Responding to an increase in demand for its expert regulatory services, leading pharmaceutical and biotech product development consultancy Boyds has made two key hires to its Regulatory Affairs team.
Dr Victoria Marsh joins the company as Director of Regulatory Affairs and Dr Kim Champion as Regulatory Affairs Manager.
A specialist in molecular biology and protein biochemistry, Victoria has extensive regulatory experience across the full clinical product lifecycle from Phase 1 clinical trials through to licence maintenance for marketed products. She has worked with and for companies developing new chemical entities, biotechnology, gene therapy and orphan medicinal products, worked as part of the Human Genome Project at the Sanger Centre and in 2005 obtained a PhD in Biochemistry from Cambridge University.
As Director of Regulatory Affairs at Boyds, she will provide regulatory advice and support to Boyds’ clients throughout the full product lifecycle and across a range of therapeutic areas for biological and new chemical entities.
Prior to joining Boyds, Victoria spent nine years working at MedImunne Limited / AstraZeneca, where she led a number of international projects. She was the global regulatory lead for a late stage MEK inhibitor for the orphan indication neurofibromatosis type 1 and early phase CD40 agonist and plasmid DNA vaccines, European regulatory lead for an irreversible EGFR-TKI in advanced NSCLC, and numerous products within Respiratory, Inflammation and Autoimmune disease areas.
Commenting on joining Boyds, Victoria says: “Boyds has a highly respected team and I am looking forward to supporting its development of drug products for the benefit of patients. The nature of Boyds’ work gives me the opportunity to support the development of unique biological products and advanced therapy medicinal products across a range of therapeutic areas.
Boyds’ new Regulatory Affairs Manager Kim Champion also brings extensive experience in the clinical operations sphere to Boyds. She joins from Cancer Research UK & UCL Cancer Trials Centre where, as Trial Group Lead for ATMP trials, she established UCL's first trials team specialising solely in gene and cell therapies.
Her other roles include Regulatory Manager in the Joint Research office at UCL where she was responsible for ATMP trials and worked in collaboration with companies such as Autolus and bluebird bio. She has also worked for the European Society for Blood and Marrow Transplantation (EBMT), progressing from Trial Coordinator to Acting Director for Clinical Trials Operations and establishing the clinical trials team. She also oversaw a portfolio of European Phase 2-3 trials in cancer, haematological, neurological and autoimmune disorders.
At Boyds, Kim will be responsible for the preparation of documentation and provision of operational support to sponsors in all stages of drug development, as she explains: “Having spent ten years working exclusively in Phase 1 & 2 clinical trials with ATMPs, I am experienced in successfully setting up and managing clinical trials in accordance with current legal and regulatory requirements, and hope to bring this expertise with me to the role.”
Professor Alan Boyd, President and CEO of Boyds, adds: “As demand for our regulatory services continues to rise, we are thrilled to welcome Victoria and Kim to the Regulatory Affairs team here at Boyds. We are confident that their specialist knowledge will complement that of the team and add value to our service offering for clients.”
V Formation Ltd