Program

Speakers & Session Details

October 13 (Tue)

2F CRYSTAL(A,B) + 3F SAPPHIRE

Title

PL1. Oncology in the Future: What Must Change in Clinical Trials

Chair

    • Byung Geon (BG) Rhee
    • Flagship Pioneering
    • KOREA, REPUBLIC OF

Summary

Oncology in the Future: What Must Change in Clinical Trials

Byoungchul Cho


Yonsei University College of Medicine


KOREA, REPUBLIC OF

Bio Essay

Title

PS1. Talkshow: K-Bio Strategy in a Shifting Global Landscape: Assessing Progress and the Road Ahead

Chair

    • ㅤ ㅤ
    • KOREA, REPUBLIC OF

Summary

Objectives and Background

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KOREA, REPUBLIC OF

Bio Essay

Government Vision & Direction: Leaping into a Top 5 Global Bio Powerhouse and Ranking 3rd in Clinical Trials

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KOREA, REPUBLIC OF

Bio Essay

Current Status and Future Direction of Clinical Development from an Industry Perspective

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KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Xiaoyuan Chen


Tsinghua University


CHINA

Bio Essay

Panel Discussion

Youngshin Lee


Korean Research-based Pharma Industry Association (KRPIA)


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

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KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Juyoung Shin


College of Pharmacy, Sungkyunkwan University


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

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KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

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KOREA, REPUBLIC OF

Bio Essay

3F SAPPHIRE

Title

S1. Regulatory Science in Clinical Development: Advancing Molecules to Market

Chair

    • Young Su (Bobby) Noh
    • Hanmi Pharm. Co., Ltd.
    • KOREA, REPUBLIC OF
    • Pignatti Francesco
    • European Medicines Agency (EMA)
    • NETHERLANDS

Summary

Importance of Biomarker Bioanalysis in Clinical Drug Development

Chongwoo Yu


U.S. Food and Drug Administration (FDA)


KOREA, REPUBLIC OF

Bio Essay

EMA Regulatory Trends and Future Directions in Clinical Trials

Pignatti Francesco


European Medicines Agency (EMA)


NETHERLANDS

Bio Essay

Evolution in Regulatory System in China

Xiaoyuan Chen


Tsinghua University


CHINA

Bio Essay

2F CRYSTAL A

Title

S2. Clinical Trial Design Strategies: Insights from Real-World Development

Chair

    • Se-Woong Oh
    • Yonsei University
    • KOREA, REPUBLIC OF
    • Eun-Jihn Roh
    • NEX-I, Selecxine
    • KOREA, REPUBLIC OF

Summary

From Platform to Patients: Clinical Trial Design and Development Strategies for Allogeneic CAR-T Therapies

Zachary J. Roberts


Allogene Therapeutics


UNITED STATES

Bio Essay

Designing Immuno-Oncology Trials for Success: Lessons from the Clinical Development of TU2218 (TGF-β/VEGF Dual Inhibitor)

Huntaek Kim


TiumBio


KOREA, REPUBLIC OF

Bio Essay

Alignment of Clinical Development with Drug Differentiation and Positioning

Judith Ertle


Yuhan Corporation


KOREA, REPUBLIC OF

Bio Essay

Lirafugratinib (Cholangiocarcinoma) case

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KOREA, REPUBLIC OF

Bio Essay

2F CRYSTAL B

Title

S3. Rethinking Toxicology: New Approaches in Safety Assessment

Chair

    • Eunsoo Jung
    • Estendbio
    • KOREA, REPUBLIC OF
    • Sukmo Kang
    • BTT Group / Keyprime Research
    • KOREA, REPUBLIC OF

Summary

The Significance of FDA Modernization Act 2.0 and Implications for Korea’s Nonclinical Regulatory Strategy

Sukmo Kang


BTT Group / Keyprime Research


KOREA, REPUBLIC OF

Bio Essay

Virtual Control Groups: Concepts, Applications, and Future Perspectives Following the EMA Guideline

Daeui Park


Korea Institute of Toxicology (KIT)


KOREA, REPUBLIC OF

Bio Essay

Enhancing Multi-Organ Safety Evaluation in Early Drug Discovery Using an AI-integrated NAMs Toolbox

Paul Walker


Cyprotex


Europe

Bio Essay

3F SAPPHIRE

Title

S4. Understanding MFDS Guidelines: Interpretation and Practical Consideration

Chair

    • Hyunjoo Rhee
    • IQVIA (Korea)
    • KOREA, REPUBLIC OF

Summary

Patient Selection Considerations in Early-Phase Oncology Trials under Non-Curative Settings

Minyoung Lim


GlaxoSmithKline (GSK, Korea)


KOREA, REPUBLIC OF

Bio Essay

Abstract

Contraception Requirements in Clinical Trials: Alignment with Korean Labeling and Regulatory Guidelines

JinKyoung Kwon


IQVIA (Korea)


KOREA, REPUBLIC OF

Bio Essay

Abstract

Commercial Drugs in Clinical Trials: Regulatory Definitions, MFDS Review Focus, and the Background to Korea’s guideline

SuhIm Bang


Merck Sharp & Dohme (MSD, Korea)


KOREA, REPUBLIC OF

Bio Essay

Abstract

From Regulation to Reality: Operationalizing Comprehensive Community Clinic Participation in Korean Clinical Trials

Heewon Lee


Eli Lilly and Company (Korea)


KOREA, REPUBLIC OF

Bio Essay

Abstract

2F CRYSTAL A

Title

S5. From Molecule to PoC: Translating Discovery into Clinical Value

Chair

    • Seoungoh Lee
    • Yuhan Corporation
    • KOREA, REPUBLIC OF
    • Wayne (Woohyung) lee
    • GI innovation, Inc.
    • KOREA, REPUBLIC OF

Summary

Navigating the IND Preparation Process

Eunjung Lee


Yuhan Corporation


KOREA, REPUBLIC OF

Bio Essay

From Bench to Bedside: Clinical Dose Selection Strategies

Seunghoon Han


AIMS BioScience, Co. Ltd.


KOREA, REPUBLIC OF

Bio Essay

From Imaging to Impact: Using PET and MRI to Optimize Drug Development

Eugenii (Ilan) A Rabiner


Perceptive Discovery


UNITED KINGDOM

Bio Essay

Regulatory Case Studies of FDA IND Approval Using Vascularized Organoid Data Without Animal Efficacy Testing

Kyu Baek


Qureator, Inc.


KOREA, REPUBLIC OF

Bio Essay

2F CRYSTAL B

Title

S6. From Data to Deals: Clinical Evidence Investors Trust

Chair

    • Yeojung Moon
    • IMM Investment
    • KOREA, REPUBLIC OF

Summary

Panel Discussion

Bora Chung


STIC Ventures


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Gisoo Kang


BNH Investment


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Hyunki Kim


Stonebridge Ventures


KOREA, REPUBLIC OF

Bio Essay

Abstract

Panel Discussion

Yeojung Moon


IMM Investment


KOREA, REPUBLIC OF

Bio Essay

Welcome Reception

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