Associate Director, Regulatory Affairs
Kathryn joined the Regulatory Affairs team at Boyds in March 2018.
Kathryn is a biological science graduate with an MPhil in Microbiology/Immunology, and a PhD in Molecular Immunology/gene therapy. She started her career in anthrax vaccine research, development and GMP manufacture at the Centre for Applied Microbiology and Research (CAMR), UK. Kathryn then progressed to the Institute of Child Health and Great Ormond Street Hospital NHS Trust, UK where she worked for 12 years in the research, development, translation, manufacture and management of gene and cell-based Phase I/II clinical trials. During this time, Kathryn trained as a Clinical Scientist in Immunology/Gene therapy and was registered with the Health Profession Council in the UK.
In 2011, Kathryn moved to PPD and progressed to Senior Manager level where she was Regulatory Affairs Lead for numerous global Phase I-IV studies involving chemical, biological (including vaccines) and Advance Therapies Medicinal Products (ATMP). Indications include prostate and cervical cancer, rheumatoid arthritis, epilepsy and rare diseases such as GM2 gangliosidosis. As a Subject Matter Expert (SME) in gene therapy and Genetically Modified Organisms (GMO’s) products, Kathryn was a key member of the team providing early engagement and product development consultancy to sponsors developing ATMP and GMO products. Kathryn was an active and leading member of the PPD Advanced Therapies forum (AT-Forum) and is a member of the British Society for Cell and Gene Therapy (BSGCT). Kathryn has presented at the BSGCT conference on early stage development of GTMP and co-authored an article on Global regulatory challenges during early stage development of gene therapy medicinal products (GTMP), published in June edition of the Regulatory Rapporteur. Kathryn played a pivotal role in GTMP education internally at PPD and externally, recently presenting on GMO’s at University College London, Regulatory Science for Advanced (Gene and Cell) Therapy: Advanced Therapies – Bench to Medicine course.
Unit M, South Cambridge Business Park
Babraham Road, Sawston
CB22 3JH, UK
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