Tu-Anh, with over 15 years of invaluable experience, has been a driving force in the biopharmaceutical sector. Her expertise lies in leading and shaping technical CMC (Chemistry, Manufacturing and Controls) strategies for a diverse portfolio of products including vaccines, antibodies and ADCs (antibody-drug conjugates). These endeavors span across oncology and immunology indications.
Tu-Anh has successfully navigated projects from the initial stages of target identification to first in human trials. Her attention to regulatory and quality compliance has been instrumental in achieving these milestones. Her proficiency also extends to late-stage development, encompassing critical areas such as scale-up, formulation development, device development, technology transfer and validation. These facets were pivotal for enabling Phase 3 trials and securing commercial approval and launch of products. Tu-Anh has directly contributed to successful global regulatory filings, including INDs, IMPDs, BLAs and MAAs. In her last role as Senior Director of CMC and Technical Operations at Chinook Therapeutics (acquired by Novartis), she was crucial in advancing an antibody product (aimed at addressing renal disease) from early to late-stage development.
With a Bachelor’s degree in Biology from Mary Baldwin College in Virginia, USA, Tu-Anh not only brings knowledge but also a passion for excellence to the teams and organizations she collaborates with. Her ability to seamlessly transition from strategic planning to execution underscores her commitment to achieving successful outcomes.