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- Oxford Clinical Trials Research Unit Research Group
OCTRU Head of Quality and Regulatory Affairs
Following on from my BSc. in Biochemistry/Immunology from King’s College London I was awarded a Wellcome Trust Scholarship at the Royal College of Surgeons London where I obtained a Ph.D. in the faculty of Medicine. My first postdoctoral training was at the Ferguson Laboratory at the University of Pittsburgh, USA where I assessed the safety and efficacy of novel vectors in pre-clinical studies leading to the world’s first Gene Therapy trial in Rheumatoid Arthritis. I followed this by a second postdoctoral position at University College London (UCL) focusing on the role of heat shock proteins in autoimmunity. I then moved on to King’s College Hospital to study the role of natural killer cells in their protection against cancer, and obtained a Leukaemia Research Fund Lectureship where I led a team to take forward the development of novel immune cellular products such as dendritic cells as potential potent anti-cancer vaccines. I played a major role in developing a suite to manufacture such vaccines to comply with EU GMP standards and test such vaccines in Phase I trials in a number of malignancies, including Acute Myeloid Leukaemia.
After 10 years of my own research at King’s and several successful publications, I took on the role of a Good Clinical Practice (GCP) Compliance Manager at the R&D office for Great Ormond Street Hospital and The Institute of Child Health where I directed and implemented the first programme of GCP compliance in Paediatric trials to meet the new Clinical Trials Directive. In February 2007, I spent 6 months at the European Medicines Agency working on procedures to implement the new EU Paediatric Regulation for medicines for children. In Sept 2007 I returned to UCL to the Joint R&D department of UCL and University College London Hospital as a senior monitor and senior pharmacovigilance co-ordinator and in Sept 2008 was promoted to Head of Clinical Trials. In June 2009, I moved to Oxford to the Oncology Clinical Trials Office (OCTO) as the Quality Assurance Manager and 2 years on took on the title of Head of Regulatory Affairs and Quality, to reflect the wider remit of the role. I hold a certificate of GCP from the Royal Pharmaceutical Society of the Royal College of Physicians, I am a full member of the British Association of Research Quality Assurance (BARQA) and ISO 9001 GCP Auditor (level 1). In October 2013, I joined OCTRU as the Head of Quality Assurance and Regulatory Affairs. I am passionate about clinical research and advancing new therapies and promoting Good Clinical Practice ensuring that clinical research in humans is conducted to the highest ethical standards.
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