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Session 2: Innovative Clinical Trial Designs in Precision Medicine
Session Chair(s)
Eric Slosberg, PhD
Senior Director, Translational Medicine
Novartis Oncology, United States
The hypercompetitive environment to gain approvals for new drugs (or new indications for already approved drugs) applies pressure onto a slow, cumbersome clinical trial system. This session will discuss novel ways to approach this. The development of new patient (molecular) profiling technologies and companion diagnostics, their incorporation into innovative clinical trial designs, and resultant clinical and regulatory issues and concerns will be addressed. Also the rapid disruption of the oncology landscape by immuno-oncology agents will be discussed.
Speaker(s)
NCI/Consortium Initiatives in Novel Clinical Trial Designs
James Doroshow, MD, FACP
National Cancer Institute, NIH, United States
Deputy Director
Diagnostic Tests Used Within a Drug Program: Overcoming the Challenges of Codevelopment
Christopher Leptak, MD, PhD
Greenleaf Health, Inc., United States
Executive Vice President, Drug and Biological Products
Leveraging Advanced Companion Diagnostics in Innovative Clinical Trial Designs: A Physician Perspective
Patricia LoRusso, DO
Smilow Cancer Center, Yale University, United States
Associate Center Director - Innovative Medicine
Companion Diagnostics for Immune Checkpoint Therapy
David L. Rimm, MD, PhD
Yale University, United States
Professor of Pathology & Medicine (Medical Oncology)
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