NAGAI Sumimasa 永井純正

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永井純正ナガイスミマサ

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Researcher Number	40579710
Other IDs
Affiliation (Current)	2025: 京都大学, 医学研究科, 教授
Affiliation (based on the past Project Information) *help	2021 – 2023: 京都大学, 医学研究科, 教授 2018 – 2020: 東京大学, 医学部附属病院, 講師 2015 – 2017: 東京大学, 医科学研究所, 講師 2011: The University of Tokyo, 医学部附属病院, その他
Review Section/Research Field	Principal Investigator Basic Section 90140:Medical technology assessment-related / Basic Section 47060:Clinical pharmacy-related / Tumor therapeutics / Hematology
Keywords	Principal Investigator 薬事規制 / 抗癌剤 / 薬事承認 / 条件付き承認 / 抗がん剤 / 再生医療等製品

Research Projects
(4 results)
Research Products
(112 results)

癌領域の医薬品、診断薬、再生医療の開発早期に必要な臨床データに関する研究Principal Investigator
- Principal Investigator
  
  永井純正
- Project Period (FY)
  2022 – 2025
- Research Category
  
  Grant-in-Aid for Scientific Research (C)
- Review Section
  
  Basic Section 90140:Medical technology assessment-related
- Research Institution
  Kyoto University
Study on a conditional approval system that contributes to early access to anticancer drugsPrincipal Investigator
- Principal Investigator
  
  Nagai Sumimasa
- Project Period (FY)
  2018 – 2023
- Research Category
  
  Grant-in-Aid for Scientific Research (C)
- Review Section
  
  Basic Section 47060:Clinical pharmacy-related
- Research Institution
  Kyoto University
  The University of Tokyo
Clinical data for conditional approval of regenerative medical products for cancerPrincipal Investigator
- Principal Investigator
  
  NAGAI Sumimasa
- Project Period (FY)
  2015 – 2017
- Research Category
  
  Grant-in-Aid for Young Scientists (B)
- Research Field
  
  Tumor therapeutics
- Research Institution
  The University of Tokyo
急性骨髄性白血病予後不良因子BAALCの機能解析Principal Investigator
- Principal Investigator
  
  永井純正
- Project Period (FY)
  2011
- Research Category
  
  Grant-in-Aid for Research Activity Start-up
- Research Field
  
  Hematology
- Research Institution
  The University of Tokyo

All 2024 2023 2022 2021 2020 2019 2018 2017 2016 2015

All Journal Article Presentation Book

[Book] 第５章がんゲノム医療の臨床　II. がんゲノムプロファイリング検査　がんゲノム病理学2021
- Author(s)
  永井純正
- Total Pages
  225
- Publisher
  文光堂
- ISBN
  9784830604850
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] 総論　アカデミア発の医療開発の現状と課題2023
- Author(s)
  永井　純正
- Journal Title
  
  BIO Clinica
  
  Volume: 38 Pages: 1170-1171
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] 医薬品の開発と承認制度の国際比較2023
- Author(s)
  永井純正
- Journal Title
  
  公衆衛生
  
  Volume: 87(2) Pages: 91-101
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] 総論　アカデミア発の医療開発の現状と課題2023
- Author(s)
  永井　純正
- Journal Title
  
  BIO Clinica
  
  Volume: 38 Pages: 1170-1171
- Data Source
  KAKENHI-PROJECT-22K12884
[Journal Article] Drug approval delays in hematologic malignancies between Europe and the US and between Japan and the US: a clinical perspective2023
- Author(s)
  Matsuda Kensuke、Nagai Sumimasa、Sugimoto Koichi
- Journal Title
  
  Japanese Journal of Clinical Oncology
  
  Volume: 53 Issue: 12 Pages: 1125-1129
- DOI
  10.1093/jjco/hyad117
- Peer Reviewed / Open Access
- Data Source
  KAKENHI-PROJECT-22K12884, KAKENHI-PROJECT-18K06779
[Journal Article] 医薬品の開発と承認制度の国際比較2023
- Author(s)
  永井純正
- Journal Title
  
  公衆衛生
  
  Volume: 87(2) Pages: 91-101
- Data Source
  KAKENHI-PROJECT-22K12884
[Journal Article] 医師主導治験の現状と課題2022
- Author(s)
  永井純正
- Journal Title
  
  腫瘍内科
  
  Volume: 29(4) Pages: 513-517
- Data Source
  KAKENHI-PROJECT-22K12884
[Journal Article] Recommendations related to the analytical equivalence assessment of gene panel testing2022
- Author(s)
  Nagai Sumimasa、Nishihara Hiroshi、Suzuki Takayoshi、Nishio Kazuto、Taniguchi Hiroya、Tsuchihara Katsuya、Nakamura Kohei、Takamatsu Reika、Ueno Toshihide、Aburatani Hiroyuki、Kohno Takashi、Kohsaka Shinji
- Journal Title
  
  Cancer Science
  
  Volume: 113 Issue: 10 Pages: 3282-3290
- DOI
  10.1111/cas.15513
- Peer Reviewed / Open Access / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779, KAKENHI-PROJECT-22K12884, KAKENHI-PROJECT-20K18232, KAKENHI-PROJECT-21H02795
[Journal Article] Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions2022
- Author(s)
  Nagai Sumimasa、Witherspoon Bartlett、Nabhan Chadi、Bennett Charles L.
- Journal Title
  
  Cancer Treatment and Research
  
  Volume: 184 Pages: 41-51
- DOI
  10.1007/978-3-031-04402-1_2
- ISBN
  9783031044014, 9783031044021
- Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779, KAKENHI-PROJECT-22K12884
[Journal Article] 医師主導治験の現状と課題2022
- Author(s)
  永井純正
- Journal Title
  
  腫瘍内科
  
  Volume: 29(4) Pages: 513-517
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Tumor mutational burden measurement using comprehensive genomic profiling assay2022
- Author(s)
  Kage Hidenori、Kohsaka Shinji、Tatsuno Kenji、Ueno Toshihide、Ikegami Masachika、Zokumasu Koichi、Shinozaki-Ushiku Aya、Nagai Sumimasa、Aburatani Hiroyuki、Mano Hiroyuki、Oda Katsutoshi
- Journal Title
  
  Japanese Journal of Clinical Oncology
  
  Volume: 52 Issue: 8 Pages: 925-929
- DOI
  10.1093/jjco/hyac063
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-18K06779, KAKENHI-PROJECT-21K12117, KAKENHI-PROJECT-22K12884, KAKENHI-PROJECT-19H01031, KAKENHI-PROJECT-21H02795, KAKENHI-PROJECT-21H03074
[Journal Article] The First 2Years of Biosimilar Epoetin for Cancer and Chemotherapy‐Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions2021
- Author(s)
  Bennett Charles L.、Nagai Sumimasa、Bennett Andrew C.、et al
- Journal Title
  
  The Oncologist
  
  Volume: none Issue: 8 Pages: e1418-e1426
- DOI
  10.1002/onco.13713
- Peer Reviewed / Open Access / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] 新医薬品等の承認審査制度、行政2021
- Author(s)
  永井純正
- Journal Title
  
  CRCテキストブック第４版
  
  Volume: none Pages: 78-84
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Current situation of oncology biosimilars in Japan2021
- Author(s)
  Nagai Sumimasa
- Journal Title
  
  The Lancet Oncology
  
  Volume: 22 Issue: 3 Pages: e82-e82
- DOI
  10.1016/s1470-2045(21)00029-2
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Regulatory hurdles for CAR T-cell therapy in Japan2021
- Author(s)
  Sumimasa Nagai
- Journal Title
  
  The Lancet Haematology
  
  Volume: 8 Issue: 10 Pages: e686-e687
- DOI
  10.1016/s2352-3026(21)00279-9
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] 血液悪性腫瘍に対する治療薬薬事承認の現状2020
- Author(s)
  永井純正
- Journal Title
  
  臨床血液
  
  Volume: 61 Pages: 437-444
- NAID
  130007852221
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] 遺伝子パネル検査によって変わる今後の医療と医薬品開発国内承認品目の審査報告書を読み解いて学ぶこと2020
- Author(s)
  永井純正
- Journal Title
  
  Pharm Stage
  
  Volume: 20 Pages: 17-21
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] がん治療のレギュラトリーサイエンス2020
- Author(s)
  永井純正
- Journal Title
  
  腫瘍内科
  
  Volume: 26 Pages: 677-684
- NAID
  40022446745
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Current Trends in Clinical Development of Gene and Cellular Therapeutic Products for Cancer in Japan2019
- Author(s)
  Nagai Sumimasa、Sugiyama Daisuke
- Journal Title
  
  Clinical Therapeutics
  
  Volume: 41 Issue: 1 Pages: 174-184
- DOI
  10.1016/j.clinthera.2018.11.003
- Peer Reviewed / Open Access
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada2019
- Author(s)
  Chen B, Nagai S, Armitage JO, Witherspoon B, Nabhan C, Godwin AC, Yang YT, Kommalapati A, Tella SH, DeAngelis C, Raisch DW, Sartor O, Hrushesky WJ, Ray PS, Yarnold PR, Love BL, Norris LB, Knopf K, Bobolts L, Riente J, Luminari S, Kane RC, Hoque S, Bennett CL.
- Journal Title
  
  The Oncologist
  
  Volume: 24 Issue: 4 Pages: 537-548
- DOI
  10.1634/theoncologist.2018-0341
- Peer Reviewed / Open Access / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan2019
- Author(s)
  Sumimasa Nagai
- Journal Title
  
  International Journal of Molecular Sciences
  
  Volume: 20 Issue: 15 Pages: 3801-3801
- DOI
  10.3390/ijms20153801
- Peer Reviewed / Open Access
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Biosimilar Filgrastim Use in the United States vs the European Union and Japan-Why Does It Lag Behind and What Can Be Done?2019
- Author(s)
  Qureshi Zaina P.、Nagai Sumimasa、Bennett Charles L.
- Journal Title
  
  JAMA Oncology
  
  Volume: 5 Issue: 3 Pages: 297-298
- DOI
  10.1001/jamaoncol.2018.5636
- Peer Reviewed / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology2019
- Author(s)
  Salgado R, Solit DB, Rimm DL, Bogaerts J, Canetta R, Lively T, Lyerly K, Span PN, Bateman-House A, Makady A, Bergmann L, Nagai S, Smith C, Robson M, Savage M, Voest E, Sweeney C, Lambin P, Thomas M, Harris L, Lacombe D, Massard C; IBCD-Faculty.
- Journal Title
  
  European Journal of Cancer
  
  Volume: 114 Pages: 128-136
- DOI
  10.1016/j.ejca.2019.03.025
- Peer Reviewed / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Drug Approval Based on Randomized Phase 3 Trials for Relapsed Malignancy: Analysis of Oncologic Drugs Granted Accelerated Approval, Publications and Clinical Trial Databases2018
- Author(s)
  Nagai S, Ozawa K
- Journal Title
  
  Invest New Drugs
  
  Volume: 印刷中 Issue: 3 Pages: 487-495
- DOI
  10.1007/s10637-018-0572-2
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-15K20967, KAKENHI-PROJECT-18K06779
[Journal Article] Global Development of Anticancer Therapies for Rare Cancers, Pediatric Cancers, and Molecular Subtypes of Common Cancers2018
- Author(s)
  Lyerly H. Kim、Ren Jun、Canetta Renzo、Kim Gi Hyun、Nagai Sumimasa、Yamaguchi Tomohiro、Hatogai Ken、Katayama Hiroshi、Da Rocha Dias Silvy、McManus Daniel、Soltys Kathy、Yang Zhimin、Olopade Olufumilayo、Goodman Nancy、Reaman Greg、Gross Thomas
- Journal Title
  
  Journal of Global Oncology
  
  Volume: 4 Issue: 4 Pages: 1-11
- DOI
  10.1200/jgo.18.00092
- Peer Reviewed / Open Access / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] CD19-CAR-T: FDA承認（小児治療抵抗性B-ALL）2018
- Author(s)
  永井純正
- Journal Title
  
  医薬ジャーナル
  
  Volume: 54 Pages: 1239-1243
- Data Source
  KAKENHI-PROJECT-18K06779
[Journal Article] Focus On 新薬承認における日米の違い2018
- Author(s)
  永井純正
- Journal Title
  
  内科
  
  Volume: 121 Pages: 521-527
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] 抗腫瘍薬とコンパニオン診断薬の薬事規制に関する国際比較2017
- Author(s)
  永井純正
- Journal Title
  
  血液内科
  
  Volume: 75 Pages: 111-116
- NAID
  40021268811
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] わが国でのレギュレーション整備への期待2017
- Author(s)
  永井純正
- Journal Title
  
  遺伝子医学MOOK
  
  Volume: 31 Pages: 265-270
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] Generic drugs in oncology-Authors’ reply2017
- Author(s)
  Bennett CL, Nagai S, Yang YT, Chen BK, Sartor O, Armitage JO
- Journal Title
  
  Lancet Oncology
  
  Volume: 18 Issue: 2 Pages: e64-e64
- DOI
  10.1016/s1470-2045(17)30016-5
- Peer Reviewed / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] ゲノム編集によるAIDS・血液疾患の治療2017
- Author(s)
  永井純正
- Journal Title
  
  臨床婦人科産科
  
  Volume: 71 Pages: 425-431
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] 次世代シークエンサーの薬事承認に向けた日本の状況2017
- Author(s)
  永井純正
- Journal Title
  
  実験医学
  
  Volume: 35 Pages: 443-444
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products2017
- Author(s)
  Nagai S, Ozawa K
- Journal Title
  
  Curr Gene Ther
  
  Volume: 17 Issue: 1 Pages: 17-28
- DOI
  10.2174/1566523217666170406123231
- Peer Reviewed
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] コンパニオン診断薬と薬事規制2017
- Author(s)
  永井純正
- Journal Title
  
  腫瘍内科
  
  Volume: 19 Pages: 495-500
- NAID
  40021196469
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] Clinical trial designs to obtain marketing authorization of drugs for haematologic malignancy in Japan, the EU and the US2016
- Author(s)
  Nagai S, Ozawa K
- Journal Title
  
  British Journal of Haematology
  
  Volume: 174 Issue: 2 Pages: 249-254
- DOI
  10.1111/bjh.14047
- Peer Reviewed / Acknowledgement Compliant / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] 次世代シークエンサーやリキッドバイオプシー等を用いたコンパニオン診断薬の承認のあり方2016
- Author(s)
  永井純正
- Journal Title
  
  腫瘍内科
  
  Volume: 18 Pages: 535-540
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] Regulatory approval pathways for anticancer drugs in Japan, the EU and the US2016
- Author(s)
  Nagai S, Ozawa K
- Journal Title
  
  International Journal of Hematology
  
  Volume: 104 Issue: 1 Pages: 73-84
- DOI
  10.1007/s12185-016-2001-7
- Peer Reviewed / Acknowledgement Compliant / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] Generic oncology drugs in developed and developing countries: are they all safe?2016
- Author(s)
  Yang YT*, Nagai S*, Chen BK* (*: co-first authors), Qureshi ZP, Lebby AA, Kessler S, Georgantopoulos P, Raisch DW, Sartor O, Hermanson T, Kane RC, Hrushesky WJ, Riente JJ, Norris LB, Bobolts LR, Armitage JO, Bennett CL
- Journal Title
  
  Lancet Oncology
  
  Volume: 17 Issue: 11 Pages: e493-e501
- DOI
  10.1016/s1470-2045(16)30384-9
- Peer Reviewed / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] Evolving Japanese regulations on companion diagnostics2016
- Author(s)
  Nagai S, Urata M, Sato H, Mikami M, Kuga W, Yanagihara R, Miyamoto D, Suzuki Y, Shikano M
- Journal Title
  
  Nature Biotechnology
  
  Volume: 34 Issue: 2 Pages: 141-144
- DOI
  10.1038/nbt.3478
- Peer Reviewed / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] Comprehensive analysis of clinical development and regulatory submission promotion schemes for oncologic drugs as the Japanese national projects2016
- Author(s)
  Nagai S, Ozawa K
- Journal Title
  
  Investigational New Drugs
  
  Volume: 34 Issue: 6 Pages: 777-791
- DOI
  10.1007/s10637-016-0380-5
- Peer Reviewed / Acknowledgement Compliant / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] 産業と行政　日本および欧米におけるコンパニオン診断薬の規制の現状および今後の展望2015
- Author(s)
  永井　純正
- Journal Title
  
  B＆Iジャーナル（バイオサイエンスとインダストリー）
  
  Volume: 73 Pages: 408-411
- NAID
  40020591918
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] 医薬品の開発および評価における留意点2015
- Author(s)
  永井　純正
- Journal Title
  
  医薬ジャーナル
  
  Volume: 51 Pages: 65-69
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] リンパ系腫瘍に対するCAR-T療法2015
- Author(s)
  永井　純正
- Journal Title
  
  medicina
  
  Volume: 52 Pages: 2210-2214
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] TOPICS「身近な話題・世界の話題」(143) 　改正薬事法と再生医療等安全性確保法2015
- Author(s)
  永井　純正
- Journal Title
  
  血液フロンティア
  
  Volume: 25 Pages: 94-98
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] ゲノム編集技術を用いたこれからの遺伝子治療2015
- Author(s)
  永井　純正
- Journal Title
  
  Pharma Medica
  
  Volume: 33 Pages: 47-50
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] コンパニオン診断薬を用いた抗がん剤の開発および評価における留意点2015
- Author(s)
  永井　純正
- Journal Title
  
  腫瘍内科
  
  Volume: 15 Pages: 519-523
- Data Source
  KAKENHI-PROJECT-15K20967
[Journal Article] 新薬及びそのコンパニオン診断薬の開発における審査課題と今後の方向性2015
- Author(s)
  永井　純正
- Journal Title
  
  コンパニオン診断の進展2015-2016-個別化医療を進めるために-臨床病理レビュー特集
  
  Volume: 154 Pages: 43-48
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] ニーズ収集を通じた臨床現場と製造業との連携について2024
- Author(s)
  永井　純正
- Organizer
  第２回京MED講演会・交流会
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] コンパニオン診断とは2024
- Author(s)
  永井　純正
- Organizer
  日本臨床腫瘍学会教育企画部会ファイザー教育プロジェクト
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] ニーズ収集を通じた臨床現場と製造業との連携について2024
- Author(s)
  永井　純正
- Organizer
  第２回京MED講演会・交流会
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 新興企業による薬剤開発と日欧におけるドラッグラグ・ドラッグロス：血液悪性腫瘍における解析2024
- Author(s)
  Matsuda Kensuke、Nagai Sumimasa、Sugimoto Koichi
- Organizer
  第21日本臨床腫瘍学会学術集会
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] アカデミア創薬のためのAROによる研究者の伴走支援について2024
- Author(s)
  永井　純正
- Organizer
  レギュラトリーサイエンス学会webシンポジウム
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] コンパニオン診断とは2024
- Author(s)
  永井　純正
- Organizer
  日本臨床腫瘍学会教育企画部会ファイザー教育プロジェクト
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] アカデミア創薬のためのAROによる研究者の伴走支援について2024
- Author(s)
  永井　純正
- Organizer
  レギュラトリーサイエンス学会webシンポジウム
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 新興企業による薬剤開発と日欧におけるドラッグラグ・ドラッグロス：血液悪性腫瘍における解析2024
- Author(s)
  Kensuke Matsuda, Sumimasa Nagai, Koichi Sugimoto
- Organizer
  第21日本臨床腫瘍学会学術集会
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 京都大学医学部附属病院のベンチャー支援機能2023
- Author(s)
  永井　純正
- Organizer
  Bio Japan 2023ジャパンヘルスケアベンチャーサミット
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 京都大学のアカデミア間連携及び企業連携の取り組み2023
- Author(s)
  永井　純正
- Organizer
  ARO協議会第10回学術集会
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 京都大学医学部附属病院におけるベンチャー支援2023
- Author(s)
  永井純正
- Organizer
  AMED令和4年度革新的医療技術創出拠点成果報告会
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 京都大学拠点における異分野シーズ支援2023
- Author(s)
  永井純正
- Organizer
  AMED令和4年度革新的医療技術創出拠点成果報告会
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 京都大学拠点における異分野シーズ支援2023
- Author(s)
  永井純正
- Organizer
  AMED令和4年度革新的医療技術創出拠点成果報告会
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] Approval Delay in Drugs from non-Global Company in Europe and Japan: Analysis of Novel Drugs for Hematologic Malignancies2023
- Author(s)
  Kensuke Matsuda, Sumimasa Nagai, Koichi Sugimoto
- Organizer
  2023 ASH (American Society of Hematology) Annual Meeting
- Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 日米欧における再生医療等製品の承認審査で求められる非臨床試験に関する検討2023
- Author(s)
  牛丸弥香, 松口純枝, 西野良, 永井純正
- Organizer
  ARO協議会第10回学術集会
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 京都大学のアカデミア間連携及び企業連携の取り組み2023
- Author(s)
  永井　純正
- Organizer
  ARO協議会第10回学術集会
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] レギュラトリーサイエンスの観点からの本邦における細胞治療開発に関する展望と課題2023
- Author(s)
  永井　純正
- Organizer
  第82回日本癌学会学術総会
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 日米欧における再生医療等製品の承認審査で求められる非臨床試験に関する検討2023
- Author(s)
  牛丸弥香, 松口純枝, 西野良, 永井純正
- Organizer
  ARO協議会第10回学術集会
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 米国で承認された血液悪性疾患への治療薬に対する、薬事承認の日欧比較2023
- Author(s)
  Matsuda Kensuke、Nagai Sumimasa、Sugimoto Koichi
- Organizer
  第85回日本血液学会学術集会
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 米国で承認された血液悪性疾患への治療薬に対する、薬事承認の日欧比較2023
- Author(s)
  Kensuke Matsuda, Sumimasa Nagai, Koichi Sugimoto
- Organizer
  第85回日本血液学会学術集会
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] Approval Delay in Drugs from non-Global Company in Europe and Japan: Analysis of Novel Drugs for Hematologic Malignancies2023
- Author(s)
  Kensuke Matsuda, Sumimasa Nagai, Koichi Sugimoto
- Organizer
  2023 ASH (American Society of Hematology) Annual Meeting
- Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 京都大学医学部附属病院におけるベンチャー支援2023
- Author(s)
  永井純正
- Organizer
  AMED令和4年度革新的医療技術創出拠点成果報告会
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] レギュラトリーサイエンスの観点からの本邦における細胞治療開発に関する展望と課題2023
- Author(s)
  永井　純正
- Organizer
  第82回日本癌学会学術総会
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 京都大学医学部附属病院のベンチャー支援機能2023
- Author(s)
  永井　純正
- Organizer
  Bio Japan 2023ジャパンヘルスケアベンチャーサミット
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] Disease-Specific Analysis of Drug Approval Delay in Hematologic Malignancies between Japan and the U.S. and between Europe and the U.S.2022
- Author(s)
  Kensuke Matsuda, Sumimasa Nagai, Koichi Sugimoto
- Organizer
  2022 American Society of Hematology Annual Meeting
- Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 医療・福祉等ニーズ起点で次世代医療機器開発を担える起業家精神を持つ人材の育成拠点2022
- Author(s)
  永井純正
- Organizer
  令和４年度第１回関西医療機器産業支援ネットワーク関係機関連絡会合
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 永井班の趣旨と提言の内容について2022
- Author(s)
  永井純正
- Organizer
  AMED医薬品等規制調和・評価研究事業　遺伝子パネル検査によるコンパニオン診断システムの標準化に向けた検討（永井班）成果報告会
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 血液領域における日米間のドラッグラグの疾患別解析2022
- Author(s)
  Kensuke Matsuda, Sumimasa Nagai, Koichi Sugimoto
- Organizer
  第81回日本癌学会学術総会
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] シーズ発掘、育成における京都大学での学内外関連組織の連携について2022
- Author(s)
  永井純正
- Organizer
  ARO協議会第9回学術集会
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] Disease-Specific Analysis of Drug Approval Delay in Hematologic Malignancies between Japan and the U.S. and between Europe and the U.S.2022
- Author(s)
  Kensuke Matsuda, Sumimasa Nagai, Koichi Sugimoto
- Organizer
  2022 American Society of Hematology Annual Meeting
- Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] イントロダクション抗悪性腫瘍薬の開発における臨床研究中核病院・橋渡し拠点の貢献2022
- Author(s)
  永井純正
- Organizer
  第32回抗悪性腫瘍薬開発フォーラム
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 医療・福祉等ニーズ起点で次世代医療機器開発を担える起業家精神を持つ人材の育成拠点2022
- Author(s)
  永井純正
- Organizer
  令和４年度第１回関西医療機器産業支援ネットワーク関係機関連絡会合
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 血液領域における日米間のドラッグラグの疾患別解析2022
- Author(s)
  Kensuke Matsuda, Sumimasa Nagai, Koichi Sugimoto
- Organizer
  第81回日本癌学会学術総会
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 京都大学拠点のビジョンと活動報告2022
- Author(s)
  永井純正
- Organizer
  令和3年度橋渡し研究戦略的推進プログラム　京都大学拠点シンポジウム
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] イントロダクション抗悪性腫瘍薬の開発における臨床研究中核病院・橋渡し拠点の貢献2022
- Author(s)
  永井純正
- Organizer
  第32回抗悪性腫瘍薬開発フォーラム
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] シーズ発掘、育成における京都大学での学内外関連組織の連携について2022
- Author(s)
  永井純正
- Organizer
  ARO協議会第9回学術集会
- Invited
- Data Source
  KAKENHI-PROJECT-22K12884
[Presentation] 東大拠点活動報告2021
- Author(s)
  永井純正
- Organizer
  東京大学先端医療シーズ開発フォーラム2021
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] Regulatory approvals of regenerative medical products in Japan2020
- Author(s)
  Sumimasa Nagai
- Organizer
  ISCT (International Society for Cell and Gene Therapy) webinar 2020 Experiences and tips for rapid approval of regenerative medicine in Japan
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 東大拠点活動報告2020
- Author(s)
  永井純正
- Organizer
  東京大学先端医療シーズ開発フォーラム2020
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] Latest regulations on biosimilars development in Japan2019
- Author(s)
  Sumimasa Nagai
- Organizer
  10th Biosimilars Asia, IBC Asia
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] NGSを使用したCDx標準化への取り組み2019
- Author(s)
  永井純正
- Organizer
  PMDAワークショップ「がんゲノム医療実装を見据えたコンパニオン診断薬規制のあり方」
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] Oncology Drug Approval: Challenges and Opportunities Japan Pharmaceuticals and Medical Devices Agency2019
- Author(s)
  Sumimasa Nagai
- Organizer
  IASLC 2019 World Conference on Lung Cancer
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] Japan: a proactive approach to regulating cell and gene therapy in Japan2019
- Author(s)
  Sumimasa Nagai
- Organizer
  Cell & Gene Therapy, IBC Asia
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] Precision medicine trials, regulatory issues: the way forward2018
- Author(s)
  Sumimasa Nagai
- Organizer
  Innovation and Biomarkers in Cancer Drug Development 2018
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] 医療イノベーションと規制のディレンマ2018
- Author(s)
  永井純正
- Organizer
  東京大学公開講座
- Invited
- Data Source
  KAKENHI-PROJECT-18K06779
[Presentation] ネオアンチゲン等を標的とした個別化がん免疫療法ー規制への新たな問いかけー2017
- Author(s)
  永井純正
- Organizer
  厚生労働省医薬品等審査迅速化事業費補助金　革新的医薬品・医療機器・再生医療等製品実用化促進事業　シンポジウム　がん免疫療法2017ー複合化と個別化の科学的基盤とレギュレーションー
- Place of Presentation
  東京大学伊藤謝恩ホール（東京都文京区）
- Invited
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] 癌治療における診断システムとしての次世代シークエンサーとリキッドバイオプシーに対する薬事規制の現状2017
- Author(s)
  永井純正
- Organizer
  お茶の水がん学アカデミア第133回集会
- Invited
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Regulations for companion diagnostics in Japan2017
- Author(s)
  Sumimasa Nagai
- Organizer
  2017 AAADV International Workshop
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Comprehensive investigation into safety information on generic oncology drugs2017
- Author(s)
  永井純正、小澤敬也
- Organizer
  第79回日本血液学会学術集会
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Perspective for companion diagnostics in Japan2017
- Author(s)
  Sumimasa Nagai
- Organizer
  24th Asia Pacific Cancer Conference
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] 抗がん剤のジェネリック医薬品の安全性についてー国際共同調査研究成果を中心にー2017
- Author(s)
  永井純正
- Organizer
  第27回日本医療薬学会年会
- Invited
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Stakeholder perspective: Japanese regulatory agency (PMDA)2016
- Author(s)
  Sumimasa Nagai
- Organizer
  FDA-AACR Public Workshop Liquid biopsies in oncology drug and device development
- Place of Presentation
  Washington DC (US)
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] 日本癌学会奨励賞受賞講演　抗癌剤及びコンパニオン診断薬の薬事規制に関する国際比較2016
- Author(s)
  永井純正
- Organizer
  第75回日本癌学会学術総会
- Place of Presentation
  パシフィコ横浜（神奈川県横浜市）
- Year and Date
  2016-10-06
- Invited
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] がん免疫療法を含む革新的治療に対する審査加速化に向けた薬事規制の国際比較2016
- Author(s)
  永井　純正、小澤　敬也
- Organizer
  第8回血液疾患免疫療法学会
- Place of Presentation
  北海道大学（北海道札幌市）
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Feasibility of randomized phase 3 trials for adults with relapsed and refractory lymphoid malignancy2016
- Author(s)
  永井　純正、小澤　敬也
- Organizer
  第78回日本血液学会学術集会
- Place of Presentation
  パシフィコ横浜（神奈川県横浜市）
- Year and Date
  2016-10-13
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Japanese point of view2016
- Author(s)
  Sumimasa Nagai
- Organizer
  Innovation and Biomarkers in Cancer Drug Development
- Place of Presentation
  Brussels (Belgium)
- Year and Date
  2016-09-08
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Analysis of Drugs for Hematological Malignancy That Were Granted Accelerated Approval and Feasibility of Randomized Phase 3 Clinical Trials for Relapsed and Refractory Hematological Malignancy2016
- Author(s)
  Sumimasa Nagai, Keiya Ozawa
- Organizer
  The American Society of Hematology 58th Annual Meeting
- Place of Presentation
  San Diego (US)
- Year and Date
  2016-12-03
- Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Feasibility of international randomized phase 3 trials for adults with relapsed and refractory lymphoid malignancy2016
- Author(s)
  永井　純正、小澤　敬也
- Organizer
  第75回日本癌学会学術総会
- Place of Presentation
  パシフィコ横浜（神奈川県横浜市）
- Year and Date
  2016-10-06
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] 次世代シークエンサーやリキッドバイオプシー等を用いたコンパニオン診断薬の承認のあり方2016
- Author(s)
  永井純正
- Organizer
  第21回抗悪性腫瘍薬開発フォーラム
- Place of Presentation
  癌研有明病院（東京都江東区）
- Invited
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] What has the development promotion scheme brought to adult patients with hematological malignancy?2015
- Author(s)
  永井　純正、小澤　敬也
- Organizer
  第77回日本血液学会学術集会
- Place of Presentation
  ANAクラウンプラザホテル金沢（石川県金沢市）
- Year and Date
  2015-10-16
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Regulatory considerations in cancer immunotherapy product development Japan Perspective2015
- Author(s)
  Sumimasa Nagai
- Organizer
  Global regulatory summit, SITC 2015 annual meeting
- Place of Presentation
  National Harbor（米国）
- Year and Date
  2015-11-04
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] What has the development promotion scheme for unapproved and off-label drugs brought to adult cancer patients in Japan?2015
- Author(s)
  永井　純正、小澤　敬也
- Organizer
  第74回日本癌学会学術総会
- Place of Presentation
  名古屋国際会議場（愛知県名古屋市）
- Year and Date
  2015-10-08
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] 次世代シークエンサーに対するレギュレーションの現状2015
- Author(s)
  永井　純正
- Organizer
  日本人類遺伝学会第60回大会
- Place of Presentation
  京王プラザホテル（東京都新宿区）
- Year and Date
  2015-10-14
- Invited
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] Regulatory perspective and challenges regarding companion diagnostics in Japan2015
- Author(s)
  Sumimasa Nagai
- Organizer
  DIA Companion diagnostics conference 2015
- Place of Presentation
  Bethesda（米国）
- Year and Date
  2015-09-30
- Invited / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-15K20967
[Presentation] 日欧米における血液領域の抗癌剤に対する承認時期と治験の主要評価項目の差異との関係についての包括的解析2015
- Author(s)
  永井　純正、小澤　敬也
- Organizer
  第５回レギュラトリーサイエンス学会学術大会
- Place of Presentation
  学術総合センター（東京都千代田区）
- Year and Date
  2015-09-04
- Data Source
  KAKENHI-PROJECT-15K20967

NAGAI Sumimasa 永井 純正

永井 純正 ナガイ スミマサ

Research Projects

Research Products

癌領域の医薬品、診断薬、再生医療の開発早期に必要な臨床データに関する研究Principal Investigator

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Study on a conditional approval system that contributes to early access to anticancer drugsPrincipal Investigator

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Clinical data for conditional approval of regenerative medical products for cancerPrincipal Investigator

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急性骨髄性白血病予後不良因子BAALCの機能解析Principal Investigator

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[Book] 第５章がんゲノム医療の臨床 II. がんゲノムプロファイリング検査 がんゲノム病理学2021

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[Journal Article] 総論 アカデミア発の医療開発の現状と課題2023

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[Journal Article] 医薬品の開発と承認制度の国際比較2023

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[Journal Article] 総論 アカデミア発の医療開発の現状と課題2023

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[Journal Article] Drug approval delays in hematologic malignancies between Europe and the US and between Japan and the US: a clinical perspective2023

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[Journal Article] 医薬品の開発と承認制度の国際比較2023

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[Journal Article] 医師主導治験の現状と課題2022

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[Journal Article] Recommendations related to the analytical equivalence assessment of gene panel testing2022

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[Journal Article] Biosimilar Epoetin in the United States: A View from the Southern Network on Adverse Reactions2022

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[Journal Article] 医師主導治験の現状と課題2022

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[Journal Article] Tumor mutational burden measurement using comprehensive genomic profiling assay2022

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[Journal Article] The First 2Years of Biosimilar Epoetin for Cancer and Chemotherapy‐Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions2021

NAGAI Sumimasa 永井純正

永井純正ナガイスミマサ

[Book] 第５章がんゲノム医療の臨床　II. がんゲノムプロファイリング検査　がんゲノム病理学2021

[Journal Article] 総論　アカデミア発の医療開発の現状と課題2023

[Journal Article] 総論　アカデミア発の医療開発の現状と課題2023

[Journal Article] 遺伝子パネル検査によって変わる今後の医療と医薬品開発国内承認品目の審査報告書を読み解いて学ぶこと2020