Laura has been in the Regulatory Science field for the past 10 years building up broad experience as CMC regulatory affairs professional while working at the FDA and in the private sector (corporate and biotech). She has experience leading and implementing the CMC strategy during product life cycle, mainly biologics, and including gene and cell therapies. Additional regulatory experience includes strategic support for analytical bioassay development and immunogenicity risk assessment for biologics. She has been invited to speak on this topic in multiple occasions and has co-authored position papers on the impact of product quality in the immune response to biotherapeutics.

Laura holds over fourteen years of experience as an Immunologist with extensive knowledge of human immunology (autoimmunity, inflammation, immune-oncology, and infectious diseases) applied to the evaluation and selection of biomarkers to fast-track clinical development into proof-of concept (POC).

 

Laura currently works as Director of CMC Regulatory Affairs with Ziopharm Oncology where she leads the CMC regulatory strategy for gene and cell therapies aimed to treat cancer.