Vaccine Discovery
19 October, 2006 Thursday
0900-0930 Historical of vaccine Discovery
Dr. Howard Engers, AHARI, Ethiopia
0930-1030 Overview of modern vaccine discovery
Dr. Howard Engers, AHARI, Ethiopia
1030-1100 Tea break
1100-1200 Screening for antigens
Prof Dr. Kenji Hirayama, Nagasaki University, Japan
1200-1330 Lunch
1330-1430 Evaluating antigens
Prof Dr. Kenji Hirayama, Nagasaki University, Japan
1430-1500 Tea break
1500-1600 Visiting Vaccine Discovery Laboratory Institute of Tropical Medicine,
Nagasaki University
20 October, 2006 Friday
0900-1030 Adjuvant -
Dr. Howard Engers, AHARI, Ethiopia
1030-1100 Tea break
1100-1200 Alternatives to antigens: DNA vaccine, Live or attenuated pathogen
Dr. Howard Engers, AHARI, Ethiopia
1200-1330 Lunch
1330-1430 Selection of development candidate and back-ups
Dr. Howard Engers, AHARI, Ethiopia
1430-1500 Tea break
1500-1630 Efficacy, toxicity, route if immunization, price, stability,
cold chain,
Dr. Howard Engers, AHARI, Ethiopia
21 October, 2006 Saturday
0900-1030 Malaria vaccine discovery
Prof. Dr.Weiqing Pan, Second Military Medical University, China
1030-1100 Tea break
1100-1200 Cholera vaccine discovery
Dr. Masahiko Ehara, Nagasaki Univesrsity, Japan
1200-1330 Lunch
1300-1400 West Nile Fever vaccine discovery
Prof. Dr.Kouichi Morita, Nagasaki University, Japan
1400-1500 Oral vaccine discovery
Dr. Takeshi Arakawa,Ryukyu University, Japan
Antigen Development
23 October, 2006 Monday
0900-1030 <Antigen Development>
1. History of Vaccine Development
2. Down period-Try and error period
3. The 2nd period - Taxoid vaccine
4. The 3rd period - Virus vaccines period
5. The 4th period - Genetic engineering period
Dr. Kiyoshi Horiuchi, GlaxoSmithKline KK, Tokyo, Japan
1030-1100 Tea break
1100-1230 Continued
Dr. Kiyoshi Horiuchi, GlaxoSmithKline KK, Tokyo, Japan
1230-1330 Lunch
1330-1430 1. Process of Vaccine Production
2. Materials for vaccines
2-1 Vaccine strain
2-2 Media, cells and animals used for vaccine product
3. Cell culture
4. Purification
5. Inactivation
6. Adjustment of the final bulk
7. Aliquoting, lyophilising and shipping
Dr. Kiyoshi Horiuchi, GlaxoSmithKline KK, Tokyo, Japan
1430-1530 Tea break
1530-1600 Continued
Dr. Kiyoshi Horiuchi, GlaxoSmithKline KK, Tokyo, Japan
Clinical Development
24 October, 2006 Tuesday
0900-1030<Quality Assurance of Vaccine>
1. Necessity of Quality Control
2. Definition of Biological Products
3. Standard Preparations
4. In-process Control and Tests
5. national Control Authority
6. Efficacy Control of Vaccines
7. Safety Control
Dr. Kiyoshi Horiuchi, GlaxoSmithKline KK, Tokyo, Japan
1030-1100 Tea break
1100-1230 Continued
Dr. Kiyoshi Horiuchi, GlaxoSmithKline KK, Tokyo, Japan
Pre-Clinical Development
25 October, 2006 Wednesday
0900-1030 Animal model used in pre-clinical studies
Dr. Shigeyuki Kano, International Medical Center of Japan, Tokyo
1030-1100 Tea break
Clinical Development
Overview
1100-1130 Assessment of pre-clinical information
Dr.Pele Chong, Taiwan
1130-1230 Clinical development plan
Professor Dr.Kenji Hirayama, Nagasaki University, Japan
1230-1330 Lunch
1330-1430 Application of immunogenicity for vaccine development
Dr. Shigeharu Ueda, The Research Foundation for Microbial Diseases of Osaka
University (BIKEN), Japan
1430-1500 Tea break
1500-1600 Dose selection and regimen
Dr. Shigeharu Ueda, The Research Foundation for Microbial Diseases of Osaka
University (BIKEN), Japan
Pre-Clinical Development
26 October, 2006 Thursday
0900-1030 Safety assessment
Toxicity test for animal: regional complications, systemic
toxicity such as fever, anaphylactic shock
Mr.Nobuhiro Noro, GlaxoSmithKline, Tokyo, Japan
1030-1100 Tea break
1100-1230 Immunogenicity assessment
Mr.Nobuhiro Noro, GlaxoSmithKline, Tokyo, Japan
1230-1330 Lunch
1330-1430 Regulatory
Mr.Yasushi Yoshino,Dr.Masaru Iwasaki, GlaxoSmithKline KK, Tokyo, Japan