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    Sanj Raut, PhD

    Principal Scientist, Biologicals Assessor
    NIBSC-MHRA
    Potters Bar, United Kingdom

    Sanj Raut, PhD, Senior Principal Scientist, Head of Haemophilia Laboratory, Study Director - Haemophilia Therapeutics, at National Institute for Biological Standards and Control (NIBSC) - Medicines and Healthcare products Regulatory Agency (MHRA), UK.

    I am responsible for the development and upkeep of World Health Organization (WHO) International Standards and British, European & Pharmacopeial Standards for measurement of Haemostasis products/analytes, in particular for coagulation Factor VIII (FVIII), with a focus on standardisation of both recombinant and plasma derived FVIII concentrates. Other standardisation responsibilities include assays of fibrinogen, factor XIII, FVIII bypassing agents and neutralising antibodies (inhibitors) to FVIII. Established > 15 WHO International Standards and Secondary (European, Pharmacopeial, & National) Working Standards in the field of Haemostasis. As Project Leader, developed, calibrated and delivered > 20 Product Specific Reference Standards for Biological products, employing CMC measures.

    My laboratory performs Independent Batch Release Control (previously OCABR) Testing of high profile Biological therapeutic products (such as FVIII therapeutic concentrates) for both UK-GB and non-UK batch release and I'm a Qualified Signatory for UK/GB batch release certification.

    My research interests include the measurement, mechanisms of action and immunogenicity of current and novel haemostasis therapeutics (e.g. FVIII & FXIII, Fibrinogen), as well as haemophilia gene and cell therapy.

    I serve on a number national and international committees and advisory boards (e.g. JPAC-SACBC, ISTH), relating to medicine safety, immunogenicity and adverse events, international standardisation and the harmonisation of diagnostic tests and I am a registered Scientific Expert with a number external Stakeholders (e.g. WHO, EDQM, ISTH, EMEA).

    Presentation(s):