October 29 (Tue)
October 30 (Wed)
October 31 (Thu)
| Time | Program | Speaker | Affilliation |
|---|---|---|---|
| 08:00~09:00 | Registration | ||
| 09:00~09:30 | Opening Ceremony | ||
| 3F HANRA 1+2+3 | |||
| 09:30~10:00 | PL 1 : Innovative Clinical Development Delivers Hope for Alzheimer’s Patients | Chair : Dae Young Zang, MD, PhD (Korean Cancer Study Group (KCSG)) | |
| 09:30~10:00 | Innovative Clinical Development Delivers Hope for Alzheimer’s Patients | Stewart Geary | Eisai Co. Ltd. |
| 10:00~10:30 | Coffee Break | ||
| 10:30~12:00 | PS 1 Talkshow : Shaping the Future of K-Bio: Strategic Insights and Collaborative Pathways | Chair :
Hanlim Moon, MD, PhD (MediRama), Seung Jae Baek (UNIST) |
|
| 10:30~11:50 | Panel Discussion | Inho Jo | Korean Fund for Regenerative Medicine(KFRM) |
| 10:30~11:50 | Panel Discussion | Sun Nam Kim, PhD | Korea Drug Development Fund(KDDF) |
| 10:30~11:50 | Panel Discussion | Myung Kee Kim | LSK Investment |
| 10:30~11:50 | Panel Discussion | Gyehoon Park | AJU IB INVESTMENT |
| 10:30~11:50 | Panel Discussion | Seong Gil Lee | Kim & Chang |
| 10:30~11:50 | Panel Discussion | Jong-Seo Lee | AbClon |
| 10:30~12:00 | Panel Discussion | Hyun Sook Park PhD | CEFO bio |
| 11:50~12:00 | Q&A | ||
| 12:00~13:30 | Lunch | ||
| 3F HANRA 1+2 | |||
| 13:30~15:00 | S1 : FDA IND Preparation | Chair : Juhee Cho, PhD (Sungkyunkwan University) | |
| 13:30~13:55 | Navigating FDA IND Preparation: Best Practices and Key Considerations for Successful Submissions | In Pyo Hong | Syneos Health |
| 13:55~14:20 | Achieving Rapid Proof of Concept and US Fast Track Designation Following a Phase 1 IND: DD01 for the treatment of MASH | Adam C. Bell, PhD | Neuraly |
| 14:20~14:45 | Challenges and Improvement Strategies for Asia Companies Obtaining FDA Approval | Jeong-Hee Yoo, PhD | DreamCIS lnc. |
| 14:45~15:00 | Q&A | ||
| 3F HANRA 3 | |||
| 13:30~15:00 | S2 : New Therapeutics | Chair :
Bong Tae Kim (HK inno.N Corp), Tae Dong Han (AbTis) |
|
| 13:30~13:55 | The FDA approval of TIL therapy | Hee Jin Lee | NeogenTC Corp. |
| 13:55~14:20 | Molecular Glue Degraders: A New Frontier in Targeted Drug Discovery | Wooseok Han | Cyrus Therapeutics, Inc. |
| 14:20~14:45 | Radiopharmaceutical therapy (RPT) and its coupled drug: Examples for prostate cancer | Dae Yoon Chi | FutureChem |
| 14:45~15:00 | Q&A | ||
| 2F RENDEZ-VOUS | |||
| 13:30~15:00 | S3 : Portfolio Management | Chair :
YoungWook Kim (Eli Lilly and Company), Jaesun Kang (CHA Biotech) |
|
| 13:30~13:55 | Strategies for Making Go/No-Go Decisions in Drug Development | Jeongsik Choi | CJ Bioscience, Inc. |
| 13:55~14:20 | R&D strategies for successful market launch | Helen Hyun Jung Lee, MD | HJLee consulting |
| 14:20~14:45 | Beyond clinical trials: Innovate portfolios | Heeyoung Kim | Certara, Inc. |
| 14:45~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| 3F HANRA 1+2 | |||
| 15:30~17:00 | S4 : FDA & EMA Updates | Chair : In-Jin Jang, MD, PhD (Seoul National University Hospital) | |
| 15:30~15:50 | Global Drug Development and MRCT: ICH E17 Guidelines and Implementation Progress | Romi Singh, PhD | Northeastern University |
| 15:50~16:10 | Drug development and MRCT : Clinical trials for New Drug Approval(NDA) in Korea | Jeong-Heun Joo | Korea National Institute of Food and Drug Safety Evaluation (NIFDS) |
| 16:10~16:30 | Regulatory Science in FDA: Updates in Accelerated Approval Pathway and Oncology Drug Dose Optimization | Seonghoon Jang | Elevar Therapeutics |
| 16:30~17:00 | EMA Updates - implications for drug developers | Sinan Sarac | Parexel |
| 3F HANRA 3 | |||
| 15:30~17:00 | S5 : Non-Clinical Design & Considerations for New Therapeutics | Chair :
Sang Ho Lee (Jeju National University College of Pharmacy), Se Woong Oh (Yuhan Corporation) |
|
| 15:30~15:55 | Key Experience-Informed Preclinical Design Considerations to Facilitate Development of DACs | James Palacino | Orum Therapeutics |
| 15:55~16:25 | New Drug Discovery for Oncolytic cell cycle arrest to control the deregulation | Soongyu Choi, PhD | Avelos Therapeutics |
| 16:25~16:50 | Non-Clinical Considerations in Global ADC Deals | Changsik Park, PhD | LigaChem Biosciences lnc. |
| 16:50~17:00 | Q&A | ||
| 2F RENDEZ-VOUS | |||
| 15:30~17:00 | S6 : Remote Monitoring | Chair :
Amy(Hyun Joo) Lee (MSD), Minyoung Lim (GSK) |
|
| 15:30~15:50 | Remote Monitoring Overview | Baljit Samra | Parexel |
| 15:50~16:10 | Exploring Remote Monitoring: Insights from US Practices | Emma Kim | AIMS BioScience Co., Ltd. |
| 16:10~16:30 | Case Studies of Remote Monitoring Utilizing the Florence Platform in Korea | Ji A Hong | Eli Lilly and Company |
| 16:30~16:50 | Rethinking Remote Monitoring in the DCT Era: A Nationwide Implementation of Clinical Trial Data Warehouses | Ki Young Huh, MD, PhD | Clinical Trials Center, Seoul National University Hospital |
| 16:50~17:00 | Q&A | ||
| 17:00~17:30 | Coffee Break | ||
| WELCOME RECEPTION (Sky Kingdom 31F) | |||
| 17:30~19:00 | Welcome Reception | ||
