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
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KOREA, REPUBLIC OF
Summary
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Objectives and Background
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KOREA, REPUBLIC OF
Bio Essay
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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
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Current Status and Future Direction of Clinical Development from an Industry Perspective
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KOREA, REPUBLIC OF
Bio Essay
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Panel Discussion
Xiaoyuan Chen
Tsinghua University
CHINA
Bio Essay
Open +
Panel Discussion
Youngshin Lee
Korean Research-based Pharma Industry Association (KRPIA)
KOREA, REPUBLIC OF
Bio Essay
Open +
Panel Discussion
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KOREA, REPUBLIC OF
Bio Essay
Open +
Panel Discussion
Juyoung Shin
College of Pharmacy, Sungkyunkwan University
KOREA, REPUBLIC OF
Bio Essay
Open +
Juyoung Shin, PhD, is a Professor at the College of Pharmacy, Sungkyunkwan University, where she serves as the Chair of the Department of Biohealth Regulatory Science. She received her BS in Pharmacy, MPH in Health Policy and Management, and PhD in Pharmacoepidemiology from Seoul National University.
Her research focuses on pharmacoepidemiology, drug safety, and the use of large-scale healthcare data to evaluate the effectiveness and safety of medications. She has extensive expertise in real-world data analysis, particularly in assessing drug interactions and adverse events across diverse populations.
Dr. Shin has published over 200 peer-reviewed articles in leading international journals, including BMJ, Gut, and JAMA Pediatrics. Her work has contributed to advancing the understanding of medication safety, including studies on cardiovascular risks associated with ADHD treatments and bleeding risks linked to antidepressant use.
She previously worked as a postdoctoral researcher at McGill University and served as the Head of the DUR Information Team at the Korea Institute of Drug Safety and Risk Management. She is actively engaged in academic and policy communities as an associate editor of international journals and a member of professional societies and government advisory committees.
Her contributions have been recognized with several awards, including the Distinguished Pharmaceutical Scientist Award and the Young Epidemiologist Award.
Panel Discussion
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KOREA, REPUBLIC OF
Bio Essay
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Panel Discussion
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KOREA, REPUBLIC OF
Bio Essay
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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
This session will bring together the FDA, EMA, and NMPA to share regulatory perspectives and insights, and will discuss global alignment and strategies for accelerating clinical development and market access.
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Importance of Biomarker Bioanalysis in Clinical Drug Development
Chongwoo Yu
U.S. Food and Drug Administration (FDA)
KOREA, REPUBLIC OF
Bio Essay
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EMA Regulatory Trends and Future Directions in Clinical Trials
Pignatti Francesco
European Medicines Agency (EMA)
NETHERLANDS
Bio Essay
Open +
Evolution in Regulatory System in China
Xiaoyuan Chen
Tsinghua University
CHINA
Bio Essay
Open +
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
This session aims to extract critical lessons from past clinical trial failures and translate them into actionable strategies for future drug development, while identifying key risk factors in the clinical design phase and establishing robust mitigation frameworks to enhance trial resilience and predictability. It will further explore advanced clinical trial design strategies to optimize development pathways and maximize the likelihood of technical and regulatory success, as well as examine the implementation of innovative and adaptive trial designs to improve flexibility, efficiency, and patient-centricity in clinical development.
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From Platform to Patients: Clinical Trial Design and Development Strategies for Allogeneic CAR-T Therapies
Zachary J. Roberts
Allogene Therapeutics
UNITED STATES
Bio Essay
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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
Open +
Alignment of Clinical Development with Drug Differentiation and Positioning
Judith Ertle
Yuhan Corporation
KOREA, REPUBLIC OF
Bio Essay
Open +
Lirafugratinib (Cholangiocarcinoma) case
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KOREA, REPUBLIC OF
Bio Essay
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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
This session will explore emerging approaches in toxicology and safety assessment, highlighting innovative methodologies that enhance the prediction of drug safety and support more efficient development.
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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
Open +
Virtual Control Groups: Concepts, Applications, and Future Perspectives Following the EMA Guideline
Daeui Park
Korea Institute of Toxicology (KIT)
KOREA, REPUBLIC OF
Bio Essay
Open +
Enhancing Multi-Organ Safety Evaluation in Early Drug Discovery Using an AI-integrated NAMs Toolbox
Paul Walker
Cyprotex
Europe
Bio Essay
Open +
3F SAPPHIRE
Title
S4. Understanding MFDS Guidelines: Interpretation and Practical Consideration
Chair
Hyunjoo Rhee
IQVIA (Korea)
KOREA, REPUBLIC OF
Summary
This session aims to enhance participants’ understanding of MFDS guidelines by exploring how regulatory requirements are interpreted in practice and how they are applied throughout the clinical trial lifecycle in Korea. Through practical examples and discussion, the session will highlight key regulatory expectations, common areas of ambiguity, and best practices for effective engagement with the MFDS.
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Patient Selection Considerations in Early-Phase Oncology Trials under Non-Curative Settings
Minyoung Lim
GlaxoSmithKline (GSK, Korea)
KOREA, REPUBLIC OF
Bio Essay
Open +
Min-young Lim is a Clinical Operations Director at GSK Korea with over 24 years of experience in the pharmaceutical industry. She began her career at GSK Biologicals and later held leadership roles at Novartis Vaccines & Diagnostics, building strong expertise in clinical trial execution, quality, and regulatory compliance.
Since rejoining GSK, she has led Vx clinical operations as Country Clinical Operations Head for Vaccines Korea. Currently, she oversees clinical research delivery across all therapeutic areas in Korea, driving innovation through new technologies and operational excellence.
Min-young also plays an active role in shaping Korea’s clinical research environment. She served as Chair of the Clinical Trial Review Subcommittee under the MFDS CHORUS initiative (2023?2024), contributing to the improvement of clinical trial review processes and guideline revisions. Additionally, she leads regulatory initiatives within the KRPIA R&D Committee and collaborates closely with regulatory authorities to enhance clinical trial efficiency and competitiveness in Korea.
Abstract
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The landscape of oncology drug development has evolved significantly with the advent of targeted therapies and immunotherapies, leading to increasing interest in enrolling patients earlier in their treatment journey into early-phase clinical trials. Traditionally, first-in-human and other early-phase oncology studies were largely restricted to patients who had exhausted all available standard treatment options. However, in non-curative settings where long-term survival or cure is unlikely, participation in clinical trials may represent a meaningful therapeutic opportunity for patients. The recently issued Korean guidance, “Considerations for Patient Selection in Early-Phase Oncology Trials in Non-Curative Settings,” was developed to address this changing paradigm and to enhance regulatory predictability while maintaining patient protection.
This presentation will review the scientific and regulatory background that led to the development of the guidance, including evolving perspectives from major regulatory authorities on patient enrollment in early-phase oncology trials conducted in non-curative disease settings. The session will highlight key principles for patient selection, such as the role of available standard therapies, disease prognosis, treatment tolerability, and the level of evidence required to support anticipated clinical benefit.
In addition, practical implementation strategies and real-world examples will be discussed to illustrate how the guidance can be applied during protocol design and regulatory review.
Contraception Requirements in Clinical Trials: Alignment with Korean Labeling and Regulatory Guidelines
JinKyoung Kwon
IQVIA (Korea)
KOREA, REPUBLIC OF
Bio Essay
Open +
JinKyoung Kwon is a Manager in Regulatory Affairs at IQVIA Korea with over 10 years of experience in clinical research and regulatory affairs. She specializes in regulatory strategy, IND submissions, and clinical trial approvals in Korea, supporting a wide range of development programs from early-phase studies to multinational clinical trials. In her current role, she leads regulatory activities and site activation for global clinical studies, working closely with pharmaceutical and biotechnology companies. Her expertise includes Korean clinical trial regulations, regulatory submissions, study start-up strategy, and supporting multinational pharmaceutical and biotechnology companies in clinical development.
Abstract
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This presentation provides a review of frequently asked questions related to contraception requirements in clinical trials.
Clinical trial sponsors frequently encounter challenges when implementing contraception requirements in study protocols, particularly when global development strategies need to be aligned with Korean labeling information and local regulatory guidelines. While relevant requirements are described in regulations and guidance documents, questions often arise regarding their practical interpretation and application in real-world clinical trial settings.
This presentation will explore common questions and areas of ambiguity related to contraception requirements from a Korean regulatory perspective. Through practical Q&A cases, the session will discuss considerations encountered during protocol development and clinical trial application reviews, including the interpretation of Korean product labeling, the applicability of contraception requirements based on nonclinical and clinical data, acceptable contraceptive methods, and the duration of contraception measures for study participants.
The presentation will also examine situations where global protocol requirements may not fully align with local regulatory expectations and discuss approaches for providing scientific and regulatory justification. By sharing practical examples and regulatory interpretations, the session aims to help participants better understand how Korean regulatory guidelines can be applied consistently and effectively while facilitating efficient interactions with the Ministry of Food and Drug Safety (MFDS).
Participants will gain practical insights into managing contraception-related requirements and addressing common regulatory questions throughout the clinical trial life cycle in Korea.
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
Open +
SuhIm has built her career across clinical operations, regulatory affairs, and CMC, gaining broad experience in the end-to-end conduct of clinical trials in both global and local pharmaceutical settings. She began her career in clinical operations at Celltrion, where she supported and later managed global clinical studies across multiple therapeutic areas, contributing to study start-up, site management, IND preparation, and cross-functional project execution. She subsequently joined Roche, where her role expanded into local regulatory leadership, including IND submissions and amendments, regulatory consultation, and collaboration with global teams on Korea-specific regulatory strategy.
In her current role at MSD Korea, SuhIm serves as a Clinical Operations Manager with responsibilities spanning IND leadership, local regulatory management, start-up oversight, and CMC strategy for clinical studies in Korea. She has led internal efforts to build and strengthen in-house CMC capabilities, developed training programs to cultivate regulatory expertise within the organization, and serves as a subject matter expert for regulatory information management processes.
SuhIm has also played an active leadership role in CHORUS, a pharmaceutical industry?MFDS consultative working group, where she has led discussions and coordinated cross-company perspectives on key regulatory topics. Through these efforts, she has contributed to practical regulatory discussions related to IND review requirements and guideline updates, helping improve the clinical trial environment in Korea. This combination of operational, regulatory, and policy-facing experience provides the foundation for her perspective on current regulatory issues in clinical research.
She holds a Bachelor’s degree in Life Science from Chung-Ang University and a Master’s degree in Industrial Pharmaceutical Sciences from Yonsei University.
Abstract
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Commercial drugs are frequently used in clinical trials, yet their regulatory classification and the resulting documentation expectations are not always interpreted consistently in practice. In Korea, the definition of a commercially available drug in the clinical trial setting is shaped by domestic regulatory requirements as well as underlying ICH principles. How a product is classified can directly affect the scope of information expected by the Ministry of Food and Drug Safety (MFDS) during review of a clinical trial application or amendment.
This presentation will examine the regulatory definition of commercially available drugs used in clinical trials and review the relevant Korean regulations together with key ICH concepts that support their interpretation. It will also discuss the main review points considered by MFDS when assessing clinical trial applications involving such products, including the types of questions frequently raised to sponsors and the practical challenges sponsors face when preparing responses.
In addition, the presentation will share the background and rationale for proactive discussions between industry and MFDS on this topic, focusing on how recurring review questions and operational difficulties were translated into structured regulatory dialogue. These discussions contributed to the development of the MFDS guidance document, Casebook of Supplementation for Approval (Amendment) of Clinical Trial Applications. Beyond introducing the guidance itself, the session will provide practical context on how the discussion evolved, what issues were most debated, and how the resulting guidance may be interpreted and applied in real-world clinical trial planning and regulatory communication.
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
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Heewon brings ~13 years of bi-cultural clinical research experience spanning local and global environments. At Eli Lilly, she leads clinical trial allocation, site selection, and enrollment strategy for Lilly’s neuroscience pipeline in South Korea, while also contributing to CMH and oncology studies. Much of her work is driven by a single question: who gets left out of clinical studies, and why? Tackling the structural barriers to patient access has become a defining thread of her career, one she continues to pursue through new models of trial design and investigator engagement.
Abstract
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In South Korea, clinical trials can only be conducted at MFDS-designated sites, a structural constraint that has long confined trial access to large tertiary hospitals, leaving community-based clinics, and the patients they serve, outside the system. This talk shares an ongoing effort to work within and around that constraint: designing a Community-Based Research (CBR) model that formally connects a large tertiary hospital with a local private clinic, grounded in the 2024 MFDS guideline. Drawing on lessons learned so far in regulatory engagement and site-level implementation, the session offers a practical look at how regulatory frameworks can be operationalized, not just interpreted, to expand who gets to participate in clinical trials.
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
This session will explore key strategies and considerations for advancing drug candidates from discovery through IND submission and early clinical development to achieve proof of concept.
Open +
Navigating the IND Preparation Process
Eunjung Lee
Yuhan Corporation
KOREA, REPUBLIC OF
Bio Essay
Open +
From Bench to Bedside: Clinical Dose Selection Strategies
Seunghoon Han
AIMS BioScience, Co. Ltd.
KOREA, REPUBLIC OF
Bio Essay
Open +
From Imaging to Impact: Using PET and MRI to Optimize Drug Development
Eugenii (Ilan) A Rabiner
Perceptive Discovery
UNITED KINGDOM
Bio Essay
Open +
Regulatory Case Studies of FDA IND Approval Using Vascularized Organoid Data Without Animal Efficacy Testing
Kyu Baek
Qureator, Inc.
KOREA, REPUBLIC OF
Bio Essay
Open +
2F CRYSTAL B
Title
S6. From Data to Deals: Clinical Evidence Investors Trust
Chair
Yeojung Moon
IMM Investment
KOREA, REPUBLIC OF
Summary
This session will explore the clinical evidence and data attributes that investors prioritize when evaluating biopharmaceutical assets and investment opportunities.
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Panel Discussion
Bora Chung
STIC Ventures
KOREA, REPUBLIC OF
Bio Essay
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Panel Discussion
Gisoo Kang
BNH Investment
KOREA, REPUBLIC OF
Bio Essay
Open +
Dr. Gisoo Kang is a Vice President and Partner at BNH Investment, LLC, a premier venture capital firm dedicated to driving innovation in the Bio/Healthcare sector. Since joining the firm in 2018, Dr. Kang has established herself as a key investment professional, leading the discovery, rigorous evaluation, and strategic post-investment management of high-potential startups within the bio-healthcare sector. Capitalizing on her extensive global network with multinational pharmaceutical companies and international investors, she specializes in introducing promising Korean biotech companies to the global stage and actively accelerating their international expansion and cross-border partnerships.
Dr. Kang’s strength as a venture capitalist is backed by years of strategic corporate experience. Prior to BNH Investment, she served as a Senior Manager at CJ Corporation. There, she spearheaded corporate development and open innovation initiatives, analyzing global trends in healthcare and bio-based materials to propose strategic investments and global partnership opportunities.
Her investment acumen is further enhanced by a distinguished background in scientific research, allowing her to evaluate biological assets with unique technical precision. Dr. Kang previously conducted research as a Postdoctoral Fellow at the National Institutes of Health (NIH) in the United States, focusing on rare lung diseases and cellular mechanisms.
Dr. Kang holds a Ph.D. in Environmental Health Sciences (Environmental Toxicology) from New York University and a Bachelor of Science from Seoul National University. Blending deep scientific expertise, a robust global network, and extensive venture capital experience, she continues to play a pivotal role in accelerating the next generation of healthcare breakthroughs.
Panel Discussion
Hyunki Kim
Stonebridge Ventures
KOREA, REPUBLIC OF
Bio Essay
Open +
Hyun-Ki Kim is Managing Director at Stonebridge Ventures, where he leads bio and healthcare investments. Since joining in 2018, he has helped build the firm’s life sciences practice, focusing on technically differentiated companies with the potential to compete globally and deliver meaningful impact for patients.
He has been actively investing in and supporting emerging innovators such as Adel, Nex-I, and Ingenia Therapeutics, reflecting his conviction in science-driven companies that can create long-term value. His approach combines scientific expertise, global business development experience, and venture investing insight, shaped by his prior roles as a senior researcher at Dong-A Pharmaceutical, in global BD at Dong-A ST, and as a Boston-based investor at NS Investment.
He holds a B.S. in Biotechnology from Sungkyunkwan University and an M.S. in Biochemical Engineering from Seoul National University.
Abstract
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This session will discuss how investors evaluate clinical evidence when reviewing biotech investment and licensing opportunities. From an investor’s perspective, it will cover the key elements that make clinical data credible and decision-relevant, including trial design, patient selection, endpoints, safety, statistical strength, and competitive differentiation.
The session will also highlight what biotech companies should consider when planning clinical development for fundraising or partnering. Topics will include how to generate data that investors can trust, how to present clinical results clearly, and how to align clinical evidence with regulatory, commercial, and deal-making expectations.
By connecting clinical data with investment decision-making, this session aims to help biotech companies better understand what investors look for before committing capital or supporting a transaction.
Panel Discussion
Yeojung Moon
IMM Investment
KOREA, REPUBLIC OF
Bio Essay
Open +
Dr. Yeojung Moon is a passionate investor at IMM Investment with various early-to-late stage investment experiences in bio and healthcare. As the first MD into the venture capital industry, she has guided various early-stage bio and healthcare startups to establish and grow their business into global scale. Leveraging her clinical and research experience at Yonsei Severance Hospital as an OBGYN doctor, she has been recognized as an early-detector of differentiated technology and hands-on supporter to her portfolio partners. Her track record is accentuated by her distinctive contribution to Lunit (KOSDAQ:A32813) as a multi-time investor and a board member(aka Lunit’s Mom) to realize their mission to “Conquer Cancer through AI”
She holds a board seat of Hanwha Investment & Securities Co., Ltd.(KOSPI: 003530) and is a selected member of Presidential committee of Korea’s 4th industrial revolution.
Prior to joining IMM, Dr. Moon led Bio investment division at InterVest. She was also an assistant professor at Yonsei Severance Hospital. Yeojung holds PhD in Neuroscience and MD from Yonsei University.
2019- Senior managing director, IMM Investment Corp.
2016-2018 Director, Intervest Co.
2004-2016 Clinical Professor, Severance Hospital, OBGYN
2014 Yonsei University, School of Medical Science, Ph.D
2004 Yonsei university, School of Medicine, MD