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Activity Number: 644 - Statistical Methods for the Co-Development of Drug and Companion Diagnostic in Oncology
Type: Topic Contributed
Date/Time: Thursday, August 1, 2019 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #305286
Title: Drug-Device Co-Development in the Era of Precision Medicine: Industry Perspectives on Statistical Challenges
Author(s): Shunguang Wang*
Companies: Novartis Institutes for BioMedical Research Inc.
Keywords: Precision medicine; Drug-device co-development

Precision medicine promises to deliver to the right patient the right drug at the right dose at the right time via the right route. To this end, it finds that companion diagnostics are essential for the safe and effective use of the corresponding therapeutics, which calls for contemporaneous drug-device co-development. Drug-device programs pose unique statistical challenges beyond traditional drug development or device development alone. Designing the drug trial needs to consider important issues such as the performance of the corresponding device and when the device becomes available for patient enrollment. This presentation discusses the statistical challenges in drug-device co-development programs. It also highlights recent advances in statistical innovations addressing these challenges.

Authors who are presenting talks have a * after their name.

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