cell and gene therapy catapult · catapult and the global cell and gene therapy industry, and we...

15
Annual Review 2017 Cell and Gene Therapy Catapult

Upload: others

Post on 18-Sep-2020

4 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

Annual Review 2017Cell and Gene Therapy Catapult

Page 2: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

01

The Cell and Gene Therapy Catapult (CGT Catapult) was established in 2012 to grow the UK cell and gene therapy industry, bridging the gap between scientific research and full-scale commercialisation.

Our vision is for the UK to be a global leader in the development, delivery and commercialisation of cell and gene therapies. Where businesses can start, grow and confidently develop advanced therapies, delivering them to patients rapidly, efficiently and effectively.

Our goals

• To build a £10bn advanced therapies industry in the UK.

• To create sustainable jobs through licensed manufacturing and its supply chain.

• To increase the pipeline of cell and gene therapies in UK clinical trial and clinical use.

• To increase the flow of investable propositions through pathfinder projects, accelerating investment in the industry.

• To demonstrate the attractiveness of the UK as the place to develop cell and gene therapies, with increased inward investment.

Contents

01 Chairman and Chief Executive’s statements

02 Industry growth

04 Key milestones

06 Our capabilities

08 Accelerating the path of research to commercialisation

10 Building the manufacturing centre

12 Growing the manufacturing industry in the UK

14 Supporting supply chain companies developing new technology

16 Ensuring safety and efficacy

18 Creating scalable manufacturing platforms

20 Shaping and influencing the sector

22 Looking forward

24 Financial highlights

This year has seen CGT Catapult make great progress, with major milestones reached on projects, not least the sale of the WT1 technology to Cell Medica. Progress has also been made on the construction of the CGT Catapult manufacturing centre in Stevenage, with Autolus the first company agreeing to occupy space in the centre.

It is great to see so many of the companies we have worked with over the past five years succeeding and thriving. Outside of the UK CGT Catapult continues to build its global reputation in supporting cell and gene therapy developers. Over the year we have continued to develop relationships with organisations in the USA, Canada, China, Singapore, Japan and South Korea.

The next year will see us focus on a new set of barriers facing the cell and gene therapy industry. We will address these barriers at our research and development labs in Guy’s hospital and our manufacturing centre in Stevenage, though a range of platform projects and collaborations with industry.

Our success depends very much on the support of our collaborators within academia, industry and the NHS, and I would like to take this chance to thank them. I also cannot forget the CGT Catapult staff, as it is down to their dedication and enthusiasm that we have achieved so much.

Dr John Brown CBE, Chairman Keith Thompson, Chief Executive Officer

CGT Catapult is now in its fifth year, and I am proud of the progress that has been made by the organisation and the industry as a whole over this time.

CGT Catapult has established a team of over 130 cell and gene therapy specialists at our state-of-the-art laboratories in London, and are rapidly expanding the team based at the manufacturing centre in Stevenage. The experience gained by these teams over the last five years puts them in an excellent position to support the ever-evolving industry.

The industry has seen immense growth, with more than 40 new ATMP developers in the UK compared to 2012, and great progress has been made by many innovative companies. This illustrates the supportive environment we have in the UK allowing cell and gene therapy companies to thrive.

This is a very exciting time in the evolution of the CGT Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth, progress and the opening of the CGT Catapult manufacturing centre in Stevenage. I would like to thank all the stakeholders that have supported us so far and will continues to do so into the future.

Page 3: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

02 03

Industry growthSince our inception, a number of industry barriers have been lowered and we have seen substantial growth in the sector.

The opportunity for the UK Thanks to more than 20 years of investment in the research base, the UK has a critical mass of world-leading research scientists, and the opportunity to take a large share of the growing global cell and gene therapy industry.

Since our inception there has been continued growth in the UK cell and gene therapy industry. This is demonstrated by the growing number of advanced therapy companies, the number of active clinical trials and the increased inward investment into the industry. The UK is now also an attractive place for companies from around the world to do business, illustrated by the number of international companies we have worked with including Asterias, DC Prime, Ajinomoto and Rexgenero.

Regulatory pathways that were previously considered complex have now been streamlined and there is evidence of translatability from small to large scale. The supply chain is also evolving and therapies are able to attract investment.

The industry in 2017

£1.3bn+investment received by UK companies

64ATMP developers in 2017 and rapidly growing, compared to 22 in 2012

190%growth in number of ATMP therapy developers

59active clinical trials in 2017, compared to 21 in 2012

180%growth in UK clinical trials

+1,000jobs compared to 540 in 2012

22GMP facilities in 2017, compared to 11 in 2012

100%increase in the number of GMP manufacturing facilities

>7,000m2

CGT Catapult manufacturing centre opening in 2017

Page 4: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

04 05

First license agreement with UK SME

Asymptote for the Via Thaw™ thaw in

clinic device

CGT Catapult awarded three manufacturing

grants from Innovate UK CGT Catapult’s research

grade IPS cell line is available to license

Agreement signed with Ajinomoto, first contract

from Japan

Positive interim review in WT1 T-cell clinical trial

Lord Prior visits London offices and laboratories as Industrial Strategy

Green Paper is launched

ISCT awards London its Silver Jubilee

Conference

First CGT Catapult initiated pre-clinical

gene-modified immune therapy safety study

New company created to develop novel technology

to treat diabetesFirst patient in

mainland Europe recruited into WT1

clinical trial

Manufacturing centre site leadership team recruited on-site and

operational

Manufacturing centre site weather proofed

Dedicated viral vector laboratory opened in

Guy’s Hospital, London

Autolus sign collaboration agreement

to occupy space in manufacturing centre

Cell Medica acquire WT1 T-cell therapy with further

development to take place at CGT Catapult manufacturing centre

Apr 2016

Dec 2016

Apr 2016

Jan 2017

May 2016

Jan 2017

May 2016

Feb 2017

Jun 2016

Aug 2016

Feb 2017

Sep 2016

Mar 2017

Nov 2016

Apr 2017

Key milestones

Feb 2017

The Inaugural UK Regenerative Medicine

Conference co-hosted by CGT Catapult is held

Fisher BioServices announce they will

co-locate CryoHub with manufacturing centre

Page 5: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

06 07

Our capabilitiesWe have created a unique capability which is continually evolving to support the industry.

Development labs Manufacturing centre Our people ProjectsAnalytical Characterisation and Process Development Laboratory Space

Viral Vector Industrialisation Laboratory Space

Cell and Gene Therapy Catapult manufacturing centre

Our team is made up of over 130 cell and gene therapy specialists in the following areas:

Our state-of-the-art laboratories are located in Guy’s Hospital, London, and span 1,200m2. The laboratory is equipped with a unique GMP proving lab, providing the missing step in technology transfer activities.

Our viral vector laboratory was opened in June 2016 in response to the expansion of gene modified therapies. The laboratory allows the availability, cost and scale of viral vectors to be investigated to reduce this barrier for the industry.

Our large-scale GMP manufacturing centre is a response to the industry need for new manufacturing technologies. The centre will enable companies to develop their manufacturing processes whilst retaining ownership of the technology.

Industrialisation

Regulatory

Non-clinical safety

Manufacturing

Health economics and market access

Clinical operations

£32minvested across a series of 84 projects

31core projects

33commercial projects

20collaborative R&D projects

130+cell and gene therapy specialists

Page 6: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

08 09

Accelerating the path of research to commercialisation We have worked with UK companies to advance their therapeutic projects.

Creating investable opportunities from academic assets

The acquisition of Catapult Therapy TCR Ltd, the subsidiary set up to develop the gene-modified WT1 TCR T cell therapy, by Cell Medica, reflects our mission to work with academia and industry in bringing forward important new technologies that can be industrialised and turned into the advanced medicines of the future.

Immuno-oncology is an expanding discipline representing the next generation of cancer treatments. We identified WT1 as an asset of great potential, the therapy was focused on gene modifying patients’ own T-cells to recognise the WT1 antigen which is over-expressed in blood cancers and solid tumours. A novel collaboration was developed and used to spin the assets out into a company jointly owned by Touchstone Innovations, UCLB and the CGT Catapult.

Following significant reduction in cost of goods and successful delivery of the clinical trial in UK and Europe that has seen positive interim results, it was recently announced that the intellectual property and commercialisation rights to the promising therapy have been transferred to Cell Medica.

The acquisition of Catapult Therapy TCR Ltd by Cell Medica will enable and accelerate the further development and commercialisation of this innovative treatment in one of the most promising areas of cancer immunotherapy.

Further development of the technology will now take place by Cell Medica at the Cell and Gene Therapy Catapult manufacturing centre.

Helping inform clinical development and manufacturing strategies

The University of Edinburgh and Scottish National Blood Transfusion Service (SNBTS) are developing a new autologous treatment for patients suffering from liver cirrhosis. We have helped the University of Edinburgh and SNBTS to understand the baseline reimbursement potential of the treatment which can be used to inform the clinical development and manufacturing strategies and ensure they ultimately deliver a commercially viable cost-effective therapy.

This project provides a case study of two leading UK universities working together alongside a Catapult to translate their high quality research outputs into clinical stage advanced therapeutics.

TONY HICKSONMANAGING DIRECTOR, IMPERIAL INNOVATIONS LIMITED

19research groups advanced

Page 7: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

10 11

Building the manufacturing centreConstruction is coming to an end on the CGT Catapult manufacturing centre, which will officially open in 2017.

Our vision to provide the UK with the manufacturing facilities needed for later-stage cell and gene therapy clinical studies and commercialisation can now be seen with the CGT Catapult manufacturing centre due to open to its first collaborators in 2017.

Construction began on the large-scale GMP manufacturing centre in December 2015 after the approval of £55 million in funding from the UK government. Construction at the four-acre site at the Stevenage Bioscience Catalyst has progressed at pace since 2015, with the building phase now complete.

Significant work has been undertaken to put in place key quality assurance strategies and operational philosophies, achieved through close interaction with the Medicines Healthcare Regulatory Authority (MHRA). The site leadership team have also been recruited and are now fully operational.

The >7000m2 facility has space for 12 segregated modules, each 100m2, which companies can take on and adapt the space to suit their process, whether it’s allogenic, autologous or a viral vector. There will be centralised GMP support and services for the facility, allowing companies to focus on their product and process.

The first collaborators that will benefit from the innovative manufacturing facility will be Autolus and Cell Medica, who have agreed to occupy space in the centre.

>7000m2manufacturing centre with room for 12 segregated modules

Autolus

Autolus Ltd, a biopharmaceutical company focused on the development and commercialisation of next-generation engineered T-cell therapies for haematological and solid tumours, will be the first company to enter the CGT Catapult manufacturing centre.

CGT Catapult’s unique operational model allows us to grow our manufacturing capacity, while accessing a range of services provided by the centre.

JIM FAULKNERHEAD OF MANUFACTURING, AUTOLUS

Cell Medica

Since the acquisition of the WT1 T-cell therapy, Cell Medica, a UK cellular immunotherapy company, have included UK manufacturing as part of their strategy, with further development of the WT1 T-cell therapy taking place at the CGT Catapult manufacturing centre.

We are looking forward to an important collaboration with CGT Catapult to initiate manufacturing at the Stevenage GMP facility where we will work together on scale-up strategies for commercial production.

GREGG SANDOCHIEF EXECUTIVE OFFICER, CELL MEDICA

Page 8: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

12 13

The UK has a thriving life sciences sector. Government has made a commitment to advanced therapies through the Cell and Gene Therapy Catapult, and the highly anticipated manufacturing centre opening later this year.

GREG HANDS MPMINISTER OF STATE FOR TRADE AND INVESTMENT

Growing the manufacturing industry in the UKThe emerging Stevenage cluster is supporting companies developing their manufacturing strategies in the UK.

The UK is becoming a cluster for cell and gene therapy commercialisation and the CGT Catapult is at the forefront of this evolution.

DAVID MEADOWSVICE PRESIDENT AND GENERAL MANAGER, FISHER BIOSERVICES

The emergence of an advanced therapies cluster at the site of the CGT Catapult manufacturing centre in Stevenage is supporting our goal to build a world-class cell and gene therapy manufacturing cluster in the UK, which will underpin clinical studies and ultimately early commercial supply.

The location for the CGT Catapult manufacturing centre was selected after extensive research and the potential for the expansion of a cell and gene therapy cluster was key. Our vision is to catalyse the creation of a global cluster in the research, development and commercialisation of cell and gene therapies on the Stevenage BioScience Catalyst campus, by exploring new business models, industrialising novel technologies and establishing new production techniques.

The number of companies locating and expanding in the area reflects our mission to build the UK’s position as a world leader in the development and commercialisation of cell and gene therapies.

Stevenage BioScience Catalyst

This year will see the open innovation catalyst celebrate its fifth birthday. Over its first five years the campus has helped organisations draw on world-leading expertise, networks, academic support and scientific facilities, including the GSK research and development facility.

Fisher BioServices

Fisher BioServices have announced the co-location of their CryoHub solution with the CGT Catapult manufacturing centre. Combining the two offers centralised manufacturing, storage, distribution and logistics, resulting in a seamless supply chain accelerating cell and gene therapy development and commercialisation.

Page 9: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

14 15

Supporting supply chain companies developing new technologyWe have helped supply chain companies in the UK develop and strengthen their offerings.

Developing bench top thawing systems

Our work in collaboration with Asymptote to develop a bench-top thawing device strengthened the cryochain specialists portfolio prior to their acquisition by GE Healthcare. Commenting on the acquisition, GE Healthcare highlighted how the Catapult-supported suite of integrated cryochain hardware, software and consumables filled a critical gap in its end-to-end ecosystem of products and services for cell therapy production. The acquisition gives Asymptote the opportunity to significantly scale-up product development, as well as reach a larger market.

Cell-based therapies are produced and cryopreserved under strict Good Manufacturing Practice (GMP) conditions. The final delivery, thaw and administration of these often-fragile therapies is a crucial step, which has to be controlled to ensure maximum therapeutic effect for the patient. The need for a small bench-top thawing system, which could accept different packaging options (vials and bags) and meet GMP requirements, with a robust reporting architecture, was identified by CGT Catapult as fundamental to controlling and monitoring the final stages of release and use of cryopreserved therapies. CGT Catapult worked in collaboration with Asymptote to successfully create two different prototypes which fill a crucial gap in the GMP cryochain.

In 2016, we signed an exclusive, worldwide, royalty-bearing licence agreement with Asymptote, by which we granted the rights of all the foreground IP generated by our collaboration to Asymptote, enabling them to commercialise the Via Thaw™ thaw in clinic device.

Supporting the evolution of stirred tank bioreactorsWe worked with Sartorius Stedim Biotech to generate a validated computer model of their ambr® bioreactor system which can now be used to speed up and reduce the cost of the products future development.

To generate cells in the numbers needed to treat disease, they must be cultured on a large scale. This is commonly performed in devices called bioreactors, which provide the cells with the conditions needed for growth. Stirred tank bioreactors contain an impeller which agitates the cells to promote growth.

CGT Catapult worked with Sartorius Stedim Biotech in order to evaluate how effective their new bioreactor system would be for scale-up of cell therapy manufacturing processes and how it might be improved.

The CGT Catapult team used in silico computational fluid dynamic modelling to model the fluid within the bioreactor during cell culture. This allowed them to understand fluid pressures and stresses upon the cells. The model could also be used as a design tool for predicting the effect of modifications such as speed or geometries of impeller and vessel on the cells.

Page 10: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

16 17

Ensuring safety and efficacyWe are supporting commercialisation with novel analytical techniques.

Accurately measuring the action of gene-modified T-cellsAdoptive T-cell therapy for the treatment of haematological cancers and solid tumours is one of the fastest growing areas in the cell and gene therapy field. These immunotherapies use genetic modifications of T-cells to engineer their specificity or enhance their function.

Potency is a critical quality attribute for any cell therapy product and, while often difficult to measure, its assessment is required to determine quality, consistency and stability.

We have developed a novel rapid potency assay for a gene-modified T-cell receptor immunotherapy product. This assay utilises impedance-based spectroscopy to give a rapid real-time, label-free measurement of cell killing activity.

Developing rapid sterility testing for cell and gene therapiesWe are bringing together the cross-sector expertise of commercial cell therapy developer, GSK, and leading technology provider, LGC, to develop a new approach to support in-process sterility and product release testing.

Current tests for pharmaceutical sterility are not fit-for-purpose for cell and gene therapies due to the 14-day culture period. This collaborative project is developing a new approach to support in-process sterility and product release testing for a range of cell therapy products using digital PCR.

This technique offers significant benefits and fulfilling a critical, currently unmet need in supporting the development of real-time product release.

Ensuring safety and efficacy of an autologous cell therapy productWe continue to support Rexgenero in production of Rexmyelocel-T, an advanced cell-based therapy for the treatment of critical limb ischemia.

During the manufacturing process, product quality must be robustly measured. The complex mechanism of action of Rexmyelocel-T makes the development of tests that measure key functional parameters, such as potency, difficult.

Our team applied a series of specially designed analytical development tools to define the current characterisation and potency assays used during the production of Rexmyelocel-T, and determine their suitability. The team looked at assay performance and robustness, sources of variability and potential modes of assay failure.

Our collaboration with Rexgenero has allowed the company to tap into the resources of the analytical development team here at CGT Catapult and our state-of-the-art analytical development lab in Guy’s hospital to robustly measure the quality of their Rexmyelocel-T product during the manufacturing process. This enabled the company to meet tight deadlines leading up to the commencement of their Phase III clinical trial.

Page 11: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

18 19

Creating scalable manufacturing platformsOur platform projects are addressing industry barriers in the area of scalable manufacturing.

Strengthening viral vector industrialisation capabilities

Our viral vector industrialisation strategy aims to provide more viral vector industrialisation capability, currently a significant barrier to the development of clinical assets and associated manufacturing development platforms.

Viral vectors are tools commonly used by molecular biologists to deliver genetic material into cells and have shown great promise in cancer immunotherapy and for the correction of genetic defects.

Our strategy is in response to concerns that scale-up of the manufacturing processes used for some viral vectors is a barrier to their use in larger-scale and late-phase clinical trials and in commercial supply. It includes a dedicated viral vector laboratory, which was opened in June 2016, and collaborations with key industry experts.

We are working with Sartorius Stedim Biotech to investigate the use of their ambr® platform in the production and purification of viral vectors. While this technology is proven in cell therapy production and development, it is untested in the viral vector field. The technology shows successful scale potential for both lentiviral vectors and adeno-associated virus.

Our work will continue in this area to overcome the barriers in viral vector industrialisation.

Developing a scalable platform for pluripotent stem cell manufacture

Our cell plasticity programme aims to develop a foundation of bioprocessing platforms to support the industrial manufacture of affordable therapies derived from pluripotent stem cells (PSCs). PSCs have the capacity to become any type of cell of the human body and are a promising tool for the development of allogenic cell therapies. These therapies offer advantages including the ability to be manufactured in advance for off-the-shelf use in a large number of patients. Current challenges of allogeneic cell therapy manufacture include the development of automated processes for the controlled expansion and differentiation of large numbers of PSCs, and the recovery and formulation of the final differentiated product being of consistent quality and potency acceptable for clinical use.

This programme has demonstrated feasibility of automated upstream processes to culture and expand large amounts of viable high quality PSCs in adherent and aggregate-based culture in single-use, closed, and automated hollow-fibre and stirred-tank bioreactors. The team have also proposed strategies for automated downstream steps for concentration and washing integrated with the upstream expansion process, as well as analytical tools for monitoring and control the quality of the cells throughout the process.

These automated processing and analytical strategies offer the potential to reduce the cost-of-goods of the manufacturing process compared to standard manual processing and are being leveraged by companies including Asterias Biotherapeutics in the development of their PSC-derived allogeneic cell therapies.

Page 12: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

20 21

Shaping and influencing the sectorWe continually engage with the wider cell and gene therapy community to identify and reduce industry barriers, helping grow the sector.

In order to influence and help grow the sector we engage with the wider cell and gene therapy community through participation in task forces, expert groups, learned societies, trade bodies, events, conferences and by welcoming UK and international delegations to our facilities.

In March 2016 the Advanced Therapy Manufacturing Taskforce was launched by the Medicines Manufacturing Industry Partnership to secure the future of manufacturing advanced therapies in the UK. The taskforce, which includes members from CGT Catapult, works to identify opportunities and actions to anchor advanced therapy manufacturing and the associated supply chain in the UK and published its action plan in November 2016.

The report made a number of recommendations which we welcome including strengthening the fiscal landscape, maintaining science and innovation funding and securing the relevant skills required for emerging manufacturing technologies.

In May 2016 CGT Catapult joined a host of international delegates in Singapore for the ISCT 2016 Annual Meeting. Team members presented on a number of topics, including the progress of the CGT Catapult manufacturing centre, and we were also delighted to host the annual industry reception at the Ambassadors residence.

This year also saw the launch of the Inaugural Regenerative Medicine Conference, together with the UK Regenerative Medicine Platform (UKRMP). Building on the success of the 2012 Strategy for Regenerative Medicine and significant investment in the field from the UK Government, the conference bought together leading players in the field and highlighted outstanding research and advances in regenerative medicine from both the UK and internationally.

We maintain key relationships with a number of UK and international organisations including:

• Centre for Commercialization of Regenerative Medicine (CCRM)

• Alliance for Regenerative Medicine (ARM)

• International Society for Cellular Therapy (ISCT)

• BioIndustry Association (BIA)

• British Society for Gene and Cell Therapy (BSGCT)

• International Society for Stem Cell Research (ISSCR)

• Biotechnology and Biological Sciences Research Council (BBSRC)

• Engineering and Physical Sciences Research Council (EPSRC)

• Medical Research Council (MRC)

• Medicines and Healthcare products Regulatory Agency (MHRA)

• European Medicines Agency (EMA)

Lord Prior visits London offices and laboratories, January 2017

The Inaugural UK Regenerative Medicine Conference is held, September 2016

Page 13: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

2322

1

Intelligent manufacturing

In developing new technologies, processes and systems, we can increase productivity and reduce cost of goods: making the UK’s cell and gene therapy manufacturing productivity the best in the world.

2

Supply chain

By expanding the collaborative activity at the CGT Catapult manufacturing centre in Stevenage, developing a mature supply chain and a cluster for the development of manufacturing processes, we can create a world-leading cell and gene therapy industry in the UK.

3

Gene delivery systems

Through the industrialisation of new viral vector manufacturing processes, improving productivity and supporting the development of manufacturing for the next generation of gene delivery technologies, we will remove limitations on the growth and productivity for the UK gene therapy industry.

4

Proof of market

We wish to create a small number of exemplar specialist ecosystems for clinical supply, clinical adoption and reimbursement of cell and gene therapies. This will allow companies to quickly develop and demonstrate their offerings and technology, before expanding globally, making the UK the most attractive route to market for these therapies.

5

Regulatory advantage

Working alongside regulators and stakeholders we can ensure a regulatory regime that enables safe and effective ATMP medicines to be trialled and licensed rapidly, resulting in a favourable UK clinical trial environment and regulatory framework.

6

Commercialisation

In enhancing our existing activities directly bridging the gap between investors, industry and researchers, we can reduce development risk and accelerate commercialisation. We can accelerate the impact from Research Council investment and drive growth across the country.

Looking forwardFollowing industry research we have identified the following barriers affecting industry growth in 2017 and beyond. We aim to reduce these barriers through our 2017-2023 business strategy.

Strategic themes

1

Page 14: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

24

The Cell Therapy Catapult Ltd is an independent private company limited by guarantee incorporated as a not-for-profit research organisation. The financial information in this review is extracted from the consolidated statutory accounts for the Cell Therapy Catapult Ltd for the year ended 31 March 2017.

Turnover

For the year ended 31 March 20172017

£’000’s2016

£’000’s

Innovate UK core revenue grant funding 14,116 14,079Collaborative research and development

and other grant income 2,336 1,103Commercial income 1,573 1,276

18,025 16,458

Capital funding

For the year ended 31 March 20172017

£’000’s2016

£’000’s

Innovate UK capital grant funding 24,931 9,428

Balance sheet

As at 31 March 20172017

£’000’s2016

£’000’s

Fixed assets 40,019 16,448Net current assets 4,124 7,937Creditors amounts falling due greater

than one year (2,941) (6,829)Provisions for liabilities – deferred tax (6,715) (3,197)

Net assets 34,487 14,359

Capital and reserves 34,487 14,359

Financial highlights

Company information

Directors KJ ThompsonDr JR Brown CBE FRSE (Chairman)Dr S ChatfieldMB DurdyDr SE FodenS HendersonNA HigginsProfessor SJ HyllnerProfessor ML TurnerDr S WardProfessor FM WattProfessor MJ WhitakerDr JA Barry (appointed 4 February 2017)Dr NA Mount (resigned 4 February 2017)

Company SecretaryS Crossley

Cell and Gene Therapy Catapult is a trading name of Cell Therapy Catapult, limited by guarantee, registered in England and Wales under company number 07964711 with registered office at 12th Floor Tower Wing, Guy’s Hospital, Great Maze Pond, London SE1 9RT

And last, but certainly not least, we would like to say thank you to the people we have worked with over the year, including:

AdaptimmuneAglarisAjinomotoApollo TherapeuticsAscenionAsterias BiotherapeuticsAsymptoteAthersysAutolusAutostemAzellonCancer Research TechnologyCelgeneCell MedicaCellular TherapeuticsCentre for Commercialisation of Regenerative MedicineCore Facility for Korea HLA-Typed iPSC Banking (KHIB)Cranfield UniversityCryogatt SystemsCTMCRCDCPrimeEuramFIRMGammaDelta TherapeuticsGE HealthcareGreat Ormond Street HospitalGSKGSRACGuy’s and St Thomas’ NHS Foundation Trust

Imperial InnovationsInnovate UKInstytut Gruzlicy I Chorob PluciPS AcademiaJellagenJRI OrthopedicsKAN Research InstituteKanagawa Prefecture, JapanKing’s College LondonKlinikum Rechts der Isar der Technischen Universität MünchenLoughborough UniversityMaxCyteMedical University of ViennaMundipharmaNational Health ServiceNational Health Service Blood and TransplantNational University of IrelandNew York Stem Cell FoundationNHS Foundation TrustNovo NordiskOribiotechOxford MEStarOxfordBioMedicaPlasticellQueen’s University BelfastReNeuronRexgeneroSartorius Stedum BiotechScottish National Blood Transfusion Service

Sphere FluidicsStratophaseSynpromicsSynthaceTemasek International (Europe) LtdThermo Fisher Scientific TissueGeneTMC Pharma ServicesTokyo ElectronTrakCelTxCellUCLBUKRMP HubsuniQureUniversità degli studi di BresciaUniversity College LondonUniversity Hospital of South ManchesterUniversity of AberdeenUniversity of BirminghamUniversity of BristolUniversity of EdinburghUniversity of GalwayUniversity of GlasgowUniversity of LiverpoolUniversity of ManchesterUniversity of UtrechtUniversity TempereVideregenVrije Universiteit Brussel

Page 15: Cell and Gene Therapy Catapult · Catapult and the global cell and gene therapy industry, and we are very excited to be at the centre of the development. 2017 will see more growth,

Cell and Gene Therapy Catapult 12th Floor Tower Wing Guy’s Hospital Great Maze Pond London SE1 9RT

+44 (0)20 3728 9500 [email protected]

ct.catapult.org.uk

Twitter: @CTCatapult