Marie Koren-Gluzer

Associated Director, Cell Therapy Bioanalytical Lead @AstraZeneca

South San Francisco, CA, US

Bioanalytical lead in the integrated Bioanalysis team to support AZ cell therapy portfolio. • Direct and provide comprehensive oversight of bioanalytical strategies supporting AZ’s CAR-T cell therapy portfolio encompassing multiple programs at both pre-clinical and clinical development stages • Establishing and leading the cell therapy bioanalytical teams globally, fostering its growth through recruitment, hiring and mentoring • Supervising the bioanalytical endeavors of 14 scientists engaged in developing, validating and implementing innovative bioanalytical assays and emerging modalities • Spearheading the development, validation, and integration of key methods for evaluating safety, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity across AZ’s cell therapy pipeline products • Identifying intricate challenges such as raw data quality, results consistency and appropriateness of study design/approach/technology and devising innovative and viable solutions and propose creative and workable solutions. • Crafting Standard Operating Procedure (SOPs), guidelines and policies as well as composing and reviewing technical documents and regulatory submissions • Collaborate extensively with cross functional global teams (e.g. R&D, safety, clinical pharmacology, translational, clinical) to seamlessly integrate translational research into the overarching objectives of advancing the company’s pipeline products. • Proficiently communicating strategy, methodology, progress, and hurdules to stakeholders including senior leadership and the board of senior directors • Overseeing the seamless transfer of assays to Contract Research Organization (CROs) and managing sample analysis for Good Laboratory Practice (GLP) and clinical studies

Tel Aviv University

Bachelor of Science (B.Sc.), Biology/Biological Sciences, General

Tel Aviv University

Master of Science (M.S.), Genetics

Technion - Israel Institute of Technology

Doctor of Philosophy (Ph.D.), Immunology