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Success from Bench to Launch: Challenges and Opportunities with Development of Companion Diagnostics
Session Chair(s)
James Allen Wachholz, MBA
Vice President, Drug Development
ICON, United States
Experts from the field of companion diagnostics and targeted therapy will present their individual views on companion diagnostics development methdology, clinical trial designs, developing efficient and optimal integration of clinical trials and diagnostic use.
Learning Objective : Recognize the important goals in the companion drug and diagnostic development paradigm; Summarize and assess clinical utility by familiarity with patient disease and companion diagnostic decision making; Prepare for regulatory review and approval of the companion diagnostic; Describe practical clinical application by evaluating clinical trial design and test feasibility.
Speaker(s)
XALKORI Rx/Dx: Regulatory Innovation Along the Evolving Path to Precision Medicine
Erling Thor Donnelly, PhD
Pfizer Inc , United States
Team Leader, Dacomitinib and Palbociclib, Oncology
Regulatory Considerations for Companion Diagnostic Development
Elizabeth Mansfield, PhD
Foundation Medicine, United States
Vice President of Regulatory
Managing the Critical Factors for Successful Development of Companion Diagnostics
Terri Ozegovich, MBA
Astrazeneca, United States
Senior Director, Oncology Companion Diagnostics
注册方法
Registration override should work.