Dr. Zhang has 19+ years of leadership experience in clinical pharmacology, pharmacokinetics, and pharmacodynamics. Dr. Zhang provides expert consulting in all phases of development through approval and new indications for label enabling. These include clinical and clinical pharmacology plans and execution (protocols, reports, briefing documents, IND, NDA, BLA, MAAs, PIP, labels, etc.), clinical PK, PD, immunogenicity, and PK exposure-response analysis/modeling and interpretation, response to critical questions from regulatory agencies, and representation at regulatory meetings.
Dr. Zhang’s therapeutic area experience includes oncology, rare genetic diseases, neurology, rheumatology, infectious diseases, and inflammation. Dr. Zhang has worked on 62 clinical trials as clinical or clinical pharmacology lead: 21 clinical pharmacology studies (drug-drug interaction, thorough QT/QTc, special population [renal/hepatic impairment], mass balance, bioequivalence, and bioavailability); 23 Phase 1 studies for PK/PD/safety; 6 Phase 2 studies for POC and dose finding; 12 Phase 3 studies for registration; and 3 Phase 4 post-approval commitment studies. Dr. Zhang has worked on 2 NDAs, 5 BLAs, 5 sBLAs, 60+ NCA PK/PD analyses, 11 population PK modeling analyses, and 7 population PK/PD modeling analyses. She has authored or co-authored 70+ publications, 2 book chapters, and 5 patents.