Scotland:Stem Cells and Regenerative Medicine

It could be your greatest discovery……........

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Scotland is Europe’s leading location for the development of stem cell applications by establishing the optimum environment for translating research into therapeutic benefits for patients.

We have a worldwide reputation for excellence in stem cell and regenerative medicine research & development with excellent access to European markets.

This is built on a strategy, involving government, industry and academia working together, designed to support all segments of this emerging market.

• Scotland’s world-leading academic community boasts extensive experience with embryonic and adult stem cells including induced pluripotent stem cells (iPS).

• Investment in infrastructure and the provision of support for companies has created a vibrant commercial supply chain with stem cell product and service companies working alongside global Life Science corporations.

• Scotland has taken the lead in streamlining the processes that support the generation of clinical data allowing clinical trials to be approved in less than three weeks. Scotland was chosen as the place to conduct the UK’s first approved stem cell clinical trial.

Scotland: Your Competitive Edge

Ask us how Scotland can enhance your competitive edge

“Scotland has a long history of outstanding science innovation and our science and research base continues to be among the best in the world. Scotland is a world leader in stem cell research and development. The Scottish Government fully supports the sector, recognising the importance of this research to the Scottish Life Science industry and the hope it holds for people with currently incurable conditions”.

Mr Jim Mather MSPMinister for Enterprise, Energy and Tourism, Scottish Government

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Scotland holds a leadership position in the stem cell and regenerative medicine field, building on the research that produced the first cloned mammal, Dolly the sheep, in 1996. This scientific breakthrough demonstrated for the first time that a single adult somatic cell could produce a healthy animal. Since then, the technology has evolved rapidly, with Scotland’s Universities continuing to excel scientifically.

On a global level Scottish stem cell science leads the world. Scotland is:

• 1st in the world for stem cell research based on citation impact,

• 4th in the world for clinical medicine research based on citation impact, and,

• the largest stem cell cluster in Europe with major centres in Edinburgh, Glasgow, Dundee and Aberdeen.

Scottish research into the fundamental biology of stem cell growth and differentiation continues to deliver ground-breaking science, such as:

• the discovery of the embryonic stem cell pluripotency genes Oct4 by Dr Hitoshi Niwa and Nanog by Dr Ian Chambers, and,

• the development by Dr Keisuke Kaji of a non-viral reprogramming method to generate iPS cell lines from which all the exogenous factors are subsequently removed.

Clinicians in Scotland are taking discoveries into the clinic with major programs in blood, liver and cardiovascular disease as well as diabetes, bone and cartilage and corneal implants.

Scientific Excellence

“Scotland is the leading cluster country in Europe for stem-cell research”.

Professor Sir Christopher Evans OBE Group Chairman, Excalibur Fund Managers

(Sources are ScienceWatch (2007and 2009), Evidence Ltd (2009) and the UK Research Assessment Exercise 2008, Citation impact is regarded as the most widely accepted index of research quality, measured as the number of citations per paper. Analysis performed by Edinburgh Science Triangle)

Ask us how Scotland can advance your discoveries towards the clinic

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The UK Government is a long-standing advocate of the Regenerative Medicine sector. Companies moving to Scotland can be confident that the sector is supported both politically and financially.

• The UK and Europe have a regulatory environment that allows research and clinical trials to be carried out on embryonic as well as adult stem cell lines.

• Scotland has developed a number of unique mechanisms that greatly simplify the clinical trial process, making Scotland the premier European site to conduct stem cell clinical trials and to introduce new products into the European Markets.

• Scotland has a well developed supply chain and is home to a number of companies that are delivering regulatory, manufacturing and contract research services to the stem cell industry.

• Based in Scotland a range of multinationals, such as Millipore, Life Technologies and Charles River are developing specialised services and products to meet the growing demand from the regenerative medicine sector.

These companies recognise the potential of regenerative medicine to deliver shareholder value with Scotland being a major market and a springboard into Europe.

Supportive Environment

“There is also a case for identifying and building up the areas where the UK truly is a world leader. This includes stem cells and regenerative medicine, plastic electronics, satellite communications, fuel cells, advanced manufacturing, composite materials and many more.”

The Rt Hon Dr Vince Cable, MP Secretary of State for Business Innovation & Skills

Discover how such a supportive environment can help your company succeed

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Unique to Scotland are organisations that combine world class research and clinical expertise to create a world-leading platform for patient orientated research that can lead to clinical approval in days rather than months.

• The Scottish Academic Health Sciences Collaboration (SAHSC) builds on the close National Health Service and academic partnerships already existing in Aberdeen, Dundee, Edinburgh and Glasgow and through these to other Scottish Health Boards and Universities. The SAHSC invests in key areas such as scanning capability, tissue banking, clinical research support and IT capacity and provides a harmonised and streamlined system through NHS Research Scotland for contracting and costing of clinical studies.

• The Scottish Research Database Application (SreDA) is a single, national database of 5.3 million patient records enabling rapid clinical trial recruitment.

• Generation Scotland collects and stores tissues and genetic and health information from over 30,000 family members to allow diseases to be tracked through the generations. Tissue samples can be used to develop disease-specific iPS cell lines which are of particular interest as novel drug discovery tools. www.generationscotland.co.uk

• NHS Research Scotland offers a route for fast and efficient approval of multi-centre clinical research studies. www.nrspcc.org

Clinical Expertise

Discover how Scotland’s clinical infrastructure can accelerate your timelines

“The initiation of the PISCES clinical trial is a major and hard-won milestone for ReNeuron and a significant milestone in the development of therapies to address the severely disabling effects of ischemic stroke. We are delighted to be working with Professor Keith Muir and his team at one of Europe’s pre-eminent stroke treatment centres and, in so doing, helping to promote the uptake of clinical innovation in the NHS system”.

Michael HuntChief Executive Officer, ReNeuron Group plc

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Success Stories

Wellcome BloodPharming Project

A major $4.5 million research project looking at the potential of using stem cells to generate red blood cells for use in transfusions. cGMP grade red blood cells from hESC’s will be developed for use in clinical trials. This builds on existing technology and the research team will turn stem cells into red blood cells and ensure that the resulting cells are safe to use in patients.Funded by the Wellcome Trust and led by the Scottish National Blood Transfusion Service the project is a collaboration between the English National Health Service Blood & Transplant, the Irish Blood Transfusion Service, the Universities of Edinburgh and Glasgow and Roslin Cells who will be manufacturing the hESC’s.

ReNeuron, Angel Biotechnology and NHS Greater Glasgow and Clyde

ReNeuron’s ReN001 stem cell therapy is being administered to stroke patients, who have been left disabled by an ischemic stroke, in a ground-breaking Phase I trial, the world’s first using expanded neural stem cells in this indication. The “PISCES” clinical trial (Pilot Investigation of Stem Cells in Stroke) is taking place, through the NHS, at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. Angel Biotechnology manufactures the drug substance lots of ReN001 as well as providing manufacturing process validation services.

Michael Hunt, Chief Executive Officer of ReNeuron, said:

“We are pleased to continue to work with Angel as our chosen contract manufacturing partner for the PISCES clinical trial for ReN001 in stroke. Angel has consistently demonstrated its strong expertise in the field of regulatory-compliant cell manufacture, meeting ReNeuron’s needs for this important first-in-man study.”

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Scotland has a number of specialist regenerative medicine companies, as well as major life science companies, all delivering products and services into this sector.

Specialist Resources

Angel Biotechnology is a world class, contract biomanufacturing company offering process development, pre-clinical and cGMP manufacturing of Advanced Therapy Medicinal Products and other live biologics (including embryonic stem cell based therapies). They are licensed by the regulators (MHRA) for cGMP manufacture of both Investigational Medicinal Products for use in clinical trials and of products for commercial sale. www.angelbio.com

Antoxis develops novel anti-oxidant technologies for therapeutic and stem cell based applications to combat age related diseases such as diabetes, Parkinson’s, Alzheimer’s and stroke. Antoxis collaborates with leading stem cell companies and academic groups to validate the use of its proprietary compound libraries in a variety of cell types. www.antoxis.com

AvantiCell Science specialises in cell-based analysis for drug discovery and ADME screening, natural product evaluation, biomaterials testing and nanotoxicology. Assay platforms incorporate physiologically-relevant human cells with high predictive value presented as primary isolates, as differentiated cell lines or derived from hESC, MSC or iPS stem cell populations. www.avanticell.com

BioReliance is a multinational providing biosafety, analytical, toxicological and manufacturing services to the pharmaceutical and biopharmaceutical sector. All services are conducted to cGMP or GLP. www.bioreliance.com

Why not come and join this vibrant community?

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Life Technologies has its European HQ in Scotland and, as a leading provider of novel stem cell research tools, provides more than 1,500 products used by stem cell scientists in basic research, screening and drug discovery, and therapeutic applications. Life Technologies spends approximately $300 million per year in research and development. www.lifetechnologies.com

Roslin Cellab is a ‘one-stop’ stem cell facility and offers fully equipped laboratories, trained staff, stem cell lines and the appropriate licences from the regulators. It has been established to allow companies without these facilities to conduct short, focused, proof of concept studies. www.roslincellab.com

Roslin Cells are world leaders in the isolation of new clinical grade undifferentiated stem cells for use in research and therapy. The company is licensed to procure, test, process, store and distribute human tissues for human applications. As well as supplying highly characterised, thoroughly tested and documented undifferentiated stem cell lines, the company collaborates with partner organisations to develop new cell therapies which can be produced in its cGMP compliant facility. www.roslincells.com

Specialist Resources

Cellartis is a Swedish/British biotechnology company focused on human embryonic stem cells (hESC) for drug discovery, toxicity testing and regenerative medicine. Their main focus is developing hepatocytes and cardiomyocytes for hESC. They are working with companies such as AstraZeneca to provide cells for drug discovery and screening. www.cellartis.com

Immunosolv has a portfolio of products consisting of reagents and kits for the detection and removal of non-viable cells. Viability is an important issue, determining the usefulness of cells for all applications and this technology is particularly useful in generating stem cell populations of the highest quality through detection and removal of inhibitory dead cells. www.immunosolv.com

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Sistemic provides specialist contract research, discovery and development services based on a proprietary position around micro RNAs. Sistem QC is a new tool allowing stem cell identification, process characterisation and directed differentiation, as well as monitoring across passages for drift and safety. www.sistemic.co.uk

Vyvo Biosolutions provides consultancy services and specialises in the regenerative medicine sector providing flexible, responsive and independent consultation in biological medicinal product development from discovery to market. www.vyvo.net

SSCN is a membership-based, knowledge management network with the aim of creating a connected community focused on the development of a world-leading and sustainable regenerative medicine industry in Scotland. To join this vibrant community, visit www.sscn.co.uk

Supporting a robust supply side is an important part of Scotland’s regenerative medicine strategy, and companies with new products and services are entering this important new market on a regular basis.

Specialist Resources

Vitrology is a world leading contract research organisation offering a full range of validated assay services for the viral safety and impurity assessment of vaccines and biopharmaceuticals. Accredited by the MHRA, Vitrology provides GMP and/or GLP drug development services to the global biotechnology industry. Scientific data from Vitrology supports medicines and vaccines in clinical evaluation and marketed under commercial license for the treatment of the human population. www.vitrologybiotech.com

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Scotland has world class facilities in Aberdeen, Dundee, Edinburgh, Inverness and Glasgow, including Aberdeen’s Science and Technology Park, Glasgow’s West of Scotland Science Park, Dundee’s Ninewells Site, and the Edinburgh BioQuarter.

Edinburgh BioQuarter is a unique location in Europe that offers commercial facilities co-located with a world-class teaching hospital and research University. A 100 acre site that will deliver over 2 million sq.ft (200,000m2) of R&D space.

The result of a $1.2bn public private partnership and home to the largest group of stem cell researchers in the UK, BioQuarter houses:

• over 1150 researchers in the University of Edinburgh Medical School and the Queen’s Medical Research Institute,

• an 870 bed teaching hospital,

• the $90m MRC Regenerative Medicine Centre and,

• a $34m BioIncubator.

BioQuarter offers all of the key components required to build substantial biomedical businesses in today’s global market whether these are focussed on research, development or commercialisation, drugs or devices, products or services.

Facilities

“I am proud that Scotland is home to a large number of world-class academic stem cell research groups. These dynamic groups are already attracting life science companies to Scotland, and we have seen commercial interest grow enormously in recent years. I am keen to encourage these existing partnerships, and to foster the establishment of both academic and commercial collaborations between Scotland and the rest of the world.”

Prof. Sir Ian Wilmut, Director, MRC CRM

These Scottish facilities will deliver your operational needs

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The MRC Centre for Regenerative Medicine (MRC-CRM) brings together world leading basic stem cell research with established clinical excellence to deliver a “bench-to-bedside” approach aimed at developing new treatments for major diseases including cancer, heart disease, diabetes, degenerative diseases such as multiple sclerosis and Parkinson’s disease, and liver failure.

• This $90m centre for stem cell research and regenerative medicine provides state-of-the-art research, manufacturing and commercialisation facilities and houses over 220 researchers creating the largest stem cell cluster in Europe.

• Built to encourage collaboration with specially designed networking spaces, the MRC-CRM is central within the BioQuarter complex and will build on Scottish scientific excellence in the regenerative medicine field.

MRC Centre for Regenerative Medicine

The University of Edinburgh and the MRC-CRM are recognised as world leaders in regenerative medicine attracting donations from such philanthropists as J. K. Rowling whose latest donation of $16m will build The Anne Rowling Regenerative Neurology Clinic in memory of her mother who died of multiple sclerosis.

“I cannot think of anything more important, or of more lasting value, than to help the University attract world-class minds in the field of neuroregeneration, to build on its long and illustrious history of medical research and, ultimately, to seek a cure for a very Scottish disease.”

J K RowlingAuthor

“By bringing together expertise in stem cell biology with cutting edge translational medicine, we have created a unique, world-leading environment in Edinburgh. We are working to apply our knowledge of regenerative medicine to tackle the enormous challenges of degenerative and other diseases.”

Charles ffrench-Constant, Deputy Director of the MRC CRM

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Success Stories

Bio-Artificial Liver

Scientists within the University of Edinburgh and the MRC-Centre for Regenerative Medicine are defining novel ways to derive hepatocytes from embryonic stem cells and then, by attaching the cells to a proprietary polymer, utilising these cells for bio-artificial liver use. The polymer improves viability and stabilises the liver-specific function in hESC-derived hepatocytes. It is believed that the use of such devices could allow damaged livers to recover and avoid the need for transplantation.

Roslin Cells and Lonza Bioscience

Lonza has entered into a collaboration with Roslin Cells which combines Roslin Cells’ expertise in developing cGMP grade pluripotent stem cells with Lonza’s expertise in primary cell media formulation. The main purpose of this collaboration is to provide those involved in both regenerative medicine research and in the production of clinical cell-based products with high-quality, scalable, culture systems that meet the stringent regulations that govern cellular therapies.

Dr. Philip Vanek, Head of Innovation and Business Development, Lonza Bioscience commented:

“Scotland’s worldwide reputation as a leading centre of excellence for stem cell research, together with renowned clinical capabilities, was a key factor in our decision to create a partnership with Scottish-based Roslin Cells.”

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A key element of Scotland’s welcoming business environment is the work done by Scottish Development International in helping investors tap into the country’s world-class capabilities in innovation and commerce.

Uniquely, SDI provides Account Managers who open doors to a huge range of opportunities in funding, new technology, R&D and training. Potential investors receive free business and strategic advice and are supported in making crucial business contacts across Scotland.

Regional Selective AssistanceRegional Selective Assistance (RSA) grants offer funding towards investment which will create or safeguard jobs in Scotland. More than $135 million has been awarded since April 2008 and money has been allocated to more than 144 companies, from large corporations to small business concerns.

R&D FundingR&D funding can provide up to a quarter of the cost of your research and development in Scotland. This valuable financial support can cover the costs of everything from buildings and people to technology and equipment, along with any outsourcing expenditure.

R&D Tax CreditsAs part of the British Government’s strategy to support innovation and inward investment, it offers generous incentives to companies carrying out research and development in the UK. Some $2.7 billion worth of support has already been claimed through this scheme, which is open to large companies and small business concerns.

Training PlusScottish Enterprise’s Training Plus initiative provides funding to help with the cost of staff development and training. Grants can be awarded for up to 50% of expenditure on training for generic skills, or up to 25% if the training is company specific.

Financial Assistance

Find out more about the wide range of funding and support available in Scotland at www.scottish-enterprise.com

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• Scotland’s main cities, Glasgow and Edinburgh, are only 40 miles apart and served by motorway and train links as well as international airports.

• Scotland has five major international airports, Glasgow, Edinburgh, Aberdeen, Inverness and Prestwick, as well as numerous domestic airports serving outlying areas. Scotland is also connected by international ferry to various European destinations

• Edinburgh, Scotland’s capital city, is consistently ranked as one of the best locations to live and work.

• Our powerful life sciences industry research and technology base includes 630 organisations and over 32,500 employees and is the European base of several multinational Contract Research Organisations.

• Scotland’s Life Sciences contributes in excess of $4.5 billion per year.

Scotland’s profile as a location rich in opportunities continues to grow alongside its reputation as a country focussed on developing innovation, talent and potential which has already encouraged many international investors to do business here.

The Location for Innovation

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With international partnerships, global research links with major academic centres and multinational pharmaceutical companies, robust capital investments from the government and funding from private VC firms, Scotland continues to secure its standing as a world-leader in Life Sciences.

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It’s the ideal environment for developing regenerative medicines in the 21st century:

• Scotland is 1st in the world for stem cell research based on citation impact.

• The UK has a regulatory environment that supports both embryonic and adult stem cell development and clinical studies.

• Scotland has a streamlined process that allows rapid clinical trial set-up with computerised patient data, historical family study data and straight- forward access to the Scottish National Health Service.

• A vibrant specialised and multinational commercial sector

• Scotland offers state of the art facilities across the country

• Scotland provides customised financial support packages developed for each opportunity.

• Scotland has formalised collaboration and knowledge exchange mechanisms.

• Scotland’s major centres, Edinburgh and Glasgow, are both served by international airlines.

• The UK and Scottish Governments have identified regenerative medicine as a key investment area ensuring that the political environment remains supportive.

Scotland has the science, translational medicine and commercial development for stem cells all in close proximity. It’s an ideal location for academic research collaborations, stem cell technology development, manufacturing and progression to clinical trials.

Why come to Scotland?

Scotland - The Regenerative Medicine Centre of Europe

To learn more about Scotland’s dynamic and vibrant stem cell community and how your company can benefit from locating here please contact Scotland Development International: www.sdi.co.uk or email us at investment@scotent.co.uk

SE/3279/Nov10

Scottish Development International5 Atlantic Quay

150 BroomielawGlasgow G2 8LU

Tel: +44 141 228 2828Fax: +44 141 228 2089

investment@scotent.co.uk

www.sdi.co.uk

Worldwide offices in: Americas, Europe, Middle East, Africa and Asia Pacific

Scottish Development International is a government funded organisation inspiring companies from around the globe to tap into Scotland’s knowledge and innovation. We’re accessing overseas networks, developing mentoring ties and creating investment interest and collaboration whenever possible. For further information on the life science industry

in Scotland, go to www.lifesciencesscotland.com

Photography Credits:

Page 2 Header Image: Steven PollardPage 4 Header Image: Roslin Cells Insert Image: College of Life Sciences, University of DundeePage 5 Insert Image: Lowell Lab, University of EdinburghPage 6 Insert Image (top): Mountford Lab, University of GlasgowPage 7/8/9 Header Image: Mountford Lab, University of GlasgowPage 12 Insert Image (top): Roslin Cells Insert Image (bottom): Hay Laboratory, University of EdinburghPage 13 Header Image: Edinburgh Inspiring Capital (www.edinburgh-inspiringcapital.com)Page 15 Header Image: Photograph by Gillies Willis’