Princeton, New Jersey, United States
30+ years of global experience of practicing medicine, conducting clinical research in the academic healthcare setting, and developing new drugs with successful tracking records of multiple New Drug Applications (NDAs) approvals globally (including US, EU, Japan) in Oncology, Cardiovascular diseases, and Neuroscience therapeutic areas 20+ years of experience in product safety surveillance, including 15+ years as global medical safety management team leaders in clinical safety monitoring and post-marketing risk management Key expertise includes: • Organization of a cross-functional clinical safety management team • Medical safety monitoring of early clinical trials (e.g., First-in-Human clinical trials) • Signal detention and management on accumulated preclinical, clinical, literature, and data-mining findings • Safety data assessment strategy for periodic safety update reports (e.g., DSUR, PBRER, PSUR) • Product risk profile development and management plan in supporting global NDA or BLA application • Early post-marketing benefit-risk assessment, company core safety information/product labels maintenance, and risk communication with global health authorities (e.g., FDA, EMA, PMDA, NMPA) • PV audits and inspection readiness, team building, and safety data exchange agreement (SDEA)
Therapeutic Areas: Oncology/hematology, Neuroscience, Others (Lung Transplant, Covid-19) Project experience highlights: (1) US NDA approval: Led a safety team to support a US NDA for amyotrophic lateral sclerosis (ALS), with successful approval based on only Japanese patients' data. (2) Therapeutic biologics (bispecific antibodies) clinical development: Led the design/team review of the safety-related protocol design (study objectives/measurements/starting dose/step-up dose/safety review committee/incl. & excl. criteria/AESIs), medical monitoring, and safety monitoring activities, for two First-in-Human (FIH) trials (HER2/CD3 bispecifics for solid tumors and CD20/CD3 bispecifics for lymphomas); (3) Biosimilars BLA support: Provided expert guidance on the development of the RMP/safety risk sections of the product label based on key safety findings from Phase 3 trial and safety data summary (CSR/ISSs/SCS); (4) Safety-related reports development: Reviewed and summarized the accumulating safety data to prepare the Development Safety Update Reports (DSURs) with support of the timely updates of the Investigator Brochure (IB)/Reference Safety Information (RSI) and/or protocol/ICF updates as applicable; (5) US new drug IND application support: As clinical safety lead for 4 US IND applications, including two in Oncology/hematology (ongoing), one in lung transplant (completed), and one in COVID-19 (completed), and two of them with US FDA pre-IND meetings/communication experiences. (6) US new drug First-in-Human (FIH) trial support: As clinical safety lead supporting 2 FIH trials: one in adult subjects undergoing abdominoplasty (completed), one in COVID-19 (initiating). (7) Global PV team building: Supported/guided a Japanese client to successfully establish a global safety data evaluation center in the US, including a fully functioning PV team and regulatory compliance quality standard and training system and procedures.
Therapeutic Areas: Oncology/hematology, Cardiovascular diseases, Infectious diseases Experience highlights: (1) Clinical safety management team leader: Chaired and managed a global medical safety team, with experience of a successful US FDA accelerated approval (end of phase 2) and full approvals (after completion of phase 3 trials) worldwide ( including US, EU, JP, and other 50+ countries) for a new targeted cancer drug for CML, and experience in development of multiple new indications programs. (2) Post-marketing matured products global safety lead: As product global safety lead was responsible for multiple matured Oncology products including paclitaxel, carboplatin, cisplatin, etoposide, cyclophosphamide, and others. (3) Company product labeling committee PV SME: Supported the Company's labeling committee for maintenance/updates of company core data sheet (CCDS)/local labels and developed strategic risk communication with health authorities. (4) Professional awards: President Award for leading a PV team to support a global discontinuation /withdrawal of an early marketing anti-infectious drug involving many countries and regions worldwide. Other awards include outstanding medical surveillance team leadership, product risk management, and medical safety assessment for product recall.