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The current animal-based food systems are being challenged by environmental, social and economic sustainability issues. A systemic transformation from conventional agriculture to a more sustainable cellular agriculture utilising cell-cultivation technologies to produce animal products has been proposed. The aim of this study is to explore the political and policy stakeholders’ perceptions about cellular agriculture; how they perceive of the current food system and its potential transformation into a cellular agricultural system. The qualitative data comprises 13 interviews conducted with representatives of German stakeholders. The data were analysed with the Transformative Innovation Policy approach. Perceptions of the transformative potential of cultured products were classified into drivers and bottlenecks that either advance or hinder the progress of cellular agriculture in Germany. The results show that the political and policy stakeholders are aware of the changes that are needed, but anticipate that large-scale transformation to the cellular agriculture system may not be a plausible solution in the near future.

The aim of cellular agriculture is to use cell-culturing technologies to produce alternatives to agricultural products. Cultured meat is an example of a cellular agriculture product, made by using tissue engineering methods. This study aims to improve the understanding of the potential environmental impacts of cultured meat production by comparing between different bioprocess design scenarios. This was done by carrying out a life cycle assessment (LCA) for a bioprocess system using hollow fiber bioreactors, and utilizing bench-scale experimental data for C2C12 cell proliferation, differentiation and media metabolism. Scenario and sensitivity analyses were used to test the impact of changes in the system design, data sources, and LCA methods on the results to support process design decision making. We compared alternative scenarios to a baseline of C2C12 cells cultured in hollow fiber bioreactors using media consisting of DMEM with serum, for a 16-day proliferation stage and 7-day differentiation stage. The baseline LCA used the average UK electricity mix as the energy source, and heat treatment for wastewater sterilization. The greatest reduction in environmental impacts were achieved with the scenarios using CHO cell metabolism instead of C2C12 cell metabolisim (64–67 % reduction); achieving 128 % cell biomass increase during differentiation instead of no increase (42–56 % reduction); using wind electricity instead of average UK electricity (6–39 % reduction); and adjusting the amino acid use based on experimental data (16–27 % reduction). The use of chemical wastewater treatment instead of heat treatment increased all environmental impacts, except energy demand, by 1–16 %. This study provides valuable insights for the cultured meat field to understand the effects of different process design scenarios on environmental impacts, and therefore provides a framework for deciding where to focus development efforts for improving the environmental performance of the production system.

Cultured meat is an emergent technology with the potential for significant environmental and animal welfare benefits. Accurate mimicry of traditional meat requires fat tissue; a key contributor to both the flavour and texture of meat. Here, we show that fibro-adipogenic progenitor cells (FAPs) are present in bovine muscle, and are transcriptionally and immunophenotypically distinct from satellite cells. These two cell types can be purified from a single muscle sample using a simple fluorescence-activated cell sorting (FACS) strategy. FAPs demonstrate high levels of adipogenic potential, as measured by gene expression changes and lipid accumulation, and can be proliferated for a large number of population doublings, demonstrating their suitability for a scalable cultured meat production process. Crucially, FAPs reach a mature level of adipogenic differentiation in three-dimensional, edible hydrogels. The resultant tissue accurately mimics traditional beef fat in terms of lipid profile and taste, and FAPs thus represent a promising candidate cell type for the production of cultured fat.

The development of nanotechnology-enabled health products offers innovative therapeutic and diagnostic opportunities to address medical needs. At the moment, no specific regulatory framework exists for such products since they can be covered by the existing frameworks for medicinal products and medical devices. However, these frameworks do require additional guidance to fully cover the particularities of nanotechnology-enabled products. After a detailed analysis of regulatory guidance documents, standards, and scientific publications originating mainly from Europe and the US, the European project “REFINE” has released a White Paper summarising the main needs in the field. The selection of the regulatory pathway, the identification of regulatory information needs, as well as the availability of standardised testing methods are among the identified regulatory challenges. Furthermore, additional guidance is needed on how the similarity of follow-on medicinal products can be demonstrated. Also, challenges related to the classification and assessment of nanotechnology-enabled medical devices are presented. The project consortium is now collecting feedback on the identified challenges through a dedicated survey and published comments on this manuscript. The resulting discussions within the scientific community should help to understand how essential knowledge, methods, tools, and approaches can be obtained with to advance the regulatory science in the area of nanotechnology-enabled health products.

With cultured meat now available for purchase in Singapore and more countries expected to follow soon, more and more research has explored the impact of particular individual factors and information provision. To this point, no research has looked explicitly at a counter-messaging approach, whereby problems of conventional meat production are leveraged to make the case for cultured meat. This study employs a 3x1 randomized experimental design with a sample of 302 British adults where participants are provided one of two differently focused counter-messages (animal welfare or environmental impact) or a control text. The study utilizes two repeated measures (before and after information provision) to examine the change in acceptance and investigate related informational effects. Though we find the focus of counter-messaging makes no difference, such an approach does generally promote consumer acceptance. Whereas acceptance of cultured meat is higher among men, younger consumers, and those who eat meat more often, change in acceptance is predicted by perceived consumer effectiveness and, marginally, lack of prior knowledge. By demonstrating the potential of a counter-messaging approach and offering a first examination of determinants of change in acceptance, this research should prove useful for researchers, policymakers, and proponents planning for the ongoing development and marketing of cultured meat.

In many ways debate about how best to legislate and regulate crowd-sourced equity funding grapples with concerns similar to those that existed at the time of the introduction of limited liability in the United Kingdom. How best can we balance the interests of investors and businesses seeking to raise funds? In Australia these policy deliberations are taking place within a broader debate as to how to formulate a regulatory framework supportive of innovation and entrepreneurship. This paper considers how these objectives might be achieved to the best advantage of small business and the economy. The immense potential of innovative businesses may turn on the effectiveness of such policy development and its place within the legal framework. This paper argues that the legal challenge is to recognise that the regulation of crowd-sourced equity funding is not a simple matter of accommodating new fundraising activities within an existing legal framework designed for big business. Rather, the law must re-conceptualise its approach to fundraising consistent with the broader policy ambition of supporting the businesses most likely to require access to non-traditional, innovative funding models such as crowd-sourced equity funding; namely innovative firms, entrepreneurial business, start-ups and other micro, small and medium enterprises which have emerged in recent times. Part 1 considers the regulatory challenges and policy underlying the introduction of crowd-sourced equity funding regulation. I propose that the challenges in supporting innovation and entrepreneurship include the shape and range of corporate forms available to enterprise. In Part 2 crowdfunding and fintech are explained. Part 3 outlines amendments to the Corporations Act 2001 (Cth) introducing crowd-sourced equity funding. Part 4 examines the extent to which the law has met its policy objectives. In part 5 the paper suggests that it is time to rethink the corporate form in Australia with a firm eye on the reality of the corporate landscape, and that any rethink of the nature and shape of corporate vehicles should include an understanding and acknowledgement of the long term economic benefits of the innovation agenda. The paper concludes in part 6.

Introduction The increasing complexities of conducting multiregional trials and an evolving regulatory environment contribute to unprecedented new challenges for use of patient-reported outcome measures (PROMs) 1 within clinical trials. This paper presents these challenges and potential solutions. Methods Real-world examples and situations are reviewed from an industry and patient-reported outcome (PRO) 2 expert position. Conclusions An increase in the pursuit of new therapeutic targets, changes to the regulatory environment, and business pressures to expand clinical trials to more countries have significantly increased the complexity of confirmatory clinical studies that incorporate PROMs. Decisions to participate in collaborative efforts for endpoint development or proceed independently are made in the context of competing priorities of drug development timelines, drug differentiation strategies, the need for patient-related value messages, and the depth of a sponsor pipeline within specific disease areas. Study logistics are critically important; factors such as concept cultural relevancy, respondent literacy level, and quality of cross-cultural adaptation of PROMs must be evaluated when integrating into confirmatory clinical trials. Awareness of the issues relating to PROs in multiregional studies will enable companies to better plan studies and interpret results.