Xinyuan (Susie) Zhang, Ph.D.
Vice President, Regulatory Strategies
Physiologically Based Pharmacokinetics (PBPK) Solutions

About Xinyuan (Susie)
Xinyuan (Susie) Zhang brings extensive expertise in regulatory science and pharmaceutical development, having held roles in both the pharmaceutical industry and the FDA. During her time at the FDA, she was recognized as an agency-wide expert in physiologically based pharmacokinetic (PBPK) modeling and model-informed drug development, pioneering the application of PBPK modeling and simulation for Quality by Design.

Her knowledge spans biopharmaceutics, clinical pharmacology (CP), pharmacokinetics (PK), pharmacodynamics (PD), drug-drug interaction (DDI), ADME (absorption, distribution, metabolism, and excretion), and modeling and simulation, with approximately 70 publications.

At Daiichi Sankyo, Susie supported numerous programs across diverse modalities. While at the FDA’s Office of Clinical Pharmacology, she reviewed numerous INDs, NDAs, and BLAs across various therapeutic areas. She also contributed to the development of multiple guidances for both innovative and generic drug industries.

Susie holds a Ph.D. in Pharmaceutical Sciences from the University of Michigan, Ann Arbor.