September 22 (Mon)
September 23 (Tue)
September 24 (Wed)
| Time | Program | Speaker | Affilliation |
|---|---|---|---|
| 08:00~09:00 | Registration | ||
| 2F CRYSTAL(A,B) + 3F SAPPHIRE | |||
| 09:00~09:30 | Opening Ceremony | ||
| 09:30~10:00 | PL1. Pioneering Global Success in Targeted Cancer Therapies - Yuhan's Vision for Innovation and Collaboration | Chair : BG Rhee (International Vaccine Institute Korea Support Committee) | |
| 09:30~10:00 | Pioneering Global Success in Targeted Cancer Therapies - Yuhan’s Vision for Innovation and Collaboration | Yeul Hong Kim | Yuhan Corporation |
| 10:00~10:30 | Coffee Break | ||
| 10:30~12:00 | PS1. Talkshow: AI in Drug Development: Breaking Barriers, Building Futures | Chair : Jae-Ho Cheong (Yonsei University) | |
| 10:30~10:35 | Why AI Matters in Drug Development Now | Jae-Ho Cheong | Yonsei University |
| 10:35~10:50 | Expanding Role of AI in Biologic Target Identification | Jung Kyoon Choi | KAIST |
| 10:45~11:20 | Panel Discussion | Jung Kyoon Choi | KAIST |
| 10:50~11:50 | Panel Discussion | Chaok Seok | Seoul National University |
| 10:50~11:50 | Panel Discussion | Clayton (Yong Min) Park | LG AI Research |
| 10:50~11:50 | Panel Discussion | Namshik Han | University of Cambridge |
| 10:50~11:50 | Panel Discussion | Jia Chen | Medidata |
| 10:50~11:50 | Panel Discussion | Janak Joshi | Commonwealth of Massachusetts |
| 10:50~11:50 | Panel Discussion | Haemin Chon | Hanmi Pharm. co., Ltd |
| 10:45~11:20 | Panel Discussion | Chen Guo | LinkDoc Technology |
| 10:45~11:20 | Panel Discussion | Naheed Kurji | Cyclica |
| 11:50~12:00 | Q&A | ||
| 12:00~13:30 | Lunch | ||
| 3F SAPPHIRE | |||
| 13:30~15:00 | S1. FDA & EMA Updates and IND Preparation | Chair :
Dae Young Zang (Hallym University College of Medicine), Seoungoh Lee (Yuhan Corporation) |
|
| 13:30~13:50 | An Update on Changes in the Global Regulatory Environment | Paul Bridges | Parexel |
| 13:50~14:10 | EMA Updates | Nikos Zafiropoulos | European Medicines Agency (EMA) |
| 14:10~14:30 | Navigating FDA IND Preparation - Lessons Learned and Best Practices from Recent Submissions | Eunbin Park | Yuhan Corporation |
| 14:30~14:50 | Strategic Approaches to EMA CTA Preparation: Key Considerations and Lessons Learned from EURELIA Study | Younghwan Jang | LG Chem |
| 14:50~15:00 | Q&A | ||
| 2F CRYSTAL A | |||
| 13:30~15:00 | S2. Safety Management | Chair :
Min-Jung Lim (MediSafe), Sangmi Lee (ABL Bio) |
|
| 13:30~13:50 | Developing Reference Safety Information for Clinical Trials | Nicholas Costello | Merck Sharp & Dohme (MSD) |
| 13:50~14:10 | Benefit-Risk Assessment and Risk Management During a Clinical Trial | Katerina Rok Song | International Vaccine Institute (IVI) |
| 14:10~14:30 | Lifecycle Safety Strategy: Signal Detection and Risk Escalation from Clinical Trials to Market | Minkyung Shin | SELTA SQUARE Inc. |
| 14:30~14:50 | Development Safety Update Reports (DSUR): Role, Strategic Applications, and Key Considerations | Soyeon Hwang | C&R Research |
| 14:50~15:00 | Q&A | ||
| 2F CRYSTAL B | |||
| 13:30~15:00 | S3. Clinical Trial Design Through the Investor’s Lens | Chair : Yeojung Moon (IMM Investment) | |
| 13:30~14:50 | Panel Discussion | Jungran Ahn | SJ Investment Partners |
| 13:30~14:50 | Panel Discussion | Gisoo Kang | BNH Investment |
| 13:30~14:50 | Panel Discussion | Hyunki Kim | Stonebridge Ventures |
| 13:30~14:50 | Panel Discussion | Yeojung Moon | IMM Investment |
| 14:50~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| 3F SAPPHIRE | |||
| 15:30~17:00 | S4. Innovate to Elevate: Advancing Clinical Operations for Tomorrow | Chair :
Jin Seok Kim (Severance Hospital), Hyunjoo (Amy) Lee (Merck Sharp & Dohme (MSD, Korea)) |
|
| 15:30~15:50 | Transformation for Study Feasibility-Utilizing Digital Tool and Data-driven Approach | Kuanju(Rita) Chen | Sanofi |
| 15:50~16:10 | Smart Writing: Unlocking the Future of Document Authoring with AI | Liza Theron | Parexel |
| 16:10~16:30 | Transitiong from paper to eISF: Experiences, Benefits and Future Directions | Doyeon Kim | Merck Sharp & Dohme (MSD, Korea) |
| 16:30~16:50 | Next-Gen Labeling: Streamlining Clinical Supplies with Digital Technology | Timothy Hajj | Merck |
| 16:50~17:00 | Q&A | ||
| 2F CRYSTAL A | |||
| 15:30~17:00 | S5. Strategic Portfolio Management for Successful Drug Development | Chair :
Sun Nam Kim (Korea Drug Development Fund (KDDF)), Wayne (Woohyung) Lee (GI Innovation) |
|
| 15:30~16:00 | Considerations To Enhance Efficiency and Impact of Model-Informed Drug Development (MIDD) + Q&A | Jihye Ahn | Silver Spring, Maryland USA |
| 16:00~16:30 | Optimizing 4-1BB T Cell Engaging BsAb from Preclinical Study to Human Clinical Trial + Q&A | Sang Hoon Lee | ABL Bio |
| 16:30~17:00 | Integrating Early Commercialization Strategy for Successful Drug Licensing-Out + Q&A | Hee Chul Chang | Kairos Bioconsulting |
| 17:00~17:30 | Coffee Break | ||
| 2F CRYSTAL B | |||
| 15:30~17:00 | S6. The Trump 2.0 Era: U.S. Policy Shifts and Global Implications for Pharma & Biotech | Chair : Hanlim Moon (MediRama) | |
| 15:30~16:00 | Emerging US FDA Clinical Trial Regulatory & Compliance Issues for Korean Companies | Christopher A. Fanelli | Sidley Austin LLP |
| 15:30~16:00 | Emerging US FDA Clinical Trial Regulatory & Compliance Issues for Korean Companies | Kelly Cho | Sidley Austin LLP |
| 16:00~16:25 | Trump 2.0 and U.S. Economic Policy: Strategic Implications for Global Biopharma Market | Hyok Jung Kim | Korea Institute for International Economic Policy (KIEP) |
| 16:25~16:50 | Navigating U.S. Market Entry: From Clinical Development to Commercial Success | InPyo Hong | Syneos Health |
| 16:50~17:00 | Q&A | ||
| 17:00~17:30 | Coffee Break | ||
| Welcome Reception | |||
| 17:30~19:00 | Welcome Reception | ||
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