September 22 (Mon)
September 23 (Tue)
September 24 (Wed)
| Time | Program | Speaker | Affilliation |
|---|---|---|---|
| 08:00~09:00 | Registration | ||
| Room A+B+C | |||
| 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 : Byung-Geon Rhee (GI Innovation) | |
| 09:30~10:00 | PL1: Pioneering Global Success in Targeted Cancer Therapies - Yuhan's Vision for Innovation and Collaboration. Pioneering Global Success in Targeted Cancer Therapies - Yuhan’s Vision for Innovation and Collaboration | Chair : Byung-Geon Rhee | |
| Yeul Hong Kim | Yuhan Corporation | ||
| 10:00~10:30 | Coffee Break | ||
| 10:30~12:00 | PS1 Talkshow: AI and Big Data 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 | How AI is Reshaping the Drug Development Paradigm | Jung Kyoon Choi | KAIST |
| 10:50~11:20 | Panel Discussion | Jung Kyoon Choi | KAIST |
| 10:50~11:20 | Panel Discussion | Chaok Seok | Seoul University |
| 11:20~11:50 | Panel Discussion | TBD | TBD |
| 11:50~12:00 | Q&A | ||
| 12:00~13:30 | Lunch | ||
| Room A | |||
| 13:30~15:00 | S1. FDA & EMA Updates and IND Preparation | Chair :
Dae Young Zang (Hallym University Sacred Heart Hospital), Seungoh Lee (Yuhan Corporation) |
|
| 13:30~13:50 | FDA Updates | Paul Bridges | Parexel |
| 13:50~14:10 | EMA Updates | Nikos Zafiropoulos | 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 | Navigating EMA IND Preparation : Best Practices and Key Considerations for Successful Submissions(pre-IND) | Young Hwan Jang | LG Chem |
| 14:50~15:00 | Q&A | ||
| Room B | |||
| 13:30~15:00 | S2. Safety Management | Chair :
Min Jung Lim (MediSafe), Sangmi Lee (ABL Bio) |
|
| 13:30~13:50 | Reference Safety Information(RSI) | Nicholas Costello | MSD |
| 13:50~14:10 | Risk Management & Benefit-Risk Assessment | Katerina Rok Song | International Vaccine Institute (IVI) |
| 14:10~14:30 | Signal Detection and Risk Management | Min-kyung Shin | Selta Square |
| 14:30~14:50 | Considerations for DSUR | Soyeon Hwang | C&R Research |
| 14:50~15:00 | Q&A | ||
| Room C | |||
| 13:30~15:00 | S3. Clinical Trial Design Through the Investor’s Lens | Chair : TBD (TBD) | |
| 13:30~14:50 | Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement | Jung Ranh Ahn | SJ Investment Partners |
| 13:30~14:50 | Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement | Gi-soo Kang | BHN Investment |
| 13:30~14:50 | Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement | Hyun-Ki Kim | Stone Bridge |
| 13:30~14:50 | Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement | Yeo Jung Moon | IMM Investment |
| 14:50~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| Room A | |||
| 15:30~17:00 | S4. Innovate to Elevate: Advancing Clinical Operations for Tomorrow | Chair :
Jin Seok Kim (Severance Hospital), Hyun Joo Lee (MSD) |
|
| 15:30~15:50 | Empowering Decisions : The Art of Data-Informed Feasibility | Chen Kuanju(Rita) | Sanofi |
| 15:50~16:10 | Smart Writing : Unlocking the Future of Document Authoring with AI | TBD | TBD |
| 16:10~16:30 | Transitiong from paper to eISF : Experiences, Benefits and Future Directions | Doyeon Kim | MSD |
| 16:30~16:50 | Next-Gen Labeling : Streamlining Clinical Supplies with Digital Technology | Timothy Hajj | Merck |
| 16:50~17:00 | Q&A | ||
| Room B | |||
| 15:30~17:00 | S5. The Trump 2.0 Era: U.S. Policy Shifts and Global Implications for Pharma & Biotech | Chair : TBD (TBD) | |
| 15:30~16:00 | Emerging US FDA Clinical Trial Regulatory and Compliance Issues for Korean Biotechs? | Christopher A. Fanelli | Sidley Austin LLP |
| 15:30~16:00 | Emerging US FDA Clinical Trial Regulatory and Compliance Issues for Korean Biotechs? | Kelly Cho | Sidley Austin LLP |
| 16:00~16:25 | Trump 2.0 and U.S. Economic Policy : Strategic Implications for the Global Biopharma Market | Hyok Jung KIM | North America and Europe Team, Korea Institute for International Economic Policy (KIEP) |
| 16:25~16:50 | Navigating U.S. Market Entry : From Clinical Development to Commercial Success | TBD | TBD |
| 16:50~17:00 | Q&A | ||
| 17:00~17:30 | Coffee Break | ||
| Room C | |||
| 15:30~17:00 | S6. Strategic Portfolio Management for Successful Drug Development | Chair :
Sun Nam Kim (Korea Drug Development Fund), Wayne (Woohyung) Lee (GI Innovation) |
|
| 15:30~15:50 | Strategic Approaches for Successful Drug Development (MIDD, PK/PD Models) | Jihye Ahn | Silver Spring, Maryland USA |
| 15:50~16:10 | Strategic Prioritization and Resource Allocation in the Drug Development | Jahoon Kang | Samsung Biologics |
| 16:10~16:30 | Go/No-Go decision-1 | Sang Hoon Lee | ABL Bio |
| 16:30~16:50 | Go/No-Go decision-2 | Hee Chul Chang | Kairos bioconsulting LLC |
| 16:50~17:00 | Q&A | ||
| 17:00~17:30 | Coffee Break | ||
| Welcome Reception | |||
| 17:30~19:00 | Welcome Reception | ||
