title: Strategies for Utilizing Neuroimaging Biomarkers in CNS Drug Discovery and Development: CINP/JSNP Working Group Report.
abstract: 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.
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Suhara
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Chaki
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Haruhide
authors.initials: H
authors.lastname: Kimura
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Makoto
authors.initials: M
authors.lastname: Furusawa
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Mitsuyuki
authors.initials: M
authors.lastname: Matsumoto
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Hiroo
authors.initials: H
authors.lastname: Ogura
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Takaaki
authors.initials: T
authors.lastname: Negishi
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Takeaki
authors.initials: T
authors.lastname: Saijo
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Makoto
authors.initials: M
authors.lastname: Higuchi
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Omura
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Rira
authors.initials: R
authors.lastname: Watanabe
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Sosuke
authors.initials: S
authors.lastname: Miyoshi
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Noriaki
authors.initials: N
authors.lastname: Nakatani
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Shyh-Yuh
authors.initials: SY
authors.lastname: Liou
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Yuhei
authors.initials: Y
authors.lastname: Takado
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Jun
authors.initials: J
authors.lastname: Maeda
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Okamoto
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Okubo
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Makiko
authors.initials: M
authors.lastname: Yamada
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ito
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Noah M
authors.initials: NM
authors.lastname: Walton
authors.affiliation: National Institutes for Quantum and Radiological Science and Technology, Chiba, Japan (Drs Suhara, Higuchi, Takado, Maeda, and Yamada); Taisho Pharmaceutical Co., Ltd., Saitama, Japan (Drs Chaki and Omura); Takeda Pharmaceutical Co., Ltd., Kanagawa, Japan (Drs Kimura and Furusawa); Astellas Pharma Inc., Ibaraki, Japan (Drs Matsumoto and Miyoshi); Eisai Co., Ltd., Tokyo, Japan (Drs Ogura and Yamamoto); Mochida Pharmaceutical Co., Ltd., Tokyo, Japan (Dr Negishi); Mitsubishi Tanabe Pharma Co., Kanagawa, Japan (Dr Saijo); Daiichi Sankyo Co., Ltd., Tokyo, Japan (Dr Watanabe); Chugai Pharmaceutical Co., Ltd, Kanagawa, Japan (Dr Nakatani); Ono Pharmaceutical Co., Ltd., Osaka, Japan (Dr Liou); Hiroshima University, Hiroshima, Japan (Drs Okamoto and Yamawaki); Nippon Medical School, Tokyo, Japan (Dr Okubo); Fukushima Medical University, Fukushima, Japan (Dr Ito); Astellas Research Institute of America LLC, IL, USA (Dr Walton).
authors.forename: Shigeto
authors.initials: S
authors.lastname: Yamawaki
mesh_terms: D015415:Biomarkers; D002491:Central Nervous System Agents; D055808:Drug Discovery / Q000379:methods* / Q000592:standards; D006801:Humans; D059906:Neuroimaging; D009480:Neuropharmacology / Q000379:methods* / Q000592:standards; D011600:Psychopharmacology / Q000379:methods* / Q000592:standards
chemical_list: D015415:Biomarkers; D002491:Central Nervous System Agents
keywords: CNS drug development; clinical efficacy prediction; neuroimaging biomarkers; patient stratification; public-private-partnerships