Program

Speakers & Session Details

September 22 (Mon)

Room A+B+C

Title

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

Chair

    • Byung-Geon Rhee
    • GI Innovation
    • 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 and Big Data 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

How AI is Reshaping the Drug Development Paradigm

Jung Kyoon Choi


KAIST


KOREA, REPUBLIC OF

Bio Essay

Abstract

Panel Discussion

Namshik Han


University of Cambridge


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Jung Kyoon Choi


KAIST


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Chaok Seok


Seoul University


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

Clayton Park


LG AI Research


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

NaHyun Kim


Medidata AI


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion

TBD


TBD


KOREA, REPUBLIC OF

Bio Essay

Room A

Title

S1. FDA & EMA Updates and IND Preparation

Chair

    • Dae Young Zang
    • Hallym University Sacred Heart Hospital/ Korean Cancer Study Group(KCSG)
    • KOREA, REPUBLIC OF
    • Seoungoh Lee
    • Yuhan Corporation
    • KOREA, REPUBLIC OF

Summary

FDA Updates

Paul Bridges


Parexel


KOREA, REPUBLIC OF

Bio Essay

Abstract

EMA Updates

Nikos Zafiropoulos


EMA


KOREA, REPUBLIC OF

Bio Essay

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

Eunbin Park


Yuhan Corporation


KOREA, REPUBLIC OF

Bio Essay

Abstract

Navigating EMA IND Preparation : Best Practices and Key Considerations for Successful Submissions(pre-IND)

Young Hwan Jang


LG Chem


KOREA, REPUBLIC OF

Bio Essay

Abstract

Room B

Title

S2. Safety Management

Chair

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

Summary

Reference Safety Information(RSI)

Nicholas Costello


MSD


KOREA, REPUBLIC OF

Bio Essay

Abstract

Risk Management & Benefit-Risk Assessment

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

Min-kyung Shin


Selta Square


KOREA, REPUBLIC OF

Bio Essay

Abstract

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

Soyeon Hwang


C&R Research


KOREA, REPUBLIC OF

Bio Essay

Abstract

Room C

Title

S3. Clinical Trial Design Through the Investor’s Lens

Chair

    • Yeo Jung Moon
    • IMM Investment
    • KOREA, REPUBLIC OF

Summary

Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement

Jung Ranh Ahn


SJ Investment Partners


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement

Gi-soo Kang


BHN Investment


KOREA, REPUBLIC OF

Bio Essay

Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement

Hyun-Ki Kim


Stone Bridge


KOREA, REPUBLIC OF

Bio Essay

Abstract

Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement

Yeo Jung Moon


IMM Investment


KOREA, REPUBLIC OF

Bio Essay

Room A

Title

S4. Innovate to Elevate: Advancing Clinical Operations for Tomorrow

Chair

    • Jin Seok Kim
    • Severance Hospital
    • KOREA, REPUBLIC OF
    • Hyun Joo Lee
    • MSD
    • KOREA, REPUBLIC OF

Summary

Empowering Decisions : The Art of Data-Informed Feasibility

Chen Kuanju(Rita)


Sanofi


KOREA, REPUBLIC OF

Bio Essay

Smart Writing : Unlocking the Future of Document Authoring with AI

Liza Theron


Parexel


KOREA, REPUBLIC OF

Bio Essay

Abstract

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

Doyeon Kim


MSD


KOREA, REPUBLIC OF

Bio Essay

Abstract

Next-Gen Labeling : Streamlining Clinical Supplies with Digital Technology

Timothy Hajj


Merck


KOREA, REPUBLIC OF

Bio Essay

Abstract

Room B

Title

S5. 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 and Compliance Issues for Korean Biotechs?

Christopher A. Fanelli


Sidley Austin LLP


KOREA, REPUBLIC OF

Bio Essay

Abstract

Emerging US FDA Clinical Trial Regulatory and Compliance Issues for Korean Biotechs?

Kelly Cho


Sidley Austin LLP


KOREA, REPUBLIC OF

Bio Essay

Abstract

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

Hyok Jung KIM


North America and Europe Team, 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

Room C

Title

S6. Strategic Portfolio Management for Successful Drug Development

Chair

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

Summary

Strategic Approaches for Successful Drug Development (MIDD, PK/PD Models)

Jihye Ahn


Silver Spring, Maryland USA


KOREA, REPUBLIC OF

Bio Essay

Abstract

Strategic Prioritization and Resource Allocation in the Drug Development

Jahoon Kang


Samsung Biologics


KOREA, REPUBLIC OF

Bio Essay

Go/No-Go decision-1

Sang Hoon Lee


ABL Bio


KOREA, REPUBLIC OF

Bio Essay

Go/No-Go decision-2

Hee Chul Chang


Kairos bioconsulting LLC


KOREA, REPUBLIC OF

Bio Essay

Abstract

Welcome Reception

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