Societal challenges, responsible research and innovation, and synthetic biology

Transcription

1 Societal challenges, responsible research and innovation, and synthetic biology Philip Shapira 1,2,3 CMBNet Introduction to Industrial Biotechnology Short Course CPI, Wilton, UK November 15, Manchester Institute of Innovation Research, Manchester Business School, University of Manchester, UK 2. Manchester Synthetic Biology Research Centre for Fine and Speciality Chemicals (SYNBIOCHEM), Manchester Institute of Biotechnology, University of Manchester, UK 2. Georgia Institute of Technology, Atlanta, GA, USA

2 Societal challenges, responsible research and innovation, and synthetic biology 2 Overview 1. Synthetic biology drivers and context 2. UK policy framework for synthetic biology 3. Responsible research and innovation 4. Socio-economic challenges 5. Key questions to keep asking

3 1. Synthetic biology drivers and context SynBio: What is It? Underlying drivers? 3 Supply-side (technological) drivers * Synthetic biology involves redesigning biological components and systems found in the natural world or making new ones from scratch. DNA Sequencing: Decreasing cost Reading to Writing: Editing and designing genes/systems Emergence of engineering approaches to biology * Demand-side (market) drivers # Acknowledgements: * Rainer Breitling, Synbiochem, Manchester Institute of Biotechnology, University of Manchester ; # Richard Kitney, SynbiCITE, Imperial College. Sustainability: Manage natural resources; Reduced dependence on non-renewable resources; climate change mitigation Security: Food, water, energy Well-being: Predict/prevent disease; personalized health-care; employment

4 1.2 Synthetic Biology: Application targets, research and patenting Application targets Synthetic Biology Papers (to 2014) GS-SCI WoS-SCI Source: WoS, Gok & Shapira, 2015; Shapira & Youtie, (narrow def) Google Scholar & WoS, 2014 Synthetic Biology Patent Landscape (to 2014) Source: UK Synthetic Biology Roadmap, 2012 Synthetic Biology Market Expected to Reach $38.7 Million Globally by 2020 Allied Market Research (2014) Joule Biofuel Muufri

5 1.3 Synthetic Biology: Context 5 SYNTHETIC BIOLOGY: CONTEXT Late lessons from early warnings Science, public values, and trust: Post GMO world: Public trust and acceptability and how to understand and respond to public concerns about genetic and biological engineering Uncertainty about risk, returns and governance: What is synthetic biology? What are its risks? How should it be governed and regulated? Who gets to decide? Who gets to benefit? Utility of science: Is synthetic biology better (than other options) at sustainably addressing global challenges (society, economy, and environment)? And what is better?

6 2. UK policy framework for synthetic biology 2.1 Synthetic Biology: Policy Framework UK Refresh 2016 UK SYNTHETIC BIOLOGY ROADMAP (JULY 2012) 1. Invest in a network of multidisciplinary centers to establish an outstanding UK synthetic biology resource 2. Build a skilled, energized & well-funded UK-wide synthetic biology community 3. Invest to accelerate technology responsibly to market 4. Establish a leadership council (SBLC) 5. Assume a leading international role 6 Funding organizations Activities Roadmap to 2030 Trends & drivers Value chain Value creation Capability / technology Sources: UK Synthetic Biology Roadmap, 2012; A Boyce, BBSRC, 2013 Enablers

7 2.2 Synthetic Biology UK Context = US$310 million (BBSRC, EPSRC); FYI US = $810million ( ) W. Wilson, UK Synbio Landscape Strategy Synthetic Biology Strategic Importance ( Great Technology) Need to deliver results Engage public(s) Leadership Synthetic Biology Roadmap (2012) and refresh (2016) Synthetic Biology Leadership Council Research Innovation 6 UK Synthetic Biology Centres + 1 Knowledge and Innovation Centre embedded RRI GBP 200M +* University-Industry Partnerships InnovateUK SynbiCiti start-up support Bristol Cambridge Manchester Nottingham Warwick Edinburgh + Imperial

8 3. Responsible research and innovation RRI: What is it and Why? 8 EPSRC (UK) 2013 Framework for Responsible Innovation (RRI) RRI Concept Responsible Innovation is a process that seeks to promote creativity and opportunities for science and innovation that are socially desirable and undertaken in the public interest. Key elements - ANTICIPATE, REFLECT, ENGAGE AND ACT (AREA) Anticipate describing and analysing the impacts, intended or otherwise, (e.g. economic, social, environmental) that might arise. This does not seek to predict but rather to support an exploration of possible impacts and implications that may otherwise remain uncovered and little discussed. Reflect reflecting on the purposes of, motivations for and potential implications of the research, and the associated uncertainties, areas of ignorance, assumptions, framings, questions, dilemmas and social transformations these may bring. Engage opening up such visions, impacts and questioning to broader deliberation, dialogue, engagement and debate in an inclusive way. Act using these processes to influence the direction and trajectory of the research and innovation process itself. See:

9 3.2 RRI and Synthetic Biology Road Map 9 SYNTHETIC BIOLOGY ROAD MAP (2012) Five key questions that synthetic biologists should be willing and able to answer 1. what is the purpose? 2. why do you want to do it? 3. what are you going to gain from it? 4. what else is it going to do? 5. how do you know you are right? continuing responsible research and innovation: including the need for awareness, training and adherence to regulatory frameworks Synthetic Biology Road Map, Technology Strategy Board, 2012 [citing BBSRC/EPSRC (2010) Synthetic Biology Dialogue. Swindon, Biotechnology and Biological Sciences Research Council (BBSRC) and the Engineering and Physical Sciences Research Council (EPSRC)].

10 3.3 RRI: Broader Concept and Core Principles Responsible Research and Innovation: Broad Concept RRI = transparent interactive process involving societal actors and innovators to address the acceptability, sustainability and societal desirability of innovation processes and products [Adapted from von Schomberg 2011] Emergence beginning in Europe post-2000s, expanding post 2010s Core principles: Focusing research and innovation to social or environmental benefit. Involvement of society, from beginning to end of the innovation process, Assessing social, ethical and environmental impacts, risks and opportunities, both now and in the future, alongside the technical and commercial. Developing oversight mechanisms with the capability to anticipate and manage problems Openness and transparency integrated into the research and innovation process. [Adapted from Sutcliffe 2014]

11 3.4 SYNBIOCHEM: Embedded RRI Group MBS/MIOIR Innovation Research Sociology Responsible Research and Innovation [RRI] Undertakes research and analysis and facilitates collaboration and deliberation to support the centre to anticipate, prepare for, or mediate impacts of synthetic biology technologies in society, economy, and the environment. Interdisciplinary team social sciences, ethics and humanities, science & innovation policy, and sustainability Embedded in centre; Networked nationally and internationally Outputs: Research, models, practices, engagement, innovation & policy impact Shapira Randles Gok Balmer PDRAs Ribeiro Meckin PhD Liang Polson Belyakov Kadyrova Ext-Co-I Chan Industry Fellow Oldham

12 4. Socio-economic challenges Evolution, regimes, cycles and waves 12 Technological regime: Waves & cycles of technological innovation Long term technology and growth: Kondratiev Cycles (Source: MakingItMagazine.net) Cf also: Schumpeter Creative destruction (medium-term, drivers of change view)

13 4.2 Socio-economic Challenges - Complex Sociotechnical Regimes Multi-Actor Networks and Sociotechnical Regimes 13 Source: Geels, 2002

14 4.3 Socio-economic Challenges - Hype, promise, and realities 14 The promise and realities of emerging technologies Synthetic Biology? Demise Valley of Death Gartner Hype Cycle Firms Technologies See also: Double Boom Schmoch, 2007

15 4.4 Socio-economic challenges - failure 15 Why new ( disruptive ) technologies fail? Scale-up challenges (technical efficiency) Resources (money) Regulatory issues, standards Power of the incumbent technology Power of incumbent firms Lack of network economies Lack of market / societal / public acceptance

16 4.5 Socio-economic challenges new models 1 16 Open Innovation Closed innovation funnel

17 4.6 Socio-economic challenges Open approaches 17 Open source technology transfer Synthetic biology Technology, Education, Law, Community Standardize & share biological parts Parts Devices Systems Researchers (universities, industry), companies, students Open disclosure / open participation Public benefit corporation 501(c)(3) non-profit Founded 2006 Drew Endy & scientific / industrial colleagues NSF & foundation sponsorship Developing membership model Mechanisms Software sharing Conferences Standards for bio-parts BioBricks Public Agreement / alternative to conventional patenting Open materials transfer Users and Partnerships 20,000 users (OpenWetWare) 700 attendees 2016 conference Links with igem (5,000 participants) / Registry of Standard Biological Parts BIOFAB (BioBricks, UCB SynbioERC, LBNL, NSF) open parts fab and library

18 4.7 Socio-economic challenges new models 2 18 Discovery-Based Approaches Reis,

19 4.8 Socio-economic challenges new models 2 19 Embedding public values in lean startups Start-Up Components I-Corps Business Questions New: Public Values Questions Novel functionality Customers What is the technical specification that makes this application unique? What problem does this technology solve? How is this solution better than the status quo? Who will think this application is valuable or useful? How would you contact them? What societal problem does this technology solve? What types of potential customers would you likely overlook? Who might find this useful but might not be able to pay for it? Partners Value proposition Who might promote this new technology? Who would be a good partner for bringing this technology to market? What are the key activities that are required to deliver value to the customer? J Youtie & P Shapira, Exploring public values implications of the I-Corps program, J Technology Transfer, Who might oppose this technology? Who might lose their job if this technology is widely commercialized? Are there any potential environmental health, and safety risks from this application?

20 4.9 Socio-economic challenges new models 3 20 DIYbio Citizen bio-innovation Biohack Lab (Madlab) Manchester Woodrow Wilson Synbio Poject: ovement/ Code of ethics:

21 4.10 Socio-economic challenges new models 4 21 End-to-End Menthol Study: RESEARCH TO COMMERCIALIZATION Menthol flavor and fragrance Conventional production methods: natural, chemical Biological turn? Re-engineer mint plant DNA into E. coli to brew menthol Anticipation of issues Saleable? Sustainable? Equitable? Acceptable? Research approach Landscape of menthol production, research and innovation, economic and policy, implications of biological turn. Framing of responsibility in the laboratory and by companies How publics and NGOs feel about menthol sourced from genetically engineered bacteria. Creative methods of sketching, photography and object elicitation: how menthol figures in people s everyday lives and how this might be affected by a change in the source. Farmers earning high profit in mint growing, Daily Star (India) 4/21/13 U.Choudry A. Balmer A. Balmer

22 4.11 Socio-economic challenges public acceptance 22 SYNTHETIC BIOLOGY [Pauwels 2013] Perceptions of balance of risk and benefits Framing matters regenerative medicine cloning genetic engineering Applications matter Synbio fuels from bacteria v. engineering life Social & sustainability goals Concerns Unintended consequences Trust and transparency E. Pauwels, Public Understanding of Synthetic Biology, Bioscience, Public perspectives

23 4.12 Socio-economic challenges public acceptance 23 What the public wants to know about science and technology (Hilary Sutcliffe)

24 5. Key questions to keep asking 24 Key Issues 1 of 2 1. How will innovation occur in synthetic biology? What will be incremental? What might be disruptive? 2. What will be the roles of large firms and small firms in synthetic biology innovation? 3. What will be the markets for innovative synthetic biology applications? And how receptive are those markets? 4. How can we address ethical, safety, equity, and other concerns about synthetic biology innovation, and do so with transparency and trust?

25 5.2 Key questions to keep asking 25 Key Issues 2 of 2 5. How can attention to responsible innovation in synthetic biology be introduced early? What should scientists, companies, and others do? 6. When is precaution in synthetic biology innovation warranted? 7. What is the likelihood that synthetic biology innovations can be successfully implemented in the UK (Vs. other nations? Or with other nations?) 8. What public policies, relationships, and programmes need to be in place to ensure responsible innovation in synthetic biology?

26 Leadership in science, technology and innovation policy Manchester Institute of Innovation Research Alliance Manchester Business School University of Manchester, UK 英国曼彻斯特大学商学院创新研究中心 YEARS The Manchester Institute of Innovation Research is a centre of excellence for the economics, management and policy of innovation and science