Richard Pazdur
理查德·帕兹杜尔
MD
Director, Oncology Center of Excellence肿瘤卓越中心主任
👥Biography 个人简介
Richard Pazdur has led FDA oncology drug review for over two decades, pioneering accelerated approval and breakthrough therapy designation pathways that transformed access to novel cancer therapies. He oversaw approval of hundreds of oncology drugs, reshaping the global regulatory landscape.
🧪Research Fields 研究领域
🎓Key Contributions 主要贡献
Accelerated Approval Pathway
Championed and operationalized FDA's accelerated approval program for oncology, enabling faster patient access to promising therapies based on surrogate endpoints while confirmatory trials continue.
Breakthrough Therapy Designation
Instrumental in implementing breakthrough therapy designation for oncology drugs, streamlining development and review of transformative treatments for serious cancers.
Oncology Drug Review Leadership
Oversaw FDA approval of more than 300 oncology drugs and indications, fundamentally advancing the regulatory science of cancer therapeutics.
Representative Works 代表性著作
Accelerated Approval of Cancer Drugs — Missing Pieces of the Puzzle
New England Journal of Medicine (2019)
Outlined the rationale, successes, and ongoing challenges of the accelerated approval pathway for oncology drugs.
The FDA and the Accelerated Approval of Cancer Therapies
Nature Reviews Clinical Oncology (2021)
Comprehensive review of FDA regulatory innovation in oncology including real-world evidence integration.
Progression-Free Survival: An Important End Point in Evaluating Therapy in Advanced Colorectal Carcinoma
Journal of Clinical Oncology (1992)
Early landmark paper influencing use of surrogate endpoints in oncology regulatory submissions.
🏆Awards & Recognition 奖项与荣誉
📄Data Sources 数据来源
Last updated: 2026-01-15 | All information from publicly available academic sources
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