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Advancing Complex Innovative Clinical Trial Designs – Opportunities for Global Regulatory Convergence in Oncology
Session Chair(s)
Lucia D'Apote, DRSC, RAC
Executive Director Global Regulatory Policy
Amgen, Switzerland
This session will provide a platform for scientific exchange among the EMA, other global health authorities (FDA, PMDA), patient advocates, and drug development innovators on a range of Complex Innovative Trial Designs (CID) topics.
Learning Objective : • Foster discussions and education of the use and value of Complex Innovative Trial Designs (CID) within drug development programs • Understand learnings from FDA CID Pilot Meeting Program and experience of other Regulators
Speaker(s)
PDUFA VI Pilot Program: Primary Lessons Learned
Dionne Price, PHD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER
Considerations for Complex Innovative Designs: Case Examples in Oncology
May F Mo, MBA, MS
Amgen, United States
Executive Director, Biostatistics
Panelist
Anja Schiel, PHD
Norwegian Medical Products Agency (NOMA), Norway
Special Advisor, Lead Methodologist/Statistician; NOMA
Panelist
Christian Schneider, DrMed
PharmaLex, Denmark
Head of Biopharma Excellence and Chief Medical Officer (Biopharma)
Panelist
Frank Petavy, MS
European Medicines Agency, Netherlands
Head of Methodology