This research is concerned with how medical device designers can negotiate the twin requirements of developing both safe and innovative products. The focus is on the management of designers, and particularly how designers use the characteristics of their jobs (for example, their level of autonomy to make design decisions) in their day-to-day work. The research proposes to assess a number of variables which could influence the designers' perfomance, including facets of their working environment, for example their job characeristics and team context, aspects of their personality, and more dynamic personal influences such as levels of innovation, levels of safety-related cognitive error and important dynamic phenomena related to their job characteristicsAfter assessment of stable aspects of job characteristics and team contexts within which the designers work, at least 150 designers in 20 design teams will be tracked over the course of two working weeks, assessing the dynamic phenomena four times per day, every two hours. The results of the research will increase knowledge concerning how jobs can be configured in order to promote both safety and innovation, as well as having a practical impact in the area of the management of designers workload and working patterns.

A drug is a molecule that acts upon biological processes in the body. In contrast, a medicine is a complex product that comprises the drug and other ingredients packaged into a final dosage form that can be administered to a patient to ensure there is a beneficial therapeutic effect with minimum side-effects. To achieve therapeutic effect it is essential to ensure that the drug is delivered to the appropriate site in the body, at the right time, and in the correct amount. This is challenging: some drug molecules are poorly soluble in biological milieu, while others are either not stable or have toxic side-effects and require careful processing into medicines to ensure they remain biologically active and safe. The new drug molecules arising from drug discovery and biotechnology have particularly challenging properties. Pharmaceutical technologies are central to developing medicines from these molecules, to ensure patients are provided with safe and efficacious therapy. The design and development of new medicines is an inherently complex and cross-disciplinary process, and requires both innovative research and highly skilled, imaginative, researchers. To sustain and reinforce the UK's future global competitiveness, a new generation of highly-trained graduates educated at doctoral level is required to deliver transformative new therapeutics. Our CDT will train an empowered network of at least 60 PhD students through a consortium of multiple industry partners led by the University of Nottingham and University College London. The involvement of partners from start-ups to major international pharmaceutical companies will ensure that our students receive the cross-disciplinary scientific knowledge needed to develop future medicines, and build the leadership, resilience and entrepreneurial skills crucial to allow them to function effectively as future leaders and agents of change. Through partnering with industry we will ensure that the research work undertaken in the CDT is of direct relevance to contemporary and future challenges in medicines development. This will allow the CDT research to make significant contributions to the development of new therapies, leading ultimately to transformative medicines to treat patients. Beyond the research undertaken in the CDT, our graduates will build careers across the pharmaceutical and healthcare sector, and will in the future impact society through developing new medicines to improve the health and well-being of individuals across the world. We will train our students in four key science themes: (i) predictive pharmaceutical sciences; (ii) advanced product design; (iii) pharmaceutical process engineering; and, (iv) complex product characterisation. This will ensure our graduates are educated to approach challenges in preparing medicines from a range of therapeutic molecules, including emerging cutting-edge actives (e.g. CRISPR, or locked RNAs). These are currently at a critical stage of development, where research by scientists trained to doctoral level in the latest predictive and product design and development technologies is crucial to realise their clinical potential. Our students will obtain comprehensive training in all aspects of medicines design and development, including pharmaceutical engineering, which will ensure that they consider early the 'end game' of their research and understand how their work in the laboratory can be translated into products which can be manufactured and enter the clinic to treat patients.

The UK government's support for the Life Sciences Industry Strategy (Bell Report, 2017) recognises the importance of developing new medicines to facilitate UK economic growth. Examples include new antibody therapies for the treatment of cancer, new vaccines to control the spread of infectious diseases and the emergence of cell and gene therapies to cure previously untreatable conditions such as blindness and dementia. Bioprocessing skills underpin the safe, cost-effective and environmentally friendly manufacture of this next generation of complex biological products. They facilitate the rapid translation of life science discoveries into the new medicines that will benefit the patients that need them. Recent reports, however, highlight specific skills shortages that constrain the UK's capacity to capitalise on opportunities for wealth and job creation in these areas. They emphasise the need for 'more individuals trained in advanced manufacturing' and for individuals with bioprocessing skills who can address the 'challenges with scaling-up production using biological materials'. The UCL EPSRC CDT in Bioprocess Engineering Leadership has a successful track record of equipping graduate scientists and engineers with the bioprocessing skills needed by industry. It will deliver a 'whole bioprocess' training theme based around the core fermentation and downstream processing skills underpinning medicines manufacture. The programme is designed to accelerate graduates into doctoral research and to build a multidisciplinary research cohort; this will be enhanced through a partnership with the Synthesis and Solid State Pharmaceutical Centre (SSPC) and the National Institute for Bioprocess Research and Training (NIBRT) in Ireland. Research projects will be carried out in partnership with leading UK and international companies. The continued need for the CDT is evidenced by the fact that 96% of previous graduates have progressed to relevant bioindustry careers and many are now in senior leadership positions. The next generation of molecular or cellular medicines will be increasingly complex and hence difficult to characterise. This means they will be considerably more difficult to manufacture at large scale making it harder to ensure they are not only safe but also cost-effective. This proposal will enable the CDT to train future bioindustry leaders who possess the theoretical knowledge and practical and commercial skills necessary to manufacture this next generation of complex biological medicines. This will be achieved by aligning each researcher with internationally leading research teams and developing individual training and career development programmes. In this way the CDT will contribute to the future success of the UK's bioprocess-using industries.

Particulate products are made in industries including pharmaceuticals, agro-chemicals, dyes and pigments, food, detergents and formulation additives. It is well known that particle morphology is extremely important to products end-use properties e.g. dissolution rate and bio-availability of pharmaceuticals and processability e.g. flowability. In extreme cases, resulting in a company's loss of the license to make the drug product. However, optimisation and control in formulation and manufacture of the shape distribution of a particle population in a reactor has long been considered to be too challenging to achieve. Therefore, previous efforts have focused on optimising and controlling particle size distribution where the size of a particle is defined as the diameter of a sphere that has the same volume of the particle. This clearly misses important information of particle shape. The group led by Professor Xue Wang has been researching technologies for measurement (using in-process imaging), modeling, and optimisation and control of the shape distribution for a particle population. The research has led to two major breakthrough advance - the development of a multi-scale image analysis technique and a morphological population balance process model, which not only positioned the research in a world leading position, but also created a rare opportunity for commercialisation. A development project is close to be signed with GlaxoSmithKline focusing on analysing the SEM images of pharmaceutical particles with the aim of understanding and minimising batch to batch variation. Other industrial collaborators (AstraZeneca, Syngenta, National Nuclear Laboratory and Pfizer) have also expressed interest in such a commercialised product.In this EPSRC follow-on grant proposal we want to commercialise the technologies and tools developed through the EPSRC funded research. At the end of the 12 moths, we aim to develop a prototype tool that has unique features that no existing system can compete, and can be marketed to potential customers (including end-user customers i.e. particulate product manufacturers; instrument suppliers; research organisations), used to provide data analysis services to customers, and attract new investment for full commercialization and the spin-off company growth.

Large-Area Electronics is a branch of electronics in which functionality is distributed over large-areas, much bigger than the dimensions of a typical circuit board. Recently, it has become possible to manufacture electronic devices and circuits using a solution-based approach in which a "palette" of functional "inks" is printed on flexible webs to create the multi-layered patterns required to build up devices. This approach is very different from the fabrication and assembly of conventional silicon-based electronics and offers the benefits of lower-cost manufacturing plants that can operate with reduced waste and power consumption, producing electronic systems in high volume with new form factors and features. Examples of "printed devices" include new kinds of photovoltaics, lighting, displays, sensing systems and intelligent objects. We use the term "large-area electronics" (LAE) rather than "printable electronics" because many electronic systems require both conventional and printed electronics, benefitting from the high performance of the conventional and the ability of the printable to create functionality over large-areas cost-effectively. Great progress has been made over the last 20 years in producing new printable functional materials with suitable performance and stability in operation but despite this promise, the emerging industry has been slow to take-off, due in part to (i) manufacturing scale-up being significantly more challenging than expected and (ii) the current inability to produce complete multifunctional electronic systems as required in several early markets, such as brand enhancement and intelligent packaging. Our proposed Centre for Innovative Manufacturing in Large-Area Electronics will tackle these challenges to support the emergence of a vibrant UK manufacturing industry in the sector. Our vision has four key elements: - to address the technical challenges of low-cost manufacturing of multi-functional LAE systems - to develop a long-term research programme in advanced manufacturing processes aimed at ongoing reduction in manufacturing cost and improvement in system performance. - to support the scale-up of technologies and processes developed in and with the Centre by UK manufacturing industry - to promote the adoption of LAE technologies by the wider UK electronics manufacturing industry Our Centre for Innovative Manufacturing brings together 4 UK academic Centres of Excellence in LAE at the University of Cambridge (Cambridge Integrated Knowledge Centre, CIKC), Imperial College London (Centre for Plastic Electronics, CPE), Swansea University (Welsh Centre for Printing and Coating, WCPC) and the University of Manchester (Organic Materials Innovation Centre, OMIC) to create a truly representative national centre with world-class expertise in design, development, fabrication and characterisation of a wide range of devices, materials and processes.