Our centre of excellence. World class expertise, capabilities and facilities in GMP manufacturing

Transcription

1 Our centre of excellence World class expertise, capabilities and facilities in GMP manufacturing

2 Our corporate profile Oxford BioMedica is a world leader in the development of innovative treatments to improve the lives of patients with debilitating and life-threatening diseases. We have established platform technologies in gene delivery and immunotherapy, protected by an extensive intellectual property estate. Through in-house development programmes and collaborations with leading industry partners, our pipeline addresses diseases for which there are currently no treatments or that are inadequately treated today; including age-related and inherited neurodegenerative and ocular diseases. Together with our collaborators, we are also developing novel targeted therapies and therapeutic vaccines to treat multiple types of cancer. Oxford BioMedica was founded in 1995 by Professors Alan and Susan Kingsman as a spin-out from the University of Oxford s Department of Biochemistry. The Company listed on AIM in December 1996 and moved to the main market of the London Stock Exchange in April 2001 (LSE: OXB). Oxford BioMedica is headquartered in Oxford, UK. Our mission To build a leading, profitable biopharmaceutical company founded on the successful development and commercialisation of breakthrough gene-based medicines. Through our in-house development programmes and collaborations with leading industry partners, our goal is to improve the lives of patients with debilitating and life-threatening diseases whilst creating shareholder value. Contents 01 A gene therapy pioneer 02 Oxford BioMedica s manufacturing history 04 Our vision 05 The OXB Solutions strategy 06 Our value proposition 09 Why use a lentiviral based vector? 12 Our operational leadership 14 Our core technology 16 Our intellectual property 18 Our operational focus 20 Our capabilities 22 Our facilities 24 Our alliance management

3 A gene therapy pioneer Oxford BioMedica is a biopharmaceutical company specialising in lentiviral based vectors for gene therapy and immunotherapy with a platform of technologies for underpinning design, development and manufacture of unique gene-based medicines. We believe that the advances we have made over many years in the industrialisation of our LentiVector platform are leading to best in class products that are scalable for commercial production. Our pipeline addresses diseases for which there is currently no treatment or that are inadequately treated today, including ocular diseases, neurodegenerative disorders and cancer, and our product candidates have the potential to transform treatment landscapes. We believe our in-house know-how and expertise is unparalleled in terms of our research; cell and vector engineering, analytical testing and process development capabilities; clinical development and proven regulatory track record; and our ability to design and validate custom analytics for lentiviral based vectors. Through our in-house development programmes and collaborations with leading industry partners, our goal is to improve the lives of patients with debilitating and life-threatening diseases. Our goal is to improve the lives of patients with debilitating and life-threatening diseases Oxford BioMedica plc Our centre of excellence 01

4 Oxford BioMedica s manufacturing history From a University of Oxford spin-out to the leading company in gene and immunotherapy, this timeline -summarises some of our milestones related to lentiviral vector manufacturing, development services, products and collaborations Oxford BioMedica was founded in 1995 by Professors Alan and Susan Kingsman from the University of Oxford s Department of Biochemistry 1996 Initial public offering (IPO) on the alternative investment market (AIM) of the London Stock Exchange 2001 Oxford BioMedica moved to the main market of the London Stock Exchange 2007 Acquisition of Oxxon therapeutics Limited Initiation of Phase I/II study for ProSavin in Parkinson s disease, the world s first direct in vivo administration of a lentiviral based vector GMP licence for testing/qp release of lentiviral vectors 2009 New collaboration with Sanofi to develop four novel, gene-based therapies for ocular disease StarGen received orphan designation from the Committee for Orphan Medicinal Products of the EMA 2010 UshStat received orphan designation from the Committee for Orphan Medicinal Products of the EMA Licensing agreement with Emergent BioSolutions Inc RetinoStat IND application approved by the FDA for a Phase I/II clinical trial in neovascular wet age-related macular degeneration (AMD) Oxford BioMedica plc Our centre of excellence 02

5 A medical first We were the first worldwide to administer a lentiviral based vector treatment to patients in vivo (ProSavin Phase I/II trial, December 2007, AFSSAPS regulatory approval received end of 2007, first patient dosed in March 2008) Quality accredited We attained GLP accreditation in 2004; GMP in 2005; and GCP certification in 2006 from the MHRA and have continued to operate under GLP, GMP and GCP accreditations ever since 2011 Acquisition of a manufacturing facility in Cowley, Oxford StarGen IND application approved by the FDA for a Phase I/II clinical trial in Stargardt disease Research collaboration with ImaginAb UshStat IND application approved by the FDA for a Phase I/II clinical trial in Usher syndrome type 1B New R&D collaboration with Mayo Clinic to develop a novel gene therapy for the treatment of chronic glaucoma 2012 ProSavin Phase I/II study met primary endpoints MHRA approval for the manufacturing facility, to enable GMP manufacturing for clinical supply Sanofi acquires exclusive worldwide rights to develop and commercialise StarGen and UshStat New collaboration with Immune Design Corp 2013 Lentiviral Based Vector Development and Manufacturing Collaboration with Novartis Funding award of 7.7 million under the UK Government s Advanced Manufacturing Supply Chain Initiative Option agreement with GlaxoSmithKline for non-exclusive licence using LentiVector platform technology patents in the development and commercialisation of up to six products targeting rare orphan diseases 2014 Publication of ProSavin Phase I/II Study in The Lancet Oxford BioMedica completes patient recruitment into RetinoStat Phase I trial New Novartis process development and manufacturing collaboration which includes LentiVector licence agreement Oxford BioMedica acquires Windrush Court office and laboratory facilities for 3.2 million Oxford BioMedica plc Our centre of excellence 03

6 Our vision We are proud of our pioneering spirit and the contribution we have made to develop the rapidly growing market for gene-based therapies. For many years we have been at the forefront of the industrialisation and commercialisation of gene-based medicines. We are also leading the way in engaging with pharma and biotech companies globally as a trusted partner in providing the necessary services and solutions that deliver novel therapies that foremost improve the lives of patients with debilitating and lifethreatening diseases. By investing in our people, our capabilities and expanding our facilities we have established a world-class Centre of Excellence in process development and manufacturing services for lentiviral based vectors coupled with a totally integrated supply chain that underpins our ability to provide high quality products and services, to eliminate inefficiencies and reduce COGS to the benefit of all our partners. Oxford BioMedica is committed to advancing the wider development of gene and cell therapies by offering licences under its LentiVector platform IP. We are proud of our pioneering spirit and the contribution we have made to develop the rapidly growing market for gene-based therapies Oxford BioMedica plc Our centre of excellence 04

7 The OXB Solutions strategy Oxford BioMedica does not operate as a traditional contract manufacturing organisation. Instead Oxford BioMedica is a platform and product development company with a unique combination of technical expertise, vector-related intellectual property (including know-how), a proprietary LentiVector platform coupled with process development and in-house GMP manufacturing/testing services. Furthermore, we have a wealth of regulatory experience with a specific focus on lentiviral vectorbased products. As a consequence, the Oxford BioMedica preferred business model is to build mutually beneficial long-lasting relationships as a collaborative partner. Our intentions are to build our GMP manufacturing and development services operations, OXB Solutions, into a profitable arm of our business by exploiting and leveraging our Centre of Excellence and the LentiVector platform. For more information, please visit OXB Solutions enables us to actively capitalise on the demand for GMP manufacturing and development services by offering our skills and expertise to third parties Oxford BioMedica plc Our centre of excellence 05

8 Our value proposition The value of our unique platform is winning widespread recognition among our peers US & EU We value our relationships with the US & EU regulatory agencies and have a successful track record in bringing novel gene-based products into clinical development 1st The first to establish a lentiviral vector multi-product alliance Oxford BioMedica plc Our centre of excellence 06

9 Over the past 18 years, Oxford BioMedica has established itself as a leader in gene and cellular therapeutics. Using our LentiVector platform technology, one of the most advanced gene delivery systems available, we are focused and committed to developing high quality gene-based medicines with broad-based and highgrowth market appeal. Oxford BioMedica has, through the endeavours of its scientists and engineers, established a broad IP estate in the field, generating patents and know-how in the LentiVector platform. As an integral part of our LentiVector platform, our in-house know-how and capabilities continue to drive delivery of our pipeline and those of our key partners. It is this unique value proposition that makes Oxford BioMedica a partner of choice to other companies working with Advanced Therapy Medicinal Products (ATMPs). The recognition we have received from our key partners in helping them develop high-profile products within their cell and gene therapy drug development pipelines, underlines our in-depth process development, manufacturing and quality assurance capabilities and core competences. Such partnerships are a clear recognition of the quality of Oxford BioMedica s scientists and engineers and their skill and expertise in relation to manufacturing challenges for complex gene and cell therapy products. We are also recognised as world leaders in the design and validation of custom analytics for lentiviral vectors. 18 years Industry recognised experts with more than 18 years leading the field and a strong track record of excellence in bringing gene-based products into clinical development Our regulatory success Product Indication Agency Date of approval Clinical trial sites ProSavin Parkinson s disease AFSSAPS Dec-07 (CTA) France MHRA Oct-10 (UK site) UK RetinoStat Wet age-related macular FDA Nov-10 (IND) US degeneration StarGen Stargardt disease FDA Mar-11 (IND) US AFSSAPS Jul-11 (CTA) France UshStat Usher syndrome type 1B FDA Oct-11 (IND) US Glossary: AFSSAPS: Agence française de sécurité sanitaire des produits de santé CTA: Clinical trial application FDA: US Food and Drug Administration IND: Investigational new drug application MHRA: UK Medicines and Healthcare products Regulatory Agency Oxford BioMedica plc Our centre of excellence 07

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11 Why use a lentiviral based vector? Factors that influence the selection of a delivery system for gene therapy include the target cell type, the duration of gene expression required for therapeutic effect, and the size of the genetic payload. The versatility of the LentiVector platform and its ability to deliver genetic material efficiently and stably makes it a valuable tool for gene therapy and gene knockdown using RNA interference. The platform can be used in many therapeutic areas, with specific advantages in certain neurological and ocular disorders for localized in vivo delivery to non-dividing cells, as well as for ex vivo cell therapies where permanent genetic modification of dividing cells is required. A single administration of a lentiviral based vector gene therapy has the potential to achieve permanent therapeutic benefit. As a research tool, the technology also has applications in transgenesis, stem cell manipulation, somatic disease models, target validation, and gene discovery. Oxford BioMedica is currently investing heavily in its GMP capacity and infrastructure Our world class facilities provide the full range of services from proof of concept through GMP manufacture and supply for clinical trials Key features of lentiviral-derived vectors for clinical application Efficiency of gene delivery Capacity Genetic stability Toxicity Expression Manufacturing High, including brain and eye 9-10 Kb Stable None observed including brain, eye, systemic Long-term/permanent Established proprietary process and quality assays Oxford BioMedica plc Our centre of excellence 09

12 Our teams of highly skilled scientists and engineers have an established track record of delivery Oxford BioMedica plc Our centre of excellence 10

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14 Our operational leadership Our people As a science-led, gene-based biopharmaceutical company, the contribution of our people is extremely important to us. Our experience and expertise is apparent across every phase of the product development lifecycle from discovery, new product development, GMP manufacture & supply, to regulatory affairs and clinical trial management. Our highly skilled teams of scientists and engineers have an established track record of delivery in relation to collaborative partnerships including those with Sanofi, Immune Design and Novartis. Kyriacos Mitrophanous, PhD Chief Scientific Officer Areas of Responsibility Over 16 years of experience in the development of clinically relevant lentiviral vector based medicines, platform technology, production and analytics. Kyriacos has responsibility for new product development as well as analytical and LentiVector platform improvements. He is also responsible for co-leadership of all the technical aspects of the alliance management of the collaborative programmes. He is a named inventor on several patents in the field. James Miskin, PhD Chief Technical Officer Areas of Responsibility James has over 14 years of experience in GxP assay development, routine testing, lentiviral based vector manufacturing development and GMP manufacturing. In his current role he has overall responsibility for all manufacturing and supply activities as well as manufacturing development. He is also responsible for co-leadership of all the technical aspects of the alliance management of the collaborative programmes. He is a named inventor on several patents in the field. Team Expertise Process development Regulatory - lentiviral vectors Alliance technical programme management Analytics Team Expertise Manufacturing Specialist analytics Process development Regulatory - lentiviral vectors Alliance technical programme management Our integrated teams of leading scientists and engineers have an established track record of delivery in relation to collaborative partnerships Oxford BioMedica plc Our centre of excellence 12

15 Matthew Ryan, MSc, PGDip (Ind. Pharma), CBiol, MSB Head of Quality & Qualified Person (QP) Peter Jones, MSc (Eng), CEng, CSci, DMC, FIChemE Lead, Manufacturing Sciences & Technology Simon Simpkins, PhD Senior Production Manager Areas of Responsibility Over 17 years of experience in biologics. As Head of Quality, Matthew is responsible for leading the QA, QC and validation functions within the Company. He is responsible for on-going evaluation of quality systems to ensure conformance to EU GMP requirements and has significant experience in terms of oversight of the quality management systems pertinent to biologics investigational medicinal products (IMPs) development, manufacture, certification and release into the clinical trial supply chain. Areas of Responsibility Peter has over 30 years experience in bioprocess development, scale-up, GMP manufacturing and technology transfer. He has held positions of increasing responsibility at Genzyme and GlaxoSmithKline. Peter is responsible for the Process R&D and Manufacturing Science & Technology groups whose activities are to deliver bioprocesses which are commercially viable and regulatory compliant for all future LentiVector platform product development and commercial activities. Areas of Responsibility Simon worked for 6 years at SAFC within a GMP manufacturing facility producing API for clinical trials before coming to OXB. Simon is responsible for the day-today manufacturing operations and production staff at OXB working very closely with the Quality and MSAT teams. He has a broad range of experience in making systematic improvements to production systems, including leading Six Sigma projects with proven efficiency savings. Team Expertise Establishment of quality management systems Biopharmaceutical GMP compliance strategies IMP batch certification & release GMP supplier & contractor auditing Team Expertise Process development Operations management Project and programme management Operational excellence Team Expertise GMP manufacturing Operations management Operational excellence Oxford BioMedica plc Our centre of excellence 13

16 Our core technology The LentiVector platform and know-how has been built on pioneering work carried out at the University of Oxford and subsequent work by Oxford BioMedica over the past 18 years and utilises a third generation minimal lentiviral based vector with key safety features for clinical applications. We have developed two minimal lentiviral based vector systems based on the equine infectious anaemia virus (EIAV) and the human immunodeficiency virus-1 (HIV-1). Oxford BioMedica s scientists have pioneered the use of minimal lentiviral based vectors and were responsible for the world s first direct in vivo administration of a lentiviral based vector to patients (ProSavin for the treatment of Parkinson s disease). We have established strong relationships with US & EU regulatory agencies, successfully opening 4 CTAs in Europe and 3 INDs in the US with lentiviral based vector products. To date, 56 patients have been treated with LentiVector -based products. The benefits of advancing the industrialisation of our LentiVector platform are now being realised for both our in-house programmes and those of our key partners. We have either licensed or developed proprietary technologies and processes to deliver high quality gene therapy products at scale. These advances provide us with a unique opportunity to drive further improvements in potency, purity, and yield in an efficient and scalable manner and to reduce COGS to the advantage all our partners. Technology highlights of the LentiVector platform include long-term or permanent efficacy following delivery of genetic material into dividing or non-dividing cells, no toxicity or adverse immune reactions and a large capacity allowing for large or multiple genes within a single vector. Oxford BioMedica has recently developed the TRiP system, a technology that increases the yield of vectors containing transgenes that interfere with production and improves vector particle purity. This technology has been protected with publication of the patent application expected in mid A lentiviral based vector multi-product alliance was initiated with Sanofi in 2009, with a view to develop four ocular indications. To illustrate the ability of Oxford BioMedica to progress projects rapidly, the first clinical trial as part of this collaboration (RetinoStat ) was open within 18 months of signature, including completion of proof of concept, non-clinical safety, manufacturing, analytics and product release (all coordinated by Oxford BioMedica). Our LentiVector platform utilises a third generation minimal lentiviral vector with key safety features for clinical applications Oxford BioMedica plc Our centre of excellence 14

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18 Our intellectual property Oxford BioMedica has built an extensive patent portfolio that provides comprehensive coverage of lentiviral vector-based gene delivery technologies. In addition to over 100 patents and patent applications, the company has wide-ranging know-how associated with the industrialisation of lentiviral based vectors and their manufacture and testing. A list of patent families covering Oxford BioMedica s LentiVector platform is shown below. Oxford BioMedica LentiVector platform patent families Minimal lentiviral vectors WO 98/17815 (granted in US, EP, JP, CN, AU and NZ) EIAV vectors WO 98/51810 (granted in US, EP, JP, CN, KR, AU and NZ) WO 99/32646 (granted in US, EP, GB, JP, CN and AU) SIN Vectors US patents: 6,924,123 & 7,056,699 Codon optimised gag/pol WO 99/41397 (granted in US and AU) WO 01/79518 (granted in EP, CN, JP and AU) WO 95/30763 (granted in EP and JP) VSV-G pseudotyped vectors US patent 5,817,491 Stable HIV production (STAR) system WO 2004/ (Granted in US & JP) WPRE with mutation in X region which prevents expression of X region US patent 7,419,829 Rev-less production systems WO 03/ (issued in EP and JP) Downstream processing of vectors WO 2009/ Oxford BioMedica plc Our centre of excellence 16

19 Oxford BioMedica has built an extensive patent portfolio that provides comprehensive protection for gene-based delivery technologies and their therapeutic application. This portfolio contains over one hundred patents/patent applications which are either owned by the Company or exclusively licensed to it by third parties Oxford BioMedica is committed to advancing the wider development of gene therapy approaches by offering licences under its intellectual property, provided these do not overlap with products the Company is developing itself Over many years Oxford BioMedica has pioneered the design and development of third generation minimal vectors based on EIAV and HIV-1 Oxford BioMedica plc Our centre of excellence 17

20 Our operational focus Manufacturing development The role of manufacturing development is to apply cutting edge science and technology and good business practices to our novel gene therapies to cost effectively deliver the pipeline products for late stage clinical development and market supply. Our scientists and engineers are tasked with finding the best ways to improve our systems, processes and procedures in order to keep us at the forefront of science and technology. The business focus of manufacturing development is the end-to-end balancing of resources to ensure speedy delivery with regulatory success. Manufacturing and supply We work in collaborative partnerships with internal and external customers, adding value through leveraging our expertise, knowledge and management of our GMP facilities. The facilities have been designed to be multi-purpose and are suitable for Phase I, II and III clinical studies. They meet current US and EU GMP standards (i.e. MHRA inspected) for the production of investigational products for human clinical trials as well as the EU Clinical Trial Directive. The controlled infrastructure allows us to offer multiple services, provided by well-trained personnel, in the manufacture of drug substance and drug product. Oxford BioMedica plc Our centre of excellence 18

21 Analytical support Oxford BioMedica benefits from a highly skilled team of analysts and scientists which complements the manufacturing and manufacturing development activities. Our multi-skilled high performing teams have a proven track record in successful assay development, qualification, validation and routine testing. This has been essential for the development of the well-established validated product-specific and compendial methods necessary for lentiviral based vector characterisation, quality control (QC) and stability testing, as well as preparation of chemistry, manufacturing and control (CMC) documentation for multiple regulatory submissions to the EU and US agencies. Quality organisation Oxford BioMedica is fully committed to its quality policy and operates to the highest quality standards. The Company sees investment in its quality management system to ensure its continuing suitability, adequacy and effectiveness as key to its ongoing goal to discover and develop unique gene-based medicines with patient safety being paramount at all times. Quality is critical to the future success of our business. Oxford BioMedica plc Our centre of excellence 19

22 Our capabilities Developing, manufacturing and commercialising novel gene therapies Research and Bioprocessing Pioneering technology and know-how in lentiviral based vector products and manufacturing process development Cutting edge research in vector and cell line development Vector production via transient transfection or by development of stable packaging/producer cell lines Media development Process development, optimisation and of adherent 2D planar technologies such as cell factories and 3D packed bed technologies; scale-up of serum-free suspension culture in single-use bioreactors up to 200L scale Process characterisation studies Process validation Assay development and validation Technology transfer expertise Manufacturing & Supply Chain MHRA licensed for IMP manufacture Technical support capabilities GMP manufacturing capabilities GMP QC and release testing CRO network for specialised assays Oxford BioMedica plc Our Annual centre Report of excellence and Accounts

23 Stability testing Aseptic processing and fill/finish Transportation and cold-chain infrastructure Established CMO network for additional IMP production Clinical, Regulatory Successful completion of clinical trials Regulatory dossiers in EU and US Preparation of CMC documentation for multiple INDs and CTAs Product-specific consultation meetings with FDA, EMA, MHRA and AFSSAPS (ANSM) Active participation in ATMP guidance development Testing patient clinical samples GLP/GCP accreditation We have developed different manufacturing approaches to increase the ease of development and speed to market Commercial and IP Strong IP estate (patents and know-how) The LentiVector Platform Licensing Programme (LP) 2 Extensive business development experience for LentiVector platform vectors and therapeutic products Research and Bioprocessing Manufacturing & Supply Chain Cross-over expertise Gene therapy is a specialised area of drug development and the LentiVector platform technology is based on a proprietary manufacturing process developed from scratch by Oxford BioMedica. With our manufacturing team, we combine in-house expertise with significant operational and technical knowledge Cross-over expertise Clinical, Regulatory Commercial & IP Oxford BioMedica plc Our centre of excellence 21

24 Our facilities The facilities include: Office and admin rimary change P Provides appropriate cleanroom appropriate gowning, goggles, hair nets and face masks Material transfer/temperaturecontrolled storage Temperature monitored and validated cold storage equipment facilitates the storage of raw materials, drug substance and drug product Plant and utilities The heating, ventilation and air conditioning (HVAC) system is situated here. The plant utilises four independent HVAC systems for providing single pass air supply to the clean room facilities Fill and finish Aseptic Fill & Finish is the last step of a biologic drug manufacturing process and results in packaged product in its final form Oxford BioMedica plc Clean room suites With two primary clean room suites on the first floor and additional capacity on the ground floor, we have the capability to run up to three specialist manufacturing suites in parallel Central services Used to prepare media/buffer and any other equipment, assemblies and materials required for the manufacturing bill of materials rocess development P Dedicated laboratories that are fully equipped to support all aspects of upstream and downstream process development icro/qc labs M Where we perform quality control (QC) activities such as environmental monitoring; raw material analyses; and cleaning validation and testing Our centre of excellence 22

25 Our world-class facilities provide the full range of GMP manufacturing services from pre-clinical through to GMP manufacture and supply of clinical trial materials. Oxford BioMedica owns a fully operational GMP manufacturing facility (1,480m2, 16,000 sq ft in Oxford, UK), with a fully contained GMP processing suite, and an annex for warehousing and office areas. This facility allows for the production of lentiviral based vector products for Phase I/II and Phase III clinical trials for our pipeline products and for providing material to external partners for clinical supply and launch. Our operational activities are further supported by a network of audited third party CRO/CMO s that augment the range of analytical, manufacturing and vial-filling activities carried out by Oxford BioMedica to support both in-house programmes and those of our key partners and collaborators. Oxford BioMedica is continually investing in its manufacturing capabilities, GMP clean-room capacity and infrastructure. On completion of the ongoing expansion plan, in addition to the current capacity, our facilities will be able to accommodate additional adherent 2D planar technologies such as cell factories as well as scaled-up production in 3D packed bed technologies and 200L single-use stirred-tank bioreactors with associated areas for downstream processing. This will provide access during 2015/2016 to unrivalled GMP production facilities as well as a new GMP-compliant filling suite that has been designed for aseptic processing and semi-continuous vial-fill to support Phase I/II IMP clinical material supply. This investment by Oxford BioMedica in state-of-the-art specialist facilities will address one of the main hurdles associated with the rapid progression of products through clinical development and on to market supply. 390m2 The current fully-operational clean room area covers 390m2, which is supported by an additional ~1100m2 providing warehouse, QC, office, utilities and fallow space. An extensive expansion plan is currently underway. 1,900m2 The total cleanroom area on completion of the expansion plan will exceed 1,900m2 (in upstream and downstream processing areas across multiple independent suites plus a separate custom suite for Fill and Finish Oxford BioMedica plc Our centre of excellence 23

26 Our alliance management Oxford BioMedica has established a successful track record of delivery in relation to collaborative partnerships. We have proven to be a highly competent partner, who can provide unique experience and expertise in the development, manufacture and testing of lentiviral based vectors. By entering into a partnership with Oxford BioMedica, you would have access to a total solution for the process development, manufacture and analytics for lentiviral based vector products. There are few, if any, other organisations worldwide that we believe would be able to provide such a complete solution. Current partners and/or licensees include Sanofi, Pfizer, Novartis, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec (research use only licence), Immune Design, Emergent BioSolutions, and ImaginAb. At Oxford BioMedica, our experienced technical programme managers are the customer champions throughout the company and act as the key contact point between the key partner and the project team, keeping you informed of the progress of the project from initiation to completion. Their primary objective is to ensure delivery of the project is on time, on budget and to the quality standards expected by all our key partners. We recognise the importance of building strong relationships and industry alliances in delivering success We were the first to establish a lentiviral based vector multiproduct alliance with Sanofi for four ocular indications (April 2009) Oxford BioMedica plc Our centre of excellence 24

27 Designed and produced by Printed by Pureprint Group using their pureprint environmental print technology, a guaranteed, low carbon, low waste, independently audited process that reduces the environmental impact of the printing process. Pureprint Group is a CarbonNeutral company and is certified to Environmental Management System, ISO and registered to EMAS, the Eco Management and Audit Scheme.

28 Oxford BioMedica plc Oxford BioMedica (UK) Limited Windrush Court Transport Way Watlington Road Oxford, OX4 6LT United Kingdom Tel: +44 (0) Fax: +44 (0)