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

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

研究成果: ジャーナルへの寄稿総説査読

23 被引用数 (Scopus)

抄録

Despite large unmet medical needs in the field for several decades, 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). A recent working group was organized jointly by CINP and Japanese Society of Neuropsychopharmacology (JSNP) to discuss the utility of biomarkers as tools to overcome issues of CNS drug development. The consensus statement from the working group aimed at creating more nuanced criteria for employing biomarkers as tools to overcome issues surrounding CNS drug development. To accomplish this, a reverse engineering approach was adopted, in which criteria for the utilization of biomarkers were created in response to current challenges in the processes of drug discovery and development for CNS disorders. Based on this analysis, we propose a new paradigm containing 5 distinct tiers to further clarify the use of biomarkers and establish new strategies for decision-making in the context of CNS drug development. Specifically, we discuss more rational ways to incorporate biomarker data to determine optimal dosing for INDs with novel mechanisms and targets, and propose additional categorization criteria to further the use of biomarkers in patient stratification and clinical efficacy prediction. Finally, we propose validation and development of new neuroimaging biomarkers through public-private partnerships to further facilitate drug discovery and development for CNS disorders.

本文言語英語
ページ(範囲)285-294
ページ数10
ジャーナルInternational Journal of Neuropsychopharmacology
20
4
出版ステータス出版済み - 01-04-2017
外部発表はい

All Science Journal Classification (ASJC) codes

  • 医学一般

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