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Forsite Diagnostic

Forsite Diagnostic

Achievement of sustained economic success in Europe‘s biotechnological environment

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Roberto Nibali

October 19, 2012
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  1. FORSITE DIAGNOSTIC Biotechnology: Seminar Presentation P. Garnero, L. Landinez, C.

    Cámara, R. Nibali Barcelona, December 14th 2009 MESI 2009/2010
  2. A TALE FROM RESEARCH TO REVENUE The information in the

    following presentation has been extracted from the webpage of Forsite, affiliated companies and a presentation given by CEO Chris Danks. Pending approvement.
  3. FOOD AND ENVIRONMENT RESEARCH AGENCY (FERA)  Ownership model: Part

    of DEFRA (Net Running Cost Agency) operated on efficient business lines within the public sector.  Role: Science support for evidence-based policies, implementation of regulations and provision of contingency capacity.  Outlook: National laboratory: collaborating with equivalent laboratories globally; forming alliances to strengthen competitive position.  Capabilities: Multi-disciplinary science base, world-class facilities and professional administration teams. Objective
  4. FERA DIAGNOSTICS DEVELOPMENTS  Novel rapid nucleic acid purification and

    storage technology – patent application  Extensive expertise and know-how in the area of lab- based PCR analysis services, plus out-licensing arrangement  Bacteriophage-based methods of bacterial detection – extensive patent coverage, licensed to diagnostics company  Extensive expertise and know-how in the area of design and use of microarrays for diagnostic purposes  Lateral Flow Devices
  5. FERA LEADING TO FORSITE  1996 The initial research 

    2000 Launch of Pocket Diagnostic Brand  2001 Winner of Westminster Medal  2002 Separate business unit  2004 Winner of Venture fest York  2006 Commercial spin-out from FERA leading to Forsite Diagnostics Ltd
  6. FORSITE‘S PROFILE  Spin-out from FERA in January 2007, with

    private sector investment.  Active in plant health, animal health, food safety and human “well-being”.  Focused entirely on contract development and manufacture of lateral flow tests.  Parent company is Safeguard Biosystems, which has interests in veterinary diagnostics.  FERA retains 24% equity, 10% for transferring staff, Safeguard Biosystems remaining 66% majority. http://www.forsitediagnostics.com
  7. FORSITE‘S PORTFOLIO Products  Pocket Diagnostic  Antibodies Services 

    Contract Manufacturing of lateral flow devices (LFD) in a wide range of industry sectors.  Part-processing or full- scale manufacture of housed or dipstick rapid assays.
  8. POCKET DIAGNOSTIC™  Test kit contains :  The test

    device – carrying the antibodies and other reaction ingredients  The extraction bottle and buffer – breaking up the plant material in extraction buffer  The pipette – for adding 2-3 drops of sample to the test device  Pocket Diagnostic is a product for on-site plant disease testing using a combination of LFD and DNA analysis.
  9. POCKET DIAGNOSTIC™ CHARACTERISTICS Limitations  Analysis is not quantitative. 

    Species-specific analysis.  Sensitive to high levels of contaminants  Foliage and 'soft' samples. Advantages  Collecting a sample, extracting the pathogen and running the test will take under 10 minutes in total  Cost-effective identification of several species  Once the LFD test has been run, the bound sample is stable.  Validation of the technique has been carried out alongside conventional laboratory methods (97%)
  10. POCKET DIAGNOSTIC™ TECHNOLOGY An ultra-sensitive molecular detection method known as

    real-time PCR is used to confirm the identity of the target pathogen on the LFD The monoclonal antibody at the core of the LFD recognizes a mycelial protein found in the pathogen
  11. ANTIBODIES  Antibodies:  proteins found in bodily fluids, used

    by the immune system to identify and neutralize foreign objects such as viruses and bacteria  Antigen (antibody generator):  any molecule that binds specifically to an antibody  Monoclonal antibodies:  antibodies produced from cloned immune cells from a single parent cell (thus identical)
  12. USES OF ANTIBODIES  To identify or purify a substance

    (the antigen)  Can create monoclonal antibodies that bind to almost any substance  Uses  Diagnostic tests  identify a substance  Cancer treatment  immunological response  Chimerical and humanized antibodies  incompatibilities: half mice, half human  Fully human monoclonal antibodies  in vitro or with genetically modified mice
  13. MARKET PENETRATION Pocket Diagnostic Sales (pre-Forsite) Growth of market shares

    and sales income (in k£) 0 1'000 2'000 3'000 4'000 5'000 2006 2007 2008 2009 Contract Services Animal Health Food Safety & Quality Plant Health 0 20'000 40'000 60'000 80'000 100'000 120'000 2002/03 2003/04 2004/05 2005/06 LFDs Distributor Sales Direct Sales
  14. FORSITE‘S INNOVATION  Product Innovation: Combine known technologies and transfered

    patented IP into small LFD to revolutionize on-site in-field diagnostics of plant deseases (5 minutes versus 1 week).  Process Innovation: ISO 9001 sustained Contract Manufacturing of industral-ready assays (OEM products out of antibodies and LFDs) as a service.  Open Innovation: active strategic utilisation of the outside world (customer integration and coupled processes in contract manufacturing) leads to growth of own innovation potential.
  15. THRIVING INNOVATION ECOSYSTEM FACTORS  Government through research laboratories generate

    ideal incubator of ideas and environment to nurture business strategies.  FERA complex in York creates an ongoing source of collaboration and information on technical advances practically in-house.  Lay bricks beneficial to embrace networking opportunities.  Provide just-in-time access to facilities, technology and expertise (temporal and spatial distance between industry and research).
  16. CHALLENGES & OPPORTUNITIES  Creating a spin-out (versus start-ups as

    business models in biotechnology).  Search for funding (FP7 program, diminishing financial risks).  Protection of IP in environments of potentially conflicting interests (shareholders’ perspective of FERA and Safeguard Biosystems).  Managing emerging risks of moral hazards in current constellation with regard to success (IP participation and renumeration for employees).  Opportunity-driven niche-market identification by strategically expanding research horizon using tacit knowledge.  Use of LFD to support governmental policies for eradication and containment of Phytophthora in the UK.