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Program Details

October 10 (Tue)

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 파일 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 파일 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 파일 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 파일 Sun Jin Kim Kolon Life Science
13:50~14:10 Nonclinical Strategy in the PK/PD Data Generation to Utilize Pharmacometrics for Human Prediction 파일 Andrew (Soo Yong) Chung AIMS BioScience
14:10~14:30 Hair Growth Efficacy CRO Service 파일 Nahyun Choi Epibiotech
14:30~14:50 Behavioral Assessment Tools in CNS Disease Models and Therapeutic Intervention 파일 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 파일 Dae Ho Lee Asan Medical Center
14:30~14:50 Recent Trend in Oncology Clinical Trial (futility analysis) 파일 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 파일 Young Geun Shin Chungnam National University
15:55~16:20 Nonclinical Package Management to Accelerate Drug Development 파일 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 파일 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 파일 Jong Hyuk Lee Chung-Ang University
15:50~16:10 Market Access Input in Drug Development Phase for Improving Patient Access to New Drugs 파일 JoonSu Kim AbbVie Korea
16:10~16:30 Evaluating Ten Years of Risk Sharing Agreements in South Korea 파일 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 파일 Jeonghoon Ahn Ewha Womans University
16:50~17:00 Q&A
17:30~19:00 Welcome Reception