October 20, Thursday (Day 9)
Session 1: Discovery
Objective: To describe the principles of basic immunology and the process of vaccine discovery
9:00-10:00 What is immune system?
Professor Dr. Kenji Hirayama, Institute of Tropical Medicine
(NEKKEN) Nagasaki University, Japan
11:15-10:15 Tea break
10:15-11:15 Innate Immunity
Professor Dr. Kenji Hirayama, Institute of Tropical Medicine
(NEKKEN) Nagasaki University, Japan
11:15-12:15 Adaptive Immunity 1
Professor Dr. Kenji Hirayama, Institute of Tropical Medicine
(NEKKEN) Nagasaki University, Japan
12:15-14:00 Lunch
14:00-15:00 Adaptive Immunity 2
Professor Dr. Kenji Hirayama, Institute of Tropical Medicine
(NEKKEN) Nagasaki University, Japan
15:00-15:15 Tea break
15:15-16:30 Vaccine platform technology and adjuvant development
Associate Professor, Dr. Takeshi Arakawa, Tropical Biosphere
Research Center, University of the Ryukyus
16:40-17:10 Presentation subjects
Professor Dr. Kenji Hirayama, Institute of Tropical Medicine
(NEKKEN) Nagasaki University, Japan
October 21, Friday (Day 10)
Session 2: Pre-Clinical Development
Objective: To describe the process of pre-clinical development of vaccine
9:00-10:00 CMC
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs
Division, GlaxoSmith Kline, K.K.
10:00-10:15 Tea break
10:15-12:15 Immunogenicity and protect activity assessment
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs
Division, GlaxoSmith Kline, K.K.
12:15-13:15 Lunch
13:15-14:15 Safety assessment: toxicity test in animals: regional complications, systemic toxicity
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs
Division, GlaxoSmith Kline, K.K.
14:15-14:30 Tea break
14:30-15:30 Examples of pre-clinical development
Dr. Nobuhiro Noro, Head, Clinical Research/Biologicals,
Alliance and Rare Diseases, Development & Medical Affairs
Division, GlaxoSmith Kline, K.K.
October 24, Monday (Day 11)
Session 3: Clinical Development
Objective: To describe the process of vaccine clinical development
9:00-10:00 Assessment of pre-clinical information
Dr. Daisuke Tsuzuki, Sanofi Pasteur KK. Tokyo, Japan
10:00-10:15 Tea break
10:15-12:15 Clinical development plan
Dr. Daisuke Tsuzuki, Sanofi Pasteur KK. Tokyo, Japan
12:15-13:15 Lunch
13:15-14:15 Dose selection and regimen
Dr. Daisuke Tsuzuki, Sanofi Pasteur KK. Tokyo, Japan
14:15-14:30 Tea break
14:30-15:30 Regulatory
Dr. Daisuke Tsuzuki, Sanofi Pasteur KK. Tokyo, Japan
15:30-17:00 Review and Exam (Module 3)
Professor Dr. Kenji Hirayama and Professor Dr. Kesara Na-Bangchang
October 25, Tuesday (Day 12)
10:00-12:00 Presentation 15min + 5min
Professor Dr. Kenji Hirayama, Institute of Tropical Medicine
(NEKKEN) Nagasaki University, Japan
12:00-13:00 Lunch
13:00-15:00 Presentation 15min + 5min
Professor Dr. Kenji Hirayama, Institute of Tropical Medicine
(NEKKEN) Nagasaki University, Japan
15:00-15:15 Tea break
15:15-16:30 Allergy autoimmune immune evasion
Professor Dr. Kenji Hirayama, Institute of Tropical Medicine
(NEKKEN) Nagasaki University, Japan
16:30-17:30 Review Exam