Scientific Program

Previous Conference

October 31(WED)

Time Program Speaker Affilliation
08:30 Registration
Grand Ballroom A·B & Park Ballroom (3F, 5F)
09:00~09:10 Welcome Remarks Neunghoo Park MOHW
09:10~09:20 Welcome Remarks Sun-Hee Lee MFDS
09:20~09:30 Opening Remarks Deborah Chee KoNECT
09:30~10:00 Plenary Lecture 1. Bio-Health Innovation Plan for Korea Chair : Yil-Seob Lee
Ju Young Kim MOHW
10:00~10:30 Coffee Break
Grand Ballroom A·B & Park Ballroom (3F, 5F)
10:30~12:00 S1: Recent Regulatory Updates in Clinical Trials Chair : Nakyung Kim, Hea-Young Cho
10:30~11:00 Clinical Trial Regulation Implementation in Germany Janet Koenig BfArM
11:00~11:25 Regulatory Reform to Support Clinical Development of Innovative Products in China Ling Su Shenyang Pharmaceutical University and Lilly Asia Ventures
11:25~11:50 Preparedness and Execution of Chinese Regulatory Reform Chang Lee PAREXEL
11:50~12:20 Regulatory Update for Clinical Trials in KOREA Byoung Sam Kim MFDS
12:20~13:30 Lunch
Grand Ballroom A (3F)
13:30~15:00 S2: Facing ICH-E17 in North East Asia (Collaborated with KRPIA) Chair : Don Woong Choi,
Helen Heakyoung Cho
13:30~14:00 A Consideration on Implementing E17 Guidance in Clinical Development Akira Wakana MSD
14:00~14:30 Facing ICH-E17 in North East Asia: Academic Perspective In Jin Jang Seoul National University Hospital
14:30~15:00 New Regulatory Dynamics in China Hwei-Gene Wang BMS
Grand Ballroom B (3F)
13:30~15:00 S3: Are You Ready for Implementation of RBM? (Collaborated with KSCD) Chair : Carlo Maccarrone, Hyewon Song
13:30~14:00 Overview of TransCelerate RBM Methodology Masato Kobayashi Astellas, TransCelerate representative
14:00~14:30 Key Role of Centralized Monitoring - Going forward in RBM - Yumi Sugiura BMS
14:30~15:00 What Other CRA Capability Should be Required in a New RBM Process? Barbara Grassi GSK
Park Ballroom (5F)
13:30~15:00 S4: Non-Clinical Studies Enabling Successful Clinical Development (Collaborated with KSNS) Chair : Joonghoon Park, Dong Hwan Kim
13:30~14:00 Translation of Non-Clinical Studies to Clinical Trials Dong Hwan Kim Konyang University
14:00~14:30 PKPD Considerations for New Drug Development Hyun Joo Shim Dong-A ST Pharm
14:30~15:00 Accelerating Clinical Development Using Cutting Edge Preclinical Technologies and E-data Submission Takayuki Anzai Showa University School of Medicine
15:00~15:30 Coffee Break
Grand Ballroom A (3F)
15:30~17:00 S5: Real World Data for Clinical Development Chair : Chiyoung Ahn, Rae Woong Park
15:30~16:00 Effective Clinical Trial Planning Using Real World Data Andrew Roddam GSK
16:00~16:30 Utilization of RWD in Korea Nam-Kyong Choi Ewha Womans University
16:30~17:00 Enhancing Clinical Development through the Use of RWD Bruce Crawford Syneos Health
Grand Ballroom B (3F)
15:30~17:00 S6: Patient Journey In Clinical Trials - From Enrollment To Trial Completion Chair : Hailey Chae ,
Catherine Yi-San Lee
15:30~16:00 The Common Registry Data Packet: TransCelerate’s Initiative to Improve Data in Clinical Trial Registries / eLabels: Understanding the Benefits for Patients, Sites and sponsors Keris Huang MSD, TransCelerate representative
16:00~16:30 Patient-Centric, Patients-First Approach to Feasibility Gaurav Bhatnagar PPD
16:30~17:00 The Digital Patient Journey Catherine Yi-San Lee Pfizer
Park Ballroom (5F)
15:30~17:00 S7: New Approaches to Pharmacovigilance & Their Applications to Clinical Development? Chair : Soo Youn Chung, Stewart Geary
15:30~16:00 ICH E19: Update and Expectation from Industry Seong Choon Choe Boryung Pharmaceutical Company
16:00~16:30 Pharmacovigilance for Oncology Combination Studies with Checkpoint Inhibitors Stewart Geary Eisai
16:30~17:00 Innovative Technology for Case Intake to Enable Process Improvements and Focus on Data Analysis Jamie Portnoff Foresight

November 1(THU)

Time Program Speaker Affilliation
08:30 Registration
Grand Ballroom A·B & Park Ballroom (3F, 5F)
09:00~09:40 Plenary Lecture 2. Transforming Clinical Research with the Patient, for the Patient Chair : Deborah Chee
Andreas Koester J&J
09:40~10:00 Patient Voice. Voice of Lymphoma Patient Chair : SungJa Cho
Wonyoung Jang Korea Blood Cancer Association
10:00~10:30 Coffee Break
Grand Ballroom A·B & Park Ballroom (3F, 5F)
10:30~12:00 S8: Data Driven Approaches in Drug Development Chair : Sam Muk, Soo Kyung Shin
10:30~11:00 Practical Application of New Solutions for Drug Development: From Strategic Development Decisions to Patient’s Perspective Kate Lawrey IQVIA
11:00~11:30 Healthcare Big Data: Real World Data for Clinical Trials Kyu-pyo Kim Asan Medical Center
11:30~12:00 Healthcare Blockchain Seyoung Jung Seoul National University Bundang Hospital
12:00~13:30 Lunch
Grand Ballroom A (3F)
13:30~15:00 S9: Patient Centric Clinical Development Chair : Jessica Liu, Jun Li
13:30~14:00 Patient Centric Protocol Optimisation Daivid Yoshii PAREXEL
14:00~14:30 Implementing Novel Patient-centric Solutions: Case Studies Fuqu Wang J&J
14:30~15:00 Tissue Chips for Personalized Medicine in Risk Assessment during Drug Life Cycle Management Tagle Danilo National Institutes of Health (NIH)
Grand Ballroom B (3F)
13:30~15:00 S10: Clinical Development Strategy for Precision Medicine Chair : Young Suk Park, Hyerim Lee
13:30~14:00 Application of NGS in Clinical Trials, Clinical Research and Practice Kyoung-Mee Kim Samsung Medical Center, Sungkyunkwan University School of Medicine
14:00~14:30 Innovative IO Strategy in the Era of Precision Medicine Hyerim Lee MSD
14:30~15:00 Refractory Cancer Basket Trials and Cancer Genomics Hyo Song Kim Yonsei Cancer Center
Park Ballroom (5F)
13:30~15:00 S11: Changing Ethics in Clinical Trials (Collaborated with KAIRB) Chair : Sun Young Rha, Jerry Menikoff
13:30~14:00 Understanding the Revisions to the Common Rule Jerry Menikoff U.S. Department of Health & Human Services
14:00~14:30 Opportunities and Challenges of Single IRB vs Central IRB Yong-Jin Kim Kyungpook National University Hospital
14:30~15:00 Conflict of Interest Management Plan Dae Ho Lee University of Ulsan College of Medicine, Asan Medical Center
15:00~15:30 Coffee Break
Grand Ballroom A (3F)
15:30~17:00 S12: Building Industrial Capabilities in Early Phase Development (Collaborated with KSPM) Chair : SungJa Cho, Jongho Ahn
15:30~16:00 Early Phase Clinical Pharmacology Studies – Timing, Contents, and Impact Joseph Kim PAREXEL
16:00~16:30 How to Design Clinical Trial with Considering Statistical Methodology Byung-Ho Nam Herings Global
16:30~17:00 Leveraging Companion Diagnostics in Early Phase Oncology Development Brian Lamon BMS
Grand Ballroom B (3F)
15:30~17:00 S13: Role of Clinical Trial Centers in Global Collaboration (Collaborated with KACTC) Chair : In Jin Jang, Yoon-Duk Han
15:30~16:00 Quility Improvement of a CTC by Certification Program Min-Gul Kim Chonbuk National University Hospital
16:00~16:30 Overseas Engagement of Clinical Research to Develop Academic Seeds:
Efforts of Osaka University Hospital
Daisaku Nakatani Osaka University Hospital
16:30~17:00 Evolution of Clinical Trials Centers in Korea Min Soo Park Yonsei University College of Medicine
Park Ballroom (5F)
15:30~17:00 S14: A Step forward in IIT Chair : Young-suk Lim, Il Ju Choi
15:30~16:00 Opportunities and Challenges in Conducting IIT in Korea Il Ju Choi National Cancer Center
16:00~16:30 Infrastructure of IIT in Singapore Ivanus Manopo Singapore Clinical Research Institute
16:30~17:00 Medical Innovation Led by Academia in Japan and Scope of Global ARO Network Masanori Fukushima Translational Research Center for Medical Innovation (TRI), Foundation for Biomedical Research and Innovation at Kobe

November 2(FRI)

Time Program Speaker Affilliation
08:30 Registration
Grand Ballroom A (3F)
09:00~10:30 S15: How Smart will Clinical Trials Centers be? (Collaborated with KCGI) Chair : Min Soo Park, Jae-Wook Ko
09:00~09:30 Smart Clinical Trials Management System Dong-Wan Kim Seoul National University Hospital
09:30~10:00 Smart Clinical Development Support System Min-Gul Kim Chonbuk National University Hospital
10:00~10:30 AI-based Clinical Trial Resources Information System (ACTRiS) Janghee Hong Chungnam National University College of Medicine and Hospital Clinical trials Center
Grand Ballroom B (3F)
09:00~10:30 S16: Securing Quality and Compliance in Clinical Trials Chair : Sora Lee, Helen Wong
09:00~09:30 ICH GCP (R2): Quality Management System & Risk Management Helen Wong MSD
09:30~10:00 How to Embed cQMS into Daily Work Hannah Chen J&J
10:00~10:30 The Role of Quality Assurance in Multi-Center Trials Choy Kiew Cheong IQVIA
Park Ballroom (5F)
09:00~10:30 S17: Trends in Gene & Cell Therapy Chair : Hun Che Cho, Ho-Sang Jeong
09:00~09:25 Gene and Cell Therapy: How It Started, Where We Are, and What Is Next? Young Jik Kwon University of California
09:25~09:50 Global Trend & Case Study in Cell Therapeutics Antonio Lee MEDIPOST
09:50~10:15 Current Status of Gene Therapy Jae-Gyun Jeong ViroMed Co., Ltd.
10:15~10:40 Recent Perspective of Korean Gene & Cell Therapy Regulations Kyungtak Nam MFDS
10:40~11:00 Coffee Break
Grand Ballroom A (3F)
11:00~12:30 S18: Adaptive Design of Clinical Trials in Oncology Drug Development Chair : Jin Hyoung Kang, Eric Groves
11:00~11:30 Why Adaptive Clinical Trials in Oncology Drug Development? Hanlim Moon CUREnCARE Research
11:30~12:00 Benchmark and Ongoing Adaptive Trials in Oncology Jee Hyun Kim Seoul National University Bundang Hospital
12:00~12:30 Practical Considerations for Adaptive Trials Eric Groves IQVIA
Grand Ballroom B (3F)
11:00~12:30 S19: Answering Clinical Questions Using Medical Big Data Chair : Kenneth Paik, Hayoung Park
11:00~11:30 Data Ecosystems and Data Sharing to Enable Practical Medical Analytics Kenneth Paik Massachusetts Institute of Technology
11:30~12:00 Medical Big Data in the Field Hyung Jin Yoon Seoul National University College of Medicine
12:00~12:30 How AI Technologies Can Enhance Our Understanding of Health and Disease Mornin Feng Saw Swee Hock School of Public Health, National University of Singapore
Park Ballroom (5F)
11:00~12:30 S20: Clinical Trials in Rare Diseases Chair : Sin Gon Kim, Seong Choon Choe
11:00~11:25 PARTNER’S Platform to Activate Clinical Trials for Rare Diseases Using Nation-Wide Big Data Kyong Hwa Park Korea University College of Medicine
11:25~12:50 Rare Disease Research: Opportunities and Challenges Tagle Danilo National Institutes of Health (NIH)
12:50~12:15 The Rare Diseases and Pediatric Clinical Research Networks in Europe Jacques Demotes ECRIN
12:15~12:40 Orphan Drug Development: A Regulatory Perspective Changwon Park MFDS

November 1 (Wed)

Time Program
08:30 Registration
Room A / A-1 / B
09:00~09:10 Opening Remarks
Deborah Chee KoNECT, Korea
Barbara Lopez Kunz DIA, USA
Welcome Address
09:10~09:20 Congratulatory Remark
Sung Il Yang MOHW, Korea
09:20~09:30 Congratulatory Remark
Won Sik Lee MFDS, Korea
09:30~10:00 PLENARY LECTURE 1. Bio-Health Innovation Plan for Korea
Chair Yil-Seob Lee GSK, Korea
Joo-young Kim MOHW, Korea
10:00~10:30 Coffee Break
Room A/B
10:30~12:00 SESSION 1. Patient Centric Clinical Development
Chair Yeul Hong Kim
           Carlo Maccarrone
Korea University College of Medicine, Korea
GSK, Australia
10:30~10:40 Voice of Patients on Clinical Trials
Ji Yeon Lee The Patient Award in Clinical Trials Experience, Korea
10:40~11:05 Is Patient Centricity the room approach to engagement?
Trish Caruana Rare Disease Solutions, USA
11:05~11:30 Digital Enabled Tactics to Achieve Patient-Centricity
David Hou QuintilesIMS, Singapore
11:30~11:55 Patient Centric Recruitment, Lesson Learned from Study
Mariah Baltezegar INC Research, USA
12:00~13:20 Lunch
Room A
13:20~15:00 SESSION 2. Updates on Regulatory Science
Chair Dae Cheol Kim
           Yoshiaki Uyama
MFDS, Korea
PMDA, Japan
13:20~13:45 Regulatory Science Initiatives at FDA to Streamline Early Clinical Drug Development
Hae-Young Ahn U.S. FDA, USA
13:45~14:10 Update on MRCT Guideline (ICH E17)
Yoshiaki Uyama Pharmaceuticals and Medical Devices Agency(PMDA), Japan
14:10~14:35 Expedited Pathways for Biopharmaceuticals in Korea
Kyungtak Nam Ministry of Food And Drug Safety(MFDS), Korea
14:35~15:00 Update on China Reform in Regulatory Science
Jessica Liu Tigermed Co. Ltd / DreamCIS, INC., China
Room B
13:30~15:00 SESSION 3. Real World Evidence and Clinical Development
Chair Sung Ja Cho
           Sung Chun Kim
Janssen, Korea
KDDF, Korea
13:30~14:00 How to Use Real World Study Data for Drug Development
Bart Vannieuwenhuyse J&J, Belgium
14:00~14:30 What are Opportunities and Barriers for Real World Study
Sumitra Shantakumar GSK, Singapore
14:30~15:00 Real-World Study Cases : from Preclinical to Clinical Trials
Hae-Sim Park Ajou University School of Medicine, Korea
15:00~15:30 Coffee Break
Room A
15:30~17:10 SESSION 4. Holistic Approach in Drug Development: Bridging the Gap
Chair Hanlim Moon
           Hyunsang Muk
CUREnCARE Research, Korea
KDDF, Korea
15:30~15:55 Joining Preclinical and Clinical Development: Discovery with IND in Mind
Seonggu Ro PiMedBio, Korea
15:55~16:20 Critical Points to Consider in Clinical Development Plan in Early Stage
Jeewoong Son LG Chem, Korea
16:20~16:45 Strategy for Asian Clinical Development in Global CDP in Multinational Company
Sam Lim AstaZeneca, China
16:45~17:10 How to Choose the Comparator with Rapidly Changing Standard of Care (Oncology Example)
Hanlim Moon CUREnCARE Research, Korea
Room B
15:30~17:00 SESSION 5. Precision Medicine and Clinical Development
Chair Young Suk Park
           Soonmyung Paik
Samsung Medical Center, Korea
Severance Biomedical Science Institute, Korea
15:30~16:00 N of One Trial in Clinical Development
Young Suk Park Samsung Medical Center, Korea
16:00~16:30 Companion Diagnostic and Clinical Development (Example of Keytruda)
Sally Bai MSD, Singapore
16:30~17:00 Clinical Development in Breast Cancer
Soonmyung Paik Severance Biomedical Science Institute, Korea

November 2 (Thu)

Time Program
08:30 Registration
Room A
09:00~09:30 PLENARY LECTURE 2. Medical & Social Value of Clinical Trials
Chair      Min Soo Park
Speaker Kathy Rouan
KCGI, Korea
09:30~10:20 SESSION 6. 4th Industrial Revolution and Clinical Development
Chair Sin Gon Kim
           Jongho Ahn
Korea University College of Medicine, Korea
MSD, Korea
09:30~09:50 4th Industrial Revolution, and Healthcare Industry
Wonjae Lee YOZMA Group, Korea
09:50~10:20 4th Industrial Revolution, Medical Care and Drug Development
Alice Landis-McGrath IBM Watson Health, USA
10:20~10:50 Coffee Break
Room A
10:50~12:10 SESSION 7. Clinical Trials: More Unseen Than Seen
Chair Choong Heon Lee
           Jeong Rim Moon
Medical Journalist of KBS, Korea
19th National Assembly Member of the Republic of Korea, Korea
10:50~11:10 Public Awareness and Perception of Clinical Trials
Sung-ho Beck ASAN Medical Center, Korea
11:10~11:30 PMDA’s Initiative for Introducing Innovative Medical Products
Masayoshi Shibatsuji PMDA, Japan
11:30~11:50 Social Value of IIT on Public Health
Young-suk Lim ASAN Medical Center, Korea
11:50~12:10 Successful Cases of Public IIT - Development of Optimal Busulfan Dosing Based on Pharmacokinetic Modeling
Hyoung Jin Kang Seoul National University Hospital, Korea
12:10~13:30 Lunch
Room A
13:30~15:00 SESSION 8. Evolving Ethical Topics in Clinical Trials
Chair Min Soo Park
           Barbara Bierer
KCGI, Korea
Multi-Regional Clinical Trials Center of BWH and Harvard, USA
13:30~14:00 Patient Protection Activities in Clinical Trial
Seung Min Kim Korean Association of Institutional Review Boards(KAIRB), Korea
14:00~14:30 Building Human Research Protections Programs in Korea: AAHRPP Perspective
Elyse Summers Association for the Accreditation of Human Research Protection Programs, USA
14:30~15:00 Emerging Ethical Issues in Clinical Trials
Barbara Bierer Multi-Regional Clinical Trials Center of BWH and Harvard, USA
Room B
13:30~15:00 SESSION 9. Clinical Operational Excellence with New Technologies
Chair Soo Kyung Shin
           Jae Gook Shin
QuintilesIMS, Korea
Inje University Busan Park Hospital, Korea
13:30~14:00 The Application of Digital Healthcare to Clinical Trial - Not to Prove, But to Improve
Kwang Joon Kim Yonsei University College of Medicine, Korea
14:00~14:30 Informed Consent Entering the Digital World: The TransCelerate eConsent Initiative
Nozomi Sakurai Janssen, Japan
14:30~15:00 EMR data quality and standardization
Mi Ra Kang Mi Ra Kang Samsung Medical Center, Korea
15:00~15:30 Coffee Break
Room A
15:30~17:00 SESSION 10. Data Driven Approaches in Clinical Development
Chair In Jin Jang
           Hun Che Cho
Seoul National University Hospital, Korea
KDAR, Korea
15:30~16:00 Harnessing Big Data for Clinical Trial Design
Dustin Owen PPD, Singapore
16:00~16:30 Data Driven Approaches in Clinical Development
Jerome Armellini QuintilesIMS, Singapore
16:30~17:00 How Big Data and Analytics are Changing Clinical Trials
Eunho Shin Medidata, Korea
Room B
15:30~17:00 SESSION 11. Adaptive Design in Clinical Trials: When and How to Apply
Chair Howard Lee
           Hye-Jong Yoo
Seoul National University College of Medicine, Korea
AstraZeneca, Korea
15:30~16:00 Principle of Adaptive Design & Regulatory Requirement for Adaptive Clinical Trials
Howard Lee Seoul National University College of Medicine, Korea
16:00~16:30 Practical Aspects of Designing and Implementing Adaptive Design Trials in immune-oncology
Naftali Bechar Covance Inc., USA
16:30~17:00 Infrastructure and Processes Required for Optimal Delivery of Adaptive Clinical Trials
Jerry Wang Merck Serono, China