Therese Choquette

Scientist with PhD in Rheumatology, MS in Biomedicine, and background as a licensed practical nurse working with T cell-based cell therapies since 2014. Passionate about providing high quality cell and gene therapy to patients, and translational analyses combining CMC and clinical data (patient-to-product-to-patient for autologous products) to understand manufacturability, clinical efficacy, and adverse events. Experience in all stages of clinical studies from early development up to commercial phase, biotech and pharma, analytical development and QC labs. Participated in successful IND and BLA submissions, working closely with Regulatory CMC authoring sections and responding to questions from HA. Enjoying scientific writing and presentations, speaking at conferences on a regular basis. Long term experience in managing teams and projects and working in matrix environments, appreciates a collaborative environment. Skilled in immunology, immuno assays, assay development, qualifications/validations, GxP, analytical CMC, stability and comparability studies, quality control, ICH/FDA/EMA guidelines, US and EU Pharmacopeia.