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
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
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
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
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.
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.
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%)
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
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)
(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
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.
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).
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.
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