Program

Speakers & Session Details

September 22 (Mon)

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

Title

PL1. Pioneering Global Success in Targeted Cancer Therapies - Yuhan's Vision for Innovation and Collaboration

Chair

    • BG Rhee
    • International Vaccine Institute Korea Support Committee
    • KOREA, REPUBLIC OF

Summary

Pioneering Global Success in Targeted Cancer Therapies - Yuhan’s Vision for Innovation and Collaboration

Yeul Hong Kim


Yuhan Corporation


KOREA, REPUBLIC OF

Bio Essay

Abstract

Title

PS1. Talkshow: AI in Drug Development: Breaking Barriers, Building Futures

Chair

    • Jae-Ho Cheong
    • Yonsei University
    • KOREA, REPUBLIC OF

Summary

Why AI Matters in Drug Development Now

Jae-Ho Cheong


Yonsei University


KOREA, REPUBLIC OF

Bio Essay

Abstract

Expanding Role of AI in Biologic Target Identification

Jung Kyoon Choi


KAIST


KOREA, REPUBLIC OF

Bio Essay

Abstract

Panel Discussion

Jung Kyoon Choi


KAIST


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Chaok Seok


Seoul National University


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Clayton (Yong Min) Park


LG AI Research


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Namshik Han


University of Cambridge


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Jia Chen


Medidata


UNITED STATES

Bio Essay

Panel Discussion

Janak Joshi


Commonwealth of Massachusetts


UNITED STATES

Bio Essay

Panel Discussion

Haemin Chon


Hanmi Pharm. co., Ltd


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Chen Guo


LinkDoc Technology


CHINA

Bio Essay

Panel Discussion

Naheed Kurji


Cyclica


CANADA

Bio Essay

3F SAPPHIRE

Title

S1. FDA & EMA Updates and IND Preparation

Chair

    • Dae Young Zang
    • Hallym University College of Medicine
    • KOREA, REPUBLIC OF
    • Seoungoh Lee
    • Yuhan Corporation
    • KOREA, REPUBLIC OF

Summary

An Update on Changes in the Global Regulatory Environment

Paul Bridges


Parexel


UNITED KINGDOM

Bio Essay

Abstract

EMA Updates

Nikos Zafiropoulos


European Medicines Agency (EMA)


NETHERLANDS

Bio Essay

Abstract

Navigating FDA IND Preparation - Lessons Learned and Best Practices from Recent Submissions

Eunbin Park


Yuhan Corporation


KOREA, REPUBLIC OF

Bio Essay

Abstract

Strategic Approaches to EMA CTA Preparation: Key Considerations and Lessons Learned from EURELIA Study

Younghwan Jang


LG Chem


KOREA, REPUBLIC OF

Bio Essay

Abstract

2F CRYSTAL A

Title

S2. Safety Management

Chair

    • Min-Jung Lim
    • MediSafe
    • KOREA, REPUBLIC OF
    • Sangmi Lee
    • ABL Bio
    • KOREA, REPUBLIC OF

Summary

Developing Reference Safety Information for Clinical Trials

Nicholas Costello


Merck Sharp & Dohme (MSD)


UNITED STATES

Bio Essay

Abstract

Benefit-Risk Assessment and Risk Management During a Clinical Trial

Katerina Rok Song


International Vaccine Institute (IVI)


KOREA, REPUBLIC OF

Bio Essay

Abstract

Lifecycle Safety Strategy: Signal Detection and Risk Escalation from Clinical Trials to Market

Minkyung Shin


SELTA SQUARE Inc.


KOREA, REPUBLIC OF

Bio Essay

Abstract

Development Safety Update Reports (DSUR): Role, Strategic Applications, and Key Considerations

Soyeon Hwang


C&R Research Inc.


KOREA, REPUBLIC OF

Bio Essay

Abstract

2F CRYSTAL B

Title

S3. Clinical Trial Design Through the Investor’s Lens

Chair

    • Yeojung Moon
    • IMM Investment
    • KOREA, REPUBLIC OF

Summary

Panel Discussion

Jungran Ahn


SJ Investment Partners


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Gi Soo 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

3F SAPPHIRE

Title

S4. Innovate to Elevate: Advancing Clinical Operations for Tomorrow

Chair

    • Jin Seok Kim
    • Severance Hospital
    • KOREA, REPUBLIC OF
    • Hyunjoo (Amy) Lee
    • Merck Sharp & Dohme (MSD, Korea)
    • KOREA, REPUBLIC OF

Summary

Transformation for Study Feasibility-Utilizing Digital Tool and Data-driven Approach

Kuanju(Rita) Chen


Sanofi


Chinese Taipei

Bio Essay

Abstract

Smart Writing: Unlocking the Future of Document Authoring with AI

Liza Theron


Parexel


SOUTH AFRICA

Bio Essay

Abstract

Transitiong from paper to eISF: Experiences, Benefits and Future Directions

Doyeon Kim


Merck Sharp & Dohme (MSD, Korea)


KOREA, REPUBLIC OF

Bio Essay

Abstract

Next-Gen Labeling: Streamlining Clinical Supplies with Digital Technology

Timothy Hajj


Merck


UNITED STATES

Bio Essay

Abstract

2F CRYSTAL A

Title

S5. Strategic Portfolio Management for Successful Drug Development

Chair

    • Sun Nam Kim
    • Korea Drug Development Fund (KDDF)
    • KOREA, REPUBLIC OF
    • Wayne (Woohyung) Lee
    • GI Innovation
    • KOREA, REPUBLIC OF

Summary

Considerations To Enhance Efficiency and Impact of Model-Informed Drug Development (MIDD) + Q&A

Jihye Ahn


Silver Spring, Maryland USA


KOREA, REPUBLIC OF

Bio Essay

Abstract

Optimizing 4-1BB T Cell Engaging BsAb from Preclinical Study to Human Clinical Trial + Q&A

Sang Hoon Lee


ABL Bio


KOREA, REPUBLIC OF

Bio Essay

Abstract

Integrating Early Commercialization Strategy for Successful Drug Licensing-Out + Q&A

Hee Chul Chang


Kairos Bioconsulting


KOREA, REPUBLIC OF

Bio Essay

Abstract

2F CRYSTAL B

Title

S6. The Trump 2.0 Era: U.S. Policy Shifts and Global Implications for Pharma & Biotech

Chair

    • Hanlim Moon
    • MediRama
    • KOREA, REPUBLIC OF

Summary

Emerging US FDA Clinical Trial Regulatory & Compliance Issues for Korean Companies

Christopher A. Fanelli


Sidley Austin LLP


UNITED STATES

Bio Essay

Abstract

Emerging US FDA Clinical Trial Regulatory & Compliance Issues for Korean Companies

Kelly Cho


Sidley Austin LLP


UNITED STATES

Bio Essay

Abstract

Trump 2.0 and U.S. Economic Policy: Strategic Implications for Global Biopharma Market

Hyok Jung Kim


Korea Institute for International Economic Policy (KIEP)


KOREA, REPUBLIC OF

Bio Essay

Abstract

Navigating U.S. Market Entry: From Clinical Development to Commercial Success

InPyo Hong


Syneos Health


KOREA, REPUBLIC OF

Bio Essay

Abstract

Welcome Reception

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