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.

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.

An aerosol consists of solid particles or liquid droplets dispersed in a gas phase with sizes spanning from clusters of molecules (nanometres) to rain droplets (millimetres). Aerosol science is a term used to describe our understanding of the collective underlying physical science governing the properties and transformation of aerosols in a broad range of contexts, extending from drug delivery to the lungs to disease transmission, combustion and energy generation, materials processing, environmental science, and the delivery of agricultural and consumer products. Despite the commonality in the physical science core to all of these sectors, doctoral training in aerosol science has been focussed in specific contexts such as inhalation, the environment and materials. Representatives from these diverse sectors have reported that over 90% of their organisations experience difficulty in recruiting to research and technical roles requiring core expertise in aerosol science. Many of these will act as CDT partners and have co-created this bid. We will establish a CDT in Aerosol Science that, for the first time on a global stage, will provide foundational and comprehensive training for doctoral scientists in the core physical science. Not only will this bring coherence to training in aerosol science in the UK, but it will catalyse new collaborations between researchers in different disciplines. Inverting the existing training paradigm will ensure that practitioners of the future have the technical agility and confidence to move between different application contexts, leading to exciting and innovative approaches to address the technological, societal and health challenges in aerosol science. We will assemble a multidisciplinary team of supervisors from the Universities of Bristol, Bath, Cambridge, Hertfordshire, Imperial, Leeds and Manchester, with expertise spanning chemistry, physics, biological sciences, chemical and mechanical engineering, life and medical sciences, pharmacy and pharmacology, and earth and environmental sciences. Such breadth is crucial to provide the broad perspective on aerosol science central to developing researchers able to address the challenges that fall at the boundaries between these disciplines. We will engage with partners from across the industrial, governmental and public sectors, and with the Aerosol Society of the UK and Ireland, to deliver a legacy of training packages and an online training portal for future practitioners. With partners, we have defined the key research competencies in aerosol science necessary for their employees. Partners will provide support through skills-training placements, co-sponsored studentships, and contribution to taught elements. 5 cohorts of 16 doctoral students will follow a period of intensive training in the core concepts of aerosol science with training placements in complementary application areas and with partners. In subsequent years we will continue to build the activity of the cohort through summer schools, workshops and conferences hosted by the Aerosol Society, virtual training and enhanced training activities, and student-led initiatives. The students will acquire a perspective of aerosol science that stretches beyond the artificial boundaries of traditional disciplines, seeing the commonalities in core physical science. A cohort-based approach will provide a national focal point for training, acting as a catalyst to assemble a multi-disciplinary team with the breadth of research activity to provide opportunities for students to undertake research in complementary areas of aerosol science, and a mechanism for delivering the broad academic ingredients necessary for core training in aerosol science. A network of highly-skilled doctoral practitioners in aerosol science will result, capable of addressing the biggest problems and ethical dilemmas of our age, such as healthy ageing, sustainable and safe consumer products, and climate geoengineering.

Manufacture of nanometre particulate form products in suspensions is becoming increasingly important to the pharmaceutical, speciality chemical, and functional material industries. For instance, nano-processing is now used as an effective drug-delivery method for solid form hydrophobic pharmaceuticals due to the dramatically increased drug solubility and bioavailability at nano-scale. The biggest challenge to nano-processing under industrial conditions has been highlighted as the difficulty in achieving consistency in product quality as characterised by particle size distribution. The objective of this proposed research is to investigate on-line characterisation and process modelling techniques that can be applied under industrial operational conditions. The research on on-line sensing will focus on photon correlation spectroscopy and acoustic spectroscopy for real-time particle sizing. The work will tackle the key challenge posed by multiple scattering and particle-particle interactions, which are known to be the cause leading to incorrect measurement at high solid concentrations. High solid concentration is not only the economically viable range for commercial manufacture of nanoparticles (a much larger reactor would be required to process the same amount of particles in low concentration), but also technically essential for producing ultra-fine particles for many processes. The on-line real-time measurement will provide invaluable data to the development of process models using population balance equations. The focus will be on quantitatively deriving models for particle breakage and aggregation to be used in the population balance equations, as well as intelligent interpretation of the data to improve the qualitative understanding of the process. The process chosen for investigation is wet nano-milling, a very important operation for processing nanoparticles in the pharmaceutical, agrochemical and materials industries.