Advanced therapies and the Brexit process: emerging geographies of legal responsibilities and market opportunities

This paper analyses how so-called Brexit, that is the United Kingdom’s departure from the European Union (EU), has modified the regional geography of Advanced Therapy Medicinal Products (ATMPs). The latter are therapies deriving from cell manipulation, gene editing, tissue engineering, or a combination of these techniques. Their development and delivery have been realised through research collaborations and commercial relations of international scope. In the EU, this has happened by means of a complex distribution of commercial activities and legal responsibilities. With Brexit, three main kinds of reconfigurations have occurred: the relocation of research and manufacturing activities; the reorganisation of quality control tests aimed to manage clinical risks; and the redistribution of legal responsibilities and representatives. This technical and legal reconfiguration is captured here by means of theoretical insights from the emerging domain of legal geography. Drawing on interviews conducted with both EU and UK professionals involved in ATMP development, this paper reveals the main challenges brought by Brexit to the current and future configuration of the ATMP landscape in the EU and the UK. Furthermore, it demonstrates how shifts in legal arrangements impact on science-intensive domains

Responsible innovation for digital identity systems

Digital identity (eID) systems are a crucial piece in the digital services ecosystem. They connect individuals to a variety of socioeconomic opportunities but can also reinforce power asymmetries between organizations and individuals. Data collection practices can negatively impact an individual’s right to privacy, autonomy, and self-determination. Protecting individual rights, however, may be at odds with imperatives of profit maximization or national security. The use of eID technologies is hence highly contested. Current approaches to governing eID systems have been unable to fully address the trade-offs between the opportunities and risks associated with these systems. The responsible innovation (RI) literature provides a set of principles to govern disruptive innovations, such as eID systems, toward societally desirable outcomes. This article uses RI principles to develop a framework to govern eID systems in a more inclusive, responsible, and user-centered manner. The proposed framework seeks to complement existing practices for eID system governance by bringing forth principles of deliberation and democratic engagement to build trust amongst stakeholders of the eID system and deliver shared socioeconomic benefits

The chronological and social implications of the pottery from Jebel Moya (south-central Sudan)

Continued research at Jebel Moya shows that this burial and habitation site has a very long chronology and was the locus for a number of activities. This study presents the first comprehensive analysis of pottery from stratified contexts from the new field seasons, utilizing a statistical attribute approach that provides both clarity and avenues for further research. The stratigraphic sequence and radiometric dates show that the site was inhabited from at least the late 6th millennium to 2000 years ago. Our analyses reveal previously unknown types of pottery and a wider range within assemblages. Overall, there is a longer period of mid-late Holocene habitation than previously recognised. Results are considered within a broader contextual and comparative approach with central Sudan, showing the importance of rethinking networks between south-central and central Sudan

Prehistory of Sudan

The Republic of Sudan, northeast Africa, is bordered by Egypt, Libya, Chad, the Central African Republic, South Sudan, Ethiopia, and Eritrea. To the east there is the Red Sea. With an area of 1,886,068 square kilometers, it is the third largest country in Africa. The country is marked by diversity in terms of environment, archaeology, and ways of living. The most well-known archaeological remains and periods are the pyramids from the Kingdom of Kerma (2500–1500 BC), the rise of the Kingdom of Kush (c. 785 BC–AD 350), the later Christian kingdoms of Nobatia, Makuria, and Alodia and the Funj Sultanate in central and eastern Sudan. Sudan’s complex history has seen Mahdi, Ottoman, British, and Islamist rule and is now a secular state. While the present population is estimated to be 70% Arab, there is a diverse range of groups, languages, and dialects

Point-of-Care Manufacture: Regulatory Opportunities and Challenges for Advanced Biotherapeutics

On 29 June 2021, UCL’s Future Targeted Healthcare Manufacturing Hub (FTHMH) held an online workshop to discuss the concepts and rationale of a new point-of-care (POC) manufacturing regulatory framework in development by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The proposal, which seeks to address the unique challenges of manufacturing healthcare products at, (or close to), the POC, is anticipated for publication and public consultation in summer 2021

Networked world: Risks and opportunities in the Internet of Things

The Internet of Things (IoT) – devices that are connected to the Internet and collect and use data to operate – is about to transform society. Everything from smart fridges and lightbulbs to remote sensors and cities will collect data that can be analysed and used to provide a wealth of bespoke products and services. The impacts will be huge - by 2020, some 25 billion devices will be connected to the Internet with some studies estimating this number will rise to 125 billion in 2030. These will include many things that have never been connected to the Internet before. Like all new technologies, IoT offers substantial new opportunities which must be considered in parallel with the new risks that come with it. To make sense of this new world, Lloyd’s worked with University College London’s (UCL) Department of Science, Technology, Engineering and Public Policy (STEaPP) and the PETRAS IoT Research Hub to publish this report. ‘Networked world’ analyses IoT’s opportunities, risks and regulatory landscape. It aims to help insurers understand potential exposures across marine, smart homes, water infrastructure and agriculture while highlighting the implications for insurance operations and product development. The report also helps risk managers assess how this technology could impact their businesses and consider how they can mitigate associated risks

IoT and Its Implications for Informed Consent

This report is based on a three-hour long workshop between representatives of the PETRAS IoT Hub, Pinsent Masons, and the HMG Department for Transport. The workshop is part of an ongoing investigation that explores the connections between some of the different dimensions likely to shape conceptions and applications of consent in the emerging Internet of Things (IoT). The impetus for the workshop was the recognition that two significant developments will challenge conventional approaches to online consent. From a technical perspective, the IoT will significantly increase personal data collection, use and re-use. From a regulatory perspective, the General Data Protection Regulation (GDPR) which comes into force in May 2018, will make much higher demands on practices of giving and obtaining consent. Combined, these two factors suggest that consent will be a major issue for all actors in the next five years and it requires some careful analysis now in order to adequately prepare for these developments

The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies

Point-of-care (POC) manufacture can be defined as the production of therapies in clinical settings or units close to hospitals and patients. This approach is becoming increasingly via- ble due to the emergence of flexible manufacturing technologies. Expecting an increase in this kind of production, the UK’s regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) is proposing a regulatory framework specifically designed for POC manufacture. To discuss the challenges of POC manufacture and the MHRA’s pro- posal, the EPSRC Future Targeted Healthcare Manufacturing Hub (FTHMH) organized a workshop drawing insights from specialists in cell and gene therapy manufacture. Through presentations and discussion roundtables, the workshop highlighted the challenges for the UK and other countries implementing POC manufacture. The workshop attendees stressed four main issues: quality control; standardization and equipment use; availability of qualified personnel; and the challenges to be met by hospitals participating in POC manufacture systems. This commentary provides a summary of the points discussed in this workshop