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Joanna Black

BSc, PhD

OCTRU Head of Regulatory Affairs and Quality Assurance (HoRAQ)

Following on from my B.Sc. 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 publications including in the Journal of Immunology and PNAS, 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 Assurance, 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.   In October 2013, I joined OCTRU as the Head of Regulatory Affairs and Quality Assurance.    Our portfolio of trials includes CTIMPs, ATMPS, nonCTIMPS and Device Trials.   During the COVID pandemic we have been working on trials that look for potential treatments for COVID that have the potential to lessen the severity of the disease.  

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.