Faculty Profiles - SHIMIZU Shinobu

写真a

SHIMIZU Shinobu

Organization

Nagoya University Hospital Associate professor

Graduate School

Graduate School of Medicine

Degree 1

Doctor (Pharmacy) （ 2005.3 Nagoya City University ）

To the head of Degree.▲

Research History 5

Nagoya University Department of Advanced Medicine, Nagoya University Hospital Associate professor

2019.5

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Country：Japan
Nagoya University Department of Advanced Medicine, Nagoya University Hospital Lecturer of hospital

2018.7 - 2019.4

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Country：Japan
Nagoya University Center for Advanced Medicine and Clinical Research, Nagoya University Hospital Lecturer of hospital

2013.1 - 2018.6

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Country：Japan
Nagoya University Center for Advanced Medicine and Clinical Research, Nagoya University Hospital Pharmacist

2011.4 - 2012.12

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Country：Japan
Pharmaceuticals and Medical Devices Agency

2005.8 - 2011.3

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Country：Japan

To the head of Research History.▲

Papers 36

Systemic administration of clinical-grade multilineage-differentiating stress-enduring cells ameliorates hypoxic–ischemic brain injury in neonatal rats. Reviewed

1. Ueda K, Sato Y, Shimizu S, Suzuki T, Onoda A, Miura R, Go S, Mimatsu H, Kitase Y, Yamashita Y, Irie K, Tsuji M, Mishima K, Mizuno M, Takahashi Y, Dezawa M, Hayakawa M.

SCIENTIFIC REPORTS Vol. 13 ( 1 ) page： 14958 2023.9

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1038/s41598-023-41026-3.

Other Link： https://www.nature.com/articles/s41598-023-41026-3
Mexiletine in spinal and bulbar muscular atrophy: a randomized controlled trial Reviewed International journal

Yamada Shinichiro, Hashizume Atsushi, Hijikata Yasuhiro, Inagaki Tomonori, Ito Daisuke, Kishimoto Yoshiyuki, Kinoshita Fumie, Hirakawa Akihiro, Shimizu Shinobu, Nakamura Tomohiko, Katsuno Masahisa

ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY Vol. 9 ( 11 ) page： 1702 - 1714 2022.11

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1002/acn3.51667

Web of Science

PubMed
Influence of background characteristics in responders of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence Reviewed International journal

Yamanishi Tomonori, Ishizuka Osamu, Shimizu Shinobu, Kobayashi Yumiko, Kinoshita Fumie, Yamamoto Tokunori, Mizokami Atushi, Narimoto Kazutaka, Toriyama Kazuhiro, Kamei Yuzuru, Kuwatsuka Yachiyo, Mizuno Masaaki, Gotoh Momokazu

LUTS-LOWER URINARY TRACT SYMPTOMS Vol. 14 ( 4 ) page： 273 - 280 2022.7

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1111/luts.12433

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PubMed
Protocol for a Phase 1, Open-Label, Multiple-Center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 in the Treatment of Immunoglobulin A Nephropathy Reviewed International journal

Tanaka Akihito, Furuhashi Kazuhiro, Fujieda Kumiko, Maeda Kayaho, Saito Shoji, Mimura Tetsushi, Saka Yosuke, Naruse Tomohiko, Ishimoto Takuji, Kosugi Tomoki, Kinoshita Fumie, Kuwatsuka Yachiyo, Shimizu Shinobu, Nakai Yasuhiro, Maruyama Shoichi

FRONTIERS IN MEDICINE Vol. 9 page： 883168 2022.5

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.3389/fmed.2022.883168

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PubMed
Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial Reviewed

Matsuyama Nao, Shimizu Shinobu, Ueda Kazuto, Suzuki Toshihiko, Suzuki Sakiko, Miura Ryosuke, Katayama Akemi, Ando Masahiko, Mizuno Masaaki, Hirakawa Akihiro, Hayakawa Masahiro, Sato Yoshiaki

BMJ OPEN Vol. 12 ( 4 ) page： e057073 2022.4

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1136/bmjopen-2021-057073

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PubMed
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation Reviewed

Nakamura Kenichi, Ozawa Hitoshi, Shibata Taro, Ushirozawa Nobuko, Hata Tomomi, Okita Natsuko, Fuse Nozomu, Sato Norihiro, Ikeda Koji, Hanaoka Hideki, Maruyama Tatsuya, Wada Michihiko, Shimizu Shinobu, Kasai Hiroi, Yamamoto Yoichi, Sakurai Jun, Todaka Koji, Tashiro Shimon, Yamamoto Haruko

THERAPEUTIC INNOVATION & REGULATORY SCIENCE Vol. 56 ( 2 ) page： 220 - 229 2022.3

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1007/s43441-021-00350-4

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Safety and efficacy of MIKE-1 in patients with advanced pancreatic cancer: a study protocol for an open-label phase I/II investigator-initiated clinical trial based on a drug repositioning approach that reprograms the tumour stroma Reviewed

BMC CANCER Vol. 22 ( 1 ) page： 205 2022.2

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1186/s12885-022-09272-2

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PubMed
Comparison of Successful and Unsuccessful Cases of New Drug Approvals Based on the International Council on Harmonization E5 Guidelines in Japan Reviewed

Asada Ryuta, Shimizu Shinobu, Nakamura Harumasa, Ono Shunsuke, Yamaguchi Takuhiro

CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT Vol. 10 ( 5 ) page： 434 - 439 2021.5

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DOI： 10.1002/cpdd.942

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PubMed
The evaluation of the safety and efficacy of intravenously administered allogeneic multilineage-differentiating stress-enduring cells in a swine hepatectomy model. Reviewed

Iseki M, Mizuma M, Wakao S, Kushida Y, Kudo K, Fukase M, Ishida M, Ono T, Shimura M, Ise I, Suzuki Y, Sueta T, Asada R, Shimizu S, Ueno Y, Dezawa M, Unno M

Surgery today Vol. 51 ( 4 ) page： 634 - 650 2021.4

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DOI： 10.1007/s00595-020-02117-0

PubMed
Biological characterization of adipose-derived regenerative cells used for the treatment of stress urinary incontinence Reviewed

Okabe Yuka Tsukagoshi, Shimizu Shinobu, Suetake Yukihiro, Matsui-Hirai Hisako, Hasegawa Shizuka, Takanari Keisuke, Toriyama Kazuhiro, Kamei Yuzuru, Yamamoto Tokunori, Mizuno Masaaki, Gotoh Momokazu

INTERNATIONAL JOURNAL OF UROLOGY Vol. 28 ( 1 ) page： 115 - 124 2021.1

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1111/iju.14408

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PubMed
Intravenously delivered multilineage-differentiating stress enduring cells dampen excessive glutamate metabolism and microglial activation in experimental perinatal hypoxic ischemic encephalopathy. Reviewed International coauthorship

Suzuki T, Sato Y, Kushida Y, Tsuji M, Wakao S, Ueda K, Imai K, Iitani Y, Shimizu S, Hida H, Temma T, Saito S, Iida H, Mizuno M, Takahashi Y, Dezawa M, Borlongan CV, Hayakawa M

Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism page： 271678X20972656 2020.11

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DOI： 10.1177/0271678X20972656

PubMed
Regenerative treatment for male stress urinary incontinence by periurethral injection of adipose-derived regenerative cells: Outcome of the ADRESU study Reviewed

Gotoh, M; Shimizu, S; Yamamoto, T; Ishizuka, O; Yamanishi, T; Mizokami, A; Narimoto, K; Toriyama, K; Kamei, Y; Nakayama, S; Kuwatsuka, Y; Mizuno, M; Hirakawa, A

INTERNATIONAL JOURNAL OF UROLOGY Vol. 27 ( 10 ) page： 859 - 865 2020.10

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1111/iju.14311

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PubMed
Influence of human adipose stem cells on prostate cancer cell growth. Reviewed

Tokunori Yamamoto, Momokazu Gotoh, Naoshi Koide, Yasuhito Funahashi, Shinobu Shimizu, Yoshifumi Takei.

Nagoya Journal of Medical Science Vol. 82 ( 2 ) page： 217 - 224 2020.5

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.18999/nagjms.82.2.217

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PubMed

Other Link： https://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/822/07_Yamamoto.pdf
Efficacy and Safety of Rituximab in Refractory CIDP With or Without IgG4 Autoantibodies (RECIPE): Protocol for a Double-Blind, Randomized, Placebo-Controlled Clinical Trial Reviewed

Shimizu, S; Iijima, M; Fukami, Y; Tamura, N; Nakatochi, M; Ando, M; Nishi, R; Koike, H; Kaida, K; Koga, M; Kanda, T; Ogata, H; Kira, JI; Mori, M; Kuwabara, S; Katsuno, M

JMIR RESEARCH PROTOCOLS Vol. 9 ( 4 ) page： e17117 2020.4

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.2196/17117

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PubMed
Phase I study of vorinostat with gefitinib in BIM deletion polymorphism/epidermal growth factor receptor mutation double-pnositive lung cancer Reviewed International coauthorship

Takeuchi, S; Hase, T; Shimizu, S; Ando, M; Hata, A; Murakami, H; Kawakami, T; Nagase, K; Yoshimura, K; Fujiwara, T; Tanimoto, A; Nishiyama, A; Arai, S; Fukuda, K; Katakami, N; Takahashi, T; Hasegawa, Y; Ko, TK; Ong, ST; Yano, S

CANCER SCIENCE Vol. 111 ( 2 ) page： 561 - 570 2020.2

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DOI： 10.1111/cas.14260

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PubMed
A Novel Treatment with Stem Cells from Human Exfoliated Deciduous Teeth for Hypoxic-Ischemic Encephalopathy in Neonatal Rats Reviewed

Kitase, Y; Sato, Y; Ueda, K; Suzuki, T; Mikrogeorgiou, A; Sugiyama, Y; Matsubara, K; Okabe, YT; Shimizu, S; Hirata, H; Yukawa, H; Baba, Y; Tsuji, M; Takahashi, Y; Yamamoto, A; Hayakawa, M

STEM CELLS AND DEVELOPMENT Vol. 29 ( 2 ) page： 63 - 74 2020.1

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1089/scd.2019.0221

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PubMed
Src inhibition attenuates polyglutamine-mediated neuromuscular degeneration in spinal and bulbar muscular atrophy Reviewed

Iida, M; Sahashi, K; Kondo, N; Nakatsuji, H; Tohnai, G; Tsutsumi, Y; Noda, S; Murakami, A; Onodera, K; Okada, Y; Nakatochi, M; Okabe, YT; Shimizu, S; Mizuno, M; Adachi, H; Okano, H; Sobue, G; Katsuno, M

NATURE COMMUNICATIONS Vol. 10 ( 1 ) page： 4262 2019.9

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DOI： 10.1038/s41467-019-12282-7

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A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan Reviewed

Asada, R; Yoshimura, K; Hattori, K; Nonaka, Y; Kasai, H; Shimizu, S

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS Vol. 15 page： 100416 2019.9

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1016/j.conctc.2019.100416

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Design of a Randomized Controlled Clinical Study of tissue-engineered osteogenic materials using bone marrow-derived mesenchymal cells for Maxillomandibular bone defects in Japan: the TEOM study protocol Reviewed

Shimizu, S; Tsuchiya, S; Hirakawa, A; Kato, K; Ando, M; Mizuno, M; Osugi, M; Okabe, K; Katagiri, W; Hibi, H

BMC ORAL HEALTH Vol. 19 ( 1 ) page： 69 2019.4

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1186/s12903-019-0753-1

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PubMed
Treatment of male stress urinary incontinence using autologous adipose-derived regenerative cells: Long-term efficacy and safety. Reviewed

Gotoh M, Yamamoto T, Shimizu S, Matsukawa Y, Kato M, Majima T, Takai S, Funahashi Y, Toriyama K

International journal of urology : official journal of the Japanese Urological Association Vol. 26 ( 3 ) page： 400 - 405 2019.3

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DOI： 10.1111/iju.13886

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PubMed

Other Link： https://onlinelibrary.wiley.com/doi/epdf/10.1111/iju.13886
Preparation of Standard Operating Procedures Reflected the Latest Information for Investigator-initiated Clinical Trials. Reviewed

Vol. 47 page： s134 - s147 2019

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Language：Japanese Publishing type：Research paper (scientific journal)
腹圧性尿失禁に対する治療括約筋再生

山本徳則，清水忍，後藤百万

臨床泌尿器科 Vol. 73 ( 2 ) page： 130 - 135 2019

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Language：Japanese
Phase I study of combined therapy with vorinostat and gefitinib to treat BIM deletion polymorphism-associated resistance in EGFR-mutant lung cancer (VICTROY-J)

Hase, T; Takeuchi, S; Ando, M; Hata, A; Kenmotsu, H; Fujiwara, T; Shimizu, S; Nagase, K; Yoshimura, K; Katakami, N; Takahashi, T; Hasegawa, Y; Yano, S

ANNALS OF ONCOLOGY Vol. 28 2017.11

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Design of a single-arm clinical trial of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence in Japan: the ADRESU study protocol Reviewed

Shimizu Shinobu, Yamamoto Tokunori, Nakayama Shinobu, Hirakawa Akihiro, Kuwatsuka Yachiyo, Funahashi Yasuhito, Matsukawa Yoshihisa, Takanari Keisuke, Toriyama Kazuhiro, Kamei Yuzuru, Narimoto Kazutaka, Yamanishi Tomonori, Ishizuka Osamu, Mizuno Masaaki, Gotoh Momokazu

BMC UROLOGY Vol. 17 ( 1 ) page： 89 2017.9

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.1186/s12894-017-0282-7

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PubMed
Human Muse cells, non-tumorigenic pluripotent-like stem cells, have the capacity for liver regeneration by specific homing and replenishment of new hepatocytes in liver fibrosis mouse model. Reviewed

Iseki M, Kushida Y, Wakao S, Akimoto T, Mizuma M, Motoi F, Asada R, Shimizu S, Unno M, Chazenbalk G, Dezawa M.

Cell Transplant. Vol. 26 ( 5 ) page： 821 - 840 2017

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Language：Japanese Publishing type：Research paper (scientific journal)

DOI： 10.3727/096368916X693662

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PubMed
Phase I study of combined therapy with vorinostat and gefitinib to treat BIM deletion polymorphism-associated resistance in EGFR-mutant lung cancer (VICTROY-J): a study protocol. Reviewed

Takeuchi S, Yoshimura K, Fujiwara T, Ando M, Shimizu S, Nagase K, Hasegawa Y, Takahashi T, Katakami N, Inoue A, Yano S

The journal of medical investigation : JMI Vol. 64 ( 3.4 ) page： 321 - 325 2017

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Language：English Publishing type：Research paper (scientific journal)

DOI： 10.2152/jmi.64.321

PubMed
尿失禁に対する脂肪幹細胞が作り出す微小環境を活用した治療の開発

山本徳則，舟橋康人，松川宜久，中山忍，清水忍，後藤百万

泌尿器外科 Vol. 29 ( 4 ) page： 335-338 2016

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Language：Japanese Publishing type：Research paper (scientific journal)
Basic thinking for non-clinical development toward practical application of medicine Invited

Shimizu S.

Vol. 33 ( 3 ) page： 453-458 2016

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Authorship：Lead author Language：Japanese Publishing type：Research paper (scientific journal)
What Factors Lead to prolonged Regulatory Review Times for New Drugs in Japan? Reviewed

Yoneda S, Asada R, Shimizu S, Ono S, Yamaguchi T

J Clin Trials Vol. 5 ( 6 ) page： 247 2015

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Underlying issues in clinical data package of oncology drug. Reviewed

Hirakawa A, Kinoshita F, Mori Y, Shimizu S

Regulatory Science of Medical Products Vol. 46 ( 10 ) page： 714-720 2015

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Language：Japanese Publishing type：Research paper (scientific journal)

Clinical development of oncology drugs in Japan is based on the guideline for clinical evaluation of oncology drugs published by the Ministry of Health, Labour and Welfare in November 2005. Under this guideline, the submission of phase 3 trial results is required to get approval of the indication for the specific cancer (e.g., non-small cell lung, gastric, colon, and breast cancers); however, there is insufficient information on the clinical data package in oncology that would be accepted by regulatory agency.
In this study, we analyzed the clinical data packages of 106 oncology drugs approved between April 2004 and March 2015 to identify underlying controversial issues regarding the clinical data packages submitted for drug approval. We categorized the clinical data packages into 10 types according to the type of clinical trial and evaluated the associations of the package types with fiscal year, drug type (molecularly targeted agent [MTA] or non-MTA), application (new drug application [NDA] or supplementary NDA), cancer type (solid or hematologic), and orphan drug designation (yes or no).
We found the two underlying issues in oncology drug applications that (1) whether a phase 1 trial in Japanese patients is necessary in the case of supplementary NDA; (2) whether a phase 2 trial in Japanese patients is necessary when the clinical data package includes a phase 3 trial conducted in foreign countries.
Nagoya University Ethics Committee's preliminary review process: a descriptive study. Reviewed

Shinobu Shimizu, Shinobu Nakayama, Yoshihiko Iijima, Katsuyoshi Kato, Masahiko Ando, Masaaki Mizuno, Tomoki Naoe

Japanese Journal of Clinical Pharmacology and Therapeutics Vol. 44 ( 6 ) page： 443-450 2013.11

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Authorship：Lead author Language：Japanese Publishing type：Research paper (scientific journal)
Analysis of new drugs whose clinical development and regulatory approval were hampered during their introduction in Japan. Reviewed

Asada R, Shimizu S, Ono S, Ito T, Shimizu A, Yamaguchi T.

J Clin Pharm Ther. Vol. 38 ( 4 ) page： 309-313 2013.8

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What is known and Objective: Many drugs fail during development. However, detailed reasons for failure during drug development are almost never disclosed. We focused on the drugs whose clinical development and registration were initially hampered, but which were finally approved to identify reasons that delayed their marketing approval in Japan.
Methods: We analysed 727 new drug applications (NDAs) approved in Japan between 2001 and 2011.
Results and Discussion: Fifty-three NDAs had serious and identifiable problems during drug development. Of these, 43 NDAs had `problem related to clinical data'. We found that the problems for withdrawal of these NDAs could be ascribed largely to inappropriate clinical data package and study design for supporting the intended indications and usage and to unclear clinical results for defining dosage regimen or efficacy of the drugs.
What is new and Conclusion: Our results indicate the importance of careful determination of the optimal dosage regimen and the choice of objective endpoints in clinical trials. Further, it is important to establish a clear strategy for generating the clinical data package, to include careful design of clinical trials on the basis of the nature of the target disease and target population. For drugs marketed in Japan, there is a need to include sufficient numbers of Japanese patients in the trials.

DOI： 10.1111/jcpt.
Functional alteration of inhibitory influences on spinal motor output in painful diabetic neuropathy in rats. Reviewed

Tanabe M, Shimizu S, Takabayashi K, Honda M, Ono H.

Neurosci Lett. Vol. 389 ( 3 ) page： 152-156 2005.12

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Diabetes is frequently accompanied by painful polyneuropathies that are mediated by enhanced neuronal excitability in the spinal cord, partly because of decrease in spinal intrinsic inhibitory influences. Changes in spinal excitatory-inhibitory balance may alter spinal segmental motor output. In the study presented here, the mono- and disynaptic (the fastest polysynaptic) reflexes (MSR and DSR, respectively) were recorded from L5 ventral roots in response to stimulation of the ipsilateral L5 dorsal root in spinalized streptozotocin (STZ)-induced diabetic rats with a reduced withdrawal threshold to mechanical stimuli. The diabetic rats generally exhibited larger spinal reflex amplitudes, the DSR being influenced in particular. We addressed whether recurrent and presynaptic inhibition of the spinal reflexes were altered in STZ-treated animals. The recurrent inhibition of the MSR and DSR elicited by preceding antidromic conditioning stimulation delivered to the recorded L5 ventral root was markedly suppressed in diabetic rats. By contrast, the presynaptic inhibition of the MSR and DSR elicited by preceding conditioning stimulation to the ipsilateral L4 dorsal root was not impaired. Thus, in diabetic painful neuropathy, reduced spinal intrinsic inhibition in the ventral horn contributes to an enhanced spinal segmental motor output.
Role of descending noradrenergic system and spinal α₂-adrenergic receptors in the effects of gabapentin on thermal and mechanical nociception after partial nerve injury in the mouse. Reviewed

Tanabe M, Takasu K, Kasuya N, Shimizu S, Honda M, Ono H.

Br J Pharmacol. Vol. 144 page： 703-714 2005.3

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1. To gain further insight into the mechanisms underlying the antihyperalgesic and antiallodynic actions of gabapentin, a chronic pain model was prepared by partially ligating the sciatic nerve in mice. The mice then received systemic or local injections of gabapentin combined with either central noradrenaline (NA) depletion by 6-hydroxydopamine (6-OHDA) or α-adrenergic receptor blockade. 2. Intraperitoneally (i.p.) administered gabapentin produced antihyperalgesic and antiallodynic effects that were manifested by elevation of the withdrawal threshold to a thermal (plantar test) or mechanical (von Frey test) stimulus, respectively. 3. Similar effects were obtained in both the plantar and von Frey tests when gabapentin was injected intracerebroventricularly (i.c.v.) or intrathecally (i.t.), suggesting that it acts at both supraspinal and spinal loci. This novel supraspinal analgesic action of gabapentin was only obtained in ligated neuropathic mice, and gabapentin (i.p. and i.c.v.) did not affect acute thermal and mechanical nociception. 4. In mice in which central NA levels were depleted by 6-OHDA, the antihyperalgesic and antiallodynic effects of i.p. and i.c.v. gabapentin were strongly suppressed. 5. The antihyperalgesic and antiallodynic effects of systemic gabapentin were reduced by both systemic and i.t. administration of yohimbine, an α₂-adrenergic receptor antagonist. By contrast, prazosin (i.p. or i.t.), an α₁-adrenergic receptor antagonist, did not alter the effects of gabapentin. 6. It was concluded that the antihyperalgesic and antiallodynic effects of gabapentin are mediated substantially by the descending noradrenergic system, resulting in the activation of spinal α₂-adrenergic receptors.

DOI： 10.1038/sj.bjp.0706109
GABA_B receptors do not mediate the inhibitory actions of gabapentin on the spinal reflex in rats. Reviewed

Shimizu S, Honda M, Tanabe M, Ono H.

J Pharmacol Sci. Vol. 96 ( 4 ) page： 444-449 2004.12

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responsible for those actions, however, are still not clearly understood. We have recently demonstrated that gabapentin reduces the spinal reflex in rats via mechanisms that do not involve gamma-aminobutyric acid (GABA)_A receptors. In the study, we attempted to explore the involvement of GABA_B receptors in gabapentin-induced inhibition of the spinal reflexes in spinalized rats. Stimulation of the dorsal root at L5 elicited the segmental mono-(MSR) and polysynaptic reflex (PSR) in the ipsilateral ventral root. The microinjection of gabapentin (1.5 and 5 nmol) into the ventral horn reduced both MSR and PSR, whereas the injection into the dorsal horn only inhibited the PSR, indicating that systemic gabapentin inhibits the MSR at the ventral horn and it inhibits the PSR at both the ventral and dorsal horns. The GABA_B-receptor antagonist CGP35348 (0.5 nmol) injected into the ventral horn antagonized the inhibition of the spinal reflexes by the GABA_B-receptor agonist baclofen (i.v.) but not by gabapentin (i.v.). Thus, GABA_B receptors do not appear to contribute to the gabapentin-induced inhibition of the spinal reflex.
Endogenous GABA does not mediate the inhibitory effects of gabapentin on spinal reflexes in rats. Reviewed

Shimizu S, Honda M, Tanabe M, Oka J, Ono H.

J Pharmacol Sci. Vol. 94 ( 2 ) page： 137-143 2004.2

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The novel antiepileptic drug gabapentin was designed as a structural analog of gamma-aminobutyric acid (GABA). However, its mechanism of action remains unclear. In the present study, we investigated the effect of gabapentin on spinal reflexes in anesthetized rats. The mono- and polysynaptic reflex potentials were recorded from the ipsilateral L5 ventral root after stimulation of the L5 dorsal root. The dorsal root reflex potential, an index of presynaptic inhibition, was recorded from the ipsilateral L4 dorsal root. In non-spinalized (intact) and spinalized rats, intravenously administered gabapentin reduced the mono- and polysynaptic reflex potentials in a dose-dependent manner. These inhibitory effects of gabapentin were not suppressed by the GABA_A antagonist picrotoxin. Moreover, gabapentin also decreased spinal reflexes in spinalized rats depleted of spinal GABA with semicarbazide, an inhibitor of the GABA-synthesizing enzyme. The dorsal root reflex potentials were not affected by gabapentin. These results suggest that endogenous GABA does not mediate the inhibitory effects of gabapentin on spinal reflexes.

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To the head of Papers.▲

Presentations 87

低体温療法を実施した新生児低酸素性虚血脳症に対するCL2020の安全性及び忍容性を検討する用量漸増臨床試験

佐藤義朗、清水忍、上田一仁、三浦良介、安藤昌彦、平川晃弘、津田兼之介、岩田欧介、村松友佳子、城所博之

第23回日本再生医療学会総会 2024.3.21 再生医療学会

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Event date： 2024.3

Language：Japanese Presentation type：Oral presentation (general)

Venue：新潟 Country：Japan
二次治療抵抗性膵癌に対するタミバロテン（AM80）とペムブロリズマブ併用療法の有効性及び安全性を検討する探索的臨床研究

飯田忠、天野祐里、清水忍、川嶋啓揮

革新的医療技術創出拠点令和5年度成果報告会 2024.2.15 日本医療研究開発機構

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Event date： 2024.2 - 2024.3

Language：Japanese Presentation type：Poster presentation

Venue：東京 Country：Japan
The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab (Genetical Recombination) for the Treatment for Idiopathic MEmbranous Nephropathy with Nephrotic Syndrome

2024.2.15

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Event date： 2024.2 - 2024.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
非臨床データの把握・解釈～治験開始時に向けての検討～ Invited

清水忍

一般社団法人ARO協議会認定講習会 2023.12.17 一般社団法人ARO協議会

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Event date： 2023.12

Language：Japanese Presentation type：Public lecture, seminar, tutorial, course, or other speech

Venue：神戸 Country：Japan
The Evaluation of Efficacy and Safety Additional Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies by Patient-Proposed Healthcare Services. International conference

Fukami Y, Iijima M, Shimizu S, Nishiwaki S, Koike H, Katsuno M

2023 Peripheral Nerve Society (PNS) Annual Meeting 2023.6 Peripheral Nerve Society

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Event date： 2023.6

Language：English Presentation type：Poster presentation

Country：Denmark
患者申出療養によるIgG4自己抗体陽性CIDP患者へのリツキシマブの有効性と安全性評価

深見祐樹、飯島正博、清水忍、西脇聡史、木下文恵、安藤昌彦、小池春樹、勝野雅央

第64回日本神経学会学術大会 2023.5.31 日本神経学会

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Event date： 2023.5 - 2023.6

Language：Japanese Presentation type：Oral presentation (general)

Venue：幕張 Country：Japan
Stem cells from human exfoliated deciduous teeth ameliorates neurological deficits induced by perinatal hypoxic-ischemic encephalopathy in a rat model of cerebral palsy, even when administered in the chronic phase International conference

Kanzawa T, Sato Y, Yue X, Goto R, Takamoto Y, Suzuki S, Ueda K, Miura R, Suzuki T, Onoda A, Shimizu S, Takahashi Y, Hayakawa M

Pediatric Academic Societies (PAS) Annual Meeting 2023 2023.4.29

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Event date： 2023.4 - 2023.5

Language：English Presentation type：Oral presentation (general)

Country：United States
IgG4自己抗体陽性の慢性炎症性脱髄性多発神経炎（CIDP）に対するリツキシマブの有効性と安全性を確認する医師主導治験

清水忍，飯島正博，深見祐樹，松山奈央，田村奈津子，中杤昌弘，安藤昌彦，海田賢一，山﨑亮，神田隆，桑原聡，勝野雅央．

革新的医療技術創出拠点　令和4年度成果報告会「革新拠点から広がる取組～基礎・臨床・実用化から患者・社会へ～」 2023.3.2 日本医療研究開発機構

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Event date： 2023.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
治験開始前に非臨床試験で確認しておくこと

清水忍

第5回つながり対話会 2023.2.3

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Event date： 2023.2

Language：Japanese Presentation type：Public lecture, seminar, tutorial, course, or other speech
日本における希少疾病用医薬品指定の現状と承認医薬品及び指定取消医薬品に関する検討

浅田隆太、清水忍、石塚量見、中村治雅

第43回臨床薬理学会学術集会 2022.11.30

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Event date： 2022.11 - 2022.12

Language：Japanese Presentation type：Oral presentation (general)

Venue：横浜 Country：Japan
RECIPE: A PHASE II RANDOMIZED CONTROLLED TRIAL OF RITUXIMAB FOR REFRACTORY CIDP WITH IGG4 AUTOANTIBODIES International conference

Iijima Masahiro, Shimizu Shinobu, Fukami Yuki, Koike Haruki, Kaida Kenichi, Mori Masahiro, Kuwabara Satoshi, Koga Michiaki, Kanda Takashi, Ogata Hidenori, Yamasaki Ryo, Kira Jun-ichi, Katsuno Masahisa

the 2022 Peripheral Nerve Society Annual Meeting 2022.5

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Event date： 2022.5

Language：English Presentation type：Poster presentation
再生医療の臨床研究に向けたプロジェクトマネジメント

清水忍，菊地佳代子，伊藤達也，池田浩治

第21回日本再生医療学会総会 2022.3.17 日本再生医療学会

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Event date： 2022.3

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Venue：Web Country：Japan
IgG4自己抗体陽性の難治性慢性炎症性脱髄性多発神経炎（CIDP）患者を対象としたリツキシマブの有効性と安全性評価に関する多施設共同臨床試験

飯島正博，清水忍，深見祐樹，田村奈津子，中杤昌弘，安藤昌彦，小池春樹，海田賢一，古賀道明，神田隆，緒方英紀，山﨑亮，吉良潤一，森雅裕，桑原聡，勝野雅央.

神経免疫班

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Event date： 2022.1

Language：Japanese Presentation type：Oral presentation (general)

Country：Japan
審査報告書のGCP実地調査結果に基づく治験実施医療機関におけるGCP遵守状況に関する研究

浅田隆太，清水忍．

第42回日本臨床薬理学会学術総会日本臨床薬理学会

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Event date： 2021.12

Language：Japanese

Venue：仙台 Country：Japan
臨床研究・医師主導治験PMの実務について

清水忍

ARO協議会第8回学術集会 2021.9.10 ARO協議会

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Event date： 2021.9

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Venue：Web Country：Japan
試験開始前に、ここで困った！何とか乗り越えられた！事例紹介②

清水忍

2021年度　プロジェクトマネジメント専門家連絡会セミナー 2021.7.19 ARO協議会

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Event date： 2021.7

Language：Japanese Presentation type：Public lecture, seminar, tutorial, course, or other speech

Venue：Web Country：Japan
Development of a novel treatment for neonatal brain injuries by Multilineage-differentiating stress-enduring cells —Exploratory investigator-initiated clinical trial— International conference

Sato Y, Shimizu S, Ueda K, Suzuki T, Miura R, Go S, Arai S, Kitase Y, Onoda A, Tsuji M, Hayakawa M.

Hershey conference 2021

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Event date： 2021.6

Language：English Presentation type：Oral presentation (general)
A multilineage differentiating stress enduring (Muse) cell product ameliorates neonatal hypoxic ischemic brain injury: towards an exploratory investigator-initiated clinical trial. International conference

Ueda K, Sato Y, Suzuki T, Onoda A, Miura R, Go S, Mimatsu H, Kitase Y, Yamashita Y, Irie K, Tsuji M, Mishima K, Shimizu S, Hayakawa M.

Hershey conference 2021

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Event date： 2021.6

Language：English Presentation type：Oral presentation (general)
AROにおけるPM業務の意義

清水忍

アカデミア発最先端医療開発の支援～大学病院で働く魅力～ 2021.3.18 AMED橋渡し研究戦略的推進プログラム拠点間ネットワーク事業プロジェクトマネージャー育成事業

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Event date： 2021.3

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Country：Japan
多職種共同臨床研究計画ワークショップの開催から見えた画期的な教育効果とコンピテンシーに基づく業務パフォーマンス評価の方向性～令和2年度中央IRB促進事業（2次公募）多職種班の検討報告～．

真田昌爾，岩崎幸司，南学，大谷直由，清水忍，有田悦子，浅田隆太，桃井章裕，鈴木由加利，成田さわな，吉田寿子，河合稜太，松野康子，西崎祐史，松嶋由紀子，高田宗典，出居真由美，氏原淳，菊地佳代子，佐藤研介，新谷歩，山口拓，上村尚人．

日本臨床試験学会第12回学術集会総会 2021.2.12 日本臨床試験学会

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Event date： 2021.2

Language：Japanese Presentation type：Poster presentation

Country：Japan
IgG4自己抗体陽性の慢性炎症性脱髄性多発神経炎（CIDP）に対するリツキシマブの有効性と安全性を確認する医師主導治験の運用．

清水忍，松山奈央，飯島正博，田村奈津子，片山朱美，中杤昌弘，安藤昌彦，海田賢一，山﨑亮，神田隆，桑原聡，勝野雅央．

日本臨床試験学会第12回学術集会総会 2021.2.12 日本臨床試験学会

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Event date： 2021.2

Language：Japanese Presentation type：Poster presentation

Country：Japan
ネガティブな結果を含む臨床試験に基づく臨床試験計画時の留意点の一覧表の検討．

浅田隆太，清水忍，中村治雅，小野俊介，山口拓洋．

第41回日本臨床薬理学会学術総会 2020.12.5 日本臨床薬理学会

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Event date： 2020.12

Language：Japanese Presentation type：Poster presentation

Country：Japan
SHIELD試験の立ち上げ：低体温療法を実施した新生児低酸素性虚血性脳症に対するCL2020の安全性及び忍容性を検討する用量漸増臨床試験．

松山奈央，清水忍，片山朱美，平川晃弘，安藤昌彦，上田一仁，鈴木俊彦，佐藤義朗．

第41回日本臨床薬理学会学術総会 2020.12.5 日本臨床薬理学会

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Event date： 2020.12

Language：Japanese Presentation type：Poster presentation

Country：Japan
臨床研究の開始に向けた準備と臨床研究における規制．

清水忍

令和2年度臨床研究・治験従事者養成研修 2020.10.17

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Event date： 2020.10

Language：Japanese Presentation type：Public lecture, seminar, tutorial, course, or other speech

Country：Japan
医師臨床研修制度見直しから見た医学生や研修医に対するTR教育．

鶴田敏久，天野学，中井康博，藤田一司，五十部穣，植田康平，清水忍，鍬塚八千代，木下文恵，安藤昌彦，水野正明，安藤雄一．

日本臨床試験学会第11回学術集会総会 2020.2.14 日本臨床試験学会

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Event date： 2020.2

Language：Japanese Presentation type：Poster presentation

Country：Japan
実用化研究におけるスコープ計画の取り組み．

清水忍

第4回DIAプロジェクトマネジメント・シンポジウム 2019.12.18 DIA

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Event date： 2019.12

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Country：Japan
日本の既承認新医薬品の臨床データパッケージに含まれる比較試験（ピボタル試験）におけるネガティブな結果を含む試験に関する研究．

浅田隆太，清水忍，中村治雅，小野俊介，山口拓洋．

第40回日本臨床薬理学会学術総会 2019.12.5 日本臨床薬理学会

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Event date： 2019.12

Language：Japanese Presentation type：Poster presentation

Country：Japan
Significance and examples of TPP and R&D strategic documents in academia.

Shinobu Shimizu

16th DIA Japan Annual Meeting 2019 2019.11.12 DIA

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Event date： 2019.11

Presentation type：Symposium, workshop panel (nominated)

Country：Japan
治験開始前に非臨床試験で確認しておくこと．

清水忍

ARO協議会第7回学術集会 2019.9.26 ARO協議会

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Event date： 2019.9

Language：Japanese Presentation type：Public lecture, seminar, tutorial, course, or other speech

Country：Japan
RECIPE試験の立ちあげ：IgG4自己抗体陽性の慢性炎症性脱髄性多発神経炎（CIDP）に対するリツキシマブの医師主導治験．

松山奈央，清水忍，飯島正博，西村千穂，田村奈津子，北原裕子，今井美和，中杤昌弘，安藤昌彦，海田賢一，吉良潤一，神田隆，桑原聡，勝野雅央．

ARO協議会第7回学術集会 2019.9.28 ARO協議会

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Event date： 2019.9

Language：Japanese Presentation type：Oral presentation (keynote)

Country：Japan
Muse細胞を用いた新生児慢性肺疾患に対する規治療法の開発．

佐藤義朗，鈴木俊彦，清水忍，呉尚治，三浦良介，上田一仁，Mahboba Jabary，小野田淳人，山本英範，加藤太一，早川昌弘．

第40回日本炎症・再生医学会 2019.7 日本炎症・再生医学会

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Event date： 2019.7

Language：Japanese Presentation type：Poster presentation

Country：Japan
RECIPE: a phase II randomized controlled trial of rituximab for refractory CIDP with IgG4 autoantibodies. International conference

Iijima M, Shimizu S, Fukami Y, Nishi R, Koike H, Ogata H, Kira JI, Kaida K, Koga M, Kanda T, Mori M, Kuwabara S, Katsuno M.

2019 PNS Annual Meeting 2019.6 PNS

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Event date： 2019.6

Language：English Presentation type：Oral presentation (general)

Country：Italy
これから応用される研究は確実なステップを踏んでいるのか？

佐藤義朗，清水忍

第61回日本小児神経学会学術集会 2019.5.31 日本小児神経学会

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Event date： 2019.5 - 2019.6

Language：Japanese Presentation type：Symposium, workshop panel (public)

Country：Japan
Development of a novel treatment for perinatal brain injuries by Multilineage-differentiating stress-enduring cells.

Sato Y, Suzuki T, Kitase Y, Ueda K, Onoda A, Miura R, Go S, Shimizu S, Tsuji M, Hayakawa M.

IPOKRaTES Japan 2019 conference 2019.5

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Event date： 2019.5

Language：English Presentation type：Poster presentation

Country：Japan
A multilineage-differentiating stress-enduring (Muse) cell-based formulation (CL2020) ameliorates neonatal hypoxic-ischemic brain injury.

Ueda K, Sato Y, Suzuki T, Onoda A, Miura R, Go S, Mimatsu H, Kitase Y, Yamashita Y, Irie K, Tsuji M, Mishima K, Shimizu S, Hayakawa M.

IPOKRaTES Japan 2019 conference 2019.5

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Event date： 2019.5

Language：English Presentation type：Poster presentation

Country：Japan
Development of a novel treatment for neonatal bronchopulmonary dysplasia by multilineage-differentiating stress-enduring cells. International conference

Sato Y, Suzuki T, Shimizu S, Go S, Ueda K, Mimatsu H, Kitase Y, Kato T, Hayakawa M.

Pediatric Academic Societies Meeting 2019 Pediatric Academic Societies

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Event date： 2019.4 - 2019.5

Language：English Presentation type：Poster presentation
一般社団法人ARO協議会薬事専門家連絡会の活動「再生医療法下で実施する臨床研究の支援について」．

笹井雅夫，大内麻悠子，浅山恵，清水忍，平松信祥，西村秀雄，山口頂，伊藤達也，遠藤佳代子，上田恵子，菊地佳代子，菅原岳史，山地学，名井陽．

第18回日本再生医療学会総会 2019.3 日本再生医療学会

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Event date： 2019.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
アカデミアから実用化を進めるために－ADRESU試験の事例も踏まえ－．

清水忍

第2回新生児基礎・トランスレーショナルリサーチ研究会 2019.2.24 新生児基礎・トランスレーショナルリサーチ研究会

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Event date： 2019.2

Language：Japanese Presentation type：Oral presentation (invited, special)

Country：Japan
医療機器の多施設共同医師主導治験の治験事務局業務における取組み．

石黒陽子，清水忍，藤田由美，中山忍，浅井三千代，末竹幸広，山本徳則，後藤百万．

日本臨床試験学会第10回学術集会総会 2019.1 日本臨床試験学会

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Event date： 2019.1

Language：Japanese Presentation type：Poster presentation

Country：Japan
治験開始前に非臨床試験で確認しておくこと．

清水忍

ARO協議会医師主導治験におけるスタディマネジメントセミナー 2018.11.17 ARO協議会

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Event date： 2018.11

Language：Japanese Presentation type：Public lecture, seminar, tutorial, course, or other speech

Country：Japan
Toward Implementation of Investigator-initiated Clinical Trial in Academia.

Shinobu Shimizu

15th DIA Japan Annual Meeting 2018 2018.11.12 DIA

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Event date： 2018.11

Language：English Presentation type：Symposium, workshop panel (nominated)

Country：Japan
Use of the TPP as a tool in academia.

Shinobu Shimizu

15th DIA Japan Annual Meeting 2018 2018.11.12 DIA

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Event date： 2018.11

Language：English Presentation type：Symposium, workshop panel (nominated)

Country：Japan
実用化へ向けた名古屋大学AROの活動．

清水忍，水野正明

第2回実践に基づく医療イノベーション研究会 2018.6.29 実践に基づく医療イノベーション研究会

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Event date： 2018.6

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Country：Japan
Development of a novel treatment for perinatal brain injuries by Multilineage-differentiating stress-enduring cells. International conference

Sato Y, Suzuki T, Kitase Y, Shimizu S, Tsuji M, Hayakawa M.

11th Hershey Conference on Developmental Brain Injury 2018 2018.6

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Event date： 2018.6

Language：English Presentation type：Poster presentation
Development of a novel treatment for neonatal bronchopulmonary dysplasia by multilineage-differentiating stress-enduring cells. International conference

Sato Y, Suzuki T, Shimizu S, Go S, Ueda K, Mimatsu H, Kitase Y, Kato T, Hayakawa M.

Pediatric Academic Societies Annual Meeting 2018.5 Pediatric Academic Societies

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Event date： 2018.5

Language：English Presentation type：Oral presentation (general)
A novel treatment for perinatal hypoxic ischemic encephalopathy using Multilineage-differentiating stress enduring cells. Pediatric Academic Societies Meeting International conference

Suzuki T, Sato Y, Shimizu S, Tsuji M, Hida H, Hayakawa M.

Pediatric Academic Societies Annual Meeting 2018.5 Pediatric Academic Societies

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Event date： 2018.5

Language：English Presentation type：Poster presentation
骨髄由来間葉系細胞による顎骨再生療法の評価と臨床展開．

土屋周平，清水忍，片桐渉．

第17回日本再生医療学会総会 2018.3.23 日本再生医療学会

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Event date： 2018.3

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Country：Japan
Multilineage-differentiating stress enduring cellsの低酸素性虚血性脳症モデルに対する治療効果の検討．

鈴木俊彦，佐藤義朗，清水忍，串田良祐，若尾昌平，水野正明，飛田秀樹，辻雅弘，出澤真理，早川昌弘．

第17回日本再生医療学会総会 2018.3.21 日本再生医療学会

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Event date： 2018.3

Language：Japanese Presentation type：Oral presentation (general)

Country：Japan
Multilineage-differentiating stress enduring cellsを用いた新生児慢性肺疾患に対する新規治療法の開発．

佐藤義朗，鈴木俊彦，清水忍，串田良祐，若尾昌平，呉尚治，北瀬悠磨，見松はるか，水野正明，出澤真理，早川昌弘．

第17回日本再生医療学会総会 2018.3.21 日本再生医療学会

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Event date： 2018.3

Language：Japanese Presentation type：Oral presentation (general)

Country：Japan
PETイメージングによる新生児低酸素性虚血性脳症モデルラットに対するMuse細胞治療の検討．

辻雅弘，小川優子，天満敬，圓見純一郎，鈴木俊彦，清水忍，北瀬悠磨，上田一仁，田中えみ，出澤真理，飯田秀博，佐藤義朗．

第17回日本再生医療学会総会 2018.3 日本再生医療学会

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Event date： 2018.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
本邦における希少疾病用医薬品に関するアンケート調査．

清水忍，浅田隆太，吉村健一，中村治雅，小野俊介，渋川勝一，森田正実．

第38回日本臨床薬理学会学術総会 2017.12.8 日本臨床薬理学会

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Event date： 2017.12

Language：Japanese Presentation type：Poster presentation

Country：Japan
本邦における新医薬品の承認審査期間の長期化の要因に関する検討．

浅田隆太，清水忍，中村治雅，小野俊介，山田悠人，山口拓洋．

第38回日本臨床薬理学会学術総会 2017.12.8 日本臨床薬理学会

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Event date： 2017.12

Language：Japanese Presentation type：Poster presentation

Country：Japan
腹圧性尿失禁における脂肪由来再生（幹）細胞分離装置の開発．

清水忍，後藤百万．

平成29年度中部地区医療・バイオ系シーズ発表会 2017.12.7

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Event date： 2017.12

Language：Japanese Presentation type：Oral presentation (general)

Country：Japan
Phase I study of combined therapy with vorinostat and gefitinib to treat BIM deletion polymorphism-associated resistance in EGFR-mutant lung cancer (VICTROY-J). International conference

Hase T, Takeuchi S, Ando M, Hata A, Kenmotsu H, Fujiwara T, Shimizu S, Nagase K, Yoshimura K, Katakami N, Takahashi T, Hasegawa Y, Yano S.

ESMO Asia 2017.11.18

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Event date： 2017.11

Language：English Presentation type：Poster presentation

Country：Singapore
腹圧性尿失禁に対する脂肪組織由来再生幹細胞の臨床応用と臨床検体解析．

鳥山和宏，高成啓介，山本徳則，後藤百万，清水忍，水野正明，亀井譲．

第26回日本形成外科学会基礎学術集会 2017.10.20 日本形成外科学会

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Event date： 2017.10

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Country：Japan
中部先端医療開発円環コンソーシアム（C-CAM）におけるアカデミアシーズの協同開発.

8. 清水忍，植田康平，水野正明．

ARO協議会第5回学術集会 2017.9.26

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Event date： 2017.9

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Country：Japan
名古屋大学医学部附属病院におけるトランスレーショナルリサーチ支援の取組み：腹圧性尿失禁を対象とした医師主導治験の特性解析に着目して．

岡部由香，清水忍，阿部譲，末竹幸広，藏元典子，谷口香織，行方千華，長谷川静香，鳥山和宏，亀井譲，山本徳則，後藤百万，水野正明．

ARO協議会第5回学術集会 2017.9.26 ARO協議会

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Event date： 2017.9

Language：Japanese Presentation type：Poster presentation

Country：Japan
医師主導治験の30日調査におけるPMDAおよびIRBに対する手続きの問題点．

伊師賢樹，伊藤達也，清水忍，杉田修，池田浩治．

ARO協議会第5回学術集会 2017.9.26 ARO協議会

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Event date： 2017.9

Language：Japanese Presentation type：Poster presentation

Country：Japan
当院での新たな細胞培養加工施設の立ち上げにおける構造設備の適格性検討とその対応．

末竹幸広，鈴木哲，谷田部京子，清水忍，加藤勝義，水野正明．

ARO協議会第5回学術集会 2017.6.26 ARO協議会

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Event date： 2017.9

Language：Japanese Presentation type：Poster presentation

Country：Japan
信頼性確保のために必要な臨床研究準備段階におけるCRCの支援業務－効率的な臨床研究の実施を目指して－．

若杉宜美，浅井三千代，安藤幸子，清水忍，加藤勝義，安藤昌彦．

第2回日本臨床薬理学会東海・北陸地方会 2017.5.27 日本臨床薬理学会

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Event date： 2017.5

Language：Japanese Presentation type：Oral presentation (general)

Country：Japan
腹圧性尿失禁に対して傍尿道部に注入する脂肪由来再生（幹）細胞（ADRCs）の特性解析

清水忍，岡部由香，末竹幸広，阿部譲，谷口香織，行方千華，加瀬仁美，浅井三千代，長谷川静香，中山忍，髙成啓介，鳥山和宏，亀井譲，舟橋康人，山本徳則，後藤百万，水野正明

第16回日本再生医療学会総会

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Event date： 2017.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
臨床試験の科学性

清水忍

第10回中部橋渡し研究支援シンポジウム

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Event date： 2016.12

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Venue：名古屋大学医学部附属病院 Country：Japan
実用化研究の立ち上げに関するアカデミアでの状況

清水忍

第1回プロジェクトマネジメント・シンポジウム～医薬品の実用化研究について全体最適を考慮したマネジメントの視点で考える～

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Event date： 2016.12

Language：Japanese Presentation type：Symposium, workshop panel (public)

Country：Japan
腹圧性尿失禁に対する脂肪由来再生（幹）細胞を用いた再生医療の実用化のための薬事対応～医師主導治験の実施に至るまで～

清水忍，中山忍，石黒陽子，藤田由美，浅井三千代，若杉宜美，鍬塚八千代，平川晃弘，舟橋康人，山本徳則，水野正明，後藤百万

第37回日本臨床薬理学会学術総会

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Event date： 2016.12

Language：Japanese Presentation type：Oral presentation (general)

Country：Japan
本邦における希少疾病用医薬品の指定制度に関する現状

浅田隆太，清水忍，吉村健一，中村治雅，小野俊介，渋川勝一，森田正実

第37回日本臨床薬理学会学術総会

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Event date： 2016.12

Language：Japanese Presentation type：Poster presentation

Country：Japan
臨床試験の科学性について．

清水忍

平成28年度臨床研究・治験従事者研修 2016.11.13

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Event date： 2016.11

Language：Japanese Presentation type：Public lecture, seminar, tutorial, course, or other speech

Country：Japan
医薬品を臨床開発する前に非臨床で検討して欲しいこと（非臨床の通知、ICH-M3ガイドライン、薬理、動態、毒性等それぞれの項目に関して）

清水忍

ARO協議会第4回学術集会

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Event date： 2016.8

Language：Japanese Presentation type：Public lecture, seminar, tutorial, course, or other speech

Country：Japan
Phase I study of anti-GD2 antibody ch14.18/CHO long term infusion in recurrent or refractory neuroblastoma patients in Japan International conference

Narita A, Takahashi Y, Siebert N, Nishio N, Wang X, Xu Y, Okuno Y, Kojima D, Suzuki K, Murakami N, Taniguchi R, Ichikawa D, Hamada M, Kataoka S, Sekiya Y, Kawashima N, Nishikawa E, Kamei M, Muramatsu H, Hama A, Kamijo T, Nakazawa A, Hosoi H, Kinoshita Y, Shimizu S, Kato K, Mizuno M, Loibner H, Tajiri T, Nakagawara A, Ladenstein R, Lode HN, Kojima S.

ANR 2016

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Event date： 2016.6

Language：English Presentation type：Poster presentation

Country：Australia
Phase I bridging study of ch14.18/CHO long-term infusion in recurrent or refractory neuroblastoma patients in Japan International conference

Takahashi Y, Narita A, Siebert N, Nishio N, Wang X, Xu Y, Okuno Y, Kojima D, Suzuki K, Murakami N, Taniguchi R, Ichikawa D, Hamada M, Kataoka S, Sekiya Y, Kawashima N, Nishikawa E, Kamei M, Muramatsu H, Hama A, Kamijo T, Nakazawa A, Hosoi H, Kinoshita Y, Shimizu S, Kato K, Mizuno M, Loibner H, Tajiri T, Nakagawara A, Ladenstein R, Lode HN, Kojima S.

2016 ASCO Annual Meeting

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Event date： 2016.6

Language：English Presentation type：Poster presentation

Country：United States
再生医療安全性確保法に基づく先進医療Bの臨床試験実施体制の構築について～骨髄由来間葉系細胞を用いた顎骨欠損に対する骨再生医療研究～

清水忍，豊永亜希子，細野恵美，城田真里，鈴木哲，末竹幸広，平井寿子，西村千穂，田邊めぐみ，小倉佳奈，川影美千代，安藤幸子，鍬塚八千代，平川晃弘，加藤勝義，安藤昌彦，水野正明，片桐渉，日比英晴

日本臨床試験学会第7回学術集会総会

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Event date： 2016.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
システムを用いた試験薬温度管理プロセスの評価

平光彩乃，中山忍，小倉佳奈，石黒陽子，西垣はづき，樋口妙子，東郷由佳，清水忍，加藤勝義，水野正明，長谷川好規，石黒直樹

日本臨床試験学会第7回学術集会総会

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Event date： 2016.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
治験審査委員会（IRB）の効率化と利便性の向上を目指した会議システムの構築

石黒陽子，中山忍，小倉佳奈，平光彩乃，西垣はづき，樋口妙子，東郷由佳，清水忍，加藤勝義，水野正明，長谷川好規，石黒直樹

日本臨床試験学会第7回学術集会総会

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Event date： 2016.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
AROモニターによる医師主導治験のモニタリングの実際と課題

若杉宜美，川影美千代，天野祐里，浅井三千代，安藤幸子，清水忍，加藤勝義，安藤昌彦，水野正明，石黒直樹

日本臨床試験学会第7回学術集会総会

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Event date： 2016.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
抗悪性腫瘍薬の臨床データパッケージ分析からみる今後の課題 International conference

平川晃弘，木下文恵，森由美子，清水忍

日本臨床試験学会第7回学術集会総会

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Event date： 2016.3

Language：Japanese Presentation type：Poster presentation

Country：Japan
ロードマップ

清水忍

ARO協議会第3回学術集会

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Event date： 2015.9

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Venue：伊藤国際学術研究センター Country：Japan
中部先端医療開発円環コンソーシアムにおけるWeb登録・割付システムの紹介

平川晃弘，木下文恵，鍬塚八千代，森由美子，中村真由美，杉下明隆，清水忍，水野正明

ARO協議会第3回学術集会

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Event date： 2015.9

Language：Japanese Presentation type：Poster presentation

Venue：伊藤国際学術研究センター Country：Japan
医療機器の非臨床試験支援の質向上に向けた取り組み

池田浩治，鈴木友人，清水忍，笠井宏委，姚香景，小居秀紀，内山麻希子，中村哲也，菊池佳代子，佐藤喬俊，古矢修一，杉田修

ARO協議会第3階学術集会

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Event date： 2015.9

Language：Japanese Presentation type：Poster presentation

Venue：伊藤国際学術研究センター Country：Japan
Challenges in development of pharmaceuticals and medical devices in academia.

Shinobu Shimizu

The 135th Annual Meeting of the pharmaceutical Society of Japan

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Event date： 2015.3

Language：Japanese Presentation type：Symposium, workshop panel (nominated)

Country：Japan

In Academia, those selected for the `Translational Research Center' of `Coordination, Support and Training Program for Translational Research' by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) have implemented investigator-initiated clinical trials and started to show some success. This was brought about by government's healthcare policy which promotes medical research and its development even in academia. The policy's intent is to further develop innovative medicinal products (e.g. pharmaceuticals, medical devices, regenerative medicines) until their application in the medical services. In this process, the `Translational and Clinical Research Core Center' plays the leading role.
Generally, it is difficult to develop medicinal products based only on medical knowledge, and the presence of those with various expertise (e.g. project management, data management, biostatistics, regulatory affairs, intellectual property) is essential. Especially, to enable each `Translational and Clinical Research Core Center' to function as an `Academic Research Organization (ARO)' that is capable of overall development of medicinal products, involvement of pharmaceutical research/researchers is inevitable.
In this presentation, I will show some problems in development of medicinal products in academia and discuss how pharmaceutical research/researchers can contribute to its success.
中部先端医療開発円環コンソーシアムにおけるWeb登録・割付システムの紹介

平川晃弘，木下文恵，清水忍，鍬塚八千代，室谷健太，森由美子，中村真由美，杉下明隆，水野正明

日本臨床試験学会第6回学術集会総会

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Event date： 2015.2

Language：Japanese Presentation type：Poster presentation

Venue：日本教育会館一ツ橋ホール Country：Japan
質の高い臨床試験を実施するための試験薬管理体制

小倉佳奈，中山忍，石黒陽子，平光彩乃，西垣はづき，樋口妙子，東郷由佳，清水忍，加藤勝義，水野正明，長谷川好規，石黒直樹

日本臨床試験学会第6回学術集会総会

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Event date： 2015.2

Language：Japanese Presentation type：Poster presentation

Venue：日本教育会館一ツ橋ホール Country：Japan
名古屋大学における人材育成セミナーと臨床研究認定者制度に関する取組み

平川晃弘，清水忍，鍬塚八千代，室谷健太，木下文恵，中杤昌弘，杉下明隆，飯島祥彦，加藤勝義，安藤昌彦，水野正明

日本臨床試験学会第6回学術集会総会

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Event date： 2015.2

Language：Japanese Presentation type：Poster presentation

Venue：日本教育会館一ツ橋ホール Country：Japan
名古屋大学における臨床研究認定者制度に関する取組み

清水忍，平川晃弘，鍬塚八千代，室谷健太，木下文恵，中杤昌弘，杉下明隆，飯島祥彦，加藤勝義，安藤昌彦，水野正明

ARO協議会【第2回学術集会】

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Event date： 2014.9

Language：Japanese Presentation type：Poster presentation

Venue：北海道大学医学部学友会館フラテホール Country：Japan
アカデミアにおける医師主導治験・臨床試験のプロジェクトマネジメント

ARO協議会プロジェクトマネジメント専門家連絡会（杉田修，林宏至，池田浩治，鈴木章史，鈴木友人，柄澤麻紀子，清水忍，藤原忠美，遠藤佳代子，笠井宏委，村山敏典，須崎友紀，斎藤勝久，松山琴音，千葉仁，内山麻希子，末吉愛，清水章）

ARO協議会【第2回学術集会】

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Event date： 2014.9

Language：Japanese Presentation type：Poster presentation

Country：Japan
中部先端医療開発円環コンソーシアム（C-CAM）支援プロジェクトにおける相互モニタリングの実施に関する報告

清水忍，安藤幸子，川影美千代，南出ちさと，武重榮子，太田康之，西川政勝，水野正明

日本臨床試験研究会第5回学術集会総会

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Event date： 2014.3

Language：Japanese Presentation type：Poster presentation

Venue：東京大学伊藤国際学術研究センター Country：Japan
本邦における心医薬品の開発及び承認審査段階におけるハードルの検討

浅田隆太，清水忍，小野俊介，伊藤達也，清水章，山口拓洋

第34回日本臨床薬理学会学術総会

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Event date： 2013.12

Language：Japanese Presentation type：Oral presentation (general)

Country：Japan
任意参加のPGx検討を伴う治験の同意説明文書の形態に関する一考察

安藤幸子，浅井三千代，今井美和，天野祐里，藤田由美，若杉宜美，渡邉亜紀子，中山忍，清水忍，加藤勝義，長谷川好規，石黒直樹

第34回日本臨床薬理学会学術総会

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Event date： 2013.12

Language：Japanese Presentation type：Poster presentation

Country：Japan
名古屋大学における生命倫理審査委員会の事前審査について

清水忍，中山忍，飯島祥彦，加藤勝義，安藤昌彦，水野正明，直江知樹

第33回日本臨床薬理学会学術総会

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Event date： 2012.11 - 2012.12

Language：Japanese Presentation type：Poster presentation

Country：Japan

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Research Project for Joint Research, Competitive Funding, etc. 7

参照系AI技術を応用した痙攣性発声障害診断システムとチタンブリッジ手術支援機器開発に関する研究

2024.5 - 2027.3

難治性疾患実用化研究事業

讃岐徹治

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Authorship：Coinvestigator(s) Grant type：Competitive
球脊髄性筋萎縮症に対するメキシレチン塩酸の有効性及び安全性を検討する医師主導治験

2024.4 - 2028.3

臨床研究・治験推進研究事業

勝野雅央

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球脊髄性筋萎縮症に対するメキシレチン塩酸の有効性及び安全性を検討する医師主導治験

2024.4 - 2028.3

臨床研究・治験推進研究事業

勝野雅央

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Authorship：Coinvestigator(s) Grant type：Competitive
実践研修の実施と検証による研究マネジメント人材育成及びネットワーク構築に関する研究

2023.8 - 2025.3

研究開発推進ネットワーク事業

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Authorship：Coinvestigator(s) Grant type：Competitive

Grant amount：\1560000 （ Direct Cost: \1200000 、 Indirect Cost：\360000 ）
QbDの概念が導入された業務フローの活用による多職種連携の研究計画支援体制・方法の汎用化に向けた検討

2023.8 - 2024.3

研究開発推進ネットワーク事業

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Authorship：Coinvestigator(s) Grant type：Competitive

Grant amount：\650000 （ Direct Cost: \500000 、 Indirect Cost：\150000 ）
膵癌における免疫チェックポイント阻害感受性増強のための間質コンディショニング法の開発

2023.4 - 2027.3

臨床研究・治験推進研究事業

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Authorship：Coinvestigator(s) Grant type：Competitive
悪性中皮腫に対する新規ドラッグデリバリーシステムを用いた個別化治療の開発

2023.4 - 2025.3

創薬基盤推進事業

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Authorship：Coinvestigator(s) Grant type：Competitive

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