Analysing responsible innovation along a value chain-A single-cell protein case study.

The British Standards Institution's Publicly Available Specification 440 (PAS 440) provides a Responsible Innovation Framework (RIF) that companies can use to continuously monitor the societal, environmental and health benefits and risks of their innovations, as well as relevant changes to the supply chain and regulations. PAS 440 is intended to help companies achieve the benefits of innovation in a timely manner and avoid any potential harm or unintended misuse of a new product, process or service. Here, the authors have applied the PAS 440 RIF to a novel single-cell protein (SCP) animal feed ingredient taking into consideration the perspectives of the value chain partners (VCPs), companies and laboratories involved in an Innovate UK research project. The authors' findings show how VCPs can use PAS440 to demonstrate that they are innovating responsibly. Using this approach to responsible innovation along the value chain-from manufacturing scale-up, through regulatory approval, to incorporation in animal feed and from there to food on supermarket shelves-can support the development of innovations that contribute to the economic and environmental sustainability of the animal feed sector. The authors conclude that the PAS 440 Guide can facilitate the progress of a new product throughout a value chain and contribute to coordinating responsible behaviour among companies involved in the value chain.

Responsible innovation: Its role in an era of technological and regulatory transformation.

In the development of innovative technology products, companies of all sizes are being encouraged to innovate responsibly and regulators are encouraged to adapt their regulatory systems to be smarter, more proportionate and adaptive to the needs of innovative technologies. The British Standards Institution Responsible Innovation (RI) Guide (Publicly Available Specification [PAS] 440) is an industry-wide standard relevant to both these policy trends. It supports companies by providing a framework to demonstrate the balance between the potential benefits and harms and, if necessary, to take action to maximise the benefits and/or minimise the harms. It includes guidance on engagement with stakeholders and will codify what stakeholders can expect from companies undertaking responsible innovation, paving the way to more harmonious relationships among stakeholders with differing interests and values. A cross-sectoral survey of innovative companies showed that 90% favoured the development of such a standard. PAS 440 was also trialled in two early-stage biotechnology companies and its expected benefits included contributing to coordinated responsible behaviour along a supply chain; better company and stakeholder understanding of the product properties; supporting decision-making on whether or not to start a company; considering the risks of not developing the product and avoiding reputational risks. Benefits were expected to be increasingly significant as the RI standard becomes widely adopted.

Evolution of Business Models in Regenerative Medicine: Effects of a Disruptive Innovation on the Innovation Ecosystem.

PURPOSE: This article focuses on 10 case studies of companies/organizations that are part of the current innovation ecosystem of regenerative medicine (RM) in the United Kingdom. It analyzes the actors, linkages, and influences that will determine the future shape of the RM industry sector and its capacity to live up to its initial expectations. METHODS: Using the case study approach, purposive sampling was used to get 18 interview respondents from 10 RM companies/organizations in the United Kingdom. We used semistructured interviews for data gathering and thematic analysis for identifying gaps in the RM value chain (ie, the range of activities required for bringing a product from conception to market and end-use) and the influences of the innovation ecosystem on the evolving RM business models. FINDINGS: RM promises to address currently unmet health care needs by restoring the normal form and function of cells, tissues, and organs. The innovations emerging to support the progress of RM to satisfy these important health care markets will disrupt the business models of incumbent industry sectors, particularly pharmaceuticals. Companies involved in this area must develop innovative business models and value chains and negotiate the complex influences of the innovation ecosystem, including regulatory systems and standards, financial support systems, and new market dynamics. IMPLICATIONS: This article highlights the needs for more systemic analyses of the needs of potentially disruptive innovations, in RM and more widely, and for policymakers to give greater attention to these insights in planning regulatory and other supporting initiatives, with the promotion of innovation in mind.

Horizon scanning implanted biosensors in personalising breast cancer management: First pilot study of breast cancer patients views.

AIMS: This study aimed to explore breast cancer patients' understanding and acceptability of implanted biosensors (BS) within the primary tumour to personalise adjuvant radiotherapy, and to determine optimal design and number of BS, and evaluate potential clinical benefits as well as concerns about tolerance, toxicity, dwell time, and confidentiality of data. PATIENTS AND METHODS: A total of 32 patients treated by surgery (29 breast conserving, 3 mastectomy), postoperative radiotherapy and systemic therapy for early breast cancer, were recruited from a posttreatment radiotherapy clinic at a cancer centre. Patients participated in semistructured interviews. Interview transcripts were analysed using qualitative methods. RESULTS: Participants were aged 39 to 87 years, with a median age of 62 years. Most (N = 23[72%]) were unfamiliar with biosensors. The majority (N = 29[90.6%]) were supportive of the technology's potential use in future breast cancer treatment and were willing to accept biosensors (N = 28[88%]) if they were endorsed by their breast cancer consultant. Only 3 patients expressed concerns, predominantly about uncertainties on their role in the diagnostic and treatment pathway. Patients were flexible about the size and shape of BS, but had a preference for small size (N = 28 [87.5%]). Most (N = 22[69%]) would accept implantation of more than 5 BS and were flexible (N = 22[69%]) about indefinite dwell time. Patients had a strong preference for wireless powering of the BS (N = 28[87.5%]). Few had concerns about loss of confidentiality of data collected. All patients considered biosensors to be potentially of important clinical benefit. CONCLUSIONS: While knowledge of biosensors was limited, patients were generally supportive of biosensors implanted within the primary tumour to collect data that might personalise and improve breast cancer radiotherapy in future.

A transatlantic perspective on 20 emerging issues in biological engineering.

Advances in biological engineering are likely to have substantial impacts on global society. To explore these potential impacts we ran a horizon scanning exercise to capture a range of perspectives on the opportunities and risks presented by biological engineering. We first identified 70 potential issues, and then used an iterative process to prioritise 20 issues that we considered to be emerging, to have potential global impact, and to be relatively unknown outside the field of biological engineering. The issues identified may be of interest to researchers, businesses and policy makers in sectors such as health, energy, agriculture and the environment.

Towards a more open debate about values in decision-making on agricultural biotechnology.

Regulatory decision-making over the use of products of new technology aims to be based on science-based risk assessment. In some jurisdictions, decision-making about the cultivation of genetically modified (GM) plants is blocked supposedly because of scientific uncertainty about risks to the environment. However, disagreement about the acceptability of risks is primarily a dispute over normative values, which is not resolvable through natural sciences. Natural sciences may improve the quality and relevance of the scientific information used to support environmental risk assessments and make scientific uncertainties explicit, but offer little to resolve differences about values. Decisions about cultivating GM plants will thus not necessarily be eased by performing more research to reduce scientific uncertainty in environmental risk assessments, but by clarifying the debate over values. We suggest several approaches to reveal values in decision-making: (1) clarifying policy objectives; (2) determining what constitutes environmental harm; (3) making explicit the factual and normative premises on which risk assessments are based; (4) better demarcating environmental risk assessment studies from ecological research; (5) weighing the potential for environmental benefits (i.e., opportunities) as well as the potential for environmental harms (i.e., risks); and (6) expanding participation in the risk governance of GM plants. Recognising and openly debating differences about values will not remove controversy about the cultivation of GM plants. However, by revealing what is truly in dispute, debates about values will clarify decision-making criteria.

Novel GM animal technologies and their governance.

Scientific advances in methods of producing genetically modified (GM) animals continue, yet few such animals have reached commercial production. Existing regulations designed for early techniques of genetic modification pose formidable barriers to commercial applications. Radically improved techniques for producing GM animals invite a re-examination of current regulatory regimes. We critically examine current GM animal regulations, with a particular focus on the European Union, through a framework that recognises the importance of interactions among regulatory regimes, innovation outcomes and industry sectors. The current focus on the regulation of risk is necessary but is unable to discriminate among applications and tends to close down broad areas of application rather than facilitate innovation and positive industry interactions. Furthermore, the fields of innovative animal biosciences appear to lack networks of organisations with co-ordinated future oriented actions. Such networks could drive coherent programmes of innovation towards particular visions and contribute actively to the development of regulatory systems for GM animals. The analysis presented makes the case for regulatory consideration of each animal bioscience related innovation on the basis of the nature of the product itself and not the process by which it was developed.

Analysing stratified medicine business models and value systems: innovation-regulation interactions.

Stratified medicine offers both opportunities and challenges to the conventional business models that drive pharmaceutical R&D. Given the increasingly unsustainable blockbuster model of drug development, due in part to maturing product pipelines, alongside increasing demands from regulators, healthcare providers and patients for higher standards of safety, efficacy and cost-effectiveness of new therapies, stratified medicine promises a range of benefits to pharmaceutical and diagnostic firms as well as healthcare providers and patients. However, the transition from 'blockbusters' to what might now be termed 'niche-busters' will require the adoption of new, innovative business models, the identification of different and perhaps novel types of value along the R&D pathway, and a smarter approach to regulation to facilitate innovation in this area. In this paper we apply the Innogen Centre's interdisciplinary ALSIS methodology, which we have developed for the analysis of life science innovation systems in contexts where the value creation process is lengthy, expensive and highly uncertain, to this emerging field of stratified medicine. In doing so, we consider the complex collaboration, timing, coordination and regulatory interactions that shape business models, value chains and value systems relevant to stratified medicine. More specifically, we explore in some depth two convergence models for co-development of a therapy and diagnostic before market authorisation, highlighting the regulatory requirements and policy initiatives within the broader value system environment that have a key role in determining the probable success and sustainability of these models.

From maturity to value-added innovation: lessons from the pharmaceutical and agro-biotechnology industries.

The pharmaceutical and agro-biotechnology industries have been confronted by dwindling product pipelines and rapid developments in life sciences, thus demanding a strategic rethink of conventional research and development. Despite offering both industries a solution to the pipeline problem, the life sciences have also brought complex regulatory challenges for firms. In this paper, we comment on the response of these industries to the life science trajectory, in the context of maturing conventional small-molecule product pipelines and routes to market. The challenges of managing transition from maturity to new high-value-added innovation models are addressed. Furthermore, we argue that regulation plays a crucial role in shaping the innovation systems of both industries, and as such, we suggest potentially useful changes to the current regulatory system.

The economy-wide impact of pandemic influenza on the UK: a computable general equilibrium modelling experiment.

OBJECTIVES: To estimate the potential economic impact of pandemic influenza, associated behavioural responses, school closures, and vaccination on the United Kingdom. DESIGN: A computable general equilibrium model of the UK economy was specified for various combinations of mortality and morbidity from pandemic influenza, vaccine efficacy, school closures, and prophylactic absenteeism using published data. SETTING: The 2004 UK economy (the most up to date available with suitable economic data). MAIN OUTCOME MEASURES: The economic impact of various scenarios with different pandemic severity, vaccination, school closure, and prophylactic absenteeism specified in terms of gross domestic product, output from different economic sectors, and equivalent variation. RESULTS: The costs related to illness alone ranged between 0.5% and 1.0% of gross domestic product ( pound8.4bn to pound16.8bn) for low fatality scenarios, 3.3% and 4.3% ( pound55.5bn to pound72.3bn) for high fatality scenarios, and larger still for an extreme pandemic. School closure increases the economic impact, particularly for mild pandemics. If widespread behavioural change takes place and there is large scale prophylactic absence from work, the economic impact would be notably increased with few health benefits. Vaccination with a pre-pandemic vaccine could save 0.13% to 2.3% of gross domestic product ( pound2.2bn to pound38.6bn); a single dose of a matched vaccine could save 0.3% to 4.3% ( pound5.0bn to pound72.3bn); and two doses of a matched vaccine could limit the overall economic impact to about 1% of gross domestic product for all disease scenarios. CONCLUSION: Balancing school closure against "business as usual" and obtaining sufficient stocks of effective vaccine are more important factors in determining the economic impact of an influenza pandemic than is the disease itself. Prophylactic absence from work in response to fear of infection can add considerably to the economic impact.