药学前沿大讲堂652讲
From Discovery to NDA/BLA: How to de-risk new drug development with nonclinical strategy and regulatory thinking
报告人简介:
Senior Biopharmaceutical Executive and Board-Certified Toxicologist (DABT) with 25+ years of global leadership in nonclinical development, safety assessment, and regulatory strategy across small molecules, biologics, gene and cell therapies, and immunomodulatory drugs. Proven track record in leading multidisciplinary teams, managing departmental operations and budgets, and guiding programs from discovery through IND, NDA, and BLA approvals with FDA, EMA, PMDA, and OECD agencies. Recognized for strategic decision-making, mentoring scientific talent, and representing organizations in high-level negotiations with global health authorities. Adept at integrating complex safety data into development plans that accelerate timelines, mitigate risk, and support successful global product registrations.
