October 13 (Tue)
October 14 (Wed)
October 15 (Thu)
| Time | Program | Speaker | Affilliation |
|---|---|---|---|
| 09:00~18:00 | Registration | ||
| 2F CRYSTAL(A,B) + 3F SAPPHIRE | |||
| 09:00~09:30 | Opening Ceremony | ||
| 09:30~10:00 | PL1. Oncology in the Future: What Must Change in Clinical Trials | Chair : BG Rhee (Flagship Pioneering) | |
| 09:30~10:00 | ㅤ | Byoungchul Cho | Yonsei University College of Medicine |
| 10:00~10:30 | Coffee Break | ||
| 10:30~12:00 | PS1. Talkshow: K-Bio Strategy in a Shifting Global Landscape: Assessing Progress and the Road Ahead | Chair : ㅤ ㅤ (ㅤ) | |
| 10:30~10:35 | Objectives and Background | ㅤ ㅤ | ㅤ |
| 10:35~10:45 | Government Vision & Direction: Leaping into a Top 5 Global Bio Powerhouse and Ranking 3rd in Clinical Trials | HYE JIN KIM | KoNECT |
| 10:45~10:55 | Current Status and Future Direction of Clinical Development from an Industry Perspective | ㅤ ㅤ | ㅤ |
| 10:55~11:50 | Panel Discussion | Xiaoyuan Chen | Tsinghua University |
| 11:50~12:00 | Q&A | ||
| 12:00~13:30 | Lunch | ||
| 3F SAPPHIRE | |||
| 13:30~15:00 | S1. Regulatory Science in Clinical Development: Advancing Molecules to Market | Chair : ㅤ ㅤ (ㅤ) | |
| 13:30~13:55 | Importance of Biomarker Bioanalysis in Clinical Drug Development | Chongwoo Yu | U.S. Food and Drug Administration |
| 13:55~14:20 | EMA Regulatory Trends and Future Directions in Clinical Trials | ㅤ ㅤ | ㅤ |
| 14:20~14:45 | Practical Insights into the Latest Drug Development Regulatory Trends in China | Xiaoyuan Chen | Tsinghua University |
| 14:45~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| 2F CRYSTAL A | |||
| 13:30~15:00 | S2. Clinical Trial Design Strategies: Insights from Real-World Development | Chair :
Sewoong Oh (Yonsei University), Eunjihn Roh (NEX-I, Selecxine) |
|
| 13:30~13:50 | From Platform to Patients: Clinical Trial Design and Development Strategies for Allogeneic CAR-T Therapies | ZacharyJ. Roberts | Allogene Therapeutics |
| 13:50~14:10 | Designing Immuno-Oncology Trials for Success: Lessons from the Clinical Development of TU2218 (TGF-β/VEGF Dual Inhibitor) | Huntaek Kim | TiUMBIO |
| 14:10~14:30 | Alignment of Clinical Development with Drug Differentiation and Positioning | Judith Ertle | Yuhan Corporation |
| 14:30~14:50 | Lirafugratinib (Cholangiocarcinoma) case | ㅤ ㅤ | ㅤ |
| 14:50~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| 2F CRYSTAL B | |||
| 13:30~15:00 | S3. Rethinking Toxicology: New Approaches in Safety Assessment | Chair : ㅤ ㅤ (ㅤ) | |
| 13:30~13:55 | The Significance of FDA Modernization Act 2.0 and Implications for Korea’s Nonclinical Regulatory Strategy | Sukmo Kang | Biotoxtech |
| 13:55~14:20 | Virtual Control Groups: Concepts, Applications, and Future Perspectives Following the EMA Guideline | Daeui Park | Korea Institute of Toxicology (KIT) |
| 14:20~14:45 | Enhancing Multi-Organ Safety Evaluation in Early Drug Discovery Using an AI-integrated NAMs Toolbox | Paul Walker | Cyprotex |
| 14:45~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| 3F SAPPHIRE | |||
| 15:30~17:00 | S4. Navigating MFDS Guidelines: Regulatory Interpretation and Practical Application | Chair : Hyunjoo Rhee (IQVIA) | |
| 15:30~15:50 | Patient Selection Considerations in Early-Phase Oncology Trials under Non-Curative Settings | Minyoung Lim | GlaxoSmithKline (GSK, Korea) |
| 15:50~16:10 | Contraception Requirements in Clinical Trials: Alignment with Korean Labeling and Regulatory Guidelines | ㅤ ㅤ | ㅤ |
| 16:10~16:30 | Practical Considerations for Using Approved Drugs in Clinical Trials: Managing Discrepancies with Korean Labeling | Seoim Bang | Merck Sharp & Dohme (MSD, Korea) |
| 16:30~16:50 | Enhancing Clinical Trial Access: Expanding Participation of Regional Sites in Korea | Heewon Lee | Eli Lilly and Company (Korea) |
| 16:50~17:00 | Q&A | ||
| 2F CRYSTAL A | |||
| 15:30~17:00 | S5. From Molecule to PoC: Translating Discovery into Clinical Value | Chair : ㅤ ㅤ (ㅤ) | |
| 15:30~15:50 | Navigating the IND Preparation Process | Eunjung Lee | Yuhan Corporation |
| 15:50~16:10 | From Bench to Bedside: Clinical Dose Selection Strategies | Seunghoon Han | The Catholic University of Korea, College of Medicine |
| 16:10~16:30 | From Imaging to Impact: Using PET and MRI to Optimize Drug Development | Eugenii (Ilan) A Rabiner | Perceptive Discovery |
| 16:30~16:50 | Regulatory Case Studies of FDA IND Approval Using Vascularized Organoid Data Without Animal Efficacy Testing | Kyu Baek | Qureator, Inc. |
| 16:50~17:00 | Q&A | ||
| 2F CRYSTAL B | |||
| 15:30~17:00 | S6. From Data to Deals: Clinical Evidence Investors Trust | Chair : ㅤ ㅤ (ㅤ) | |
| 15:30~15:50 | Panel Discussion | Bora Chung | STIC Ventures |
| 15:50~16:10 | Panel Discussion | Gisoo Kang | BNH Investment |
| 16:10~16:30 | Panel Discussion | Hyunki Kim | Stonebridge Ventures |
| 16:30~16:50 | Panel Discussion | Yeojung Moon | IMM Investment |
| 16:50~17:00 | Q&A | ||
| Welcome Reception | |||
| 17:30~19:00 | Welcome Reception | ||
