FUTURE TARGETED HEALTHCARE MANUFACTURING HUB

Lead Research Organisation: University College London
Department Name: Biochemical Engineering

Abstract

By 2025 targeted biological medicines, personalised and stratified, will transform the precision of healthcare prescription, improve patient care and quality of life. Novel manufacturing solutions have to be created if this is to happen. This is the unique challenge we shall tackle. The current "one-size-fits-all" approach to drug development is being challenged by the growing ability to target therapies to only those patients most likely to respond well (stratified medicines), and to even create therapies for each individual (personalised medicines). Over the last ten years our understanding of the nature of disease has been transformed by revolutionary advances in genetics and molecular biology.

Increasingly, treatment with drugs that are targeted to specific biomarkers, will be given only to patient populations identified as having those biomarkers, using companion diagnostic or genetic screening tests; thus enabling stratified medicine. For some indications, engineered cell and gene therapies are offering the promise of truly personalised medicine, where the therapy itself is derived at least partly from the individual patient. In the future the need will be to supply many more drug products, each targeted to relatively small patient populations. Presently there is a lack of existing technology and infrastructure to do this, and current methods will be unsustainable. These and other emerging advanced therapies will have a critical role in a new era of precision targeted-medicines. All will have to be made economically for healthcare systems under extreme financial pressure. The implications for health and UK society well-being are profound

There are already a small number of targeted therapies on the market including Herceptin for breast cancer patients with the HER2 receptor and engineered T-cell therapies for acute lymphoblastic leukaemia. A much greater number of targeted therapies will be developed in the next decade, with some addressing diseases for which there is not currently a cure. To cope, the industry will need to create smarter systems for production and supply to increasingly fragmented markets, and to learn from other sectors. Concepts will need to address specific challenges presented by complex products, of processes and facilities capable of manufacture at smaller scales, and supply chains with the agility to cope with fluctuating demands and high levels of uncertainty.

Innovative bioprocessing modes, not currently feasible for large-scale manufacturing, could potentially replace traditional manufacturing routes for stratified medicines, while simultaneously reducing process development time. Pressure to reduce development costs and time, to improve manufacturing efficiency, and to control the costs of supply, will be significant and will likely become the differentiating factor for commercialisation.

We will create the technologies, skill-sets and trained personnel needed to enable UK manufacturers to deliver the promise of advanced medical precision and patient screening. The Future Targeted Healthcare Manufacturing Hub and its research and translational spokes will network with industrial users to create and apply the necessary novel methods of process development and manufacture. Hub tools will transform supply chain economics for targeted healthcare, and novel manufacturing, formulation and control technologies for stratified and personalised medicines. The Hub will herald a shift in manufacturing practice, provide the engineering infrastructure needed for sustainable healthcare. The UK economy and Society Wellbeing will gain from enhanced international competitiveness.

Planned Impact

WHO WILL BENEFIT FROM THE RESEARCH
The impact of the Future Targeted Healthcare Manufacturing Hub will extend far beyond the Hub itself with significant benefits for manufacturing companies, healthcare providers, UK citizens and the economy as a whole.

Companies
The stratified protein medicines and cellular therapies of the future cannot be made or developed using the manufacturing technologies in use for current therapies. A radical step-change and innovation to deliver the economically viable processes is required. UK companies will benefit from new process technologies designed to deliver these step changes with the necessary cost performance and speed of development. The companies will also benefit from new decision support tools that will provide a robust framework for selecting processes and manufacturing options reducing the risk of misallocating significant cost and time. The researchers trained in the Hub will have the skills and experience required by industry to transfer and implement these technologies in practice.

Healthcare Providers
It is recognised that in some diseases only 20-30% of patients are effectively treated by the standard treatment care and that there may be serious adverse reactions among those that are not. This represents a very significant wasted resource in time and materials for healthcare providers under enormous pressure to reduce costs. Targeted medicines are designed to match effective treatments to patients but this promise can only be delivered if new therapies can be developed more quickly than currently and if they have greater cost effectiveness including lower manufacturing costs than existing medicines. The processes and decision-support tools developed in the Hub will enable product manufacturers to meet these challenges.

Patients
Faster development and more economic processes for targeted therapeutics will allow the promise of precision to be realised for the patient. They will enable patients to access promptly new stratified and personalised therapies, in some cases for diseases not currently treated and they will reduce ineffective treatments and adverse side effects.

UK Economy
The UK has a strong established pharmaceutical industry and a growing number of new companies developing new protein and cellular therapies. The development of new processes and tools to guide selection of processes and manufacturing option will enable this sector to commercialise successfully their rapidly increasing research effort in targeted medicines and increase the GVA of this part of the pharmaceutical industry.

HOW WILL THEY BENEFIT FROM THE RESEARCH
The Grand Challenge research in the hub will create new process technologies to address key manufacturing challenges identified following extensive discussion with the industry. Additionally the Hub with create new decision-support tools that will be used to accelerate the development and optimisation of manufacturing processes at appropriate scales. These tools will address the complexity of new clinical trial structures and increasingly decentralised manufacturing.

User-led feasibility projects with companies of the User Group, part of the Hub's platform research, will help test and evaluate these products. The Hub will have IP arrangements designed to achieve rapid exploitation and broad uptake and will involve three Catapults to facilitate translation of the technologies developed to market. 18 PDRAS, 28 CDT, 23 PhD and 14 EngD researchers on projects aligned to the hub will be trained with the process development skills required by industry. The Hub will engage with regulators to ensure they are briefed and informed on the emerging new technologies to allow appropriate regulatory strategies to be developed and put in place.

The successful commercialisation of new targeted biological medicines by companies will strengthen the UK manufacturing community with direct impacts on people employed and UK wealth generated.

Organisations

Publications

10 25 50
 
Description The Hub has embarked on an ambitious set of strategic research targets, closely informed by its strong industry and regulatory consortium. Our focus is to develop and examine technological solutions for the rapid realization of targeted healthcare and include: pioneering studies in the utility of cell-free synthesis for just-in-time manufacture of valuable therapeutics; engineering characterization of novel bioreactor geometries for effective process development and delivery of cell and gene therapy products; as well as advanced software tools to help in decision-making for the industry. Over the past year, we have made significant advances in our scientific understanding and technology innovations, and we are now working closely with our user community to deliver user feasibility studies which are designed to test our methods, and to gauge the utility of new approaches in an industrial setting. Four such studies were supported within the last 12 months, in addition to seven that have been completed and two that are ongoing. The results of these studies will be used to inform new research directions and to further our understanding of the evolving manufacturing landscape. This close integration with industry means that our progress makes a defined impact on manufacturing practice. Research and Impact Highlights from GC1: Transforming supply chain management and economics for targeted medicines (a) Cell-free synthesis economics: Case studies have highlighted the differences in cost of goods and performance targets for cell-free synthesis compared to traditional mammalian processes for antibody-drug conjugates (b) CAR T-cell process and supply chain economics: Decisional tools have identified the current cost of goods (COG) of CAR T-cell therapies, which manufacturing platforms are most cost-effective at different dose scenarios, the key cost drivers, and the risk-reward trade-offs between centralised manufacture versus GMP-in-a-box configurations (c) CAR T-cell supply chain optimisation: Existing supply chains have been characterized and likely future supply chain workflows have been proposed (d) Regulation: Significant differences between Europe and the United States have been found for regulatory pathways of cell and gene therapies related to factors such as marketing application review times and flexibility around CMC and post-marketing requirements (e) Reimbursement: NICE's approach to appraising CAR T-cell therapies Yescarta® (axicabtagene ciloleucel) and Kymriah® (tisagenlecleucel) has been mapped out and analysed for its longer-term feasibility (f) Clinical production planning of stratified proteins: An economic model has been constructed to understand incentivization mechanisms for the development of companion diagnostics for stratified proteins (g) Data analytics for biomarker stratification: Datamining tools have been developed to help clinicians make personalised decisions on aspects such as follow-up timelines (h) Data analytics for protein aggregation prediction: Novel predictive models have rapidly detected early aggregation signals and predicted the potential aggregation level and the impact of key attributes (i) Continuous chromatography monitoring: A tool for real-time analysis and monitoring of continuous bioprocesses with adaptive control methods has been developed and tested with user data.

Research and Impact Highlights from GC2: Sustainable manufacturing for future targeted medicines.
(a) Formulation: New biophysical analysis methods have been developed that are able to monitor the degradation of protein mixtures. The technique has now been patented and developed for commercialisation. In addition, it is now being explored in partnership with Pall Europe specifically for bioprocess monitoring. The co-formulation of multiple proteins has been found surprisingly to lead to improved stability of proteins against aggregation and fragmentation. This paves the way for combination therapies and improves the chances of finding an acceptable formulation for each new product in industry. (b) Nanoencapsulation: Novel nanoparticle manufacturing has been established that is able to encapsulate and co-formulate multiple proteins, as well as to deliver proteins into cells. (c) Cell-free synthesis protocols: Scalable cell-free synthesis with model proteins can be achieved consistently using in-house protocols and the formation of product-related impurities can be mitigated by altering the synthesis conditions. (d) CAR T-cell manufacturing platforms: T-cells can now be cultivated in an automated stirred-tank bioreactor system, and their growth has been shown to be consistently and significantly better than in T-flask static culture, with equivalent cell quality. This paves the way for lower cost of goods and shorter timelines for the production of CAR-T products. (e) CAR T-cell predictive models and control: T-cell cultures have been characterised by both mechanistic and multivariate statistical models, which enables improvements to the consistency and productivity of these processes (f) T-cell analytics: Digital Holography Microscopy provides a rapid analytical tool to discern activated from non-activated T-cells, which will enable future control strategies via online process monitoring.
Exploitation Route User-led feasibility studies, Spinouts, open source software
Sectors Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

 
Description Public dissemination and debate of key issues surrounding personalized medicines. Novel analytical technologies for protein formulations have been developed and patented. This is currently being further developed for commercialisation. In addition, it is now being explored in partnership with Pall Europe specifically for bioprocess monitoring. The option of stable coformulated proteins has been demonstrated, which paves the way for combination therapies and improves the chances of finding an acceptable formulation for each new product in industry. T-cell production in automated stirred-tank bioreactor systems will now enable a lower cost of goods for their manufacture. Meanwhile control strategies have enabled faster processes, which will shorten the time for delivery of personalised medicines to patients.
First Year Of Impact 2018
Sector Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Societal,Policy & public services

 
Description Advsory Board for reviewww of Defence Academy
Geographic Reach National 
Policy Influence Type Participation in a national consultation
 
Description Attendance of EPSRC Centre for Innovative Manufacturing in Food, Advisory Board
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
 
Description BSI Commitee member
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
 
Description CCMI Scale-Up and Challenges in Manufacturing of ATMP workshop
Geographic Reach Europe 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Committee Member, Institution of Chemical Engineers Biochemical Engineering Special Interest Group
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact The IChemE BESIG committee focuses on addressing and representing the Biochemical Engineering interests for the Institution of Chemical Engineers. As a member on the committee, I represent the cell and gene therapy activity which aligns with the Hub. As part of the committee, we have contributed to the Institution's BioFutures agenda which has been forwarded to government. This calls for action to boost the skills diversity of biochemical engineering graduates to prepare them for the greater diversity of roles requiring biochemical engineers.
 
Description EPSRC SAN
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
Impact The EPSRC SAN is instrumental in helping the Council to formulate its research funding priorities
 
Description ESACT-UK Scientific Programme Lead
Geographic Reach Europe 
Policy Influence Type Participation in a advisory committee
Impact ESACT-UK is the UK Society for Cell Culture Biotechnology. Dr Qasim Rafiq leads up the Scientific Programme for the society. The society promotes the communication of knowledge and experience between scientists and engineers whose work has a direct or indirect bearing on cell culture biotechnology and the products derived from it. A particular emphasis is to ensure both the inclusion, and the active participation, of less experienced scientists in industry or academic institutions. ESACT-UK actively encourages interactions between academia, governmental and policy making agencies, and the manufacturing and service industries. One product of such interactions, which involved members of ESACT-UK, is the international Good Cell Culture Practice (GCCP) Guidance Document.
 
Description Elected Management Board Member of BBSRC BioProNet
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Impact BioProNet coordinates the entire UK academic and industrial community for Bioprocess Manufacturing, via network meetings, workshops and managed proof of concept funding. Research outputs feed into larger InnovateUK proposals.
 
Description Hub User Feasibility Study fed into MMIP business case on "A UK Strategy for the Manufacture of GMP Viral Vectors"
Geographic Reach National 
Policy Influence Type Participation in a national consultation
Impact Hub User Feasibility Study fed into MMIP business case on "A UK Strategy for the Manufacture of GMP Viral Vectors". The models predicted that switching to a scalable process at any stage of clinical trials was more cost-effective, in terms of both the total cost of development and profitability, than sticking with a non-scalable process throughout development and commercialisation. This has been used in the case for suitable viral vector capacity and capability building in the UK.
URL https://www.bioindustry.org/uploads/assets/uploaded/1d1066a9-be76-44a9-b9458c9ce8c1b040.pdf
 
Description Member, BIA (BioIndustry Association) Cell and Gene Therapy Advisory Committee (biannual)
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact The Committee is linked to implementing recommendations from the MMIP Advanced Therapies Taskforce e.g. to encourage manufacturing of cell and gene therapies to stay in the UK.
 
Description Member, BIA (BioIndustry Association) Manufacturing Advisory Committee for Bioprocessing Industries (2009 - present)
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
Impact A skills initiative was established with the 1st cohort 16-17 and the 2nd cohort 17-18. This aims to build a network of next generation bioprocess leaders, giving them an opportunity to visit each other's facilities for a day to learn about manufacturing of different medicine types. The programme to take place over 12 months. All companies and organisations taking part host a visit.
 
Description Member, BioIndustry Association (BIA) Cell and Gene Therapy Advisory Commitee
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact The BIA CGTAC is a nationally leading committee in the cell and gene therapy field which has significant national and international influence. It has been involved in implementing the MMIP Advanced Therapies Taskforce and within the committee we have developed a series of four explainer booklets and five videos that highlight and celebrate the the work taking place in UK bioscience companies to create innovative new drugs and treatments for patients. This includes a Guide to Cell and Gene Therapy and UK Excellence in the Field aimed at policy makers and the public, which was published as part of this series.
 
Description Member, ISCT (International Society for Cellular Therapy) Business Models and Investment Subcommittee
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost efficient therapeutic manufacturing. This roadmap guides the analysis of Cost of Goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. Planning and accounting for COG at each step in the production process could reduce costs, allowing for more affordable market pricing to improve the long term viability of the cell therapy product and facilitate broader patient access to novel and transformative cell therapies.
 
Description Membership of a guideline committee - Elected Management Board Member of BBSRC BioProNet (2015)
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Impact BioProNet is key to advising and shaping the funding opportunities between BBSRC and EPSRC
 
Description Response to EMA public consultation on strategy "Regulatory Science to 2025"
Geographic Reach Europe 
Policy Influence Type Participation in a national consultation
Impact Hub participation in an EMA public consultation helped to shape the EMA's regulatory science strategy enabling them to decide where the future priorities and resources should be attributed. As part of the consultation, respondents were asked to select three top priorities which the EMA should consider in their strategy. Of the 3 priorities recommended by the Hub, 2 were considered in greater detail during a follow-up workshop to discuss the findings of the consultation. Under the EMA strategic goal to "Develop network-led partnerships with academia to undertake fundamental research in strategic areas of regulatory science" the Hub was cited as an example of an academic research centre with which the EMA should be collaborating (see: https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-develop-network-led-partnerships-academia-undertake_en.pdf)
URL https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-2025
 
Description Response to EMA public consultation on strategy "Regulatory Science to 2025" (2019) - Reimbursement Perspective
Geographic Reach Europe 
Policy Influence Type Participation in a national consultation
Impact Hub participation in an EMA public consultation helped to shape the EMA's regulatory science strategy enabling them to decide where the future priorities and resources should be attributed. Key points highlighted from a reimbursement perspective: HTAs' preparedness and downstream decision-making for innovative medicines. Cost-effectiveness of emerging cell and gene therapies is based on evidence from clinical effectiveness studies, preferences regarding health outcomes and the cost of technologies. Uncertainty in the available evidence effects the estimates of incremental costs, health benefits and the decisions made about implementation of these therapies. Potential solutions to addressing uncertainty have been managed entry agreements (MEAs), which ensure the risks and benefits of technologies are shared between the payers and manufacturers. In addition to MEAs, we recommend the introduction of EU clinical registries post-launch, with input from the EMA and HTA on data requirements. Clinical registries would provide highly structured clinical data to healthcare professionals on safety and effectiveness, and can be used to compare the effectiveness of different treatments for the same disease or condition. However, we recognise that registries would require significant investment in registry design, operating data systems, training and licencing. The cost of running the registries should be factored in HTA evaluations, with further discussions on the distribution costs between the payer and manufacturers. A distinct feature of clinical trials for cell and gene therapies are that they have tended to be small, single-arm, or single-centre, early phase clinical trials. In the context of Europe's publicly-funded healthcare systems, it is evident that they are not geared to make one-off, large up-front payments for therapies with uncertainty. Amortisation and payment by performance models have emerged to as a means to financing high-cost technologies. We suggest, HTA bodies stipulate a resource impact assessment applying the annuity and payment by performance models. This criteria would serve as a tool to predict future expenditure and identify the best reimbursement model early on. Finally, we expect HTA bodies to continue authorising future cell and gene therapies with conditional approval, in which case it is important to understand how the HTA bodies plan on addressing the decommissioning of failed therapies. We suggest, the EMA and HTA bodies evaluate the safety and efficacy of the therapies in consultation with one another, to create a culture where they work in parallel to meet their objectives. This will avoid duplication of data review and expedite the pathway to commercialisation.
URL https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-2025
 
Description UCL Cell and Gene Therapy MBI Course
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact The UCL Cell and Gene Therapy MBI course was designed to align with the Hub activity in mind to address the arising skills gap within the advanced therapy sector. The course is specifically aimed at industrial delegates to provide them with the necessary depth and breadth to address the manufacturing and commercialisation issues associated with these advanced therapies. Over 30 industrial delegates were present for the 3 day course representing large pharmaceutical companies (e.g. GSK), SMEs (e.g. ReNeuron) and also regulatory agencies and representatives from multiple countries including Hong Kong, Qatar and Brunei.
 
Description Advanced Bioprocess 2
Amount £100,973 (GBP)
Organisation Advanced Bioprocess Services Ltd 
Sector Private
Country United Kingdom
Start 01/2018 
End 12/2018
 
Description Advanced Bioprocess 3
Amount £41,333 (GBP)
Organisation Advanced Bioprocess Services Ltd 
Sector Private
Country United Kingdom
Start 01/2019 
End 12/2019
 
Description Advanced Co-Formulation of Targeted Biologic Therapeutics
Amount £2,000 (GBP)
Organisation University of Nottingham 
Sector Academic/University
Country United Kingdom
Start 08/2018 
End 07/2019
 
Description Autolus EngD Studentship
Amount £54,000 (GBP)
Organisation Autolus Limited 
Sector Private
Country United Kingdom
Start 10/2018 
End 09/2022
 
Description CONCORD: CO-ordiNated Care Of Rare Diseases
Amount £732,217 (GBP)
Funding ID HS&DR/16/116/82 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 06/2018 
End 11/2020
 
Description Centre of Excellence
Amount £1,393,742 (GBP)
Organisation PALL Europe 
Sector Private
Country United Kingdom
Start 01/2018 
End 12/2024
 
Description Development of a stability and preservation strategy for NKT cells - Collaborate to Innovate round 2: Advanced Therapies
Amount £99,998 (GBP)
Organisation MedCity 
Sector Public
Country United Kingdom
Start 09/2019 
End 08/2020
 
Description GCRF establishment of biopharmaceutical and animal vaccine production capacity in Thailand and neighbouring South East Asian countries
Amount £4,090,773 (GBP)
Funding ID BB/P02789X/1 
Organisation Biotechnology and Biological Sciences Research Council (BBSRC) 
Sector Public
Country United Kingdom
Start 10/2017 
End 12/2021
 
Description H2020 Marie Sklodowska-Curie Innovative Training Network Grant
Amount £3,991,008 (GBP)
Funding ID 812909 
Organisation Marie Sklodowska-Curie Actions 
Sector Charity/Non Profit
Country Global
Start 02/2019 
End 02/2023
 
Description High-throughput directed evolution to engineer thermostable therapeutic proteins
Amount € 195,454 (EUR)
Funding ID 795539 
Organisation Marie Sklodowska-Curie Actions 
Sector Charity/Non Profit
Country Global
Start 07/2018 
End 07/2020
 
Description Industrial Fellowship - Carlos Julia - Aglaris
Amount £110,672 (GBP)
Organisation Royal Commission for the Exhibition of 1851 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2018 
End 09/2021
 
Description Industrial Fellowship - Shaun Mansfield Biovault Technical
Amount £109,490 (GBP)
Organisation Royal Commission for the Exhibition of 1851 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2017 
End 09/2020
 
Description Innovate UK
Amount £952,551 (GBP)
Funding ID 6667 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 06/2018 
End 05/2020
 
Description InnovateUK Collaborative R&D
Amount £545,024 (GBP)
Funding ID 104377 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 07/2018 
End 09/2019
 
Description InnovateUK KTP between SureScreen Limited & University of Nottingham: Implementing technologies for manufacture of personalised nutritional supplements
Amount £266,910 (GBP)
Funding ID KTP011734 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 11/2019 
End 11/2022
 
Description InnovateUK KTP with Aber Instruments - Development of a Biocapacitance Probe for Real-Time, Online ATMP Analytics
Amount £232,720 (GBP)
Funding ID Ref No: KTP 12049 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 06/2020 
End 05/2022
 
Description InnovateUK KTP with Biovault Technical
Amount £307,617 (GBP)
Funding ID KTP011128 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 04/2019 
End 04/2022
 
Description Knowledge Transfer Partnership
Amount £286,705 (GBP)
Funding ID KTP011678 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start  
 
Description New Industrial Systems: Optimising Me Manufacturing Systems
Amount £1,520,745 (GBP)
Funding ID EP/R022534/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 02/2018 
End 09/2020
 
Description Responsive Mode Manufacturing the Future
Amount £406,203 (GBP)
Funding ID EP/R031649/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 12/2018 
End 11/2021
 
Description Royal Commission Industrial Studentship: Development of experimentally-integrated process models for adaptive CAR-T cell therapy manufacturing
Amount £94,000 (GBP)
Organisation Royal Commission for the Exhibition of 1851 
Sector Charity/Non Profit
Country United Kingdom
Start 10/2019 
End 09/2022
 
Description Sartorius EngD Studentship
Amount £50,000 (GBP)
Organisation Sartorius 
Department Sartorius Stedim Biotech
Sector Private
Country France
Start 10/2017 
End 09/2020
 
Description The Effect of Feed Quality Due to Clarification Strategy on the Design and Performance of Protein A Periodic Counter-Current Chromatography
Amount £95,716 (GBP)
Organisation 3M 
Sector Private
Country United States
Start 05/2017 
End 11/2017
 
Description The Future Vaccine Manufacturing Research Hub (Vax-Hub)
Amount £6,968,180 (GBP)
Funding ID EP/R013756/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 04/2018 
End 03/2021
 
Description The Pluripotent Stem Cells and Engineered Cell (PSEC) Hub
Amount £4,095,179 (GBP)
Funding ID MR/R015724/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 06/2018 
End 05/2023
 
Description UCL-MedImmune Centre of Excellence
Amount £667,000 (GBP)
Organisation MedImmune Ltd 
Sector Private
Country United Kingdom
Start 09/2017 
End 12/2020
 
Description UKRI Future Leaders Fellowship
Amount £1,167,524 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 11/2020 
End 11/2024
 
Description Unitive Design Analysis EngD Studentship
Amount £40,000 (GBP)
Organisation Unitive Design and Analysis, Ltd. 
Sector Private
Country United Kingdom
Start 10/2018 
End 09/2022
 
Description Viral Lasers for Biological Detection
Amount € 100,000 (EUR)
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 10/2019 
End 03/2020
 
Description Viral lasers for biological detection.
Amount £60,000 (GBP)
Organisation Royal Society of Edinburgh (RSE) 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2020 
End 01/2021
 
Title development of UCL CFPS platform 
Description UCL developed their CFPS platform including reaction mix and method for the scalable production of high specific activity extract. This work was conducted by Noelle Colant and Dr Olotu Ogonah. 
Type Of Material Technology assay or reagent 
Year Produced 2020 
Provided To Others? Yes  
Impact A feasibility study by Noelle Colant with Fujifilm Diosynth Biosciences has looked at using the UCL platform for their plasmids. The sensitivity of the CFPS react to the plasmid purification process was identified. *Soon to be submitted for publication by Noelle Colant 
 
Title Cell-free synthesis Micro-24 Microbioreactor 
Description Several data-sets of 19-24 observations (repeats) each with varying process parameters such as length of reaction, pH, Temperature and DO. They contain final titre and aggregation % measurements and on-line pH, Temperature and DO measurements. 
Type Of Material Database/Collection of data 
Year Produced 2019 
Provided To Others? No  
Impact The data-sets were useful for analyses which involved process characterization, optimization, and comparability between experiments 
 
Title Cost of development model 
Description A cash-flow spreadsheet model capturing different costs occurring during research, development, regulatory approval and commercialisation of a new therapeutic drug. 
Type Of Material Computer model/algorithm 
Year Produced 2019 
Provided To Others? No  
Impact The model offer the ability to estimate the expected net present value of different manufacturing and business strategies and identify the optimum. 
 
Title Mixed Integer Linear Programming model for supply chain optimisation of CAR T cell therapies 
Description Two functions are selected as candidate minimisation objectives; namely the total cost and the average network response time, reflecting the urgency of the treatment. The total network cost is associated with the capital, fixed operational (leukapheresis and in-house quality control expenses), manufacturing and transportation cost. The responsiveness of the network is measured through the average lead time for the production and delivery of a therapy, which is the sum of the time a treatment spends at every stage of the supply chain. For the cost minimisation scenarios, an upper bound on the average response time (ART) is introduced (ART=U, where U corresponds to the maximum time allowed before the therapy is be administered to the patient). A set of network and transportation constraints, ensures that only feasible connections are established inside the supply chain network. As regulatory authorities require manufacturers of biological medicinal products to conduct comparability studies for the introduction of new manufacturing facilities, an upper bound constraint is introduced to prevent the establishment of more than two production sites. Sequencing constraints and material balances at each supply chain node impose the correct sequence of events inside the supply chain for every treatment. Finally, capacity constraints on the treatment centres and the manufacturing sites enforce upper bound limitations on the scheduling of therapies. Publication to become available in the 2nd trimester of 2020 - paper submitted and accepted 
Type Of Material Computer model/algorithm 
Year Produced 2019 
Provided To Others? No  
Impact The model allows economic performance of each network evaluated through the achievable average cost per therapy. The results demonstrate that the cost significantly decreased with an increase in patient demand. The high demand scenarios presented reduced operational costs, due to higher manufacturing capacity utilisation. In addition, there is a clear cost trade-off between the supply chain responsiveness and economies of scale. Strict time constraints resulted in higher infrastructure and transportation costs, decreasing the profit gap per therapy. Finally, the capital costs are identified as the major cost contributor in the production of CAR-T cell therapies, while transportation costs only correspond to ~ 2% of the total therapy cost. 
 
Title Multivariate statistical / Neural network Models of Cell-Free synthesis 
Description These data-based models estimate protein titre from process parameters measurements (Such as DO, Temperature, pH, etc.). 
Type Of Material Computer model/algorithm 
Year Produced 2019 
Provided To Others? No  
Impact It was possible to compare the quality of predictions from different modelling techniques. 
 
Title Multivariate statistical / Neural network Models of T-cell expansion 
Description These data-based models estimate cell growth and fold-expansion from process parameters measurements (Such as DO, Temperature, Glucose consumption, Lactate production, pH, etc.). 
Type Of Material Computer model/algorithm 
Year Produced 2019 
Provided To Others? No  
Impact It was possible to compare the quality of predictions from different modelling techniques. 
 
Title T-cell expansion (wells and flasks) 
Description Several data-sets of 7-24 observations (repeats) each. They contain final cell growth, final fold expansion, off-line flow cytometry and on-line process measurements such as pH, Temperature and DO in 100ml flasks. 
Type Of Material Database/Collection of data 
Year Produced 2019 
Provided To Others? No  
Impact The data-sets were useful for analyses which involved process characterization, optimization, and comparability between experiments 
 
Title Techno-economic engine for autologous cell therapies 
Description An object-oriented model to simulate technical and financial aspects in bioprocessing for autologous cell therapies. The model offers the ability to simulate the manufacture of CAR-T therapies and evaluate multiple manufacturing strategies considering different process flowsheets. 
Type Of Material Computer model/algorithm 
Year Produced 2019 
Provided To Others? No  
Impact Alternative technologies (e.g integrated systems, rocking motion bioreactors, hollow fibre bioreactors) can be rapidly evaluated under technical and financial criteria and determine their fit into a manufacturing facility. Additionally, key cost driver can be identified along with the necessary process improvements to design a feasible and cost-effective manufacturing process. 
 
Title Techno-economic engine for biopharmaceuticals 
Description An object-oriented model to simulate technical and financial aspects in bioprocessing for therapeutic proteins. The model offers the ability to simulate the manufacture of different therapeutic proteins (e.g. monoclonal antibodies, antibody drug conjugates, fusion proteins etc.) and evaluate multiple manufacturing strategies considering different process flowsheets (cell culture, cell-free synthesis, chromatographic purification, column-free purification etc.) and modes of operation (batch, fed-batch, perfusion, hybrids). Additionally, the model offers the option to simulate multiple process flowsheets in the same manufacturing facility. 
Type Of Material Computer model/algorithm 
Year Produced 2018 
Provided To Others? No  
Impact Alternative technologies (e.g cell-free synthesis) can be rapidly evaluated under technical and financial criteria and determine their fit into a manufacturing facility. Additionally, key cost driver can be identified along with the necessary process improvements to design a feasible and cost-effective manufacturing process. 
 
Description 3M (FTHM Hub Partner) 
Organisation 3M
Department 3M UK & Ireland
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £15,000 per year from 2019 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to societ
Start Year 2017
 
Description Access to HDX MS at LGC 
Organisation LGC Ltd
Country Global 
Sector Private 
PI Contribution UCL produces protein formulations to be further analysed at LGC. We have also helped LGC to develop the capability for HDX on solid state (freeze-dried) materials.
Collaborator Contribution LGC have provided access to their Mass spectrometry facility, particularly to carry out HDX and peptide mapping of proteins and their formulations.
Impact LGC have trained two PhD students - both funded by the EPSRC CDT, and also one PDRA from the EPSRC Hub. They have also provided access to their facilities to carry out a large body HDX peptide mapping for GCSF and IgG formulations.
Start Year 2016
 
Description Adaptimmune Therapeutics (FTHM Hub Partner) 
Organisation Adaptimmune
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £7000.00 per year from 2019 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2019
 
Description Advanced Bioprocess Services 
Organisation Advanced Bioprocess Services Ltd
Country United Kingdom 
Sector Private 
PI Contribution We have partnered with Advanced Bioprocess Services to deliver technology and process development expertise to clinical stage therapeutic product companies. These have included pre-clinical bioreactor process development and modelling for several Boston (US) based blood products companies, and process development for leading UK based companies in neural stem cell and immunotherapies. Our contribution has been specifically in novel process model development, novel methods to improve process efficiency, and technology design.
Collaborator Contribution Advanced Bioprocess Services manage the interface with companies seeking process development and provide extensive high value reagents and consumables for project work, either directly or via other collaborating companies, as well as providing access to the most relevant and protected industrial processes for development of our research. Since 2016 Advanced Bioprocess Services have directly funded 258,000 GBP of research and impact activity through the University as of end of 2019
Impact Novel industrially applied processes
Start Year 2016
 
Description Aglaris (FTHM Hub Partner) 
Organisation Aglaris Ltd
Country Spain 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £1000 per year from 2018 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Sponsored a Hub User Feasibility Study in collaboration with the University of Manchester Spoke (this has been report in a separate P&C record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2018
 
Description Albumedix (FTHM Hub Partner) 
Organisation Albumedix Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £3000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Sponsor of multiple separate user feasibility studies with Hub and Spoke University partners (these have been reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Allergan (FTHM Hub Partner) 
Organisation Allergan
Country Global 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £15000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description AstraZeneca (FTHM Hub Partner) 
Organisation AstraZeneca
Department AZ Medimmune
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £7000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1500 per day contributed Provision of advice and guidance on the overall direction and progress of the Hub research programme ensuring it is appropriate to their medium to long term needs while satisfying the remit of the Hub, via Advisory Board, valued @£1500 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Autolus (FTHM Hub Partner) 
Organisation Autolus Limited
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £1000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Provision of advice and guidance on the overall direction and progress of the Hub research programme ensuring it is appropriate to their medium to long term needs while satisfying the remit of the Hub, via Advisory Board, valued at £1000 per day contributed Provision of expert input on cell therapy manufacture and analytics
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description BIA Separations (FTHM Hub Partner) 
Organisation BIA Separations
Country Slovenia 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation at Hub meetings and working groups, valued @£2000.00 per day contributed Equipment, PATfixTM system, valued at £83,500 Conference registration fees, valued at £3000 Provision of training, valued at £5000
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description BioIndustry Association (FTHM Hub Partner) 
Organisation BioIndustry Association
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Conference & Training course registration fees, annually (e.g. BioProcess UK, UK Bioscience Forum) valued @ £320 per head Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Provision of advice and guidance alignment of Hub with sector and national biotech strategies, valued @1000 per day contributed Organising committee for partnered-Hub events (1 per year, e.g. manufacturing ATMPs in 2018, Viral Vecs in 2019), valued @1000 per day contributed Dissemination using BIA media channels/database of bioscience companies, valued @ 3000 per year Assistance in identifying user demonstrated feasibility projects designed to illustrate the impact of the Hub research outputs, valued @1000 per day contributed Sponsored a user feasibility project in partnership with UCL and with member-companies of BIA- Manufacturing Advisory Group (BIA-MAC, reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Biologic B Consulting (FTHM Hub Partner) 
Organisation BioLogicB LLC
Country United States 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings, working groups, dedicated consultation meetings, incl international travel, valued @£2500.00 per day contributed Provision of expert input on future directions for the development and manufacture of stratified biologics and cell therapies Provision of advice and guidance on the overall direction and progress of the Hub research programme, as a national resource and international network/profile (e.g. NIIMBLE)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Biopharm Services (FTHM Hub Partner) 
Organisation Biopharm Services
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £1000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Provision of Software, BioSolve Process valued at £28,000 per year, from 2017 Provision of Sofware, BioSolve Connect valued at £40,000 plus £12,500 per year from 2017
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Cancer Research UK (FTHM Hub Partner) 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Co-organised a Hub event, Cell Therapy Technology Showcase event, valued at £1000 per day contributed Sponsored a user feasibility project in partnership with UCL around cell-free synthesis (reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2019
 
Description Cell & Gene Therapy Catapult (FTHM Hub Partner) 
Organisation Cell Therapy Catapult
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Provision of expert advice and guidance on the Healthcare Reimbursement workstream via 1:1 meetings with team members, valued @£500 Assistance in identifying and prioritising user demonstrated projects designed to illustrate the impact of the Hub research outputs via Translation and Impact Committee, valued @ £1000 per day contributed Provision of advice and guidance on the overall direction and progress of the Hub research programme ensuring it is appropriate to their medium to long term needs while satisfying the remit of the Hub, via Advisory Board, valued @£1000 per day contributed Conference & Training course registration fees (e.g.Cell and Gene Therapy Manufacturing Workshop) valued @ £500 Sponsored a user feasibility project in partnership with Loughborough University (reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Cell Medica (FTHM Hub Partner) 
Organisation Cell Medica Ltd.
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £1000 per year, collected for their first year (2019) Provision of advice and guidance on the overall direction and progress of the Hub, via participationat Hub meetings and working groups, valued @£1000.00 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2019
 
Description Centre for Process Innovation (FTHM Hub Partner) 
Organisation Centre for Process Innovation (CPI)
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Assistance in identifying and prioritising user demonstrated projects designed to illustrate the impact of the Hub research outputs via Translation and Impact Committee, valued @£1000 per day contributed Provision of advice and guidance on the overall direction and progress of the Hub research programme ensuring it is appropriate to their medium to long term needs while satisfying the remit of the Hub, via Advisory Board, valued @ 1000 per day contributed Sponsored the Cell-Free Synthesis Specialist Working Group meeting at Darlington site, valued @£2000
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to societ
Start Year 2017
 
Description Characterisation of degradations in biotherapeutics coformulation 
Organisation MedImmune
Department MedImmune Cambridge
Country United Kingdom 
Sector Private 
PI Contribution The co-formulation of biotherapeutics has been researched as a form of drug combination product which brings conveniences of storage and administration. We study the analytics and control strategy for degradation in coformulated therapeutic proteins, primarily antibodies, using a range of biophysical techniques.
Collaborator Contribution MedImmune provides three antibodies under the MTA framework. The materials provided by MedImmune will be mixed into ratios for aggregation study in our team.
Impact Aggregation kinetics of these MedImmune antibodies is studied at the moment. The prelimarily result shows a concentration-dependent kinetics of aggregation for some of these antibodies. Another therapeutic proteins which is previously shown to be aggregation-inhibitory will be mixed with MedImmune antibodies to test if the aggregation can be prevented.
Start Year 2018
 
Description Collaboration on phenotyping of immunotherapeutic T/CAR-T cell products by Raman spectroscopy 
Organisation University College London
Department Biochemical Engineering
Country United Kingdom 
Sector Academic/University 
PI Contribution Optimise recently installed (BioScience DivRaman spectroscopy for live single cell analysis. Co-supervise MSc student affilated with FTHM Hub 2.3a project on characterization of immune cells by Raman spectroscopy. Participate in acquisition of Raman spectra of immunotherapeutic T cells. Multivariate analysis of T cells Raman spectra alowing to distinquish non-activated and activated human T cells by its unique biochemical content.
Collaborator Contribution Access to new Raman facilities. Participate in acquisition of limited sets of T cells Raman spectra.
Impact Non-activated and activated human T cells were distinquished by Raman spectroscopy combined with chemometrics methods - i.e. by its unique biochemical content.
Start Year 2019
 
Description Collaboration on phenotyping of immunotherapeutic T/CAR-T cell products by Raman spectroscopy 
Organisation University College London
Department Department of Cell and Developmental Biology
Country United Kingdom 
Sector Academic/University 
PI Contribution Optimise recently installed (BioScience DivRaman spectroscopy for live single cell analysis. Co-supervise MSc student affilated with FTHM Hub 2.3a project on characterization of immune cells by Raman spectroscopy. Participate in acquisition of Raman spectra of immunotherapeutic T cells. Multivariate analysis of T cells Raman spectra alowing to distinquish non-activated and activated human T cells by its unique biochemical content.
Collaborator Contribution Access to new Raman facilities. Participate in acquisition of limited sets of T cells Raman spectra.
Impact Non-activated and activated human T cells were distinquished by Raman spectroscopy combined with chemometrics methods - i.e. by its unique biochemical content.
Start Year 2019
 
Description Collaboration with Cell Medica 
Organisation Cell Medica Ltd.
Country United Kingdom 
Sector Private 
PI Contribution We have provided Cell Medica with relevant expertise in the scale-up and manufacture of iNKTs as well as techniques for the scalable cryopreservation of iNKT cell therapies.
Collaborator Contribution Cell Medica have provided a significant amount of consumables for research work at UCL, in excess of £15,000 of consumable items.
Impact A key output will be a paper that draws on the key research findings that have emanated from the study.
Start Year 2019
 
Description Collaboration with Sartorius on ambr250 use for Cell and Gene Therapy 
Organisation Sartorius
Department Sartorius Stedim Biotech
Country France 
Sector Private 
PI Contribution We (the FTHM Hub) have provided significant expertise and knowledge to the development of the new cell and gene therapy amb250 bioreactor vessel. We have also demonstrated and published on data highlighting it's use for cell and gene therapy applications, including T-cell production.
Collaborator Contribution Sartorius have provided a 3-year loan of the ambr250 bioreactor system (value of loan is £50,000) which is likely to be extended for an additional period of time. They have also provided all of the consumables required for the project, including bioreactor vessels, filters and tubing sets free of charge. The estimated cost of this for the 3 year period is in excess of £50,000.
Impact (1) A new bioreactor vessel has been released by Sartorius with direct input and involvement from academics at UCL. (2) A paper has been published in Biotechnology and Bioengineering which demonstrates the use of the ambr250 for T-cell production. (3) A white paper has been published by Sartorius for the use of the ambr250 for cell and gene therapy applications. (4) 8 presentations both nationally and internationally have been delivered on this work. (5) 2 more papers are in submission showing the use of the system for CAR-T and scalability between ambr15, ambr250 and the 1-L Stirred-tank systems.
Start Year 2017
 
Description Eli Lilly (FTHM Hub Partner) 
Organisation Eli Lilly & Company Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £15000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£2000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description FUJIFILM Irvine Scientific collaboration 
Organisation Irvine Scientific
Country United States 
Sector Private 
PI Contribution Postdoctoral expertise, intellectual input.
Collaborator Contribution Intellectual input, materials and reagents.
Impact -The viral titre from serum-free, chemically-defined, suspension system is comparable to that of the conventional serum-containing, adherent system. -Healthy donor CAR-T cells can be effectively grown in serum-free, chemically-defined conditions. -The media in which CAR-T cells are grown may affect their killing capability in vitro. This collaboration is not multi-disciplinary.
Start Year 2019
 
Description Francis Biopharma Ltd (FTHM Hub Partner) 
Organisation Francis Biopharma
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via meetings with the Hub leadership valued @£2000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description FujiFilm Diosynth Biotechnologies (FTHM Hub Partner) 
Organisation Fujifilm
Department Fujifilm Diosynth Biotechnologies
Country United States 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £7000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Sponsored a user feasibility project in partnership with UCL (reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description GSK (FTHM Hub Partner) 
Organisation GlaxoSmithKline (GSK)
Country Global 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £15000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Provision of advice and guidance on the overall direction and progress of Hub workstreams via consultation with individual team members valued @£1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Industry partnership for materials from UCB Pharma 
Organisation UCB Pharma
Country United Kingdom 
Sector Private 
PI Contribution We analysed the aggregation behaviour of a Fab protein obtained from UCB Pharma under a wide range of conditions. This has provided general information on the aggregation mechanisms, formulations and stabilising factors in Fab molecules, useful for therapeutic formulations and bioprocessing.
Collaborator Contribution UCB Pharma provided an E. coli strain that produces the A33 Fab fragment. They also provided advice for its expression and analysis.
Impact Scientific outputs on formulation of Fab and understanding of aggregation mechanisms. The access to this material has also enabled us to develop novel analytical techniques in other grants. The partnership has also led to three CASE-PhD collaborations with UCB in 2017.
Start Year 2011
 
Description Ipsen (FTHM Hub Partner) 
Organisation Ipsen
Country Global 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £7000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Provision of advice and guidance on workstream-related collaborative funding bid, via consultation with senior academic team valued @£1000 per day contributed Sponsored a user feasibility project in partnership with UCL (reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Knowledge Transfer Network (KTN, FTHM Hub Partner) 
Organisation Knowledge Transfer Network
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Provision of advice and guidance on the overall direction and progress of the Hub research programme ensuring it is appropriate to their medium to long term needs while satisfying the remit of the Hub, via Advisory Board, valued @£1000 per day contributed Support for co-sponsored networking events, valued @ £3000 per year (1) Vaccine Development Workshop, 6th September 2017, London (2) https://ktn-uk.co.uk/news/manufacturing-atmps-moving-from-approvable-to-commercial-success (3) https://ktn-uk.co.uk/news/viral-vectors-for-vaccines-and-gene-delivery Dissemination using database of bioscience companies, access to proprietary roadmap, valued @ £2000 pear year
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description LGC (FTHM Hub Partner) 
Organisation Laboratory of the Government Chemist (LGC) Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Access/exploitation of mass spectrometry capabilities and instrumentation, including training and supervision (collaborating with UCL, reported as a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Lonza (FTHM Hub Partner) 
Organisation Lonza Group
Department Lonza Biologics
Country United States 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £15000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1500 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Materials and facility access from NIBSC 
Organisation National Institute for Biological Standards and Control (NIBSC)
Country United Kingdom 
Sector Public 
PI Contribution We analysed the aggregation behaviour, and stability of a GCSF protein and mutants of this, obtained from NIBSC under a wide range of formulations. This has provided general information on the aggregation mechanisms, formulations and stabilising factors in GCSF molecules, useful for therapeutic formulations and bioprocessing.
Collaborator Contribution NIBSC provided an E. coli strain that produces the GCSF. They also provided advice for its expression and analysis. They also provided access to NMR, pilot-scale freeze dryers, Karl Fischer analysis, biological potency assays, and Mass spectrometry.
Impact This partnership has involved one EPSRC EngD, one BBSRC PhD, and two EPSRC CDT PhD students, formal partnership and strategic advice for the EPSRC Formulation project, Centre for Innovative Manufacturing and Future Targeted Healthcare Manufacturing Hub, as well as attendance by NIBSC at Hub events and workshops. The partnership is multi-disciplinary, bringing together protein biophysics (UCL), protein engineering (UCL), protein aggregation (UCL), freeze-drying (NIBSC), biological assays (NIBSC), NMR (NIBSC) and Mass spectrometry (NIBSC). Outputs therefore include, 3 graduated PhD/EngDs, 1 PhD currently running, 3 PDRAs receiving training and carrying out work in NIBSC facilities, 5 co-authored publications.
Start Year 2007
 
Description Materials from Medimmune/AZ 
Organisation AstraZeneca
Department AZ Medimmune
Country United Kingdom 
Sector Private 
PI Contribution We have analysed the antibody samples using novel analytics
Collaborator Contribution Donation of five antibody and bispecific samples.
Impact Molecules have enabled an assessment of analytical techniques we have developed. Molecules have also been used to elucidate new mechanisms involved in protein aggregation in medical formulations. This will enable improved future formulations of antibody therapies.
Start Year 2018
 
Description Medicines Manufacturing Industry Partnership (MMIP, FTHM Hub Partner) 
Organisation Medicines Manufacturing Industry Partnership
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on alignment of Hub with sector and national biotech strategy, valued at £1000 per day contributed Additional contributions captured within the C&P records for Knowledge Transfer Network (KTN) , Association of Biopharmaceutical Industry (ABPI) and BioIndustry Association (BIA)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description NIBSC (FTHM Hub Partner) 
Organisation National Institute for Biological Standards and Control (NIBSC)
Country United Kingdom 
Sector Public 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Oxford BioMedica (FTHM Hub Partner) 
Organisation Oxford BioMedica UK Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £1000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£2000 per day contributed Assistance in identifying and prioritising user demonstrated projects designed to illustrate the impact of the Hub research outputs via Translation and Impact Committee Sponsored a user feasibility project in partnership with UCL & BIA-Manufacturing Advisory Committee (reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Pall (FTHM Hub Partner) 
Organisation PALL Europe
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £15000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups,valued @£1000.00 per day contributed Assistance in identifying and prioritising user demonstrated projects designed to illustrate the impact of the Hub research outputs via Translation and Impact Committee, valued @£1000.00 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Pall Europe collaboration 
Organisation PALL Europe
Country United Kingdom 
Sector Private 
PI Contribution Evaluating samples supplied by Pall in the new instrumentation.
Collaborator Contribution Supply of antibody samples of different grades for analysis.
Impact Led to a follow on EngD project in collaboration with Pall Europe
Start Year 2017
 
Description Perceptive Engineering (FTHM Hub Partner) 
Organisation Perceptive Engineering Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000.00 per day contributed Access to Software, valued at £30,000, and associated training, valued at £3,000
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Puridify (FTHM Hub Partner) 
Organisation Puridify
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £1000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000.00 per day contributed Time filming a stakeholder interview for the Hub promotional video, valued at £1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Purolite (FTHM Hub Partner) 
Organisation Purolite International Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £7000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Time in 1:1 discussions with members of the senior academic team, valued @£1000 per day contributed Sponsored a user feasibility project in partnership with UCL (reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description ReNeuron (FTHM Hub Partner) 
Organisation Reneuron
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £1000 per year from 2017 1:1 discussions with the senior acadeimic team, valued @£1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description SSC Bio (FTHM Hub Partner) 
Organisation SSC Bio
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£2000 per day contributed Provision of expert input on healthcare regulation and reimbursement, NICE, valued @ £2000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Sartoruus (FTHM Hub Partner) 
Organisation Sartorius
Department Sartorius Stedim UK Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £15,000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1500 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Stability of coformulated biotherapeutics in the presence of serum albumin 
Organisation Albumedix Ltd
Country United Kingdom 
Sector Private 
PI Contribution The co-formulation of biotherapeutics has been researched as a form of drug combination product which brings conveniences of storage and administration. However, the mixture of therapeutic proteins could lead to co-aggregation and reduced shelf life. Human serum albumin (HSA) is a widely used protein stabilising biologics in many formulations. We investigate whether HSA can aid the stability of biotheraputics in co-formulations.
Collaborator Contribution Albumedix provides the HSA material under MTA framework for us to make analysis.
Impact The mixture of HSA and antibodies has been created under a few pH conditions. The prelimarily data shows HSA cannot be separated using SEC-HPLC from antibodies. Therefore, other form of separation such as HIC and RP-HPLC are under investigation.
Start Year 2017
 
Description Sutro Biopharma (FTHM Hub Partner) 
Organisation Sutro Biopharma
Country United States 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £2000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£2000 per day contributed Provision of expert input on cell-free synthesis route for personalised medicines Sponsored a user feasibility project in partnership with UCL (reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description The Association of the British Pharmaceutical Industry (ABPI, FTHM Hub Partner) 
Organisation Association of the British Pharmaceutical Industry
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via attendance at Hub meetings and working groups, valued @£1000.00 per day contributed Provision of advice and guidance on the overall direction and progress of the Hub research programme ensuring it is appropriate to their medium to long term needs while satisfying the remit of the Hub, via Advisory Board
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Towards the development of a robust scalable platform for the production of Stratified medicines using Cell Free Protein Synthesis: training and knowledge transfer. 
Organisation Sutro Biopharma
Country United States 
Sector Private 
PI Contribution After ann analysis of the published literature we (UCL) recognised the need to accelerate our Cell Free Protein Synthesis capabilities through an acceleration of our technical/hands-on skills and knowledge transfer/organisational learning processes. We recognised that one of the HUB industrial partners is already a leader in this field. Thus a representative of Sutro Biopharma was contacted and a project proposal put forward with very clearly defined outcomes, outputs and benefits. This proposal was accepted and a 1 month secondment for a member of the HUB technical staff to Sutro's South San Francisco research centre took place in the summer of 2018. IN addition to the secondment an agreement was reached where UCL researchers were allowed to use propriety Sutro developed reagents in the UCL Bloomsbury laboratories for the process of staff training/process development.
Collaborator Contribution Sutro Biopharma are the world leaders in the use of cell free protein synthesis for the production of biologicals for thearupitic use at an industrial scale. Here at UCL we are working towards the development of a robust scalable platform for the production of Stratified medicines using Cell Free Protein Synthesis (CFPS). CFPS is a new area of research to us; in order to meet the agreed program objectives and timelines it was imperative for the UCL scientists to rapidly become profecient in the use of this system. Although there is significant amount of data/information published in this area most are from academic sources, and of somewhat limited application to us. Through this colaboration with Sutro Biopharma we were able to rapidly upskill our team members through hands on training methods training as well as acceleratino the organisational learning process through knowledge transfer. We have estimate that the knowledge and training gained through this secondment/colaboration has accelerated our process development timelines by 9 - 12 months.
Impact We have estimate that the knowledge and training gained through this secondment/collaboration has accelerated our process development timelines by 9 - 12 months. Specifically, we have developed a scalable, robust method for the production of a key propriety reagent (extract), the insight gained have allowed a deeper understanding on possible additional genetic/molecular biology modifications/tweeks needed to improve process yields, and the knowledge and 'tricks' gained through this collaboration has enabeled us to develop 'trade secrets' which have directly led to higher process efficiencies/yields.
Start Year 2017
 
Description TrakCel (FTHM Hub Partner) 
Organisation TrakCel
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £1000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1500 per day contributed Sponsored a user feasibility project in partnership with Imperial College (reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description UCL-BIA User Feasibility Study: Economic evaluation of switching to a scalable GMP process for the manufacture of viral vectors at different stages of the drug development pathway 
Organisation BioIndustry Association
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution We (the FTHM hub) developed and linked the models (a CART, a Viral vector and a drug development model) to simulate the cost of goods, the cost of drug development and the net present value of in vivo and ex vivo therapies at different commercial demands. We interviewed other industrial specialist along with academics and clinicians to help us establish a representative drug development pathway and all associated costs except manufacturing costs which we simulated. We performed the simulations, the analysis and the visualisation of the results.
Collaborator Contribution BIA and OXB proposed the context and the key research question for the user feasibility study. BIA and OXB helped to fine-tune the models, participate in teleconferences and sanity check the results. Contribution valued @£2000 per day.
Impact • Evaluated the cost of drug development (i.e. process development, technology transfer, clinical manufacturing, etc.) and the profitability (net present value) of different therapies assuming a switch to a scalable process at different stages in the drug development pathway. • The analysis demonstrated the need for viral vector capacity using scalable manufacturing processes to supply clinical and commercial demand. The initial findings of this work have been used to support the ongoing development of a joint industry-academia business case that holistically illustrates the benefits of adopting future-proofed scalable viral vector manufacturing processes and platforms for the development of ATMPs. This work provides supporting data for a key deliverable from the advanced therapies workstream of the Medicines Manufacturing Industry Partnership (MMIP). Overall it will be used to further outline to policymakers and government the importance of investment and enabling policy work to secure a long term future of ATMP manufacture in the UK. The expertise of the UCL team, coupled with the use of objective modelling tools ensure that a robust set of data and findings are now available to support this important work. It also helps to generically illustrate the importance of investing in future-proofed scalable manufacturing processes and platforms for this group of important and emerging new medicines - the ATMPs - which are one of the fastest growing and most heavily invested-in areas of pharmaceutical development at the current time globally.
Start Year 2019
 
Description UCL-BIA User Feasibility Study: Economic evaluation of switching to a scalable GMP process for the manufacture of viral vectors at different stages of the drug development pathway 
Organisation Oxford BioMedica UK Ltd
Country United Kingdom 
Sector Private 
PI Contribution We (the FTHM hub) developed and linked the models (a CART, a Viral vector and a drug development model) to simulate the cost of goods, the cost of drug development and the net present value of in vivo and ex vivo therapies at different commercial demands. We interviewed other industrial specialist along with academics and clinicians to help us establish a representative drug development pathway and all associated costs except manufacturing costs which we simulated. We performed the simulations, the analysis and the visualisation of the results.
Collaborator Contribution BIA and OXB proposed the context and the key research question for the user feasibility study. BIA and OXB helped to fine-tune the models, participate in teleconferences and sanity check the results. Contribution valued @£2000 per day.
Impact • Evaluated the cost of drug development (i.e. process development, technology transfer, clinical manufacturing, etc.) and the profitability (net present value) of different therapies assuming a switch to a scalable process at different stages in the drug development pathway. • The analysis demonstrated the need for viral vector capacity using scalable manufacturing processes to supply clinical and commercial demand. The initial findings of this work have been used to support the ongoing development of a joint industry-academia business case that holistically illustrates the benefits of adopting future-proofed scalable viral vector manufacturing processes and platforms for the development of ATMPs. This work provides supporting data for a key deliverable from the advanced therapies workstream of the Medicines Manufacturing Industry Partnership (MMIP). Overall it will be used to further outline to policymakers and government the importance of investment and enabling policy work to secure a long term future of ATMP manufacture in the UK. The expertise of the UCL team, coupled with the use of objective modelling tools ensure that a robust set of data and findings are now available to support this important work. It also helps to generically illustrate the importance of investing in future-proofed scalable manufacturing processes and platforms for this group of important and emerging new medicines - the ATMPs - which are one of the fastest growing and most heavily invested-in areas of pharmaceutical development at the current time globally.
Start Year 2019
 
Description UCL-Ipsen User Feasibility Study: Techno-economic evaluation of a cell-free synthesis system for the expression of highly potent recombinant proteins 
Organisation Ipsen
Country Global 
Sector Private 
PI Contribution We (the FTHM hub) developed and the model to simulate the different process configurations relevant to Ipsen comparing their platform process to a cell-free synthesis process. We performed the simulations, the analysis and the visualisation of the results.
Collaborator Contribution Ipsen proposed the context and the key research questions of the user feasibility study. Ipsen provided all necessary data to feed into the model. Ipsen validated the initial results and provided constructive feedback to help fine-tune the model and finalise the scenarios. Input from Ipsen staff valued at £1000 per day.
Impact • Benchmarked the cost of goods (COG) of Ipsen's current manufacturing platform process. • Evaluated the COG using a cell-free synthesis process. • Evaluated in-house and outsourcing options for the supply of the necessary extract for the CFS process. • Evaluated the impact of alternative purification strategies on the COG (e.g. introduction of an affinity chromatography resin for the capture step that would also cause the removal of the intermediate purification chromatography step). • Evaluated and compared the cost-effectiveness and operational feasibility of the platform process and the CFS process for a multi-product facility at different dose sizes.
Start Year 2019
 
Description UFS - Historical batch analysis and trajectory optimisation for T-cell expansion process control 
Organisation Aglaris Ltd
Country Spain 
Sector Private 
PI Contribution - Multivariate statistical data analysis of T-cell manufacturing data. Based on the historical data analysis, this study will seeked to optimise the trajectory (-ies) of one or more Critical Process Parameters (CPPs) found to have an important effect in product quality. These were carried out by a Design of Experiments (DoE) in collaboration with Aglaris.
Collaborator Contribution Total value of £8,300 - Manufacturing data (e.g. yields, concentrations, measurable CPPs, etc.). - Feedback and technical support from the T-cell manufacturing team. - Application of the DoE strategy on the manufacturing site and the collection of further process data. Contribution based on input from Aglaris: Labour costs £4,000, materials £3,500, overheads (20% labour costs) £800
Impact In review - Multivariate statistical data analysis journal article indicating the ability of regression models to estimate product quality Multi-disciplinary collaboration: - Research expertise within the HUB focuses on Process Control at the School of Electrical and Electronic Engineering in The University of Manchester. - Reserach expertise within Aglaris focuses on Biomedical Engineering at the R&D System Automation Engineering in Aglaris Ltd.
Start Year 2018
 
Description Univercells (FTHM Hub Partner) 
Organisation Univercells Ltd
Country Belgium 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £2000 per year from 2019 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed Sponsored a user feasibility project in partnership with UCL(reported in a separate C&P record)
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2019
 
Description User Feasibility Study with Albumedix 
Organisation Albumedix Ltd
Country United Kingdom 
Sector Private 
PI Contribution We have been working with Albumedix to formulate nanoparticles and microparticles using their recombinant human serum albumin as a scaffold. We have been using the microparticles to solubilise poorly soluble small molecule drugs within the albumin scaffiolds.
Collaborator Contribution Albumedix have provided the albumin required for the experiments. They have also offered the time of their scientists and we are carrying some stability studies in their laboratories.
Impact None as yet.
Start Year 2019
 
Description User Feasibility Study with Cancer Research UK 
Organisation Cancer Research UK
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Bringing experience with cell-free synthesis and in-house developed protocols / materials for cell-free extract and reaction mix preparation. 3 months of FT from a post doctoral researcher. UCL have committed to continuing to collaborate with CRUK on this project (assuming a successful feasibility study).
Collaborator Contribution CRUK originated to suggested area of collaboration. CRUK will be contributing by conducting analytics, and driving continued development of the technology to GMP / clinical trial stages (assuming a successful feasibility study).
Impact TBC
Start Year 2019
 
Description User Feasibility Study with FujiFilm Diosynth 
Organisation Fujifilm
Department Fujifilm Diosynth Biotechnologies, UK
Country United Kingdom 
Sector Private 
PI Contribution 3 months of a PhD candidate's (Noelle Colant's) time. Using the CFS platform developed in-house at UCL to trial expression of "difficult to express" plasmids at Fujifilm Diosynth, and applying in-house developed expertise to troubleshoot.
Collaborator Contribution Access to facilities for conducting experiments. Use of in-house plasmids. Some experimentation towards troubleshooting.
Impact Identification of an inappropriate plasmid purification kit, which is incompatible with cell-free.
Start Year 2019
 
Description User Feasibility Study with West Pharma - Performance Comparability of Cyclic Olefin Polymer Vials and Ethylene Vinyl Acetate Bags for Storage of T Cells 
Organisation West Pharmaceutical Services
Country United States 
Sector Private 
PI Contribution This user feasibility study allowed us (the FTHM Hub) to undertake novel bioprocessing research investigating the comparability of using cryovials for the endstage cryopreservation versus cryobags. Experimental work has been completed for the study. Access to the expertise and cell material of UCL through the Hub has enabled the following key learnings: 1) The data showed similar recovery of T cells, in terms of viability, growth kinetics, immunophenotype and cell exhaustion, whether stored in vials or bags. This highlights that rigid vials may be a suitable container for cell therapies that can be used without the risks of dead volume and breakage that accompanies storage in bags. 2) While the thermodynamic behavior of the two vessels is quite different, with vials taking an average of 6x longer to thaw than bags, the fundamental cell characteristics evaluated do not appear to be affected by the extended warming. If confirmed, this enhanced stability in a rigid vial could be shown to be advantageous for cell therapy users struggling with handling, transport, or cold chain logistics by providing a longer time window to transfer between processing steps.
Collaborator Contribution West Pharmaceutical Services provided access to consumables and the cyclic olefin vials used for the study. They also provided the context and key research questions for this study and, through regular consultations, ensured that the research questions and experimental goals remained on track.
Impact Presentations at major national and international conferences. A white paper on the use of vials vs cryobags and adoption of protocols and processes internally within West Pharmaceutical Services.
Start Year 2019
 
Description User feasibility study with TrakCel 
Organisation TrakCel
Country United Kingdom 
Sector Private 
PI Contribution Identification of bottlenecks, challenges and opportunities of the current supply chain network are identified and addressed. Alternative solutions towards time & cost minimisation, risk mitigation and seamless scalability will be proposed in the space of clinical and/or manufacturing site distribution. Development, simulation and assessment of the following Mixed Integer Linear Programming Problems: • Classic supply chain structure (hospital-manufacturing-hospital) • Outsourcing versus in-house QC analysis • Potential of intermediate storage/cryopreservation facilties
Collaborator Contribution Expert insight, data sets and results assessment. Trakcel helped to develop the initial proposal with its key research questions. During the study, they provided datasets and contributed with their Expert insight and assessment of resullts to the fine-tuning of the model. Input from Trakcel valued at £1500 per day [total of £12000].
Impact 1. Moschou D. Papathanasiou M.M, Lakelin M., Shah, N., "Investment Planning in Personalised Medicine", European Symposium on Computer Aided Process Engineering (ESCAPE) 30 2. Papathanasiou M.M, Stamatis C. Lakelin M, Farid S., Tichener-Hooker N., Shah N., "Autologous CAR T-cell therapies supply chain: Challenges and Opportunities?", l submitted at Cancer Gene Therapy Nature 3. Papathanasiou M.M, Lakelin M., Shah N., "Enabling Precision Healthcare through Patient-Centric Supply Chain Networks", AIChE Annual Meeting 2019
Start Year 2018
 
Description WestPharma (FTHM Hub Partner) 
Organisation West Pharmaceutical Services
Country United States 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Annual cash contribution: £15,000 per year from 2017 Provision of advice and guidance on the overall direction and progress of the Hub, via participation in Hub meetings and working groups, valued @£1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description Wyatt UK (FTHM Hub Partner) 
Organisation Wyatt Technology Corporation
Department Wyatt Technology UK Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of input to the Hub as an original core partner, valued @£1000 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society
Start Year 2017
 
Description deltaDOT (FTHM Hub Partner) 
Organisation deltaDOT Ltd
Country United Kingdom 
Sector Private 
PI Contribution Collaborating Organisation and Partnership under the Future Targeted Healthcare Manufacturing Hub
Collaborator Contribution Provision of advice and guidance on the overall direction and progress of the Hub, via participationat Hub meetings and working groups, valued @£1500 per day contributed
Impact Working within a network of users and academics to deliver the vision: to address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to societ
Start Year 2017
 
Description 1-Day Teaching Seminar in Microfluidics 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Together with an industrial partner in microfabrication, I taught a one day seminar in microfluidics ahead of the Lab on Chip conference in Mumbai, India, 2018.
Year(s) Of Engagement Activity 2018
URL https://selectbiosciences.com/conferences/index.aspx?conf=MLOAC18
 
Description 1st International Training Course - Application of microbioreactors (MBR) in bioprocess development. September 24-28, 2018, TU Braunschweig, Germany http://www.eurombr.nu/ 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact 5-day training course with lecture programme and laboratory hands-on
Topics:
- Microfabrication
- Microfluidics, Transport phenoma, Fluid flow - Sensors and Inline-Analytics
- Enzyme immobilisation
- Biocatalysis
- Cultivation
- Modeling and Design of microfluidic processes
Year(s) Of Engagement Activity 2018
URL http://www.eurombr.nu/
 
Description A specialist working group (SWG) on cell free synthesis (CFS). 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact A specialist working group (SWG) on cell free synthesis (CFS).
The group meets twice a year to discuss the challenges of using CFS as a platform for biotherapeutic manufacture to meet the needs of targeted healthcare.
This is an important activity within the EPSRC Future Targeted Healthcare Manufacturing hub (https://www.ucl.ac.uk/biochemical-engineering/research/hub).
Bringing together supplier and user companies to consider the challenges and possibilities in the area.
The scope is from the experimental challenges to costing and regulatory issues.
Year(s) Of Engagement Activity 2017,2018,2019
 
Description BioMAN 2019 Summit. Technology and Innovation for Sustainable Manufacturing of Advanced Therapy Medicinal Products. Cambridge USA, 11-12 December 2019 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact The Summit was related to Technology and Innovation for Sustainable Manufacturing of Advanced Therapy Medicinal Products.
It was orginised by MIT Centre for Biomedical Innovation.
Top people from industry and academia (including Harvard University and MIT as a majour players on this Summit) discussed the current state and future directions of Manufacturing of Advanced Therapy Medicinal Products.
Presenting a poster "Label-free recognition of non-activated and activated human T cells by Quantative Phase Imging" and further overall discussions over non-invasive methods for cell Quality Control of manufacturing of safe and potent immunotherapeutic cell products.
A particular interest was a presentation of newly created SMART-CAMP MIT/Singapour Interdisciplinary research group regarding their activities in developing of Critical Analytics for manufacturing of Cell Therapy products.
Year(s) Of Engagement Activity 2019
 
Description BioProNet Bioprocess Intensification Symposium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact BioProNET Bioprocess Intensification Symposium
4th July 2018
The continued growth of the biopharmaceutical industry is being challenged by a greater number and variety of products than in the past. The industry is also increasingly concerned with the affordability of these products. These key factors means process intensification has become a critical objective. The goal is higher productivity processes to enable small process trains, resulting in cost-effective, lean, and agile manufacturing facilities. The symposium assembles 8 leaders from the biopharmaceutical industry and academia who will present their latest findings and opinions on the subject. By bringing together scientists and engineers from academia and industry who are actively engaged in bioprocess intensification the event will provide forum for lively debate.
Year(s) Of Engagement Activity 2018
URL http://biopronetuk.org/biopronet-funded-collaboration-building-workshops/
 
Description Bioprocess Asia Conference 
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 BPA is an international conference and I am part of the Scientific Advisory Committee
Year(s) Of Engagement Activity 2018
 
Description Bioprocessing Skills School (STARS) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Ran half-day session entitled "Innovative therapies but what about the societal and economic implications", introducing health economic concepts and thinking to participants.
Year(s) Of Engagement Activity 2017
 
Description Cell and Gene Innovation Summit 2020. Liders Inspire action. Berlin 5-6 February 2020 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact The Summit was related to Innovations in Cell and Gene Therapy.
Top people from industry and academia presented and discussed different topics in Cell and Gene Therapy with particular focus on innovations.
As a speaker of the Summit I presented a 30-minutes talk on a topic "Could key cell attributes be defined and monitored label-free for Quality Control of manufacturing a safe and potent immunotherapeutic cell products". Topis covered included application of Quantative Phase Imaging and Raman spectroscopy as analytical methods for label free cell recognition, detection of non-activated and activated human T cells by Phase Imaging on a chip, monitoring of viral loading in cells by Quantative Phase Imaging.
Year(s) Of Engagement Activity 2020
 
Description Chair for the Young Members Forum of London and South East Coast IChemE 
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 Since October 2018 I am chairing the Young Members Forum of London and South East Coast IChemE organisign events that are related and targeted to:

- Undergraduate Chemical Engineering students
- Postgraduate Chemical Engineering students
- Chemical Engineering professionals

I am actively involved in initiating and supporting networking activities, educative pilot plant tours and social activities amongst the group members and beyond.
Year(s) Of Engagement Activity 2018,2019
 
Description Clarke Society Panel Discussion: ''Responsible' Innovation; True or Gimmick? 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact The UCL postdoctoral society of Biochemical Engineering hosted a series of events entitled 'An Afternoon of Innovation' to inform, inspire and celebrate innovation of all disciplines. This was funded by a EPSRC IAA Knowledge Exchange fund.

The event on the 15th Nov 2019 looked at innovation from the perspective of 'True' Innovation and the Science-Society Interface. The event was open to UCL and the Public.

The keynote speaker for this event was Mr David Rowan (Founding Editor-In-Chief of WIRED UK). The panel discussion focused on the concept of 'Responsible Innovation' and entitled - ''Responsible' Innovation; True or Gimmick? - Driving Innovation towards Societal Good.' The Panel host was Mr Jim Dawton (Director at Impeller Ventures). Paul Dalby was one of the four panel members.
Year(s) Of Engagement Activity 2019
 
Description Co-chair at AIChE Annual Meeting 2019 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Chaired the Process Intensification through Process Systems Engineering session ( CAST Division (10A05)) at the AIChE Annual Meeting 2019
Year(s) Of Engagement Activity 2019
URL https://www.aiche.org/conferences/aiche-annual-meeting/2019/proceeding/session/process-intensificati...
 
Description Decisional Tools Specialist Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The Decisional Tools Specialist Working Group (SWG) has met x2 a year since the Hub launch, The SWG discusses the use of Hub Decisional Tools to aid decision-making in the development, manufacture and commercialisation of autologous cell therapies and stratified therapies and includes invited user expert presentations. The aim of this specialist working group meeting is to:
Assess whether decisional tools research plans are addressing the key challenges within stratified protein therapies and personalised cell therapies.
Identify any emerging areas, or current weaknesses in the proposal.
Identify key materials and resources required for the projects proposed.
Evaluate potential risks to the success of the decisional tools workpackages within the Hub.
Year(s) Of Engagement Activity 2017,2018
 
Description Dolomite News 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Featured in dolomites news article detailing the application of microfluidics for the synthesis of nano and microparticles to augment therapeutic delivery and biosensing.
Year(s) Of Engagement Activity 2019
URL https://www.dolomite-microfluidics.com/news/fluorescent-biosensors-as-tools-for-drug-therapeutics/
 
Description FTHM Hub Session at the World Advanced Therapy Congress 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact On behalf of the FTHM Hub, Dr Rafiq organised two dedicated sessions at the World Advanced Therapy Congress Meeting in May 2019. This included 3 talks from FTHM Hub users as part of a "Future Leaders" session, including Rhian Carter from Oxford BioMedica and Emma Chan from Autolus, and also organised a specific session on Hub research which included presentations from Hub Researchers and Investigators. Included presentations for Hub researchers and users (Autolus, CRUK, Oxford BioMedica).
Year(s) Of Engagement Activity 2019
 
Description FTHM Hub/NHS England Meeting - Industrial Economics, 14th January 2020 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Follow-up meeting with NHS England Medicines Analysis Strategy and Policy Team - Summary and Future Interactions

Presentation given to the Hub by NHS England on the challenges when deciding what to pay for a new treatment?
Conclusion: Health Opportunity Cost is a vital consideration for HTA and society. Nishma Patel to liaise with John Spoors to discuss future collaborations.
Year(s) Of Engagement Activity 2020
 
Description Formulation Specialist Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The formulation Specialist Working Group meets every 6 months (twice in 2017, once in 2018 so far) to enable industry, regulatory agency, government laboratory and academic experts to discuss the arising challenges, and potential solutions on a 5-10 year horizon, in the area of formulation for stratified proteins, and cell and gene therapies. Over 30 different users have attended to date, and the meetings have refined the Hub research agenda, scoped out topics for review articles, and engaged the regulatory agencies which raises their awareness of future challenges that they will also need to address.
Year(s) Of Engagement Activity 2017
 
Description Formulation Specialist Working Group - 2018 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact 1. Assess the current second level plan for formulation work proposed within the Hub, in terms of whether it is addressing the key challenges within stratified protein therapy.
2. Identify any emerging areas, or current weaknesses in the proposal.
3. Identify key materials and resources required for the project proposed.
4. Evaluate potential risks to the success of the formulation workpackages within the Hub.
Year(s) Of Engagement Activity 2018
 
Description Future Food Formulations Factories 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Schools
Results and Impact University of Nottingham Student Magazine Article.

With the advent of nanotechnology and the food industry looking for novel applications to maximise the benefits of food nutrition, there have been key advancements in the nutraceutical market.

The researchers at the University of Nottingham's School of Pharmacy have an in depth understanding of the fundamental formulation parameters. We are now enhancing particle formulation by preparing custom designed polymers. These polymers permit targeted delivery of therapeutics and nutraceuticals to specific cellular systems. We believe that the research being conducted at our school is paving the way to transform food security of an ever-growing world population with a limited number of resources
Year(s) Of Engagement Activity 2018
URL https://impactnottingham.com/2018/04/future-food-factories/
 
Description Health Economics Workshop, 12th February 2019 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Other audiences
Results and Impact 1/2 day course

1) Introduction to economic evaluation in health care (Steve Morris)
2) How to conduct an economic evaluation (Nishma Patel)
3) Case study - highly specialised technologies (Nishma Patel)
Year(s) Of Engagement Activity 2018,2019
 
Description Healthcare Specialist Working Group 
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 Healthcare Specialist Working Group involving round table discussions with health care providers, policy makers and industry about reimbursement of personalised cell therapies and stratified medicines.
Year(s) Of Engagement Activity 2017,2018
 
Description Healthcare Specialist Working Group, 10th May 2019 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact This meeting explored the future direction for the Healthcare SWG:
• How do managed access agreements (MAA) unlock access to highly specialised technologies (HST)? What do we know about how expensive they are to administer? Who bears the cost?
• What changes to manufacturing processes for cell and gene therapies will affect the costs to the NHS and benefits to patients of these therapies? What are the likely pathways to impact?
• For CAR-T cell therapy to extend beyond early clinical phase one trials, cryopreservation is essential. How will this impact on the NHS? What are the likely costs and benefits?
Year(s) Of Engagement Activity 2019
 
Description Healthcare Specialist Working Group, 11th October 2019 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact The objective of this meeting were to understand how real-world data is accessed or generated and used to produce or generate real-world evidence (registries)
See whether use is aligned with international standards. Particpants explored the core principles that govern how real-world data and how the data could be credibly used, with the potential to developing 'international standards' to support decisions in healthcare systems.
Key message were the how existing databases could be updated for the purposes of OBR is possible, or through part automation. However, it were evident that this approach were fragmented and costly. The participants explored pros and cons of building a new system, or integrating existing sources into a new platform.
Year(s) Of Engagement Activity 2019
 
Description Healthcare Specialist Working Group, 16th October 2018 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The focus of this meeting was on the challenges in obtaining evidence for regulatory approval and reimbursement of cell and gene therapies. The National Institute for Health and Care Excellence (NICE) rejected the use of Novartis's CAR-T therapy Kymriah in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the NHS. The draft guidance concluded that Kymriah was not cost-effective and highlighted concerns about the data and evidence received. Similarly, Gilead's CAR-T therapy Yescarta (axicabtagene ciloleucel) for diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma was also rejected. What were the driving factors behind these rejections? What implications do they have for how we measure the cost-effectiveness of cell and gene therapies? Roundtable discussion on healthcare reimbursement issues:
1. What are the expectations of regulators and payers for data and evidence in approval and coverage decisions?
2. How can reimbursement decisions about targeted healthcare be handled to accelerate adoption of targeted healthcare?
3. When treatments are recommended for use in the NHS by NICE, commissioners are legally required to provide patients with access to these medicines within three months of the positive recommendation. What barriers to implementing the recommendations should be expected and how can these be overcome?
4. Economic evaluations are conducted to assess the cost-effectiveness of targeted health care. How should these barriers be incorporated in the evaluation?
Year(s) Of Engagement Activity 2018
 
Description Healthcare Specialist Working Group, 1st November 2017 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact In this SWG we aimed at sharing knowledge, experience of different stakeholder perspectives in order to facilitate the progress of the integration of marketing approval and
reimbursement. Roundtable discussion on healthcare reimbursement issues:
1. What are the main challenges in the reimbursement of personalised cell therapies and stratified medicines?
2. What models of drug pricing and reimbursement strategies are currently used and are likely to be used in future for personalised cell therapies and in stratified medicine?
3. What implications does this have for manufacturing?
4. What research questions should the Hub be addressing
Year(s) Of Engagement Activity 2017
 
Description Healthcare Specialist Working Group, 25th April 2018 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The second Healthcare Specialist Working Group explores current realities and future challenges and opportunities in the areas of reimbursement and regulation of targeted proteins and cell-based therapies. The working group are introduced by a summary of the outcomes of the previous meeting and of further issues suggested by the work of the two postdoctoral researchers working on reimbursement and regulations. Roundtable discussion on healthcare reimbursement issues:
1. What are the expectations of reimbursement agencies and payers for data and evidence in approval and coverage decisions for targeted health care, and how and why should these differ from other innovations?
2. Once a product has been authorised, what are the costs of collecting evidence required for adaptive or conditional regulatory approvals? Who bears these costs?
3. When targeted health care innovations are recommended for use in the NHS what barriers are typically faced to implement them? How can these be overcome?
4. Economic evaluations are conducted to assess the cost-effectiveness of tar
Year(s) Of Engagement Activity 2018
 
Description Industry-Academia Networking Event on Application of Artificial Intelligence & Big Data for Early Cancer Detection 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact The activity was related to meet people from Academia and from Industry on Application of AI and Big Data.
It is annual event international event on front edge techniques like AI/Big Data used in Medicine and in Academia research for Early Cancer Detection.
I was there to understand potential of Quantative Phase Microscopy combined with mashine learning techniques for early cancer detection and the routes how to build up AI apropriate algorithms.
Year(s) Of Engagement Activity 2019
 
Description Invited Interview 
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 Professional Practitioners
Results and Impact "Advances in enabling smart technologies across the cell therapy supply chain", Cell and Gene Therapy Insights
Year(s) Of Engagement Activity 2018
URL https://insights.bio/cell-and-gene-therapy-insights/journal/articles/advances-in-enabling-smart-tech...
 
Description Invited Seminar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Invited seminar at the Texas A&M Energy Institute with title "Pharma 4.0: Advancing the current state of the art through Process Systems Engineering approaches". More than 50 people attended, coming from all academic levels (UG to faculty), as well as a few industrial practitioners. Most of the interested was raised around the unique challenges faced in the design and optimisation of the supply chain of CAR T cell therapies. My talk initiated further conversations with members of the faculty and I am now exploring how those can move forward.
Year(s) Of Engagement Activity 2018
URL https://energy.tamu.edu/events/energy-institute-lecture-series-dr-maria-m-papathanasiou/
 
Description Joint UCL and Cancer Research UK Technology Showcase 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact CRUK-Lonza Technology Showcase: Dr Qasim Rafiq, as part of the Future Targeted Healthcare Manufacturing Hub, organised and hosted an event for Hub users to showcase a novel technology developed by Hub Partner (Lonza) for personalised therapy manufacture prior to the general launch. This was the launch of their Cocoon system for manufacturing of autologous therapies and over 60 industrial, commercial and postgraduate users attended. Good technical discussions were had and it was a good opportunity for the user community to engage directly with the technology developers, gain understanding on the new system and showcase the latest technology available for cell and gene therapy.
Year(s) Of Engagement Activity 2019
 
Description Lecture at skills workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Presented workshop at STARS Bioprocessing Skills School. "Innovative therapies but what about the societal and economic implications: Building a compelling case - making the health economics stack up." Darlington, September 2018.
Year(s) Of Engagement Activity 2018
URL http://biopronetuk.org/stars-school-2018-embedding-the-industrial-perspective/
 
Description Lecture on cell therapies 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Lecture on cell therapies in the framework of the Advanced Bioprocess Engineering course for the MSc Advanced Chemical Engineering, Department of Chemical Engineering, Imperial College
Year(s) Of Engagement Activity 2018,2019
 
Description Manufacturing ATMPs: moving from approvable to commercial success 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The Hub presentation on our CAR T research for this KTN event/workshop
Year(s) Of Engagement Activity 2018
 
Description Manufacturing ATMPs: moving from approvable to commercial success 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The Hub and KTN partnered to deliver this meeting enabling industry and academia engagement and collaboration, and showcasing of the relevant translational research being undertaken by the Hub in collaboration with industry. The focus of this meeting was on the current UK innovation landscape for advanced therapies, in support of enabling gene and cell therapy products to go from approvable to commercially successful; translational research projects in support of manufacturing readiness, a future looking session regarding key challenges from clinical, regulatory and skills perspectives. One of the purposes of this meeting was to promote and give an updated view of the Hub to organisations outside of the current consortium. Approx 77% of the attendees were from outside companies & organisations and we got 4 new enquiries about becoming Hub members.
Year(s) Of Engagement Activity 2018
URL https://ktn-uk.co.uk/events/manufacturing-atmps-moving-from-approvable-to-commercial-success
 
Description Manufacturing personalised medicines: overcoming the affordability barrier (Policy Dialogue Event organised by Dr Penny Carmichael), 5th February 2020 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact ***Event organised by Dr Penny Carmichael***
***Reimbursement led by Nishma Patel***
The Hub were awarded £2,000 funding from a UCL-held EPSRC Impact Acceleration account. The aim of the funding is to accelerate the impact of UCL's EPSRC-funded research outputs by supporting knowledge exchange. To make use of this funding, an event is being scheduled around Hub work on manufacturing personalised CAR T-cell therapies. The event brought together researchers with and invited group of policy-makers, clinicians and industry stakeholders providing an opportunity to explore questions around the long-term sustainability of delivering personalised CAR T-cell (and other ex-vivo cell and gene) therapies to NHS patients.

The following objectives were set for the day:
(1) Provide Hub researchers with an opportunity to build relationships with the policy-making and health provider communities and to raise the profile of the Hub with these stakeholders;
(2) To agree the main challenges for CAR T delivery in the UK now - opportunity to highlight manufacturing issues to policy-makers/healthcare providers; and
(3) To agree to what extent these challenges are already being met and what other steps might be required

My role was to lead sessions on the challenges of implementing CAR Ts in the area of reimbursement. By the end of the session, with the groups I agreed what the top two challenges were, and think about how these challenges might be overcome.
Year(s) Of Engagement Activity 2020
 
Description NHS England Accelerated Access Collaborative, 11th February 2020 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact This AAC address issues the National Health Service is confronting; how best to access innovation for the benefit of patients and to improve health care efficiency. The
approach to accessing innovation in the NHS has become increasingly challenging; creating frustration for innovators who see the NHS as an interesting environment for demonstrating the value of their products, for patients who often have to wait long periods of time before life-saving therapies are available, and for clinicians who are frustrated by the multiple barriers to both approval and adoption. One work stream is looking at ATMPs and easing their adoption in the NHS.

We discussed the possibility of Hub members contributing to the following work streams:
1. Standardisation of system requirements (Suzy, Qasim & Irina)
2. Data infrastructure (Nishma/Steve)
3. NICE methods review (Nishma/Steve)
4. Exploration of reimbursement approaches (Nishma/Steve)
5. Supporting data generation opportunities (Irina)
Year(s) Of Engagement Activity 2020
 
Description NHS England Medicines Analysis Strategy and Policy Team, 22nd November 2019 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Key points raised from the meeting:

• Since ATMPs often receive market authorisation through accelerated regulatory pathways, when they reach the Health Technology Assessment (HTA), information gaps exist. There is a tension between the political pressure to push for ATMP access early in product life-cycle and robust and fair HTAs.
• To cope with the novelty of ATMPs and the high price-tag, people have jumped straight to "we need a pricing model" without thinking about the steps needed for market access. What we need to do is step back and think about the following, stressing the unmet need:
o What is the disease?
o What is the burden?
o How does it affect the patient?
o Why is it different to any other disease?
o Is it best for the patient and NHS?
Using this kind of thinking, a commercial framework needs to be drafted for ATMPs.
• There is still financial uncertainty with current pricing and payments models. NHS England suggested that the Hub use the evidence already gathered, but supplement this with information from EU5 markets and invite experts from each to form an advisory board and they can translate the information and provide at least qualitative summaries. Could also consider inviting someone from Canada.
• Since pharma is global, products can be brought to market in one region, e.g. the US and then pressure is on other regions to provide patients with access to the therapy, but there may have been improper consideration of (using gene therapy for macular degeneration as an example):
o Add on costs e.g. genetic counselling
o Gene testing and failures
o Efficacy waning (depends on the disease)
o Patient population with high prevalence and low incidence
o Uncertain clinical evidence
o The opportunity cost of preventing a new product coming through
o Irrecoverable costs off loaded surplus prices into patent prices
• It is not clear that all these costs for the extra levels of service provision necessary for ATMPs are adequately being captured. ATMPs will also require ramping up of services at both a national and regional level to meet the infrastructure and technical implementation requirements.
• An area of concern was the provision first-generation ATMPs precluding patients from receiving more advanced next-generation therapies when they become available.
• Voluntary Pharmaceutical Pricing Regulation Scheme (PPRS) has changed - we'd normally expect a better value proposition in exchange for the complexity of the product e.g. Italian system (treatments thought to be initially effective came with huge risks)
Year(s) Of Engagement Activity 2019
 
Description News interview for Royal Society fo Chemistry (Chemistry World) on Nobel Prize Awards to Frances Arnold and Greg Winter in 2018 
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 Media (as a channel to the public)
Results and Impact Interviewed to comment on the Nobel Prize Awards to Frances Arnold and Greg Winter in 2018. Quoted in an article online and also in Chemistry World magazine published by the Royal Society of Chemistry.

https://www.chemistryworld.com/features/how-chemical-evolution-took-the-2018-chemistry-nobel-prize/3009626.article
Year(s) Of Engagement Activity 2018
 
Description News interview for the Guardian on Nobel Prize Awards to Frances Arnold and Greg Winter in 2019 
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 Media (as a channel to the public)
Results and Impact News interview for the Guardian on Nobel Prize Awards to Frances Arnold and Greg Winter in 2019. Quoted in article printed in the Guardian and online.
Year(s) Of Engagement Activity 2018
 
Description Policy engagement scoping meetings 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact A series of scoping meetings were held with policymakers with the aim to:

1. Identify areas where Hub research may align with/impact current policy-making questions and concerns; and
2. Raise the profile of the Hub within the policy-making community.

The following key meetings were held:
1. 20th June 2019: HM Treasury's Health and Social Care team, to provide an overview of the Hub research and identify areas of mutual interest;
2. 1st July 2019: Office for Life Sciences Investment and Engagement Team, to provide an overview of the Hub research and identify areas of mutual interest;
3. 19th September 2019: a follow-on meeting was held with the HM Treasury Health and Social Care team to discuss Hub research on the cost-of-goods for CAR T manufacture.;
4. 30th October: Commercial Medicines Directorate NHS England, to provide an overview of the Hub research and identify areas of mutual interest;
5. 22nd November 2019: NHS England Medicines Analysis Strategy/Policy Team, to provide an overview of the Hub research and identify areas of mutual interest;

This series of scoping meetings led to the development of a network of policy professionals with whom to engage on Hub research. Additionally, the cost-of-goods for CAR T manufacture and how this varies under different scenarios emerged as an area of particular interest to the individuals with whom we met. As a result, a 'policy dialogue' meeting is being held in February 2020 which will convene a range of policy and industry stakeholders to consider the business and reimbursement challenges for CAR T manufacture and implementation in the NHS.
Year(s) Of Engagement Activity 2019
 
Description Poster Presentation, 15th May 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact This meeting was an opportunity to update users on the progress of Hub research and to network with other potential researchers and industry partners.
Year(s) Of Engagement Activity 2018
 
Description Poster Presentation, 7th November 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Poster presentation part of the User Steering Committee meeting in 7th November 2017. Used to engage with collaborators and industry attendees.
Year(s) Of Engagement Activity 2017
 
Description Recovery of Biological Products Board Conference Series . 
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 Chair of Recovery of Biological Products Board Conference Series . 2011- 2012 Now member of Scientific Board. The Recovery Conference Series is the premier international forum for the presentation and discussion of the status, direction and trends in the recovery of biological products of therapeutic, diagnostic and industrial value to the society.


. Awarding Body - Recovery of Biological Products Board Conference Series, Name of Scheme - Recovery of Biological Products
Year(s) Of Engagement Activity 2012,2014,2016,2018
 
Description Reimbursement, Market Access Approval and Evidence for Cell and Gene Therapies (poster presentation). User Steering, Committee 5th November 2019 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The poster reports outcomes from three case studies and (i) examined the impact of limited clinical evidence on the cost-effectiveness of cell and gene therapies
and emerging reimbursement/payment models for the following:
• Strimvelis
• Kymriah (Tisagenlecleucel)
• Yescarta (Axicabtagene Ciloleucel)
Year(s) Of Engagement Activity 2019
 
Description Reimbursement, Regulation & Portfolio Management. User Steering Committee 21st May 2019 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Cell and Gene therapy products entail complex research, development, manufacturing and delivery. These complexities are reflected in the processes for portfolio planning, regulatory approval and reimbursement. At the stage of portfolio planning, manufacturers need to determine the optimal development sequence and resource utilisation for hedging products, to maximise the overall projected profits during the market exclusivity period. To authorise access to these products regulators must assess the quality of the product and its risk benefit profile, while healthcare providers/insurers need to assess its affordability. We described the challenges and success of cell and gene therapies, using Strimvelis and Kymriah as our case studies.
Year(s) Of Engagement Activity 2019
 
Description Royal Society of Chemistry Conference Organisation 2017 
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 I organised a conference for the Royal Society of Chemistry Biotechnology Group titled "Biotransformations: From Science to Industrial Application", in London. This was attended by approx 70 delegates from across academia and industry, internationally. The conference enabled discussions on the sustainable use of biomass for production of high value chemicals and biologics, including regulatory issues.
Year(s) Of Engagement Activity 2017
 
Description Spring school on 3D-printing of columns, devices and stationary materials 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact This workshop originates in response to the increasingly significant role of Additive Manufacturing (AM, or 3D printing) in the separation sciences.

This three day course was elaborate on current work and future prospects of 3D printing. It covered the full pipeline to produce separation devices, from conceptual design to CAD modelling to manufacture using 3D printers to post-processing, evaluation and troubleshooting. Lectures on 3D printing methods, CAD design, and applications in the separation sciences will be combined with hands-on tutorials with CAD design software and practicums on 3D printers.
Year(s) Of Engagement Activity 2018
URL https://3dprintchromatographycolumns.wordpress.com/
 
Description T-cell Processing Specialist Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The T-cell Processing Specialist Working Group (SWG) has met twice a year since the launch of the Hub. The focus of the T-cell Processing SWG is to discuss the the research activity and strategic direction of the T-cell autologous cell therapy development activity within the Hub, engaging users of their perspectives, as a platform for dissemination and ensure that the research plans are addressing key challenges within the sector. With input and presentation from Hub users (including professional practitioners from industry and the clinic) it is also used to highlight the state of the art in the sector and identify emerging areas for research exploitation and areas that need addressing. It is also designed to identify potential risks or additional work that could be undertaken in the T-cell processing work packages.
Year(s) Of Engagement Activity 2017,2018
 
Description Towards Regulatory Scenarios for Proteins and Cell Therapies: mapping the regulatory drivers and decision nodes 
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 On February the 15th 2018, at the Bioengineering Department of UCL, as part of the activity of the Grand Challenge 1.2c - regulatory strategies- Giovanni De Grandis and Arthur Petersen convened a workshop bringing together junior and senior staff from the hub and some high-profile experts in biopharmaceutical regulations and policy. Through a combination of group work and presentations, the workshop performed a small-scale horizon scanning exercise, aimed at identifying regulatory challenges and opportunities for the hub.
Year(s) Of Engagement Activity 2018
 
Description UCL 3D Printing in Healthcare Research Symposium 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Bioprinting background, skills, facilities and contacts who worked in UCL in the field.
Year(s) Of Engagement Activity 2018
 
Description UCL Cancer Institute, UCL CAR T programme, Dr Claire Roddie and Professor Karl Peggs, 10th October 2019 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Discussion on the reimbursement and health technology assessment of cell and gene therapies, including CAR T-cell therapy. We explored the potential of a collaboration using existing trial data for a feasibility study. A proposal were submitted to the group in January 2020.

The proposal objectives are:
(1) To identify the cost to the NHS for patients who receive CAR T-cell therapy and have adverse events
(2) To calculate the difference in costs by type of adverse event
(3) Evaluate the cost associated with adverse events of CAR T-cell therapy with blinatumomab
Year(s) Of Engagement Activity 2019
 
Description User Steering Committee Meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact This is a meeting of the whole Hub consortium - academic team, members from the Hub's Industrial and non-corporate partner organizations, independent members of the Hub Advisory Board. The purpose of this bi-annual meeting is to provide an update on the progress of Hub research and (once a year) an update of the research in the Centres for Doctoral Training (CDT) aligned to the Hub. The format includes formal presentations, poster sessions, round-table workshop discussions and structured networking elements.
Year(s) Of Engagement Activity 2017,2018,2019
 
Description User Steering Committee meeting, 15th May 2018 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The User Steering Committee is an important part of the hub. It is was an opportunity to identify how companies can help the project by provision of my project in terms of:
advice, data, equipment or access to equipment, resources materials, future evaluation of experimental techniques, or participation in user feasibility or adaptation studies.
Year(s) Of Engagement Activity 2018
 
Description User Steering Committee meeting, 7th November 2017 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The User Steering Committee is an important part of the hub. It is was an opportunity to identify how companies can help the project by provision of my project in terms of:
advice, data, equipment or access to equipment, resources materials, future evaluation of experimental techniques, or participation in user feasibility or adaptation studies.
Year(s) Of Engagement Activity 2017
 
Description User Steering Committee meetings 
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 User Steering Committee meeting was an excellent platform to engage industry and academics to highlight our latest research work being done in the hub. The benefit of this kind of meeting is that work groups/researchers can have interdisciplinary interactions with other scientists and provide a fresh perspective while everyone learns through the interaction. We've had overwhelmingly positive feedback from everyone involved.
Year(s) Of Engagement Activity 2016,2017,2018
 
Description Vaccines Development and Manufacturing Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact The Hub co-hosted a workshop on vaccine manufacturing and development with the KTN on 6 September 2017 at UCL. The event brought together more than 90 delegates from the vaccine development and manufacturing community in human health in the UK. Presentations were given on the latest innovative technologies, current UK capabilities, Department of Health investments to date and the work of the UK Vaccine network. It highlighted potential funding opportunities through the Industrial Strategy Challenge Fund.
Year(s) Of Engagement Activity 2017
URL https://ktn-uk.co.uk/news/the-future-of-vaccines-development-and-manufacture
 
Description Viral Vectors for Vaccines and Gene Delivery, 9th Sept 2019 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact This one-day meeting was jointly organised by this Hub, the Future Vaccine Manufacturing Research Hub (Vax-Hub) and the Knowledge Transfer Network and offered a programme of invited talks, a poster session and an interactive panel discussion. The meeting bought together ~110 participants from industry, academia, government, sector organisations, to inform and discuss the common manufacturing and analytical challenges across the major viral vector products.
Year(s) Of Engagement Activity 2019
URL https://ktn-uk.co.uk/news/viral-vectors-for-vaccines-and-gene-delivery/
 
Description Workshop "Ideas to Impact", Entrepreneurship Essentials for Researchers (SPERO) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Industry/Business
Results and Impact A nice workshop on Entrepreneurship Essentials for Researchers (SPERO)
Year(s) Of Engagement Activity 2018
 
Description Workshop in Bioproceesing 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Postgraduate students
Results and Impact A workshop and lecturing session were designed for Nottingham University Master students who visited CBE centre at Loughborough university.
Year(s) Of Engagement Activity 2020
 
Description Workshop- User Steering Committee, 6th November 2018 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact As high-priced personalised healthcare moves towards a pivotal change, healthcare providers like the NHS are faced with affordability challenges and pressures of resource allocations. We explore the financial challenges ahead for the healthcare payers and products developers. We looked at some recent initiatives and decisions by European regulators (EMA) and British health technology assessors (NICE) and buyers (NHS). There is currently misalignment about what counts as sufficient evidence for clinical effectiveness. Clearly different goals need to be balanced: for instance offering more therapeutic options to patients in need, promoting innovation in therapeutic areas with unmet needs, allocating limited healthcare resources fairly and efficiently. But can a balance acceptable to all stakeholders be found? Can new products benefit patients and reward developers if requirements are not harmonised? We ran two workshops with users to bring their perspective to this important discussion and explored the following:
1. How do accelerated pathways affect the production process
2. Can the evidence requirements for effectiveness of the EMA and national HTA bodies and payers be harmonized?
3. How can manufacturers and NICE work together to formulate reimbursement models?
4. How can we bring down the cost of goods and services to align them with the NHS budget?
Year(s) Of Engagement Activity 2018