Innovations In Clinical Neuroscience

ISCTM Supplement 2015

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Page 37 of 41

Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 2 , N U M B E R 3 – 4 , S U P P L E M E N T A , M A R C H – A P R I L 2 0 1 5 ] 38S addition be of interest for the individualized titration in a given subject. There are several important a spects, which have to be stressed for the success of this path. One is that the technical validity for a marker has to be convincingly demonstrated before its use. This is given for the examples in this overview. The clinical and regulatory validity comes out of the demonstration that biomarker positive and biomarker negative subgroups behave differently with regard to the treatment outcome with a specific compound. As long as this differentiation was pre-specified it can be utilized for regulatory purposes. This is a path to personalized medicine, which is technically feasible and necessary for the success of CNS drug development in the future. With this focused approach the goal of developing new compounds, which are superior to standard of care, can and must be achieved. ACKNOWLEDGMENTS The authors would like to thank Rolando Gutierrez-Esteinou and Kevin Craig, both at Covance, for their helpful comments. REFERENCES 1. Hurko O, Ryan JL. Translational research in central nervous system drug discovery. NeuroRx. 2005;2:671–682. 2. Cook D, Brown D, Alexander R, et al. Lessons learned from the fate of AstraZeneca's drug pipeline: a five- dimensional framework. Nat Rev Drug Discov. 2014;13:419–431. 3. Miresco MJ, Kirmayer LJ. The persistence of mind-brain dualism in psychiatric reasoning about clinical scenarios. Am J Psychiatry. 2006;63:913–918. 4. Biomarkers Definitions Working G. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Therapeut. 2001;69:89–95. 5. Binder EB, Salyakina D, Lichtner P, et al. 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