研究本部・トランスレーショナルリサーチ本部

発表論文・寄稿

創薬基盤技術開発

• MAbs (2023) DOI:10.1080/19420862.2023.2244214

  Monte Carlo Thompson sampling-guided design for antibody engineering

  T. Kakuzaki, H. Koga, S. Takizawa, S. Metsugi, H. Shiraiwa, Z. Sampei, K. Yoshida, H. Tsunoda, R. Teramoto

• Pharm Res (2021) DOI:10.1007/s11095-021-03054-4

  Analysis of Non-linear Pharmacokinetics of P-Glycoprotein Substrates in a Microfluidic Device Using a Mathematical Model that Includes an Unstirred Water Layer (UWL) Compartment

  F. Igarashi, T. Nakagawa, Y. Shinohara, T. Tachibana

新規物質創生 バイオ医薬品

• Antibodies (Basel) (2023) DOI:10.3390/antib12020036

  Complement Activation by an Anti-Dengue/Zika Antibody with Impaired Fcγ Receptor Binding Provides Strong Efficacy and Abrogates Risk of Antibody-Dependent Enhancement

  Z. Sampei, C. X. Koo, F. J. Teo, Y. X. Toh, T. Fukuzawa, S. W. Gan, T. Nambu, A. Ho, K. Honda, T. Igawa, F. Ahmed, C. I. Wang, K. Fink, J. Nezu

• MAbs (2023) DOI:10.1080/19420862.2023.2222441

  Efficient production of bispecific antibody by FAST-Ig(TM) and its application to NXT007 for the treatment of hemophilia A

  H. Koga, T. Yamano, J. Betancur, S. Nagatomo, Y. Ikeda, K. Yamaguchi, Y. Nabuchi, K. Sato, Y. Teranishi-Ikawa, M. Sato, H. Hirayama, A. Hayasaka, T. Torizawa, K. Haraya, Z. Sampei, H. Shiraiwa, T. Kitazawa, T. Igawa, T. Kuramochi

• MAbs (2022) DOI:10.1080/19420862.2022.2040350

  Comprehensive engineering of a therapeutic neutralizing antibody targeting SARS-CoV-2 spike protein to neutralize escape variants

  T. Kuramochi, S. W. Gan, A. W. S. Ho, B. Wang, N. Kageji, T. Nambu, S. Iida, M. Okuda-Miura, W. S. Chia, C. Y. Yeo, D. Chen, W. H. Lee, E. Z. X. Ngoh, S. N. Mohd Salleh, C. I. Wang, T. Igawa, H. Shimada

• MAbs (2022) DOI:10.1080/19420862.2022.2068213

  Elimination of plasma soluble antigen in cynomolgus monkeys by combining pH-dependent antigen binding and novel Fc engineering

  Y. Hori, K. Ohmine, H. Katada, Y. Noguchi, K. Sato, T. Nambu, L. R. Adeline, G. S. Wan, K. Haraya, K. Ozeki, M. Nanami, T. Tachibana, Z. Sampei, T. Kuramochi, J. Nezu, K. Hattori, T. Igawa

• Sci Rep (2021) DOI:10.1038/s41598-021-85274-7

  Antibody design using LSTM based deep generative model from phage display library for affinity maturation

  K. Saka, T. Kakuzaki, S. Metsugi, D. Kashiwagi, K. Yoshida, M. Wada, H. Tsunoda, R. Teramoto

新規物質創生 ケミカル医薬品

• J Am Chem Soc (2023) DOI:10.1021/jacs.3c03886

  Development of Orally Bioavailable Peptides Targeting an Intracellular Protein: From a Hit to a Clinical KRAS Inhibitor

  M. Tanada, M. Tamiya, A. Matsuo, A. Chiyoda, K. Takano, T. Ito, M. Irie, T. Kotake, R. Takeyama, H. Kawada, R. Hayashi, S. Ishikawa, K. Nomura, N. Furuichi, Y. Morita, M. Kage, S. Hashimoto, K. Nii, H. Sase, K. Ohara, A. Ohta, S. Kuramoto, Y. Nishimura, H. Iikura, T. Shiraishi

• J Med Chem (2022) DOI:10.1021/acs.jmedchem.2c01296

  Broadly Applicable and Comprehensive Synthetic Method for N-Alkyl-Rich Drug-like Cyclic Peptides

  K. Nomura, S. Hashimoto, R. Takeyama, M. Tamiya, T. Kato, T. Muraoka, M. Kage, K. Nii, K. Kotake, S. Iida, T. Emura, M. Tanada, H. Iikura

• J Med Chem (2022) DOI:10.1021/acs.jmedchem.2c01099

  Discovery of CH7057288 as an Orally Bioavailable, Selective, and Potent pan-TRK Inhibitor

  T. Ito, K. Kinoshita, M. Tomizawa, S. Shinohara, H. Nishii, M. Matsushita, K. Hattori, Y. Kohchi, M. Kohchi, T. Hayase, F. Watanabe, K. Hasegawa, H. Tanaka, S. Kuramoto, K. Takanashi, N. Oikawa

• J Med Chem (2020) DOI:10.1021/acs.jmedchem.9b01743

  Lead Optimization and Avoidance of Reactive Metabolite Leading to PCO371, a Potent, Selective, and Orally Available Human Parathyroid Hormone Receptor 1 (hPTHR1) Agonist

  Y. Nishimura, T. Esaki, Y. Isshiki, Y. Furuta, A. Mizutani, T. Kotake, T. Emura, Y. Watanabe, M. Ohta, T. Nakagawa, K. Ogawa, S. Arai, H. Noda, H. Kitamura, M. Shimizu, T. Tamura, H. Sato

薬効・薬理研究

• Pharmacol Res Perspect (2023) DOI:10.1002/prp2.1094

  Novel oral SPT inhibitor CH5169356 inhibits hepatic stellate cell activation and ameliorates hepatic fibrosis in mouse models of non-alcoholic steatohepatitis (NASH)

  N. Hada, A. Katsume, K. Kenichi, C. Endo, N. Horiba, M. Sudoh

• Nature Communications (2023)

  Single-cell multi-omics analysis identifies two distinct phenotypes of newly-onset microscopic polyangiitis

  M. Nishide, K. Nishimura, H. Matsushita, R. Edahiro, S. Inukai, H. Shimagami, S. Kawada, Y. Kato, T. Kawasaki, K. Tsujimoto

• Haemophilia (2022) DOI:10.1111/hae.14581

  Emicizumab enhances thrombus formation in vitro under high shear flow conditions in whole blood from patients with type 1 and type 3 von Willebrand disease

  H. Yaoi, Y. Shida, K. Ogiwara, T. Kitazawa, M. Shima, K. Nogami

• Pharmacol Res Perspect (2022) DOI:10.1002/prp2.973

  EOS789, pan-phosphate transporter inhibitor, ameliorates the progression of kidney injury in anti-GBM-induced glomerulonephritis rats

  Y. Tsuboi, Y. Ichida, A. Murai, A. Maeda, M. Iida, A. Kato, S. Ohtomo, N. Horiba

• Nat Commun (2022) DOI:10.1038/s41467-022-32952-3

  Combination of T cell-redirecting bispecific antibody ERY974 and chemotherapy reciprocally enhances efficacy against non-inflamed tumours

  Y. Sano, Y. Azuma, T. Tsunenari, Y. Kayukawa, J. Shinozuka, E. Fujii, J. Amano, Y. Nishito, T. Maruyama, Y. Kinoshita, Y. Sakamoto, A. Yoshida, Y. Miyazaki, Y. Sato, C. Teramoto-Seida, T. Ishiguro, T. Tanaka, T. Kitazawa, M. Endo

• PLoS One (2022) DOI:10.1371/journal.pone.0265081

  TNF-α induces Claudin-1 expression in renal tubules in Alport mice

  M. Iida, S. Ohtomo, N. A. Wada, O. Ueda, Y. Tsuboi, A. Kurata, K. I. Jishage, N. Horiba

• Haemophilia (2021) DOI:10.1111/hae.14272

  Emicizumab improves thrombus formation of type 2A von willebrand disease under high shear condition

  H. Yaoi, Y. Shida, T. Kitazawa, M. Shima, K. Nogami

• Cell (2021) DOI:10.1016/j.cell.2021.03.056

  Dynamic landscape of immune cell-specific gene regulation in immune-mediated diseases

  M. Ota, Y. Nagafuchi, H. Hatano, K. Ishigaki, C. Terao, Y. Takeshima, H. Yanaoka, S. Kobayashi, M. Okubo, H. Shirai, Y. Sugimori, J. Maeda, M. Nakano, S. Yamada, R. Yoshida, H. Tsuchiya, Y. Tsuchida, S. Akizuki, H. Yoshifuji, K. Ohmura, T. Mimori, K. Yoshida, D. Kurosaka, M. Okada, K. Setoguchi, H. Kaneko, N. Ban, N. Yabuki, K. Matsuki, H. Mutoh, S. Oyama, M. Okazaki, H. Tsunoda, Y. Iwasaki, S. Sumitomo, H. Shoda, Y. Kochi, Y. Okada, K. Yamamoto, T. Okamura, K. Fujio

• Sci Rep (2021) DOI:10.1038/s41598-021-81669-8

  Novel myostatin-specific antibody enhances muscle strength in muscle disease models

  H. Muramatsu, T. Kuramochi, H. Katada, A. Ueyama, Y. Ruike, K. Ohmine, M. Shida-Kawazoe, R. Miyano-Nishizawa, Y. Shimizu, M. Okuda, Y. Hori, M. Hayashi, K. Haraya, N. Ban, T. Nonaka, M. Honda, H. Kitamura, K. Hattori, T. Kitazawa, T. Igawa, Y. Kawabe, J. Nezu

• Nephrol Dial Transplant (2021) DOI:10.1093/ndt/gfaa156

  Evidence of an intestinal phosphate transporter alternative to type IIb sodium-dependent phosphate transporter in rats with chronic kidney disease

  Y. Ichida, S. Ohtomo, T. Yamamoto, N. Murao, Y. Tsuboi, Y. Kawabe, H. Segawa, N. Horiba, K. I. Miyamoto, J. Floege

薬物動態研究

• BioDrugs (2023) DOI:10.1007/s40259-022-00566-2

  Translational Approach for Predicting Human Pharmacokinetics of Engineered Therapeutic Monoclonal Antibodies with Increased FcRn-Binding Mutations

  K. Haraya, T. Tachibana

• Biol Pharm Bull (2022) DOI:10.1248/bpb.b21-01026

  Cellular Binding and Internalization Assay for an Anti-FcγRIIB Antibody Using Human Liver Non-parenchymal Cells

  Y. Noguchi, K. Ozeki, H. Akita

• Pharmaceuticals (Basel) (2022) DOI:10.3390/ph15050508

  Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation

  K. Haraya, H. Tsutsui, Y. Komori, T. Tachibana

• Aaps j (2021) DOI:10.1208/s12248-020-00539-9

  A Novel Total Drug Assay for Quantification of Anti-C5 Therapeutic Monoclonal Antibody in the Presence of Abundant Target

  H. Watanabe, M. Shibuya, N. Shibahara, Y. Ruike, Z. Sampei, K. Haraya, T. Tachibana, T. Wakabayashi, A. Sakamoto, H. Tsunoda, N. Murao

• Sci Rep (2021) DOI:10.1038/s41598-021-87912-6

  A cell based assay for evaluating binding and uptake of an antibody using hepatic nonparenchymal cells

  Y. Noguchi, K. Ozeki, H. Takesue, H. Akita

• Biol Pharm Bull (2021) DOI:10.1248/bpb.b20-00578

  Evaluation of Methods to Assess CYP3A Induction Risk in Clinical Practice Using in Vitro Induction Parameters

  H. Tsutsui, S. Kuramoto, K. Ozeki

安全性研究

• J Toxicol Sci (2023) DOI:10.2131/jts.48.399

  Preclinical in vitro evaluation of immune suppression induced by GYM329, Fc-engineered sweeping antibody

  Y. Iwata, H. Katada, M. Okuda, Y. Doi, T. J. Ching, A. Harada, A. Takeiri, M. Honda, M. Mishima

• Exp Anim (2023) DOI:10.1538/expanim.23-0017

  Effects of 2-week food-restriction on toxicological parameters in cynomolgus monkeys

  N. Fujisawa, T. Matsushita, S. Matsuo, M. Hiranuma, H. Azabu, R. Saito, S. I. Komatsu, A. Kato, N. Toyota, J. Taketo, H. Suzuki

• MAbs (2023) DOI:10.1080/19420862.2023.2253570

  Rapid in vitro assessment of the immunogenicity potential of engineered antibody therapeutics through detection of CD4(+) T cell interleukin-2 secretion

  Y. Arata, S. Motoyama, M. Yano, T. Ikuno, S. Ito, T. Matsushita, A. Takeiri, Y. Nishito, N. Yabuki, H. Mizuno, Z. Sampei, M. Mishima, M. Honda, J. Kiyokawa, H. Suzuki, S. Chiba, M. Tabo, C. Kubo

• Histol Histopathol (2022) DOI:10.14670/hh-18-374

  Protruding structures with high expression of LGR5 are formed during regrowth phase after chemo-treatment in xenograft model of colorectal adenocarcinoma

  M. Yamazaki, A. Kato, N. Sawada, T. Watanabe, M. Suzuki

• J Pathol Inform (2022) DOI:10.1016/j.jpi.2022.100120

  Digital workflows for pathological assessment of rat estrous cycle stage using images of uterine horn and vaginal tissue

  S. Onishi, R. Egami, Y. Nakamura, Y. Nagashima, K. Nishihara, S. Matsuo, A. Murai, S. Hayashi, Y. Uesumi, A. Kato, H. Tsunoda, M. Yamazaki, H. Mizuno

• J Toxicol Pathol (2022) DOI:10.1293/tox.2021-0054

  Lipomatosis of axillary lymph nodes in a cynomolgus monkey (Macaca fascicularis)

  M. Nakagawa, S. Hayashi, S. Matsuo, M. Yamazaki, A. Kato

• Histol Histopathol (2022) DOI:10.14670/hh-18-450

  Class II lupus nephritis with podocyte injury in imiquimod-induced lupus-prone mice

  A. Murai, M. Yamazaki, K. Nishihara, A. Kito, S. Oyama, N. Horiba, A. Kato

• Sci Rep (2022) DOI:10.1038/s41598-022-08951-1

  In vivo imaging with two-photon microscopy to assess the tumor-selective binding of an anti-CD137 switch antibody

  C. Kaneko, H. Tsutsui, K. Ozeki, M. Honda, K. Haraya, Y. Narita, M. Kamata-Sakurai, J. Kikuta, M. Tabo, M. Ishii

• Toxicol Appl Pharmacol (2022) DOI:10.1016/j.taap.2022.115986

  Priming treatment with T-cell redirecting bispecific antibody ERY974 reduced cytokine induction without losing cytotoxic activity in vitro by changing the chromatin state in T cells

  Y. Iwata, Y. Narushima, A. Harada, M. Mishima

臨床薬理

• 医学のあゆみ (2023)

  Application of physiologically-based pharmacokinetic (PBPK) modeling and simulation in the drug discovery research of therapeutic monoclonal antibodies

  T. Tachibana, K. Haraya

• Expert Rev Clin Pharmacol (2023) DOI:10.1080/17512433.2023.2243213

  Clinical pharmacology of emicizumab for the treatment of hemophilia A

  K. Yoneyama, C. Schmitt, A. Portron, A. Kiialainen, N. Kotani, F. Jaminion, S. Retout, J. I. Adamkewicz

• Sci Rep (2023) DOI:10.1038/s41598-023-39425-7

  Development of rat duodenal monolayer model with effective barrier function from rat organoids for ADME assay

  K. Tanaka, S. Kawai, E. Fujii, M. Yano, T. Miyayama, K. Nakano, K. Terao, M. Suzuki

• Drug Metabolism and Pharmacokinetics (2023)

  Physiologically based pharmacokinetic (PBPK) model that describes enhanced FcRn-dependent distribution of monoclonal antibodies (mAbs) by pI-engineering in mice

  S. Naoi, M. Yamane, T. Nemoto, M. Kato, R. Saito, T. Tachibana

• Pharm Res (2023) DOI:10.1007/s11095-023-03541-w

  Development of a New Method to Evaluate the Biodistribution of Antibodies Using Non-Radioactive Metal Labeling and Inductively Coupled Plasma Mass Spectrometry

  M. Nagayasu, Y. Takano, K. Ozeki

• J Pharmacol Exp Ther (2023) DOI:10.1124/jpet.123.001595

  Quantitative prediction of OATP-mediated disposition and biliary clearance using human liver chimeric mice

  T. Miyake, H. Tsutsui, M. Hirabayashi, T. Tachibana

• ファルマシア (2022)

  小児医薬品開発における薬物動態情報の活用

  江本千恵, 米山洸一郎

• J Clin Pharmacol (2022) DOI:10.1002/jcph.1968

  A Model-Based Framework to Inform the Dose Selection and Study Design of Emicizumab for Pediatric Patients With Hemophilia A

  K. Yoneyama, C. Schmitt, T. Chang, C. Dhalluin, S. Nagami, C. Petry, G. G. Levy

• Xenobiotica (2021) DOI:10.1080/00498254.2021.1942588

  In vivo-in vitro correlation of antitumor activity of heat shock protein 90 (HSP90) inhibitors with a pharmacokinetics/pharmacodynamics analysis using NCI-N87 xenograft mice

  N. Ohminato, M. Nagayasu, K. Ozeki, R. Saitoh, N. Ono, N. Shibahara, A. Suda, K. Yoshinari

• Biol Pharm Bull (2021) DOI:10.1248/bpb.b20-00775

  Prediction of Human Pharmacokinetics Profile of Monoclonal Antibody Using hFcRn Transgenic Mouse Model

  G. Nakamura, K. Ozeki, H. Takesue, M. Tabo, K. I. Hosoya

• Pharm Res (2021) DOI:10.1007/s11095-021-03028-6

  Combination of cassette-dosing and microsampling for reduced animal usage for antibody pharmacokinetics in cynomolgus monkeys, wild-type mice, and human FcRn transgenic mice

  M. Nagayasu, K. Ozeki

• Br J Pharmacol (2021) DOI:10.1111/bph.15612

  Quantitative prediction of P-glycoprotein-mediated drug-drug interactions and intestinal absorption using humanized mice

  T. Miyake, H. Tsutsui, K. Haraya, T. Tachibana, K. Morimoto, S. Takehara, M. Ayabe, K. Kobayashi, Y. Kazuki

• Sci Rep (2021) DOI:10.1038/s41598-021-03708-8

  Generation of a lung squamous cell carcinoma three-dimensional culture model with keratinizing structures

  S. Kawai, K. Nakano, K. Tamai, E. Fujii, M. Yamada, H. Komoda, H. Sakumoto, O. Natori, M. Suzuki

• DMPK New Letter (2021)

  奨励賞を受賞して　―お世話になった多くの方々への感謝をこめて―

  江本千恵

学会発表

＜創薬基盤技術開発＞

• ISMB (2023)

  Monte-carlo Thompson sampling for antibody design

  T Kakuzaki et al.

• American Society of Nephrology (2023)

  Capturing spatial transcriptomics around cysts with deep learning and image processing is a novel method to reveal therapeutic targets in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

  Y Uesumi et al.

• 日本プロテオーム学会 (2022)

  中外製薬で求めるプロテオミクス人財

  K Nagano et al.

• 第一回日本抗体学会 (2022)

  機械学習技術による抗体創薬プロセスの変革「MALEXA®：MAchineLEarning x Antibody」

  K Shirai et al.

• ゲノム創薬・創発フォーラム (2021)

  多層的オミックスデータベース構築による腫瘍免疫システムの解明と医薬品開発への応用

  H Mizuno et al.

• 日本ヒトプロテオーム学会 (2021)

  血漿プロテオミクスによる子宮内膜症のバイオマーカー探索

  K Nagano et al.

• 日本生物物理学会第59回年会 (2021)

  RNA-seq based expression analysis of the extracellular ATP dependent tumor-selective response of the STA551 antibody targeting CD137

  S Metsugi et al.

＜新規物質創生 バイオ医薬品 / 薬物動態研究＞

• Fc Receptor Pathway Targeted Therapies Summit (2023)

  Fc Engineering for Maximizing Soluble Target Antigen Sweeping Efficacy by Enhanced FcgRIIb Binding and Charge Modulation

  Y Noguchi et al.

• Immuno-Oncology Summit (2023)

  A Novel Next-Generation T Cell Bispecific Antibody with a Unique Mechanism to Optimize TME

  S. Ishii et al.

• PEGS (2022)

  Focused Library Approach to Generate Environment-Responsive Antibodies

  S. Shimizu et al.

• Antibody Engineering & Therapeutics 2022 (2022)

  Fc Engineering for Maximizing Soluble Target Antigen Sweeping Efficacy by Enhanced FcγRIIb Binding and Charge Modulation

  K. Haraya et al.

• AACR 2021 (2021)

  Responses of a novel tumor selective anti-CD137 agonist antibody activated by elevated extracellular ATP in tumor microenvironment

  M. Sakurai et al.

• JFCR-ISCC (2021)

  A novel tumor selective anti-CD137 agonist antibody activated by elevated extracellular ATP in tumor microenvironment

  M. Sakurai et al.

• Antibody engineering and therapeutics (2021)

  A novel next generation T cell bispecific antibody platform

  S. Shimizu et al.

＜新規物質創生 ケミカル医薬品＞

• E-JAWS 第2回製薬分科会 (2023)

  中外製薬：創薬計算化学での活用事例紹介

  A Arakawa et al.

• ACS Fall 2023 (2023)

  Synthetic studies on aromatic amino acids for acceleration of mid-size molecule drug discovery

  M Wadamoto et al.

• CBI学会2021年大会 (2021)

  中外製薬の創薬研究におけるAWS活用事例紹介

  A Arakawa et al.

• PISTOIA ALLIANCE/QED-C/QUPHARM/QPARC QUANTUM COMPUTING COMMUNITY SUMMIT (2021)

  Experience in QPARC

  A Arakawa et al.

• 有機合成化学協会東海支部 若手研究者のためのセミナー (2020)

  経口投与可能なPTHR1受容体アゴニストPCO371の創製

  Y Nishimura et al.

＜薬効薬理研究＞

• AACR Annual Meeting 2023 (2023)

  A DLL3/CD3/CD137 trispecific T cell engager shows potent antitumor activity in small cell lung cancer models

  H Mikami et al.

• 日本エンドメトリオーシス学会学術講演会 (2023)

  サルの自然発症子宮内膜症モデルを用いた炎症、特に、IL-8を標的とした病態制御の研究

  I Sato et al.

• World Congress on Endometriosis (2023)

  Role of IL-8 and Involvement of Macrophages in Fibrosis of Endometriosis

  I Sato et al.

• 日本肝臓学会総会 (2022)

  胆汁うっ滞性慢性肝疾患における胆汁酸組成・合成経路と治療効果との関係

  M Iida et al.

• International liver congress 2022 (2022)

  Association of bile acids composition and synthetic pathway with therapeutic effect of bezafibrate in chronic cholestatic liver disease

  M Iida et al.

• AACR2022 (2022)

  Single cell RNA sequencing revealed that the mechanism of the synergistic efficacy of STA551 and immune checkpoint inhibitor results from the induction of highly activated T cells in tumor

  R Uchikawa et al.

• 19th International Celiac Disease Symposium (2022)

  DONQ52: A Novel Bispecific Antibody Targeting HLA-DQ2.5/Gluten peptides Blocks DQ2.5/Gluten dependent immune response

  A Mizoroki et al.

• AACR Annual Meeting (2021)

  GPRC5D is a target for the treatment of multiple myeloma with bispecific T cell-redirecting antibody

  I Nakai et al.

• 日本がん免疫学会 (2021)

  腫瘍選択的抗CD137アゴニスト抗体STA551の創製とその全身性免疫反応に関する検討

  R Uchikawa et al.

• 日本がん分子標的治療学会 (2021)

  腫瘍選択的抗CD137アゴニスト抗体STA551の創製とその全身性免疫反応に関する検討

  H Mikami et al.

• JFCR－ISCC (2021)

  Combination efficacy of STA551, a novel CD137 agonist activated by extracellular ATP, with immune targeted therapy

  H Mikami et al.

• 日本免疫学会 (2021)

  STA551, a novel ATP-dependent CD137 agonist improved anti-tumor efficacy of T cell bispecific antibody in vivo.

  S Horikawa et al.

• 日本がん免疫学会総会 (2021)

  腫瘍選択的抗CD137アゴニスト抗体STA551の創製とその全身性免疫反応に関する検討

  R Uchikawa et al.

• World Immunotherapy Council’s (WIC) 4th Young Investigators Symposium (2021)

  Evaluation on tumor selectivity of immune response driven by STA551, an anti-CD137 agonist antibody activated in the presence of extracellular ATP

  R Uchikawa et al.

＜安全性研究＞

• 第10回ASVP/第10回JCVP合同学術集会 (2023)

  A case of extrahepatic cholangicellular carcinoma in a beagle dog

  H Ono et al.

• CSC (2023)

  Histopathological evaluation of crypt fission during intestinal development in neonatal mice

  M Yamazaki et al.

• 日本毒性学会 (2023)

  腸管オルガノイドと免疫細胞の共培養系を用いたT-cell engagerによる毒性及び種差研究へのアプローチ

  Y Arata et al.

• 日本毒性学会学術年会 (2023)

  Target safety assessment and examples of drug discovery and development strategies

  S Akai et al.

• HAB研究機構学術年会 (2023)

  毒性研究におけるヒトiPS細胞の応用

  J Kiyokawa et al.

• 日本動物実験代替法学会講習会 (2023)

  医薬品研究開発の視点から見た代替法とその現状

  J Kiyokawa et al.

• 日本毒性病理学会 (2023)

  Time course of skin lesions in a mouse model of bleomycin-induced systemic sclerosis

  J Shinozuka et al.

• 日本毒性病理学会 (2023)

  実験的自己免疫性脳脊髄炎モデルの経時的な病理組織学的変化とFingolimod薬理作用発現の関係

  C Kato et al.

• 日本毒性学会学術年会 (JSOT2023) (2023)

  Fc改変抗体の免疫抑制作用に対するin vitro評価 ～サルからヒトへの外挿性を問う～

  Y Iwata et al.

• 日本先天異常学会 (2023)

  ミコフェノール酸モフェチルの生殖発生毒性試験結果

  R Katagiri et al.

• Charles River Biotech Symposium (2023)

  Scientific Rationales of Safety to Support Human Extrapolation in Engineered Monoclonal Antibody Development

  M Honda et al.

• 日本毒性病理学会 (2022)

  Detailed investigation of the relationship between artifacts in rat eyes and fixation times in Davidson’s fixative and modified Davidson’s fixative

  M Nakagawa et al.

• 第13回日本安全性薬理研究会学術年会 (2022)

  hERG current assessment using Qpatch: How much does CiPA recommended protocol make a difference to in-house legacy protocol?

  C Kaneko et al.

• 第49回日本毒性学会学術年会 (2022)

  ヒトiPS細胞を用いた新たなin vitro胚・胎児発生毒性アッセイの確立と有用性

  M Ishida et al.

• 第49回日本毒性学会学術年会 (2022)

  開発者からみたバイオ医薬品の開発事例に基づく非臨床安全性評価への問題提起

  M Honda et al.

• 第49回日本毒性学会学術年会 (2022)

  Motion Field ImagingによるヒトiPS細胞由来心筋細胞を用いた心機能評価の有用性と課題

  C Kaneko et al.

• 第49回日本毒性学会学術年会 (2022)

  二光子イメージングを用いた細胞外ATP依存的なCD137アゴニスト抗体による全身免疫活性化低減の検証

  C Kaneko et al.

• 日本毒性病理学会 (2022)

  Detection of Glomerulosclerosis using Halo AI in a mouse model of anti–glomerular basement membrane glomerulonephritis

  A Murai et al.

• 第49回日本毒性学会学術年会 (2022)

  二重特異性T細胞誘導抗体のCRS軽減を目指して

  Y Iwata et al.

• 第49回日本毒性学会学術年会 (2022)

  ヒトiPS細胞を活用したin vitro毒性評価への応用研究事例

  J Kiyokawa et al.

• 第49回日本毒性学会学術年会 (2022)

  ヒトiPS細胞からの樹状細胞及び肥満細胞の作製と創薬研究における有用性

  J Kiyokawa et al.

• 第49回日本毒性学会学術年会 (2022)

  First in human dose selection strategy of bispecific antibodies

  S Akai et al.

• 第49回日本毒性学会学術年会 (2022)

  Case reports: Application of Microsampling Methods to rats in GLP studies

  Y Yamamuro et al.

• 医薬品毒性機序研究会 (2022)

  血管内皮細胞と免疫細胞の共培養系を用いたバイオ医薬品の免疫複合体の毒性リスク評価

  S Ito et al.

• 日本免疫毒性学会 (2022)

  Involvement of Fc receptors in the immunotoxicity of biopharmaceuticals

  S Ito et al.

• 日本毒性病理学会 (2022)

  Detection of Glomerulosclerosis using Halo AI in a mouse model of anti–glomerular basement membrane glomerulonephritis

  A Murai et al.

• 第96回年会 日本薬理学会 (2022)

  Early non-clinical safety evaluation strategies and case studies for small molecule drug discovery

  S Akai et al.

• BioSafe General Membership Meeting (2022)

  EIH Approach and Discussion with Health Authorities for an MHC Targeting Antibody for a Non-Oncology Indication

  H Ikegami et al.

• 日本免疫毒性学会 (2022)

  バイオ医薬品開発におけるヒト安全性予測向上を目指した非臨床免疫毒性・免疫原性研究

  C Kubo et al.

• 日本環境変異原ゲノム学会 (2022)

  DNA polymerase kappa不活性化マウスにおいてmitomycin Cによって誘発されるγH2AXの免疫組織学的解析

  A Takeiri et al.

• 日本毒性学会学術年会 (2021)

  非臨床におけるin vivo QT延長・催不整脈性評価の現状と今後の展望

  R Komatsu et al.

• 日本毒性学会 (2021)

  抗体医薬品の免疫原性の非臨床評価及び低減化

  C Kubo et al.

• 日本毒性学会 (2021)

  in vivo消化管毒性評価におけるバイオマーカーの有用性

  N Fujisawa et al.

• 日本環境変異原ゲノム学会 (2021)

  Ames試験陽性フォローアップとしてのTK6細胞γH2AX評価系の有用性検討；構造異性体および類縁体からの検証

  M Tanaka et al.

• Pharma R&D (2021)

  Immunogenicity Case Studies and De-Immunization Strategy

  C Kubo et al.

• 日本毒性病理学会学術年会 (2021)

  生着臓器に依存する転移腫瘍細胞の病理形態学的特徴とcancer organoidsによるモデル化

  M Yamazaki et al.

• 日本毒性病理学会学術年会 (2021)

  アルポート症候群モデルマウスの腎臓の病理学的特徴

  A Murai et al.

＜臨床薬理＞

• 日本エンドメトリオーシス学会 学術講演会 (2023)

  ヒト子宮内膜症患者由来細胞を用いた線維化モデルにおけるIL8とマクロファージの影響

  K Nakano et al.

• 日本薬物動態学会 (2023)

  改変抗体のヒト初回投与量

  M Nagayasu et al.

• 日本薬物動態学会 (2023)

  Quantitative prediction of CYP3A-mediated drug-drug interactions by correctly estimating fraction metabolized using human liver chimeric mice

  T Miyake et al.

• 日本薬物動態学会 (2023)

  薬物動態学の視点から: in vitro/in vivoデータ同時モデリングによるP-gp基質のヒト吸収非線形性予測

  T Mochizuki et al.

• 日本薬物動態学会 (2023)

  Development of human intestinal organoid-derived monolayer model for drug absorption study

  K Tanaka et al.

• ISSX (2023)

  Human liver chimeric mouse and trasngenic animals are useful tools for quantitatively predicting clearance and drug-drug interactions in human

  T Nakagawa et al.

• 国際薬物動態学会 (2023)

  In silico approach shows good predictability for free fraction in plasma and volume of distribution in human for drugs subjected to lysosomal trapping

  C Emoto et al.

• 24th Annual Simcyp Consortium Meeting (2023)

  Comparison of in Silico Prediction Methods of Volume of Distribution for Drugs Subjected to Lysosomal Trapping

  C Emoto et al.

• 第20回DIA日本年会2023 (2023)

  Dose optimizationのためのFDAガイダンスと臨床薬理に期待される役割

  S Takahashi et al.

• 日本臨床薬理学会 (2023)

  日本人小児の発達薬理学 研究および小児薬物動態 予測への応用

  C Emoto et al.

• 日本毒性学会 (2023)

  新規ヒト肝キメラマウス由来細胞（Hu-liver cell）の安全性研究への応用検討

  S Kawai et al.

• 札幌国際がんシンポジウム (2023)

  Hierarchical lung squamous cell carcinoma organoid model for investigating cellular heterogeneity

  K Nakano et al.

• 薬物動態談話会セミナー (2022)

  Beyond the rule of five 医薬品創製における薬物動態研究の全体戦略

  T Miyake et al.

• 日本薬物動態学会 (2022)

  Development of a novel method for evaluating the biodistribution of biopharmaceuticals using non-radioactive metal labeling and inductively coupled plasma mass spectrometry

  M Nagayasu et al.

• 日本薬物動態学会 (2022)

  バイオ医薬品の非放射性金属を用いた標識法とマトリクスの影響を受けない誘導結合プラズマ質量分析法（ICP-MS）を用いた新規動態評価法の開発

  M Nagayasu et al.

• 日本薬物動態学会 (2022)

  中外製薬Dx戦略と創薬研究の転換

  K Ozeki et al.

• 日本薬学会 (2022)

  CYP3A基質における代謝クリアランスのin vitro-in vivo外挿：変動要因とその補正

  K Morita et al.

• 日本動物実験代替法学会 (2022)

  抗体医薬品の体内動態予測のためのModeling＆Simulationアプローチ

  K Ozeki et al.

• 国際薬物動態学会-PBPK workshop (2022)

  Pharmacokinetic prediction of etanercept in Japanese patients with rheumatoid arthritis using PBPK model

  C Emoto et al.

• 23rd Annual Simcyp Consortium Meeting (2022)

  Pharmacokinetic prediction of etanercept in Japanese patients with rheumatoid arthritis using PBPK model

  C Emoto et al.

• Asian Pharmacometrics Symposium 2022 (2022)

  Applications of physiologically-based pharmacokinetic modeling in drug development: Current status and future challenges

  C Emoto et al.

• GastroPlus users meeting (2022)

  小児医薬品開発におけるPBPK活用の現状と今後について：小児動態の理解と企業事例紹介

  C Emoto et al.

• 日本臨床薬理学会 (2022)

  MEK阻害剤の臨床薬理学的特徴における共通点と相違点

  M Enomoto et al.

• 日本臨床薬理学会 (2022)

  OATP1B内在性バイオマーカーCoproporphyrin Iの臨床試験への活用に関する動向

  T Miyake et al.

• The 64th American Society of Hematology Annual Meeting and Exposition (2022)

  A population pharmacokinetic analysis of emicizumab in patients with acquired hemophilia A enrolled in a phase III study (AGEHA)

  K Yoneyama et al.

• The 64th American Society of Hematology Annual Meeting and Exposition (2022)

  Quantitative estimation of the in vivo equivalent factor VIII activity of NXT007, an emicizumab-based, next-generation, activated factor VIII-mimetic bispecific antibody, from nonclinical data

  K Yoneyama et al.

• The 30th Congress of the International Society on Thrombosis and Haemostasis (2022)

  Correlation of factor VIII activity measured by one-stage clotting and chromogenic substrate assays in a phase III study of emicizumab prophylaxis for acquired hemophilia A (AGEHA)

  K Yoneyama et al.

• 第84回日本血液学会学術集会 (2022)

  後天性血友病A模倣血漿におけるエミシズマブの薬力学的反応

  K Yoneyama et al.

• 第43回日本臨床薬理学会学術総会 (2022)

  後天性血友病A患者におけるエミシズマブの母集団薬物動態解析

  K Yoneyama et al.

• 日本薬物動態学会 (2021)

  Predicting quantitatively P-glycoprotein mediated drug-drug interactions and intestinal absorption using humanized mice

  T Miyake et al.

• 日本薬物動態学会 (2021)

  Studies on human pharmacokinetic predictions to accelerate drug development and understand inter-patient variabilities in clinical settings

  C Emoto et al.

• 国際薬物動態学会 (2021)

  Lysosomal pH as a key determinant on volume of distribution for drugs subjected to lysosomal trapping: Use of an in silico approach

  C Emoto et al.

• The 63rd American Society of Hematology Annual Meeting and Exposition (2021)

  A healthy volunteer-derived, factor VIII-neutralized, acquired hemophilia A-mimetic plasma produces similar pharmacodynamic responses of emicizumab to those in patients with congenital hemophilia A with or without inhibitors

  K Yoneyama et al.