Regenerative medicine (RM) is a convergence of conventional pharmaceutical sciences, medical devices and surgical intervention employing novel cell and biomaterial based therapies. RM products replace or regenerate damaged or defective tissues such as skin, bone, and even more complex organs, to restore or establish normal function. They can also be used to improve drug testing and disease modelling. RM is an emerging industry with a unique opportunity to contribute to the health and wealth of the UK. It is a high value science-based manufacturing industry whose products will reduce the economic and social impact of an aging population and increasing chronic disease.The clinical and product opportunities for RM have become clear and a broad portfolio of products have now entered the translational pipeline from the science bench to commercialisation and clinical application. The primary current focus for firms introducing these products is first in man studies; however, success at this stage is followed by a requirement for a rapid expansion of delivery capability - the 'one-to-many' translation process. This demands increasing attention to regulatory pathways, product reimbursement and refinement of the business model, a point emphasised by recent regulatory decisions demanding more clarity in the criteria that define product performance, and regulator initiatives to improve control of manufacturing quality. The IMRC will reduce the attrition of businesses at this critical point in product development through an industry facing portfolio of business driven research activities focussed on these translational challenges. The IMRC will consist of a platform activity and two related research themes. The platform activity will incorporate studies designed to influence public policy, regulation and the value system; to explore highly speculative and high value ideas (particularly clinically driven studies); and manufacturing-led feasibility and pilot studies using state of the art production platforms and control. The research themes will focus on areas identified as particular bottlenecks in RM product translation. The first theme will explore the delivery, manufacturing and supply processes i.e. the end to end production of an RM product. Specifically this theme will explore using novel pharmaceutical technology to control the packaged environment of a living RM product during shipping, and the design of a modular solution for manufacturing different cell based therapies to the required quality in a clinical setting. The second research theme will apply quality by design methods to characterise the quality of highly complex RM products incorporating cells and carrier materials. In particular it will consider optical methods for non-invasive process and product quality control and physicochemical methods for process monitoring.The IMRC will be proactively managed under the direction of a Board and Liaison Group consisting of leading industrialists to ensure that the Centre delivers maximum value to the requirements of the business model and assisting the growth of this emerging industry.

The Synthetic Biology CDT (SBCDT) will focus on the design and engineering of biologically based parts, novel devices and systems as well as the re-design of existing, natural biological systems across all scales from molecules to organisms. Its distinguishing feature will be breadth and depth: the SBCDT will build on the multi-disciplinary expertise offered by the research environment at the Universities of Oxford, Bristol and Warwick to provide training that covers all parts of this extremely broad remit, including not only individual cells but self-assembled biomimetic systems, engineered microbial communities and multicellular organisms, combining the multiple perspectives of engineering and the life and physical sciences. We believe that such coverage is vital in the emerging area of Synthetic Biology; but, equally, this is only currently possible through a collaborative effort across institutions such as ours. In close partnership with our industrial and other partners, with whom we have developed this bid, we will address the recommendation of the recently published Synthetic Biology Roadmap for a "skilled, energized and well-funded UK-wide Synthetic Biology community", which has "the opportunity to revolutionise major industries in bio-energy and bio-technology in the UK" (David Willetts, Minister for Universities and Science). The SBCDT will provide five annual 15-student strong cohorts with high-quality and highly practical training in Synthetic Biology that will fill this skills gap and deliver the next generation of internationally excellent researchers and industrial leaders. The training will be based on a varied and innovative programme that will range from classes and seminars to student-led group projects and exploratory and PhD research projects at the forefront of the development of Synthetic Biology. Ethical, Legal and Social considerations, public engagement, and the needs of industrial, academic and potential end users of Synthetic Biology will be integrated into the training programme from the start. We will engender within the cohort a sophisticated, multi-faceted appreciation of the opportunities and potential hazards of Synthetic Biology that is essential to Responsible Innovation. Training will be delivered by a team of world-leading researchers which, like the student intake, will be highly multidisciplinary. We will ensure that the SBCDT takes full advantage of the opportunities provided by the three Universities and will act as a catalyst for inter-university research initiatives underpinned by the unifying influence of a cohesive cohort of students. This will ensure development of Synthetic Biology across the UK and that the UK strengthens its global competitiveness in this very promising field.