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Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines
Session Chair(s)
Nancy Linda Styple
Project Management Leader
Bayer AG, United States
Review principles of FDA's Project Optimus and discuss the impact on oncology clinical development strategies. Scenario analysis with risk management is needed to balance project cost, timelines, patient centricity and health equity approaches.
Learning Objective : Describe the essential points of FDA's Project Optimus Guidance and how it may impact drug development; Discuss how project managers and oncology development teams gain insight into options to consider in order to balance cost, timelines, and risk during dose finding/dose optimization in new molecular entities and new indications.
Speaker(s)
Patient Update
Julia Maues, MA
Patient-Centered Dosing Initiative, United States
Patient Advocate
Industry Update
Gary Wilkinson, PhD
Ryvu Therapeutics, Poland
Director of Clinical Pharmacology
Project Management Considerations for Project Optimus
Nancy Linda Styple
Bayer AG, United States
Project Management Leader
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