Synthetic Biology: Synthetic Biology: A Transforming Technology A - - PowerPoint PPT Presentation

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 August 18-

• 22, 2008

22, 2008

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

• Bacteriophage

Bacteriophage φ

φX174 genome synthesis

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 pharmaceuticals -

• vaccines, diagnostics, therapeutics.

vaccines, diagnostics, therapeutics.

• 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
• ccuring

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 Synthesis of Select Agents (December 2006) (December 2006)

• Describes the biosecurity concerns that are raised

Describes the biosecurity concerns that are raised by the ability to reconstruct Select Agents by the ability to reconstruct Select Agents de novo. de novo.

• 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 a the Select Agent Regulations with respect to synthetic nucleic acids. cids.

• Engaging industry and academia to identify, evaluate, and suppor

Engaging industry and academia to identify, evaluate, and support t establishment of a screening infrastructure for use by commercia establishment of a screening infrastructure for use by commercial l providers and users of synthetic nucleic acids. providers and users of synthetic nucleic acids.

• Modifying the

Modifying the NIH Guidelines for Research Involving Recombinant NIH Guidelines for Research Involving Recombinant DNA Molecules DNA Molecules to more explicitly address synthetic nucleic acids. to more explicitly address synthetic nucleic acids.

• 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.

QUESTIONS QUESTIONS