The lifETIME CDT will focus on the development of non-animal technologies (NATs) for use in drug development, toxicology and regenerative medicine. The industrial life sciences sector accounts for 22% of all business R&D spend and generates £64B turnover within the UK with growth expected at 10% pa over the next decade. Analysis from multiple sources [1,2] have highlighted the limitations imposed on the sector by skills shortages, particularly in the engineering and physical sciences area. Our success in attracting pay-in partners to invest in training of the skills to deliver next-generation drug development, toxicology and regenerative medicine (advanced therapeutic medicine product, ATMP) solutions in the form of NATs demonstrates UK need in this growth area. The CDT is timely as it is not just the science that needs to be developed, but the whole NAT ecosystem - science, manufacture, regulation, policy and communication. Thus, the CDT model of producing a connected community of skilled field leaders is required to facilitate UK economic growth in the sector. Our stakeholder partners and industry club have agreed to help us deliver the training needed to achieve our goals. Their willingness, again, demonstrates the need for our graduates in the sector. This CDT's training will address all aspects of priority area 7 - 'Engineering for the Bioeconomy'. Specifically, we will: (1) Deliver training that is developed in collaboration with and is relevant to industry. - We align to the needs of the sector by working with our industrial partners from the biomaterials, cell manufacture, contract research organisation and Pharma sectors. (2) Facilitate multidisciplinary engineering and physical sciences training to enable students to exploit the emerging opportunities. - We build in multidisciplinarity through our supervisor pool who have backgrounds ranging from bioengineering, cell engineering, on-chip technology, physics, electronic engineering, -omic technologies, life sciences, clinical sciences, regenerative medicine and manufacturing; the cohort community will share this multidisciplinarity. Each student will have a physical science, a biomedical science and a stakeholder supervisor, again reinforcing multidisciplinarity. (3) Address key challenges associated with medicines manufacturing. - We will address medicines manufacturing challenges through stakeholder involvement from Pharma and CROs active in drug screening including Astra Zeneca, Charles River Laboratories, Cyprotex, LGC, Nissan Chemical, Reprocell, Sygnature Discovery and Tianjin. (4) Embed creative approaches to product scale-up and process development. - We will embed these approaches through close working with partners including the Centre for Process Innovation, the Cell and Gene Therapy Catapult and industrial partners delivering NATs to the marketplace e.g. Cytochroma, InSphero and OxSyBio. (5) Ensure students develop an understanding of responsible research and innovation (RRI), data issues, health economics, regulatory issues, and user-engagement strategies. - To ensure students develop an understanding of RRI, data issues, economics, regulatory issues and user-engagement strategies we have developed our professional skills training with the Entrepreneur Business School to deliver economics and entrepreneurship, use of TERRAIN for RRI, links to NC3Rs, SNBTS and MHRA to help with regulation training and involvement of the stakeholder partners as a whole to help with user-engagement. The statistics produced by Pharma, UKRI and industry, along with our stakeholder willingness to engage with the CDT provides ample proof of need in the sector for highly skilled graduates. Our training has been tailored to deliver these graduates and build an inclusive, cohesive community with well-developed science, professional and RRI skills. [1] https://goo.gl/qNMTTD [2] https://goo.gl/J9u9eQ

Biological structure of proteins determines their functionality. It dictates how the proteins interact with other molecules, which is significantly important in medical diagnostics that use proteins to detect markers for disease or modern therapeutics where drugs will interact with proteins in the body. Determining the changes to a protein structure can be extremely useful in improving diagnostic capabilities by simplifying current chemical tests so that clinicians can get results faster and with added information about how the proteins interacted. This can improve their ability to diagnose patients and provide appropriate medication immediately. With the inexorable emergence of antimicrobial-resistant pathogens, this would be extremely useful to curtail excessive antibiotics. However, determining the structure of a protein requires detailed, tedious and expensive techniques such as x-ray crystallography. Optical spectroscopy techniques are not sensitive to the entire structure of a protein and all these methods require large sample quantities, eliminating their use for rapid routine diagnostics. I propose to develop and exploit a new class of label-free biostructure sensitive tests (assays) for diagnostics based on the novel phenomenon of chiral plasmonic sensing. This technique, discovered through EPSRC funded research, is capable of rapidly sensing conformational (structural) changes in a monolayer of biomolecules. The proposed "Chiral Plasmonic Assays" (CPAs) will enable applications such as detection of multiple pathogens and improve drug discovery techniques. These unique assays will use conformational changes to detect biophysical activity and provide insight into the behaviour of the molecular structure for rapid routine diagnostics. CPAs will be sensitive to picomole quantities of the target in clinical samples (blood serum, saliva) without complex flow systems, hence overcoming the limitations faced by current optical techniques such as surface plasmon resonance. CPAs will mitigate the need for multiple chemical steps that are required in popular chemical assays and require minute sample quantities without multiple reagents and problems like cross-reactivity. Using unique templated plasmonic devices pioneered in Glasgow, made using the same technology as Blu-ray discs, chiral plasmonic assays will be low-cost, high-throughput diagnostic kits. This innovation will use rapid imaging tools developed through funding from QUANTIC (EPSRC) with industrial partners HORIBA Scientific and cutting-edge customisable protein technology developed by industrial partner Avacta Life Sciences to achieve highly multiplexed diagnostics. In particular, this research will develop CPAs to detect diseases like sepsis, a leading cause for hospital deaths and invasive aspergillosis, a fungal infection that plagues cancer patient undergoing chemotherapy. This technology will penetrate into the label-free diagnostic market (>£1 billion by 2022) and in vitro diagnostics market worth over £40 billion, supporting UK's position as a leader in healthcare technology. This fellowship will enable myself to dedicate my time and provide resources to develop and prove this revolutionary new diagnostic platform that will fuel my entrepreneurial ambitions to change our current approach to biochemical diagnostics.