Michael Morrison

As regenerative medicine products scale up, researchers turn their attention beyond the ongoing technical challenges of collecting, preserving and delivering gene- and cell-based products to manufacturing and business operations, including process control, automation, supply chain and logistics, and the viability of business model alternatives. Assessing readiness for clinical use, however, requires an integrated assessment across all of these crucial components, including how well they fit together (or not), how synergies might enable platform opportunities and, critically, what kinds of infrastructures should be created to support a range of cell- and tissue-based products and services. Infrastructures reveal the way that futures are anticipated while shaping things in the present [1]. Yet large investments, including major changes to physical facilities, organizational structures and processes, can make it difficult to change things later [2]. There is much at stake, then, for institutional readiness in terms of having robust, yet adaptable, infrastructures. We suggest that analysis of the spatial and temporal aspects of infrastructure is a useful way to take a more integrated view across all manufacturing phases, participants and components of regenerative medicine when assessing institutional readiness. We use the concept of institutional readiness [3] as a way to frame the interrelation of material technologies, knowledge bases and social and economic factors affecting translation. We focus on the UK and use the term ‘advanced therapy medicinal products’ to encompass the variety of cell-, tissue- and gene-based therapies that involve altering biological characteristics. Although it is self-evident that there are specific spatial and temporal needs for different cell types and delivery models, we discuss major planning issues that all share.

Responsible Research and Innovation (‘RRI’) is a cross-cutting priority for scientific research in the European Union and beyond. This paper considers whether the way such research is organised and delivered lends itself to the aims of RRI. We focus particularly on international consortia, which have emerged as a common model to organise large-scale, multi-disciplinary research in contemporary biomedical science. Typically, these consortia operate through fixed-term contracts, and employ governance frameworks consisting of reasonably standard, modular components such as management committees, advisory boards, and data access committees, to co-ordinate the activities of partner institutions and align them with funding agency priorities. These have advantages for organisation and management of the research, but can actively inhibit researchers seeking to implement RRI activities. Conventional consortia governance structures pose specific problems for meaningful public and participant involvement, data sharing, transparency, and ‘legacy’ planning to deal with societal commitments that persist beyond the duration of the original project. In particular, the ‘upstream’ negotiation of contractual terms between funders and the institutions employing researchers can undermine the ability for those researchers to subsequently make decisions about data, or participant remuneration, or indeed what happens to consortia outputs after the project is finished, and can inhibit attempts to make project activities and goals responsive to input from ongoing dialogue with various stakeholders. Having explored these challenges, we make some recommendations for alternative consortia governance structures to better support RRI in future.