation of the National Environmental Technology Strategy, the Greening of the White House, and the Education for Sustainability Initiative. Before moving to OSTP, he was head of the Future Studies Unit at the Environmental Protection Agency. He spent four years in Hamburg, Germany working for the Environmental Agency, Department of Public Health, and Department of Urban Renewal and, in the late 1970’s, founded and co-directed a non-profit involved in energy conservation and renewable energy technologies. He sits on the advisory boards of a number of organizations, including the UK Open Plant Project, the NSF-funded Synthetic Biology Engineering Research Center (SynBERC), DARPA’s ‘Living Foundries’ Program, the Center for Environmental Policy at American University, and the Journal of Industrial Ecology. He has also served on NSF’s Advisory Committee for Environmental Research and Education; EPA’s Science Advisory Board and Board of Scientific Counselors; the Committee on Science, Engineering and Public Policy of the American Association for the Advancement of Science (AAAS); the Board on Global Science and Technology of the National Academies of Sciences, Engineering and Medicine; and Games for Change. He has graduate degrees in public administration and environmental design from Harvard University and Yale University and a degree in industrial design from the Rhode Island School of Design.

Jeffrey D. Wolt

Dr. Wolt is currently professor in the programs of Agronomy, Environmental Science, and Toxicology at Iowa State University. He started his academic career studying biology at Case Western Reserve University and completed his BS in bio-agricultural science at Colorado State University. He received his MS and PhD in agriculture from Auburn University with emphasis in environmental soil chemistry. His expertise includes soil solution chemistry, environmental chemistry, biogeochemistry, ecotoxicology, and risk assessment. Prior to coming to Iowa State, he held academic appointments with the University of Tennessee, the University of Hawaii, and Purdue University. He also worked as an environmental chemist and risk analyst with Dow Chemical. Dr. Wolt’s current research interests include biotechnology safety analysis applied to risk management and science policy decision-making; environmental and ecotoxicological risk assessment; soil and environmental chemistry applied to exposure assessment, efficacy, environmental monitoring, environmental toxicology, and environmental fate of xenobiotics and genetically modified agricultural products; and applied soil solution chemistry. He also works with regulators and scientists throughout the world to formulate and promote harmonized approaches for assessing the safety of genetically-engineered plants. His lab group works on the environmental fate of plant products introduced into agroecosystems.

Log In

Sign in to access your saved publications, downloads, and email preferences.

Former MyNAP users: You'll need to reset your password on your first login to MyAcademies. Click "Forgot password" below to receive a reset link via email. Having trouble? Visit our FAQ page to contact support.

Members of the National Academy of Sciences, National Academy of Engineering, or National Academy of Medicine should log in through their respective Academy portals.

Email (required)
Password (required)

Don't have an account?

Register

Email (required)
New password (required)
Retype password (required) Password must be at least 8 characters
I accept the terms of use
terms of use

Thank You

Thank you for creating a MyAcademies account!

Enjoy free access to thousands of National Academies' publications, a 10% discount off every purchase, and build your personal library.

Forgot Password

Enter the email address for your MyAcademies (formerly MyNAP) account to receive password reset instructions.

Reset Requested

We sent password reset instructions to your email . Follow the link in that email to create a new password. Didn't receive it? Check your spam folder or contact us for assistance.

Reset Password

New password (required)
Retype password (required) Password must be at least 8 characters

Reset Password

Your password has been reset.

Log In

Verify email

Verify Your Email Address

We sent a verification link to your email. Please check your inbox (and spam folder) and follow the link to verify your email address. If you did not receive the email, you can request a new verification link below

Subscribe

First Name
Last Name
Email (required)
I agree to receive emails from the National Academies (required)

We respect your privacy and will never share your information.

Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System

Featured publication

Description

Collaborators

Committee

Sponsors

Staff

Major units and sub-units

Contact

Contact us

Provide feedback

Request materials

More like this

Review of the draft United by Nature assessment

Modernizing Mathematics Education for Grades 9-14

Health Care Financing to Improve Availability of Affordable Contraception: Identifying Promising Practices

Transit Cooperative Research Program

Review of the draft United by Nature assessment

Modernizing Mathematics Education for Grades 9-14

Promoting Safe and Secure Science Through a Regional Middle East and South Asia Biological Sciences Conference

Agriculture, Food Systems and Climate Security: A Workshop

Communities, Climate Change, and Health Equity Workshop Series: Exploring flood adaptation strategies to support health equity

Additional materials

Publication information

Suggested citation

My Academies

Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System

Dropdown items

Featured publication

Preparing for Future Products of Biotechnology

Description

Collaborators

Committee

Sponsors

Staff

Major units and sub-units

Contact

Contact us

Provide feedback

Request materials

More like this

Review of the draft United by Nature assessment

Modernizing Mathematics Education for Grades 9-14

Health Care Financing to Improve Availability of Affordable Contraception: Identifying Promising Practices

Transit Cooperative Research Program

Review of the draft United by Nature assessment

Modernizing Mathematics Education for Grades 9-14

Promoting Safe and Secure Science Through a Regional Middle East and South Asia Biological Sciences Conference

Agriculture, Food Systems and Climate Security: A Workshop

Communities, Climate Change, and Health Equity Workshop Series: Exploring flood adaptation strategies to support health equity