EPSRC Fellowships in Manufacturing - Regenerative Medicine Manufacture: A Systems Based Research Platform

Lead Research Organisation: Loughborough University
Department Name: Wolfson Sch of Mech, Elec & Manufac Eng

Abstract

Regenerative medicine (RM) is the application of living cells and tissues to resolve disease or injury. It has the potential to revolutionise healthcare. RM has been named by the Government as one of the priority technologies for UK competitiveness. The market has a global value estimated to grow to $20.0B by 2025. This Fellowship will enable a five-year programme of manufacturing research to be conducted using industrial practice and experience. The aim is to accelerate the commercialisation of RM.

The work will focus initially on methods that can be used to increase the speed of growth of cell and tissue products and that will provide the means for more effective control of production than is currently possible. The aim is to open up the commercialisation of RM to different modes of production than are currently possible, enabling entrepreneurs to choose business models that fit the type of product and the way it must be delivered to clinic. This will involve working on example systems that have the same characteristics as particular types of RM product and measuring the response of the growing cells or tissue to systematic changes in the feeding regime and the physical environment. The results will be simplified to provide robust, controllable growth instructions that can be built into self-contained, automated units for reliable manufacturing even with non-specialised staff working in non-factory settings.

The programme will be pre-competitive, that is, it will concentrate on the common features of RM manufacture and will aim to provide generic solutions that can be tailored for specific products. Researchers will acquire a commercial outlook and will become fluent in the regulatory and economic aspects of RM manufacture. This meets EPSRC's ambition to create leaders who will deliver engineering excellence and real-world outcomes.

The work will take place at Loughborough University where the Wolfson School of Mechanical and Manufacturing Engineering, the EPSRC Centre for Innovative Manufacturing in RM and the EPSRC Doctoral Training Centre in RM comprise an ideal setting. The School sets the pace of UK innovation in engineering-driven methods to commercialise RM.
The Fellowship will enable Nick Medcalf, an industrial engineer with experience leading collaborative research in cell- and tissue-based therapeutics, to move into academia and to influence the direction and practices of RM research at Loughborough University and beyond.
By the end of year five the Fellowship will have:

1. Created a thriving network of pre-competitive research collaborators from industry who are seeking and sharing practical methods for rapid RM commercialisation
2. Delivered 'demonstrator' projects based upon selected clinical indications
3. Created new production tools (reactors and control systems) that are practical and pragmatic, flexible yet robust
4. Identified novel modes of manufacture that are accessible to new RM business with modest outlay in capital and labour.
5. Built a team that works to a shared vision of systematisation of research. This method of working will make the team immediately recognisable to industry as one that speaks their language. It is hoped that the team will become, in time, the team of choice for entrepreneurs who need pragmatic engineering support for RM manufacture
In the longer term the Fellowship will enable the Fellow to achieve a personal ambition to change the way that the innovation pipeline in RM is managed in terms of the manufacturing research.

Planned Impact

The Fellowship will benefit six categories of stakeholder:

1. Academics working in regenerative medicine will benefit via: ability to relate their work to the growing knowledge base and to place their activity in a framework using a common language of defined unit operations. A community of learning will be established oriented towards the industrial challenges and led with pragmatism. The focus on pre-competitive work will encourage sharing of best practice. The intention is to nurture researcher-entrepreneurs who will plan and execute work based upon objective risk criteria for business and not simply on the quest for more understanding.
2. Commercial organisations will benefit from an increasing ease of adoption of innovations in regenerative medicine. There will be a progressive trend towards a whole-process outlook among researchers when making a pitch to investors or big business to adopt innovations. Both new and established enterprises will benefit. Established enterprises will benefit from the creation of a body of pre-competitive learning which can be added to in an incremental way. New enterprises will find the research platform an easier point of entry into the manufacturing issues.
3. Clinics will benefit through access to more cost-effective treatments based upon regenerative medicine solutions. The cost-effectiveness will result partly from improved manufacture (less waste, more control) and partly from improved delivery resulting in improved scheduling.

4. Patients will benefit from increasingly remedial treatments rather than conservative care only. As regenerative solutions become more readily available they will be more likely to be adopted as a first-line treatment.

5. The University of Loughborough will benefit from its increasing impact at the centre of a global community of pragmatic, challenge-led research with a distinctive commercial culture.

6. The United Kingdom will benefit from the competitive lead that will accrue from being first-in-market with new modes of operation and production that meet regulatory standards. Direct benefit to the UK economy will be through increased competitiveness and international leadership in research. Indirect benefit will be consolidating the country at the centre of this culture of integrated manufacturing research making a barrier to entry for overseas business and attracting foreign businesses to establish bases here.

Impact will be enhanced through collaboration and co-production opportunities. These will take the following forms.
A. Co-production opportunities with professional societies (the Royal Academy of Engineering, the Institution of Chemical Engineering, the British Association of Research Quality Assurance) based around 'sandpit' events and mentoring start-up businesses
B. Oral presentation at conferences and publication in peer-reviewed journals and trade magazines
C. Table-top presence at relevant trade events
D. Value promotion to clinical centres by direct contact and working with key opinion leaders in clinical practice to ensure a) that relevant constraints and opportunities are built into the work and b) that these same leaders can eventually act as champions for the uptake of findings from the work
It is essential for maximum impact that the Fellowship adds to, and does not detract from, the other main initiatives. Early meetings will be sought with the management of the following organisations to ensure complementary work plans.
-The Cell Therapies Catapult
-UCL Centre for Stem Cells and Regenerative Medicine
-MRC Centre for Regenerative Medicine
This will be reviewed at least annually.

The work will be directed with milestones. Some of these that follow are additional to those described in the Fellowship Plan sheet.
Six months Dialogue established with named contact in regulatory authority - US and UK
Three years Workshop delivered via professional society
Four years Publication strategy executed.

Publications

10 25 50
 
Description The work is still ongoing; this is an interim report. The research has begun to identify the characteristics of de-centralised operations that can manufacture and supply advanced therapeutics (principally cell-based therapies). The work in progress is now quantifying the costs of a representative operation in order to establish which features exercise the most influence over operational expense.

Additional report for 2017:

There has been a degree of convergence between the findings of the Fellowship and events in the wider sector, particular importance is attached to this in the wake of the Brexit vote because we are now looking for UK advantage based upon e.g. the dynamic of the NHS in relation to near-patient manufacturing of advanced therapeutics. In this connection the importance of the use of 'collaborative enterprise networks' has been shown in order to manage the chain of custody between manufacture of advanced therapeutics and the maintenance of quality of cell-, tissue- and gene-based therapeutics right up to administration in clinic. In addition the CEN concept should help to minimise cost of goods. These principles are now being applied in my new job at Innovate UK where one of the important aspects of the Advanced Therapy Treatment Centres (awards to be announced January 2018) is to maximise synergy and operational learning between sites.

Additional report for 2018:

There is a market failure in the UK related to small-volume, agile manufacture of medicines, personalised or for clinical trial batches. During 2018 the Fellow made some improvements to the UK research landscape through the ISCF funding stream in the form of new funding proposals for the consideration of UKRI and/or the Office for Life Sciences. He continues to build on this with his membership of the MMIP, the BioIndustry Association (Cell and Gene Therapy Advisory Committee and the Manufacturing Advisory Committee) and, latterly, Innogen. Further publications have been issued concerning the economics and operation of distributed manufacturing chains of custody. The microfactory concept is now gaining traction through the Medicines Manufacturing Innovation Centre and support from GSK.

Additional report for 2019:

During the 2019-20 reporting year the Fellow took steps to place more information and recommendations in the public domain through publications about the advantages of de-centralised manufacture. In his current post at Innovate UK he launched a competition with more than £3M ISCF funding in mechanisation of advanced therapy manufacture, building on concepts developed during his funded work at Loughborough University. The aim of this funding is to encourage businesses to accelerate the commercial manufacture of cell-, gene- and tissue-based therapies by applying tools and techniques to allow more process control at a lower cost than full automation. On the standards and guidance front the Fellow has worked with Japanese colleagues and with the UK Standards Liaison Group in Advanced Therapies to prepare justification for a new international standard in quality management for cell therapy manufacture. If approved this proposal will be promoted to ISO to draft a new standard that will assist academic researchers to more their advanced therapy inventions to rapid commercial uptake.
Exploitation Route The work will be of use to new start-up companies and to the designers of manufacturing equipment. The work will also be applied in the creation of a pre-competitive community of practice in cell-based therapeutics. This CoP is a key part of the Fellowship work and is now being worked up into workshop plans with EATRIS and the European Medicines Agency for an event later in 2016.

Additional report for 2017:

The concept of the Collaborative Enterprise is gaining traction in the Advanced Therapeutics community and has especial relevance to the Advanced Therapy Treatment Centres which are about to be announced at the time of writing. In this connection the Fellow has transferred from academia to Innovate UK to develop the next wave of strategy within the ISCF. He is currently conducting visits, workshops and meetings with industry and academia, primarily in the UK but also in the EU and Japan, with the express purpose of building on the systems engineering aspects of his work for the benefit of the UK overall.

Additional report for 2018:

The funding and workshops that are needed to build the community of practice have been, and continue to be, put forward within the framework of UK strategy as part of the Ageing Society Grand Challenge in the UK Life Science Industrial Strategy.

Additional report for 2019:

The formation, with the Knowledge Transfer Network, of a UK 'Medicines Manufacturing Challenge Community' during this year will act as the pre-competitive community of practice envisaged by the Fellow in the original grant. Meanwhile the Fellow has been seeking opportunities for international collaborations with Germany, Sweden and Canada in the form of international meetings and follow-up through proposals for UKRI funding collaterally with those countries.
Sectors Healthcare,Pharmaceuticals and Medical Biotechnology

URL https://dspace.lboro.ac.uk/dspace-jspui/handle/2134/32152
 
Description Report entered for 2015: The Narrative Impact from the Fellowship to date should be considered in the light of two other initiatives from the EPSRC. These are a) the EPSRC Re-distributed Manufacturing in Healthcare Network ('RiHN', commenced in 2015) and b) the Centre for Innovative Manufacturing in Regenerative Medicine at Loughborough University (concluded in February 2016). The Network (in which the Fellow initiated and drove the initiative by which the Network was set up and awarded as a result of the submission by the PI, Dr Wendy Phillips, of UWE, has since become a major vehicle for progressing the systems engineering aspect of the Fellowship. This indirect (i.e. non-PI) approach was adopted in response to discussion with Dr Mark Claydon-Smith of the EPSRC-ESRC panel that set up the award call. The Fellow and Dr Claydon-Smith agreed that it would be appropriate for a fresh PI to be recruited to make a bid for the Network with the assistance of the Fellow. This approach was in recognition that the Fellow had recently (2014) been appointed Director of the Centre for Innovative Manufacturing in Regenerative Medicine and that this commitment would not permit him adequately to address the Network if he were the PI. The Fellow has remained a leading contributor to the Network since its award and has been intimately connected with the arrangement of the workshops, feasibility studies and public events. The aspects of the network that will relate to impact in industrial and societal terms are those that arise from the feasibility studies and from the thematic workshops in 2015-16. Meanwhile the CIM has occupied the main part of the Fellow's contribution to the sector and the outputs from the CIM are reported more fully under the Narrative Impact for that grant (EP/H028277/1). The market research that was conducted in order to make two bids (2014-15) by the Fellow for EPSRC Future Manufacturing hubs has provided clear directions for future research and has built important relationships with industrial (GSK, LGC, the Cell and Gene Therapy Catapult) and academic (universities of Birmingham, Keele, Newcastle, Nottingham, UCL and York). These thematic directions 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 by the Fellow and used to form the basis of single-theme applications for funding with co-production from industry collaborators. The Fellow has adopted an important position in emerging international standards and guidance via BSi. He has a leading role in the regenerative medicine work of ISO Technical Committee 276 (Bioprocessing), working alongside BSi and LGC. In November 2015 the Fellow organised a workshop 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. The Fellow is leading this activity which will result in a white Paper in 2016 co-produced by the Japanese, US, UK and South Korean delegates. A strategically-important spin-off study from the Fellowship 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. The Fellow 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. Additional report entered for 2016: The work on the EPSRC Re-distributed Manufacturing in Healthcare network has led to project opportunities being identified from military medicine (woundcare project) and operational research (Collaborative Enterprises). These are being worked up into fundable value propositions. The support of the Researcher has been sought out by regional enterprise (Future Health Technologies and Nu-Vision) for assistance with business development. Work with the Royal Academy of Engineering has resulted in an invitation to take part in a knowledge exchange delegation in April 2017 to Shanghai where the Researcher will represent innovative healthcare manufacturing for possible Anglo-Chinese collaborative development. Research on Bioartificial Liver support systems with the company Asymptote during 2016 has shown the fundamental challenge with such systems to be a dichotomy between the need for a cell strain that is both metabolically active and that is capable of expansion to commercially-meaningful levels. A change in direction of this Innovate UK-funded project will determine in 2017 whether this gap can be bridged using genetic manipulation. Other products in this area have not addressed the challenge. The Researcher has taken the operation that was the hub of the Centre for Innovative Manufacturing in Regenerative Medicine (the Centre for Biological Engineering) and is taking steps to change the management structure so that it is self-supporting in the future as an 'Academic Business Unit'. It is hoped that this change will be an innovation in operating style for Loughborough University that may be reportable in its own right in 2017. Additional report for 2017: The work on the systems approach to process design led to a radical change for the Fellow in terms of where and how to exploit the findings. In Q2 2017 he took the decision to apply for the post of Innovation Lead - Advanced Therapies with Innovate UK and was appointed on 4th September 2017. The work that he is carrying out in terms of standards, creation of new funding opportunities, monitoring of the Cell & Gene Therapy Catapult and creation of communities of practice associated with the objectives of the Industrial Strategy Challenge Fund would not have been possible without this fellowship. He retains a Visiting Professor status at Loughborough University where he continues to supervise a small number of PhD students. The publications pipeline that was generated by the Fellowship is continuing with the approval of the Communications Team at Innovate UK and will furnish new Research Fish entries for 2018. Additional report for 2018: During the interval 2017-18 the Fellow undertook a programme of work at Innovate UK which included the following; Management of the Wave 1 portfolio for the Medicines Manufacturing Challenge (March to November 2018) as Interim challenge Director: This included the establishment of the Advanced therapy Treatment Centres (the Northern Alliance, Midlands and South Wales and iMATCH at Manchester). These centres demonstrate many of the characteristics of the Fellowship subject matter, especially the operational research component. The investment case was made by Mike Sullivan shortly before the Fellow joined innovate UK. The establishment of the Standards Coordinating Group for Advanced Therapies, including delegates from the MHRA, LGC, the Cell and Gene Therapy Catapult and NIBSC: This began as a joint initiative between the Fellow, Julian Braybrook of LGC and Stephen Ward of the CGTC and is the body now coordinating the UK's activity in the standards and guidance area on an international stage. The creation of new investment proposals, one now launched in Digitalisation of Medicines Manufacturing (£6m) and two in preparation are directly based on principles from the Fellow's work at Loughborough University but applied without favour for the benefit of UK PLC. At the time of writing the Fellow is pursuing a new output from the work aimed at distributed manufacture and building on his launch of the Medicines Manufacturing Innovation Centre project led by CPI and the University of Strathclyde. This will explore the potential of automated microfactories for small-volume medicines manufacture in aseptic environments. Additional report for 2019: Realisation of outputs continues in the form of support and advice for national initiatives from the ISCF Wave 1 investment, contribution to Advisory Group for the EPSRC Future Targeted Healthcare Manufacturing Hub, the new Redistributed Manufacturing in Deployed Medical Care network and the generation of articles for use by the sector. As the Fellow has moved to employment in UKRI there is limited opportunity for primary research.
First Year Of Impact 2019
Sector Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Cultural,Societal,Economic,Policy & public services

 
Description ISO TC 276 (Bioprocessing)
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guideline committee
URL http://www.iso.org/iso/home/standards_development/list_of_iso_technical_committees/iso_technical_com...
 
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 Optimed-ID evaluation scheme
Amount £43,048 (GBP)
Organisation East Midlands Academic Health Science Network 
Sector Charity/Non Profit
Country United Kingdom
Start 02/2015 
End 11/2015
 
Description Re-distributed Manufacturing Call for Networks
Amount £467,417 (GBP)
Funding ID EP/M017559/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2015 
End 12/2016
 
Description Technology Strategy Board CR&D Competition
Amount £508,288 (GBP)
Funding ID 101620 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 08/2014 
End 07/2017
 
Description Visit academics in Japan to explore collaboration opportunities in therapeutic cell manufacturing between UK and Japan
Amount £1,800 (GBP)
Funding ID 4810 
Organisation The Great Britain Sasakawa Foundation 
Sector Charity/Non Profit
Country United Kingdom
Start 08/2015 
End 08/2015
 
Description Visits to institutions in Japan to initiate collaborative projects in regenerative medicine
Amount £2,500 (GBP)
Funding ID 4735 
Organisation The Great Britain Sasakawa Foundation 
Sector Charity/Non Profit
Country United Kingdom
Start 09/2015 
End 09/2015
 
Description EP/M017656/1 A feasibility study of mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D printing 
Organisation 3Dynamics
Country Australia 
Sector Private 
PI Contribution Horizon scanning/research questions mapping/case scenarios selection. Planning/access to informants/sites. Arrangement for interviews and contacts for focus group. Contribution of sections to project report.
Collaborator Contribution Project leadership, organisation of Focus Group workshop, overall control of the report, specialist knowledge.
Impact The project was multidisciplinary comprising law, regulatory affairs, sociology and technical aspects. A publication in preparation.
Start Year 2016
 
Description EP/M017656/1 A feasibility study of mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D printing 
Organisation University of Exeter
Country United Kingdom 
Sector Academic/University 
PI Contribution Horizon scanning/research questions mapping/case scenarios selection. Planning/access to informants/sites. Arrangement for interviews and contacts for focus group. Contribution of sections to project report.
Collaborator Contribution Project leadership, organisation of Focus Group workshop, overall control of the report, specialist knowledge.
Impact The project was multidisciplinary comprising law, regulatory affairs, sociology and technical aspects. A publication in preparation.
Start Year 2016
 
Description EP/M017656/1 A feasibility study of mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D printing 
Organisation University of Sussex
Department Sussex Drug Discovery Center
Country United Kingdom 
Sector Academic/University 
PI Contribution Horizon scanning/research questions mapping/case scenarios selection. Planning/access to informants/sites. Arrangement for interviews and contacts for focus group. Contribution of sections to project report.
Collaborator Contribution Project leadership, organisation of Focus Group workshop, overall control of the report, specialist knowledge.
Impact The project was multidisciplinary comprising law, regulatory affairs, sociology and technical aspects. A publication in preparation.
Start Year 2016
 
Description UK Standards Coordination Group for Advanced Therapies 
Organisation Cell and Gene Therapy Catapult
Country United Kingdom 
Sector Private 
PI Contribution During 2018 I was instrumental, with Dr Julian Braybrook of LGC and Dr Stephen Ward of the CGTC, in setting up this new body which will act to harmonise standards and guidance for the UK in the manufacture of cell- and gene-based therapies. The first meeting was held in late 2018. The next will be in February 2019. The main current initiative is to create, with the University of Nagoya, Japan, a guidance document aimed at early career-stage researchers who wish to design processes for commercialization.
Collaborator Contribution During 2018 I was instrumental, with Dr Julian Braybrook of LGC and Dr Stephen Ward of the Cell and Gene Therapy Catapult, in setting up this new body which will harmonise UK standards and guidance in cell- and gene-therapy medicinal product manufacture. The first meeting was in late 2018. The next will be in February 2019. The early work is to produce guidance documents for early career stage researchers who wish to design processes for manufacture.
Impact It is too early to list these.
Start Year 2018
 
Description UK Standards Coordination Group for Advanced Therapies 
Organisation Laboratory of the Government Chemist (LGC) Ltd
Country United Kingdom 
Sector Private 
PI Contribution During 2018 I was instrumental, with Dr Julian Braybrook of LGC and Dr Stephen Ward of the CGTC, in setting up this new body which will act to harmonise standards and guidance for the UK in the manufacture of cell- and gene-based therapies. The first meeting was held in late 2018. The next will be in February 2019. The main current initiative is to create, with the University of Nagoya, Japan, a guidance document aimed at early career-stage researchers who wish to design processes for commercialization.
Collaborator Contribution During 2018 I was instrumental, with Dr Julian Braybrook of LGC and Dr Stephen Ward of the Cell and Gene Therapy Catapult, in setting up this new body which will harmonise UK standards and guidance in cell- and gene-therapy medicinal product manufacture. The first meeting was in late 2018. The next will be in February 2019. The early work is to produce guidance documents for early career stage researchers who wish to design processes for manufacture.
Impact It is too early to list these.
Start Year 2018
 
Description UK Standards Coordination Group for Advanced Therapies 
Organisation Medicines and Healthcare Regulatory Agency
Country United Kingdom 
Sector Public 
PI Contribution During 2018 I was instrumental, with Dr Julian Braybrook of LGC and Dr Stephen Ward of the CGTC, in setting up this new body which will act to harmonise standards and guidance for the UK in the manufacture of cell- and gene-based therapies. The first meeting was held in late 2018. The next will be in February 2019. The main current initiative is to create, with the University of Nagoya, Japan, a guidance document aimed at early career-stage researchers who wish to design processes for commercialization.
Collaborator Contribution During 2018 I was instrumental, with Dr Julian Braybrook of LGC and Dr Stephen Ward of the Cell and Gene Therapy Catapult, in setting up this new body which will harmonise UK standards and guidance in cell- and gene-therapy medicinal product manufacture. The first meeting was in late 2018. The next will be in February 2019. The early work is to produce guidance documents for early career stage researchers who wish to design processes for manufacture.
Impact It is too early to list these.
Start Year 2018
 
Description UK Standards Coordination Group for Advanced Therapies 
Organisation National Institute for Biological Standards and Control (NIBSC)
Country United Kingdom 
Sector Public 
PI Contribution During 2018 I was instrumental, with Dr Julian Braybrook of LGC and Dr Stephen Ward of the CGTC, in setting up this new body which will act to harmonise standards and guidance for the UK in the manufacture of cell- and gene-based therapies. The first meeting was held in late 2018. The next will be in February 2019. The main current initiative is to create, with the University of Nagoya, Japan, a guidance document aimed at early career-stage researchers who wish to design processes for commercialization.
Collaborator Contribution During 2018 I was instrumental, with Dr Julian Braybrook of LGC and Dr Stephen Ward of the Cell and Gene Therapy Catapult, in setting up this new body which will harmonise UK standards and guidance in cell- and gene-therapy medicinal product manufacture. The first meeting was in late 2018. The next will be in February 2019. The early work is to produce guidance documents for early career stage researchers who wish to design processes for manufacture.
Impact It is too early to list these.
Start Year 2018
 
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 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 Final workshop on Re-distributed Manufacturing in Healthcare 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Study participants or study members
Results and Impact This was the final workshop for the Re-distributed Manufacturing in Healthcare Network (RiHN) that ran for Caledar Years 2016 and 2017. The workshop presented the findings from the feasibility studies, prompted debate about the significance and onward work and formed the final input before drafting the report that was issued at the end of 2017.
Year(s) Of Engagement Activity 2017
URL https://www.linkedin.com/feed/update/urn:li:activity:6344476344876875776/
 
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 International Symposium (Shanghai) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact International Symposium on Smart and Optimal Manufacturing in the Process Industry at ECUST (East China University of Science and Technology, Shanghai, China
19-21 April, 2017).
Organizers
- East China University of Science and Technology, China
- University College London, United Kingdom
- The University of Sheffield, United Kingdom
Supporters
- Chinese Academy of Engineering, China
- Royal Academy of Engineering, United Kingdom (with whom I was the invited delegate on advanced healthcare engineering and was able to describe the motivations and findings of my Fellowship work at Loughborough)
Sponsors
- Key Laboratory of Advanced Control and Optimization for Chemical Processes, Ministry of Education, China
- State Key Laboratory of Chemical Engineering, China
Year(s) Of Engagement Activity 2017
URL http://www.sciencedirect.com/journal/engineering/vol/3/issue/2
 
Description Navigating Regulatory Requirements for Redistributed Manufacturing in Healthcare 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact This event reviewed and advanced understanding of regulatory requirements affecting distributed models of manufacturing in healthcare. Expert speakers addressed the aspects of standardisation, economics, business models and gaps in current regulations.
Year(s) Of Engagement Activity 2016
URL http://rihn.org.uk/event/navigating-regulatory-requirements-for-redistributed-manufacturing-in-healt...
 
Description Redistributed manufacturing in deployed operations workshop 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact 30 professionals drawn from academia and from the Defence Medical Services unit at Edgbaston attended the workshop in order to identify and explore subjects of mutual value that could give rise to value-generating research in de-centralised manufacture of healthcare products.
Year(s) Of Engagement Activity 2017
URL https://www.researchgate.net/project/Redistributed-Manufacturing-in-Deployed-Operations
 
Description Workshop on Collaborative Enterprise Networking for The Midlands 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact 18 delegates comprising representatives of regional NHS Trusts and regenerative medicine research groups attended a workshop at Kegworth to explore the feasibility of a collaborative enterprise to accelerate the translation of Advanced Therapeutic Medicinal Products (ATMPs).

Goal
To deliver ATMPs to the Midlands, economically and in a resilient and agile manner and in a manner that fits with NHS practice at the time.

Objectives
• System to cope with high and low volume production
• System must use current infrastructure
• Single Quality System with minimum safe checking [consistent with patient need - Editor comment on writeup]
• Enables participation of SMEs
• Enables sub-contracting of operations
Year(s) Of Engagement Activity 2016