Natalie Ward

Dr. Natalie Ward is currently an Associate Director within the Gene Therapy Regulatory CMC team at BioMarin. Here, she is the CMC regulatory lead on a number of early-stage AAV based products developing CMC and global regulatory strategy plans and ensuring that the development programs (manufacturing and analytical) are fit for purpose and meet quality and regulatory requirements. Natalie has 15 years’ experience in development of advanced therapy medicinal products (ATMPs) with R&D experience gained during her PhD and postdoctoral posts, and CMC development experience at GSK where she worked on the late-stage development of autologous ex vivo gene therapy products, including Strimvelis which was the first ex vivo stem cell gene therapy product to gain marketing authorization in Europe in 2016. Prior to joining BioMarin Natalie worked at the UK Cell and Gene Therapy Catapult within the Regulatory Affairs team where she supported the development of a wide variety of novel ATMPs, the majority in early development with SMEs or academic groups. Natalie’s current interests include understanding the CMC challenges experienced for ATMPs and other complex products and how these can be mitigated.