Synthetic Biology: Synthetic Biology: A Transforming Technology A Transforming Technology Biological and Toxin Weapons Convention Biological and Toxin Weapons Convention Meeting of Experts Meeting of Experts August 18- -22, 2008 22, 2008 August 18
What is Synthetic Biology? What is Synthetic Biology? � Synthetic biology refers to: Synthetic biology refers to: � � the design and fabrication of biological components and the design and fabrication of biological components and � systems that do not already exist in the natural world; and systems that do not already exist in the natural world; and � the re the re- -design and fabrication of existing biological systems. design and fabrication of existing biological systems. � (SyntheticBiology.org) (SyntheticBiology.org) � Interdisciplinary field that includes biologists, engineers, Interdisciplinary field that includes biologists, engineers, � chemists, and computer modelers. chemists, and computer modelers.
Synthesis of Complete Genomes Synthesis of Complete Genomes � Chemical synthesis of poliovirus Chemical synthesis of poliovirus � � August 2002 August 2002 � � 7.5 kb 7.5 kb � φ X174 genome synthesis Bacteriophage φ � Bacteriophage X174 genome synthesis � � December 2003 December 2003 � � 32 kb 32 kb � � Reconstruction of the 1918 pandemic influenza virus Reconstruction of the 1918 pandemic influenza virus � � October 2005 October 2005 � � 10 kb 10 kb � � Chemical synthesis of a Chemical synthesis of a Mycoplasma genitalium Mycoplasma genitalium genome genome � � February 2008 February 2008 � � 583 kb 583 kb �
The Promise of Synthetic Biology The Promise of Synthetic Biology � Rapid, inexpensive, and efficient production of Rapid, inexpensive, and efficient production of � pharmaceuticals - - vaccines, diagnostics, therapeutics. vaccines, diagnostics, therapeutics. pharmaceuticals � Anti Anti- -malarial drug artemisinin. malarial drug artemisinin. � � Branched DNA assay to detect HIV Branched DNA assay to detect HIV- -1 and HCV. 1 and HCV. � � Creation of systems to detect toxic chemicals and Creation of systems to detect toxic chemicals and � environmental pollutants. environmental pollutants. � Production of biofuels by engineered microbes. Production of biofuels by engineered microbes. � � Development of non Development of non- -ethanol diesel and gasoline alternatives. ethanol diesel and gasoline alternatives. �
An Enabling Technology for An Enabling Technology for Pathogen Synthesis Pathogen Synthesis � de novo de novo synthesis of naturally synthesis of naturally- -occuring occuring � pathogens pathogens � access to sequences and organisms of concern access to sequences and organisms of concern � � evasion of current regulatory and physical access evasion of current regulatory and physical access � controls (e.g., U.S. Select Agents, Australia Group, controls (e.g., U.S. Select Agents, Australia Group, pathogen security processes and procedures) pathogen security processes and procedures) � de novo de novo synthesis of novel biological agents synthesis of novel biological agents � � pathogens with unique properties pathogens with unique properties �
U.S. National Science Advisory U.S. National Science Advisory Board for Biosecurity (NSABB) Board for Biosecurity (NSABB) � Advisory committee to the U.S. Government. Advisory committee to the U.S. Government. � � Provides recommendations on strategies for Provides recommendations on strategies for � minimizing the possibility that biological research minimizing the possibility that biological research knowledge and technologies will be misused to knowledge and technologies will be misused to threaten public health or national security. threaten public health or national security. (http://www.biosecurityboard.gov) (http://www.biosecurityboard.gov)
NSABB Report NSABB Report � Addressing Biosecurity Concerns Related to the Addressing Biosecurity Concerns Related to the � Synthesis of Select Agents (December 2006) (December 2006) Synthesis of Select Agents � Describes the biosecurity concerns that are raised Describes the biosecurity concerns that are raised � by the ability to reconstruct Select Agents de novo. de novo. by the ability to reconstruct Select Agents � Assesses the adequacy of the current U.S. Assesses the adequacy of the current U.S. � domestic regulatory framework to safeguard domestic regulatory framework to safeguard against the misuse of synthetic biology. against the misuse of synthetic biology. � Recommends strategies for addressing concerns. Recommends strategies for addressing concerns. � (http://www.biosecurityboard.gov) (http://www.biosecurityboard.gov)
U.S. Government Approach U.S. Government Approach � Synthetic biology Synthetic biology… … � � has provided significant scientific, health, and economic benefi has provided significant scientific, health, and economic benefits; ts; � and and � is a potentially enabling technology for the is a potentially enabling technology for the de novo de novo � reconstruction of dangerous pathogens, either in part or in reconstruction of dangerous pathogens, either in part or in whole. whole. � Development of any oversight mechanism must Development of any oversight mechanism must… … � � balance the need to minimize the risk of misuse with the need to balance the need to minimize the risk of misuse with the need to � ensure that science and innovation are encouraged. ensure that science and innovation are encouraged. � involve engagement of the synthetic nucleic acid industry, the involve engagement of the synthetic nucleic acid industry, the � scientific community, and other stakeholders. scientific community, and other stakeholders.
Current U.S. Government Activities Current U.S. Government Activities Developing guidance for the scientific community and industry on Developing guidance for the scientific community and industry on � � the Select Agent Regulations with respect to synthetic nucleic acids. cids. the Select Agent Regulations with respect to synthetic nucleic a Engaging industry and academia to identify, evaluate, and support t Engaging industry and academia to identify, evaluate, and suppor � � establishment of a screening infrastructure for use by commercial establishment of a screening infrastructure for use by commercia l providers and users of synthetic nucleic acids. providers and users of synthetic nucleic acids. Modifying the NIH Guidelines for Research Involving Recombinant NIH Guidelines for Research Involving Recombinant Modifying the � � DNA Molecules to more explicitly address synthetic nucleic acids. to more explicitly address synthetic nucleic acids. DNA Molecules Developing recommendations for risk assessment and risk Developing recommendations for risk assessment and risk � � management principles and practices for research involving management principles and practices for research involving synthetic nucleic acids. synthetic nucleic acids. Commissioning a U.S. National Academies of Science study to Commissioning a U.S. National Academies of Science study to � � identify the list of scientific advancements necessary before a identify the list of scientific advancements necessary before a predictive oversight system can be postulated, developed, predictive oversight system can be postulated, developed, evaluated, and potentially implemented. evaluated, and potentially implemented.
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