한국임상시험본부 KIC

Program Details

September 22 (Mon)

Time	Program
08:00~09:00	Coffee Break
2F CRYSTAL(A,B) + 3F SAPPHIRE
09:00~09:30	Coffee Break
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 Speaker : Yeul Hong Kim Affilliation : 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 Speaker : Jae-Ho Cheong Affilliation : Yonsei University
10:35~10:45	Expanding Role of AI in Biologic Target Identification Speaker : Jung Kyoon Choi Affilliation : KAIST
10:45~11:50	Panel Discussion Speaker : Jung Kyoon Choi Affilliation : KAIST
10:45~11:50	Panel Discussion Speaker : Clayton (Yong Min) Park Affilliation : LG AI Research
10:45~11:50	Panel Discussion Speaker : Namshik Han Affilliation : University of Cambridge
10:45~11:50	Panel Discussion Speaker : Jia Chen Affilliation : Medidata
10:45~11:50	Panel Discussion Speaker : Janak Joshi Affilliation : Commonwealth of Massachusetts
10:45~11:50	Panel Discussion Speaker : Haemin Chon Affilliation : Hanmi Pharm. co., Ltd
10:45~11:50	Panel Discussion Speaker : Chen Guo Affilliation : LinkDoc Technology
10:45~11:50	Panel Discussion Speaker : Naheed Kurji Affilliation : Cyclica
11:50~12:00	Coffee Break
12:00~13:30	Coffee Break
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 Speaker : Paul Bridges Affilliation : Parexel
13:50~14:10	EMA Updates Speaker : Nikos Zafiropoulos Affilliation : European Medicines Agency (EMA)
14:10~14:30	Navigating FDA IND Preparation - Lessons Learned and Best Practices from Recent Submissions Speaker : Eunbin Park Affilliation : Yuhan Corporation
14:30~14:50	Strategic Approaches to EMA CTA Preparation: Key Considerations and Lessons Learned from Multi-Regional Clinical Trial Speaker : Younghwan Jang Affilliation : LG Chem
14:50~15:00	Coffee Break
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 Speaker : Nicholas Costello Affilliation : Merck Sharp & Dohme (MSD)
13:50~14:10	Benefit-Risk Assessment and Risk Management During a Clinical Trial Speaker : Katerina Rok Song Affilliation : International Vaccine Institute (IVI)
14:10~14:30	Lifecycle Safety Strategy: Signal Detection and Risk Escalation from Clinical Trials to Market Speaker : Minkyung Shin Affilliation : SELTA SQUARE Inc.
14:30~14:50	Development Safety Update Reports (DSUR): Role, Strategic Applications, and Key Considerations Speaker : Soyeon Hwang Affilliation : C&R Research Inc.
14:50~15:00	Coffee Break
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 Speaker : Jungran Ahn Affilliation : SJ Investment Partners
13:30~14:50	Panel Discussion Speaker : Gi Soo Kang Affilliation : BNH Investment
13:30~14:50	Panel Discussion Speaker : Hyunki Kim Affilliation : Stonebridge Ventures
13:30~14:50	Panel Discussion Speaker : Yeojung Moon Affilliation : IMM Investment
14:50~15:00	Coffee Break
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 Speaker : Kuanju(Rita) Chen Affilliation : Sanofi
15:50~16:10	Smart Writing: Unlocking the Future of Document Authoring with AI Speaker : Liza Theron Affilliation : Parexel
16:10~16:30	Transitiong from paper to eISF: Experiences, Benefits and Future Directions Speaker : Doyeon Kim Affilliation : Merck Sharp & Dohme (MSD, Korea)
16:30~16:50	Next-Gen Labeling: Streamlining Clinical Supplies with Digital Technology Speaker : Timothy Hajj Affilliation : Merck
16:50~17:00	Coffee Break
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 Speaker : Jihye Ahn Affilliation : Silver Spring, Maryland USA
16:00~16:30	Optimizing 4-1BB T Cell Engaging BsAb from Preclinical Study to Human Clinical Trial + Q&A Speaker : Sang Hoon Lee Affilliation : ABL Bio
16:30~17:00	Integrating Early Commercialization Strategy for Successful Drug Licensing-Out + Q&A Speaker : Hee Chul Chang Affilliation : 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 Speaker : Christopher A. Fanelli Affilliation : Sidley Austin LLP
15:30~16:00	Emerging US FDA Clinical Trial Regulatory & Compliance Issues for Korean Companies Speaker : Kelly Cho Affilliation : Sidley Austin LLP
16:00~16:25	Trump 2.0 and U.S. Economic Policy: Strategic Implications for Global Biopharma Market Speaker : Hyok Jung Kim Affilliation : Korea Institute for International Economic Policy (KIEP)
16:25~16:50	Navigating U.S. Market Entry: From Clinical Development to Commercial Success Speaker : InPyo Hong Affilliation : Syneos Health
16:50~17:00	Coffee Break
17:00~17:30	Coffee Break
Welcome Reception
17:30~19:00	Coffee Break