Malvern, Pennsylvania, United States
Seasoned Clinical Pharmacology leader with 20 years of experience in early development, clinical pharmacology, and translational medicine in pharmaceutical/biotech. Experienced in the development of small molecules and biologics (antibody, peptides, and vaccines) in CNS, Immunology, Oncology, Cardiovascular/Metabolic disease areas. Successful BLA and NDA submissions with health authorities including US, Canada, EU, and Asia Pacific region.
Managed Clinical Pharmacology and Bioanalytical functions and provided clinical pharmacology development strategy for oncology assets. Led the successful US NDA submissions and approval of AUGTYRO™ (repotrectinib).
Developed clinical pharmacology strategy for the oncology and hepatitis B portfolios including HQP1351 (a third generation TKI), APG-2575 (a BCL-2 inhibitor), APG-115 (a MDM2 antagonist), APG-1252 (a BCL-2/BCL-xL dual inhibitor), APG-1387 (an IAP inhibitor), and APG-2449 (a FAK/ALK/ROS1 inhibitor) Successfully submitted the first company NDA for Olverembatinib (HQP1351) and gained approval in China