Sharon LonghurstHead of CMC at Immunicum
Sharon has 20 years’ experience of product and process development for biological products and ATMPs. Her experience encompasses 6 years in contract manufacture of gene therapy vectors for clinical studies, 6 years as a Quality Assessor at the MHRA, where she was a member of the GTWP and an active participate at the BWP, both working parties of the EMA at that time. A period of CMC/regulatory consulting at PAREXEL International followed before she moved back into industry; firstly in AKARI Therapeutics where she was responsible for all CMC related activities and CMC regulatory strategy for a recombinant protein, and for the past 2 years at IMMUNICUM AB as Head of CMC. Immunicum are developing a dendritic cell therapy for the treatment of solid tumours in combination with CPI/TKI, with an active process development program of work being performed in readiness for phase 3 clinical development and ultimately commercial supply.