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performance standards.
The successful functioning of designed biological systems is
already confirming the growing extent of our understanding.
The concept of a design–build–test cycle reflects the evidencebased
nature of the synthetic biology process. Improving
design capability reduces the number of iterations of the
cycle required to achieve a specific performance target, and
may therefore improve the efficiency and cost-effectiveness
of identifying potential solutions. Even when public or private
sector incentives are specifically applied to address a given
challenge, the benefits may not be realized unless sufficient
cost-effectiveness is achieved to underpin sustainable
commercial production. Improving the design and synthesis
processes not only facilitates the automation of novel system
development — it may also permit practitioners to focus
less attention on the mechanics of construction, and place
more attention on the robustness of the resulting system’s
performance.
Regulatory challenges
Synthetic biology has the capacity to deliver solutions where
conventional methods are ineffective, too expensive or simply
do not exist. In the near- to mid-term, such solutions are
expected to fall within the range of established channels to
market, each subject to its particular operational constraints
and prevailing regulatory standards. These standards are
regularly reviewed, and the considered expert view is that
such applications remain adequately addressed by current
regulations.
Nevertheless, because synthetic biology represents a leading
edge of current understanding, it is reasonable to anticipate
that further innovations will emerge over time that could
present regulatory challenges. To ensure that society benefits
from synthetic biology in a timely and affordable manner,
key stakeholders must continue to identify and address any
potentially new risks that could be associated with such future
innovations.
Every conceivable application will have its own particular
benefit/risk profile. To manage risk, it is important to maintain
a broad perspective across the whole opportunity space.
This requires balancing the assessed risks of an innovation
against the loss of opportunity associated with failing to move
forwards. Attempting to reduce potential risk by blocking
a particular activity may inadvertently block access to even
greater future benefits in related areas. In these respects, the
principles of risk management relating to synthetic biology are
no different from those that apply to other cutting-edge areas
of innovation.
Taking a long-term view of the future provides a structured
opportunity to anticipate risks and associated issues, and also
gives more time to reflect upon and address them. The UK
Synthetic Biology Roadmap 2 has paid considerable attention
to mapping out a multi-decade vision of the future, raising
awareness of the underlying directions, values and envisaged
timelines. In addition to the ongoing process of review by
regulatory bodies, numerous other checks and balances have
been put in place. The Synthetic Biology Public Dialogue 4 , for
example, provided an opportunity to engage a wide range
of stakeholders outside the scientific community, identifying
concerns and viewpoints that have helped to shape current
responses. As potential applications emerge, wider societal
conversations may be required. Such conversations should
not only be about potential risks but also about desirable
trajectories and priorities, set against alternative solutions to
given challenges. These conversations need to take place well
before specific regulatory consultations.
From bench to marketplace
From the perspective of industrialists and investors, the
presence of effective (but not excessively bureaucratic)
mechanisms for managing risk in the marketplace — ranging
from clear regulatory frameworks to best practice guidelines
and standards — can be highly welcome, because they
provide a reliable basis for overall risk assessment and
strategic investment decisions. Industrial interest covers a
broad spectrum of organizational structures, ranging from
specialist start-ups to broad-based multi-nationals. For the
larger established companies, successful product lines and
services, and satisfied customers, provide the benchmark.
Commercial choices will be based not only on confidence in
technical delivery, strategic fit and reputational impact, but
also on current and anticipated marketplace needs and values.
Synthetic biology is increasingly forming the core of specialist
start-ups, which may help deliver toolkit advances or address
very specific challenges. At present, the United States has well
over 100 such companies, with the United Kingdom hosting
almost 50. Such a broad-based community of practitioners
helps to ensure that a wide spectrum of practical experience is
becoming available to inform ongoing discussions.
The potential of synthetic biology also attracts many
students, and the field is benefitting from their enthusiastic
engagement, innovative capacity and critical judgment. A prime
example of this is the International Genetically Engineered
Machine (iGEM) competition 5 . Over the past decade, many
hundreds of student iGEM teams from the world’s top
universities have taken part in this annual competition,
discovering how synthetic biology can generate a wide range
of potentially beneficial applications. In many cases, iGEM
projects have led to more detailed professional research
projects, and even to the formation of start-up companies.
Examples of such projects include a cost-effective arsenic
sensor to verify the safety of drinking water, and a system
that can address a challenging health issue such as gluten
intolerance.
Synthetic biology is inherently multi-disciplinary, stimulating
constructive challenges and the sharing of best practice. This
reinforces a culture of ‘responsible research and innovation’ 2 ,
which helps practitioners to consider the potential implications
and impacts of their work beyond its immediate focus.
Proactive approaches such as these must be encouraged,
because effective risk management is key to instilling
confidence both in potential investors, and in society as a
whole. After all, it is society that stands to benefit not only
from the products and services delivered by synthetic biology,
but also from the jobs and economic growth arising from
successful commercial operations.
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