October 10 (Tue)
October 11 (Wed)
October 12 (Thu)
| Time | Program | Speaker | Affiliation |
|---|---|---|---|
| 08:00~09:00 | Registration | ||
| 09:00~09:30 | Opening Ceremony | ||
| [Room A] PL 1: Clinical Development of DXd ADC Franchise | |||
| Objectives: In this session, unique features of the DXd ADC and an overview of the development strategy will be shared. | |||
| 09:30~10:00 | PL 1: Clinical Development of DXd ADC Franchise | Chair : Dae Young Zang (KCSG, KACTC, and HUMC) | |
| 09:30~10:00 |
Clinical Development of DXd ADC Franchise
|
Koichi Miyazaki | Daiichi Sankyo |
| 10:00~10:30 | Coffee Break | ||
| [Room A] PS 1 Talk Show: Thriving Through the Dip | |||
| Objectives: In an economically challenging environment, how do we find strategies to go through and fly ourselves again? | |||
| 10:30~12:00 | PS 1 Talk Show: Thriving Through the Dip [Special Panel: Hanlim Moon(MediRama)] | Chair : Seungjae Baek (UNIST), Seongsik Kang (DreamCIS) |
|
| 10:30~11:50 | Panelists: Myoung Ho Jang(GI Innovation), Mahn Soon Hwang(Korea Investment Partners), Seong Gil Lee(Kim & Chang), Hyemin Huh(Kiwoom Securities), Ali Pashazadeh(Treehill Partners), Jamie Jae Eun Kim (1ST Biotherapeutics, Inc.) | ||
| 11:50~12:00 | Q&A | ||
| 12:00~13:30 | Lunch & Sponsor Session(OPIS, Dt&C, Fortrea) | ||
| [Room A] S1: Medicine Development Strategy (Development Roadmap to Business Success) | |||
| Objectives: Understand initial development strategies of medicine to enhance the chance of successful commercialization (including technology transfer), and reflect them in actual development strategies. | |||
| 13:30~15:00 | S1: Medicine Development Strategy (Development Roadmap to Business Success) | Chair : Myunghoon Kim (KMD Bio), Haein Sin (SK Biopharmaceuticals) |
|
| 13:30~13:50 |
TPP; A Navigator to Business Success
|
Myunghoon Kim | KMD Bio |
| 13:50~14:10 | Strategies and Preparation for a Successful Partnering | Haein Sin | SK Biopharmaceuticals |
| 14:10~14:30 |
Streamlining Preclinical-Clinical Development for PoC
|
Dong-Seok Yim | The Catholic University of Korea |
| 14:30~14:50 | Establishment in the Global Market K-CAB’s Rise to Mainstream GERD Treatment | Jae Won Lee | HK.inno N |
| 14:50~15:00 | Q&A | ||
| [Room B] S2: Non-Clinical Studies for Drug Development: Efficacy - Model | |||
| Objectives: Discuss how to demonstrate and explain mechanisms of new drug candidates using various technologies, tools, and disease models according to different disease areas or modalities, and how to design the most appropriate experimental model for prediction of clinical efficacy | |||
| 13:30~15:00 | S2: Non-Clinical Studies for Drug Development: Efficacy - Model | Chair : Sun Jin Kim (Kolon Life Science), Bongtae Kim (inno.N) |
|
| 13:30~13:50 |
Orthotopic Animal Models for Evaluation of Efficacy of Anticancer Drugs
|
Sun Jin Kim | Kolon Life Science |
| 13:50~14:10 |
Nonclinical Strategy in the PK/PD Data Generation to Utilize Pharmacometrics for Human Prediction
|
Andrew (Soo Yong) Chung | AIMS BioScience |
| 14:10~14:30 |
Hair Growth Efficacy CRO Service
|
Nahyun Choi | Epibiotech |
| 14:30~14:50 |
Behavioral Assessment Tools in CNS Disease Models and Therapeutic Intervention
|
Mi Hyun Nam | Biotoxtech |
| 14:50~15:00 | Q&A | ||
| [Room C] S3: Consideration for CT: Methods and Tools | |||
| Objectives: To discuss recent advances in clinical trial designs for efficient development and regulatory success | |||
| 13:30~15:00 | S3: Consideration for CT: Methods and Tools | Chair : Lauren Young-Mi Lee (Yuhan Corporation), Jee Eun Lee (Asan Medical Center) |
|
| 13:30~13:50 | Rare Disease Drug Development and Regulatory Success - A Clinical Pharmacology Perspective | Jiang Liu | US FDA |
| 13:50~14:10 | Application of AI on Drug Development and Regulatory Decision | Menglun Wang | US FDA |
| 14:10~14:30 |
The Future of Clinical Trial Design in Oncology
|
Dae Ho Lee | Asan Medical Center |
| 14:30~14:50 |
Recent Trend in Oncology Clinical Trial (futility analysis)
|
Jae Yun Lim | AstraZeneca |
| 14:50~15:00 | Q&A | ||
| 15:00~15:30 | Coffee Break | ||
| [Room A] S4: Non-Clinical Safety: Safety, PK | |||
| Objectives: Discuss primary considerations in Lead Optimization phase and IND-enabling Toxicity Studies, importance of PM, case-oriented considerations, and etc. | |||
| 15:30~17:00 | S4: Non-Clinical Safety: Safety, PK | Chair : Sang Ho Lee (Jeju National University), Soohyeon Kim (QuBEST BIO) |
|
| 15:30~15:55 |
Considerations of Bioanalysis for Drug Development: Drug Metabolism, Pharmacokinetics and Toxicokinetics Perspectives
|
Young Geun Shin | Chungnam National University |
| 15:55~16:20 |
Nonclinical Package Management to Accelerate Drug Development
|
Eunsoo Jung | Bridge Biotherapeutics |
| 16:20~16:45 | Exploring Translational Potential: Unraveling Pre-Clinical Development Perspectives | Woo Chan Son | Asan Medical Center |
| 16:45~17:00 | Q&A | ||
| [Room B] S5: Pharmacovigilance (including DSUR) | |||
| Objectives: Systematic Approach to Risk Management: A Key to Improving Medication Safety: This session is to highlight the importance of systematic safety management in improving medication safety. The benefits of a systematic approach to risk management and how it can be implemented to improve patient safety will be discussed. | |||
| 15:30~17:00 | S5: Pharmacovigilance (including DSUR) | Chair : Soo Youn Chung (DreamCIS), Min-Jung Lim (MediSafe) |
|
| 15:30~15:55 | DSUR Development in Practice | Youngji Bang | JW Pharmaceutical |
| 15:55~16:25 | Systematic Approach to Managing Safety during Clinical Development | Hyojung Lee | Yuhan Corporation |
| 16:25~16:50 |
Management of Safety Information from Clinical Development to Post-Marketing
|
Min-Jung Lim | MediSafe |
| 16:50~17:00 | Q&A | ||
| [Room C] S6: Market Access in Late Stage Development | |||
| Objectives: Establish clinical evidence for successful market access in the late clinical stage of new drug development. Find connections between cost-effectiveness and decision-making factors, such as managed entry agreements, to consider in strategy developments. | |||
| 15:30~17:00 | S6: Market Access in Late Stage Development | Chair : Hyunju Yang (Daiichisankyo Korea), JungShin Park (SK Biopharmaceuticals Co., Ltd) |
|
| 15:30~15:50 |
Defining the Value of First-in-class and Justified Price Compensation from the Perspective of Market Access
|
Jong Hyuk Lee | Chung-Ang University |
| 15:50~16:10 |
Market Access Input in Drug Development Phase for Improving Patient Access to New Drugs
|
JoonSu Kim | AbbVie Korea |
| 16:10~16:30 |
Evaluating Ten Years of Risk Sharing Agreements in South Korea
|
Kyung-Bok Son | Hanyang University |
| 16:30~16:50 |
Introduction of Selective Post-reimbursement Evaluation System on Cost Effectiveness of Orphan Drugs for Improving Patient Access to Innovative Drugs
|
Jeonghoon Ahn | Ewha Womans University |
| 16:50~17:00 | Q&A | ||
| 17:30~19:00 | Welcome Reception | ||
