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Chapter 13 - Leveraging disruptive technologies to drive innovation in CNS clinical drug development

Published online by Cambridge University Press:  05 July 2012

By
Penny Randall ,
Judith Dunn  and
Amir Kalali
Edited by
Amir Kalali ,
Sheldon Preskorn ,
Joseph Kwentus  and
Stephen M. Stahl
Amir Kalali
Affiliation:
University of California, San Diego
Sheldon Preskorn
Affiliation:
University of Kansas School of Medicine
Joseph Kwentus
Affiliation:
University of Mississippi
Stephen M. Stahl
Affiliation:
University of California, San Diego
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Summary

This chapter reviews recent technological advancements that are currently being applied in clinical medicine, and explores how the pharmaceutical industry might integrate these technologies to drive innovation through the drug development process specifically for CNS drug development. The types of data that can now be captured by wireless sensors and remotely monitored are quite broad and include body temperature, blood pressure, respiratory rate, heart rate variability analysis, ECG tracings, single-channel EEG data, and even polysomnography data. Pharmaceutical companies have already begun to apply wireless sensor technologies to clinical trials and product development. Fundamentally, wireless technology allows the capture and analysis of real-time, continuous physiological data at relatively low cost and allows for a range of benefits in drug development. Today, the value proposition offered by drug manufacturers for their new products involves therapeutic innovation. Innovation could be pushed further by monitoring the individual patient's ability to tolerate the medication.

Keywords

biological informationbiomarkersdosing frequencypersonalized medicinephase II clinical developmentdrug developmentindication selection
Type
Chapter
Information
Essential CNS Drug Development , pp. 192 - 199
Publisher: Cambridge University Press
Print publication year: 2012

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