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Forsite Diagnostic

Forsite Diagnostic

Achievement of sustained economic success in Europe‘s biotechnological environment


Roberto Nibali

October 19, 2012


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

    Cámara, R. Nibali Barcelona, December 14th 2009 MESI 2009/2010
  2. OVERVIEW  History of Forsite Diagnostics  Technological Aspects and

    Product Presentation  Economic Outlines
  3. 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.

    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
  5. 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
  6. 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
  7. 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
  8. 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.

  10. 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.
  11. 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%)
  12. POCKET DIAGNOSTIC™ FUNCTIONALITY & APPLICATION Fungi, bacteria & virus causing

    disease in:
  13. 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
  14. 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)
  15. 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

  17. RESEARCH VALORISATION THROUGH SPIN-OUT VENTURES Definition of “spin-out”: http://ideas.repec.org/p/ant/wpaper/2007008.html

  18. 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
  19. 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.
  20. 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).
  21. 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.
  22. THANK YOU Biodot RR4500 reel to reel sprayer Foil packaging

    of finished LFD cassettes