Journal Article Strategies for utilizing neuroimaging biomarkers in CNS drug discovery and development: CINP/JSNP working group report.

Suhara, Tetsuya  ,  Chaki, Shigeyuki  ,  Kimura, Haruhide  ,  Furusawa, Makoto  ,  Matsumoto, Mitsuyuki  ,  Ogura, Hiroo  ,  Negishi, Takaaki  ,  Saijo, Takeaki  ,  Higuchi, Makoto  ,  Omura, Tomohiro  ,  Watanabe, Rira  ,  Miyoshi, Sosuke  ,  Nakatani, Noriaki  ,  Yamamoto, Noboru  ,  Shyh-Yuh, Liou  ,  Takado, Yuhei  ,  Maeda, Jun  ,  Okamoto, Yasumasa  ,  Okubo, Yoshiaki  ,  Yamada, Makiko  ,  Ito, Hiroshi  ,  M Walton, Noah  ,  Yamawaki, Shigeto

20 ( 4 )  , pp.285 - 294 , 2016-12 , Oxford University Press
Despite large unmet medical needs in the field for several decades, central nervous system (CNS) drug discovery and development has been largely unsuccessful. Biomarkers, particularly those utilizing neuroimaging, have played important roles in aiding CNS drug development, including dosing determination of investigational new drugs (INDs). The utility of biomarkers as tools to overcome issues of CNS drug development is the subject for this review.In this review aimed at employing biomarkers as tools to overcome issues surrounding CNS drug development, we first analyzed problems in utilizing biomarkers in processes of drug discovery and development for CNS disorders. Based on this analysis, we propose a new paradigm containing five distinct tiers to further clarify the use of biomarkers and establish new strategies for decision-making in the context of clinical drug development. Specifically, we discuss more rational ways to determine optimal dose for INDs with novel mechanisms and targets, and propose additional categorization criteria to further the use of biomarkers in patient stratification and efficacy prediction. Finally, we propose validation and development of new neuroimaging biomarkers through Public-Private-Partnerships to realize rational and successful drug discovery and development for CNS disorders.

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