Vice President
Simulations Plus
Boyds, Maryland, United States
Xinyuan (Susie) Zhang, Ph.D. is Vice President of Regulatory Strategies at Simulations Plus, bringing deep expertise in regulatory science and pharmaceutical development. Her career spans both industry and regulatory sectors, including impactful roles within the pharmaceutical industry and at the U.S. Food and Drug Administration (FDA).
During her tenure at the FDA’s Office of Clinical Pharmacology, Dr. Zhang was recognized as an agency-wide expert in physiologically based pharmacokinetic (PBPK) modeling and model-informed drug development (MIDD). She pioneered the application of PBPK modeling and simulation in support of Quality by Design initiatives and contributed to the review of numerous INDs, NDAs, and BLAs across a wide range of therapeutic areas. In her prior role at Daiichi Sankyo, Dr. Zhang supported a variety of development programs across diverse therapeutic modalities.
Dr. Zhang’s expertise encompasses biopharmaceutics, clinical pharmacology (CP), pharmacokinetics (PK), pharmacodynamics (PD), drug-drug interactions (DDIs), and ADME (absorption, distribution, metabolism, and excretion), as well as modeling and simulation. She has authored or co-authored approximately 70 scientific publications and has played a key role in the development of regulatory guidances for both innovative and generic drug products.
She earned her Ph.D. in Pharmaceutical Sciences from the University of Michigan, Ann Arbor.
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