Vol.30, Suppl �]�\ 2003 Simultaneous, Worldwide Development Strategies

contents
Preface	Takeuchi M Lagakos SW	iii
Faculty Members		iv-vii
Program		viii-xii
Opening Remarks and Welcoming Address	Sato T	1
	Doogan DP	3
Congratulatory Remarks	Hayashi Y	5-6
SESSION 1: SIMULTANEOUS/WORLDWIDE 　DEVELOPMENT STRATEGIES: OVERVIEW	Session Chairperson: 　 Yazaki Y	7-79
Several Years Experience on Bridging 　　　Studies and the Future	Fujiwara Y	9-24
CLINICAL UPDATE IN ASIA
Evaluation of Ethnic Sensitivity in Taiwan and the 　　　Related Issues of Statistical Consideration	Wu CH	25-35
Experience in Korea on Bridging Studies	Jang IJ	37-47
Pharmacogenetics of Antipsychotic Drug Response	Malhotra AK	49-59
How Does Difference in Medical Practice in Japan 　　　and the Rest of the World Affect Drug Development?	Murasaki M	61-4
How Scientific is Placebo Use?	Ishigooka J	65-72
Panel Discussion		73-9
SESSION 2: SIMULTANEOUS/WORLDWIDE 　DEVELOPMENT STRATEGIES: NEW CHALLENGIES	Session Chairperson: 　Imura H	81-122
New Approches of Dose Range Finding	Tanigawara Y	83-93
Role of Surrogate Markers in Psychiatry 　　　-Imaging of neurotransmitter binding sites with PET-	Takei N	95-102
The Search for Alternatives to Randomized 　　　Comparative Studies	Boyle P	103-12
Panel Discussion		113-22
SESSION 3: SIMULTANEOUS/WORLDWIDE 　DEVELOPMENT STRATEGIES: ICH-E5	Chaired by 　 Lagakos SW	123-61
Update and Progress on ICH E5: 　　　Report from the meeting of February, 2002 in Brussels 　　　and September, 2002 in Washington DC	Robert T. O'Neill	125-33
Use of Foreign Data for Drug Approval	Farrel A	135-41
Panel Discussion 　　　Implementation of the E5 Guideline: 　　　Status and Next Steps	Loew CN	143-5
Issues for Simultaneous Global Drug Development	Ferris MJ	147-9
E5 GL Evolves from a Conjecture (or a Grand Excuse) 　　　to a Solid Ground	Ono S	151-3
Discussion		155-61
SESSION 4: MORE CONCRETE PLAN AND ACTIONS 　BASED ON ICH AGREEMENT, APEC REPORT AND 　TODAY'S DISCUSSION	Session Chairperson: 　Takeuchi M	163-92
Genetics as a Means of Understanding Intrinsic Ethnic 　　　Differences 　　　-genetic variation on metabolism/ transporter/ receptor-	Azuma J	165-82
Workshop: Short summary and action plan aiming at 　　　simultaneous worldwide development		183-92
SESSION 5: PHARMACOGENOMICS: DRUG DISCOVERY 　AND DRUG DEVELOPMENT BASED ON THE GENETIC 　ANALYSIS	Session Chairperson: 　Kamataki T	193-253
New Monoclonal Antiboby Approved for Advanced Breast 　　　Cancer: Trastuzumab	Nihira S	195-204
The Human Approach to Target Validation and Drug Discovery	Riddell AJ	205-17
From Genomics to Drugs -gene haplotypes and drug response-	Kevin Rakin	219-28
Toxicogenomics in the USA -molecular toxicological approach 　　　in drug discovery and development-	Horii I	229-38
Regenerative Medicine	Sasai Y	239-47
Panel Discussion		249-53
SESSION 6: IMPLEMENTATION OF GLOBAL 　DEVELOPMENT PROGRAMS	Chaired by 　Doogan DP	255-89
Drug Development in Asia -an industry perspective-	Uden S	257-65
Lessons Learned from a Global Clinical Trial 　　　-an experience of 'RENAAL' study-	Kurokawa K	267-78
Experience of a Japan/ Korea Regional Trial	de Koning Gans HJ	279-89
SUMMARY AND CONCLUSION		291-308
Summary and Conclusion	Lagakos SW	293-9
Closing Remarks	Takeuchi M	301-8

Back to Controller Committee home page
Back to Rinsho Hyoka(Clinical Evaluation)