Janet Woodcock

Janet Woodcock served as FDA Commissioner and Director of the Center for Drug Evaluation and Research, shaping regulatory frameworks that accelerated cancer drug approvals through breakthrough therapy designation, accelerated approval based on surrogate endpoints, and adaptive clinical trial design acceptance. Her regulatory leadership has enabled faster access to effective cancer therapies while maintaining safety standards. She contributed to policies governing biomarker-driven oncology approvals and has influenced global regulatory alignment for cancer drug development. Woodcock's career-long contributions to regulatory science have profoundly shaped the modern oncology drug development landscape.