Wednesday, November 15
08:30-09:00 REGISTRATION
09:00-09:10 Opening
Kyungsoo Park, Chair, Organizing Committee
09:10-09:15 Welcoming address
Min Soo Park, Director, Clinical Trials Center, Severance Hospital
09:15-09:20 Congratulatory address
Hoon Sang Chi, CEO/President, Yonsei University Health Care System
09:20-09:40 Introduction to Modeling & Simulation in Drug Development
Kyungsoo Park
Session 1: Concepts in clinical pharmacology
Chairmen Terry Blaschke & Hyung-Keun Roh
09:40-10:05 Prediction of pharmacokinetic profile in pediatric patients from data in adults for intravenous beta-lactam antibiotics
Yoshitaka Yano, Kyoto University, Japan
10:05-10:30 Detection and prediction of drug safety
Takahiko Tanigawa, Bayer Yakuhin, Ltd, Japan
10:30-10:55 BREAK
Chairmen Atsunori Kaibara & Young Moon Chae
10:55-11:20 Talking Technology to Nontechnoligical Audience
Howard Lee, UCSF, USA
11:20-11:45 Looking into the population analysis of densely sampled pharmacokinetic data
Dong-Seok Yim, The Catholic University, Korea
11:45-12:10 Functional Implication of Transporters on Pharmacokinetics during Nitrosative Stress
Suk-Jae Chung, Seoul National University, Korea
12:10-13:40 LUNCH
Session 2: Pharmacokinetic and pharmacodynamic modeling
Chairmen Nick Holford & Dongwoo Kang
13:40-14:05 Modelling of the glucose-insulin system
Mats Karlsson, Uppsala University, Sweden
14:05-14:30 Application of PPK modeling and simulation to clinical development of
S-1, a DPD inhibitory fluoropyrimidine
Kenichiro Yoshida, Taiho Pharmaceutical Corp., Japan
14:30-14:55 PK/PD modeling for fexofenadine with polysomsography
Young-Ran Yoon, Kyungpook National University, Korea
14:55-15:20 Population PK-PD Modeling of Clopidogrel
Kyun-Seop Bae, University of Ulsan, Korea
15:20-15:50 BREAK
Chairmen Mats Karlsson & Suneel Gupta
15:50-16:15 Simultaneous versus sequential population PK/PD modeling
Liping Zhang, Bristol-Myers Squibb Co., USA
16:15-16:40 PK/PD model building and validation
Takuya Okagaki, Tanabe Seiyaku Co., Ltd, Japan
16:40-17:05 Promises and challenges: what lies ahead for population modeling?
Paolo Vicini, University of Washington, USA
Thursday, November 16
Session 3: Optimization of dosage regimen & clinical trial design
Chairmen Jaap Mandema & Kyung Hwan KIM
09:00-09:25 Modeling and simulation approach for study design of FK506 (tacrolimus) in patients with ulcerative colitis
Atsunori Kaibara, Astellas Pharmaceutical Corp., Japan
09:25-09:50 Population PK/PD analysis of compound X to find appropriate dosage regimen in clinical trial
Tomoo Funaki, Otsuka Pharmaceutical Corp., Japan
09:50-10:15 Pharmacokinetic and Pharmacodynamic Guided Product Design
Suneel Gupta, ALZA Corporation, USA
10:15-10:40 Application of adaptive design to enhance clinical trial
Dongwoo Kang, Pfizer, USA
10:40-11:10 BREAK
Session 4: Biomarkers and surrogate endpoints
Chairmen Yusuke Tanigawara & Sang-Goo Shin
11:10-11:35 Antiretroviral Drugs for HIV Infection: What Allowed Surrogate Endpoints to be Used for Approval?
Terry Blaschke, Stanford University, USA
11:35-12:00 Application of PK-PD modeling and clinical trial simulation in drug development: Example of PET imaging biomarkers
Kyung-Sang Yu, Seoul National University, Korea
12:00-13:30 LUNCH
13:30-14:30 POSTER SESSION
Session 5: Modeling and simulation in drug development, regulatory decision and clinical applications
Chair: To be announced
Chairmen Carl Peck & Yil-Seob LEE
14:30-14:55 Importance of PK/PD in Internationally Harmonized Drug Development
Yusuke Tanigawara, Keio University, Japan
14:55-15:20 Modeling of Disease: The Time Course of Depression
-- What Happens in Clinical Trials?
Nick Holford, University of Auckland, New Zealand
15:20-15:45 Impact of non compliance on anticancer oral drugs: in silico study using PK-PD models with application to continuous and categorical biomarkers
Pascal Girard, INSERM - EA 3738 Univ Lyon I, France
15:45-16:10 BREAK
Chairmen Pascal Girard & Howard Lee
16:10-16:35 Utility of Monte Carlo Simulation in Anti-infective Agent Development
Hui Kimko, Johnson & Johnson, USA
16:35-17:00 Value of model-based meta-analyses for drug development and approval
Jaap Mandema, Quantitative Solutions Inc, USA
17:00-17:25 Factors Affecting Impacts of PKPD in Drug Development & Regulation
Carl Peck, UCSF, USA
17:25-17:50 Round table discussion
17:50-18:00 Closure
Kyungsoo Park

Secretariat of PKPD Yonsei 2006: c/o Ms. Ji Hye Lee, Clinical Trials Center, Yonsei University Medical Center
134 Shinchon-Dong, Seoul 120-752, Korea, Tel: +82-2-2228-0479 / Fax: +82-2-392-0668, E-mail: