Program > Scientific Program Plenary Lecture 1 14:00-15:00 The Role of Pharmacogenomics in Drug Development and Clinical Practice Lawrence Lesko (FDA, USA)   Symposium 1_Pharmacogenomics I: Biomarkers for the Development of Personalized Medicine Chairs: Keith Wilner (Pfizer, USA), Yung-Jue Bang (Seoul National University, Korea) 15:10-15:40 Biomarker-based personalized therapies for cancer: a sequential approach to development and testing Tze Leung Lai (Stanford University, USA) 15:40-16:10 Molecular-targeted Therapy for Genetically Diverse Cancer Tae-You Kim (Seoul National University, Korea) 16:10-16:40 Translation Medicine: Pharmacogenomics to Guide Patient Selection in Clinical Trials Richard Finn (UCLA, USA) 16:40-17:10 Imaging Drug Kinetics and Dynamics to Predict and Monitor Treatment in Oncology Anthony F. Shields (Karmanos Cancer Institute, USA) 17:10-17:40 Personalized Medicine: an Industry Perspective Keith Wilner (Pfizer, USA)   Plenary Lecture 2 08:00-09:00 History of personalized medicine Arthur Atkinson (Northwestern University, USA)   Symposium 2_Pharmacogenomics II: PGx for Personalized Health Care and Ethnopharmacology Chairs: Lawrence Lesko (FDA, USA), Hyung-Keun Roh (Gachon University, Korea) 09:10-09:45 Race and Genetics: Understanding Variabilitity in Drug Development Issam Zineh (FDA, USA) 09:45-10:20 Assessing Pharmacogenomic Biomarkers for Personalized Medicine Brian Spear (Abbott, USA) 10:20-10:55 Germline pharmacogenomics in the treatment of breast cancer David A. Flokhart (Indiana University, USA) 10:55-11:30 Ethnic difference of drug disposition pharmacogenomics in Asian populations and Asian network for pharmacogenomics research Jae-Gook Shin (Inje University, Korea)   11:30-13:00 Poster Presentation & Lunch Lucheon Symposium, Lon Cardon (GSK, USA)   Symposium 3_Pediatric Clinical Pharmacology Chairs: Gregory L. Kearns (Children's Mercy Hospitals and Clinics, USA), Min-Soo Park (Yonsei University, Korea) 13:00-13:35 The importance of including children in clinical pharmacology researchawrence Gregory L. Kearns (Children's Mercy Hospital, USA) 13:35-14:10 International Efforts to Improve Pediatric Pharmacology and Medicines for Children Hidefumi Nakamura (National Center for Child Health and Development, Japan) 14:10-14:45 Challenges in Conducting Pediatric Clinical Trials and How to Overcome Them John N. van den Anker (Children's National Medical Center, USA) 14:45-15:20 Pediatric personalized medicine Stephen Spielberg (Children's Mercy Hospital, USA)   Symposium 4_IND/NDA Points To Consider: Regulatory Issues in Accepting Foreign Data for Different Ethnic Groups and by Different Regulatory Agencies Chairs: Carl Peck (University of Califonia, USA), Sang-Goo Shin (Seoul National University, Korea) 15:50-16:15 Ethnic differences in pharmacokinetics between Asians and caucasians; analysis from multiple phase I Studies Paul Morgan (Pfizer, USA) 16:15-16:40 Use of Efficacy Data from Foreign Sites to Support New Drug Applications in the US: An FDA Perspective Ni A. Khin (FDA, USA) 16:40-16:55 IND/NDA Points To Consider: Regulatory Issues in Accepting Foreign Data for Different Ethnic Groups and by Different Regulatory Agencies Junko Sato (PMDA, Japan) 16:55-17:10 Innovative Drug Development in China Rae Yuan (Hoffmann-la Roche, China) 17:10-17:25 How to Accept Foreign Clinical Data in Taiwan Chi-Hsun Chen (Center for Drug Evaluation, Taiwan) 17:25-17:40 Review of Multinational Clinical Trial Results for Bridging Data in Korea Jungyun Chang (KFDA, Korea) 17:40-18:10 Panel Discussion   Plenary Lecture 3 08:00-09:00 Targeting the optimal patients Yung-Jue Bang (Seoul National University, Korea)   Symposium 5_Quantitative Analysis for Personalized Medicine: Exposure-response, Disease Progress, Modeling & Simulation and Regulatory Issues Chairs: Diane Mould (University of Rhode Island, USA), In-Jin Jang (Seoul National University, Korea) 09:10-09:40 An overview of disease progress models: improving signal to noise in clinical trials Diane Mould (University of Rhode Island, USA) 09:40-10:10 Quantitative Approaches in Drug Development: Application in Neurosciences Richard Lalonde (Pfizer, USA) 10:10-10:40 Model-Based Approaches for Metabolic Disorders Donald E. Mager (University at Buffalo, SUNY, USA) 10:40-11:10 Quantitative Decision Analysis with Understanding of Drug and Disease Holly Kimko (Johnson & Johnson, USA) 11:10-11:40 Modleing and Simulation for the Evaluation of Ethnic Similarities in Drug Response In-Jin Jang (Seoul National University, Korea)   11:40-13:00 Poster Presentation & Lunch Luncheon Symposium, Brian Kim (Celltrion Inc., Korea) Development Strategy of Biosimilar - Industry Perspective   Symposium 6_DM/PK and Drug Interactions: In vitro to In Vivo Prediction, Herb Drug Interaction, Multiple Drug Interactions, Biological Drug Interaction, Drug Interaction and Pharmacogenetics, and Regulatory Issues Chairs: Shiew-Mei Huang (FDA, USA), Jae-Gook Shin (Inje University, Korea) 13:00-13:35 DDIs on Drug Metabolism and Drug Transport: Current Status and Academic Perspectives Im-Sook Song (Inje University, Korea) 13:35-14:10 An Industry Perspective on DDIs: Risk Assessment versus Prediction Steve Hall (Eli Lilly, USA) 14:10-14:45 In vitro-in vivo extrapolation of potential drug-drug interactions using PBPK: model requirements for evaluation of complex multiple interactions Amin Rostami-Hodjegan (University of Sheffield, UK) 14:45-15:20 Drug Interactions and Adverse Drug Reactions Shiew-Mei Huang (FDA, USA)   Symposium 7_Development of Biologicals for Personalized Health Care: Comparability Issues and Regulatory Issues Chairs: Hae-Young Ahn (FDA, USA), Yil-Seob Lee (GSK, Korea) 15:40-16:15 A Comparability Design of Therapeutic Protein in Clincial Study Hyi-Jeong Ji (LGLS, Korea) 16:15-16:50 Pharmacokinetic Comparability Strategy for Therapeutic Monoclonal Antibodies Honghui Zhou (Johnson & Johnson Biotechnology Center of Excellence, USA) 16:50-17:25 Regulatory Perspective : Comparability of Biotechnology Products Soo-Kyong Suh (KFDA, Korea) 17:25-18:00 Comparability Assessment during Drug Development Hae-Young Ahn (FDA, USA)