Synthetic Biology UK
Biotechnology Products:
Enhancing the Regulatory System
Lionel Clarke - NAS Washington DC - 1 June 2016
UK Roadmap Vision (2012):
…of a synthetic Biology Sector that is:
 economically vibrant, diverse and sustainable:
 cutting edge:
 of clear public benefit:
an exemplar of responsible innovation, incorporating the views of
a range of stakeholders and addressing global societal and
environmental challenges within an effective, appropriate and
responsive regulatory framework
Seek Balance between Distributed Responsibility and
Proportionate Regulation to deliver intended Public Benefit
Synthetic Biology is the design and engineering of biologically based parts,
novel devices and systems as well as the redesign of existing, natural systems
Development of Synthetic Biology
Royal Academy of Engineering ‘Synthetic Biology’ report 2009; UK Synthetic Biology Roadmap 2012
Biodesign
Design-to-outcome processes accelerated
Speed and Predictability increased
Produce
Analyse
Design
Test
Build
Rapid, accurate gene-editing tools developed (e.g. CRISPR)
Registries of standardized parts
‘Digital’
1990-2003 Human Genome Project Sanger
*e.g. cost of sequencing per base pair reduced x100,000,000 1988-2015
Costs of data handling and analysis reduced
1984: DNA fingerprinting Jeffreys
1970’s: genetic engineering developed
Costs of Reading and Writing DNA reduced*
‘Analogue’
High Throughput Analysis techniques developed
1953: Discovery of structure of DNA Crick and Watson
…the real paradigm shift stemmed from the fact that it introduced of the idea of
information and its physical embodiment in DNA sequences. Brenner 2013
Engineering Principles of
characterisation, standardisation, modularisation
Synthetic Biology: a timely response
linking technological potential to market needs
Synthetic Biology
Biodesign
Rapid but not Hasty
value system, regulatory
development, governance and
social engagement embedded
in Roadmap and Strategic Plan
Produce
Analyse
Test
Design
Build
Rapid Technological
Development
DNA sequencing, synthesis and
automated high-throughput analysis
increasing speed and predictability
DNA design and gene assembly
becoming much cheaper and more
widely accessible, facilitating routes
to innovative bio-based solutions
Ref: UK Synthetic Biology Roadmap July 2012
Global Challenges and Needs Increasing
effective new solutions becoming
technologically possible
and commercially viable
Roadmap 2012 recommendations
1. Invest in a network of multidisciplinary centres to
establish an outstanding UK synthetic biology resource
2. Invest to accelerate technology responsibly to market
3. Establish a Leadership Council (SBLC)
4. Build a skilled, energised & well-funded
synthetic biology community
5. Assume a leading international role
Synthetic Biology Community:
Special Interest Group broadly based
UK Infrastructural Investments provide broad-based resource
in synthetic biology (spanning social and physical sciences)
Industrial
Translation, Training and
Commercialisation
Platform
Technologies and
Applications
Doctoral training
– bioprocess
engineering
Sustainable
manufacturing –
fine and speciality
chemicals
Protein design;
Health and industrial
applications
RESEARCH and
TRANSLATION
Imperial
Imperial, Cambridge
Edinburgh, Kings, Newcastle
industrialisation
Whole-cell design;
mammalian system
applications
Bristol University
CATEGORIES
health
biomaterials
University College London
EXAMPLE OUTPUT
CAPABILITIES
biomanufacturing
INFRASTRUCTURAL
INVESTMENTS
Edinburgh University
plant
toolkits
biochemicals
Cambridge University,
John Innes Centre,
Sainsbury Lab
Design tools for
plant synthetic
biology;
applications
biological
organization
Manchester University
biofuels
toolkits and interoperability
standards parts
assembly
Sustainable fuels Nottingham University
and chemicals from
single carbon gases
Imperial
Platform Technologies
and Applications
DNA
Synthesis
Foundries
Synthetic Biology
Doctoral Training Centre
Open Plant
Cambridge, JIC
Edinburgh, Imperial, Liverpool,
TGAC-Norwich, MRC
DNA synthesis research,
assembly and analysis
Multicentre
synthetic biology
doctoral training
Design across scales
biological organization;
applications
SynBio at the heart of the
bioeconomy
Benefits
Other?
Delivery
Pharma
Translation
Diagnostics
& Health .
Smart
systems
Chemicals
SynBio
Innovation
Platform
Energy
Materials
AgriFood
Remediation
Integrated with
other Leadership
Councils
Synthetic Biology – 2016 UK Strategic Plan
mapping out routes to industrialisation and commercialisation
from innovative research base
Developing
Economic and
Social Value
Grand Challenges and Aspirations
Quick Wins
INDUSTRIALISATION
AND COMMERCIALISATION
Leading-edge
Accessible
infrastructure
Translation and
Delivery Focus
Skilled
Effective
Governance
Responsiveness
Entrepreneurial
mindset
Responsible
stewardship
Agility
Standards &
Metrology
Value-driven
Networked
and Partnered
Structured
Training
Design Tools
Supplying the
Pipeline with
Options
SUPPORTIVE
BUSINESS
ENVIRONMEN
T
EFFICIENT
ENTERPRISE
EFFECTIVE
TOOLKITS
Translating
Investing
Commercializing
EXPERT
WORKFORCE
HEALTHY RESEARCH BASE – INNOVATIVE OPTIONS
Coordination
Confidence
to invest
SBLC
UK Synthetic Biology
Leadership Council
Co-Chairmen:
George Freeman MP
Professor Lionel Clarke
+Governance sub-group
+Sci & Tech sub-group
+BIA SynBio Advisory Committee
Annual
Open
Meeting
Mar 2016: Approved by WHO for tackling Zika Virus
Thank You