biological weapons convention 2019 meeting of experts: mx2...
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Biological Weapons Convention
2019 Meeting of Experts: MX2
31 July and 2 August, 2019
@ Geneva
Biological risk assessment of leading-edge
life science and its management
Nariyoshi Shinomiya, MD, PhDNational Defense Medical College Research Institute
Japan
Dual Use Nature in Life Science
Life Science Technology
• Development of biological weapons
• Bioterrorism
• Destruction of environment
• Malign purposes
• Unintentional misuse
• Promotion of biotech enterprise
• New therapeutic methods
• Improvement of social welfare
• Initial purpose
• Healthy applications
Dual Use Research of Concern (DURC)
Leading-edge life science technology and DURC
2. Reverse geneticsReconstruction of 1918 Spanish flu virus (2005)
Airborne transmission of H5N1 influenza virus (2012)
3. Synthetic biologyChemical synthesis of poliovirus (2002)
Complete chemical synthesis of bacterial genome (2008)
Creation of a bacterial cell controlled by synthetic genome (2010)
Design and synthesis of minimal bacteria (2016)
Construction of an infectious horsepox virus (2017)
1. Recombinant DNA technologyFrancisella tularensis strain that produces b-endorphin (1993)Expression of hemolysin gene in Bacillus anthracis vaccine strain
Genetic modulation of mousepox virus (2001) (1997)
Fink report (2004)
1. Would demonstrate how to render a vaccine ineffective.
2. Would confer resistance to therapeutically useful antibiotics or
antiviral agents.
3. Would enhance the virulence of a pathogen or render a
nonpathogen virulent.
4. Would increase transmissibility of a pathogen.
5. Would alter the host range of a pathogen.
6. Would enable the evasion of diagnostic/detection modalities.
7. Would enable the weaponization of a biological agent or toxin.
Seven classes of experiments
= All these are related to the aggravation of biological weapons
New framework for influenza
GOF research (2013)US government DURC policy
(2015)
Year
Nu
mb
er
ofp
ub
lish
ed
pa
pe
rs / y
ea
r
Genome editing
Synthetic biology
Pathogenicity
modulation
High throughput
sequencing
Based on PubMed
Trends in emerging life science technologies (1)
NGS
2000DNA synthesizer
1986
Cost reduction
2006
CRISPR/Cas9
2012
2000
Deep learning
Neural network
1980
Expert system
Trends in emerging life science technologies (2)
1956
0
1000
2000
3000
4000
5000
6000
7000
8000
2018
2016
2014
2012
2010
2008
2006
2004
2002
2000
1998
1996
1994
1992
1990
1988
1986
1984
1982
1980
1978
1976
1974
1972
1970
1968
1966
1964
1962
1960
artificial intelligenceArtificial intelligenceN
um
be
ro
fp
ub
lish
ed
pa
pe
rs / y
ea
r
Advanced Biological Agents
Genetically Modified Traditional Agents/
Biochemical Agents
Traditional Agents
Pre-Genomic Era
1999 20202003
Thre
at
Genomic Era
Modified from:Petro, J. B., Plasse, T. R., and McNulty, J. A.: Biotechnology: Impact on Biological Warfare and Biodefense.
BioSecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 1(3): 161-168, 2003.
(http://www.liebertonline.com/doi/abs/10.1089/153871303769201815)
Development of life science technology and
timeline of biological warfare threat
Human Genome
Sequenced (Draft)Human Genome
Sequencing (Completed)
1970’s
1990’s
After 2000 • Synthetic biology
• Genome editing
Dual use problems about
pathogens research
Science Council of Japan
(January 23, 2014)
Section meeting on pathogens research
Proposal for DURC issues in Japan
2012
STRATEGIC PROPOSALPreparedness Framework and Its
Governance of Dual Use Research of
Concern for Promising Progress of
life Science
CRDSCenter for Research and Development Strategy,
Japan Science and Technology Agency
Issues related to biological threat and the relationship
among biosafety/ethics, infection control, and biosecurity
Genome
editing
How to implement effective governance in dealing with dual use
issues among different R&D levels and different stakeholders
“Dual-use issues and the role of life scientists”
Side Event to the 7th Review Conference of the
Biological and Toxin Weapons Convention
December 12th, 2011 Palais des Nations, Geneva
Survey of Universities’ Education for DURC in Japan (2016)
Bachelor course Master/Doctor course
School Fink report BWC,CWCIAP statement
on biosecurityFink report BWC,CWC
IAP statement on
biosecurity
School of
Medicine 26.2% 14.3% 42.9% 23.8% 19.0% 52.4%
School of
Biotechnology 22.0% 19.5% 36.6% 17.1% 19.5% 36.6%
Medicine +
Biotechnology24.1% 16.9% 39.8% 20.5% 19.3% 44.6%
2. Make reference to "Dual use" in current education: Rates
Biosafety (%) Biosecurity (%) Dual use (%)
76.2% 64.3% 50.0%
85.4% 73.2% 43.9%
80.7% 68.7% 47.0%
SchoolSchool of
MedicineSchool of
BiotechnologyMedicine +
Biotechnology
1. Problem recognition by school staff
Total number
80
72
152
SchoolSchool of
MedicineSchool of
BiotechnologyMedicine +
Biotechnology
According to a journalist of “The Guardian” James Randerson, all it took was an invented company name, a mobile phone number, a free email address and a house in north London to receive the order of variola virus DNA by post. The investigation makes clear that anyone, without attempting to prove a link to a legitimate research organisation, can order DNA sequences from any potential pathogen without fear of extensive questioning.In this case the provider company did not realise it was supplying part of the smallpox genome, but many scientists argue that it is the responsibility of companies selling custom-made pieces of DNA to check their orders for potentially dangerous sequences.
Custom DNA synthesis is very easy to order
(June, 2006)
From vaccinia virus to horsepox virus
• Possibility of saving other virus genomes using artificial chromosome
• Possibility of making virulent virus particles from the construct
(2002)
(2018)
After 15 years, horsepox virus was artificially synthesized
Creation of variola virus
has been technically
cleared!
Evaluation item Outline / Policy
1. Gene sequence
screening
• Screen the complete DNA sequence of every synthetic gene order
• Use a common Regulated Pathogen Database (RPD), and the international
sequence reference databanks (i.e., NCBI/GenBank, EBI/EMBL, or DDBJ)
• Screen against all pathogen and toxin genes (the US Select Agents and Toxins
List, the US Commerce Control List, and the EU list of dual-use items)
2. Customer
screening
• Identify data from all potential customers, including at a minimum a shipping
address, institution name, country, telephone number, and email address
3. Record keeping • Retain records of every gene synthesized and delivered for a minimum of 8
years after shipping
4. Order refusal &
reporting
• Reserve the right to refuse to fill any order and to notify other IGSC members
and/or authorities upon identifying potentially problematic orders
• Establish relationships with local and national law enforcement and intelligence
authorities
5. Regulatory
compliance
• Comply with all applicable laws and regulations governing the synthesis,
possession, transport, export, and import of gene synthesis and other products
• Will not synthesize gene sequences unique to Variola virus DNA
6. Consortium
collaborative
activities
• Update annually the IGSC Regulated Pathogen Database
• Include all gene sequences identified as potentially hazardous by authoritative
groups such as the CDC, the Australia Group, and the U.S. and European
governments
Harmonized Screening Protocol© v2.0Gene Sequence & Customer Screening to Promote BiosecurityBy International Gene Synthesis Consortium (19 November 2017)
https://genesynthesisconsortium.org/* The ICGS companies together represent approximately 80% of commercial gene synthesis
capacity world-wide.
1. To properly manage biological risks, timely evaluation of trends
in emerging life science technologies related to this convention
is essential.
2. Construction of a suitable framework for biological risk
assessment and management at the national science council
level as well as at academic conference levels is needed.
3. Recognition of dual use risks in emerging life science fields at
university education levels has been improved in Japan during
these several years.
4. To support healthy development of life science, construction of a
more appropriate biosecurity screening system at service
providing company/consortium levels is required.
5. For increased transparency, information exchange about the
activities related to synthetic biology among different countries
is important.
Conclusions / Recommendations
Thank you very much for your attention!