Development and Clinical Implementation of Next-Generation CAR-T cell Manufacture Methodology

Chimeric Antigen Receptor (CAR) T-cell therapies for haematological malignancy have revolutionised the treatment of patients with relapsed/refractory B-cell cancers. The scope of these therapies in other haematological and even solid cancers holds much promise for the future. However, there are several major bottlenecks for delivery of these novel therapies: availability of academic clinical trials for CAR T-cell therapies is limited in the UK and in particular, the paucity of manufacturing slots means that the majority of potentially eligible patients cannot access these therapies. Streamlining the manufacturing process and pipeline to enhance manufacturing capability and scalability would begin to address this challenging issue. Secondly, a large proportion of patients referred for consideration of autologous CAR T-cell therapy are heavily pre-treated with chemotherapy and their T-cell populations for harvest are often numerically (and in some cases functionally) compromised. Referring patients early, prior to several lines of toxic chemotherapy would be optimal, but this is logistically challenging. Another approach would be to review apheresis practice and work to enhance T-cell collection at the front end. Lastly, these new therapies are associated with a constellation of unique potential side effects. The clinical delivery of bespoke gene-modified T-cell therapies in routine Haemato-Oncology Units requires a paradigm shift in medical, nursing, pharmacy and stem cell lab care pathways. This project undertakes to address these issues through the initiation and delivery of an academic study of autologous CD19 CAR T-cells for relapsed/refractory acute lymphoblastic leukaemia (B-ALL). This project will (1) investigate and establish a streamlined manufacturing platform for CAR T-cell manufacture for the UCL CAR T-cell programme; (2) explore the single-centre apheresis practice at UCLH to define a model/guideline for successful CAR T-cell apheresis and (3) to begin to establish the clinical infrastructure required to deliver these therapies ‘routinely’ at a large central London teaching hospital

An assessment of the Irish speciality food enterprises’ use of the internet as a marketing tool

End of Project ReportThis study set out to explore the role of the Internet as a marketing tool for Irish speciality food producers and to research on-line speciality food sales as a business opportunity. The project achieved this through a combination of consumer focus groups, a producer web audit, producer depth interviews and an e-mailed on-line producer survey. Irish consumers acknowledged potential for on-line sales of Irish speciality food products to export and gift markets; however they could not see significant advantages for on-line sales in the domestic market. Experience with the product (and consequent importance of the purchase experience), the high delivery cost of an already premium priced product and difficulties associated with receipt of deliveries were identified as the main reasons for not purchasing on-line

Improving Technology Transfer and Research Commercialisation in the Irish Food Innovation System

End of project reportThe process by which knowledge generated by publicly-funded research is transferred to industry – technology transfer – has been criticised as being inefficient and having limited success. This research project aimed to obtain a better understanding of the technology transfer process and thereby contribute to policy development and provide guidance for researchers to improve the process. Through a series of focus groups, surveys, case studies and depth interviews, the research identified five key challenges that exist in the context of the Irish food innovation system. These relate to communication, industry capabilities, research capabilities, strategic management and socialisation. To address these challenges, a selection of tools, illustrative case studies and recommendations for a range of stakeholders on how to deal with each of these challenges is provided on the project website (www.dit.ie/toolbox/)

Technology Transfer in the Irish Food Industry: Researcher Perspectives

The public R&D system represents an important part of the framework conditions for carrying out innovation activities and creating commercially applicable knowledge (Drejer and Jørgensen, 2004). It is an important source of information for companies, particularly those that are developing new products (Tijssen, 2004). However, Rubenstein (2003) stated that there has been a perception that public research capacity and results were not being optimally used and thus that potential economic benefits were not entirely realised. It is also suggested that research conducted in the public sector is not efficiently or successfully transferred to industry (Markman et al, 1999) and that it is necessary to understand and improve the means of technology transfer for society to reap the benefits of public science (Geuna and Nesta, 2003). Thus, there is a growing interest, and indeed pressure, among policymakers and academics to ensure informed spending of taxpayers’ money, that useful and relevant research is conducted that represents good “value for money” and that wealth is generated from publicly-funded research (Carr, 1992; Lyall et al., 2004; Mustar et al., 2006). To achieve this requires, amongst other things, the establishment of scientific and technical human capital which is the sum of researchers’ professional network ties and their technical skills and resources (Bozeman and Coreley, 2004). This paper examines the interactions engaged in by researchers from Irish public science providers (public research centres and higher education institutions), with a particular focus on researchers- industry interactions, as well as their skills and resources. To provide context, it firstly briefly outlines the actors involved in conducting publicly funded R&D in Ireland. It then describes the methodology and presents the results of a national survey of publicly funded food researchers focusing on the extent and nature of researcher interactions with other researchers and with industry, the barriers to and motivations for researcher-industry interaction and researcher skills regarding technology transfer. It concludes with a discussion and some policy recommendations.Agribusiness, Agricultural and Food Policy, Farm Management, Food Consumption/Nutrition/Food Safety, Industrial Organization,

Interactions in Ireland's Food Innovation System

This paper presents an analysis of the Irish food innovation system. The research was conducted as part of a larger project aimed at developing a research commercialisation toolbox to assist public research organisations and universities improve technology transfer and commercialisation of publicly funded food research. Ireland’s food innovation system (FIS) is discussed for the first time to identify key actors, agencies and knowledge flows that contribute to food innovation nationally. Following a section in which a FIS is defined, an overview of the food industry and its research activities are presented to provide context for the current research and the discussion that follows. The methodology adopted for this research is then outlined with identification and discussion of the key actors in the FIS the focus of the next section. The main findings of the research are then presented, followed by conclusions and an outline of future research to be conducted on the Irish FIS.Agribusiness, Research and Development/Tech Change/Emerging Technologies,

Knowledge Transfer in the Irish Food Innovation System: Industry and Researcher Perspectives

The new EU Animal Health Strategy suggests a shift in emphasis away from control towards prevention and surveillance activities for the management of threats to animal health. The optimal combination of these actions will differ among diseases and depend on largely unknown and uncertain costs and benefits. This paper reports an empirical investigation of this issue for the case of Avian Influenza. The results suggest that the optimal combination of actions will be dependent on the objective of the decision maker and that conflict exists between an optimal strategy which minimises costs to the government and one which maximises producer profits or minimises negative effects on human health. From the perspective of minimising the effects on human health, prevention appears preferable to cure but the case is less clear for other objectives.Knowledge transfer, technology transfer, Irish food sector, Research and Development/Tech Change/Emerging Technologies,

Food supply chain vulnerability: a review of emerging challenges and responses

Purpose: Increasing globalisation and pressures to reduce costs and improve efficiencies have increased food supply chain complexity. This has given rise to conditions that increase food firm vulnerability to both food fraud (for economic gain) and attack (for psychological or ideological reasons), (van Ruth, et al. 2017; Spink et al., 2017). Thus it is timely to review food defence initiatives across a number of countries to determine the feasibility of incorporating specific food defence measures in supply chain risk management systems. Design/methodology/approach: Due the emergent nature of the challenges associated with food defence grey as well as academic literature were reviewed. Based on an initial scan of the literature (academic, grey and open) specific search terms and keywords, key authors, key institutions (e.g. European Food Safety Authority (EFSA), FDA, WHO) and key publications were identified. Terminology used was also scanned across social media platforms (in particular Twitter). This informed the key words used in a systematic review of literature using the following databases Google Scholar, Science Direct, Web of Science, EBSCO (business complete) and Scopus and the searches were extended to non-peer reviewed publications. The “grey” literature included publications by companies involved in food safety training, industry magazines, white papers, publications of standards groups such as GFSI, SSAFE, GMA and the BRC, regulatory authorities and online blogs and websites. Findings: The development of food supply chain defence initiatives is at an early stage and represents an area of on-going activity and trial. A review of such initiatives identifies key strategies (deterrence; detection; control and countermeasures), increased and ongoing effort to develop rapid tests, and vulnerability assessment tools developed within a regulatory framework. This review points to the need for ongoing development of food supply chain actor capacity to use vulnerability tools and associated databases and to embed fraud/threat defences into their management processes. Value: A number of factors combine to increase the challenges posed by food fraud and attack in this decade. This study aims to contribute to emerging research by exploring the context, considering key characteristics of food fraud/attack and evaluating responses by companies and regulatory authorities, in the context of resilient supply chains. As such it may be of interest to researchers, policy makers and food supply chain actors. Research limitations/implications: This paper is limited to the review stage of a larger research project. Practical implications: In addition to providing an evidence base to underpin the development of a more food resilient food supply chains, this study aims to raise awareness and knowledge about the challenges posed by fraud/attack

GROWING UP IN IRELAND. COHORT ’08 (Infant Cohort). Report on the Pilot for Wave Five of the Cohort ’08 Survey (at 9 Years of Age)

This report summarises the experience of the pilot fieldwork with the Growing Up in Ireland Cohort ’08 (formerly the Infant Cohort) at 9 years of age. This wave represents the fifth survey for this cohort who were first interviewed at age 9 months – and subsequently surveyed at 3, 5 and 7/8 years. It is also the first time that the younger cohort has reached an age where there was also data collection for Cohort ’98 (formerly the Child Cohort). The report is intended to inform data-users of the role played by the pilot process in informing the final instrumentation and procedures for the main phase of data collection