October 13 (Tue)
October 14 (Wed)
October 15 (Thu)
| Time | Program | Speaker | Affilliation |
|---|---|---|---|
| 08:00~09:00 | Registration | ||
| 3F SAPPHIRE | |||
| 09:00~12:00 | S13. Current Trends and Future Directions in Oncology Clinical Trials (KCSG Joint Session) |
Chair :
Tae-Yong Kim
(Seoul National University Hospital) , Sang Joon Shin (Yonsei Cancer Center) |
|
| 09:00~10:15 | S13-1. The New Era of Precision Small Molecule Inhibitors |
Chair :
Tae-Yong Kim
(Seoul National University Hospital) |
|
| 09:00~09:15 | KRAS Inhibition: Current Landscapes and Beyond | Eun Joo Kang | Korea University Guro Hospital |
| 09:15~09:30 | Precision Targeting of the PI3K Pathway | Kabsoo Shin | The Catholic University of Korea Seoul st. Mary's Hospital |
| 09:30~09:45 | Epigenetic Modulators in Solid Tumors: from Mechanism to Clinic | Min Hwan Kim | Yonsei Cancer Center / Yonsei University College of Medicine |
| 09:45~10:00 | Targeted Protein Degradation: Redefining the Druggable Targets in Oncology | Joo-Hwan Park | Gachon University Gil Medical Center |
| 10:00~10:15 | Q&A | ||
| 10:15~10:30 | Coffee Break | ||
| 10:30~11:50 | S13-2. ADC Beyond Organ Boundaries |
Chair :
Sang Joon Shin
(Yonsei Cancer Center) |
|
| 10:30~10:45 | HER2-Low: Expanding the Breast Cancer Frontier | Hyunji Jo | Ewha Womans University Seoul Hospital |
| 10:45~11:00 | Tissue-Agnostic application of ADCs | JinWon Kim | Seoul National University Bundang Hospital |
| 11:00~11:15 | Nectin-4 & Trop-2: Ending the Platinum Era in Urothelial Cancer | Inkeun Park | Asan Medical Center (AMC) |
| 11:15~11:30 | Novel combination strategies in lung cancer | Jang Ho Cho | Gachon University Gil Medical Center |
| 11:30~11:50 | Q&A, Discussion | ||
| 12:00~13:30 | Lunch | ||
| 2F CRYSTAL A | |||
| 09:00~12:00 | S14. AI and Digital Automation in Clinical Operations: Optimizing Trial Execution |
Chair :
Hyunju Lee
(Sanofi-Aventis Korea) , Eunji Kwon (Bristol Myers Squibb (BMS, Korea)) , Sung Hwan Lee (CHA Bundang Medical Center / CHA University)1 , Jaesun Kang (CHA Biotech) |
|
| 09:00~10:00 | S14-1. AI and Digital Automation in Clinical Operations: Optimizing Trial Execution |
Chair :
Hyunju Lee
(Sanofi-Aventis Korea) , Eunji Kwon (Bristol Myers Squibb (BMS, Korea)) |
|
| 09:00~09:20 | Leveraging Data and AI for Smarter Clinical Decision-Making | Andrea Cipriani | University of Oxford |
| 09:20~09:40 | Digital Data Flow: Unlocking the Power of the Protocol | Azusa Oda | TransCelerate Biopharma Inc./ Novartis |
| 09:40~10:00 | Better Site Selection through a Data-Driven, Objective Approach | Elie Sullivan | Bristol Myers Squibb (BMS) |
| 10:00~10:30 | Coffee Break | ||
| 10:30~12:00 | S14-2. AI and Digital Automation in Clinical Operations: Optimizing Trial Execution |
Chair :
Sung Hwan Lee
(CHA Bundang Medical Center / CHA University) , Jaesun Kang (CHA Biotech) |
|
| 10:30~10:50 | Artificial Intelligence in Clinical Trial Recruitment | Merissa Govender | Sanofi |
| 10:50~11:10 | Accelerating Study Start-Up: Simplifying Budgeting and Contracting via Practical AI | Jihyun Lee | Syneos Health |
| 11:10~11:30 | AI-Powered Clinical Trial Data Flow From Source Data to Endpoint Evidence: Lessons from Global Cancer Centers and End-to-End Digital Trial Platforms | Kyung Won Kim | Asan Medical Center (AMC) / Trial Informatics |
| 11:30~11:50 | Agentic AI in Clinical Development: From Automation to Autonomous Execution | Greg Lever | IQVIA |
| 11:50~12:00 | Q&A | ||
| 12:00~13:30 | Lunch | ||
| 2F CRYSTAL B | |||
| 09:00~12:00 | S15. Beyond GLP-1: The Future of Diabetes and Obesity Clinical Development |
Chair :
Cheol Soo Choi
(Gachon University College of Medicine) , Haemin Chon (Hanmi Pharm. Co., Ltd.) , JaeJin Na (Daewoong Pharmaceutical Co., Ltd.)1 , Yuna Kim (Eli Lilly and Company (Korea)) |
|
| 09:00~10:20 | S15-1. Beyond GLP-1: The Future of Diabetes and Obesity Clinical Development |
Chair :
Cheol Soo Choi
(Gachon University College of Medicine) , Haemin Chon (Hanmi Pharm. Co., Ltd.) |
|
| 09:00~09:40 | Advancing the Global Development Landscape of Obesity Therapeutics: Opportunities, Challenges, and Future Directions | Young Min Cho | Seoul National University College of Medicine / Seoul National University Hospital |
| 09:40~10:00 | Beyond GLP-1: Exploring Emerging Mechanisms and Innovation Trends in Next-Generation Obesity Drug Development | Yong-ho Lee | Yonsei University College of Medicine/Severance Hospital |
| 10:00~10:20 | Are We Ready for Obesity Prevention Trials? | James W. Snyder | Syneos Health |
| 10:20~10:30 | Coffee Break | ||
| 10:30~12:00 | S15-2. Beyond GLP-1: The Future of Diabetes and Obesity Clinical Development |
Chair :
JaeJin Na
(Daewoong Pharmaceutical Co., Ltd.) , Yuna Kim (Eli Lilly and Company (Korea)) |
|
| 10:30~10:55 | Expanding the Therapeutic Potential of GLP-1-Based Treatments: Emerging Modalities and Evolving Therapeutic Strategies | Eun Ji Park | D&D Pharmatech |
| 10:55~11:25 | Navigating Opportunities and Challenges in Korea's Diabetes and Obesity Clinical Trial Landscape | Jiyeon Chu | Eli Lilly and Company (Korea) |
| 11:25~11:50 | Assessing the Limitations, Safety Considerations, and Real-World Evidence of GLP-1 Therapies | Chang Hee Jung | University of Ulsan College of Medicine / Asan Medical Center (AMC) |
| 11:50~12:00 | Q&A | ||
| 12:00~13:30 | Lunch | ||
| 3F SAPPHIRE | |||
| 13:30~15:00 | S16. Patient-Focused Drug Development: Integrating the Patient Voice in Clinical Development |
Chair :
Joonwoo Bahn
(Asan Medical Center (AMC)) , YoungWook Kim (Eli Lilly and Company (Korea)) |
|
| 13:30~13:50 | From Patient Voice to Regulatory Evidence: Implementing FDA's Fit-for-Purpose COA Framework and eCOA in Patient-Centered Clinical Trials | Stella Ha | Gilead Sciences (Korea) |
| 13:50~14:10 | Designing Trials Together: Industry Approaches to Co-Creating Clinical Trial Protocols with Patients, Caregivers, and Site Staff | Jade Cherie Dennis | Eli Lilly and Company |
| 14:10~14:30 | Finding the Right Patient for the Right Trial: AI-Powered and Patient-Focused Approaches to Clinical Trial Matching | SeoYoon Park | Asan Medical Center (AMC) |
| 14:30~14:50 | What Patients Say Matters: Incorporating PRO Data into Clinical Trial(s) | Juhee Cho | Samsung Medical Center (SMC) |
| 14:50~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| 2F CRYSTAL A | |||
| 13:30~15:00 | S17. Winning Strategies Behind Innovative K-Drug Success |
Chair :
Byung Geon (BG) Rhee
(Flagship Pioneering) |
|
| 13:30~13:55 | Global Clinical Trial Design and Execution in Alzheimer’s Disease: Lessons from Phase 3 Studies | Fred Kim | AriBio Co., Ltd. |
| 13:55~14:20 | A small Biotech’s Survival Strategy & Key Decisions: Therapeutic Approach for Hearing Loss and Neurodegenerative Diseases via Synaptopathy | Joseph Park | Neuracle Science |
| 14:20~14:45 | From Innovation to Global Impact: Structuring Partnerships for the Successful Development and Commercialization of Korean Biotech Products | Robert Crawford | Goodwin |
| 14:45~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| 2F CRYSTAL B | |||
| 13:30~15:00 | S18. Overcoming Scientific Challenges in Rare Diseases |
Chair :
Woohyung Wayne Lee
(Gradiant Bioconvergence) , Julie Raskin (Congenital Hyperinsulinism International) |
|
| 13:30~13:50 | Recent Updates and Shifting Trends in FDA Guidelines for Rare Diseases | Frank Li | BLA Regulatory, LLC |
| 13:50~14:10 | How sustained collaboration with a rare disease patient advocacy organization can strengthen biotech drug development | Julie Raskin | Congenital Hyperinsulinism International |
| 14:10~14:30 | Navigating Global Clinical Development for Rare Diseases: Lessons from Real-World Cases | Moon Hee Lee | Hanmi Pharm. Co., Ltd. |
| 14:30~14:50 | Thinking Global from Day One: From Public R&D to Global Success | Hyun-Sook Park | CEFO Co., Ltd. |
| 14:50~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| 3F SAPPHIRE | |||
| 15:30~17:00 | S19. Global Drug Development Strategy: From Regulatory Pathways to Market Entry |
Chair :
Eun-Jihn Roh
(NEX-I, Selecxine) , Julie Clark (4DMT) |
|
| 15:30~15:50 | Designing for Accelerated Approval: An Integrated Regulatory Strategy from Early Development to Confirmation of Clinical Benefit | Seong Hoon Jang | Korea National Enterprise for Clinical Trials (KoNECT) |
| 15:50~16:10 | Global Clinical Development Strategies: Optimizing Country Selection for Speed and Success | S. Suhail Ali | ICON plc |
| 16:10~16:30 | What Makes Clinical Data Deal-Ready? Strategies for Successful Licensing-Out | Yewon (Sofia) Choi | Merck & Co., Inc. |
| 16:30~16:50 | Global Development and Commercialization Strategies for AAV Gene Therapies | Julie Clark | 4DMT |
| 16:50~17:00 | Q&A | ||
| 2F CRYSTAL A | |||
| 15:30~17:00 | S20. From CMC Development to Clinical Supply: Strategies for Trial Readines |
Chair :
Doyeon Kim
(Merck Sharp & Dohme (MSD, Korea)) , Yousoon Kim (ICON plc (Korea)) |
|
| 15:30~15:55 | IND Submission 101 for Clinical Operations | Ji-Young (Karen) Park | BeOne Medicines (Korea) |
| 15:55~16:20 | CMC Information in IND: What It Really Means for Trial Execution | Jooha Kwon | MEDVIA Co.,Ltd. |
| 16:20~16:45 | From IND to IMP: How CMC Commitments Drive Clinical Trial Readiness | Areum Kang | GC Biopharma |
| 16:45~17:00 | Q&A | ||
| 2F CRYSTAL B | |||
| 15:30~17:00 | S21. Navigating Clinical Approval in Advanced Regenerative Medicine: Case Studies and Practical Guidance for Investigators |
Chair :
Jeeyoun Kim
(Korea Fund for Regenerative Medicine (KFRM)) , ㅤ ㅤ (ㅤ) |
|
| 15:30~15:55 | CMC and IND Approval Strategies for Clinical Translation of iPSC-Derived Therapies | Ji Hyeon Ju | YiPSCELL / The Catholic University of Korea |
| 15:55~16:20 | Development of a First-in-Class Pluripotent Stem cell Therapeutics for Urinary Disorders | Hyung Min Chung | Miraecellbio Co., Ltd. / Konkuk Univ. School of Medicine |
| 16:20~16:45 | Clinical Approval Roadmap for Next-Generation Advanced Regenerative Therapies | Jaejin Cho | CELLinCELLS co.,Ltd. / Seoul National University |
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