Regenerative Medicine Manufacturing - EPSRC
Transcription
Regenerative Medicine Manufacturing - EPSRC
Regenerative Medicine Manufacturing: Towards 2020 Centre for Innovative Manufacturing in Regenerative Medicine 2-3 Background to the EPSRC Centre 4-5 Executive summary Contents 6-7 Ways of working with us 8-9 Stakeholder engagement activities 10-11 Research portfolio: Characterisation and control 12-13 Research portfolio: Manufacturing and automation 14-15 Research portfolio: Delivery and 3D products 16-19 Rising stars in regenerative medicine manufacturing 20-21 Training the next generation 22-23 Engaging learners of all ages with science and engineering 24-25 Leadership team and key people How we define regenerative medicine manufacturing Regenerative medicine is a high value field of healthcare with the potential to transform lives for the better. It covers a wide range of therapies designed to enable damaged, diseased or defective skin, bone and other tissues – and even perhaps organs – to work normally again. The regenerative medicine manufacturing sector seeks to translate these therapies to the clinic in sufficient quantity and in safe and cost effective ways to ensure the viability of the industry as a whole. The UK has the chance to be a leader in this field [regenerative medicine] and this opportunity must not be missed… the UK could and should be a world leader in this field. House of Lords Science and Technology Select Committee Report on Regenerative Medicine, July 2013 Our Centre works to equip the industry with manufacturing tools, technologies and platforms by considering the supply chain from end to end. We utilise a systems approach to draw together the many processes involved in transferring the right therapies to the right patient at the right time. What is an EPSRC Centre for Innovative Manufacturing? The sixteen EPSRC Centres for Innovative Manufacturing are part of a novel approach to maximise the impact of innovative research for the UK, supporting existing industries and, more importantly, opening up new industries and markets in growth areas. Each Centre receives five years of funding to retain staff, develop collaborations and carry out feasibility studies. Centres vary from medical devices and regenerative medicine to photonics and liquid metal engineering. The EPSRC Centre for Innovative Manufacturing in Regenerative Medicine was created in 2010 and is led from Loughborough University, in partnership with complementary groups at Keele University and The University of Nottingham. About our funder, the EPSRC The Engineering and Physical Sciences Research Council (EPSRC) is the main UK government agency for funding research and training in engineering and the physical sciences, investing more than £800million a year in a broad range of subjects - from mathematics to materials science, and from information technology to structural engineering. 2-3 Executive summary 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 Engineering and Physical Sciences Research Council (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 Medical Research Council (MRC) sustains our training pipeline for over 100 PhD students. £55M ADDITIONAL GRANT INCOME 11 FELLOWSHIPS AWARDED 102 PEER-REVIEWED PUBLICATIONS 7,145 WEBSITE VISITS EPSRC Centre for Innovative Manufacturing in Regenerative Medicine 7,100 LEARNERS ENGAGED The EPSRC Centre continues to evolve, reflecting the dynamic nature of investments in the regenerative medicine innovation system, and further alignment with emerging national priorities will be possible next year. The summer has seen a change of Director to prepare the EPSRC Centre for its next phase of work with industry. We would like to thank David Williams deeply for his contributions to the EPSRC Centre and wish him well with his future plans. We were delighted to hear that David has been recognised with an OBE for his services to science and engineering. The host department of the EPSRC Centre at Loughborough University, the Wolfson School of Mechanical and Manufacturing Engineering, has also been awarded a 2013 Queen’s Anniversary Prize for Higher and Further Education, recognising its impact through research and skills development in high value manufacturing to create economic growth. 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. Current research funded by the EPSRC Centre is focused on our 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 – we look forward to working with the new Cell Therapy Manufacturing Centre. 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. 103 GRANTS AWARDED 959 HEART BLOG VISITS 878 TWITTER FOLLOWERS Nick Medcalf, Director from September 1st 2014 David Williams, Founding Director Richard Archer, Chair Nick Medcalf becomes Director at a time when there is much to do to prepare the EPSRC Centre for the next phase of its development. 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. Without a thorough understanding of how to make regenerative medicines safely, economically and in sufficient quantity, these therapies will never reach their full potential. September 2014 4-5 Ways of working with us Key collaborators: Our fruitful collaboration with the EPSRC Centre at Loughborough University has given us access to manufacturing science expertise and specialist equipment, to support the progress of two of our flagship projects. Asymptote Athersys Baker Ruskinn Bose ElectroForce Systems Group BSI Stephen Ward, COO, Cell Therapy Catapult CCRM Cell Therapy Catapult GE Healthcare Life Sciences GSK Harvard Stem Cell Institute Heriot-Watt University Instron TGT Intercytex International Organization for Standardization I-Stem Knowledge Transfer Network LGC Locate Therapeutics Medilink East Midlands and West Midlands Collaborative research Contract research MHRA We collaborate with academic, clinical and commercial organisations on a wide range of funded research, both within our existing EPSRC Centre funding and in applying for new funding for co-designed projects. We are building a pre-competitive community of practice to share best practice in regenerative medicine manufacturing. Costeffective ways of working with us include part- or fully-sponsoring a PhD studentship. Colleagues within the EPSRC Centre are available to work on confidential research projects for commercial clients. Businesses can commission the Centre’s researchers to work on problems specific to their needs. NC3Rs Neusentis Newcastle upon Tyne Hospitals NHS Trust NHS Blood and Transplant NIBSC ReNeuron Scottish National Blood Transfusion Service Facilities and services Each of the universities within the EPSRC Centre has cutting edge facilities available for working with collaborators including quality-managed biological engineering laboratories, advanced manufacturing workshops and analytical measurement suites. Knowledge Transfer Partnerships (KTPs) KTPs are relationships formed between a commercial organisation and a university, facilitating the transfer of knowledge, technology and skills to which the commercial partner currently has no access. Projects can vary in length from 6 to 36 months and support can be provided in preparing the funding application. Investment and licensing Opportunities arise from time to time for tools and technologies to be licensed to commercial organisations or for spin-out companies to be created. Potential investors or licensees are invited to contact us. Smith & Nephew TAP Biosystems University College London University Hospitals of Leicester NHS Trust University of Bath University of Birmingham To discuss joining our group of collaborators through any of the above ways of working, please contact us using the details on the back cover of this document. 6-7 Stakeholder engagement activities The EPSRC Centre has developed its engagement activities to focus on different groups of stakeholders – from academics and clinicians to commercial organisations and the public. Building new consortia Our engagement funding featured four £50,000 awards for the funding of new consortia working on key manufacturing challenges with clinical relevance. Three ‘sandpit’ events have been held to date in the areas of manufacturing bone, optimising islet cell transplantations and tissue engineering of hollow structures. Sandpits comprise networking, project-scoping sessions and a dragons’ den style pitch to secure funding. Project teams are encouraged to seek additional external funding. Engaging the national community Engaging internationally The EPSRC Centre continues to build a national community focused on regenerative medicine manufacturing. An event held with the Knowledge Transfer Network brought together many industries, including food, biologics and pharmaceuticals, to discuss the challenges of logistics in our sector – an output paper has been published in StemBook (see later on this page). We have enhanced our European engagement through membership of the Nanomedicine European Technology Platform and through presentations at meetings organised by the EATRIS translational medicine infrastructure and the TERM, REMEDIC and Biomat-IN consortia. The 2014 regenerative medicine manufacturing summit focused on the tools and technology platforms needed to support the sector in producing sufficient regenerative medicines safely. The guidance received from commercial organisations will help shape the EPSRC Centre’s future research. A well-attended careers awareness event was organised in conjunction with Regener8 where mentors from academic, clinical and commercial organisations gave advice based on their range of roles in the sector. Sophie Dale-Black published an article in Orthopaedic Product News discussing the need for regular careers awareness events to minimise the potential leakage of highly skilled researchers from the sector. Further afield, we have worked with the Harvard Stem Cell Institute (HSCI) to introduce a new manufacturing section to StemBook, an open access online collection of peer-reviewed chapters aimed at stem cell and non-specialist researchers. EPSRC Centre colleagues have published manufacturing-themed papers in StemBook and Founding Director David Williams has joined the editorial board. A UK-wide competition for undergraduate students to attend the highly prestigious HSCI Internship Program was won by Elizabeth Cheeseman of Loughborough University. Elizabeth joined 20 other international interns on the 10-week scheme at Harvard. Engaging the public and learners of all ages is discussed later in this document. 8-9 Case studies Researchers at the EPSRC Centre have worked with ReNeuron to apply quality by design (QbD) methodology to cell culture and cryopreservation processes. By defining critical parameters and operating tolerances, better control of product development and production quality can be achieved. Working with Neusentis, the team has developed a robust method for measuring cell viability after a cryopreservation process, defining improved cell banking and product thawing operations. Research portfolio: Characterisation and control Our team has developed a novel, label-free, high resolution, multimodal light microscope that is capable of imaging sub-micron particles and the cellular membrane. The microscope can acquire sequential bright field and phase contrast images and uses a label-free approach to deliver video monitoring of live cells in higher resolution than has previously been possible, making this a viable method for quantitative in-process analysis. The most recent project in the characterisation and control challenge looks at closed-loop control for improving cell culture processes when input and process variables require real-time adjustment to increase productivity. Using haematopoietic cells as an exemplar, researchers are developing a new non-immunological method of rapidly characterising haematopoietic cell populations to provide online monitoring of cells and the resolution between cell sub-populations necessary to implement an effective control loop in the process. Key outputs Patent application pending for a novel, label-free, high resolution, multi-modal light microscope. EPSRC Career Acceleration Fellowship awarded to Melissa Mather, who co-invented the novel microscope. Success through industrial collaborations with Neusentis and ReNeuron on quality by design projects has led to a framework agreement on process development with the Cell Therapy Catapult. Key publications in journals including Journal of Biotechnology, Tissue Engineering, Biotechnology Letters and British Medical Bulletin. Industrial collaborations In partnership with the Cell Therapy Catapult, the EPSRC Centre has accelerated ReNeuron’s manufacturing development work into scaled up and automated systems for a cell based regenerative product for phase III clinical trials and beyond. The regenerative medicine industry requires the manufacture of high quality medical products at an economically acceptable cost. The safe and reproducible delivery of a commercially viable and clinically effective regenerative medicine product is key to its success. In-process characterisation of the cell component, scaffold and combined product will allow efficient and precise process development and will enable process analytical technology for manufacture to be selected on the basis of the most useful data. Rapid identification of deviation during manufacture will allow a corrective in-process response to be made, reducing failure rates and decreasing the dependence on end-product testing; this will positively impact both risk and cost of manufactured product. Gary Brooke, Project Manager for Cell Manufacture and Development, ReNeuron Collaborating with Nottingham researchers within the EPSRC Centre is leading to the development of live and label-free cell imaging, which serves a long-term objective of providing industry with exploitable metrics of cell-biomaterial interactions. Max Ryadnov, Principal Research Scientist, NPL To view all our research projects, please visit bit.ly/RM_Research 10-11 Industrial collaborations Research portfolio: Manufacturing and automation As regenerative medicine products evolve, regulation is clarifying the requirements of platforms to deliver the medicines to the patient and systems for the manufacture and supply of the products. The EPSRC Centre addresses the challenges of the straightforward, consistent, cost effective supply of cellular therapies by developing tools and technologies that will equip the growing industry. Collaborating with commercially driven UK researchers is resulting in developing novel automation, which will secure future sustainable production of affordable cell therapies. David Newble, CEO, TAP Biosystems The EPSRC project has provided the essential proof of principle for HypoxyCOOLTM, and through such support has better ensured positive outcomes both in terms of the application of autologous cell production and adding value to the Ruskinn business. Huw David Thomas, UK Commercial/Sales Manager, Baker Ruskinn Case studies The EPSRC Centre team are investigating alternative manufacturing models that will more appropriately satisfy the comparability requirements of regulators – where products made at two or more different sites must be shown to be of equivalent quality. HypoxyCOOL™ was designed to engineer a unique system to mimic components of the physiological niche, increasing stem cell recovery and survival post-transplantation. HypoxyCOOL™ is a rapid and effective means of reducing the dissolved oxygen concentration of cell culture media to minimise oxidative-stress during stem cell recovery. The team have also worked to test and validate a prototype hydrostatic pressure growth chamber from Instron TGT. Externally applied hydrostatic pressure delivered by the bioreactor can independently stimulate bone growth and also act synergistically with soluble factors added into the cell culture media to enhance bone development in the laboratory. Researchers have worked with TAP Biosystems and other companies to design manufacturing platforms that minimise the requirement for manual intervention in cell production and provide opportunities for scale-up of manufacturing. The viability of such manufacturing platforms is further investigated using tools such as cost of goods sold (COGS) analysis. In conjunction with companies and clinics, researchers are investigating the regulatory and operational logistics of ‘microfactories’ or clinics close to the bedside. Key outputs Patent application pending for HypoxyCOOLTM. Demonstration of a range of applications for an advanced micro bioreactor system, the ambr™ from TAP Biosystems. PAS 83:2012 - Developing human cells for clinical applications in the European Union and the United States of America (BSI, 2012). Recognition of projects and oral evidence from David Williams in House of Lords Science and Technology Committee Report on Regenerative Medicine, July 2013. To view all our research projects, please visit bit.ly/RM_Research 12-13 Research portfolio: Delivery and 3D products The delivery of cells to the patient in a clinical setting raises scientific and technological challenges. Simple injection of cell suspensions into a disease site is inefficient, resulting in wastage of cells, compromised viability of the medicine and poor starting conditions for the regeneration of the target tissue. The EPSRC Centre investigates the development of materials to aid cell delivery to the target tissue, with a particular focus on the challenges of creating reproducible 3D scaffolds. Case studies Researchers have developed novel polymers that have the potential to be used as injectable scaffolds for tissue engineering applications. These polymers are thermally responsive, forming strong gels at body temperature. Working with a leading ear, nose and throat consultant treating patients following tumour removal, researchers are using the exemplar of 3D printed nasal replacement structures to investigate the challenges of printing 3D cellscaffold combination products – co-printing live cells within a polymer scaffold, characterising the combination product and the regulatory considerations of this process. Electrospinning techniques have been used to produce scaffolds to support the epithelial stem cell niche. 3D patterns were identified, patterned collectors fabricated and then electrospun scaffolds manufactured so that they bore the tailored geometries. These patterns were found to affect both fibre deposition and arrangement, and the resulting scaffold geometries have been found to influence in vitro cell migration. A recent project investigated an in vitro 3D model lymph node comprising human dendritic cells and T cells housed within a perfusable 3D fibronectincoated polymer scaffold. This resulted in a new manufacturing method to enhance the porosity of supercritical CO2 foamed scaffolds using an ultrasound technique post-scaffold fabrication. In one of our newest projects, we collaborate with Calabrodental, a dental technologies organisation in Italy. A new regenerative spray has been invented for dental applications, and the further development and manufacture of this product will be progressed via EU funding. Industrial collaborations Working with Prof Shakesheff and the EPSRC Centre has accelerated Calabrodental’s product development work and created a new important opportunity to manufacture a regenerative product for dental and maxillofacial applications. To view all our research projects, please visit bit.ly/RM_Research Key outputs Patent application pending for scaffold manufacture from responsive magnetic particulate dispersions for ex-vivo cellular expansion. High profile publication ‘Combined hydrogels that switch human pluripotent stem cells from self-renewal to differentiation’ published in the Proceedings of the National Academy of Sciences. Kevin Shakesheff named RISE Leader in EPSRC’s Recognising Inspirational Scientists and Engineers programme. Key journal publications in Polymer, Biomaterials, Acta Biomaterialia, Biomedical Materials and Journal of Colloid and Interface Science. Locate Therapeutics has benefitted greatly from collaborating with the EPSRC Centre. Accessing first-class materials and drug delivery expertise has helped transition ideas from early proof of concept into full development. The outputs have great potential across a range of regenerative medicine applications. Rob Quirk, Director, Locate Therapeutics Marco Tatullo, Director of Research, Calabrodental 14-15 Rising stars in regenerative medicine manufacturing To maintain the UK’s global research standing in the context of increasing international competition, UK research councils focus a significant proportion of their investment on supporting those individuals who are deemed to have the most potential to deliver the highest quality research which meets UK and global priorities. The regenerative medicine manufacturing sector provides a perfect environment for such fellowships as considerable growth is required to ensure the success of the industry and the developing leaders can integrate their work into the wider innovation system. Nick Medcalf, Melissa Mather, Robert Thomas, Lisa White, Loughborough University The University of Nottingham Loughborough University The University of Nottingham Nick is conducting research at Loughborough University into the production and delivery of regenerative medicines under an EPSRC Manufacturing Fellowship. He is identifying and investigating technologies that will accelerate translation of new products into manufacture using a systemsbased approach. Nick is bringing his previous industry experience to bear on the challenge of enabling new business models for a variety of cell- and tissue-based therapeutics. His research has a strong focus on cold supply chain issues and distributed manufacturing. Melissa holds an EPSRC Career Acceleration Fellowship at the Institute of Biophysics, Imaging and Optical Science, based at The University of Nottingham. Her research lies in the application of ultrasound, optical and opto-acoustic techniques for non-invasive characterisation of live cells, biomaterials and tissue. The focus of Melissa’s Fellowship is the development of nano-sized ultrasound transducers to remotely probe tissue properties for improved disease diagnosis and to track therapeutic cells inside the body used in regenerative medicine. Rob’s EPSRC Early Career Fellowship team at Loughborough University is developing tools and processes for haematopoietic cell manufacture. Haematopoietic cells can give rise to multiple clinically useful cell types from red cells to immune cells to progenitors. The team aim to develop manufacturing technology that can deliver significant jumps forward in control, cost reduction and scalability of manufacture to hasten the clinical impact of these cell therapies. Lisa has secured a prestigious Marie Curie International Outgoing Fellowship, a European Commission programme designed to enable researchers to undertake their research in a country outside Europe. Lisa’s research focuses on developing innovative supercritical fluid decellularisation technology. She will be based within Stephen Badylak’s lab at the University of Pittsburgh for 15 months before continuing her research within the Tissue Engineering Group at The University of Nottingham for a further 12 months. 16-17 Rising stars in regenerative medicine manufacturing In our 2013 brochure, we reported on the progress of our ETERM Fellows, and we are delighted to have increased this community to seven Fellows with an eighth Fellow having secured a lectureship within her university. The final two ETERM fellowships will be awarded competitively in 2015. Alex Lyness, Mark McCall, Loughborough University Loughborough University Alex holds a Loughborough University Enterprise Fellowship funded from the EPSRC Impact Acceleration Account and is affiliated with the EPSRC Centre. During the fellowship Alex will be able to accelerate the impact of and exploit IP and knowhow that was generated during his postdoc role, where he developed devices capable of delivering conventional pharmaceuticals and cell-based therapies. Alex is also currently working with several consortia providing engineering design input to current and future drug delivery systems. Elizabeth Ratcliffe, Loughborough University Elizabeth holds a Loughborough University Enterprise Fellowship funded from the EPSRC Impact Acceleration Account. Her research focuses on developing synthetic biology solutions to barriers in the translation of advanced therapeutic medicinal products to the clinic. Elizabeth has developed new opportunities and partnerships at this interface, working with leading synthetic biology company Synpromics and University College London, in particular their Gene Therapy Consortium and MHRA-regulated Gene Therapy Manufacturing Suite. Mark holds a Loughborough University Enterprise Fellowship funded from the EPSRC Impact Acceleration Account. His research focuses on modelling and reducing the cost of goods sold (COGS) of cell therapies. Mark is also engaged in commercialising new technologies that reduce cell therapy COGS and is working with industry partners to develop new manufacturing processes. He is the co-inventor (with Rob Thomas) of a new patentpending low cost manufacturing platform for adherent cells. Jing Yang, The University of Nottingham Jing holds a Nottingham Research Fellowship funded by The University of Nottingham. His research focuses on 3D printing of human tissues for drug screening and regenerative medicine applications. 3D printing is capable of assembling living cells and biomaterials in a spatially defined manner to mimic the natural organisation of cells and extracellular matrix in human tissues/organs. In particular, Jing is interested in developing materials that are compatible with the printing process and support cell function. 18-19 Training the next generation EPSRC-MRC Centre for Doctoral Training in Regenerative Medicine The Loughborough, Nottingham and Keele university consortium has operated an EPSRC Centre for Doctoral Training in Regenerative Medicine since 2008. A new grant of over £3.5million has been awarded jointly by the EPSRC and MRC to continue supporting the training programme, resulting in a combined pipeline of over 100 PhD graduates by 2022. Example destinations of PhD graduates: Example Centre for Doctoral Training collaborators: Cell Therapy Catapult GSK Anthony Nolan CM Technologies Locate Therapeutics TAP Biosystems Cobra Biologics Future Health Biobank Royal College of Surgeons in Ireland FUJIFILM Diosynth Biotechnologies ETERM Fellowships Bose ElectroForce Systems Group University of Washington AstraZeneca Queensland University of Technology Pall Corporation PhD students within the Centre for Doctoral Training undertake a four-year programme that incorporates broad regenerative medicine science, engineering and business training at each of Loughborough, Nottingham and Keele universities in the first year and a focused PhD project at one institution for the final three years. Companies within the regenerative medicine sector contribute to the success of the doctoral training programme through providing real-world challenges for students to approach during their thesis projects. Members of the sector also act as mentors for skills and careers sessions and as ‘dragons’ in business plan competitions. We are delighted to support the INSPIRE programme as this combines the EPSRC Centre’s target areas of commercial engagement, training of the next generation and raising awareness of careers in the regenerative medicine sector. Sophie Dale-Black, Head of Engagement, EPSRC Centre INSPIRE summer placements programme The EPSRC Centre for Innovative Manufacturing has worked with the INSPIRE programme at Keele University to design four summer training placements allowing undergraduate medical students to get a flavour of regenerative medicine manufacturing research while working with industrial collaborators. The INSPIRE programme is designed to ensure that the next generation of GPs and surgeons have an understanding of cutting edge research. Collaborators are being sought for future training projects. INSPIRE project collaborators: nanoTherics Ltd Waters Corporation PA Consulting 20-21 Engaging learners of all ages with science and engineering Early career researchers in both the EPSRC Centre for Innovative Manufacturing and the EPSRC-MRC Centre for Doctoral Training have developed the brand ‘HEART: Healthcare Engineering and Regenerative Therapies’ to describe their work in communicating regenerative medicine science and engineering to learners of all ages. The HEART team have undergone training in advanced outreach skills and have designed a series of experiments, presentations and handson demonstrations to engage learners with the technologies that can ‘help the body to fix itself’. The HEART team have exhibited at the Big Bang Fair at the NEC, the largest activity of its kind in the UK for learners of ages 7 to 19 with a footfall of around 75,000 over four days. The team appeared live on BBC Breakfast and later on the BBC News website, describing polymerbased experiments designed to show learners how scaffolds are built. Exhibitions at educational festivals have continued, with HEART team members attending Big Bang Fair London and Bollington Festival. The HEART team are preparing a selection of workshops for delivery in schools. These workshops will feature a general overview of regenerative medicine followed by hands-on experiments tailored to the class subject and the age of the learners. Workshops will close with a careers discussion to show the type of jobs that are available following science, technology, engineering, mathematics and medicine (STEMM) university courses. All the work of the HEART team is underpinned by the HEART blog, which can be found at www.heartblog.net – an excellent follow-up resource for learners and their teachers. Learners have the opportunity to ask scientists and engineers to answer their regenerative medicine related questions. See www.heartblog.net for more details! 22-23 Leadership team Alicia El Haj Co-Director Nick Medcalf FREng Director Richard Archer Chair Richard Archer is a life science process engineer who was a founder of both The Technology Partnership in Cambridge and The Automation Partnership, where he was CEO. He continues to work with government, academia and corporations in building a strong UK regenerative medicine industry. Nick Medcalf is a Chartered Chemist and Chartered Chemical Engineer with over thirty years of experience in the healthcare products sector, principally in process development for pharmaceuticals, medical devices and cell- and tissuebased therapeutics. He has held senior research management positions in industry and joined Loughborough University in 2013 under a Manufacturing Fellowship from the EPSRC. Alicia El Haj is Chair of Cell Engineering and Director of the Institute of Science & Technology in Medicine at Keele University. She has been involved in bringing together interdisciplinary groups within biomedicine, physical sciences and engineering interested in aspects of cell and tissue engineering. She holds a Royal Society Wolfson Research Merit Award and is Chairman of the European Council of the International Society for Tissue Engineering and Regenerative Medicine (TERMIS). To view profiles for the academic team, please visit http://bit.ly/RM_academics Kevin Shakesheff Co-Director Kevin Shakesheff is Chair in Tissue Engineering at The University of Nottingham and he is the founder of Locate Therapeutics, and co-founder of the UK Tissue and Cell Engineering Society. Kevin qualified as a pharmacist in 1992, and his research focuses on the integration of cell biology and tissue engineering. Kevin holds a Royal Society Wolfson Research Merit Award. Robert Thomas Deputy Director Rob Thomas is a Senior Lecturer at Loughborough University and an EPSRC Early Career Fellowship holder. He works with leading regenerative medicine companies to establish manufacturing processes for cell based products, with an academic focus on control, cost reduction and scalability of haematopoietic derived cell production. David Williams OBE FREng Founding Director David Williams has held senior leadership positions in academia and industry, working for much of his career at their interface. For the past fifteen years he has focused on healthcare and pharmaceuticals. He has been Professor of Healthcare Engineering in the Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University since 2003 and is University academic lead in Health and Wellbeing. David was Director of the EPSRC Centre until August 2014. Sophie Dale-Black Head of Engagement Sophie Dale-Black gained a PhD and postdoctoral experience in pharmaceutical chemistry before moving into engagement and operations management. Sophie became Head of Engagement for the EPSRC Centre in early 2013, where she oversees the engagement of national stakeholders in regenerative medicine manufacturing research and has led on the development of the HEART public engagement programme. Key people Cameron Alexander Nick Forsyth Jon Petzing The University of Nottingham Keele University Loughborough University Eleri Bristow Sourav Ghosh Svetan Ratchev Loughborough University Loughborough University The University of Nottingham Lee Buttery Liam Grover James Richardson Virginie Sottile The University of Nottingham University of Birmingham Keele University The University of Nottingham Divya Chari Paul Hourd Paul Roach Alexandra Stolzing Keele University Loughborough University Keele University Loughborough University Karen Coopman Oksana Kehoe Felicity Rose Ivan Wall Loughborough University Keele University The University of Nottingham University College London John Crowe Mark Lewis Joel Segal Lisa White The University of Nottingham Loughborough University The University of Nottingham The University of Nottingham Chris Denning Yang Liu David Smith Nik Willoughby The University of Nottingham Loughborough University Keele University Heriot-Watt University Marianne Ellis Melissa Mather Michael Somekh Visiting Professor, Ying Yang University of Bath The University of Nottingham The University of Nottingham Keele University 24-25 www.epsrc-regen-med.org www.heartblog.net Research enquiries: Engagement and general enquiries: Prof Nick Medcalf EPSRC Centre Director Loughborough University Leicestershire LE11 3TU Dr Sophie Dale-Black Head of Engagement Loughborough University Leicestershire LE11 3TU T +44 (0)1509 564898 E [email protected] T +44 (0)1509 227649 E [email protected] www.facebook.com/heartblog @RM_Outreach @HEARTregenmed