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.
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.
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.
Organisations
- Loughborough University (Fellow, Lead Research Organisation)
- Cell and Gene Therapy Catapult (Collaboration)
- University of Sussex (Collaboration)
- 3Dynamics (Collaboration)
- Medicines and Healthcare Regulatory Agency (Collaboration)
- National Institute for Biological Standards and Control (NIBSC) (Collaboration)
- Laboratory of the Government Chemist (LGC) Ltd (Collaboration)
- UNIVERSITY OF EXETER (Collaboration)
People |
ORCID iD |
| Nicholas Medcalf (Principal Investigator / Fellow) |
Publications
Medcalf N
(2014)
The Stem Cell Research Community, StemBook
Hourd P
(2014)
Regulatory challenges for the manufacture and scale-out of autologous cell therapies
in StemBook
Coopman K
(2014)
From production to patient: challenges and approaches for delivering cell therapies
in StemBook
Lyness A
(2015)
Overcoming the translational challenges of the effective administration and delivery of cells
in Cytotherapy
Hourd P
(2015)
A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes
in Regenerative Medicine
Thurman-Newell, JA
(2016)
Cell Micro-factories: Feasibility of a redistributed manufacturing model for cell based therapeutics
Abou-El-Enein M
(2016)
Putting a price tag on novel autologous cellular therapies
in Cytotherapy
Harrison R
(2016)
Automating decentralized manufacturing of cell & gene therapy products
in Cell and Gene Therapy Insights
Medcalf N
(2016)
Stem Cell Manufacturing
| Description | The award concentrated on the way in which the design of manufacturing processes for advanced therapies is influenced by their especial needs for process control and consistent handling during transfer to the clinic and subsequent administration. The implications of the research project have informed government funding initiatives since the period of this grant ended. In the financial year 2020-21 the EPSRC Fellow, in his new role as ISCF Deputy Challenge Director for Medicines Manufacture at UKRI, has been able to apply the insights gained to the management and control of grants to industry in the 'Mechanising and improving Advanced Therapy Manufacture' competition (https://apply-for-innovation-funding.service.gov.uk/competition/419/overview). The continuing interest in the focus area of the EPSRC Fellowship has led to an invitation to contribute a 'Perspective' article to the journal 'Regenerative Medicine' and this is in final stages of preparation at the time of this report. The EPSRC Fellow now applies the insights gained to his role in the oversight of the Advanced Therapy Treatment Centre network, a significant infrastructural investment in Wave 1b of the UK Industrial Strategy Challenge Fund. |
| Exploitation Route | The findings of the funding are being applied in the development of the Advanced Therapy Treatment Centres via the Fellow's job at UKRI and via the direct tuition of a new cadre students in the 'Manufacture and Commercialisation of Stem Cell and Gene Therapies MSc' at University College London, where the EPSRC Fellow is now a mentor and tutor pro bono. The risk- and cost-based decision-making tools that have been or are about to be published are an addition to the toolkit available to researchers making the transition to industry. |
| Sectors | Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| 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. Additional report for 2020: The Fellow continues in his work at UKRI as Head of Advanced Therapies in the Health and Life Sciences Sector Team and Deputy Challenge Director for the ISCF Medicines Manufacturing Challenge. In this capacity since the last report he has worked with the Medicines Manufacturing Industry Partnership Leadership Team (specifically with Martin Wallace of GSK) to refresh the MMIP Technology and Innovation Roadmap which should be rolled out in 2021. The Roadmap includes challenge areas rleated to the Fellowship in the agile and flexible manufacturing area and in the topics related to advanced process control. Additional report for 2021: During the 2021-22 reporting period the Fellow contributed to the development of the new series of proposals for medicines manufacturing innovation funding for consideration by BEIS/OLS in advance of the 2021 Spending Review announcement on 27 Oct 2021. Specifically the Fellow worked with Dr Phil Packer on a proposal for Pandemic Preparedness and another on Transforming Medicines Manufacture. In both cases there were arguments in favour of the creation of a more agile, robust and responsive UK medicines manufacturing sector through the encouragement of a network of manufacturing facilities. These proposals built in part on the studies undertaken under the EPSRC award. During this period the Fellow was called upon on several occasions to provide information and insight to members of the Office for Life Sciences in relation to capital-efficient investment for the manufacture of complex medicines. From June 2021 the Fellow acted in the capacity of Innovation Lead for the oversight of the Advanced Therapy Treatment Centre Network on behalf of Innovate UK, a role built on his work in decentralised manufacture dating from the EPSRC award. Addition for 2022-23 submission: The Fellow took the decision to retire in March 2023 from his job in Innovate UK. During the previous twelve months the Fellow generated the business case for two new funding awards for Innovate UK's 'Transforming medicines Manufacturing' portfolio. A total of £15m was set aside for a direct award (£10m) and a competitive R&D award (£5m) in intracellular drug delivery, aimed at improving the efficacy and removing off-target effects in mRNA vaccines and treatments. The Fellow was approached by AI Digital to act as the first Specialist Advisor to the new spin-out Biomatics. AI Digital was instrumental in enabling the UK to manage public test data during the pandemic and is now seeking to implement some of the ideas in distributed manufacture of advanced therapies that were the core of the Fellow's funded work, |
| 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 | Contract Manufacturing in the Development of New Gene Therapies for Rare Disorders |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | This was an invited talk concerning the role of new business models and the contract manufacturing sector in the innovation of gene therapies at small volumes. I fielded some inquiries following the talk. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://genetherapy-europe.com/day-one/ |
| 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 | Interview for trade magazine GEN |
| 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 | Industry/Business |
| Results and Impact | I was invited to give a short interview concerning distributed manufacture of advanced therapies by a journalist working for Genetic Engineering and Biotechnology News, a free trade magazine that is circulated widely in hard-copy and electronic form. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.genengnews.com/topics/bioprocessing/decentralized-manufacturing-of-advanced-therapies/ |
| 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 |