EPSRC Centre for Innovative Manufacturing in Regenerative Medicine
Lead Research Organisation:
Loughborough University
Department Name: Sch of Mechanical and Manufacturing Eng
Abstract
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.
Planned Impact
The impact of the research will be in three key areas: improved public health, improved business and national economic performance, and better informed public policy. Public health will be improved through the IMRC's facilitation of new therapies for unmet clinical needs. The focus of RM on chronic diseases and aging related conditions mean that these innovations will affect the population with highest levels of morbidity and therefore have maximum impact on population health. The research will have many levels of economic impact through supporting the growth of a high value industry. Key industrial collaborations will assist UK located large companies and SME's in understanding of the commercial value of their therapies and other enabling technology products, product development, and in developing cost effective manufacturing approaches. Realisation of more products in a shorter timescale will directly support both national and global economic growth but also ultimately contribute to improved public finances through reducing the escalating long term costs associated with aging and chronic disease. The establishment of a UK based centre of enabling technology in RM translation will assist in attracting inward investment to the UK from product developers who are suffering from a global skill deficit. It will create skilled employment opportunities and boost product, technology and knowledge based exports. Policy forming and regulatory bodies will benefit from our industrially informed influencing studies and focus groups. Public policy will be influenced by the preparation and dissemination of evidence documents to key stakeholders and by active participation by IMRC partners in key national and international fora and networks. The NHS are well represented in the IMRC and this involvement will be critical in any UK led clinical adoption of advanced RM therapies. The IMRC approach directly complements the public regulators' mission to drive quality and safety into product development. The clear economic, health and policy impacts will only be realised if the IMRC transforms the product development and manufacturing status of the RM industry. We are in a unique position to achieve this through the internationally competitive lead established by the remedi Grand Challenge and our extensive commercial sector engagement with a track record of focussing academic teams on solving real problems presented through our industrial collaborators. This momentum will ensure early impact from the IMRC. The Liaison Group and Board will ensure continued impact by representing the voice of industrial stakeholders and guiding the research, as well as providing a direct route back to industrial application. The timing of the impact will be three phased. The technological impact to improve product development and manufacturing process will be rapid as the IMRC builds on the momentum and work established with partners under the remedi Grand Challenge. The economic benefit will build over the first few years as technological and methodological development enable industrial partners to meet milestones, reduce risk and therefore attract investment. Health benefits and the additional associated economic benefits of lower morbidity have longer term impact due to regulatory approval and clinical adoption times. We anticipate the IMRC's activities will have visible impact in this area within a decade through traceable contributions to key product successes in this emerging industry.
Organisations
- Loughborough University (Lead Research Organisation)
- SRG (Collaboration)
- Puridify (Collaboration)
- LOUGHBOROUGH UNIVERSITY (Collaboration)
- Fondazione Filarete (Collaboration)
- SynbiCITE (Collaboration)
- UNIVERSITY OF BIRMINGHAM (Collaboration)
- University of Pittsburgh (Collaboration)
- Terumo BCT (Collaboration)
- Newcastle University (Collaboration)
- Tissue Growth Technologies (Collaboration)
- JRI Orthapaedics (Collaboration)
- UNIVERSITY OF CAMBRIDGE (Collaboration)
- Cool Logistics (Collaboration)
- Syngenta International AG (Collaboration)
- UNIVERSITY OF GLASGOW (Collaboration)
- TAP Biosystems (Collaboration)
- Unilever (Netherlands) (Collaboration)
- Smith and Nephew (Collaboration)
- Anthony Nolan Cell Therapy Centre (Collaboration)
- LGC Ltd (Collaboration)
- British Mass Spectrometry Society (Collaboration)
- UNIVERSITY OF LEEDS (Collaboration)
- UNIVERSITY OF LIVERPOOL (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- Synthace (Collaboration)
- INNOVATE UK (Collaboration)
- Ruskinn Technology Ltd (Collaboration)
- World Courier (Collaboration)
- UNIVERSITY OF LEICESTER (Collaboration)
- Athersys Inc. (Collaboration)
- Roslin Cells Ltd (Collaboration)
- Nanotherics Ltd (Collaboration)
- NHS National Services Scotland (NSS) (Collaboration)
- Lucideon (Collaboration)
- Future Health Technologies (Collaboration)
- Waters Corporation (Collaboration)
- University of Bath (Collaboration)
- MCR Media Group (Collaboration)
- Lonza Group (Collaboration)
- PA Consulting (Collaboration)
- Dana-Farber Cancer Institute (Collaboration)
- HARVARD UNIVERSITY (Collaboration)
- National Institute of Health and Medical Research (INSERM) (Collaboration)
- Synpromics (Collaboration)
- Bose Corporation (Collaboration)
- Ludwig Boltzmann Institute for Experimental and Clinical Traumatology (Collaboration)
- Mica Biosystems (Collaboration)
- Reneuron (Collaboration)
- Regentec (Collaboration)
- The Orthopaedic Institute (Collaboration)
- Cell Therapy Catapult (Collaboration)
- Asymptote (Collaboration)
- National Physical Laboratory (Collaboration)
- Grimsby Institute of Further and Higher Education (Collaboration)
- Pfizer Ltd (Collaboration)
- Department for Business, Energy & Industrial Strategy (Collaboration)
- University College London (Collaboration)
- Oswestry Hospital (Collaboration)
- Moorfields Eye Hospital NHS Foundation Trust (Collaboration)
- WiCell (Collaboration)
- Haemostatix (Collaboration)
- Intercytex (Collaboration)
- Nottingham University Hospitals NHS Trust (Collaboration)
- BioIndustry Association (Project Partner)
- Future Health Biobank (Project Partner)
- East Midlands Strategic Health Authority (Project Partner)
- Smith & Nephew (United Kingdom) (Project Partner)
- Wake Forest University (Project Partner)
- Smith & Nephew Group Research (Project Partner)
- McGowan Institute for Regenerative Medicine (Project Partner)
- Medilink East Midlands (Project Partner)
- bioProcessUK KTN (Project Partner)
- Pfizer (United Kingdom) (Project Partner)
- Locate Bio (United Kingdom) (Project Partner)
- National Physical Laboratory (Project Partner)
- Cell Medica (United Kingdom) (Project Partner)
- Sartorius (United Kingdom) (Project Partner)
- MedCell (Project Partner)
- Inst for Surface and Boundary Layers (Project Partner)
- Lonza (United Kingdom) (Project Partner)
- Association of British HealthTech Industries (Project Partner)
- Takeda (United Kingdom) (Project Partner)
- Medicines & Healthcare pdts Reg Acy MHRA (Project Partner)
- Critical Pharmaceuticals (United Kingdom) (Project Partner)
- EMD Group (United States) (Project Partner)
- EpiStem Ltd (Project Partner)
- National Institute for Biological Standards and Control (Project Partner)
- Intercytex (United Kingdom) (Project Partner)
- NHS Innovations East Midlands (Project Partner)
- Unilever - SEAC (Project Partner)
- East Midlands Development Agency (Project Partner)
- RepRegen Ltd (Project Partner)
- National Health Service (Project Partner)
- CSO Pfizer Regenerative Medicine (Project Partner)
- University Hospitals of Leicester NHS Trust (Project Partner)
- British Standards Institution (Project Partner)
Publications
Hu B
(2014)
Control of smooth muscle a-actin (SMA) up-regulation in HBMSCs using remote magnetic particle mechano-activation.
in Nanomedicine : nanotechnology, biology, and medicine
Hu B
(2013)
Methionine sulfoxide reductase A as a marker for isolating subpopulations of stem and progenitor cells used in regenerative medicine.
in Medical hypotheses
Ian Wimpenny (Author)
(2011)
Investigation of cell proliferation and alkaline phosphatase activity on powder and solid materials
Iftimia-Mander A
(2013)
Mesenchymal stem cell isolation from human umbilical cord tissue: understanding and minimizing variability in cell yield for process optimization.
in Biopreservation and biobanking
Kay AG
(2015)
BMP2 repression and optimized culture conditions promote human bone marrow-derived mesenchymal stem cell isolation.
in Regenerative medicine
Kehoe O
(2014)
Intra-articular injection of mesenchymal stem cells leads to reduced inflammation and cartilage damage in murine antigen-induced arthritis.
in Journal of translational medicine
Kelly C
(2012)
Supercritical CO 2 : A Clean and Low Temperature Approach to Blending P DL LA and PEG
in Advanced Functional Materials
Knychala J
(2013)
Pore geometry regulates early stage human bone marrow cell tissue formation and organisation.
in Annals of biomedical engineering
Description | The EPSRC Centre for Innovative Manufacturing in Regenerative Medicine is one of the primary national interventions supporting the growth of the UK regenerative medicine industry. Its role is to define, deliver and disseminate world-leading, high impact, fundamental and translational manufacturing research building upon its original funding from the EPSRC. Significant additional funding (approximately nine times the original grant received) has been secured from diverse sources. EPSRC Centre members participate significantly in hubs and projects funded by the UK Regenerative Medicine Platform. The recent re-funding of our Centre for Doctoral Training by both EPSRC and the MRC sustains our training pipeline for over 100 PhD students. |
Exploitation Route | The EPSRC Centre for Innovative Manufacturing (CIM) in Regenerative Medicine has come to a conclusion at the end of February 2016. The portfolio of projects that are managed by the participants at Keele, Nottingham and Loughborough continues to evolve and to enlarge. The engagement with the regulatory authorities and with the international community has increased during 2015 with initiative undertaken with the European Medicines Agency and the international Standards Organisation that will outlive the CIM. Opportunities have been identified to work in new collaborations in the USA (via MIT), France (through I-STEM), Italy (with IBSL) and Japan (through Sasakawa Foundation initiatives). Two unsuccessful bids have been made for Future Manufacturing hubs and the content of these will be re-developed for focused research projects with the industrial and academic partners concerned. As noted last year engagement goes from strength to strength through the development of new consortia-led projects, the promotion of the UK academic community in Europe and the communication of regenerative medicine science and engineering to school-age learners and their teachers. The wider EPSRC Centre has a focus on people development through EPSRC-funded Early Career, Career Acceleration and Manufacturing Fellowships. Support for early career researchers is provided through fellowships from a variety of funders, including the EPSRC-funded Engineering, Tissue Engineering and Regenerative Medicine (ETERM) Fellowship Programme and host university programmes. The research funded by the EPSRC Centre during the second half of its term was focused on the cross-institution challenge project where key manufacturing technology themes are integrated using a framework based on regulatory science to facilitate translation. We are now working actively with the Cell Therapy Catapult on industry projects and partnering strategically on research and translational projects. The work here has led to new initiatives in the area of distributed manufacturing. The relationship with the Cell and Gene Therapy Manufacturing Centre has been strengthened. Work on policy and standards and to inform regulation continues with contributions to the work of the Department of Health Regenerative Medicine Expert Group and international standards groups. Regenerative medicine manufacturing remains a key focus nationally and internationally. We are planning for success against this opportunity-rich background. We seek the ongoing support of community members, as both advocates for the importance of EPSRC funding for manufacturing research and in particular as collaborators in research that enables the new industry of regenerative medicine to grow and deliver increasing healthcare benefits. To this end the CIM has worked on policy influence as well as research output and the findings underscore the importance of a systems-level approach to manufacturing research for these advanced products. Without a thorough understanding of how to make regenerative medicines safely, economically and in sufficient quantity, these therapies will never reach their full potential. |
Sectors | Healthcare Manufacturing including Industrial Biotechology Pharmaceuticals and Medical Biotechnology Other |
URL | http://www.epsrc-regen-med.org/ |
Description | Centre's impact on Industry: Quotes from Collaborators giving examples of the Centre's impact on Industry. The Centre has made significant impact within the Regenerative Medicine Industrial community as evidenced by the following quotes: From Dr Amr Abid, Head of Strategic Growth & Development, Life Sciences, GE Healthcare: "GE Healthcare Life Sciences had the opportunity to experience first-hand the uniqueness of the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine at Loughborough University by working on industrial process development for our human cardiomyocytes differentiation from human stem cells. The Centre has combined in one team different capabilities, skills and talent in engineering and biology coming from industry and academia. This unique and rare blend of people, expertise and capabilities has been, and is still, extremely valuable for the project we have been working on." From David Newble, CEO, TAP Biosystems: "I am writing to endorse the collaborative support we have received from the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine. In particular they have highlighted regulatory changes required to remove barriers to establishing cell therapy processing capabilities in hospital environments - a major hurdle for the adoption of certain cell therapies." From Guy Parkes, Head of Special Projects, Anthony Nolan: "The automated process that we use to extract stem cells from an umbilical cord blood collection is one of the major limiting factors in our processing chain. Our work with the team at Loughborough analysing our existing protocols and experimenting with new solutions has allowed us to both understand the limitations of our current processing system with regard to cellular yields and to identify a new method to substantially improve those yields." Hermann Hauser, 'Review of the Catapult Network: Recommendations on the future shape, scope and ambition of the programme' November 2014: "The CTC is able to work with Loughborough's recognised experts in the manufacture and quality control of cells and tissues used in cell therapy, as well as linking with the University's Engineering and Physical Sciences Research Council (EPSRC) Centre for Innovative Manufacturing and its Doctoral Training Centre in Regenerative Medicine." 1. Introduction (The items listed here that are cited under the individual output sections of ResearchFish are included in order to provide a continuous narrative only. The references given in square brackets may be found in the 'Publications' section.) As one of sixteen EPSRC Centres for Innovative Manufacturing, the EPSRC Centre for Innovative Manufacturing (CIM) in Regenerative Medicine was created in 2010 and was led from Loughborough University in the UK, in partnership with complementary groups at Keele University and The University of Nottingham. Each university brought its own expertise to create a unique partnership combining leadership in regulated manufacturing, tissue engineering and clinical science. As a National Centre, the EPSRC Centre has had an engagement programme that brought together the UK regenerative medicine manufacturing community to create a distributed centre of excellence. The EPSRC Centre was closely aligned with the EPSRC-MRC Centre for Doctoral Training in Regenerative Medicine and the E-TERM Landscape Fellowships Programme providing an integrated platform of fundamental and translational research. The EPSRC Centre for Innovative Manufacturing in Regenerative Medicine has worked to equip the industry with manufacturing tools, technologies and platforms by considering the supply chain from end to end. We have utilised a systems approach to draw together the many processes involved in transferring the right therapies to the right patient at the right time. The CIM builds on synergies between the three main universities. Keele University has provided an especially close connection with clinical application though its work with the RJAH Orthopaedic Hospital at Oswestry. The practical, logistical and clinical insight that this collaboration brings has made it possible to ensure that the CIM innovation and regulatory insights are grounded in the practical realities of the hospital setting. Nottingham has a strong materials background. The work by the group under Prof Kevin Shakesheff in thermoreversible scaffold polymers to allow integration of cell manufacture and administration reflects this. During the last three years the especial emphasis of the Nottingham work has been on integrating cell and polymer bioprinting as described below. The role of Loughborough has been twofold. On the one hand Loughborough has brought the application of automated solutions to cell processing into applications-based research. On the other hand Loughborough has focused on the regulatory context of the manufacturing research, leading to a succession of papers on the business, regulatory and quality assurance challenges and how these might be addressed. The CIM was originally structured with three major research themes: manufacturing and automation, characterisation and control, and delivery and 3D constructs. These reflected the capability of the Centre partners and the key requirements of industry. The CIM went through its international mid-stage review in April 2013. The review panel for this was chaired by Michael May, President and CEO of the Centre for Commercialization of Regenerative Medicine (CCRM), Toronto, and included international and national academic and industrial members in addition to EPSRC and TSB observers. The mid-stage review had a positive outcome with recognition of the role and potential of the Centre nationally and internationally. In summary, the review identified the Centre as "..one of a few that understands and addresses cell manufacturing bottlenecks - a critical gap in regenerative medicine commercialization". Underpinning this, the review identified the following strengths: • Partnership between three institutions, each bringing unique capabilities: Loughborough, with its industry perspective and focus on process, scale and quality systems; Nottingham, with its academic research focus and depth; and Keele with its clinical capabilities. • A strong culture of training and programmes in place to deliver highly qualified personnel with unique skill sets. • Visionary leadership tied to an extensive network of academic and industry contacts. • Excellent governance and good record keeping, with external Board representation. • Industry input to provide market pull, balancing the technology push of academia; projects that address "real-life" problems in the field. • Records indicating a rigorous, stage-gated project approval/review process. • Initial funding for an ambitious national outreach plan to connect key institutions advancing Regenerative Medicine and Cell Therapy across the UK." The review identified several major achievements attributed to the strengths of the Centre: • The CIM had widened its scope and mandate and maintained strong collaboration among the three institutions. • The CIM had identified and funded a substantial pipeline of projects in a relatively short period of time. • The CIM had attracted industry to support projects and commit time to advisory roles and Board positions. • This had brought scientists with different backgrounds and perspectives together, creating "common language and understanding", which is critical to success in such a multidisciplinary, emerging field. • Management had leveraged the Centre to create new opportunities and attract new funding to a core network of investigators. • The CIM had created links with other key players in the UK regenerative medicine research system (e.g., the Cell and Gene Therapy Catapult). Recognising the dynamic nature of the UK landscape/innovation system for regenerative medicine and its impact on the Centre, the review panel did, however, advise that to maximize its impact and track towards sustainability, the Centre needed to clarify and reinforce its vision, address succession of its leadership and make key strategic changes to its project portfolio. An action plan in response to these recommendations was successfully delivered within six months (October 2013). As a consequence, the EPSRC Centre's vision and strategic objectives (including outreach strategy) were updated, taking account of changes to the UK funding environment, in particular the Cell and Gene Therapy Catapult (CGTC, then the CTC) and the Joint Research Councils UK Regenerative Medicine Platform (UKRMP). Prof Nick Medcalf became Director of the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine on 1st September 2014, succeeding the founding Director, Prof David Williams OBE. A flagship cross-institution disruptive challenge project started in November 2013. This signalled the next phase of the EPSRC Centre's research, which, by integrating key manufacturing technology themes (personalised 3D bioprinting, product characterisation and closed-loop process control) using a framework based on regulatory science, has successfully addressed significant translational bottlenecks in the industry. 1.1. The original themes The original three themes during the first review period of the CIM were compiled under the directorship of Prof David J Williams. These themes interacted in terms of their emphasis on control of processes and the role of automated equipment. Work in manufacturing and automation built upon the achievements of the remedi Grand Challenge but with a strong focus on near-patient cell processing. The projects examined the creation of novel modular process equipment for use in hospitals (with TAP Biosystems and Dana Farber Cancer Institute, Harvard), media-conditioning equipment (with Ruskinn), novel platforms for adherent culture to reduce the cost of goods (resulting in two patents), and culture in hydrostatic conditions (with Tissue Growth Technologies [Henstock 2013]). A strongly emerging theme was the management of biological variation by process design to reduce its effect. This was demonstrated in a clinical setting with the Anthony Nolan Trust [Win Niang 2015], and for human embryonic stem cell culture [Ratcliffe 2013] and cryopreservation [Mitchell 2014]. Work on near-patient processing identified the significant regulatory issues with transferring manufacture to multiple sites and the interaction between manufacturing strategy and regulation. An influential consensus white paper developed with industry shared these issues [Hourd 2014] and led to work in the key areas of quantification of biological variation (with Dana Farber and from the literature [Thurman-Newell 2015]) and the development of techniques and methods of demonstrating process comparability [Archibald 2015]. As part of PhD Candidate Jamie Thurman-Newell's project, a collaboration was struck between the Boston hospital and LU, to investigate the extent of biological variation within clinic and explore potential cell processing issues. This resulted in two on-site visits and the collaborators are now writing a joint paper. This theme has been continued as a main focus of the Loughborough involvement in the UKRMP Pluripotent Stem Cell Platform. Later work has begun to explore the manufacturing problems at the boundary of regenerative medicine and synthetic biology. A second aspect of the automation theme was research focussed on the use of statistical models within a Quality-by-Design framework to improve cell processing. The challenges that were addressed included selecting assays that had sufficient throughput and were informative enough to develop meaningful models of cell function. In particular the Centre published exemplars of the use of focussed (via appropriate risk assessment) and linked statistical models to greatly improve reproducibility and quality of high risk process operations such as cryopreservation [Ratcliffe 2013 and Mitchell 2014]. Delivery and 3D constructs was a third area of research and this was developed into a leading activity following the mid-term review. The detail is described below. 1.2. Research themes following the mid-term review After the mid-term review there were a further three themes, linked by an emphasis on the regulatory challenge that must be addressed before technology can be deployed. 'Regulatory science' was an integrating project, overarching the other three: ".. the science that will inform and enable robust regulatory decisions by both influencing and informing the regulator and assisting the manufacturer in providing the knowledge base to deliver confidence in these products". EPSRC Centre Manufacturing Industrial Summit, 2012 As part of its systems approach to the manufacture and translation of Regenerative Medicine, the Centre has built in a strong and strategic regulatory science component across the project portfolio. In the description given here the regulatory-related activity of the CIM is recounted for the whole life of the Centre and not merely the activity following the mid-term review. However, the emphasis on this aspect grew in the second half of the term. In addressing important issues identified in these and other parallel research activities, such as the TSB-funded VALUE project, and by industry stakeholders at the 'EPSRC Centre Manufacturing Industrial Summit' in 2012, new concepts addressing the major challenges for the manufacture and commercialisation of autologous and 3D tissue engineered therapies were developed. Captured in a two key positioning papers this work has contributed directly to the Centre's increased engagement with the UK regulator (MHRA), the European Regulator (EMA) and other stakeholders, including the Harvard Stem Cell Institute and the International Society for Cellular Therapy (notably via input to consultations on EU and US regulatory guidance by its Commercialisation Committee) and has directly influenced national policy with input into the Regenerative Medicine Expert Group (RMEG) (one of the key consequences of the House of Lords Report). "building stronger links between the regulators and those who are regulated would be a vital step in overcoming the difficulties of GMP requirements". House of Lords Science and Technology Committee report on Regenerative Medicine, July 2013 This work continues to influence manufacturing themes in healthcare via input into feasibility studies currently being undertaken by the EPSRC Re-Distributed Manufacturing in Healthcare Network (RiHN), in particular the 3-D Bioprinting and Cell Microfactories feasibility studies. In parallel with other research activities, for example under the UKRMP Pluripotent Stem Cell Platform (PSCP), the Centre has also driven or been involved in a number of national and international industrial and academic workshops in the regulatory science space (upstream of the CGTC). The most significant of these were the Centre-led Industry translation session at International Society for Cellular Therapy regional meeting (Philadelphia, Sept 2013), the 'Safety & Starting Materials' workshop (Sheffield, 8-9th Jan 2015, and the Comparability & Characterisation' workshop (Cambridge, 14-15th Sept 2015). Providing valuable insight into issues faced by regenerative medicine businesses, another key role of the Centre has been to provide regulatory support to regenerative medicine SMEs via the creation of a specialised role funded by the EPSRC Knowledge Transfer Account at Loughborough. Examples of companies that have benefited from this work include Organogenesis, TAP Biosystems, Cell Medica, Videregen and Intercytex, with the products ranging from stem cell treatments to wound-healing matrices. Through this role and via membership of standards committee at the British Standards Institute, the Centre has made significant contributions to three regulatory guidance documents relating to the development of cellular medicines (PAS93:2011, PAS83:2012, PAS157:2015). This work has enhanced the regulatory knowledge of the Centre, provided input into teaching materials for the Doctoral Training Centre programme and input into the development and validation of the Cell Therapy Manufacturing Facility of the Loughborough Centre for Biological Engineering. Throughout its lifetime, the Centre has indirectly influenced [Hourd 2014 and Hourd 2015] regional, national and EU policy, with invited evidentiary input into programmes such as the GO-Science Foresight 'Future of Manufacturing' project, which was presented directly to Vince Cable (Secretary of State for Business, Innovation and Skills) and the Ministerial Industry Strategy Group future strategy for medicines manufacture in the UK. This has been complemented by sustained input into several targeted stakeholder consultation programmes, including consultation on Department of Health's Advisory Committee on the Safety of Blood, Tissues, and Organs (SaBTO) cell therapies guidance; on diagnostics for Stratified Medicine (Catapult); on the Foundation for the Accreditation of Cellular Therapy (FACT) Common Standards guidance and consultation with BSI on the application of Quality by Design (QbD) to cell therapy development and standards for evaluation of materials. In November 2015 the Centre contributed to the development of Good Manufacturing Practice for Advanced Therapy Medicinal Products (European Commission). Under the Regulatory Science Work Package were three technical work packages. The first of these was the Closed-loop control activity. The purpose of the project, closely linked to the following 'Sensors' project, has been to examine the impact that management of cell culture using responsive feeding could have on the otherwise open-loop menu-driven culture that is usual for manual T-flask systems. There were two main areas of work in this section of the program. The first involved the modification of bioreactor vessels in order to achieve bleed-feed loops for nutrition management and resulted in manual in-house modification of the disposable vessels in the AMBR bioreactor system to enable progressive medium replacement and adjustment. (The AMBR is a workhorse piece of equipment in the CBE, manufactured by TAP Biosystems.) The second focussed on a worked example of real-time management of medium composition to drive the growth of chondroprogenitor cells. Preliminary studies using bovine cells from primary tissue were conducted. Further work is being continued under the EPSRC Fellowship held by N Medcalf (EP/K037099/1) The published regulatory guidance from the US and the EU highlights the importance of on-line and at-line bioprocess monitoring and control. Currently there exist fundamental engineering science challenges that limit the state-of-the-art process analytical technologies to address this need. Specificity of signal and avoidance of fouling of sensors are amongst the biggest of these challenges. To address these challenges, in the 'Sensors' project we explored a novel nonlinear acoustic detection technology for rapid receptor-based detection of biological cells and proteins. This was implemented on a 14.3 MHz quartz crystal resonator, which was driven at relatively high oscillation amplitude and acceleration (~million g). The resulting inertial loading on the attached bioparticles was observed to dissociate non-specific binding from the sensor surface, reducing fouling. The use of aptamers as bioreceptors further improved the specificity of detection. The entirely electronic detection technology implemented on a microfluidic cartridge is modular and favours easy integration with the cell reactor for online biological monitoring. The current research, extending beyond the life of the CIM, is focusing on studying the heat transfer and fluid mechanical problems for thermal stability, and fast and efficacious capture of bioparticles. This project has recently received funding from BioProNET, a BBSRC supported network, to work with the Centre for Process Innovation (CPI), a Catapult Centre, to feasibility test the technology with industry-relevant biomolecules and conditions. The Bioprinting/customised products work package (Joel Segal) has focussed on potential future clinical translation of the bioprinting process for personalised/customised combination products. Throughout the project, there has been substantial and regular clinical review (surgeon and prostheticist) which has provided essential inputs about establishing product specifications, defining critical parameters and the testing and verification required. This meant that the design of the product has been optimised for clinical need. A strongly emerging theme was the lack of a current regulatory framework for these product scenarios. This has led directly to a feasibility study project supported by the Redistributed Manufacturing in Healthcare Network (EPSRC - EP/M017559/1) Key achievements are:- • Development of a process to 3D-print tissue engineering nose constructs based on medical scans. • Creation of a bespoke insulated enclosure to control the bioprinting environment (air temperature and cooling air flow rate). • Development of an effective printing process for polycaprolactone and hydrogel (temperature settings, print extrusion rate, etc.). • Study and understanding of the effect of hydrogel formulation on printing fidelity and cell viability. • An optimal scaffold design was agreed with the surgeon and created using 3D modelling software - The scaffold needed to be as thin as possible but porous enough to enable a suturing needle to pass through without excessive force. Slots were included to house cartilage plates. • Produced software to allow finer control of the 3D print path and printing parameters for test samples than off-the-shelf software: The program enabled a novel print path concept to be utilised for control of surface porosity. The effect of surface porosity was quantified for compressive modulus, suturing forces, cell seeding and cell proliferation [Ruiz-Cantu 2016]. Software was developed to generate printer control code for a full 3D nose model. It enables fine control over the porosity: • Several different print configurations were utilised and two polymer types to achieve a range of scaffolds. Feedback from the surgeon suggested the scaffolds were ideal for this application. The work has also been presented at several conferences including Biofabrication 2015, TCES 2015 and TERMIS 2015. 2. Impact channels (International impacts, both academic and industrial, are included in section 3.) The presentation of CIM output and capability has been made principally through the Industry Days. Usually annual, the most recent of these, a two-day event at Cambridge University (Madingley Hall) in January 2016 enabled researchers to showcase their work and to co-produce a series of research priorities with the delegates via workshops on day two. The output of the meeting has been briefed informally to the EPSRC and will form the basis of a White Paper after the current reporting round. The CIM has directly and indirectly benefited industry (manufacturers and equipment providers), academia, trade organisations and regulatory and standards bodies as noted above. The industrial influence has been upon translation and practice. The Cell and Gene Therapy Catapult was established during the middle period of the EPSRC Centre funding period. There was a natural alignment between the Centre and the Catapult with the former able to supply emerging technologies, equipment and specialist services to the latter. The Centre signed a memorandum of understanding with the CGTC early in its operation, and subsequently a framework agreement to facilitate rapid deployment of packages of work. This collaborative relationship continues as part of the Centre's sustainability and forms a pipeline through which the Centre ensures that its research is positioned slightly upstream of the CGTC, providing tools, techniques and insights to operation (e.g. the work on distributed manufacture, which aligns with the CGTC theme of 'seamless freight'). The significant amount of industry work, especially by Rob Thomas' group, is partly a result of this close working relationship. The previous CEO of TAP Biosystems (now Sartorius), David Newble, commissioned a study with the CIM to evaluate the impact of the lack of a centrifugation step in the TAP cell therapy automated cell culture platform, CompacT SelecT®. This study (valued by TAP at £103k) was incorporated in the EPSRC Centre project EP051 in June 2013. Results of the testing with various cell types have been reported by the EPSRC Centre and by TAP in their marketing brochures [Archibald 2015, Archibald 2016, French 2015]. Since the first purchase of the CompacT SelecT® platform by the Centre for Biological Engineering there have been many publications on the benefits of automation of cell culture and has resulted in increased sales of the machine around the world, helping to establish it as a platform technology. The EPSRC Centre also contributed to an international effort for enabling consistency in stem cell derived products leading to the experimental design of the project. As part of PhD candidate Jamie Thurman-Newell's project, collaboration was initiated between the pharmaceutical giant GSK and LU. The aim of this collaboration was to examine how to address the processing and variation issues within cell therapy. This continued over a three year period and resulted in useful feedback that informed both industrial and academic direction. This concluded in a seminar given to the GSK Cell and Gene Therapy team Prior to the Centre the team had worked with ReNeuron to develop an automated process for manufacture of their lead clinical cell line, CTX, currently in Phase I/II trials for stroke therapy. The Centre went on to collaborate with ReNeuron to define a robust upstream process for production of CTX cells that would enable delivery at phase III clinical trial and market scale. This relationship continues to grow with a pipeline of work planned to support ReNeuron's large scale clinical manufacture. Baker Ruskinn played a pivotal role in two CIM projects in addition to contributing to the Mid-term Review. Projects which befitted directly from Baker Ruskinn participation were the Hypoxycool project and the Invertebral disc engineering project. Baker Ruskinn have now licensed the Hypoxycool IP from Keele University and have subsequently developed a commercially-available product. The intervertebral disc project stimulated a technology redesign within Baker Ruskinn such that their hypoxia workstation can now incorporate flexibility to accommodate bioreactor products. Asymptote is a globally-significant specialist company delivering cryogenic equipment to the industry. The CIM has built an excellent relationship with Asymptote and this has resulted in a successful bid for InnovateUK funding to develop a bioartificial liver device. The Centre and UCL have worked hard to sustain a strategic relationship. This is evidenced by a number of joint proposals and more particularly by the Joint UCL-Loughborough bid for the Cell Therapy Catapult. This made it to the final interview stage as one of three candidates. More recently the 2014 Loughborough-UCL bid for an EPSRC Manufacturing Hub (Medcalf and Velayudhan) passed the EOI stage. The work of remedi and more recently the CIM has supported and given context to the doctoral training activity. A successful start to the DTC programme led to the award of an E-TERM (Engineering Tissue Engineering and Regenerative Medicine) EPSRC Landscape Programme, bringing together for the first time the six University DTC teams (Loughborough, Nottingham, Keele, Leeds, Sheffield and York). This programme provided an opportunity to combine the research strengths of the six institutions to deliver a strategic collaborative programme of cross-disciplinary research, and to further develop a cohort of future multidisciplinary research leaders. Twelve Early Career Fellows have been appointed to date, located at Sheffield, York, Keele, Nottingham and Loughborough universities, of which eight have now completed their individual research programmes. The CIM has assisted Innogen with their recent surveys and report to BSi relating to Standards and Regulations for advanced therapeutics. The work at Innogen and at the CIM is complementary in the area of viable business models for the sector and currently Joyce Tait, Geoff Banda and Nick Medcalf are planning a collaborative workshop with industry and clinicians on this topic for later in 2016. The relationship between the Centre and the MHRA has been very strong and we will continue to nurture this pathway to impact. John Wilkinson (Director of Devices, MHRA) is using the CIM 3D bioprinting paper within MRHA as a benchmark for ways of working to inform regulation in this area. Ian Rees (MHRA Inspectorate) is a regular correspondent in meetings informal and formal and has contributed valuable insights to the research. The Centre occupies an important position in the emerging standards and guidance via BSi. On the international stage the Centre has a leading role in the regenerative medicine work of ISO Technical Committee 276 (Bioprocessing), working alongside BSi and LGC. In November 2015 a workshop was held at Loughborough at the request of the Japanese delegation and convener (Heki, Tatsuo of FIRM) to examine the topic of 'manufacturability' i.e. that property of well-designed cell processes that can provide out-scalable manufacture. Nick Medcalf is leading this activity which will result in a white Paper in 2016 co-produced by the Japanese, US, UK and South Korean delegates. Keele University (El Haj) has been an important contributor to EMA initiatives such as the 2012 Workshop on Focus Groups: a model for fruitful interaction between the CAT and its interested parties. The Centre has also been active within the European Regulatory area through an initiative with EATRIS. In 2015 a joint meeting was held with the European Medicines Agency at Canary Wharf with the objective of introducing the Centre/EATRIS initiative in distributed manufacturing. An invitation has been extended by the EMA for Loughborough to put key research questions to the Committee for Advanced Therapeutics in 2016 which could result in cooperative effort to establish a collaborative program of work in EMA priority areas. The CIM provided written and oral evidence to the 2012 - 2013 House of Lords Science and Technology Committee Inquiry into Regenerative Medicine. The oral evidence was focussed on manufacturing and was sought from a panel made up of David Newble of TAP Biosystems, Keith Thompson CEO of the CGTC and David J Williams of Loughborough [HoL 2013]. The House of Lords Inquiry led to the formation of the Regenerative Medicine Expert Group in order to address the key issues identified. David Williams was on the expert group. The Centre made particular contributions to the Regulation and Licencing Subgroup (via Williams, Medcalf and Chandra) in particular using evidence of the complexity of near-patient processing issues to signal regulatory issues [RMEG 2014]. The joint Innovate-MRC Biomedical Catalyst has been the major national intervention to support medical technology innovation in industry and was put in place as a consequence of the downturn. David Williams served as a member of its Major Awards Committee. The Centre has occupied a strategic role in the international research and policy community in regenerative medicine. The items below are illustrative. One of the most significant translational centres internationally is CCRM (the Canadian Centre for Regenerative Medicine). The Centre has cultivated and continues to cultivate a strategic relationship with CCRM. Significantly Michael May, the CCRM CEO, led the mid-term review. The Centre and CCRM have collaborated in particular by means of DTC/CDT student secondment and co-publishing especially on adoption issues [Rose 2012]. The CIM has focussed on ISCT (The International Society for Cell Therapy) as a key international target for both dissemination and influencing. Activities with ISCT have included regular attendance at US and International ISCT conferences, the use of the Society Journal, Cytotherapy, as the destination for policy influencing "white" papers, and by actively contributing to the work of the Society's Commercialisation Committee (Williams). As part of building a strategic relationship with the Boston Area, a number of discussions have been held with the MIT Centre for Biomedical Innovation. These culminated in the invitation of three Centre researchers (Williams, Thurman-Newell, McCall) to give presentations (including a keynote) at the 2015 Biomanufacturing Summit. Discussions are proceeding with MIT on areas for future collaboration. Importantly MIT are shaping their own research activity to focus on analytical techniques taking account of the UK capabilities in processing developed in the Centre. There is a significant interest in manufacturing strategy and the enablers for the distribution of manufacturing. Through the Centre Outreach program there is an ongoing relationship between the Centre and the Harvard Stem Cell Institute. Arianna Rech, a Chemical Engineering undergraduate student from Loughborough, was awarded an internship at the Wyss Institute at Harvard University (Don Ingber's Laboratory) to assist with development of 'Bone Marrow on a Chip'. The purpose is to provide a test platform for understanding disease and the effects of radiation on bone health. A study led from Keele (Forsyth, El Haj) gave a high impact demonstration of near patient cell processing. The study mapped and observed the transfer of a leading edge regenerative medicine product from the industrial development setting into delivery application within a UK hospital. Working in collaboration with key stakeholders, the NHS, the Stroke Research Network, and a significant regenerative medicine industry partner (the American company Athersys), the researchers evaluated the ease of transition of a cell-based product into a UK hospital setting. The product was targeted for the treatment of an acute neurological disorder. The primary outcome of the evaluation was that the UK hospital setting can successfully integrate manufactured cell-based regenerative medicine products into the healthcare delivery platform. There are, however, substantial baseline requirements for this to be met. These include the onsite localisation of GMP grade clean rooms (with Class A handling), 24/7 readiness and coordinated lines of communication from patient to processor. The French AFM-Telethon and the Sociétés de Projets Industriels equity fund headed by the Banque publique d'investissement are investing in the creation of the largest European centre for the development and manufacturing of gene and cell therapies with a planned size of 13,000 m2 in Evry, France. To reach industrial scale, the facility will be equipped with the latest automation equipment including platforms for the expansion of stem cells. The EPSRC Centre has been collaborating with I-Stem, France in the EP051 automation project. Researchers from the EPSRC Centre (Chandra, Williams) are currently working with the I-Stem to specify the automation platform(s) and use their experience for validation to produce therapeutics. One of the European major centres for the automation of cell and tissue processing is FhG-IBMT. This organisation is also investing in the Babraham Science Park. Loughborough is working in collaboration with FhG-IBMT via the UKRMP PSCP Partnership Project on automated cell culture comparability, an opportunity that has arisen through the positional work in the CIM on automation. In addition to the ISO work detailed above the Centre has applied funding from the Sasakawa Foundation to enable two researchers (Hao Zhang and Tom Heathman) to make trips to Japan to build links with relevant research groups in Osaka, Kyoto, Tokyo and Tsukuba. The CIM has established strong links with SIMTech (Singapore) via the researcher May Win-Naing and this important near-patient cell processing link will continue to play an important role in the future. 3. Outreach The CIM has played an important role in providing trainees for the future, in raising public awareness and in providing for regulatory development for the sector. The CIM has provided two fully funded undergraduate internships at Harvard Stem Cell Institute, strengthening the relationship between UK and US institutions. Following their experiences, the first candidate is undertaking a PhD and the second secured funding to return to HSCI and will apply for a PhD on their return. The CIM supported training of four undergraduate medical students to take part in the INSPIRE programme at Keele University. It combined the CIM's target areas of commercial engagement, training of the next generating and raising awareness of careers in regenerative medicine sector. To promote the CIM's activities, a monthly/bi-monthly newsletter was distributed to more than 500 subscribers including industrial contacts, lead academics and researchers. The CIM institutions will continue to communicate with the established database to inform stakeholders of future projects and events. Through the CIM, the Healthcare Engineering and Regenerative Therapies (HEART) programme has been formed to bring regenerative medicine, science and engineering to learners of all ages. The CIM and HEART group has been invited to exhibit at more than 10 events over the past two years, to communicate the centre's research to members of the public. Notable events include Big Bang Fayre, Birmingham & London, Cheltenham Science Festival, Cheltenham and Imagineering, Coventry. A HEART blog has been established, aimed at school age readers, which delivers accessible research to learners, in addition to providing suitable classroom material for teachers. The blog attracts 100+ views per day with up to 92% being new users. In addition to the larger exhibitions, the team have also run tailored workshops in schools. The HEART team is comprised of CIM researchers, DTC/CDT researchers and E-TERM fellows. Continuity of research communication will be maintained through the two latter groups. A total of four projects have been funded at approximately £40k each as a result of thematic sandpit events held by the CIM. Researchers at the universities at Bath (Modular manufacturing of bone), Newcastle (Wave-based panning for pancreatic islets), Birmingham (ElectroStim optic nerve scaffolds) and UCL (Magnetic patterning of cells for hollow organ tissue engineering) have conducted focused projects awarded on a competitively-funded basis. A significant component of the outreach activity was to support the development of promising early career researchers outside the core partners. Four researchers were particularly identified: Liam Grover (Birmingham), Marianne Ellis (Bath), Lucy Foley (Formerly of Newcastle), and Ivan Wall (UCL). These were encouraged to form a network and to "raise their game" by exposure to the Boston innovation system in a one week visit. The relationships have been sustained and grown particularly in the cases of Grover and Wall. The network was actively encouraged to participate in the Sandpit activities as above. One of the core challenges for any centre of excellence is to decide how it manages the interface with Europe and EU Funding as this can be resource hungry with comparatively little return. A strategic decision was therefore made to interact via a translational organisation, EATRIS, and to have a particular focus on regulatory issues and to leverage the EATRIS relationship with the EMA (European Medicines Agency) as noted above. This is ongoing. 4. IP generation A major focus of the CIM has been the securing of intellectual property through patents and through know-how. The patents are listed elsewhere in ResearchFish and range over equipment, instruments and materials. 5. Leverage Selected Leveraged Projects in addition to those described already include: UK Regenerative Medicine Platform: Confirming that EPSRC Centre partners are major players in UK regenerative medicine research, Centre academics are involved in three of the five Hubs. This includes directing the Acellular (smart material) Hub which provides approaches for therapeutic delivery (Kevin Shakesheff, University of Nottingham) and contribution from an EPSRC Centre member within the core team (Alicia El Haj, Keele University). The Stem Cell Niche Hub is supported by EPSRC Centre member (El Haj). The Cell Behaviour, Differentiation and Manufacturing Hub - Pluripotent Stem Cell Platform (PSPC) includes EPSRC Centre members within its core team (David Williams, Robert Thomas, Nick Medcalf, Loughborough University). As part of a DARPA-funded consortium led by Celgene Cellular Therapeutics, in close partnership with TAP Biosystems, EPSRC Centre members have cultured haematopoietic progenitor cells derived from umbilical cord through an expansion and erythroid lineage commitment process to test and engage in process development programmes. This project led to two additional complementary investments. The first was an EPSRC Early Career Fellowship for Rob Thomas. The second utilised funding from the EPSRC Centre and the Wellcome Trust to collaborate with an existing Wellcome Trust-funded consortium seeking to produce red blood cells in the laboratory. The consortium comprises The University of Bristol, The University of Edinburgh, The University of Glasgow, NHS Blood and Transplant, the Scottish National Blood Transfusion Service, the Irish Blood Transfusion Service and Roslin Cells. The TSB Regenerative Medicine Value Systems and Business Models project: 'Navigating the Uncertainties' was designed to address the entire value system of regenerative medicine by taking a perspective encompassing four key uncertainties: Technological - Product, Process and Supply; Regulatory - Status and Application; Reimbursement - Public and Private and Financial - Business and Investment models. This research has been cited in the 'The case for public support of innovation: At the sector, technology and challenge area levels' report published by the UK Government's Department of Business, Innovation and Skills (2014). 6. Continuity The CIM has been the location for effective career progression and continuity in research. Melissa Mather, a key researcher at Nottingham, was made Professor of BioMedical Imaging at Keele University in recognition of her work on medical imaging. During the period of the Centre Rob Thomas was awarded an early career Fellowship to develop processes and technologies for haematopoietic cell products. (He has also been awarded a Readership in Manufacturing for Cell-Based Therapies.) In conjunction with a Wellcome Trust award to develop manufacturing processes for first in man clinical studies with red blood cells this enabled a group to be established working on process control and characterisation for a specific and high value set of near market products. This work continues to evolve with new process development approaches and further products such as platelets and immunotherapies. Nick Medcalf transferred from the Smith & Nephew Research Centre, York, in 2013 as an EPSRC Manufacturing Fellow and took up the post of CIM Director in 2014 from Dave Williams. Nick brings a strong systems focus to the research work and is also now representing industry readiness training for the CDT offering. A number of research assistants and associates and DTC students involved in CIM projects have now secured lectureships: Liz Ratcliffe and Mark McCall (Loughborough), Lisa White (Nottingham) and Arum Saeed (UEA). Significantly the scale and visibility of the activity has also drawn in internationally recognised translational researchers to UK academic positions in particular Alexandra Stolzing, now a Senior Lecturer in Loughborough, from FhG-IZM, Leipzig. A characteristic of the Centre has been its commercial orientation. The research program and the ethos resulted in three enterprise fellowships. Dr Alex Lyness is an Enterprise Fellow at Loughborough University and funded via EPSRC IAA awarded by the LU Enterprise Office. His work is focused on identifying the needs and requirements of enabling technologies to deliver the cell-based therapies to patients in the clinic. In his role Alex is developing his research in the field of cell delivery into a device ready for IP protection by the end of the Fellowship and has also conducted work for the Cell Therapy Catapult, where he is the Technical Lead on project to develop an intradermal delivery device to deliver a cell-based therapy. Mark McCall held the first EPSRC Impact Acceleration Account funded Enterprise Fellowship at Loughborough University working on commercially exploitable projects with both UK based SME's and multinationals. The fellowship focused on novel approaches to cost reduction in bioprocess manufacturing and development through process improvement and technology innovation. During the first 20 months of the 24-month fellowship Mark took a novel scaled expansion bioreactor technology from an early demonstration system to a medium-scale operational prototype, which led to extensive due diligence with a leading developer of bioprocess tools and platforms. He also supervised complex technical and process development activities for commercial clients including multiples processes and products intended for clinical use within the next two years. Elizabeth Ratcliffe, a researcher within the CIM, was awarded an EPSRC Impact Acceleration Enterprise Fellowship (£140k): 'Developing Synthetic Biology strengthened tools for Gene Therapy translation'. This was a competitive 16 month Enterprise Fellowship in Synthetic Biology breaking new ground for Loughborough University, working on challenge-led translational science and technology development in collaboration with Dr Michael Roberts, CSO and founder of Synpromics Ltd. (a leading Synthetic Biology platform technology company) and Professor Michael Linden, Professor of Virology, University College London / Pfizer. The project involves developing synthetic biology-strengthened cells and viral vectors for gene therapy research and combining this with scalable automated manufacturing methods and process development methods for HEK293T cell expansion and transfection to make informed advancements in the bioprocess development and scaling of gene therapy manufacture. 7. New directions The CIM, its predecessor remedi, and the related grant portfolios including the DTC and CDT have resulted in the development of an internationally distinctive capability in regenerative medicine manufacturing with a hub at Loughborough. Importantly this has been consolidated and is now sustained by a large group of permanent academic staff funded via new national and university initiatives in particular HEFEC Catalyst funding and Vice Chancellor's Lectureships and with EPSRC Fellowship support. The market research that was conducted in order to make the two bids for EPSRC Future Manufacturing hubs has provided the Centre with clear directions for future research. These concentrate around the subject of control, systems engineering and improved methods for ensuring reproducibility of processes, site-to-site and between teams. Some of this work is now being developed in the UKRMP project. The remainder will be re-examined and used to form the basis of single-theme applications for funding with co-production from our industry collaborators. The subject of systems analysis and technology gaps comes together in the current work on re-distributed manufacturing. By means of work at the management level for the network and in the feasibility studies for microfactories and bioprinting the CIM will exert leadership in influence over future research directions for the EPSRC and the ESRC. Recommendations are due by the end of 2016. A strategically-important spin-off study from the CIM in the regulatory/systems area has been the study of the implementation of 'Optimed-ID', an automated medicines dispensing platform at Leicester General Hospital. The system is being assessed for its impact on medicines costs across the four renal wards by removing losses in-system and improving ordering precision. LU has reported on the system to the committee chaired by lord Carter of Coles and also to the Department of Health. The work is expected to generate opportunities for integrating fresh-preserved medicines in this rapid and fully-traceable supply chain system. It has become increasingly clear as the CIM has evolved that there is a requirement to get closer to clinical adopters in particular to determine product quality requirements and that Defence Medicine has a history of being a first mover innovator adopter in transformative medical approaches and technologies. These combined with the success of the Loughborough involvement in the DARPA Blood project and the recent £300M investment in the Defence and National Rehabilitation Centre at Stanford Hall has led to an increased focus on defence medical requirements at Loughborough. David Williams is university academic lead on Defence Medicine. 8. Operational learning and management organisation The Centre was led from Loughborough University by Prof David William as Director and PI for the research and supported by a Deputy Director (Dr Rob Thomas) and a Programme Manager (Dr Paul Hourd) in partnership with complementary groups at Keele University and The University of Nottingham. Having some degree of external governance and oversight of the Centre is an integral part of EPSRC's requirements, a Board was appointed as the primary vehicle for delivering that governance and ensuring that output from the Centre was of high quality and met the deliverables outlined in the proposal. The Board, chaired by Richard Archer (an industrialist), comprised the most senior and experienced members of the Executive and four 'non-executive' members, appointed by the major collaborators in addition to an EPSRC representative. An Executive Committee was also appointed to manage the operational aspects of the programme, which incorporated a research portfolio management process to provide visible budget, resource and new proposal review as well as the phase-gated project management of selected major research projects. This Executive Committee comprised the major academic theme/project leaders from Loughborough, Keele and Nottingham, including the Programme Manager. Both the Board and the Executive Committee met formally four times per year. Minutes of the meetings were recorded and issued within 1 week of the meeting with all actions traceable to completion or closure. A confidential Register of Interests was maintained to ensure that potential conflicts were transparent to and recognised by the Board. Applied to individual elements and across the whole programme, this structure provided a robust (and academically atypical) management approach, which together with strong leadership from the Chairman and Director, was very important to ensuring good governance and the delivery of high value Centre outcomes. 9. CDT interface Several DTC/CDT students, including Peter Archibald and Mark McCall, have contributed to CIM projects. Furthermore, the CIM and the DTC/CDT in Regenerative Medicine have worked closely together on a number of initiatives including joint outreach campaigns. For example, the HEART blog started by Sophie Dale-Black, Head of Engagement at the CIM, is now run by a CDT student. Involvement with the DTC/CDT has also highlighted a gap between the amount of multi-disciplinary training provided for PhD students working in this sector and that which we provide for our RAs. This shortfall is something PIs within the CIM, through their own RAs and by influencing the Universities and research councils are continuing to address. It is important to recognise the support that remedi and the CIM have received from the EPSRC. The Loughborough team under the leadership of Prof David Williams has managed, in a competitive research environment, to secure and leverage investments and support for the CDT Interface. This vital strategic support has enabled the Loughborough/Keele/Nottingham research teams to co-ordinate activity from the CDT, the CIM, ETERM and the Fellowships to give research synergy and to establish critical mass for the research portfolio. 10. CGTC interface The presence of the Cell and Gene Therapy Catapult in the UK research system has given a powerful boost to the UK advanced therapeutics translational capability. The influence of the CGTC upon the CIM has been largely positive and we must be careful to manage the unique position of the CGTC in terms of the impact that it has upon the role and profile of the Centre. The CIM Management has been aware that with the new CGTC facility in London and the production site being built in Stevenage there is now a perception amongst grant reviewers that the UK has all the investment that it currently needs in the subject of regenerative medicine manufacturing research. There is, however, still a role for the creation of enabling technology upstream of the CGTC and this is recognised by that organisation. 11. Summary The CIM has built on the achievements of its forerunner, remedi, and continues to play a leading role in the UK regenerative medicine research system that will endure beyond its term of funding through the excellence of its published science, a rich people pipeline, policy influence and leveraged funding activity. 12. Additional information in 2017 The activity of the CIM in automated manufacturing of cell therapies, as reported by, in particular, Dr Amit Chandra, Prof. David Williams, Dr Robert Thomas, Dr Peter Mitchell and Dr Peter Archibald, attracted the attention of I-STEM (Evry, France) and, as a consequence of the close support that has been given by Dr Amit Chandra to I-STEM over the last twelce months, Dr Chandra departed the Loughborough Laboratories in December 2016 to take up the post of Business Development Manager at I-STEM. This important appointment at the Banque de la Republique-funded labs in France demonstrates the importance of the CIM in providing industry-relevant research and capability to major international ventures. |
First Year Of Impact | 2013 |
Sector | Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
Impact Types | Societal Economic |
Description | House of Lords Inquiry |
Geographic Reach | National |
Policy Influence Type | Contribution to a national consultation/review |
Impact | David Williams gave oral evidence to the House of Lords Science and Technology Committee for their Inquiry into regenerative medicine focussing on both clinical and economic impacts. EPSRC Centre's research and impact noted in paragraph 96 of the report, including a reference to testing and validation of a project with Instron TGT investigating a prototype hydrostatic pressure growth chamber. David Williams has joined the Regenerative Medicine Expert Group that was formed after the publication of the House of Lords report. This is focussed on improvements in clinical services. |
URL | http://www.publications.parliament.uk/pa/ld201314/ldselect/ldsctech/23/23.pdf |
Description | Regenerative Medicine Expert Group |
Geographic Reach | National |
Policy Influence Type | Citation in other policy documents |
URL | https://www.nice.org.uk/Media/Default/About/what-we-do/Research-and-development/regenerative-medicin... |
Description | A hub for engineering and exploiting the stem cell niche |
Amount | £17,488 (GBP) |
Funding ID | MR/K026666/1 |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 05/2013 |
End | 05/2017 |
Description | Additional Funds to EPSRC Centre for Innovative Manufacturing in RM |
Amount | £65,914 (GBP) |
Funding ID | EP/H028277/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 09/2012 |
End | 08/2015 |
Description | Arthritis Research UK Tissue Engineering Centre |
Amount | £713,417 (GBP) |
Funding ID | 19429 |
Organisation | Versus Arthritis |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 03/2011 |
End | 04/2016 |
Description | BIODESIGN: Rational Bioactive Materials Design for Tissue Regeneration |
Amount | £348,000 (GBP) |
Funding ID | 262948-2 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 01/2012 |
End | 12/2016 |
Description | Bar-Coded Biomaterials |
Amount | £308,637 (GBP) |
Funding ID | EP/H005625/1X |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 06/2012 |
End | 07/2016 |
Description | Bioprocessing Research for Cellular products |
Amount | £325,501 (GBP) |
Funding ID | BB/I017062/1 |
Organisation | Biotechnology and Biological Sciences Research Council (BBSRC) |
Sector | Public |
Country | United Kingdom |
Start | 02/2011 |
End | 02/2014 |
Description | Construction of a miniaturized human lymph node model as an alternative to the Local Lymph Node Assay |
Amount | £60,000 (GBP) |
Funding ID | NC/K500318/1 |
Organisation | National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) |
Sector | Public |
Country | United Kingdom |
Start | 08/2012 |
End | 08/2016 |
Description | Contract Process Development |
Amount | £535,000 (GBP) |
Organisation | Cell Therapy Catapult |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 07/2013 |
End | 06/2015 |
Description | Defining the mechanisms on anti-inflammatory and chondroprotective effects of MSCs in arthritis |
Amount | £12,000 (GBP) |
Organisation | Institute of Orthopaedics |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 04/2013 |
End | 11/2013 |
Description | Developing generic scaleable and standardised selection methods for human therapeutic cells |
Amount | £452,430 (GBP) |
Funding ID | BB/I017143/1 |
Organisation | Biotechnology and Biological Sciences Research Council (BBSRC) |
Sector | Public |
Country | United Kingdom |
Start | 02/2011 |
End | 02/2014 |
Description | E-TERM |
Amount | £2,884,739 (GBP) |
Funding ID | EP/I017801/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 03/2012 |
End | 03/2018 |
Description | EPSRC Fellowships in Manufacturing - Regenerative Medicine Manufacture: A Systems Based Research Platform |
Amount | £887,759 (GBP) |
Funding ID | EP/K037099/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 07/2013 |
End | 11/2018 |
Description | EPSRC Impact Acceleration Account |
Amount | £139,000 (GBP) |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 08/2014 |
End | 09/2015 |
Description | EPSRC National Centre |
Amount | £534,000 (GBP) |
Funding ID | EP/H028277/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 03/2012 |
End | 08/2015 |
Description | Enduring Challenge Competition (human performance - medical) |
Amount | £98,147 (GBP) |
Funding ID | DSTLX1000088675 |
Organisation | Defence Science & Technology Laboratory (DSTL) |
Sector | Public |
Country | United Kingdom |
Start | 05/2014 |
End | 11/2015 |
Description | Engineering Biological Science-Processes and Systems for Haematopoietic Stem Cell Based Therapy Manufacture |
Amount | £1,294,482 (GBP) |
Funding ID | EP/K00705X/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 08/2013 |
End | 09/2018 |
Description | Equipment purchase of BD Jazz Cell Sorter |
Amount | £154,000 (GBP) |
Organisation | Loughborough University |
Sector | Academic/University |
Country | United Kingdom |
Start | 06/2013 |
End | 08/2013 |
Description | Fully Funded Studentship - Uni of Kurdistan Hewler |
Amount | £55,000 (GBP) |
Organisation | University of Kurdistan Hewler |
Sector | Academic/University |
Country | Iraq |
Start | 09/2012 |
End | 09/2014 |
Description | Grant from Anne Duchess of Westminster Charity |
Amount | £1,500 (GBP) |
Organisation | Anne Duchess of Westminster Charity |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 01/2014 |
End | 02/2014 |
Description | High resolution live cell imaging tool for early predication of cell quality and safety |
Amount | £59,468 (GBP) |
Organisation | University of Nottingham |
Sector | Academic/University |
Country | United Kingdom |
Start | 03/2013 |
End | 09/2013 |
Description | KTA: Supporting the Establishment and Validation of a Regulated Manufacturing Facility for Contract Research and Manufacturing of Cell Therapies |
Amount | £141,694 (GBP) |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 05/2011 |
End | 07/2012 |
Description | KTA: Supporting the Improvement and Optimisation for Cell Culture for Regenerative Medicine Products Companies |
Amount | £91,403 (GBP) |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 01/2011 |
End | 07/2012 |
Description | KTA: Supporting the Regulation and Reimbursement of Regenerative Medicine Products in the UK |
Amount | £50,291 (GBP) |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 08/2010 |
End | 04/2012 |
Description | MRc UKRMP Aceleular Delivery Hub |
Amount | £750,000 (GBP) |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 03/2014 |
End | 04/2018 |
Description | Medical Research Grant |
Amount | £98,000 (GBP) |
Organisation | The Dowager Countess Eleanor Peel Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 12/2013 |
End | 12/2015 |
Description | Modifications to CBE laboratories to increase capacity |
Amount | £131,000 (GBP) |
Organisation | Loughborough University |
Sector | Academic/University |
Country | United Kingdom |
Start | 05/2013 |
End | 07/2013 |
Description | Nottingham Catalyst Partnership Fund |
Amount | £500 (GBP) |
Organisation | University of Nottingham |
Sector | Academic/University |
Country | United Kingdom |
Start | 09/2014 |
End | 12/2014 |
Description | Rational Bioactive Materials Design for Tissue Regeneration |
Amount | £402,880 (GBP) |
Funding ID | 262948-2 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 01/2012 |
End | 01/2016 |
Description | Redistributed Manufacturing in Healthcare Network - Feasibility Studies |
Amount | £49,000 (GBP) |
Funding ID | EP/M017559/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 11/2015 |
End | 04/2016 |
Description | Research Fellowships Scheme (Marianne Ellis) |
Amount | £47,137 (GBP) |
Organisation | Royal Academy of Engineering |
Department | The Leverhulme Trust/Royal Academy of Engineering |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 05/2014 |
End | 05/2015 |
Description | Research Grant |
Amount | £12,000 (GBP) |
Funding ID | RPG 139 |
Organisation | Institute of Orthopaedics |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 01/2014 |
End | 01/2016 |
Description | Self assembling liposome nano-transducers |
Amount | £733,386 (GBP) |
Funding ID | EP/J001953/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 09/2011 |
End | 10/2016 |
Description | Sensor integrated Bioreactors (SIBs) |
Amount | £402,995 (GBP) |
Funding ID | 101101 |
Organisation | Innovate UK |
Sector | Public |
Country | United Kingdom |
Start | 03/2012 |
End | 03/2014 |
Description | Stem Cells as Therapeutic Agents in Arthritis |
Amount | £98,735 (GBP) |
Organisation | The Dowager Countess Eleanor Peel Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 03/2013 |
End | 11/2013 |
Description | Stuart Jenkins Fellowship |
Amount | £185,000 (GBP) |
Funding ID | EP/I017801/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 09/2012 |
End | 09/2014 |
Description | Supporting regenerative medicine and cell therapies |
Amount | £922,367 (GBP) |
Funding ID | 32065-222136 |
Organisation | Innovate UK |
Sector | Public |
Country | United Kingdom |
Start | 07/2014 |
End | 07/2017 |
Description | UK Regenerative Medicine Platform Hub: Acellular |
Amount | £3,499,345 (GBP) |
Funding ID | MR/K026682/1 |
Organisation | Medical Research Council (MRC) |
Sector | Public |
Country | United Kingdom |
Start | 08/2013 |
End | 08/2017 |
Description | Wellcome Trust Translational Scheme |
Amount | £583,461 (GBP) |
Organisation | Wellcome Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 09/2013 |
End | 04/2017 |
Description | skelGEN |
Amount | £21,000 (GBP) |
Funding ID | 318553 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 12/2012 |
End | 11/2016 |
Title | ECP023 Characteristics of Cells |
Description | MSCs that differentiate towards cartilage formation are potentially associated with the higher performing cell population in our pre-clinical model. This information could be used as design input to a further study to test/validate these relationships. |
Type Of Material | Model of mechanisms or symptoms - mammalian in vivo |
Year Produced | 2014 |
Provided To Others? | Yes |
Impact | Our pre-clinical model over a short time period allows assessment of input and output variables to be measured and assessed linked to manufacturing expertise to define cell parameters for quality markers. |
Title | Identification of Subpopulations within Mesenchymal Stem Cell Cultures |
Description | We have discovered a novel technique that could measure this osteogenic potential from a small marrow sample. The same technique can subsequently separate and enrich the population of highly osteogenic cells from the full cell population. |
Type Of Material | Technology assay or reagent |
Year Produced | 2014 |
Provided To Others? | Yes |
Impact | Patentability of the technique is currently being evaluated. |
Description | ECP001 - TAP Biosystems |
Organisation | TAP Biosystems |
Country | United Kingdom |
Sector | Private |
PI Contribution | Efficient (next generation) Manufacturing Platform for adherent allogeneic cell therapies |
Start Year | 2010 |
Description | ECP002 - Syngenta |
Organisation | Syngenta International AG |
Country | Switzerland |
Sector | Private |
PI Contribution | Development of a Tissue Engineered 3D in vitro lymph node model. Syngenta have expressed an interest in the development of an in vitro model of human lymph node as it has direct relevance to their industry. Although not providing any financial contribution to the studentship, they are providing academic expertise through attendance at quarterly supervisor meetings. |
Start Year | 2012 |
Description | ECP002 - Unilever |
Organisation | Unilever |
Country | United Kingdom |
Sector | Private |
PI Contribution | Development of a Tissue Engineered 3D in vitro lymph node model |
Start Year | 2010 |
Description | ECP002 - University of Leeds |
Organisation | University of Leeds |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Development of a Tissue Engineered 3D in vitro lymph node model. In order to enhance the permeability of the scaffolds being used for this project to the cells being used for model development, we used an ultrasound treatment developed and conducted at Leeds University. |
Start Year | 2010 |
Description | ECP003 - Smith & Nephew |
Organisation | Smith and Nephew |
Country | United Kingdom |
Sector | Private |
PI Contribution | Near Patient Cell Processing, Phase 1: Enabling manufacturing & supply of cell therapies in hospital settings |
Start Year | 2010 |
Description | ECP003 - TAP Biosystems |
Organisation | TAP Biosystems |
Country | United Kingdom |
Sector | Private |
PI Contribution | Near Patient Cell Processing, Phase 1: Enabling manufacturing & supply of cell therapies in hospital settings |
Start Year | 2010 |
Description | ECP003 Anthony Nolan |
Organisation | Anthony Nolan Cell Therapy Centre |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | Mapping processes |
Start Year | 2010 |
Description | ECP003 Dana Farber Cancer Institute |
Organisation | Dana-Farber Cancer Institute |
Country | United States |
Sector | Hospitals |
PI Contribution | Developing research opportunities |
Collaborator Contribution | Access to comprehensive data on biological variation in a key clinical procedure including manufacturing steps. |
Impact | Multi-disciplinary spanning medicine, biology and engineering. |
Start Year | 2011 |
Description | ECP003 FHT |
Organisation | Future Health Technologies |
Country | United Kingdom |
Sector | Private |
PI Contribution | Mapping processes |
Start Year | 2010 |
Description | ECP003 Oswestry Hospital |
Organisation | Oswestry Hospital |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | Developing research opportunities |
Start Year | 2010 |
Description | ECP003 QMC |
Organisation | Nottingham University Hospitals NHS Trust |
Department | Pathology Department |
Country | United Kingdom |
Sector | Hospitals |
PI Contribution | Mapping processes |
Start Year | 2010 |
Description | ECP003 UCL Institute of Opthamology |
Organisation | University College London |
Department | Institute of Ophthalmology UCL |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Developing research opportunities and mapping processes |
Start Year | 2010 |
Description | ECP004 - Ludwig Boltzmann Institute |
Organisation | Ludwig Boltzmann Society |
Department | Ludwig Boltzmann Institute for Experimental and Clinical Traumatology |
Country | Austria |
Sector | Academic/University |
PI Contribution | A new 3D delivery platform for regenerative medicine |
Start Year | 2011 |
Description | ECP004 - McGowan Institute |
Organisation | University of Pittsburgh |
Country | United States |
Sector | Academic/University |
PI Contribution | A new 3D delivery platform for regenerative medicine |
Start Year | 2012 |
Description | ECP004 - RegenTec |
Organisation | Regentec |
Country | United Kingdom |
Sector | Private |
PI Contribution | A new 3D delivery platform for regenerative medicine |
Start Year | 2011 |
Description | ECP005 - Moorfields Eye Hospital |
Organisation | Moorfields Eye Hospital NHS Foundation Trust |
Country | United Kingdom |
Sector | Public |
PI Contribution | Label Free Assessment of Live Cell Quality with Total Internal Reflection Microscopy |
Start Year | 2012 |
Description | ECP005 - National Physical Laboratory |
Organisation | National Physical Laboratory |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Label Free Assessment of Live Cell Quality with Total Internal Reflection Microscopy |
Start Year | 2011 |
Description | ECP005 - Reneuron |
Organisation | Reneuron |
Country | United Kingdom |
Sector | Private |
PI Contribution | Label Free Assessment of Live Cell Quality with Total Internal Reflection Microscopy |
Start Year | 2011 |
Description | ECP007 - Tissue Growth Technologies |
Organisation | Tissue Growth Technologies |
Country | United States |
Sector | Private |
PI Contribution | Development & validation of TGT Hydrostatic Bioreactor for tissue processing and manufacturing in regenerative medicine |
Start Year | 2011 |
Description | ECP008 - Ruskinn Technology |
Organisation | Ruskinn Technology Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | Near Patient Processing: HypOxyCool for Improved Autologous Cell Production |
Start Year | 2011 |
Description | ECP013 - Pfizer |
Organisation | Pfizer Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | Evaluation of Functionalised Membranes for use in Immunisolatory devices for Regenerative Medicine and Cell based therapies |
Start Year | 2010 |
Description | ECP015 - Neusentis |
Organisation | Pfizer Ltd |
Department | Neusentis Pfizer |
Country | United Kingdom |
Sector | Private |
PI Contribution | Quality by Design (QbD) approach to risk reduction and optimisation for a unit operation of cell therapy manufacture |
Start Year | 2011 |
Description | ECP020 - Bose |
Organisation | Bose Corporation |
Department | Bose ElectroForce |
Country | United States |
Sector | Private |
PI Contribution | Control of human mesenchymal stem cell differentiation to a nucleus pulposus phenotype by improving the design of physiologically relevant in vitro conditions |
Start Year | 2011 |
Description | ECP020 - Fondazione Filarete |
Organisation | Fondazione Filarete |
Country | Italy |
Sector | Private |
PI Contribution | Control of human mesenchymal stem cell differentiation to a nucleus pulposus phenotype by improving the design of physiologically relevant in vitro conditions. This collaboration has included a number of secondments to take advantage of training and access to facilities: PhD Student HH from Loughborough spent three months at Fondzione Filarete 07/10/11 to 13/01/12 PhD Student AF from Loughborough spent three months at Fondazione Filarete 13/05/12 to 04/09/12 PhD Student TS from Fondazione Filarete spent two weeks at Loughborough 12/03/13 to 24/03/13 PhD Student AF from Loughborough spent two months at Fondazione Filarete 17/02/13 to 19/04/13 |
Start Year | 2011 |
Description | ECP020 - Ruskinn Technology |
Organisation | Ruskinn Technology Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | Control of human mesenchymal stem cell differentiation to a nucleus pulposus phenotype by improving the design of physiologically relevant in vitro conditions |
Start Year | 2011 |
Description | ECP021 - Anthony Nolan |
Organisation | Anthony Nolan Cell Therapy Centre |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | Near Patient Cell Processing, Phase 2: Enabling manufacturing & supply of cell therapies in hospital settings |
Start Year | 2012 |
Description | ECP021 - TAP Biosystems |
Organisation | TAP Biosystems |
Country | United Kingdom |
Sector | Private |
PI Contribution | Near Patient Cell Processing, Phase 2: Enabling manufacturing & supply of cell therapies in hospital settings |
Start Year | 2011 |
Description | ECP022 - Ceram |
Organisation | Lucideon |
Country | United Kingdom |
Sector | Private |
PI Contribution | Nano-structured zirconias as an enabling material for enhanced ceramic implants |
Start Year | 2011 |
Description | ECP023 - Orthopaedic Institute |
Organisation | The Orthopaedic Institute |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | From Science Bench to the Clinical Application: Establishing a stem cell population with consistent therapeutic behaviours ? Kehoe , Richardson, El Haj (KU) |
Start Year | 2011 |
Description | ECP028 - University of Cambridge |
Organisation | University of Cambridge |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | A Novel Method to Develop Electrospun Scaffolds with Tailored Geometries for in vitro models of Skin |
Start Year | 2011 |
Description | ECP029 - Haemostatix |
Organisation | Haemostatix |
Country | United Kingdom |
Sector | Private |
PI Contribution | In vitro optimisation and evaluation of a series of flow-able gelatin paste composites for wound healing |
Start Year | 2011 |
Description | ECP030 - Newcastle University |
Organisation | Newcastle University |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Evaluation of Injectable scaffolds for use in accelerated anterior cruciate ligament (ACL) reconstruction |
Start Year | 2011 |
Description | ECP031 - Cellon |
Organisation | MCR Media Group |
Country | Israel |
Sector | Private |
PI Contribution | SIFT-MS Monitoring of cell growth in Cellon CELL-tainer bioreactor |
Start Year | 2011 |
Description | ECP037 - Neusentis |
Organisation | Pfizer Ltd |
Department | Neusentis Pfizer |
Country | United Kingdom |
Sector | Private |
PI Contribution | Optimisation of a Delivery Membrane |
Start Year | 2012 |
Description | ECP038 - Nottingham University Hospitals NHS Trust |
Organisation | Nottingham University Hospitals NHS Trust |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Defining and manufacturing a cell therapy product for the generation of bone in spinal surgery applications |
Start Year | 2012 |
Description | ECP038 - RegenTec |
Organisation | Regentec |
Country | United Kingdom |
Sector | Private |
PI Contribution | Defining and manufacturing a cell therapy product for the generation of bone in spinal surgery applications |
Start Year | 2012 |
Description | ECP040 - Cool Logistics |
Organisation | Cool Logistics |
Country | United Kingdom |
Sector | Private |
PI Contribution | Modelling Thermal Performance of a Cold Chain Transportation System. During this project we developed and validated a computational model capable of describing, analysing and predicting the thermal performance of the Credo cold chain transportation packaging system under diverse loads and ambient conditions. |
Start Year | 2012 |
Description | ECP043 - Neusentis |
Organisation | Pfizer Ltd |
Department | Neusentis Pfizer |
Country | United Kingdom |
Sector | Private |
PI Contribution | Optimisation of a Delivery Membrane - Phase 2 |
Start Year | 2012 |
Description | ECP044 - Glasgow University |
Organisation | University of Glasgow |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | RBC production from hESC |
Start Year | 2012 |
Description | ECP045 - Mica Biosystems |
Organisation | Mica Biosystems |
Country | United Kingdom |
Sector | Private |
PI Contribution | Development of dynamic 3D models for regenerative medicine |
Start Year | 2012 |
Description | ECP048 - Glasgow University |
Organisation | University of Glasgow |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | RBC production from hESC in scalable suspension format - Phase 2 |
Start Year | 2013 |
Description | ECP049 - Cell Therapy Catapult |
Organisation | Cell Therapy Catapult |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | QbD approach to risk reduction and optimisation of CTX culture and cryopreservation manufacturing processes |
Start Year | 2013 |
Description | ECP049 - ReNeuron |
Organisation | Reneuron |
Country | United Kingdom |
Sector | Private |
PI Contribution | QbD approach to risk reduction and optimisation of CTX culture and cryopreservation manufacturing processes |
Start Year | 2013 |
Description | ECP050 - Dr Belinda Clarke |
Organisation | Innovate UK |
Country | United Kingdom |
Sector | Public |
PI Contribution | Staff time, in person meetings and discussions, TSB workshop presentations, hosting at Loughborough to showcase facilities |
Collaborator Contribution | Advice, Letter of Support for fellowship bid |
Impact | Contributed towards being awarded fellowship funding and towards meeting key Synthetic Biology figureheads (SynBiCITE directors) and industrial partnerships |
Start Year | 2013 |
Description | ECP050 - Dr Ivan Wall |
Organisation | University College London |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Staff time, in-person meetings, joint proposal writing and maintaining the partnership |
Collaborator Contribution | Staff time, in-person meetings, joint proposal writing and maintaining the partnership |
Impact | Submitted Joint Proposal to Manufacturing the Future competition, multidisciplinary; Synthetic Biology, Regenerative Medicine, Biochemical Engineering and Manufacturing Engineering |
Start Year | 2014 |
Description | ECP050 - Roslin Cells |
Organisation | Roslin Cells Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | Exploring the feasibility of Synthetic Biology applications in systematic engineering of cell therapies |
Start Year | 2013 |
Description | ECP050 - SynBiCITE |
Organisation | SynbiCITE |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Staff time, in-person meetings, maintaining the partnership and progress updates |
Collaborator Contribution | Staff time, in person meetings, Letters of Support for fellowship funding |
Impact | Contributed to Fellowship award, raised Loughborough University's profile within Synthetic Biology and facilitated access to state of the art Synthetic Biology research groups |
Start Year | 2013 |
Description | ECP050 - Synpromics |
Organisation | Synpromics |
Country | United Kingdom |
Sector | Private |
PI Contribution | Generation of a collaborative Fellowship project, staff time, in-person meetings, bid writing, maintenance of the collaboration |
Collaborator Contribution | Staff time, meetings, technology and materials contributions, letters of support for fellowship bid |
Impact | Contributed to successful award of fellowship funding, multidisciplinary collaboration; Synthetic Biology, Stem Cell research, Gene Therapy research, Engineering |
Start Year | 2014 |
Description | ECP050 - Synthace |
Organisation | Synthace |
Country | United Kingdom |
Sector | Private |
PI Contribution | Staff time, in person meetings, discussions and scoping for potential collaborative research projects |
Collaborator Contribution | Staff time, in person meetings, discussions and scoping for potential collaborative research projects |
Impact | Raising profile of EPSRC Centre among Synthetic Biology Industry leaders, potential for future collaboration |
Start Year | 2013 |
Description | ECP050 - University College London |
Organisation | University College London |
Department | UCL Cancer Institute |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Exploring the feasibility of Synthetic Biology applications in systematic engineering of cell therapies |
Start Year | 2013 |
Description | ECP051 - CECS/I-STEM |
Organisation | National Institute of Health and Medical Research (INSERM) |
Department | Institute for Stem cell Therapy and Exploration of Monogenic diseases (I-Stem) |
Country | France |
Sector | Academic/University |
PI Contribution | Create a working cell bank, perform manual and automated expansion of the hiPSC line, bank these cells and then perform quality metrics to the I-STEM metrics. In addition, these cells will be differentiated to MSCs and the cells will be tested for their quality. I-STEM have developed a protocol for the automated expansion of their hiPSC lines. They want to see whether the protocols are comparable over multiple sites and Loughborough University will be able to present them with this data. |
Collaborator Contribution | Cells, protocols for automated and manual expansion, telephone contact with I-STEM research staff |
Impact | This collaboration has led to the inclusion of Loughborough University in the I-STEM lead Horizon 2020 project |
Start Year | 2013 |
Description | ECP051 - LGC |
Organisation | LGC Ltd |
Department | Cell Metrology |
Country | United Kingdom |
Sector | Private |
PI Contribution | Provide cells to the research group at LGC |
Collaborator Contribution | Analyse the cells for differences in the automation protocols |
Impact | Analysis of the cells for differences in the automation protocols |
Start Year | 2013 |
Description | ECP051 - Loughborough University |
Organisation | Loughborough University |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Process engineering and techniques enabling the automation of GMP cell culture processes |
Start Year | 2013 |
Description | ECP051 - TAP Biosystems |
Organisation | TAP Biosystems |
Country | United Kingdom |
Sector | Private |
PI Contribution | Process engineering and techniques enabling the automation of GMP cell culture processes |
Start Year | 2013 |
Description | ECP051 - University College London |
Organisation | University College London |
Department | UCL Cancer Institute |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Process engineering and techniques enabling the automation of GMP cell culture processes |
Start Year | 2013 |
Description | ECP051 - Wicell Research Institute |
Organisation | Wicell Research Institute |
Country | United States |
Sector | Charity/Non Profit |
PI Contribution | Process engineering and techniques enabling the automation of GMP cell culture processes |
Start Year | 2013 |
Description | Engagement Activity - Dragon's Den Sandpit, Birmingham - Clinical Leadership & Mentoring |
Organisation | University of Birmingham |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Organisation of Dragon's Den Sandpit Event in Opthalmology |
Collaborator Contribution | Clinical leadership provided by Prof Robert Scott and Saaeha Rauz. Mentoring provided by Prof Liam Grover, Prof Ann Logan and Dr Graham Wallace. |
Impact | One project funded by EPSRC Centre - Electrospin & Electrostim. Additional projects being worked up. |
Start Year | 2014 |
Description | Engagement Activity - Dragon's Den Sandpit, Birmingham - organisation |
Organisation | University of Birmingham |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Organisation and facilitation of the sandpit event, with funding provided for one project by the EPSRC Centre. |
Collaborator Contribution | Provision of venue free of charge. |
Impact | One project funded by EPSRC Centre - Electrospin & Electrostim. Additional projects being worked up. |
Start Year | 2014 |
Description | Engagement Activity - Dragons Den Sandpit Event Bath |
Organisation | University of Bath |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Organisation of the event, payment for accommodation and catering. |
Collaborator Contribution | Free of charge provision of a meeting room, some local administrative organisation. |
Impact | Numerous projects created at the event and one project funded with £40,000 (80% fEC value). |
Start Year | 2012 |
Description | Engagement Activity - Dragons Den Sandpit Event London |
Organisation | University College London |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Organisation of the event, payment for accommodation and catering. |
Collaborator Contribution | Free of charge provision of a meeting room, some local administrative organisation. |
Impact | Numerous projects created at the event and one project funded with £40,000 (80% fEC value). |
Start Year | 2014 |
Description | Engagement Activity - Dragons Den Sandpit Event, Birmingham - Mentoring SA |
Organisation | University of Liverpool |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Organisation of Dragon's Den Sandpit in Opthalmology |
Collaborator Contribution | Mentoring provided by Dr Sajjad Ahmad |
Impact | One project funded by EPSRC Centre - Electrospin & Electrostim. Additional projects being worked up. |
Start Year | 2014 |
Description | Engagement Activity - Dragons' Den Sandpit Event Newcastle |
Organisation | Newcastle University |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Organisation of the event, payment for accommodation and catering. |
Collaborator Contribution | Free of charge provision of a meeting room, some local administrative organisation. |
Impact | Numerous projects created at the event and one project funded with £40,000 (80% fEC value). |
Start Year | 2013 |
Description | Engagement Activity - Harvard Stem Cell Institute Internship Programme |
Organisation | Harvard University |
Department | Harvard Stem Cell Institute |
Country | United States |
Sector | Academic/University |
PI Contribution | Organised a nationwide competition for UK undergraduate students to apply for a place at the Harvard Stem Cell Institute summer internship program. Housing and travel costs covered by the EPSRC Centre. |
Collaborator Contribution | Considerable training of the winner, Elizabeth Cheeseman of Loughborough University, in stem cell techniques, and provision of a development opportunity for her. |
Impact | Internship competition winner Elizabeth Cheeseman is planning to apply for a PhD for 2015 entry. Ongoing relationship with Harvard, with joint StemBook activities. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors |
Organisation | GlaxoSmithKline (GSK) |
Country | Global |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | CV clinic mentor (1 day plus prep time). |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors |
Organisation | Intercytex |
Country | United Kingdom |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | CV clinic mentor (1 day plus prep time). |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors |
Organisation | Lonza Group |
Country | Global |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | CV clinic mentor (1 day plus prep time). |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors |
Organisation | Terumo BCT |
Country | United States |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | CV clinic mentor (1 day plus prep time). |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event CV Clinic Mentors |
Organisation | University of Leeds |
Department | Medical Technologies IKC |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | CV clinic mentor (1 day plus prep time). |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event Regener8 |
Organisation | University of Leeds |
Department | Regener8 |
Country | United Kingdom |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | Co-organiser, marketing and speaker contribution. |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event SRG |
Organisation | SRG |
Country | United Kingdom |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | Training session provider (1 day plus prep time). |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event Speakers |
Organisation | Cell Therapy Catapult |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors] |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event Speakers |
Organisation | JRI Orthapaedics |
Country | United Kingdom |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors] |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event Speakers |
Organisation | NHS National Services Scotland (NSS) |
Department | Scottish National Blood Transfusion Service |
Country | United Kingdom |
Sector | Public |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors] |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event Speakers |
Organisation | Puridify |
Country | United Kingdom |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors] |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event Speakers |
Organisation | Smith and Nephew |
Country | United Kingdom |
Sector | Private |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors] |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Regen Med Careers Awareness Event Speakers |
Organisation | University of Leicester |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Organisation and publicity of the event, 66% subsidy on cost of attendance for early career researchers, payment of speakers' travel costs. |
Collaborator Contribution | Speaker role and CV clinic mentor (1 day plus prep time). [Cell Therapy Catapult provided 2 CV clinic mentors] |
Impact | Increase in awareness within early career community of alternative careers in the regenerative medicine sector. Increased confidence of early career researchers in applying for roles outside of the 'normal' route to postdoc/fellowship. |
Start Year | 2014 |
Description | Engagement Activity - Right Product, Right Patient, Right Time KTN |
Organisation | Knowledge Transfer Network |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | Provided funding and local venue booking support for hosting the 'Right product, right patient, right time' meeting with the KTN at Loughborough University. Provided input to the design of the agenda, promoted the event and attracted the EPSRC's academic and industrial partners. |
Collaborator Contribution | Organisational support for the event - registration, logistics on the day. Led on design of the agenda. Considerable input into promotion among the KTN's network. |
Impact | StemBook publication resulted from the variety of talks during the event - http://www.stembook.org/node/6149 |
Start Year | 2013 |
Description | Engagement Activity - Right Product, Right Patient, Right Time Speakers |
Organisation | Asymptote |
Country | United Kingdom |
Sector | Private |
PI Contribution | Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network. |
Collaborator Contribution | Attendance at the event and speaker slot. |
Impact | Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman. |
Start Year | 2013 |
Description | Engagement Activity - Right Product, Right Patient, Right Time Speakers |
Organisation | Cell Therapy Catapult |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network. |
Collaborator Contribution | Attendance at the event and speaker slot. |
Impact | Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman. |
Start Year | 2013 |
Description | Engagement Activity - Right Product, Right Patient, Right Time Speakers |
Organisation | Grimsby Institute of Further and Higher Education |
Country | United Kingdom |
Sector | Academic/University |
PI Contribution | Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network. |
Collaborator Contribution | Attendance at the event and speaker slot. |
Impact | Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman. |
Start Year | 2013 |
Description | Engagement Activity - Right Product, Right Patient, Right Time Speakers |
Organisation | Intercytex |
Country | United Kingdom |
Sector | Private |
PI Contribution | Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network. |
Collaborator Contribution | Attendance at the event and speaker slot. |
Impact | Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman. |
Start Year | 2013 |
Description | Engagement Activity - Right Product, Right Patient, Right Time Speakers |
Organisation | World Courier |
Country | United States |
Sector | Private |
PI Contribution | Co-organised the event 'Getting the product to the patient - right time, right place and safe to deliver: Challenges and innovation in cold chain, supply logistics and transport' with the Knowledge Transfer Network. |
Collaborator Contribution | Attendance at the event and speaker slot. |
Impact | Transfer of best practice from various sectors to facilitate step-change improvements in the regenerative medicine supply chain. Resulted in publication of StemBook paper 'From production to patient: challenges and approaches for delivering cell therapies' by Nick Medcalf and Karen Coopman. |
Start Year | 2013 |
Description | Engagement Activity - StemBook |
Organisation | Harvard University |
Department | Harvard Stem Cell Institute |
Country | United States |
Sector | Academic/University |
PI Contribution | Provided guidance on potential manufacturing content for StemBook, an online peer-reviewed repository aimed at stem cell experts and non-experts. David Williams joined the editorial board. EPSRC Centre members co-authored numerous papers within the new manufacturing chapter created. |
Collaborator Contribution | Editorial support for new manufacturing chapter - arranging peer-review of papers and maintenance of online repository. |
Impact | New manufacturing chapter for StemBook, providing material for knowledge exchange and training. Numerous papers include EPSRC Centre authors. |
Start Year | 2014 |
Description | Engagement Activity - Summer Student British Mass Spectrometry Society |
Organisation | British Mass Spectrometry Society |
Country | United Kingdom |
Sector | Charity/Non Profit |
PI Contribution | Design and supervision of the project, training the next generation of doctors. |
Collaborator Contribution | Sponsorship of student bursary for summer project. |
Impact | Work presented at Mercia Stem Cell Alliance meeting. Training the next generation of doctors. |
Start Year | 2014 |
Description | Engagement Activity - Summer Student PA Consulting |
Organisation | PA Consulting |
Country | United Kingdom |
Sector | Private |
PI Contribution | PA Consulting were introduced to Keele University academics through the Head of Engagement, followed by negotiation of the summer project content and how it would be funded. |
Collaborator Contribution | PA Consulting funded the student bursary and co-supervised the project. Provided training experience for a future medical doctor. |
Impact | Progress in the design of a medical device for improving the delivery and effect of stem cell treatments to the knee. |
Start Year | 2014 |
Description | Engagement Activity - Summer Student Waters Corporation |
Organisation | Waters Corporation |
Department | Waters Corporation Centre of Mass Spectrometry Excellence |
Country | United Kingdom |
Sector | Private |
PI Contribution | Project design, supervision of the student, engagement of company. |
Collaborator Contribution | Project design with Keele academics, co-supervision of medical student for the summer. |
Impact | Work presented at a Mercia Stem Cell Alliance meeting. Training of the next generation of doctors. |
Start Year | 2014 |
Description | Engagement Activity - Summer Students x2 nanoTherics |
Organisation | nanoTherics Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | nanoTherics introduced to two projects based at Keele for the summer of 2014. Can magnetic hyperthermia safely enhance magnetic nanoparticle labelling of neural stem cells? and Using a novel multifunctional magnetic nanoparticle with a state-of-the-art 'magnetofection' device to enhance gene transfer to neural transplant cells? |
Collaborator Contribution | nanoTherics provided support in designing the two projects and provided the medical students with experience of working with an industrial company. |
Impact | Presentation at INSPIRE student conference. Training of future doctors in research and development and ways of working with industry. |
Start Year | 2014 |
Description | Engagement Activity - UK Science and Innovation Network |
Organisation | Department for Business, Energy & Industrial Strategy |
Department | UK Science and Innovation Network |
Country | United Kingdom |
Sector | Public |
PI Contribution | Interaction with UK Science and Innovation Network on a regular basis, resulting in a mission to Boston, development of a new manufacturing chapter for StemBook in collaboration with the Harvard Stem Cell Institute and a UK-wide competition to send an undergraduate student to undertake Harvard's prestigious summer internship programme. |
Collaborator Contribution | Introductions to key colleagues in Boston and the surrounding area. Organisation of the Boston mission. |
Impact | New manufacturing chapter in StemBook. Publication by EPSRC Centre authors of numerous papers within this chapter. UK-wide national competition resulting in Elizabeth Cheeseman attending Harvard's prestigious internship programme. |
Start Year | 2012 |
Description | Hypoxia cell culture equipment |
Organisation | Ruskinn Technology Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | Keele developed a system for rapid deoxygenation of cell culture media for application in cell therapy manufacturing. This technology was filed for patent in both US and EU systems. The US patent was allowed to drop and the EU patent is still pending. |
Collaborator Contribution | Baker Ruskinn licensed the technology from Keele and provided the engineering expertise to develop prototype systems to valid the system for cell therapy manufacturing purposes. |
Impact | A wide range of publications and conference presentations have resulted from this collaborative research. This was a multidisciplinary project requiring cell therapy and stem cell biology expertise coupled to engineering expertise. |
Start Year | 2009 |
Description | Near patient cell processing |
Organisation | Athersys Inc. |
Country | United States |
Sector | Private |
PI Contribution | Our cell therapy facility was utilized for closed cell processing of the Athersys Multistem cell therapy product for application in an ischemic stroke focused clinical trial. |
Collaborator Contribution | Athersys provided financial support for cell processing and were running the clinical trial. |
Impact | N/A |
Start Year | 2014 |
Title | COMPOSITION AND DELIVERY SYSTEM |
Description | An injectable agent delivery system comprising a composition that comprises: an agent for sustained delivery located within discrete particles; and an injectable scaffold material comprising discrete particles which are capable of interacting to form a scaffold, and uses thereof. |
IP Reference | WO2015019109 |
Protection | Patent application published |
Year Protection Granted | 2015 |
Licensed | Yes |
Impact | The patent forms the basis of activity for Locate Therapeutics. The technology is a platform from which formulated derivatives can be made. |
Title | Methods and apparatuses relating to cell culture media |
Description | A method and apparatus to deoxygenate cell culture media to defined set-points. |
IP Reference | 08775852.0 |
Protection | Patent application published |
Year Protection Granted | 2010 |
Licensed | Yes |
Impact | N/A |
Title | Methods and apparatuses relating to cell culture media |
Description | A method and apparatus to deoxygenate cell culture media to defined set-points. |
IP Reference | |
Protection | Protection not required |
Year Protection Granted | 2013 |
Licensed | Yes |
Impact | The intellectual property has formed the basis of a commercial instrument manufacturing and sales campaign by Baker Ruskinn. This brings an income stream to Keele under a fixed royalty arrangement. Further technological developments are being made as line extensions and as separate innovations. These items are, however, still confidential. Sales are satisfactory for a device of this size and sophistication. |
Title | Polymer Particles Prepared From Polymerisable Alkylene Glycol (Meth) Acrylate Monomers |
Description | The invention provides polymer particles that are obtainable by a method selected from emulsion methods, diffusion methods and evaporation methods carried out in the presence of surface-engineering surfactant which is one or more polymer that displays a lower critical solution temperature, in aqueous media, that is between 10 to 90° C., this polymer being the polymerisation product of one or more monomer selected from polymerisable alkyleneglycol acrylate monomers and polymerisable alkyleneglycol methacrylate monomers. The polymer particles can be used in controlled release applications, such as flavour release applications, fragrance release applications and biomedical applications. The invention also provides a cell support matrix comprising the polymer particles. |
IP Reference | US2011305767 |
Protection | Patent application published |
Year Protection Granted | 2011 |
Licensed | Commercial In Confidence |
Impact | The invention is used for controlling cell behaviour in regenerative medicine applications. The thermally-switchable behaviour opens up options for managing cell deposition for a variety of uses in advanced therapeutics. |
Title | Responsive Magnetic Particulate Dispersion for Ex-vivo Cellular Expansion on 2D and 3D Cell Culture and Cell Recovery via Magnetic Separation |
Description | Scaffold production for regenerative medicine. |
IP Reference | GB1212595.1 |
Protection | Patent granted |
Year Protection Granted | 2012 |
Licensed | Yes |
Impact | IP for this technology was licensed to Locate Therapeutics Ltd. The company has secured a 2 year Wellcome Trust award to develop for scale up of cell manufacturing. |
Title | STEM CELL CULTURE METHOD |
Description | Methods for culturing pluripotent stem cells on fiber scaffolds are provided which result in the expansion of the number of stem cells without loss of pluripotency. Cells obtained by such methods, implants containing such cells and medical methods using such cells are also disclosed. |
IP Reference | US2014050704 |
Protection | Patent granted |
Year Protection Granted | 2014 |
Licensed | No |
Impact | The technology provides a culture environment that can be used by researchers to enable biomimetic 3D culture of pluripotent cells. |
Title | Hydrostatic bioreactor for tissue engineering regenerative medicine |
Description | During the project we designed a Hydrostatic bioreactor with the company TGT in the USA. This company was then bought by Bose Enduratec. The product has been sold worldwide. |
Type | Support Tool - For Medical Intervention |
Current Stage Of Development | Wide-scale adoption |
Year Development Stage Completed | 2017 |
Development Status | Under active development/distribution |
Impact | The new design has led on to further work and further EPSRC funding. The design is now being replicated in product ranges form other companies |
Company Name | Shunxi Stem Cell Engineering Ltd. |
Description | |
Year Established | 2014 |
Impact | The company has not been in business long enough to have a significant impact in the UK. |
Description | Bioprinting talk to NC3Rs workshop |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Industry/Business |
Results and Impact | The NC3Rs, Innovate UK and the Knowledge Transfer Network jointly hosted a workshop to advance the development and application of bioprinting approaches for improved efficacy and safety testing of drugs and other chemicals. A significant number of industrialists were present and the clinical translation and regulatory emphasis of the presentation given were of particular interest to the audience and led to some new planned interactions with industry partners. |
Year(s) Of Engagement Activity | 2015 |
URL | https://www.nc3rs.org.uk/events/bioprinting-for-more-predictive-efficacy-and-safety-testing |
Description | Cell and Gene Therapy: 21st Century Medicines |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Schools |
Results and Impact | The engagement event was held in collaboration with Cobra Biologics and was designed to introduce basic knowledge and career options in the arena of Cell and Gene Therapy. We welcomed around 100 GCSE and A-level students from both local and national backgrounds to hear a range of presentations including from the Cell and Gene Therapy Catapult, Cobra Biologics, and ISTMs Prof James Richardson, himself a pioneer of cell therapy in the UK. A lively discussion was held immediately following on from the talks (~15 minutes) after which snacks and drinks were provided around a number of trade stalls where further discussion was held. Widespread positive feedback was received following on from the event including requests for next years dates. |
Year(s) Of Engagement Activity | 2017 |
URL | http://www.cobrabio.com/News/December-2017/Post-Event-21Cmed |
Description | ECP007 Bioreactor Course 2013 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | Regional |
Primary Audience | Postgraduate students |
Results and Impact | Representation of our industrial partner, Instron, at the bioreactor course and demonstration of their hydrostatic bioreactor system. Spoke to postgraduate students, colleagues and industry representatives. |
Year(s) Of Engagement Activity | 2013 |
URL | http://www.keele.ac.uk/bioreactorcourse/courseoverview/ |
Description | ECP007 Bioreactor Course 2014 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | Local |
Primary Audience | Postgraduate students |
Results and Impact | Oral presentation at the bioreactor course. Spoke to postgraduate students, academics and representatives from industry. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.keele.ac.uk/bioreactorcourse/home/ |
Description | ECP050 TSB 1 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | 1st Tools and Services for Synthetic Biology TSB Workshop, Manchester, UK 60 Industrial Enterprise and Academic representatives attended a TSB workshop in Synthetic Biology, I presented key work of the EPSRC Centre which sparked questions and discussion afterwards. Met two new collaborators with whom I had follow up meetings and discussions regarding collaborative research; 1 developed into a successful fellowship bid. |
Year(s) Of Engagement Activity | 2013 |
Description | ECP050 TSB 2 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | 2nd Tools and Services for Synthetic Biology TSB Workshop, Cardiff, UK 60 Industrial enterprise and academic research representatives attended a TSB workshop in Synthetic Biology, I presented key work of the EPSRC Centre and the automation and scaling work performed at Loughborough University. TSB Lead Technologist in Synthetic Biology requested a visit to my host department, the Centre for Biological Engineering at Loughborough University and to meet the EPSRC Centre team based at Loughborough. |
Year(s) Of Engagement Activity | 2013 |
Description | Education needs interview (The Telegraph) |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Media (as a channel to the public) |
Results and Impact | N Medcalf was interviewed by Helena Pozniak, a journalist at the Daily Telegraph for a feature on future job opportunities in medical technology as part of their "Careers of the Future" supplement. This is to show that it is technology as a growth area and explain why it offers significant opportunities for young people, as well as potential paths into a career in the field. The release will come out on the 18th March, hence "Not aware of any impact" below. |
Year(s) Of Engagement Activity | 2016 |
Description | Engagement Activity - ARMA Training |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | Yes |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Head of Engagement invited to give training session on using social media to engage partners which was delivered as part of a collaboration-building training session for research managers and administrators. Average scores of 4.4 out of 5 for format and delivery and 4.2 out of 5 for content and materials. Audience reported increase in knowledge of social media, and in particular how it can be applied to engaging partners. |
Year(s) Of Engagement Activity | 2014 |
Description | Engagement Activity - Annual Summit |
Form Of Engagement Activity | Participation in an open day or visit at my research institution |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Annual regenerative medicine manufacturing summit held, bringing together EPSRC Centre members with key collaborators from the clinical, commercial and regulatory areas. Constructive discussions regarding the focus of EPSRC Centre research projects and initiatives - especially regulatory science, engagement, training and careers awareness. |
Year(s) Of Engagement Activity | 2012,2013,2014 |
Description | Engagement Activity - Big Bang Fair 2014 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | National |
Primary Audience | Schools |
Results and Impact | Represented the EPSRC, at their invitation, on their stand at an event with a footfall of approx. 75,000. Approx. 5,000 school age learners estimated to have visited our stand. Research communicated included cell biology, scaffold creation and scale-up of cell culture. Follow-up from teachers for future schools visits. Request from Rutherford Appleton Laboratory for a speaker for their schools engagement programme, Karen Coopman will be presenting in 2015. Increase in visitors to our blog www.heartblog.net which was promoted at the event. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.thebigbangfair.co.uk/ |
Description | Engagement Activity - Big Bang Fair London 2014 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | Regional |
Primary Audience | Schools |
Results and Impact | Approx. 500 school age learners estimated to have visited our stand. Research communicated included cell biology, scaffold creation and scale-up of cell culture. Follow-up from charity specialising in supporting learners from economically deprived areas. Increase in visitors to our blog www.heartblog.net which was promoted at the event. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.thebigbangfair.co.uk/ |
Description | Engagement Activity - Biomat-IN consortium |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Invited to present at Biomat-IN consortium, to investigate possibility of UK regenerative medicine manufacturing academics working with the existing consortium to source additional funding to extend the work of the consortium. Sophie Dale-Black presented on the regenerative medicine manufacturing expertise across the UK and invited consortium members to contact her for introductions to UK academics. Introduction to fifteen Europe-wide academic and commercial organisations. Follow-up with visit to Loughborough University by consortium members. Follow-up with academic partners ongoing regarding possible Horizon 2020 European funding bids. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/ |
Description | Engagement Activity - Biomat-IN visit |
Form Of Engagement Activity | Participation in an open day or visit at my research institution |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Visit to Loughborough University by members of the Biomat-IN consortium - laboratory tour plus meeting time with academics. Follow-up discussions regarding ways of working together for EU funding calls. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/ |
Description | Engagement Activity - Bose Video |
Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | David Williams and Yang Liu interviewed for a Bose ElectroForce video regarding the EPSRC Centre's 'Hydrogels for treatment of intervertebral disc degeneration' project. Publicity of the 'Hydrogels for treatment of intervertebral disc degeneration' project and demonstration of engagement with Bose ElectroForce as a commercial partner. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.epsrc-regen-med.org/news/epsrc-centre-and-dtc-members-appear-in-new-bose-electroforce-vid... |
Description | Engagement Activity - Boston Mission |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | The EPSRC Centre undertook a mission to Boston, USA, in collaboration with the UK Science and Innovation Network at the British Consulate-General, to explore the biomanufacturing activities ongoing in Massachusetts and to develop new relationships for cooperation in cell therapy and regenerative medicine. The mission delegates had the opportunity to meet with many Boston organisations, including the MIT BioMAN Research Program site, the Harvard Stem Cell Institute, the Massachusetts Life Sciences Center and companies Xcellerex and Joule Unlimited. The mission allowed the promotion of the UK community's capabilities to a highly relevant US audience, sowing the initial seeds for future international collaborations. |
Year(s) Of Engagement Activity | 2013 |
URL | http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/ |
Description | Engagement Activity - Dragons Den Sandpit Event - Birmingham |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Dragons' Den sandpit event, themed on Opthalmology, attended by 26 participants and 9 mentors/clinical leads/facilitators. One project funded with £50K of EPSRC Centre funding 'Electrospin & Electrostim'. Four other projects deemed fundable by the panel, teams being encouraged to follow-up discussions and submit bids to external funding agencies. |
Year(s) Of Engagement Activity | 2014 |
Description | Engagement Activity - EATRIS |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Engagement of the EATRIS translational medicine infrastructure, which does not have UK members at present. Attendance of the 2013 ATMP platform meeting - presentation by Sophie Dale-Black on UK-wide regenerative medicine manufacturing activities and expertise. Attendance of the 2014 ATMP platform meeting - presentation by Mark McCall on cost of goods sold and its relationship to regenerative medicine manufacturing. Visit by EATRIS senior management to EPSRC Centre. Follow-on activities under discussion - e.g. potential white paper, talks at European conferences etc. Visit to EPSRC Centre by Giuseppe Banfi of Galeazzi Institute, Milan, to discuss possible EU bids. Introduction of Giuseppe Banfi to Cell Therapy Catapult. |
Year(s) Of Engagement Activity | 2013,2014 |
URL | http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/ |
Description | Engagement Activity - Galeazzi Institute |
Form Of Engagement Activity | Participation in an open day or visit at my research institution |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Visit by Giuseppe Banfi to EPSRC Centre, to meet with Loughborough, Nottingham and Keele university representatives. Discussion of possible collaborative EU funding bids. Reciprocal introductions of EPSRC Centre academics to members of Galeazzi Institute. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/ |
Description | Engagement Activity - HEART Blog |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | HEART blog (www.heartblog.net) is a collection of posts from 40+ students, researchers and academics who wish to communicate their research in the areas of Healthcare Engineering and Regenerative Therapies to the public, specifically to young learners of ages 11-19. The blog underpins the schools and public engagement work that is carried out by members of the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine and the EPSRC-MRC Centre for Doctoral Training in Regenerative Medicine, with guest posts from the EPSRC Centre for Doctoral Training in Targeted Therapeutics and Formulation Sciences. The HEART blog features two posts a week, at 11am UK time on a Tuesday and a Thursday. During school holidays, this is reduced to one post a week. The blog is created through Tumblr and is cross-posted to the Twitter (@HEARTregenmed) and Facebook (www.facebook.com/heartblog) social media platforms. The blog has had a total of 2,400 page views to date (Oct 27th 2014), with a returning visitor percentage of 40%. The blog also has an 'ask an expert' function where learners can ask questions of the scientists and engineers, allowing engagement with blog readers. The blog is used to follow-up after visits by researchers to schools to directly engage young learners. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.heartblog.net |
Description | Engagement Activity - HEART Outreach Brand |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Schools |
Results and Impact | The HEART (Healthcare Engineering and Regenerative Therapies) brand has been created jointly by the EPSRC Centre for Innovative Manufacturing in Regenerative Medicine and the EPSRC-MRC Centre for Doctoral Training in Regenerative Medicine. HEART is an umbrella brand covering all public and schools engagement work in the two centres, from social media (Twitter, Tumblr, Facebook, www.heartblog.net blog) to exhibitions (e.g. Big Bang Fair). HEART team members featured on BBC Breakfast News during the Big Bang Fair 2014 exhibition. Communication skills have been improved among HEART team members through receiving advanced outreach skills training and gaining experience in communicating their science through blog posts. Over 7,000 learners have been engaged through exhibitions and school workshops. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.heartblog.net |
Description | Engagement Activity - NOMs meeting |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Organised one-day meeting for National Outreach Managers from EPSRC Centres. Delivered two talks - one on outreach/engagement in regenerative medicine manufacturing and one on using social media tools to perform outreach/engagement. A number of National Outreach Managers adapted their social media strategies to include elements from our EPSRC Centre. |
Year(s) Of Engagement Activity | 2014 |
Description | Engagement Activity - Nanomedicine European Technology Platform |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | The EPSRC Centre joined the Nanomedicine European Technology Platform to represent UK academics in regenerative medicine manufacturing. Attended the 2014 annual general meeting. Contributed to the ETP's map of collaborators to ensure good UK inclusion. Joined working groups in regenerative medicine and training/education. Contributed to strategic research and innovation agenda of the ETP through both working groups. |
Year(s) Of Engagement Activity | 2013,2014 |
URL | http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/ |
Description | Engagement Activity - REMEDIC Consortium |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Attended workshop organised by the REMEDIC Consortium, to investigate the possibility of UK academics working with the existing consortium to source additional funding to extend the work of the consortium. The consortium did not contain any UK partners. Sophie Dale-Black presented on the regenerative medicine manufacturing expertise across the UK and invited consortium members to contact her for introductions to UK academics. Introduction to ten Europe-wide academic and commercial organisations. Follow-up with academic partners ongoing regarding possible Horizon 2020 European funding bids. |
Year(s) Of Engagement Activity | 2013 |
URL | http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/ |
Description | Engagement Activity - Regen Med Careers Awareness Event |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Over 55 students and postdocs from 12 institutions across the UK attended the UK's first careers awareness event in regenerative medicine, which we facilitated in conjunction with Regener8. Speakers and CV clinic mentors arranged from GSK, Lonza, SRG, TerumoBCT, Smith & Nephew, Puridify, Regner8, the Medical Technologies IKC, the University of Leicester, Loughborough University, the Cell Therapy Catapult, Intercytex, JRI Orthopaedics, SRG and the Scottish National Blood Transfusion Service. Review of the event published on EPSRC Centre website and opinion piece published in Orthopaedic Product News. Increased awareness by early career researchers of roles in the regenerative medicine industry. Should contribute to reduced leakage of skills from the sector. Should reduce oversubscription to fellowship calls as alternatives have been highlighted. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.epsrc-regen-med.org/news/review-of-the-first-national-regenerative-medicine-careers-event... |
Description | Engagement Activity - Royal Society Summer Science Exhibition |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | National |
Primary Audience | Schools |
Results and Impact | Team led by Kevin Shakesheff designed and delivered the Biology Builders exhibition during the week-long summer science exhibition. Engagement of school age learners from across the UK. Engagement of VIPs during evening soiree, including scientific TV personalities. |
Year(s) Of Engagement Activity | 2013 |
URL | http://www.epsrc-regen-med.org/biologybuilders/ |
Description | Engagement Activity - Social Media |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Social media is used to promote and disseminate the EPSRC Centre's successes to academic, clinical and commercial contacts, and also to the public as a whole. Platforms used include Twitter (@RM_Outreach and @HEARTregenmed), LinkedIn (public feed plus group and company pages), Mailchimp (e-newsletters), Tumblr (HEART outreach). Engagement of existing partners achieved in a smart way - short, directed messages and longer, aesthetically-designed e-newsletters. Engagement of new partners through public feeds on social media. Followers in excess of 1000 plus public feed immeasurable. Reach of messages enhanced through sharing/retweeting by EPSRC Centre members, the EPSRC itself and key partners such as the Cell Therapy Catapult. |
Year(s) Of Engagement Activity | 2013,2014 |
URL | http://www.epsrc-regen-med.org/outreach/ |
Description | Engagement Activity - TERM Consortium |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Other academic audiences (collaborators, peers etc.) |
Results and Impact | Invited to present at TERM Consortium annual meeting in Nantes, France, to investigate possibility of UK academics working with the existing consortium to source additional funding to extend the work of the consortium. The consortium did not contain any UK partners. Sophie Dale-Black presented on the regenerative medicine manufacturing expertise across the UK and invited consortium members to contact her for introductions to UK academics. Introduction to fifteen Europe-wide academic and commercial organisations. Visits to four companies and training sites in Nantes. Follow-up with academic partners ongoing regarding possible Horizon 2020 European funding bids. |
Year(s) Of Engagement Activity | 2013 |
URL | http://www.epsrc-regen-med.org/outreach/promoting-the-uk-community/ |
Description | Engagement Activity - Towards 2020 |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | 'Regenerative Medicine Manufacturing: Towards 2020' was published in September 2014 as a proposition to existing and new collaborators regarding ways of working with the EPSRC Centre. The publication demonstrated successes from the EPSRC Centre but primarily focused on identifying ways of working with collaborators for the next five years. Follow-up with commercial collaborators who received the publication, discussions ongoing regarding new collaborative projects. |
Year(s) Of Engagement Activity | 2014 |
URL | http://www.epsrc-regen-med.org/news/regenerative-medicine-manufacturing-towards-2020/ |
Description | Engagement Activity - UKTI proposition |
Form Of Engagement Activity | A magazine, newsletter or online publication |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Public/other audiences |
Results and Impact | Worked with UKTI to incorporate EPSRC Centre's work into the UKTI regenerative medicine proposition, and to contribute to the representation of the national picture on behalf of the UK national community. Publication through UKTI website and in-print. Publicity worldwide through a drive for incoming investment into the UK. |
Year(s) Of Engagement Activity | 2014 |
URL | http://ukti.bellman.co.uk/ |
Description | Engagement Activity - UKTI visit to Loughborough University |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Visit to Loughborough University by 25 British Embassy and Consulate representatives as part of a UKTI tour of the life sciences work in the UK. Loughborough, Nottingham, Keele, Birmingham and Leeds universities were engaged with the regenerative medicine component of this visit. Follow-ups with embassies worldwide for further information on regenerative medicine research. |
Year(s) Of Engagement Activity | 2014 |
Description | European Medicines Agency consultation |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Policymakers/politicians |
Results and Impact | The Centre has been active within the European Regulatory area through an initiative with EATRIS. In 2015 a joint meeting was held with the European Medicines Agency at Canary Wharf with the objective of introducing the Centre/EATRIS initiative in distributed manufacturing. an invitation has been extended for Loughborough to put key research questions to the Committee for Advanced Therapeutics in 2016 which could result in cooperative effort to establish a collaborative program of work in EMA priority areas. |
Year(s) Of Engagement Activity | 2015 |
Description | ISO TC276 workshop on 'manufacturability' |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Industry/Business |
Results and Impact | The Centre has a leading role in the regenerative medicine work of ISO Technical Committee 276 (Bioprocessing) working alongside BSi and LGC. In November 2015 a workshop was held at Loughborough at the request of the Japanese delegation and convener (Heki, Tatsuo of FIRM) to examine the topic of 'manufacturability' i.e. that property of well-designed cell processes that can provide out-scalable manufacture. Nick Medcalf is leading this activity which will result in a white Paper in 2016 co-produced by the Japanese, US, UK and South Korean delegates. |
Year(s) Of Engagement Activity | 2015 |
Description | Industry Day 2016 |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Industry/Business |
Results and Impact | The presentation of CIM output and capability has been made principally through the Industry Days. Usually annual, the most recent of these, a two-day event at Cambridge University (Madingley Hall) in January 2016 enabled researchers to showcase their work and to co-produce a series of research priorities with the delegates via workshops on day two. The output of the meeting has been briefed informally to the EPSRC and will form the basis of a White Paper after the current reporting round. |
Year(s) Of Engagement Activity | 2016 |
Description | Navigating Regulatory Requirements for Redistributed Manufacturing in Healthcare (MRC, London) |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Industry/Business |
Results and Impact | This workshop in conjunction with the MHRA invited experts from a range of Universities and industrial companies to discuss and review future regulatory requirements for redistributed healthcare manufacturing. |
Year(s) Of Engagement Activity | 2016 |
Description | Visit and seminar at Wyss Institute |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | I was invited to give a talk on "Manufacturing Process Developments for Bioprinting and Tissue Engineering". The audience of between 50 and 100 people consisted of Clinicians from the Massachusetts General Hospital and the Boston Childrens Hospital, research staff from Harvard, Wyss Institute research staff and a number of postgraduate researchers from Harvard. The talk focused on two main areas of manufacturing process development to support bioprinting activities and the electrospinning of cell scaffolds and the application of design for manufacture principles to contribute to the clinical translation. As a result, several discussions took place connected with bioprinting and electrospinning work funded by the EPSRC and potential collaborations are currently being explored. |
Year(s) Of Engagement Activity | 2015 |
URL | http://wyss.harvard.edu/viewevent/478/manufacturing-process-developments-for-bioprinting-and-tissue-... |