SummaryContinued improvement in the nation's health depends upon the efficient development of affordable replacement human tissue and related therapies; an acute shortage of willing organ donors and the shortcomings of conventional therapies leads to the preventable death of many patients each year. The next healthcare revolution will apply regenerative medicines, creating biological therapies or substitutes for the replacement or restoration of tissue function lost through failure or disease. However, whilst science has revealed the potential, and early products have shown the power of such therapies, there is now a need for the long term supply of people properly trained with the necessary skills to face the engineering and life science challenges before the predicted benefits in human healthcare can be realised. Because the products arising from this technology differ significantly from those made by mainstream pharmaceutical companies, training programmes currently available are poorly equipped to meet the demand for increasing numbers of appropriately trained personnel. We estimate that the number of engineers with the necessary skills to interact `on the same level' with cutting edge bioscientists and clinicians is very small, perhaps no more than 100 nationally; in such a small community 50 newly trained PhD's will have a very large impact. Here we propose a new UK based DTC in Regenerative Medicine integrated across three Universities with highly complementary expertise where students will be trained in the core skills needed to work at the life science/engineering interface and then engaged in strategic research programmes designed to address the major challenges in the field. This will ensure that the necessary people and enabling technologies are developed for the UK to lead in this rapidly growing worldwide marketplace.

Definition: A rapidly developing area at the interfaces of engineering/physical sciences, life sciences and medicine. Includes:- cell therapies (including stem cells), three dimensional cell/ matrix constructs, bioactive scaffolds, regenerative devices, in vitro tissue models for drug discovery and pre-clinical research.Social and economic needs include:Increased longevity of the ageing population with expectations of an active lifestyle and government requirements for a longer working life.Need to reduce healthcare costs, shorten hospital stays and achieve more rapid rehabilitationAn emergent disruptive industrial sector at the interface between pharmaceutical and medical devicesRequirement for relevant laboratory biological systems for screening and selection of drugs at theearly development stage, coupled with Reduction, Refinement, Replacement of in vivo testing. Translational barriers and industry needs: The tissue engineering/ regenerative medicine industry needs an increase in the number of trained multidisciplinary personnel to translate basic research, deliver new product developments, enhance manufacturing and processing capacity, to develop preclinical test methodologies and to develop standards and work within a dynamic regulatory environment. Evidence from N8 industry workshop on regenerative medicine.Academic needs: A rapidly emerging internationally competitive interdisciplinary area requiring new blood ---------------------

The broad theme of the research training addresses the most rapidly developing parts of the bio-centred pharmaceutical and healthcare biotech industry. It meets specific training needs defined by the industry-led bioProcessUK and the Association of British Pharmaceutical Industry. The Centre proposal aligns with the EPSRC Delivery Plan 2008/9 to 2010/11, which notes pharmaceuticals as one of the UK's most dynamic industries. The EPSRC Next-Generation Healthcare theme is to link appropriate engineering and physical science research to the work of healthcare partners for improved translation of research output into clinical products and services. We address this directly. The bio-centred pharmaceutical sector is composed of three parts which the Centre will address:- More selective small molecule drugs produced using biocatalysis integrated with chemistry;- Biopharmaceutical therapeutic proteins and vaccines;- Human cell-based therapies.In each case new bioprocessing challenges are now being posed by the use of extensive molecular engineering to enhance the clinical outcome and the training proposed addresses the new challenges. Though one of the UK's most research intensive industries, pharmaceuticals is under intense strain due to:- Increasing global competition from lower cost countries;- The greater difficulty of bringing through increasingly complex medicines, for many of which the process of production is more difficult; - Pressure by governments to reduce the price paid by easing entry of generic copies and reducing drug reimbursement levels. These developments demand constant innovation and the Industrial Doctorate Training Centre will address the intellectual development and rigorous training of those who will lead on bioprocessing aspects. The activity will be conducted alongside the EPSRC Innovative Manufacturing Research Centre for Bioprocessing which an international review concluded leads the world in its approach to an increasingly important area .