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Regulatory Guidance

Overview

Biotechnology is the application of knowledge about living organisms, and their components, to industrial products and processes. The UK has companies actively developing and exploiting biotechnology across the whole breadth of its application: from pharmaceuticals and diagnostics, through speciality chemicals, food and agriculture, to the environment. The UK leads in Europe in the industrial exploitation of biotechnology.

The UK is one of the best places in the world for bioscience.  The UK boasts an excellent science base, with favourable economic and political conditions, and a clear and fair regulatory regime. 

What's New

Guide to best practice in technology transfer

A comprehensive guide to best practice in technology transfer in bioscience/biotechnology in England and Wales, summarising the findings of representatives from many UK universities and other research institutions, NHS organisations and others involved in the exploitation of publicly funded bioscience research at the 2004 Inter-BEP Conference. Launched in 1999 following a successful pilot phase, the DTI's Biotechnology Exploitation Platform (BEP) Challenge encouraged universities and other publicly funded research organisations with access to complementary bioscience research to work together to improve the identification and commercialisation of biotechnology innovations arising from the UK's world-class science base. Click here for more information about BEPs.

Click here to download a PDF version of the Guide. Hard copies should be available shortly.


LINK Analytical Biotechnology programme final dissemination event, The Royal Society, London, 13 October 2005

BBSRC is hosting a final dissemination event for projects funded through the DTI/BBSRC LINK Analytical Biotechnology programme at The Royal Society, Carlton House Terrace, London on Thursday 13 October 2005. This is an excellent opportunity to hear about developments arising from these projects and to network with industrialists and academics with an interest and expertise in biotechnology research and exploitation.

The event is open to all interested parties, both industrial and academic, but companies, potential partners and investors are especially welcome. Places will be filled on a first come, first served basis.

Click here for more information and be sure to register your interest by 30 September 2005

DTI publishes independent analysis of 6 key sub-sectors of the medical devices industry

DTI have now published an independent sector competitiveness analysis of 6 key sub-sectors of the medical device industry.

The report, by Arthur D Little, sets out to explain differences between UK sources of supply of medical devices and other sources and to explore the factors creating business success, including UK strengths or weaknesses in relation to those factors.

The sub-sectors covered in the report are:

  • Medical imaging/ultrasound equipment and materials
  • Diagnostic equipment and materials
  • Radiotherapy equipment
  • Electromedical and respiratory devices
  • Active and passive implantables
  • Advance wound amangement

Click here for the analysis

UK Biotechnology sector leads Europe - new statistical report published

The report, Comparative Statistics for the UK, European and US Biotechnology Sectors - Analysis Year 2003, prepared by independent consultants, found a general fall across Europe in biotech business activity due to widespread waves of restructuring. The UK, along with many other countries, suffered falls in biotech employment. Some R&D employment was cut as firms merged and focused on best revenue prospects for long-term survival. The consultants conclude, however, that growth in the UK is more sustainable in future than elsewhere in Europe and that the UK remains the most attractive for large investment.

The report provides the DTI with a robust and defensible analysis of the UK biotechnology sector’s comparative standing against some of its key European competitors and the United States. It analyses company performances in the calendar year 2003 and, on a country-by-country basis, compares that performance with metrics for 2002 (and 2001 where appropriate).

The study shows that at the end of 2003 Europe’s biotechnology industry employed approximately 82,400 people and generated €16.3 billion of revenue. Europe’s biotechnology sector had over 420 new drugs in clinical development or awaiting approval. European companies raised €1.3 billion of equity investment in 2003.

As in previous years, the UK was the single biggest contributor to this picture.  In 2003 the UK sector’s 455 companies employed approximately 22,400 people and generated revenue of £3.6 billion. UK companies had 224 new drugs in clinical development or awaiting approval - half of the European total. UK companies raised £392 million of equity investment.

The UK biotechnology sector continues the restructuring process that started in 2002.  The report indicates that the UK, post-restructuring, has the most robust biotechnology sector in Europe and remains the most likely national sector to attract the large equity investments necessary for growth.

The report was published at a DTI led Science and Innovation Conference in Manchester that bought together key figures in business and academia in the North West to discuss the importance of driving forward innovation.

Click here for the press release

The full report can be downloaded here -
Comparative Statistics for the UK, European and US Biotechnology Sectors - Analysis Year 2003

Pre-emption Rights: Final Report published

A study by Paul Myners into the impact of shareholders' pre-emption rights on a public company's ability to raise new capital was published by DTI on 10 February 2005. The report, press notice and responses to the invitation to comment can be found at: http://www.dti.gov.uk/cld/public.htm

The Bioscience Futures Forum

The Bioscience Innovation and Growth Team (BIGT) report, released in November 2003 details the current state of the UK bioscience sector (concentrating on healthcare applications) and sets out a wide-ranging vision for the future and includes many innovative recommendations with which to challenge Government and industry.  One of its conclusions was that a more proactive stance is needed within Europe to shape future regulations and ensure they are acceptable to the UK.  It recommended the creation of a Bioscience Risk Assessment Forum now called the Bioscience Futures Forum (BFF), under the auspices of the Bioscience Leadership Council (BLC).

The BFF will monitor and assess emerging issues, develop issue management strategies, and anticipate areas where regulation may be needed.  The expert group will horizon-scan across bioscience advances and consider the ethical, social and regulatory questions, which they raise.  The group will adopt a proactive approach to bioscience regulation and reputation management, and aim to shape the UK and EU environments of the future. Dr Gill Samuels CBE, Executive Director of Science Policy & Scientific Affairs, Europe at Pfizer chairs the expert group of 11 members, bringing together people with a variety of backgrounds and experience, providing a vision and a framework for taking both short and long-term views.  The first meeting was held in February 2005.

Further details in the background note below

Bioscience Futures Forum background note

For further information and to keep up to date with the Bioscience Futures forum, please go to www.bioindustry.org/bff.

Patent Study Workshop - report published

Following the publication of the study into the impact of current UK law and practice regarding patents for genetic sequences, a workshop was held to further discuss two areas: research exemption and public perception.  The workshop in September 2004 was officially opened by Lord Sainsbury and a report of it, by the DTI Bioscience Unit, is now available. 

Patent Study Workshop Report

Measurements for Biotechnology (MfB) programme - new report published

The Measurements for Biotechnology (MfB) programme, launched in 2001 to tackle the measurement challenges of the biosciences, forms part of the National Measurement System (NMS) which is funded by DTI.  It aims to:

  • Assist in translation of biotechnology from the science base into industry
  • Develop generic reference methods and measurement standards for UK industry
  • Maintain the UK lead in developing an international framework for bioscience measurement
  • Help to base regulation more securely in measurement science
The MfB hub (BIA, LGC Ltd and NPL) consulted widely with the bioscience community to define the objectives and broad content of the new programme in biomeasurement focussing on Cell-based measurement, Gene measurement, Product characterisation and Protein measurement.

Overviews of progress in the first few years of Measurements for Biotechnology have now been published in the “Better Measurement for Biotechnology” report. You will find articles on the need for better biomeasurement and some of the first steps taken along the road for DNA, protein and cell-based measurement, measurement for biological interactions and measurement for product quality. The report identifies and features measurement as an additional element of the infrastructure supporting the bioscience sector in the drive towards improved national health and increased national wealth. Below is a link to the report.

Better Measurement for Biotechnology report

To receive a hard copy of the report, please contact Dr Samia Saad at the BIA or Dr Roy Dietz at the LGC. For further information on the MfB programme, please visit:  www.mfbprog.org.uk/index/index.asp

Prospects for Marine Biotechnology in the UK

A Study into the Prospects for Marine Biotechnology Development in the UK" by BioBridge Ltd, commissioned by the Foresight Marine Panel (FMP) Marine Biotechnology Group, was published on 5 January 2005.  The report was co-funded by DTI and the South West Regional Development Agency.  It identifies huge potential for the innovative exploitation of novel marine molecules and materials across a wide range of industrial sectors including healthcare, food, environment, pharmaceutical and cosmetics.  It recommends five areas of activity: maintaining and developing the activities of UK's world-class science base, sustaining networks, commercialisation and funding, enhancing public understanding of marine biotechnology and stimulating training.
 

Below is a link to an executive summary and full report (in 2 volumes) and associated press notice. Further details of the Foresight Marine Panel are available at www.marineuk.com

A 2015 Vision for industrial Biotechnology - Industrial Biotechnology Task Force (IBTF) Report, draft published for comments

An Industrial Biotechnology Task Force (IBTF) was set up in January 2004 to help build and develop consensus on the best opportunities for growth of industrial biotechnology.  The draft IBTF report was published on 2nd December 2004 at “UK Biotechnology: A Showcase of UK Capability”.

The IBTF report has recognised that the size of the market potential of industrial biotechnology is unclear and even UK capacity to lead its exploitation is only partially understood.  Nonetheless, IBTF believes that the potential opportunities are such that it merits targeted actions.   In the short-term at least, efforts should focus on maintaining momentum in building the UK’s particular strengths. Bio-based materials/products, together with biocatalysts and other applications of enzymes, appear to offer the most promising short to medium term opportunities.  The UK already has effective co-ordinating networks in these areas, but there is an immediate need for further R&D and technology validation projects to build operational experience and overcome scepticism.

The report includes a set of recommendations for action to achieve the 2015 vision. The IBTF report recognises that many activities and actions lie outside the remit of Government.  Success depends on all stakeholders investing the necessary resources and working in partnership.  The draft report is now closed for further comments.

The full IBTF report can be found at www.dti.gov.uk/biowise.

Healthcare Industries Task Force (HITF) report published

The Department of Health, on behalf of the Government and in conjunction with the healthcare industries, is launching the Healthcare Industries Task Force (HITF) report on Wednesday 17 November 2004 at Imperial College, London. This joint strategic initiative is the first of its kind between Government and this sector of industry. Co-Chaired by the Health Minister Lord Warner, and Sir Christopher O’Donnell, Chief Executive of Smith & Nephew, the Task Force has delivered a programme of action to benefit patients and the NHS and stimulate science and industry in the UK to improve growth in manufacturing, investment, employment and exports.

The report is available on the HITF website from 01.30 pm Wednesday 17 November: www.advisorybodies.doh.gov.uk/hitf.  

Government Strategy for non-food crops published

A Government Strategy for non-food crops was launched by Lord Whitty (Minister for Farming, Food and Sustainable Energy) on 5 November 2004 at the first annual conference of the National Non-Food Crops Centre.  The strategy, drawn up by Defra and DTI in consultation with key stakeholders is aimed at increasing commercial opportunities, stimulating innovation, cutting waste and environmental damage, and protecting precious natural resources.  

Below is a link to the strategy - which includes an action plan - and associated press notice:

A strategy for non-food crops and uses: Creating value from renewable materials

Press Notice

Bioscience Beacons – new booklet published

A new booklet has been published on the six Bioscience Beacon projects launched in November 2002 with £8M DTI funding.  The Bioscience Beacons are a new type of DTI-funded applied research project.  They are interdisciplinary, high-risk projects with strong industrial relevance, each with over £1M of DTI funding.  Averaging 3-5 years, the projects combine world-class research in bioinformatics, bioimaging and bionanotechnology with real potential to deliver wide-ranging benefits to the pharmaceutical and biotechnology industries.  The six projects are regularly assessed to maximise their relevance to industry.

The booklet provides more information on the Beacon projects. It can be downloaded here.  The Beacons website also contains information and links to each of the projects.

Patent Study on Genetic Sequences – report published

In response to the House of Lords Select Committee report on Genetic Databases, the Government made a commitment to carry out an investigation into the impact of current UK law and practice regarding patents for genetic sequences. The Intellectual Property Institute (IPI) on behalf of the DTI has now completed a study of the law and practice.

The main findings of the study show that current UK law and practice regarding patents for genetic sequences is generally meeting the needs of those currently active in this research area.  The study indicates that this is true for both public and private sectors.

Below is a link to the full report and to the House of Lord Statement.

Full report:

House of Lords Statement:


UK Biotechnology statistics - 2001/2002 report published

This report provides a robust and defensible analysis of the UK biotechnology sector’s comparative standing against some of its key European competitors and the United States. It analyses company performances in the calendar year 2002 and, on a country-by-country basis, compares that performance with metrics for 2001.

The study shows that the UK was the single biggest contributor to the picture in Europe.  In 2002 the UK sector’s 486 companies employed approximately 26,000 people and generated revenue of over €6.4 billion. UK companies accounted for 40% of products in the product development pipeline by European public companies, and 41% of biotechnology drugs in late stage clinical trials (Phase III) in Europe are from the UK. Market capitalisation of the UK’s 47 publicly quoted companies was €9.7 billion.

The full report can be downloaded here -
Comparative Statistics for the UK, European and US Biotechnology Sectors - Analysis Years 2001 & 2002


Back to Top   Government Sponsorship of the Biotechnology and Pharmaceuticals Sector

Biotechnology

The Department of Trade and Industry’s objective is to increase competitiveness and scientific excellence in order to generate higher levels of sustainable growth and productivity in a modern economy.

The Bioscience Unit takes the lead role within the UK Government in championing the commercial exploitation of biotechnology by UK industry, working to ensure that government, European and international measures affecting UK biotechnology take full account of the implications for competitiveness. The Unit focuses on four key areas: research and development policy, and technology transfer; the regulatory environment and intellectual property rights; the financing and development of small firms; and competitiveness issues of the key biotechnology subsectors. The Unit’s Ibio website provides a range of information for the biotechnology sector.

For further information from the Bioscience Unit, please contact:

Bioscience Unit
Department of Trade and Industry
151 Buckingham Palace Road
London SW1W 9SS
Tel: 020 7215 5000
Fax: 020 7215 1379

For information and advice on Biotechnology related programmes and research from the Office of Science and Technology, please contact the following:

Biotechnology and Biological Sciences Research Councils (BBSRC)
Tel: 01793 413200
Fax: 01793 413201

Medical Research Council (MRC)

Tel: 020 7636 5422
Fax: 020 7436 6179

 

Biosciences/Medical and Chemicals/Materials LINK Programme
Office of Science and Technology
link.ost@gtnet.gov.uk  

Helpline: 020 7215 0053 (Answerphone)
Fax: 020 7215 0054

 

 

Cross-Departmental Science Issues in Biotechnology and Health

Cliff Salole
Tel: 020 7215 6466

e-mail: cliff.salole@dti.gsi.gov.uk

For information and advice on Biotechnology related programmes and research from the Department of Health, please contact the following:

Human Genetics
Tel: 020 7972 4017
Fax: 020 7972 4196

Human Fertilisation and Embryology Authority
Tel: 020 7377 5077
Fax: 020 7377 1871

e-mail: admin@hfea.gov.uk

Vaccines
Tel: 020 7972 4488
Fax: 020 7972 4468

Xenotransplantation including
UK Xenotransplantation Interim Regulatory Authority
Tel: 020 7972 4822
Fax: 020 7972 4852

Novel Foods including
Advisory Committee on Novel Foods and Processes Joint Food Standards and Safety Group
Tel: 020 7238 6380 / 020 7238 6381
Fax: 020 7238 6382

Research and Development Division
Tel: 020 7972 5612
Fax: 020 7972 5665

Medical Devices Agency
Tel: 020 7972 8123
Fax: 020 7972 8111

Medicines Control Agency
Tel: 020 7273 0465
Fax: 020 7273 0062

Pharmaceuticals
The Department of Health (DoH) is the sponsoring department for the pharmaceuticals industry. The DoH undertakes to: provide a point of contact which can be used to exchange information with industry, for consultation and negotiation; represent critically industries' view on both general and specific economic trade or other related issues such as research and education in the UK, European or international dimensions; and help to get any necessary regulation right and ensure that there is a proper balance between industry needs and public protection and health interests. The DoH works closely with the DTI and relevant trade associations.

For further information and advice please contact:

Pharmaceuticals
Department of Health
Tel: 020 7210 5356

Under an Act of Parliament in 2000, three bodies were set up to look at different aspects biotechnology and how it affects society and the environment. These bodies are:

Agriculture and Environment Biotechnology Commission (AEBC)

The Agriculture and Environment Biotechnology Commission was set up with a remit to provide the UK Government and Devolved Administrations with independent, strategic advice on developments in biotechnology and their implications for agriculture and the environment. It will look at the broad picture taking ethical and social issues into account as well as the science.

Tel: 020 7215 6508
Fax: 020 7215 0313
e-mail:
aebc@dti.gsi.gov.uk

 

Human Genetics Commission (HGC)

The Human Genetics Commission advises on how new developments in human genetics will impact on people and health care.

Tel: 020 7972 1518
Fax: 020 7972 1717
E-mail:
hgc@doh.gsi.gov.uk 

 

Foods Standards Agency

The Food Standards Agency is an independent food safety watchdog set up to protect the public's health and consumer interests in relation to food.

Tel: 020 7276 8000

e-mail: helpline@foodstandards.gsi.gov.uk


Back to Top  Schemes and Initiatives

Government Schemes and Initiatives

Detailed below are schemes and initiatives run by the Government in the Biotechnology sector:

i-bio 

Provides an easy way to access a wide range of information on UK biotechnology. Whatever you're looking for, this government-led site can provide you with a rapid and comprehensive breakdown of relevant material and where to find it.

 

UK Biotechnology Regulatory Atlas

The UK Biotechnology Regulatory Atlas is a rapid retrieval system, which complements i-bio - it has been modelled on the regulatory architecture of biotechnology, and, in addition to signposting laws and official guidance, provides explanations and commentaries, which are regularly updated.

BIO-WISE
Working in partnership with you, your business associations and the UK's biotechnology industry to show how biotechnology can improve your company's competitive position.

Biotechnology Clusters
A team led by Lord Sainsbury, Minister for Science, reporting on biotechnology clusters.

Biotechnology Mentoring and Incubator Challenge
The overall aim of the BMI is to stimulate the creation and growth of high quality biotechnology companies in the UK. The Challenge is supported by a fund of up to £5 million and currently supports 8 projects around Britain. (Closed to new projects)

Biotechnology Exploitation Platform Challenge

(Closed to new projects)
The BEP web site has been discontinued but many of the BEPs have their own web sites – see below.

The BEP Challenge encourages universities and other publicly funded research institutions and intermediaries to work together to better manage and exploit the results of the UK’s world-class bioscience research.

The Pilot and Full programmes are together worth over £16 million, with DTI support in excess of £8 million.  There are 22 BEP consortia (at different stages of development) throughout the UK, involving 80 research organisations: 50 universities and 30 NHS Trusts.  Most BEPs cover a broad range of bioscience technologies but there are several specialist BEPs covering environmental science, cancer, plant and microbial science, diagnostic technologies, bio-microsystems and bio-nanotechnologies, and NHS technologies, systems and innovations (details below).

Key BEP outputs as at 30 June 2005
       
  • More than 4,100 research groups audited, 1,900 technologies identified with commercial potential, more than 850 selected for commercialisation
  • 357 new patent applications filed, 47 granted so far

  • 194 new commercial licenses signed, with an estimated lifetime value of £34 million

  • 106 new biotechnology start-up companies established, securing private investment of £34.5 million, and creating 277 jobs

  • 49 FTE technology transfer specialist jobs created

  • 5 inter-BEP conferences to promote best practice, networking, and collaboration between BEPs and other groups engaged in complementary activities

Guide to best practice in technology transfer

A comprehensive guide to best practice in technology transfer in bioscience/biotechnology in England and Wales, summarising the findings of representatives from many UK universities and other research institutions, NHS organisations and others involved in the exploitation of publicly funded bioscience research at the 2004 Inter-BEP Conference.


Biotech Advantage – the BEP Newsletter

Eleven issues of Biotech Advantage were published between December 2000 and September 2004, covering a wide range of bioscience IP management and exploitation topics and case studies. The newsletter has been discontinued - reports and BEP news are now made available via this web page - but you can download PDF versions of each issue using the links below. Please note that hard copies are no longer available.

Newsletters

Newsletter 1
Newsletter 2
Newsletter 3
Newsletter 4
Newsletter 5
Newsletter 6
Newsletter 7
Newsletter 8
Newsletter 9
Newsletter 10
Newsletter 11

Further information

For further information about BEPs please contact one of the BEP Programme Managers:


Dr Mike Barnes
Life Science Consultants
Tel: 01923 254275
E-mail: MBarnes466@aol.com


Dr Gordon Malan
Biotech-IS Ltd
Tel: 01642 570886
E-mail: PGMalan@biotech-is.co.uk


BEP contacts


Aber BioCentre BEP

(Biomedical, pharmaceutical, biological processes, agriculture, environment)

David Craddock
Tel: 01970 622385
E-mail: david.craddock@aber.ac.uk
Web site: www.aber.ac.uk/abc


Beacon Bio BEP

(Bioremediation, industrial processes, drug development and screening systems, CNS-related research, fungal and microbial diversity)

Dr Helma Kaptein
Tel: 01273 873267 or 873000
E-mail: h.kaptein@sussex.ac.uk
Web site: www.sussexip.com

BioElf Ltd BEP
(Food and plant, environment, healthcare, medical devices)

Prof. Howard Slater
Tel: 01823 430052
E-mail: info@bioelf.org
Web site: www.bioelf.org


Bioscience Partnership BEP
(Healthcare)

Dr Kay Callaghan
Tel: 0191 222 7700
E-mail: kay.callaghan@ncl.ac.uk
Web site: www.biosciencepartnership.co.uk


Bio-THRuST BEP
(Nanotechnologies and microsystems in a range of bio-industry sectors)

Dr Robert Carr
Tel: 01980 611862
E-mail: biothrust@mma.org.uk
Web site: www.mma.org.uk/biothrust.htm


Cambridge Enterprise at Addenbrooke’s BEP

(Regional healthcare)

Dr Alastair Hick
Tel: 01223 333543
E-mail: alastair.hick@rsd.cam.ac.uk


Cancer Research Technology (CRT) BEP
Susan Harris
Tel: 020 7269 3640
E-mail: sharris@cancertechnology.co.uk
Web site: www.cancertechnology.co.uk

CENTECH BEP
(Medical devices, environmental sciences, pharmaceuticals, therapeutics, diagnostics)

Dr Lyndon B Davies
Tel: 01223 262686
E-mail: lyndon@ldassoc.demon.co.uk

DiagnOx BEP
(Diagnostic technologies)

Lisa Mynheer
Tel: 01865 811127
E-mail: l.mynheer@oxin.co.uk
Web site: www.diagnox.co.uk


EmPath BEP
(Regional healthcare and biomedical)

Dr Clare O’Neill
Tel: 0116 252 3333
E-mail: cmo4@le.ac.uk


EnVision BEP
(Environmental biotechnology)

Peter Ainsworth
Tel: 020 7594 6563
E-mail: p.ainsworth@ic.ac.uk
Web site: www.eett.co.uk

 
Mercia Biotech BEP

(Regional healthcare and biomedical)
Dr Ederyn Williams
Tel: 0247 632 3315
or
Dr Shum Prakash
Tel: 0247 632 3324
E-mail: ventures@warwick.ac.uk or s.prakash@warwick.ac.uk


STEP 2000 BEP
(Biomedical, diagnostics, gene therapy, medical devices, pharmaceuticals)

Dr Sharron Bennett
Tel: 020 7848 3325
E-mail: sharron.bennett@kcl.ac.uk
Web site: www.step2000bio.co.uk


TrusTECH BEP (incorporating manIP BEP)
(Biological instrumentation and healthcare, biomaterials, diagnostics, gene tissue, medical devices, pharmaceuticals)

Dr Richard Deed
Tel: 0161 276 5763
E-mail: RichardDeed@trustech.org.uk
Web site: www.trustech.org.uk


UK MicroBEP & UK Plant Science BEP
(Microbial and plant biotechnology)

Dr Jan Chojecki
Tel: 01603 456500
E-mail: ajsc@pbltechnology.com
Web site: www.pbltechnology.com


Ventures for Health
(Regional healthcare)

Dr Mark Fisher
Tel: 020 7351 8739
E-mail: m.fisher@rbh.nthames.nhs.uk


WessexBio BEP
(Regional healthcare and biomedical)

Dr Elizabeth Fletcher
Tel: 02380 593 095
E-mail: e.j.fletcher@soton.ac.uk
Web site: www.wessexbio.com


Western Arc BEP
(Biomedical, pharmaceutical, biological processes, environment)

Dr Wendy Ross
Tel: 029 2087 4673
E-mail: rossw@cardiff.ac.uk
Web site: www.western-arc.org


White Rose BEP
(Healthcare, environment, plant science)

Simon Donoghue
Tel: 01904 435353
E-mail: cw21@york.ac.uk
Web site: www.whiterose.ac.uk

Yorkshire BioEnterprise BEP
(Diagnostic and analytical technologies, biomedical, biomaterials processing, food and agriculture, environment)

Dr David Parkinson
Tel: 0114 225 3052
E-mail: D.Parkinson@shu.ac.uk
 

Genome Valley
The economic potential and strategic importance of biotechnology in the UK.

LINK Scheme

The LINK scheme is the Government's principal mechanism for promoting partnership in pre-competitive research between industry and the research base. It aims to stimulate innovation, wealth creation and improve the quality of life. The scheme offers an opportunity to engage with some of the best and most creative minds in the country, to tackle new scientific and technological challenges so that industry can go on to develop innovative and commercially successful products, processes and services. LINK covers a wide range of technology and product areas from food and bio-sciences, through engineering to electronics and communications. Current biotech programmes are:

Sustainable Technologies Initiative LINK Programme - The overall aim of the programme is to support the development of new, more sustainable technologies to help UK business meet the sustainability challenge.  

Health Technology Devices Programme - This programme aims to stimulate and promote collaborative research aimed at the development of advanced technologies with potential, ultimately, to lead on to the development of new medical devices and healthcare technologies that are capable of exploitation by the healthcare industries yielding improved benefit to patients and a more robust UK medical devices sector.  

Bioremediation – The main aim of this programme is to help provide UK industry with the multidiscipliary capability necessary to enable the commercial application of bioscience for the clean-up of contaminated land, air and water.  

Applied Genomics - The main goal of this new LINK programme is to support the development of platform technologies that will enable UK healthcare companies to harness and exploit the output of genome sequencing projects and developments in genomics.  

Genetic and Environmental Interactions in Health - This LINK programme aims to develop collaborations between academia and industry in genetics, molecular/genetic epidemiology, pharmacogenetics and complementary disciplines and technologies.

 

Research Councils UK

Research Councils UK (RCUK) is a strategic partnership set up to champion science, engineering and technology supported by the seven UK Research Councils. Through RCUK, the Research Councils are working together to create a common framework for research, training and knowledge transfer. In doing this RCUK will work alongside OST to further support for the UK’s best academic researchers and deliver the best investment for society. 

Biotechnology and Biological Sciences Research Council (BBSRC)
The Biotechnology and Biological Sciences Research Council (BBSRC) is the leading funding agency for academic research and training in the biosciences at universities and institutes throughout the UK.

Engineering & Physical Sciences Research Council (ESRC) 

The Engineering and Physical Sciences Research Council (EPSRC) is the UK Government’s leading funding agency for research and training in engineering and the physical sciences.

They invest more than £400 million a year in world-class research that forms the basis for future economic development in the UK and leads to improvements in everyone’s health, personal well-being and lifestyle. EPSRC also actively promotes public awareness of science and engineering.

 

Medical Research Council (MRC)

The UK Medical Research Council (MRC) promotes research into all areas of medical and related science with the aims of improving the health and quality of life of the UK public and contributing to the wealth of the nation.

 

Natural Environment Council (NERC)

The Natural Environment Research Council (NERC) provides independent research and training in the environmental sciences. Their mission is to gather and apply knowledge, improve understanding and predict the behaviour of the natural environment and its resources.

REGIONAL INTIATIVES

Detailed below are regional schemes and initiatives in the Biotechnology sector:

Bioscience Yorkshire
Tel: 01904 435 104
Fax: 01904 435 135

Bioscience Yorkshire is the fast growing bioscience cluster being developed by Yorkshire Forward, the regional development agency for Yorkshire & Humber, in conjunction with its partners across the region. The bioscience community here employs over 10,000 people, and this is predicted to grow by over 10% in the next five years. A significant proportion of this growth is predicted to be associated with small, entrepreneurial drug discovery & development companies and CROs (contract research organisations).

Significant strengths of the bioscience cluster include Plant Biotech; Tissue Engineering; Genomics; Contract Research; Bio-remediation; Bioinformatics and; Drug Discovery

For further information on our cluster strategy and how it may benefit your company, as well as links to centres of excellence and all of our sub-regional partners,including companies, please visit www.bioscience-yorkshire.com

Eastern Region Biotechnology Initiative (ERBI)
Tel: 01223 421 977
Fax: 01223 421 978

ERBI has been established to promote links between companies of all sizes involved in biotechnology in the East of England and to strengthen their links with the first class science base in the region. It will also build up the capabilities of new and embryonic firms.

New and emerging bioscience start-ups, suppliers and contractors are the intended target groups for the initiative, but the aim is also to involve and engage larger established firms as well as key service providers in financial, legal and management areas.

Oxfordshire BioScience Network 
Tel: 01865 483 449
Fax: 01865 484 478

The Oxfordshire Bioscience Network is a unique public-private partnership, managed by Oxford Brookes University, promoting biotechnology business and research enterprise across Oxfordshire.

The Network provides a range of services to facilitate networking and communication, providing a gateway service that partners industry, academia, and research service providers to ensure continued sector growth and sustainability.

Southern Bioscience (website: www.southern-bioscience.org.uk)
Tel: 01483 713 342
Fax: 01483 771 507

Southern Bioscience is a networking group for the Biotech sector based in the South of England. It represents a broad range of organisations within the Biotechnology sector whose focus is on high technology, science based products in the areas of pharmaceuticals, diagnostics, instrumentation, environmental, agriculture and food biotechnology.

 

Bionow

Tel: 01925 400 100

Fax: 01925 400 400

 

Bionow has been established to encourage and nurture this growth through creating an active, progressive community based on the region's academic success and strong presence of international pharmaceutical and biotech companies and supporting service companies.

London Biotechnology Network 

Tel:020 7665 1405

Fax: 020 7665 1501

 

The London Biotechnology Network is a regional support organisation, supported by London's science and business community through London First It was formed in response to the need for a co-ordinated approach to bioscience development in London.

It is the largest regional biotechnology organisation in the UK with some 550-member organisations. London's biotechnology sector is largely derived from the enormous amount of research activity centred around the large concentration of medical schools, teaching hospitals and medical research organisations. London is indisputably the financial capital of Europe and access to funding is a major attraction for biotechnology companies.

Biotechnology in the North West

Manchester Innovation Ltd (MIL)

Tel:    0161 606 7200

Fax:    0161 606 7300

e-mail : jan.hilton@maninv.com

 

MIL has offices in and manages its own purpose-built biotechnology incubator building.  Located in the heart of the growing biomedical corridor, the Manchester Incubator Building is viewed as a major component of the growing biotechnology cluster in the North West.  The Manchester Incubator Building, with 16 turnkey laboratories and full supporting infrastructure, is ideal for University spin-outs, external start-ups, and satellite units from pharmaceutical and healthcare companies.

Specialist staff in MIL have relevant commercial experience in marketing, licensing, patenting and finance. 

MIL also manages the Genetics Innovation Network (GIN): a HEIF funded project, and the 3Bs Project (Building Biotech Businesses) :  a BMI Challenge project.

MIL is wholly owned by the University of Manchester and aims to commercialise the outputs of research from all departments of The University.  

Back to Top Specific Export Help for the Biotechnology and Pharmaceuticals Sector

UK Trade & Investment UK
UK Trade & Investment is the Government Organisation that brings together the work of the Foreign & Commonwealth Office (FCO) and the Department of Trade & Industry (DTI) in support of British trade and investment overseas.

Sector specific export help for Biotechnology and Pharmaceutical industries can be found on the Trade Partners UK website.

Back to Top Other Sector Contacts

Listed below is a selection of organisations that can offer assistance to companies in this sector.
A more extensive list of Trade Associations in this sector can be found at the Trade Association Forum web site.

Association of the British Pharmaceutical Industry (ABPI)
Tel: 020 7930 3477
Fax: 020 7747 1416

BioIndustry Association (BIA)
Tel: 020 7565 7190
Fax: 020 7565 7191

British In Vitro Diagnostics Association (BIVDA)
Tel: 020 7957 4633
Fax: 0171 957 4644
E-mail: bivda@compuserve.com

Cranfield Biotechnology Centre
Tel: 01234 754339
Fax: 01234 752401

The National Pharmaceutical Association (NPA)
Tel: 01727 832161
Fax: 01727 840858

National Prescribing Centre
Tel: 0151 794 8134
Fax: 0151 794 8139 / 8144

PharMed
Tel: 01527 592880
Fax: 01527 592881

Royal Pharmaceutical Society
Tel: 020 7735 9141
Fax: 020 7735 7629
e-mail: enquiries@rpsgb.org.uk

Back to TopGeneral Business Support, Schemes and Initiatives

DTI Business Support
This page lists many of the initiatives that the DTI and other parts of Government currently operate. Included on this page are links with various support schemes and initiatives.

DTI Information Age
This page lists many of the initiatives that the DTI and other parts of Government currently operate. Included on this page are links with schemes and initiatives offering guidance and advice relating to new technology and fast access to information.

DTI International Trade and Investment
This page offers a comprehensive menu of links to sites offering support to exporters (through UK Trade & Investment), investors in the UK and importers into the UK.

Companies House
From this site, you can link to a wide range of Government sites and Professional Bodies that can provide general guidance and support for all UK companies.

The Trade Association Forum
The Trade Association Forum helps associations to deliver best practice to members.

Small Business Service
The Small Business Service operate a number of schemes and initiatives that are designed to help small businesses in a variety of ways. Further information found on their website.


Back to Top Regulatory Guidance

The UK Biotechnology Regulatory Atlas is modelled on the regulatory architecture of biotechnology, and, in addition to signposting laws and official guidance, provides explanations and commentaries.

The BioIndustry Association (BIA) website, created by the Regulatory Affairs Advisory Group, provides basic and general guidance for biotechnology companies who are members of the BIA.

DTI Regulatory Guidance provides general guidance from the DTI and also links to other relevant DTI web pages.

The Direct Access Government website provides guidance issued by other Government Departments.

 
 
Government sites:

Biotechnology Innovation and Growth Team

i-bio

Provides an easy way to access a wide range of information on UK biotechnology. Whatever you're looking for, this government-led site provides a rapid and comprehensive breakdown of relevant material and where to find it.

UK Biotechnology Regulatory Atlas

The UK Biotechnology Regulatory Atlas is a rapid retrieval system, which complements i-bio - it has been modeled on the regulatory architecture of biotechnology, to signpost laws and official guidance, providing explanations and commentaries, which are regularly updated.

Biolinks+

A micro site connected to i-bio providing a list of UK biotechnology websites partnering with the i-bio portal as well as others of interest.
Non-Government sites:
DTI is not responsible for the content of external sites.

The BioIndustry Association (BIA)

The Association of the British Pharmaceutical Industry (ABPI)

The British In Vitro Diagnostics Association (BIVDA)