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
This keynote highlights Yuhan’s journey as the first Korean company to develop and globally commercialize an anticancer drug, Leclaza (lazertinib). It offers insights into Yuhan’s innovation strategy, global collaborations, and advancing pipeline in targeted and immune-oncology.
Pioneering Global Success in Targeted Cancer Therapies - Yuhan’s Vision for Innovation and Collaboration
Yeul Hong Kim
Yuhan Corporation
KOREA, REPUBLIC OF
Bio Essay
Yeul Hong Kim, MD, PhD is the President of R&D at Yuhan corporation, Korea. Dr. Kim was Professor of Medical Oncology at the Korea University College of Medicine from 1995 to 2023. He is certified in internal medicine and medical oncology by the Korean Association of Internal Medicine. He graduated from the Korea University Medical College and received a PhD degree in the Korea University, Seoul Korea. He was a research fellow in the Department of Gastrointestinal Medical Oncology and Thoracic/Head and Neck Medical Oncology of the MD Anderson Cancer Center, Houston, Texas, USA.
Dr. Kim is primarily interested in the new drug development in precision medicine era. He is former President of Asian Oncology Society and he served as the Director of the Korean Precision Medicine Enterprise from 2017 to 2022, which was funded from Korea Ministry of Health and Welfare.
Abstract
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In the rapidly evolving field of innovative new drug development, Yuhan Corporation stands at the forefront of innovation and collaboration.
Yuhan's vision is to contribute to the improvement of human health and the advancement of society through innovative drug development. One of Yuhan's most notable achievements is the successful development and global commercialization of Lazertinib. This groundbreaking targeted therapy, combining with Amivantamab, has set a new standard in the treatment of EGFR positive non-small cell lung cancer, offering improved efficacy and survival prolongation compared to existing treatments. The success of Lazertinib exemplifies Yuhan's commitment to advancing cancer treatment through innovative research and strategic partnerships including open innovation. The Yuhan's strategic vision, innovative research methodologies, and collaborative endeavors will be discussed further.
Title
PS1 Talkshow: AI and Big Data in Drug Development : Breaking Barriers, Building Futures
Chair
Jae-Ho Cheong
Yonsei University
KOREA, REPUBLIC OF
Summary
This session aims to provide an integrated overview of the application of AI across the entire drug development lifecycle and to identify key challenge-such as reliability, data quality, standardization, and model validation-that must be addressed for the practical adoption and broader implementation of AI in the field.
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Why AI Matters in Drug Development Now
Jae-Ho Cheong
Yonsei University
KOREA, REPUBLIC OF
Bio Essay
Open +
How AI is Reshaping the Drug Development Paradigm
Jung Kyoon Choi
KAIST
KOREA, REPUBLIC OF
Bio Essay
Open +
Oct 2024 - Present: Director, SCL-KAIST Institute of Translational Research
Sep 2024 - Present: Professor, Department of Bioengineering, KAIST
Sep 2014 - Aug 2024: Associate Professor, Department of Bioengineering, KAIST
Jan 2010 - Dec 2012: Principal Investigator, Genome Institute of Singapore (Joint appointment)
Oct 2009 - Aug 2014: Assistant Professor, Department of Bioengineering, KAIST
Abstract
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The advent of AI technologies, particularly emerging large language models and generative AI, is poised to redefine the drug development paradigm. While AI streamlines the entire drug development pipeline, its most critical impacts are evident in two key steps: target identification and drug discovery. Following a brief introduction to recent advances in the application of AI to small molecule-based drug discovery, this presentation will focus on how AI facilitates target discovery for antibody-based drugs and cancer vaccines.
Panel Discussion
Namshik Han
University of Cambridge
KOREA, REPUBLIC OF
Bio Essay
Open +
Prof Namshik Han
Group Leader, Head of AI Research
Milner Therapeutics Institute, University of Cambridge
Faculty
Cambridge Centre for AI in Medicine, University of Cambridge
Affiliated Principal Investigator
Cambridge Stem Cell Institute, University of Cambridge
Professor
Department of Quantum Information, Yonsei University
Adjunct Professor
Department of Biomedical Systems Informatics, Yonsei University
CTO & Co-founder
CardiaTec Biosciences Ltd
A highly accomplished computational drug discovery scientist, I specialize in machine learning, computational biology, and multi-omics. I serve as Professor in the Department of Quantum Information at Yonsei University and Head of AI Research at the Milner Therapeutics Institute, University of Cambridge. My academic leadership spans both institutions, where I direct research labs focused on applying quantum computing to AI-driven drug discovery, pioneering efforts at the interface of quantum technologies and translational biomedicine.
At Cambridge, I also hold appointments as Faculty at the Cambridge Centre for AI in Medicine and as an Affiliated Principal Investigator at the Cambridge Stem Cell Institute. These roles support my broader mission of developing cutting-edge AI methods for deciphering complex multimodal biomedical data, enabling the discovery of novel disease pathways, mechanisms, and therapeutic targets.
Beyond academia, I am deeply committed to translating scientific innovation into impact. I actively collaborate with industry partners to apply AI in therapeutic development and patient care, ensuring that the tools and strategies developed in my labs accelerate progress across the biomedical landscape. I am a founding scientist of Storm Therapeutics and co-founder of two AI drug discovery companies: KURE.ai Therapeutics, which focuses on NK cell-based immunotherapies, and CardiaTec Biosciences, which targets breakthrough therapies for cardiovascular disease.
Panel Discussion
Jung Kyoon Choi
KAIST
KOREA, REPUBLIC OF
Bio Essay
Open +
Oct 2024 - Present: Director, SCL-KAIST Institute of Translational Research
Sep 2024 - Present: Professor, Department of Bioengineering, KAIST
Sep 2014 - Aug 2024: Associate Professor, Department of Bioengineering, KAIST
Jan 2010 - Dec 2012: Principal Investigator, Genome Institute of Singapore (Joint appointment)
Oct 2009 - Aug 2014: Assistant Professor, Department of Bioengineering, KAIST
Panel Discussion
Chaok Seok
Seoul University
KOREA, REPUBLIC OF
Bio Essay
Open +
Chaok Seok is a Professor of Chemistry at Seoul National University, specializing in computational biology. Her research integrates deep learning and data-driven approaches to elucidate the structure and dynamics of biomolecules. After receiving her Ph.D. in theoretical chemistry from the University of Chicago, she began biomolecular modeling research at UCSF. Since joining Seoul National University in 2004, she has led the development of advanced methods for protein structure prediction and molecular interaction modeling. In 2020, she co-founded Galux, an AI-driven drug discovery startup, where she continues to lead innovation at the intersection of artificial intelligence and biopharmaceutical science.
Panel Discussion
Clayton Park
LG AI Research
KOREA, REPUBLIC OF
Bio Essay
Open +
Panel Discussion
NaHyun Kim
Medidata AI
KOREA, REPUBLIC OF
Bio Essay
Open +
Panel Discussion
TBD
TBD
KOREA, REPUBLIC OF
Bio Essay
Open +
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
This session will provide the latest regulatory updates from the FDA and EMA, with a focus on oncology drug development. It will also share practical insights from Korean industry experts on preparing successful IND submissions to both agencies. Through real-world case discussions, attendees will gain a clearer understanding of strategic, procedural, and scientific considerations in global regulatory pathways.
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FDA Updates
Paul Bridges
Parexel
KOREA, REPUBLIC OF
Bio Essay
Open +
Responsible for Parexel Consulting, practices including Medical Affairs, Regulatory Consulting, Market Access, Health Economics & Outcomes Research, Medical Communications, & Clinical Development Strategy).
A seasoned drug development leader, prior to Parexel Consulting, Paul had a regulatory leadership role in biotech and before that was pharmaceutical assessor for the UK Licensing Authority and nominated EMA expert.
Awarded a Ph.D. for his published work in respiratory medicine, Paul is a pharmacist by training.
Abstract
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In a rapidly evolving global regulatory environment, strategic IND and CTA planning is critical. With shifting FDA expectations, EU-CTR implementation, and UK regulatory reforms, sponsors must anticipate divergent requirements and engagement models. This session offers insights into how regulatory strategy can drive smarter submissions, manage uncertainty, and leverage innovation, including AI, to support accelerated global development.
EMA Updates
Nikos Zafiropoulos
EMA
KOREA, REPUBLIC OF
Bio Essay
Open +
Navigating FDA IND Preparation : Lessons Learned and Best Practices from Recent Submissions
Eunbin Park
Yuhan Corporation
KOREA, REPUBLIC OF
Bio Essay
Open +
Eunbin Park is a Regulatory Affairs Team Manager at Yuhan Corporation, where she leads IND submissions for new molecular entities domestically and internationally. She holds a pharmacy degree from Seoul National University and brings over a decade of regulatory experience from leading pharmaceutical companies including Dong-A ST, Pfizer Korea, Astellas Japan, and Chugai Japan. Her expertise spans IND/NDA/BLA submissions for both biologics and small molecules across major markets including Korea, US, and EU.
Abstract
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This presentation shares practical insights from recent FDA IND submissions, offering actionable strategies for successful regulatory navigation. Attendees will learn proven approaches for streamlining submission timelines, addressing FDA feedback efficiently, and building robust regulatory packages that minimize delays.
Navigating EMA IND Preparation : Best Practices and Key Considerations for Successful Submissions(pre-IND)
Young Hwan Jang
LG Chem
KOREA, REPUBLIC OF
Bio Essay
Open +
Professional Summary
Over 15 years of progressive experience in clinical research and the pharmaceutical industry. Extensive experience in Phase I-IV studies, including global multi-regional clinical trials conducted in Asia, North America, Latin America, and Europe.
Education
M.S. in Public Health, The Catholic University of Korea (2018-2020)
B.S. in Pharmacy, Kyung Hee University (2003-2010)
Work Experience
Clinical Study Management II Team, Clinical Operation and Strategy, LG Chem (2011-Present)
Clinical Team, Green Cross (2009-2011)
Abstract
Open +
Effective preparation for Clinical Trial Application (CTA) under the EU Clinical Trials Regulation (CTR) is critical for successful initiation and conduct of clinical trials, as well as for seeking future marketing authorization.
This presentation outlines key strategic considerations for a successful CTA submission and approval including comprehensive dossier preparation, engagement in scientific advice procedures, adherence to regulatory timelines, and interaction with Reporting Member State (RMS) and Member State Concerned (MSC).
Room B
Title
S2. Safety Management
Chair
Min Jung Lim
MediSafe
KOREA, REPUBLIC OF
Sangmi Lee
ABL Bio
KOREA, REPUBLIC OF
Summary
This session will explore key aspects of clinical trial safety management, including Reference Safety Information (RSI), signal detection, and benefit-risk assessment. Experts will share practical approaches to risk communication, DSUR preparation, and regulatory expectations, providing participants with actionable insights to enhance global pharmacovigilance practices.
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Reference Safety Information(RSI)
Nicholas Costello
MSD
KOREA, REPUBLIC OF
Bio Essay
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Nick Costello serves as the Reference Safety Information Business Process Lead in Clinical Safety and Risk Management at Merck, Sharp & Dohme. Nick has over 10 years of experience in Clinical Safety and Pharmacovigilance, having worked with both clinical research organizations and pharmaceutical companies of varying sizes. Prior to joining the pharmaceutical industry, Nick practiced as a clinical hospital pharmacist. Nick has a Bachelor of Pharmacy from the University of Sydney, Australia and is pursuing a Master of Public Health.
Abstract
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Reference Safety Information (RSI) is used for the assessment of expectedness of all ‘suspected’ serious adverse reactions (SARs) that occur in clinical trials, for the purpose of expedited and periodic regulatory reporting.
Drawing from ICH E6(R3) and the EU Clinical Trial Regulation (EU CTR), this presentation will provide a regulatory-based overview of RSI definition, purpose, development and applications; from identifying Adverse Reactions (ARs) in clinical trials, determining expectedness and its location within the Investigator Brochure, through to the connection with the core risk profile and product labeling.
Risk Management & Benefit-Risk Assessment
Katerina Rok Song
International Vaccine Institute (IVI)
KOREA, REPUBLIC OF
Bio Essay
Open +
Katerina Rok Song, MD, MPH is a research scientist in International Vaccine Institute (IVI). She graduated a medical school in Seoul, Korea, completed residency in Obstetrics & Gynecology, subspecialized in Obstetrics through fellowship. She started her vaccine career in a pharmaceutical company, Glaxosmithkline (GSK), with HPV vaccine and expanded her scope to all vaccines as a vaccine medical director in GSK Korea. She moved on to a public sector, Korea Disease Control Agency and worked in the department of national immunization program (NIP) and vaccine preventable diseases (VPD) as an epidemic intelligence service (EIS) officer/VPD team manager. Now Katerina is working in IVI, leading clinical trials as a project lead for the trials on cholera vaccines, COVID-19 vaccines and a Hepatitis E vaccine.
Abstract
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Risk assessment of an investigational product should begin early in clinical development and continue throughout the study. Sponsors should establish systems to manage immediate safety risks and regularly evaluate accumulated safety data to monitor emerging risks and update mitigation strategies as needed. These systems should be clearly described in the study protocol or relevant safety documents, including how assessment outcomes and mitigation measures will be documented over the course of the study. Benefit?risk assessment is a key component of safety evaluation and should be embedded in all aspects of safety monitoring. It must be an ongoing process, allowing evolving data to be continuously reassessed and incorporated into updated safety strategies as necessary.
Lifecycle Safety Strategy: Signal Detection and Risk Escalation from Clinical Trials to Market
Min-kyung Shin
Selta Square
KOREA, REPUBLIC OF
Bio Essay
Open +
As CEO of Selta Square, a global leader in pharmacovigilance, Minkyung Shin leads the only company in Korea offering true end-to-end PV services along with an AI/Digital Transformation-based SaaS platform. With cross-functional expertise spanning regulation, data, and technology, she supports pharmaceutical and biotech companies in building lifecycle safety strategies. She also contributes to the global PV ecosystem through academic engagement and advisory roles.
Abstract
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Effective pharmacovigilance starts in the clinical stage. This session highlights how signal detection and risk escalation practices-when embedded early in clinical PV-can lay the foundation for robust, end-to-end safety management. We will explore methods to identify emerging risks during trials, escalate them appropriately, and build a lifecycle strategy that aligns with regulatory expectations and patient safety goals throughout development and post-marketing phases.
Development Safety Update Reports (DSUR): Role, Strategic Applications, and Key Considerations
Soyeon Hwang
C&R Research
KOREA, REPUBLIC OF
Bio Essay
Open +
Soyeon Hwang, PharmD, is a PV Part Manager at C&R Research with over 7 years of pharmacovigilance experience at C&R Research (CRO) and Korea Institute of Drug Safety & Risk Management (KIDS, Health Authority). She has comprehensive PV experience from clinical trials to post-marketing phases including safety data management, RMP and active surveillance, DSUR, Long term follow up study.
Abstract
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With the recent DSUR mandate in Korea, this presentation will discuss the core structure of the DSUR based on ICH E2F, how sponsors should prepare and compile the required data, and practical strategies for writing the report. It will also explore how a well-prepared DSUR can be utilized beyond compliance, supporting ongoing safety monitoring and global regulatory alignment.
Room C
Title
S3. Clinical Trial Design Through the Investor’s Lens
Chair
Yeo Jung Moon
IMM Investment
KOREA, REPUBLIC OF
Summary
This session will examine how clinical trial strategies are evaluated by investors in the context of biotech funding and value creation. Through a panel discussion with leading venture capital and private equity professionals, the session will explore key investment criteria, clinical design red flags, and capital-raising strategies that influence biotech success.
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Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement
Jung Ranh Ahn
SJ Investment Partners
KOREA, REPUBLIC OF
Bio Essay
Open +
Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement
Gi-soo Kang
BHN Investment
KOREA, REPUBLIC OF
Bio Essay
Open +
Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement
Based on my investment experience in the U.S. and experience as a Korean biotech VC, I would like to discuss preclinical, clinical preparation and clinical progress of Korean biotech companies, and also discuss the key points that global pharmaceutical companies consider important for technology transfer by disease and modality.
Panel Discussion : Investor Insights into Biopharma and Trends in Capital Procurement
Yeo Jung 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
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
The objective of this session is to explore and highlight the transformative power of innovation in clinical operations, focusing on four key areas: data-informed feasibility, AI-driven document authoring, the transition from paper Investigator Site Files (ISF) to electronic ISF (eISF), and the implementation of digital display labeling in clinical supplies. By the end of the session, participants will be equipped with actionable insights and strategies to implement innovative practices that elevate clinical operations, ultimately leading to improved trial outcomes and enhanced patient care.
Open +
Empowering Decisions : The Art of Data-Informed Feasibility
Chen Kuanju(Rita)
Sanofi
KOREA, REPUBLIC OF
Bio Essay
Open +
Smart Writing : Unlocking the Future of Document Authoring with AI
Liza Theron
Parexel
KOREA, REPUBLIC OF
Bio Essay
Open +
Liza Theron, PhD is an experienced Medical Writing professional and has held various writing and management roles since joining Parexel Medical Writing Services in January 2019. Prior to joining Parexel, she had 26 years' experience in quality assurance (QA) of documents and procedures in various sectors, including Marketing Research, Clinical Trials and Academia.
Her current role involves applying her writing and QA experience in the development and validation of AI tools in the generation of clinical documents, via prompt engineering within a Large Language Model based system.
Abstract
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The presentation will discuss the integration of artificial intelligence (AI) within Medical Writing from the perspective of a global Contract Research Organization (CRO). This presentation will explore the changing environment of document authoring for regulatory submission by demonstrating the application of AI as part of internal document development workflows. The presentation will look at use case examples to demonstrate how AI technologies are used by medical writers during document drafting and reflect on how AI innovations are transforming the role of a medical writer.
Transitiong from paper to eISF : Experiences, Benefits and Future Directions
Doyeon Kim
MSD
KOREA, REPUBLIC OF
Bio Essay
Open +
Doyeon Kim began her clinical research career as a CRA and has since held roles such as Project Manager, Monitoring Manager, and Quality & Training Lead at various global pharmaceutical companies. Since 2019, she has worked at MSD Korea, currently serving as CRA Manager. In addition to project and people management, she has led initiatives to improve clinical operations, including the adoption of eISF. She holds a Life Sciences degree from Korea University.
Abstract
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MSD has been at the forefront of eISF adoption in Korea, where digital transition remains in progress across the industry. This session highlights benefits of shifting from paper ISF to eISF and shares practical insights from adoption, including challenges such as operational readiness, regulatory considerations, and digital maturity. It calls for collaboration among sponsors, CROs, sites, and health authorities to advance digital trials and reinforce Korea’s role in the global DCT landscape.
Next-Gen Labeling : Streamlining Clinical Supplies with Digital Technology
Timothy Hajj
Merck
KOREA, REPUBLIC OF
Bio Essay
Open +
Timothy Hajj, PharmD, is an Associate Director in Global Regulatory Affairs and Clinical Safety at Merck (Rahway, NJ), leading regulatory activities for digital innovation in clinical supply and providing regulatory insight and guidance to project teams related to drug development. Previously, he was a Global Regulatory Affairs Manager at Daiichi Sankyo, focusing on global regulatory strategy. He holds an A.S. in Chemistry from County College of Morris and a Doctor of Pharmacy from Rutgers.
Abstract
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This presentation will introduce the Digital Display Label (DDL), a cutting-edge electronic component featuring an e-paper display that provides essential labeling information. The DDL serves as a modern alternative to traditional paper labels for investigational medicinal products utilized in clinical trials. The speaker will discuss the advantages of this innovative technology, emphasizing its value to patients, its impact on clinical development, regulatory considerations and project course.
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
This session aims to explore how the evolving U.S. policy landscape under the Trump 2.0 administration may reshape the global pharmaceutical and biotech industries, including implications for clinical trials, regulatory compliance, and market entry strategies. Experts will discuss emerging FDA regulatory trends, strategic considerations for Korean biopharma companies entering the U.S. market, and the broader economic and policy shifts that could impact global collaboration, investment, and innovation. The session will also examine how Korean stakeholders can anticipate and adapt to these dynamic changes.
Open +
Emerging US FDA Clinical Trial Regulatory and Compliance Issues for Korean Biotechs?
Christopher A. Fanelli
Sidley Austin LLP
KOREA, REPUBLIC OF
Bio Essay
Open +
CHRIS FANELLI, partner at Sidley, is former Associate Chief Counsel for Enforcement at the U.S. FDA and a partner in Sidley Austin LLP’s Food, Drug and Medical Device practice. Chris’ clients include pre-commercial and early-stage commercial biotech companies, CAR T and gene therapy manufacturers, finished drug and biologics manufacturers, combination product manufacturers, and investment funds contemplating investments in this highly regulated industry. Having spent a number of years at FDA advising agency personnel on enforcement and compliance matters, Chris routinely counsels pre-commercial and commercial biotech companies on compliance with FDA’s GxP requirements; data integrity and Part 11 responsibilities; compliance with FDA’s import and export requirements; and pharmacovigilance obligations. Chris also helps clients develop and implement strategies for responding to Deficiency Letters and Complete Response Letters involving facilities, quality, and CMC issues with a focus on minimizing adverse impact to the business while helping achieve compliance objectives.
Abstract
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The change in administration has ushered in a new era for the US FDA. This session will explore emerging FDA regulatory and compliance issues affecting clinical trials, with a focus on the impact of recent policy changes, that may have significant implications for Korean biotech companies. This session will cover topics such as
- artificial intelligence (AI),
- real world evidence (RWE),
- considerations unique to rare disease clinical trials,
- FDA’s diversity action plan, and
- recent trends in FDA enforcement involving clinical trials, including sponsor oversight, data integrity, and fraud.
Sidley will provide practical insights into navigating these changes while ensuring compliance with FDA laws and expectations.
Emerging US FDA Clinical Trial Regulatory and Compliance Issues for Korean Biotechs?
Kelly Cho
Sidley Austin LLP
KOREA, REPUBLIC OF
Bio Essay
Open +
KELLY CHO is a Senior Managing Associate at Sidley and advises clients on a wide range of FDA regulatory and compliance matters affecting drugs, biological products, medical devices, cosmetics, and other products regulated by the agency. Kelly regularly assists clients on questions that may arise throughout a product’s lifecycle with respect to marketing authorization pathways, clinical trials, expedited programs and designations, FDA’s application review and approval process, and regulatory exclusivities.
Abstract
Open +
The change in administration has ushered in a new era for the US FDA. This session will explore emerging FDA regulatory and compliance issues affecting clinical trials, with a focus on the impact of recent policy changes, that may have significant implications for Korean biotech companies. This session will cover topics such as
- artificial intelligence (AI),
- real world evidence (RWE),
- considerations unique to rare disease clinical trials,
- FDA’s diversity action plan, and
- recent trends in FDA enforcement involving clinical trials, including sponsor oversight, data integrity, and fraud.
Sidley will provide practical insights into navigating these changes while ensuring compliance with FDA laws and expectations.
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
Open +
Hyok Jung Kim is an Associate Research Fellow at the Korea Institute for International Economic Policy (KIEP), where he is part of the North America and Europe Team. His recent publications at KIEP analyze the policy actions of the Trump 2.0 administration and the implications of reciprocal tariffs. Dr. Kim earned his Ph.D. in Economics from the University of California, Davis. Prior to joining KIEP, he worked as a researcher at the Korea Institute for Industrial Economics and Trade (KIET).
Abstract
Open +
The Trump 2.0 administration has undertaken a series of actions related to the biopharmaceutical industry, including reforms to government procurement rules, adjustments to tariff policies, and initiatives to strengthen manufacturing competitiveness-with more measures likely to follow. This presentation reviews the administration’s biopharma-related policies, anticipated future developments, and the rapidly evolving U.S. investment landscape.
Navigating U.S. Market Entry : From Clinical Development to Commercial Success
Inpyo Hong
Syneos Health
KOREA, REPUBLIC OF
Bio Essay
Open +
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
This session will explore strategic approaches to portfolio management that maximize the probability of success in drug development. Topics include model-informed drug development (MIDD), PK/PD modeling, resource prioritization, and Go/No-Go decision-making. Case studies will also highlight how early commercial strategies can strengthen out-licensing potential and overall R&D value.
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Strategic Approaches for Successful Drug Development (MIDD, PK/PD Models)
Jihye Ahn
Silver Spring, Maryland USA
KOREA, REPUBLIC OF
Bio Essay
Open +
Jihye Ahn has 9 years of experience in applying quantitative tools to support new drug development and regulatory science as a Clinical Pharmacologist and Pharmacometrician in the US FDA. She is passionate about promoting MIDD approaches in oncologic and hematologic drug development. She is also a registered pharmacist in Maryland, USA. She received PharmD/MS in Pharmacometrics from University of Maryland. She holds MS and BE in Electrical Engineering.
Abstract
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The role of MIDD in new drug development has evolved and expanded. Key considerations to enhance the efficiency and the impact of MIDD application in drug development include early planning and implementation, prioritization of objectives and fit-for-purpose methodology selection, and multiple-disciplinary and cross-functional collaboration. Relevant case examples are presented. Utilization of appropriate regulatory channels enables efficient and transparent communication between regulatory and drug developers.
Strategic Prioritization and Resource Allocation in the Drug Development
Jahoon Kang
Samsung Biologics
KOREA, REPUBLIC OF
Bio Essay
Open +
Go/No-Go decision-1
Sang Hoon Lee
ABL Bio
KOREA, REPUBLIC OF
Bio Essay
Open +
Dr. Lee founded ABL Bio in 2016 with the vision of “a better life” for patients through innovative science. With a focus on bispecific antibodies for cancer and neurodegeneration, he has led various R&D efforts. He has experience from global pharmaceutical companies such as Chiron (Novartis), AstraZeneca and Genentech. Dr. Lee received his Ph.D. at Ohio State and obtained his postdoctoral fellowship at the Harvard Medical School and UCSF.
Go/No-Go decision-2
Hee Chul Chang
Kairos bioconsulting LLC
KOREA, REPUBLIC OF
Bio Essay
Open +
Hee Chul Chang (Steven Chang) is a biotechnology and pharmaceutical expert with over 25 years of experience and a Ph.D. in Pharmacokinetics. He led R&D teams at Hanmi and Daewoong Pharmaceutical, and later served as Executive Director at Daewoong America, overseeing business development and licensing in North America. Now Managing Partner at Kairos Bioconsulting, he advises on global BD and M&A. He received Korea’s Best New Drug Development Researcher award and has led key licensing deals for antibodies, ADCs and small molecules.
Abstract
Open +
Early commercialization strategy is now critical to maximizing licensing-out success in the biotech sector. As deal-making increasingly hinges on demonstrating real-world market potential, companies must embed market access, pricing, and payer strategy from early R&D stages. This presentation outlines a structured, cross-functional approach to building commercialization readiness-enhancing asset attractiveness, aligning with partner expectations, and driving higher-value deals in today’s competitive licensing landscape.