Synthetic biology: A challenge for healthcare

Synthetic biology has the potential to drive significant advances in biomedicine. But there are myriad scientific, social, commercial and legal issues, which policymakers have set out to address.

In May 2010, a team of US scientists announced in the journal Science that they had used a man-made genome to engineer a new type of bacteria. The result, they said, was a revolutionary step forward in the hunt for everything from the likes of faster vaccine development to greener fuels. This man-made genome was designed on a computer, synthesised using chemicals and host organisms, and transplanted into a cell. The cell then self-replicated under the control of the synthetic genome.

Some experts have been quick to point out that the new bacteria was not strictly a fully synthetic cell, in that only the genomic structure was man-made. Still, the research director, Dr J Craig Venter, one of the leaders in producing the first draft of the human genome a decade ago, described the discovery as the first-ever synthetic cell.

According to Science Now online, the breakthrough is a milestone in synthetic biology with broad potential applicability in life sciences. Most immediately on the horizon are potential new diagnostics and drugs impacting healthcare. It reports that the same research team plans to build on their process to try to make a flu vaccine, though the research team warns that further manipulations might make the recipient cell reject the synthetic genome, which would send the team back to the drawing board.

The Venter case clearly reflects the complex issues which synthetic biology evokes, whether scientifically, ethically or morally, and how this new dynamic area touches on fundamental societal questions. As such, it is a critically important issue for policymakers to address.

In a nutshell, synthetic biology is a creative blend of science and engineering whose aim is to construct novel biological entities and redesign existing ones. It exemplifies the “systems approach” to biological sciences, with its extensive computational power and data analysis involving many teams the world over.

The potential for healthcare has been recognised for some time, from allowing a better understanding of complex diseases to speeding up the development of new vaccines. Synthetic biology opens the way for tailoring treatments to individual patients or groups of patients, and for monitoring how they respond to specific therapies. A number of health applications illustrate the potential synthetic biology offers.

In immunology, for instance, a team in Slovenia has designed a device that is capable of recognizing HIV activity and triggering an antiviral response to prevent further spread of the infection.

For cellular therapeutics, another US team has designed a biosensoring device able to recognise a drug when it is administered to a patient and then establish a circuit that instructs T cells (a type of immune system cell) to bind to, say, cancerous cells, and to act and proliferate. This circuit system principle could also be used, for example, to recognise a biomarker of a certain disease and release pertinent drugs when the marker is detected.

Given such potential, many policymakers are eager to encourage further work, and have been providing incentives and frameworks to help researchers. However, they are also determined to address the implications and risks.

Consider the ethical and moral issues, for instance, which vary from country to country. As with biotechnology, synthetic biology modifies genes to such a degree that some say it interferes with nature by attempting to create new forms of “artificial” life. Proponents of synthetic biology see it differently; even the Venter breakthrough, they argue, is not fully synthetic but essentially recreates an existing bacterial form.

Another policy issue is more concrete and concerns the risk of an accident or other incident causing synthetically-made bacteria to be released into the environment, posing a threat to public health. Scientists offer several reassurances, however. For instance, they point out that, even in laboratories, it is not easy to keep synthetic cells alive, so that an accidental release would probably kill them. Also, R&D teams now include multiple safeguards in synthetic cells, such as giving them strictly limited life spans or on/off switches, and engineering them to depend on laboratory-specific conditions. They also use unique identifying marks, so that they can be traced back to their “creators”.

Despite reassurances, political leaders need greater expertise if prudent policies are to be developed. Shortly after the Venter announcement, US President Barack Obama asked his bioethics commission to study the implications of the research, and other countries are also considering the implications for public policy for these scientific advances.

The OECD, which has been working on policy issues related to synthetic biology since 2009, supports such efforts. Though it wants to encourage the potential of the science, the OECD recognises the complex issues associated with this novel discipline. The organisation’s Working Party on Biotechnology is consulting with member governments as well as business and civil society groups, and bodies such as the Royal Society in the UK and the National Academies of Science in the US, to understand the potential medical, environmental, security and other benefits of synthetic biology, as well as any potential health and security risks.

Appropriate policy responses will only emerge from asking several broad questions: How can we decide which scientific and technological interventions to undertake for society? How do we govern the processes and outcomes of emerging sciences and technologies today? More precisely, given concerns about genetic manipulation and concerns about “synthesising” life, where do we draw the ethical, moral and practical limits?

Beyond these issues, there are questions about intellectual property rights, infrastructure investment and education to discuss, all at a global scale. The issues raised by synthetic biology are likely to be viewed differently and to attract different levels of attention across the international landscape. Significant benefits may well emerge from recent discoveries, but it is the public policy concerns across the world that will ultimately shape the future influence of synthetic biology on our lives.

For more information on OECD work in synthetic biology, please contact the Science and Technology Policy Division: Robert Wells at Robert.Wells@oecd.org or Marie-Ange Baucher at Marie-Ange.Baucher@oecd.org


References

OECD, Royal Society (2010), “Symposium on Opportunities and Challenges in the Emerging Field of Synthetic Biology – Synthesis Report”.

Visit www.oecd.org/sti/biotechnology/synbio

Pennisi, Elizabeth, and Mark Bedau (2010), Synthetic Biology Breakthrough: Your Questions Answered, in Science Magazine, May 2010: http://news.sciencemag.org/sciencenow/2010/05/synthetic-biology-answers.html

Paddock, Catharine (2010), “Synthetic Biology Breakthrough: Bacteria With Manmade Genome Self Replicates” in Medical News Today, www.medicalnewstoday.com/articles/189458.php

See also http://syntheticbiology.org/


©OECD Observer No 281, October 2010




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