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The aim of the project “Governing biomodification in the life sciences” (‘BioGOV’) was to assess the regulatory framework for three emerging ‘biomodifying’ technologies: gene editing, induced pluripotent stem cells and 3D bioprinting. Each is an emerging technology with significant scientific, economic and medical potential. The project utilised a combination of legal and regulatory analysis, and empirical social science to understand the formal regulatory frameworks and the incentives, concepts and institutional factors shaping the translation of these technologies from laboratory tools into new potential healthcare products and services. BioGOV was a collaboration between researchers at the Universities of Oxford, Sussex and York and ran from September 2018 to August 2022. The project was funded by the Leverhulme Trust through project grant RPG2017-330. The BioGOV end of project meeting took place online on 18 July 2022. The aim of the workshop was two-fold: i) to disseminate key findings from the BioGOV project and, ii) to explore new directions for research, especially with regards to the potential for citizen-centric governance of biomodifying technologies. The structure of this report echoes those core aims. Section 2 presents the background to the BioGOV project (2.1), summarises its core research goals (2.2), methods (2.3) and findings (2.4). Section 3 then reviews the end of project workshop itself, covering the purpose and scope of the meeting, reports the content of the two core presentations on the empirical (3.1) and legal/theoretical (3.2) ramifications of the project and the workshop discussions which followed each presentation. Section 4 concludes this report by summarising the range of directions identified for future research on responsible, and citizen-centred governance of technological innovation., Funded by the Leverhulme Trust (UK) under grant number RPG-2017-330

Biomodifying technologies—such as gene editing, induced pluripotent stem cells and bioprinting— are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified ‘natural’ material as a therapeutic ‘product’ by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders across the globe on the acceptable parameters for these technologies, particularly in the case of gene editing. \ud \ud Regulatory flexibility and stakeholder engagement are important, but a broader perspective is also needed to respond to the potential disruption of biomodification. Our case-study technologies problematize basic ideas — such as ‘nature,’ ‘product’ and ‘donation’— that underpin the legal categories used to regulate biotechnology. Where such foundational concepts are rendered uncertain, a socially responsive and sustainable solution would involve exploring evolutions in these concepts across different societies. We suggest that the global observatory model is a good starting point for this ‘Adaptive Societal Governance’ approach, in which a self-organising network of scholars and interested parties could carry out the multi-modal (meta)analyses needed to understand societal constructions of ideas inherent to our understanding of ‘life.’

Integrative drug safety research in translational health informatics has rapidly evolved and included data that are drawn in from many resources, combining diverse data that are either reused from (curated) repositories, or newly generated at source. Each resource is mandated by different sets of metadata rules that are imposed on the incoming data. Combination of the data cannot be readily achieved without interference of data stewardship and the top-down policy guidelines that supervise and inform the process for data combinationto aid meaningful interpretation and analysis of such data.The eTRANSAFE Consortium's effort to drive integrative drug safetyresearch at a large scale hereby present the lessons learnt and theproposal of solution at the guidelines in practice at this InnovativeMedicines Initiative (IMI) project. Recommendations in theseguidelines were compiled from feedback received from keystakeholders in regulatory agencies, EFPIA companies, and academicpartners. The research reproducibility guidelines presented in thisstudy lay the foundation for a comprehensive data sharing andknowledge management plans accounting for research datamanagement in the drug safety space - FAIR data sharing guidelines,and the model verification guidelines as generic deliverables that bestpractices that can be reused by other scientific community members at large.FAIR data sharing is a dynamic landscape that rapidly evolves withfast-paced technology advancements. The research reproducibility indrug safety guidelines introduced in this study provides a reusableframework that can be adopted by other research communities thataim to integrate public and private data in biomedical research space

Introduction Analysis of linked health data can generate important, even life-saving, insights into population health. Yet obstacles both legal and organisational in nature can impede this work. Approach We focus on three UK infrastructures set up to link and share data for research: the Administrative Data Research Network, NHS Digital, and the Secure Anonymised Information Linkage Databank. Bringing an interdisciplinary perspective, we identify key issues underpinning their challenges and successes in linking health data for research. Results We identify examples of uncertainty surrounding legal powers to share and link data, and around data protection obligations, as well as systemic delays and historic public backlash. These issues require updated official guidance on the relevant law, approaches to linkage which are planned for impact and ongoing utility, greater transparency between data providers and researchers, and engagement with the patient population which is both high-profile and carefully considered. Conclusions Health data linkage for research presents varied challenges, to which there can be no single solution. Our recommendations would require action from a number of data providers and regulators to be meaningfully advanced. This illustrates the scale and complexity of the challenge of health data linkage, in the UK and beyond: a challenge which our case studies suggest no single organisation can combat alone. Planned programmes of linkage are critical because they allow time for organisations to address these challenges without adversely affecting the feasibility of individual research projects

The development of in silico models for personalised medicine in the EU requires lawful and ethical data integration. The ultimate use of these models will also require the use of information in these automated systems in a fair and transparent way, which respects patients��� rights. This report therefore surveys the legal landscape for health data integration, and the challenges which arise when information is re-used to develop analytical or predictive models, which are then re-applied to a patient population. Particular attention is paid to the nature and role of consent in data integration and use within in silico models. Consent has a role within the Clinical Trials Regulation, the General Data Protection Regulation, and more broadly as authorising the use of private or confidential information. It also has key limitations, particularly when it cannot easily be revoked, or where it is not sufficient to allow significant decisions to be made in the context of automated processing.

The development of in silico models for personalised medicine in the EU requires lawful and ethical data integration. The ultimate use of these models will also require the use of information in these automated systems in a fair and transparent way, which respects patients’ rights. This report therefore surveys the legal landscape for health data integration, and the challenges which arise when information is re-used to develop analytical or predictive models, which are then re-applied to a patient population. Particular attention is paid to the nature and role of consent in data integration and use within in silico models. Consent has a role within the Clinical Trials Regulation, the General Data Protection Regulation, and more broadly as authorising the use of private or confidential information. It also has key limitations, particularly when it cannot easily be revoked, or where it is not sufficient to allow significant decisions to be made in the context of automated processing.

This report is the second deliverable of WP3 in the EU-STANDS4PM project. WP3 is responsible for providing guidance on the legal, ethical and policy considerations arising from data integration for in silico modelling for personalized medicine. In our first deliverable, we provided a legal and ethical analysis based on the data sources relevant for development of in silico models. The report included: 1. a survey of the international and European data protection and clinical trials regulation as well as legal and ethical regulation relevant for protection of equal access to health, and right to information and self-determination relevant for harmonization and integration of data in in silico modelling, and 2. an assessment of the challenges and opportunities this regulation provides for harmonization and integration of data for in silico modelling. The aim of this report is to explore solutions to the challenges identified in the first report and outline technically feasible as well as legally and ethically sustainable avenues for harmonization/integration of big data of relevance for personalized medicine into in silico modelling.

This report is the second deliverable of WP3 in the EU-STANDS4PM project. WP3 is responsible for providing guidance on the legal, ethical and policy considerations arising from data integration for in silico modelling for personalized medicine. In our first deliverable, we provided a legal and ethical analysis based on the data sources relevant for development of in silico models. The report included: 1. a survey of the international and European data protection and clinical trials regulation as well as legal and ethical regulation relevant for protection of equal access to health, and right to information and self-determination relevant for harmonization and integration of data in in silico modelling, and 2. an assessment of the challenges and opportunities this regulation provides for harmonization and integration of data for in silico modelling. The aim of this report is to explore solutions to the challenges identified in the first report and outline technically feasible as well as legally and ethically sustainable avenues for harmonization/integration of big data of relevance for personalized medicine into in silico modelling.

This is a report on a Patient Forum jointly hosted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the ESRC-funded Biomodifying technologies project. The Forum was hosted in January 2020. The report details the purpose of the forum, and reports on the topics of the forum: the potential clinical applications of 'biomodifying technologies' such as gene editing, 3D bioprinting and induced pluripotent stem cells, issues of risk and uncertainty, personalised or customised treatments, and long-term follow up care for patients treated with these novel medicines. The report also details the discussions with forum participants, who included independent patent representatives, representatives of patient organisations and charities, and members of different departments within the MHRA., Funding the for Biomodifying technologies project, of which this report is a part, was provided by the UK Economic and Social Research Council, through grant number ES/P002943/1. The Biomodifying technologies patient forum event was hosted and jointly organised by the UK Medicines and Healthcare products Regulatory Agency.