Scientific Program

Program Details

September 17 (Tue)

Time Program Speaker Affilliation
Workshop 1. Biologics CMC for IND
09:30~11:00 Workshop 1: Biologics CMC for IND Chair : Hyi-Jeong Ji,
HyangWon (Harriet) Min
09:30~10:00 Special Lecture - Process Control Strategy during Clinical Material Production Jeongwon (Jason) Yun Celltrion, Inc.
10:00~10:30 CMC Data Requirement of IMPD for Earlier Phase Clinical Study Authorization : Learning from EMA and US FDA Regulations Hyun Jung Kim IQVIA
10:30~11:00 Regulatory Perspectives to Ensure the CMC Safety of Investigational Biotherapeutics Jina Kim MFDS
11:00~11:30 Coffee Break
11:30~13:00 Workshop 1: Experience Sharing with Key CMC Issues of Korea-IND Chair : Yeo Wook Koh,
Esther Bang
11:30~12:00 State of the Art Technologies in the Characterization and Specification of BioPharmaceuticals Hoon Joo Kim DGMIF
12:00~12:30 Manufacturer's Experience with Early Phase Studies Yujin Jung Lilly Korea Ltd.
12:30~13:00 CRO's Experience with MNC Global Development Studies Kyunghwa Son Medihelpline
13:00~14:00 Lunch
Workshop 2. Risk-Based Quality Management
09:30~11:00 Workshop 2: Risk Management Planning Chair : Carlo Maccarrone,
Hye Jong Yoo
09:30~10:00 Introduction of Risk Based Monitoring Yoon-Duk Han Pfizer
10:00~10:30 RBM Methodology Sol Han Sanofi
10:30~11:00 MOCK RACT Exercise Using Mock Protocol Sol Han Sanofi
11:00~11:30 Coffee Break
11:30~13:00 Workshop 2: Execution of RBM Chair : Yoon-Duk Han,
Hyewon Song
11:30~11:50 On-Site Monitoring in the RBM Model Eehwa Pae Bristol-Myers Squibb
11:50~12:10 Central Monitoring Using RBM Tool Ji Hee Kwon AstraZeneca
12:10~12:30 Experience Sharing from Korean Company Jin A Jung Hanmi Pharm.Co., Ltd.
12:30~13:00 Panel Discussion All Speakers -
13:00~14:00 Lunch
Workshop 3. How to Manage Safety in Clinical Development; Lessons Learned
14:00~15:30 Workshop 3: Regulatory Updates in Clinical Development Chair : Stewart Geary,
Seong Choon Choe
14:00~14:45 Global Regulatory Framework for Clinical Safety Ann Strauss Merck
14:45~15:30 End to End Process on Clinical Safety/Safety Science in Clinical Trial Dorina Bischof Novartis
15:30~16:00 Coffee Break
16:00~17:30 Workshop 3: Safety Management in Clinical Development Chair : TaeYoun Jo,
SungHo Beck
16:00~16:45 Use of Real World Evidence in Regulatory Submissions Agnes Saint-Raymond EMA
16:45~17:15 Challenges on Implementation of Global Standards and Our Future; From global perspectives Stewart Geary Eisai Co., Ltd.
Workshop 4. Maximizing Success in Immuno-Oncology Drug Development
14:00~15:30 Workshop 4: Strategy for Success in Immuno-Oncology Drug Development Chair : Jin Hyoung Kang,
Myung Ju Ahn
14:00~14:30 Lessons from Success and Failure in Immuno-Oncology Drug Development Dae Ho Lee Asan Medical Center
14:30~15:00 Ensuring Clinical Trial Design for Immuno-Oncology Drug Sun Young Rha Yonsei University Hospital
15:00~15:30 Characteristics of Immune-Related AE and Their Management in Clinical Trials Ji-Youn Han National Cancer Center
15:30~16:00 Coffee Break
16:00~17:30 Workshop 4: Evolving Science in Immune-Oncology Chair : Woong-Yang Park,
Yeul-Hong Kim
16:00~16:30 Progress in Immune Checkpoint Biomarkers Beyond PD-L1 Antibody Development Eunkyung Kim Bristol-Myers Squibb
16:30~17:00 Multiparametric Approach through NGS for Immune-Oncology Therapy Woong-Yang Park Samsung Medical Center
17:00~17:30 Prediction of Immune-Oncology Drug Resistance for The Next Step Kyong Hwa PARK Korea University College of Medicine

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