EGN Conference 2013 – Parallel Two: Governance of New Technologies

by Elisabeth Barlow, Innogen Communications and Policy Officer

#egn13

For new technologies, policy makers are facing demands to devise and adapt regulatory systems before there is evidence on the nature of future products and processes, potential markets, or the benefits and risks to different stakeholders. They are facing a major challenge in meeting these demands without unnecessarily inhibiting innovation. This session brought together some of the leading voices in this area to discuss methods for improving the success rate of delivering life science products and processes that are both societally useful and commercially viable.

Based on a perspective from patients and families with rare diseases, Alastair Kent (Genetic Alliance UK) kicked off the session with a clear account of what a new regulatory framework could look like. Traditional regulatory decisions have been based on the licensing of small molecules for the benefit of large populations, ultimately delivering blockbuster drugs to millions while not being overly beneficial to patients and families with rare diseases.

Therefore, a new framework for regulating is needed – one in which regulation follows biology, not one that tries to make biology obey the law. In order to bring about this framework, Alastair explained a series of steps are required, including: collapsing the phases; testing using real world data; using patients as a resource; and utilising social media to spread to word and gather data.

Innogen’s Scientific Advisor, Joyce Tait, followed with a discussion on upstream and downstream regulation, in particular the need to balance top-down regulation of products and processes with bottom-up engagement and dialogue with stakeholders while maintaining a democratically governable system.

As Joyce explained, there is a need for smart, adaptive governance of innovative technology with both upstream and downstream components, including: regulation that can be modified in line with changes in risk assessment; recognising regulation’s role in constraining and enabling innovation; balancing the risks and benefits to people and the environment; balancing the interests and values of ALL relevant stakeholders; and being explicit about political influences on policy decisions.

Moving on from Joyce’s discussion, Ed Godber (GlaxoSmithKline) took the session to a more economic level. As he explained, fundamental changes on the demand and supply side for life science innovation are leaving the current system of regulation and public sector investment exposed. Ultimately, the rules that applied well to the era of blockbuster drugs and now having a distortive effect, and we are paying a penalty for not having a more adaptive, localised and collaborative model of regulation.

As a result, cultural productivity is critical to the life science model, including: patient accountability beyond consumer health; personalised outcomes vs personalised medicine; rule transparency in regulation; and remission from flare-ups in industry ways.

Alessandro Rosiello (Innogen Edinburgh) continued in the economic vein and concluded with a consideration of the effect of various factors on drug development performance, including R&D funds allocation across therapeutic areas and the proportion of biological molecules in the drug development portfolio. Ultimately, the empirical data from these factors has shown that a correlation exists between performance variables and the per-capita growth of biopharmaceutical firms’ revenues – an analysis that will hopefully be widely applicable across sectors.

NeuroEthics Film Festival asks whether or not we are zombies

Blog by Dr. Calum MacKellar, Director of Research - Scottish Council on Human Bioethics

Do we have free will, or is our behaviour ultimately controlled by our biological brains? Does morality actually exist? Recent advances in our understanding of neurobiology have raised a number of ethical questions for human beings.

Using a number of films including the 1962 film entitled The Manchurian Candidate where Frank Sinatra plays the role of a man whose mind and free will may be controlled by others and the film Clockwork Orange, a neuroethics film festival was organised between the 23-25 November 2012 at the Edinburgh Filmhouse. The event was organise in partnership with: (1) the Scottish Council on Human Bioethics , (2) the Edinburgh Filmhouse, (3) The ESRC Genomics Policy and Research Forum and (4) the Mason Institute, Law School, The University of Edinburgh.

The film festival sought to address some of these questions in post-film discussions with the general public and a number of expert panellists. The issues included whether the responsibility of an individual actually exist? If it doesn¹t what are then the consequences for our legal systems and the manner in which human beings see themselves. Could they just be considered as biological robots or
zombies?

Participants were then able to engage with some of the issues raised by new discoveries in neurobiology and the ethical implications which result from them. One question that kept recurring in the debates was whether it is better to know the truth or to be happy. What would you choose?

IB3 at The Revolution will be Bio-Based

Blog by Paul Dalgarno, IB3 at Heriot Watt University

It was a great privilege for myself and my colleagues from the Institute of Biological Chemistry, Biophysics and Bioengineering (IB3) and the Centre for Marine Biodiversity and Biotechnology (CMBB) to take part in the ESRC “The Revolution will be Bio-Based” public exhibition on Saturday 10 November. As a research led institute our work at Heriot-Watt University is based on asking, and occasionally answering, fundamental questions on biology and marine conversation. However, this event allowed us, and the visitors, to explore some of the wider reaching aspects of our work and the impact it has had, or may have, on economics, culture and society in general.

The IB3 team are at the forefront of inter-disciplinary research in cell biology, using genes from fluorescent marine organisms, such as the luminescence sea anemone on display, to probe proteins inside living cells. By combining this state-of-the-art cell biology with input from physicists, mathematician and engineers we push the limits of cellular imaging and microscopy. Our exhibition demonstrated the huge impact that fluorescence proteins and gene technology has had on modern biological science, an impact that cannot be underestimated. It led to the 2008 Chemistry Nobel price and a global industry which is now at the heart of modern biological science. It was a pleasure to discuss with the public the underlying science, importance and the role fluorescence has had on our research and biological science in general.

Our exhibition, generously supported by the Medical Research Council (MRC), and Leica Microsytems, who provided a state-of-the art fluorescence microscope for public demonstration, was split into three sections. First researchers from CMBB had the living example of a naturally fluorescent sea anemone sourced from local Fife waters. Along with a touch tank of local marine life (starfish, crabs and shrimps) this display highlighted the importance of cold water marine conservation. The fluorescent microscope provided by Leica allowed members of the public to look at fluorescently labeled cancer cells, which proved to be very popular. Finally custom-made exhibits explained bio-fluorescence and the physics behind 3-dimensional imaging techniques being developed in IB3. Together these displays took members of the public from marine biology to optical physics in three short steps.

IB3 and CMBB regularly take part in public outreach activities, which are essential so that scientists can get out of the lab and explain what they do to the public, who in many cases fund this type of research. However this event offered much more than the typical demonstrations: by encouraging us to discuss with the public the role our research has had, or may have, economically and culturally. It was a true pleasure to engage with interested members from the public, from all backgrounds and ages. All the volunteers greatly enjoyed the experience but more importantly the public seemed to enjoy the day.

The event was a great success and we would like to thank the organizers, the visitors, the other exhibitors and the speakers for making this so and we look forward to seeing you at our next outreach event.

E. coli blues in Manchester

by Steph Wright - Genomics Forum Events Manager 

On Thursday 30^th August I took a wee trip down to Manchester to play with some E.coli, all in the name of events research. When I say ‘play’, I mean partake in some citizen biology, or DIY Bio for those in the know. It’s all the rage these days in the US and increasingly so round the rest of the world. The playground was Manchester’s MadLab’s new hackspace and the gamesmaker (topical I know) was their DIY Bio group led by Asa Calow, a computer scientist by day, an amateur biologist by night. The session was titled Self-cloning Bacteria (AKA genetic modification for beginners) and it basically involved genetically modifying E. coli and if successful, it would turn bits of the agar plate blue.

“What on earth is DIY Bio?” I hear you cry so let me tell you a bit about it. It’s a movement that originated in the US and it’s a form of citizen science i.e. science carried out by amateur scientists or in some cases, non-scientists. Do It Yourself Biology has been made possible by the reduction in costs of lab equipment in the last decade and its origins is very much in line with hacker culture  (not the malevolent hacker that the media has portrayed, but more the geeky finding-out- how-stuff-works-under-the-cover hacker). DIY Bio is about anyone and everyone practising biology outwith a professional laboratory whether it’s in a garage or hackspace (communal workshop space). Why would people do this? It could be for fun, as a hobby, for the pursuit of scientific knowledge or a chance for people to pursue biology outwith academic or professional institutions.  For more information about the movement, check out www.diybio.org

Never mind the biologists, here come the biopunks!

Blog by Morgan Meyer: Genomics Forum Bright Ideas Fellow

 A new, strange breed of people has come to life. They live in major European, US and Asian cities. They provoke dreams and fears, they talk science and politics. Their object of interest is life; and hacking and tinkering with biology is what they do. They come, in fact, in various guises and call themselves “biohackers”, “biopunks”, and “DIY biologists”.

Should we be afraid of them or not? Do they represent a danger or can they empower citizens? These are some of the most common questions asked when biohackers are being discussed.

But there are other questions we can ask, for example: who are these biohackers and biopunks and how many of them are there? Do they have a tangible influence on science, politics and society? Or, if it is too early or too difficult to answer such questions, we can still ask: which visions of science, technology and society do they promote? What do they want to change? Which new institutions, forums, places, activities, objects, do they want to create?

Questions like these are, I think, a way to avoid reducing the discussion about biopunks/hackers to common dichotomies: safety vs. danger, establishment vs. anti-establishment, experts vs. citizens, responsibility vs. anarchy, innovating vs. tinkering, closed vs. open. The danger is to assume that science is all the former, and biopunks/hackers all the latter. Science on the one side of the ring, punks on the other side of the ring.

The story is more complex. Both institutional science and DIY practices also co-evolve, influence, and probably even need one another. But we must dig even deeper than that. Around the notions of garage biology, DIY biology, and biohacking, new and rather open collectives of people, ideas and objects are currently materialising. We might be witnessing the emergence of “citizen biotech-economies” (Meyer, 2012).

In order to do biology in a garage at home or in a hackerspace, hackers and bricoleurs depend on a whole economy of objects, knowledge, networks, and people. They depend on other people, on scientific institutions (even if indirectly), they rely on the sharing of information, on the circulation of tools, on Internet platforms, on emails, on donations, etc. These economies are usually non-market economies: most information and innovations are accessible for free. And, while money is not the key driver for these economies, they give rise to, and provide channels for, new ‘styles’, identities, ethics, and values for doing science.

The infamous album Never Mind the Bollocks, Here’s the Sex Pistols (1977) can actually offer us some food for thought for reflecting about biohackers and biopunks. We could, on the one hand, have long debates about whether that album’s music is actually good or bad, whether its messages are outrageous or creative, disrespectful or liberating.

The fact is: whether we like it or not, Never Mind turned out to be a highly influential album, a milestone in punk and rock music. It changed music. Punks, nowadays, are a recognisable figure in terms of music, fashion, revolts, and anti-establishment attitude. Will biopunks bring about a similar cultural revolution in science and technology? Will biohackers change, and have a tangible influence on, scientific practice, scientific institutions, and technologies?

They might. Or maybe not: “hackers today prefer to be “Anonymous” and collective force, tricksters and jokers rather than typical revolutionaries, with an agenda intentionally left open” writes Denisa Kera (2012).

For those readers interested, and who will be at the 2012 Edinburgh Book Festival, an absolute must is the session that will be dedicated to do-it-yourself biology on August the 13th. Panellists are: Alessandro Delfanti from the University of Milan, who has done his PhD (Delfanti 2010) – and who is about to publish a book – on the subject; Jane Calvert, a researcher from the University of Edinburgh who is very active in examining the field of synthetic biology from a social science perspective; Ben Hammersley, editor of the magazine Wired UK; and Pippa Goldschmidt, a writer, who will chair the session.

References 

Delfanti, A. (2010) Genome Hackers, rebel biology, open source and science ethic, PhD thesis, University of Milan

 Kera, D. (2012) ‘Hackerspaces and DIYbio in Asia: Connecting Science and Community with Open Data, Kits and Protocols’ in Journal of Peer Production, Issue 2

 Meyer, M. (2012) ‘Build your own lab: Do-it-yourself biology and the rise of citizen biotech-economies’ in Journal of Peer Production, Issue 2

Useful links:
Genomics Forum Bright Ideas Fellowships
DIY-Bio: Empowerment or Anarchy?- Genomics Forum event at the Edinburgh International Book Festival

Darwin, Dawkins and the Left

By Ken MacLeod - Genomics Forum Writer in Residence

A few months ago Chris Williams, an OU history lecturer and political activist whom I've known for years online, asked me to give this year's Darwin Memorial Lecture to the Leicester Secular Society. I suggested the topic because, a couple of years earlier, I'd put together a stash of notes and links for a blog post that I'd never quite got around to writing.

The event, at the Society's splendid Victorian red-brick Secular Hall on 13 February 2011, drew a large and lively audience, from that cross-section of radical England that you so often find in its socialist, secularist and peace movements. Their searching and informed questions often had me thinking fast on my feet.

Here's the gist of what I said - a longer version will no doubt appear on my own blog.