October 05 (Tue)
October 06 (Wed)
October 07 (Thu)
| Time | Program | Speaker | Affilliation |
|---|---|---|---|
| 09:00~09:30 | Registration | ||
| W1: NIFDS-KoNECT Multi-Regional Clinical Trials and GCP Inspection Workshop | |||
| 09:30~11:00 | Multi-Regional Clinical Trials: Expediting Global Clinical Development for Patients | Chair : HyunJoo Rhee, Paul (Neunggyu) Park |
|
| 09:30~10:00 | How to Design a Successful MRCT with a Focus on Neurodegeneration | Joanne Bell | Syneos Health |
| 10:00~10:25 | Key Consideration to Conduct MRCTs | Saumya Nayak | IQVIA |
| 10:25~10:50 | Case Study (Strategic Perspective) | Romi Singh | Pfizer |
| 10:50~11:00 | Q&A | All Chairs & Speakers | - |
| 11:00~11:30 | Coffee Break | ||
| 11:30~13:00 | GCP Inspection (TBD) | Chair : Sumi Hyun, Jung-Ah Byun |
|
| 11:30~11:50 | PV Inspection Trend | Jung-Ah Byun | MFDS |
| 11:50~12:20 | Remote Insepction Experiences | Eunjung Choi | Seqirus |
| 12:20~12:50 | Inspection Readiness on New Digital Technology | TBD | TBD |
| 12:50~13:00 | Q&A | All Chairs & Speakers | - |
| W2: Flawless IND Preparedness | |||
| 09:30~11:00 | Preparation of U.S. IND | Chair : Tae Youn Jo, Jeong Weon Park |
|
| 09:30~10:00 | CMC documentation for IND | Jun Park | ILIAS Biologics |
| 10:00~10:25 | Key to Submit a Successful IND application to the FDA | Kathryn Penhale-Unz | IQVIA |
| 10:25~10:50 | Regulatory Strategy and Practical aspect of Pre-IND meeting with FDA | Yeonhee Ahn | ImmuneOncia Therapeutics Inc |
| 10:50~11:00 | Q&A | All Chairs & Speakers | - |
| 11:00~11:30 | Coffee Break | ||
| 11:30~13:00 | Regulatory Interaction | Chair : Jina Jung, Jeong-Ja Oh |
|
| 11:30~13:00 | FDA environment for Oncology Drug Development | Zohra Lomri | Syneos Health |
| 12:10~12:50 | Communication Between IND Sponsors and Regulatory Agency during Drug Development | Yun Joo Kim | Yuhan Corporation |
| 12:50~13:00 | Q&A | All Chairs & Speakers | - |
| 13:00~14:00 | Lunch Break | ||
| W3: Practical Approaches to Global Trials (for K-Bio) | |||
| 14:00~15:30 | Preparing a Global Clinical Trial | Chair : Yukyung Kwon, Kyounghee Seo |
|
| 14:00~14:40 | How To Optimize CRO & Clinical Trial Site Selection Process in Global Trials | Kyounghee Seo | GemVax Pharmaceutical |
| 14:40~15:20 | Challenges and Opportunities for Conducting Global Trials in the COVID-19 Era | Stephen Lutsch | LEO Pharma |
| 15:20~15:30 | Q&A | All Chairs & Speakers | - |
| 15:30~16:00 | Coffee Break | ||
| 16:00~17:30 | Practices for Global Clinical Trial Operation | Chair : Byung-In Yoon, Saeyun Baik |
|
| 16:00~16:30 | Key Strategies for the Effective Study Initiation in Global Trials | Mike Park | C&R Research |
| 16:30~16:50 | Management of Clinical Supply in Global Trials | Michelle Lynskey | ICON plc |
| 16:50~17:20 | Trend Updates in Global Audit, Inspections and Findings | Jiyeon Lee | Hanmi Pharmaceuticals |
| 17:20~17:30 | Q&A | All Chairs & Speakers | - |
| W4 : Business Development and Partnering | |||
| 14:00~15:30 | BD Overview and Deals of 2020/21 | Chair : James Lee, Sung-Chun Kim |
|
| 14:00~14:40 | BD Overview and Korea 2021 Snapshot/Trends | Sung-Chun Kim | Olipass |
| 14:40~15:20 | Trends in Partnering Deals 2020-2021 (TBD) | Soomin Shim | Partners Investment |
| 15:20~15:30 | Q&A | All Chairs & Speakers | - |
| 15:30~16:00 | Coffee Break | ||
| 16:00~17:30 | Alliance Management | Chair : Sung-Chun Kim, Seungwon Jeong |
|
| 16:00~16:40 | HanAll - Roivant from 2017 to 2021 | Seungwon Jeong | HanAll Biopharma |
| 16:40~17:20 | The Beginning of Global Cooperation and Its Endless Challenges | Lauren Young-Mi Lee | Hanmi Pharmaceuticals |
| 17:20~17:30 | Q&A | All Chairs & Speakers | - |
