Vol.32, Suppl ]]U 2005 新薬のグローバル開発戦略
Global Development Strategies of New Drugs
目 次
序 文 竹内正弘(Masahiro Takeuchi)
Stephen W. Lagakos
Faculty Members iv-xix
Program xx-xxiii
Opening Remarks 柴 忠義(Tadayoshi Shiba)1-2
Congratulatory Remarks川原 章(Akira Kawahara)3-4
Welcoming AddressStephen W. Lagakos5-6
Plenary LectureChairperson:
 竹内正弘(Masahiro Takeuchi)
  Emerging science and the challenges of the new century黒川 清(Kiyosi Kurokawa)9-16
Session 1 : Changes of the Development Strategies during 5 years
   and Envisaged in the upcoming 5 years: Retrospective and
   Prospective Bridging,Simultaneous Worldwide Development,
   Multinational Trials (Global/Regional)
 井村裕夫(Hiroo Imura)
  1) What has been achieved int the past 5 yeas?竹内正弘(Masahiro Takeuchi)19-26
  2) What is the future?
   Strategic changes from bridging design to global/regional studies魚井 徹(Tohru Uwoi)27-32
   e-Patient's medical records and the network conception
     -The ubiquitousinformation network for the community based health
     services may offer optimal health care and welfare for every citizen
     by tailor-made form-
北岡有喜(Yuki Kitaoka)33-9
   Genotyping: Impact on a trial design and labeling宇山佳明(Yoshiaki Uyama)41-8
   Regulatory perspectives of simultaneous global development森 和彦(Kazuhiko Mori)49-56
  Panel Discussion 57-70
Session 2 : R&D Competitiveness of the Japanese Pharmaceutical
 Delcan P. Doogan
  Pharmaceutical industry; METI's perspective
   Overview of Biotechnology-present and future-
多喜田圭二(Keiji Takita)73-80
  Comparison of new drug development in Japan and overseas中村 洋(Hiroshi Nakamura)81-6
  What is driving cost in clinical trials? -How can we contain costs?-島谷克義(Katsuyoshi Shimatani)87-99
  Panel Discussion 101-11
Session 3-1 : New Challenges-Disease Areas- Chairperson:
 高久史麿(Fumimaro Takaku)
  Recent topics of cancer therapy:
   Investigator initiated clinical trials, combination therapy
   of anticancer agents, etc.
藤原康弘(Yasuhiro Fujiwara)115-22
  Society and aging related diseases:
   1) Alzheimer disease: The cardiovascular linkDeborah Blacker123-32
   2) Optimal trial designs in depression樋口輝彦(Teruhiko Higuchi)133-40
  Cardiovascular diseases: Hypertension: From genetic study to clinical trialsChao A. Hsiung141-8
  Panel Discussion 149-54
Session 3-2 : New Challenges-Global Trial Strategies-
 Lee-Jen Wei
  Using SNPs data to characterize patients in global trials
   -How to drive the hardest part of studying human genetic variation-
Isaac S. Kohane157-65
  Critical factors in conduct of global studies -An update on bridging
   studies, and a perspective on their future in international drug development-
Robert T. O'Neill167-74
  PGx: Regulatory perspective -Use of pharmacogenomics in drug
   development and in product labels: A clinical pharmacology perspective-
Atiqur N. Rahman175-80
  Challenges in conducting multinational trials in HIV and in extrapolating
   results from different regions
Stephen W. Lagakos181-90
  Global development strategies: Industry perspective
   -The use of prior information in medical research-
Gordon Lan191-201
  Use of SNP data and responder analyses in clinical trials:
   The drug against viral hepatitis type C
八橋 弘(Hiroshi Yatsuhashi)203-12
  Panel Discussion 213-23
Session 3-3 : New Challenges -Other Novel Technologies:
   Biomarkers, etc.-
 竹内正弘(Masahiro Takeuchi)
  Introduction of more objective endpoints into clinical trials:
   Biomarker best practice and reality in US
Stephen A. Williams227-36
  Biomarker opportunities for Japanese clinical development芝田英生(Hideo Shibata)237-41
  Research of human ES cells and its application to the future R&D
   of New drugs
中辻憲夫(Norio Nakatsuji)243-51
  Panel Discussion 253-60
Session 4 : Review System and Discussion on Good Review
 白神 誠(Makoto Shiragami)
  NDA review and relationship between reviewer, academia and industry小野俊介(Shunsuke Ono)263-73
  FDA review system
   Considerations for conduct of bridging studies
Ralph Harkins275-83
  EMEA regulatory up-to-date topicsNikolaus Mueller285-93
  Training of clinical trials and reviewers高橋希人(Kihito Takahashi)295-9
  Panel Discussion   301-11
Conclusion & Closing Remarks 313-22
  ConclusionLee-Jen Wei315-20
  Closing Remarks竹内正弘(Masahiro Takeuchi)321-2

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