10th Annual Outsourcing in Clinical Trials Korea 2025

The yearly gathering for Korea’s clinical trials community to network, exchange insights, and develop partnerships that drive smarter, faster, and more efficient outsourcing strategies

2 - 3

December

2025
  • JW Marriott Dongdaemun Square Seoul
  • Ticketed
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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2025 Sponsors Include:

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Company Information

Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

Company Website

To learn more, please visit our website - www.novotech-cro.com

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Company Information

N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We’re doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into deterministic outcomes. We are an active player in clinical trial supply chain management for over 20 years and have the majority of the top 20 pharmaceutical companies as clients.

With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster and safer decisions for patients waiting for life-changing medications.

Company Website

To learn more, please visit our website - https://lifesciences.n-side.com/

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Company Information

Akesa is an end-to-end provider of clinical trial supplies and services. Headquartered in Melbourne, Australia, Akesa boasts global reach with deep expertise in the Asia-Pacific region. We work alongside sponsors, CROs, research institutions, clinical trial sites and CDMOs to project manage the sourcing of finished products, including comparators, combination therapies, and standard-of-care medications, from validated suppliers and directly from manufacturers.

Company Website

To learn more, please visit our website - http://akesapharma.com/

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Company Information

360biolabs is Australia’s most comprehensive bioanalytical laboratory providing support for development of new therapeutics, vaccines and diagnostics. We support pharmacokinetic (PK) analysis, pharmacodynamic (PD) endpoints in a quality assured environment (GLP, GCP, ISO / IEC 17025). We provide the advantage of a Phase 1 solution in Australia and transfer or continuation of your clinical study with our team in the USA or Europe.

The benefits of conducting early phase clinical trials in Australia: 

  • Speed: No IND required, healthy volunteer study approval in ~4-6 weeks
  • Quality: Data recognized by global regulatory bodies (e.g. FDA, EMA)
  • Cost-Effectiveness: Up to 43.5% R&D tax incentive

Company Website

To learn more, please visit our website - http://www.360biolabs.com/

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Company Information

Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle.

We are trusted experts in R&D, diagnostic services, API manufacture, formulation development, clinical trial supply services and technologies through to commercial-scale manufacture and distribution.

We are recognised as an industry leader in client service, providing understanding, experience and knowledge to our clients as we work together to advance human health.

Almac is trusted by the leading global biopharma companies to provide crucial services across their drug development projects. In the last 5 years alone, we have contributed to over 50% of all FDA approved New Molecular Entities (NMEs) and are currently supporting 30% of EU approved /pre-registered Gene therapy products.

A privately owned organisation, Almac has grown organically over the past five decades, employing over 7,700 highly skilled employees across 18 facilities in Europe, North America, and Asia. Learn more about us at https://www.almacgroup.com/

Company Website

To learn more, please visit our website - https://www.almacgroup.com

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Company Information

BMclinical, your global clinical trial supply partner. We offer worldwide commercial medicine supply, from analytical samples to bulk comparators, through to the supply of co-meds and pre-meds.  We can pack and label your IMP/commercial medicines from our GMP facility, where we also offer storage and distribution services. BMclinical is uniquely positioned to offer solutions for overage and unused clinical trial stock.

Company Website

To learn more, please visit our website - https://www.bmclinical.com

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Company Information

Complex innovative clinical trial designs require a synergetic approach to assess novel drug compounds for safety and effectiveness which often span safety, regulated and esoteric outcomes in all phases of the drug development life cycle. The companies of Eurofins Bioanalytical Services, the Eurofins Central Laboratory global network, Eurofins Viracor BioPharma Services, and Eurofins Clinical Trial Supplies are strongly connected to provide a solutions-based approach to our client needs.  Eurofins Clinical Trial Solutions provides seamless, end-to-end solutions to help clients progress through the drug development cycle through a single, experienced provider. Our solutions deliver the most comprehensive range of state-of-the-art analytical technologies with an extensive geographic reach to support our clients’ testing and clinical supplies needs and stringent quality and safety requirements around the world.

Company Website

To learn more, please visit our website - https://www.eurofins.com/biopharma-services/clinical-trial-solutions/

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Company Information

George Clinical is a leading CRO in Asia Pacific, with unparalleled Investigator networks. Since 1999, we have been providing full trial management services to biopharmaceutical customers. George Clinical combines

Company Website

To learn more, please visit our website - www.georgeclinical.com

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Company Information

Scout empowers the life sciences industry with people-first solutions: Scout Meetings, Scout Clinical, and Scout Academy. We specialize in face-to-face, virtual, and hybrid clinical meeting planning, patient payment, travel, and logistics support, and virtual collaboration and education. Since 1995, we have been a trusted partner excelling in customer service, regulatory compliance, and project delivery for leading pharmaceutical and biotechnology companies. Our deep understanding of international regulations and adaptable network of resources is built on operational experience in 109 countries. With white-glove attention to detail and a customizable, comprehensive range of services, Scout makes the complex easier. Learn more at scoutclinical.com.

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Company Information

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 6,000 people across 44 countries.

Company Website

To learn more, please visit our website - http://www.medpace.com/

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Company Information

Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

Company Website

To learn more, please visit our website - www.euromed-pharma.com

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Company Information

QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive.

Company Website

To learn more, please visit our website - www.qps.com

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    Why attend?

    The leading  Outsourcing in clinical trials conference in Korea is returning in 2025. With a focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an event not to be missed.

    Why join?

    Unlike other conferences, our event focuses especially on the regional pharmaceutical business in Asia, highlighting the industry’s current difficulties as well as its exciting innovations and growth prospects.

     

    Not only will the audience be discussing clinical partnership and supply challenges, but we also have the Clinical Trial Supply Korea conference co-located with the event to give you the opportunity to define an end-to-end clinical strategy.

    Meet and network with over 250 senior industry decision makers during our dedicated networking breaks, round tables and interactive sessions.

    Agenda

    • 2 Dec 2025
    • 3 Dec 2025
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    8 AM

    Registration and refreshments

    8:40 AM

    Chairperson’s opening remarks

    8:45 AM

    How to Choose the Right Clinical CRO: A Strategic Guide for Biotech Venture

    • Determining the optimal stage for CRO engagement to maximize efficiency
    • Engaging CROs in protocol development to inform strategic decisions, including country selection and trial design considerations
    • Leveraging CRO expertise by fostering a collaborative, partnership-driven relationship

    Speakers

    Sol Han
    Chief Medical Officer, Head of Clinical Development Center, Cyrus Therapeutics

    9:15 AM

    Reserved for Novotech

    9:45 AM

    KEY NOTE: Why Listening to Patients Matters: Redefining Clinical Development Strategies

    • Understanding how prioritizing patient care enhances trial success
    • FDA guidance driving patient-centric clinical development
    • Real-world impact of patient input on protocol design and trial conduct

    Speakers

    Kazuhiko Takahata
    Senior Director, Head of Clinical Development Group 3, Clinical Development Centre, Kyowa Kirin(Japan)

    10:15 AM

    Reserved for the Event Partner

    10:45 AM

    Morning refreshments and networking

    11:30 AM

    Navigating the Pros and Pitfalls of Risk-Based Monitoring in Clinical Research

    ·        Leveraging centralized monitoring tools and analytics to prioritize site visits and actions

    ·        Identifying trial-specific RBM models that support faster regulatory approvals

    Speakers

    Choong Hee LEE
    Director of Clinical Team, MitoImmune Therapeutics

    12 PM

    Globalization of Phase 1 Clinical Trials to Maximize Program Delivery and ROI

    • Summary of market data and where Phase 1 studies are being performed.
    • What are investors looking for from Phase 1 clinical trial datasets?
    • What and where can Phase 1 studies be done to meet or exceed market demands?
    • Review relevant case studies given recent Asian-based Biotechs market success

    12:30 PM

    Patient centricity: What does patient centric clinical trial development look like in 2025?

    ·        Looking at what is working and what can be done better

    ·        Highlighting the patient perspective, providing a platform to share one’s story

    ·        Discussing opportunities of further development

    ·        Differentiating between research for research purposes and research for commercialization and how that plays out with patient populations, with current issues around data, privacy and security

    Speakers

    Youngwook Kim
    Associate Director, Investigator Engagement – Korea, Clinical Research Investigator Engagement, Delivery & Capabilities, Lilly Korea Ltd

    1 PM

    Lunch and networking

    2:15 PM

    Developing a Clinical Oversight Strategy Using Big Data and BI Tools

    ·        Enhancing oversight of CROs, vendors, and trial sites through centralized data insights

    ·        Utilizing Business Intelligence (BI) tools to visualize trial health in real time

    ·        Case examples of effective use of BI tools in optimizing clinical timelines, cost, and compliance

    Speakers

    Jongyeop (Peter) Kim
    Lead Manager, Big Data Team, Daewon pharmaceutical

    2:45 PM

    Reserved for Avance Clinical

    3:15 PM

    CASE STUDY: Optimizing T Cell Engaging Therapies from Preclinical Study to Human Clinical Trial

    Speakers

    Sangmi Lee
    Head of Clinical Development, ABL Bio

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

    Unlocking FDA Strategies for Speedy Approval and Smart Dosing in Oncology Trials

    ·        Exploring recent US FDA updates on expedited approval pathways and dosing strategies in oncology

    ·        Designing clinical trials that meet FDA expectations for surrogate endpoints and biomarker use

    ·        Developing regulatory-aligned strategies for oncology drug development under new FDA guidance

    Speakers

    Young Su (Bobby) Noh
    Director, Head of Clinical Research and Development (ONCO),Hanmi Pharm

    5 PM

    PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials

    ·        Advancing trial efficiency through AI, automation, and digital platform integration

    ·        Exploring emerging trends and innovations in clinical trial research and design

    ·        Assessing data-driven strategies to improve patient centric outcomes and value in trials

    Speakers

    Sangwoo Lee
    CEO, Jeju Biotek
    Kazuhiko Takahata
    Senior Director, Head of Clinical Development Group 3, Clinical Development Centre, Kyowa Kirin(Japan)
    Young Su (Bobby) Noh
    Director, Head of Clinical Research and Development (ONCO),Hanmi Pharm

    5:15 PM

    Chairperson’s closing remarks

    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    9 AM

    Strategic Implementation of AI to Accelerate Drug Development and Optimize Clinical Trials

    • Leveraging AI-driven approaches such as virtual screening and molecular docking
    • Utilizing machine learning models to predict biological activity and accelerate lead compound optimization
    • harnessing AI to design agile and data-driven trial protocols

    Speakers

    Amy Jung Hyun LEE
    Medical imaging expert

    9:30 AM

    Reserved for QPS

    10 AM

    KEY NOTE: Driving CRO Performance in Clinical Trials

    • Determining the optimal stage for CRO engagement to maximize efficiency
    • Engaging CROs in protocol development to inform strategic decisions, including country selection and trial design considerations
    • Leveraging CRO expertise by fostering a collaborative, partnership-driven relationship

    10:30 AM

    FIRESITE CHAT: Evolving Clinical Trial Designs: Key Considerations and Best Practices for Implementing Decentralized Clinicals(DCT)

    • Key considerations for planning and determining the suitability of DCT
    • Reviewing how DCTs can enhance trial reach and significantly boost patient recruitment
    • Sharing insights and lessons learned from an inspection of an interventional DCT

    Speakers

    Tina Sun
    Study & Site Operations Country Head, Novartis(Taiwan)

    11 AM

    Morning refreshments and networking

    11:45 AM

    Strategic Considerations for Clinical Trials in Cell Therapy Development

    • Addressing regulatory uncertainties and evolving guidance for advanced therapies
    • Building trial plans that embed real-world evidence and extended follow-up
    • Implementing robust safety monitoring strategies for acute and long term risks

    Speakers

    YOHAN BAE
    Executive Director, Clinical Development Division, Kangstem Biotech

    12:15 PM

    PANEL DISCUSSION: Overview of Clinical Trial Dynamics Affecting Small to Mid-Sized Biopharma in Korea

    • Current landscape and growth trends of clinical trials in Korea, especially for small/mid-sized biopharma
    • Navigating the evolving vendor and CRO ecosystem as a small to mid-sized sponsor
    • Regulatory environment and recent updates impacting trial initiation and approvals

    Speakers

    Sangwoo Lee
    CEO, Jeju Biotek
    Tina Sun
    Study & Site Operations Country Head, Novartis(Taiwan)
    YOHAN BAE
    Executive Director, Clinical Development Division, Kangstem Biotech

    1 PM

    Lunch and networking

    Prize Draw taking place in exhibition hall at 14:15

    Join us for a chance to win one of our prizes, including Apple products

    2:30 PM

    Speaker Hosted Roundtables

    Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

    Roundtable session lasts for 30 minutes and rotate

    ROUNDTABLE 1: Comparator Sourcing in Small Biotech: Overcoming Limits with Strategic Outsourcing
    ROUNDTABLE 2: Driving Efficiency and Results Through Strong Sponsor, CRO Partnerships

    YongGwan Kim, Associate Director, Janssen
    ROUNDTABLE 3: Key Areas to Focus on for Proactive Inspection Preparedness in Today’s Regulatory Landscape
    ROUNDTABLE 4: Integrating Packaging and Labeling with Clinical Supply Chain Operations

     

    3:30 PM

    Chairperson’s closing remarks

    END OF CONFERENCE

    Speakers

    Select a speaker to learn more

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    Priya Ravisekara
    Senior Pharma Analyst, GlobalData Plc

    Priya Ravisekara, MSc,is a senior analyst at GlobalData in London, UK, where her primary responsibilities include producing analytical reports, improving and maintaining database functionality through quality assurance testing, updating and monitoring Global Data’s Clinical Trials Intelligence Database, and answering queries directly from clients. Priya holds a Masters in Clinical Drug Development from Barts and The London School of Medicine and Dentistry, and a Bachelor of Science in Biochemistry from Brunel University, London.​

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    Sangwoo Lee
    CEO, Jeju Biotek

    With 16 years of experience in the pharmaceutical industry, including over 5 years in non-clinical pharmacology and nearly a decade in clinical development, Sangwoo Lee has managed more than 10 clinical studies across both international sites (United States, Australia, Indonesia, and Singapore) and domestic settings in South Korea.

    Specialties

    Full Scoped Clinical Development

    Clinical trial operation management and supervision based on Regulations and ICH guidelines

    Development of IND CTD module relevant for Clinical Trial and Nonclinical Study

    Planning and Management of Clinical Study Timeline and Budget

    Vendor Selection and Management (CRO, Analytical Lab, Couriers)

    Study Site Management and communication

    IMP Management (Blinded)

    Session Details:

    PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials

    2025-12-02, 5:00 PM

    Session Details:

    PANEL DISCUSSION: Overview of Clinical Trial Dynamics Affecting Small to Mid-Sized Biopharma in Korea

    2025-12-03, 12:15 PM

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    Young Su (Bobby) Noh
    Director, Head of Clinical Research and Development (ONCO),Hanmi Pharm

    Young Su (Bobby) Noh, Ph.D., is the Director, Clinical Research and Development (Oncology), Hanmi Pharma and a representative of IFPMA, ICH E22 informal Expert Working Group. Dr. Noh is also working as a committee member of KIC2025, an external Instructor in KoNECT and a reviewer of external evaluation committee of KDDF. Dr. Noh has been responsible for leading clinical program with NMEs or NBEs in multi-therapeutic area: including metabolic diseases and rare diseases as well as oncology and hematology for 17 years. Dr. Noh has a lot of experience for collaborating with global big pharma as well as biotech companies.

    Previously, Dr. Noh served as an adjunct professor, department of regulatory science for Kyung Hee university and an expert, several guidelines Working Group of MFDS. Dr. Noh received his Ph.D. in pharmacy Kyung Hee University.

    Session Details:

    Unlocking FDA Strategies for Speedy Approval and Smart Dosing in Oncology Trials

    2025-12-02, 4:15 PM

    Session Details:

    PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials

    2025-12-02, 5:00 PM

    View In Agenda
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    Kazuhiko Takahata
    Senior Director, Head of Clinical Development Group 3, Clinical Development Centre, Kyowa Kirin(Japan)

    Experienced clinical development leader with a proven record in strategic decision-making and cross-functional team leadership within global pharmaceutical organizations.

    Expertise spans immunology, oncology, and allergy therapeutic areas, with deep experience in cross-border regulatory engagement and clinical trial execution.

    Combines scientific rigor with a business-focused mindset, currently pursuing a PhD in health economics to further strengthen academic and strategic capabilities.

    Session Details:

    PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials

    2025-12-02, 5:00 PM

    Session Details:

    KEY NOTE: Why Listening to Patients Matters: Redefining Clinical Development Strategies

    2025-12-02, 9:45 AM

    View In Agenda
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    Jongyeop (Peter) Kim
    Lead Manager, Big Data Team, Daewon pharmaceutical

    Session Details:

    Developing a Clinical Oversight Strategy Using Big Data and BI Tools

    2025-12-02, 2:15 PM

    View In Agenda
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    YOHAN BAE
    Executive Director, Clinical Development Division, Kangstem Biotech

    Yohan Bae is Executive Director, Clinical Development Division at Kangstem Biotech Co. Ltd since he joined in Mar 2020. He has almost 30 years of drug development experience ranging local and global regulatory affairs, clinical development, and patient access for pharmaceutical and medical device. Before he joined in Kangstem Biotech, Mr. Bae has worked for large international pharma and medical device companies such as Alcon, Bristol-Myer Squibb, and Boehringer-Ingelheim. He holds a master’s degree in Pharmacology from Pharmacy College, Kyunghee University.

    Session Details:

    Strategic Considerations for Clinical Trials in Cell Therapy Development

    2025-12-03, 11:45 AM

    Session Details:

    PANEL DISCUSSION: Overview of Clinical Trial Dynamics Affecting Small to Mid-Sized Biopharma in Korea

    2025-12-03, 12:15 PM

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    Eunah Paek
    Executive Director, Boryung corporation

    Ms. Eun-Ah Paek, Executive Director at Boryung Co., Ltd., majored in Pharmacy at Sookmyung Women’s University, where she also earned her Master’s degree in Pharmacology. She subsequently completed her doctoral coursework in Pharmacoepidemiology at Sungkyunkwan University.

    She previously served as a project leader for central nervous system (CNS) drug development at SK Biopharm and is currently in charge of clinical trials, post-marketing clinical research, pharmacovigilance, and medical writing as the head of the Clinical Division at Boryung.

    With over 30 years of experience, she has been involved in comprehensive drug development, spanning from non-clinical research to clinical trials and post-marketing activities for pharmaceuticals.

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    Choong Hee LEE
    Director of Clinical Team, MitoImmune Therapeutics

    Session Details:

    Navigating the Pros and Pitfalls of Risk-Based Monitoring in Clinical Research

    2025-12-02, 11:30 AM

    View In Agenda
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    Amy Jung Hyun LEE
    Medical imaging expert

    Amy is a seasoned imaging clinical trial expert with a PhD in Biomedical Sciences and extensive experience in the design, execution, and evaluation of imaging across multiple therapeutic areas, including oncology, ophthalmology, neurology, dermatology, musculoskeletal, and gastroenterology. With nearly a decade of leadership in managing imaging projects, she has worked with global pharmaceutical companies, leading CROs, and major hospitals worldwide. Her career journey spans roles from imaging project manager to CEO of a Singapore-based imaging CRO, and she now brings her expertise to a global imaging CRO.

    Session Details:

    Strategic Implementation of AI to Accelerate Drug Development and Optimize Clinical Trials

    2025-12-03, 9:00 AM

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    Youngwook Kim
    Associate Director, Investigator Engagement – Korea, Clinical Research Investigator Engagement, Delivery & Capabilities, Lilly Korea Ltd

    YoungWook Kim serves as the Associate Director of Investigator Engagement for Korea within the Clinical Research Investigator Engagement, Delivery & Capabilities at Eli Lilly and Company. In this role, he is entrusted with the comprehensive oversight of investigator site management for clinical research across Lilly Korea. His responsibilities encompass a broad range of critical capabilities, including portfolio management, study feasibility assessment, site selection, patient enrollment, and monitoring.

    Holding a Bachelor's degree in Pharmacy from Sahmyook University, he has cultivated a distinguished career that spans over 15 years in the pharmaceutical industry, with a particular focus on clinical operations. His professional journey has seen him undertake various roles, from CRA to Clinical Development Consultant, Clinical Operations Portfolio Manager, Clinical Information Process Automation, and Clinical Project Management. His experience covers a diverse geographical spectrum, including Korea, Emerging Markets, and Lilly Headquarters.

    His extensive experience and deep commitment to the field are driven by a passion for enhancing the delivery of clinical research, with the ultimate goal of improving patient outcomes and advancing healthcare. His expertise and dedication are reflected in his approach to fostering innovation and efficiency in clinical research processes.

    Session Details:

    Patient centricity: What does patient centric clinical trial development look like in 2025?

    2025-12-02, 12:30 PM

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    Jaeyoung Hyun
    Unit Manager, GCCL

    Jaeyoung Hyun serves as Head of the Business Development Unit at GCCL(Global Clinical Central Lab), a leading central lab in Asia Pacific specializing in clinical trial sample analysis for global pharmaceutical and biotech sponsors. In this role, he oversees domestic and global client engagement, strategic sales, and partnership development, driving GCCL’s growth and international presence.

    With a long-standing career in domestic sales and business development within the pharmaceutical and healthcare industries, Mr. Hyun has cultivated deep expertise in fostering client relationships, shaping commercial strategies, and supporting multinational clinical programs. His professional background includes extensive collaboration with pharma and biotech companies, with a focus on overcoming logistical barriers in clinical sample management—an area he will address in his OCT Korea 2025 session, “Optimizing Central Lab Supply Chains: Overcoming Logistical Barriers in Clinical Sample Management.”

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    Seunghyun Hong
    Head of QA, GCPharma
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    Sangho Ma
    VP Development , A&J science

    Dr. Sang Ho Ma, Ph.D. in Pharmacy, is Vice President of Development at A&J Science and a member of the Expert Committee of the Ministry of Food and Drug Safety (MFDS). With over 20 years of

    experience in drug discovery and development, including CMC, regulatory affairs, and clinical research, he provides expertise across immuno-oncology, rare diseases, infectious diseases, and vaccines.

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    Sol Han
    Chief Medical Officer, Head of Clinical Development Center, Cyrus Therapeutics

    Session Details:

    How to Choose the Right Clinical CRO: A Strategic Guide for Biotech Venture

    2025-12-02, 8:45 AM

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    YongGwan Kim
    Associate Director, Janssen
    • Associate Director-Trial Delivery Leader, Medical Affairs Delivery Unit, J&J Innovative Medicine
    • Masters Degree of Supply Chain Management, MBA, Inha University
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    Alicia Kim
    Clinical Trials Team Leader, LN Robotics

    - 23Y Clinical Trial & New Drug Development Expert Professional

    - Global & Local Trials Experiences including the 1st Phase 2 COVID-19 New Oral-drug Trial PM in Korea & USA

    - Global CROs and Local Pharmacies Experiences

    - All-round Experts in Clinical Trials (Medicines & Devices)

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    HyeJung Yang
    Clinical Development Center, Clinical Team Lead, Daewoong Pharmaceutical

    Hyejung Yang is the Team Leader of the Clinical New Drug Team at Daewoong Pharmaceutical. She has over 14 years of experience in global clinical development, leading Phase I–III trials across multiple therapeutic areas, with a particular focus on new drug development projects. She has extensive expertise in project leadership, study start-up, investigational product management, and global site/vendor communication. As a clinical team leader, she has directed cross-functional teams and contributed to IND submissions, ensuring successful execution of global clinical trials.

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    Tina Sun
    Study & Site Operations Country Head, Novartis(Taiwan)

    With over 20 years of experience in clinical operations, Tina held leadership positions at Eli Lilly and Novartis, managing operations in Taiwan and Hong Kong. Besides her corporate roles, she led Transcelerate Taiwan since 2013 and served twice as the president of the Taiwan Clinical Research Association. Tina is interested in external engagement activities through her journey in clinical operations. Her authority in the field is demonstrated further through speaker roles at universities, conferences and clinical trial training programs, particularly on GCP-related topics.

    Specialties

    Global clinical trials operations and management

    Speaker of clinical trial topics in GCP training program, university and conference

    Professional Experiences

    Trial Monitoring Country Head, Novartis (Taiwan)

    Head of Clinical Operations, Eli Lilly and Company (Taiwan & Hong Kong)

    President of Taiwan Clinical Research Association (5th ,TCRA)

    Medical representative, clinical research associate, Novartis (Taiwan)

    Pharmacist, Po-Ai Hospital

    Session Details:

    FIRESITE CHAT: Evolving Clinical Trial Designs: Key Considerations and Best Practices for Implementing Decentralized Clinicals(DCT)

    2025-12-03, 10:30 AM

    Session Details:

    PANEL DISCUSSION: Overview of Clinical Trial Dynamics Affecting Small to Mid-Sized Biopharma in Korea

    2025-12-03, 12:15 PM

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    Hyesung Shin
    Director, Clinical Development Strategy, R&D Division, Aptabio

    Hyesung Shin, managing director of TiumBio Co., Ltd has worked more than 23 years of experience in clinical trial development and operations.

    She had worked during 13 years for global pharmaceutical companies at Eli Lilly, Novo Nordisk and Novartis and 6 years at Abbott for medical devices clinical development and had experienced in Korean Biotech companies of BioPharm Solutions, Aptabio Therapeutics, TiumBio for new drug development and managing phase I/II Clinical Trial.

    The works focused on managing clinical trial plan for new drug development, regulatory Filing for FDA/EMEA/MFDS IND, orphan drug Designation, vender management including CRO/Clinical Supplies/CDMO and development of  market strategy.

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    Jungwon Jung
    Production Team2 Manager , HK inno-N

    -1997 ~ 1999        :  KATRI (Korea apparel test and research institute)
    - 2000 ~ 2001        :  Green Cross     

    - 2001 ~ Present   :  HK inno-N. (old CJ Healthcare)

    * 2001 ~ 2010 Quality Assurance Team

    * 2010 ~ 2015 Technical development Team

    * 2015 ~ 2017 Quality Manager

    * 2017 ~ 2019 Project TF team (Head office) for New Plan & Bio Project

    * 2019 ~ 2022 Quality Unit Manager (Cell and Gene Therapy Plant

    * 2022 ~          Manufacturing2 Team Manager (LVP)

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    Sangmi Lee
    Head of Clinical Development, ABL Bio

    A seasoned leader with over two decades of experience in clinical development, Sangmi Lee is currently the Head of Clinical Development at ABL Bio Inc., where she spearheads the company's oncology pipeline. Her extensive career spans both global and local pharmaceutical landscapes, including leadership roles at Novartis, Chong Kun Dang, and GreenCross.

    Specializing in early-stage development, Sangmi Lee has deep expertise in advancing complex therapeutic modalities, with a particular focus on T-cell engagers, bispecific antibodies, and bispecific ADCs. Her presentation, "Optimizing T Cell Engaging Therapies from Preclinical Study to Human Clinical Trial," will draw on her comprehensive background in translating cutting-edge science into successful human clinical trials.

    Session Details:

    CASE STUDY: Optimizing T Cell Engaging Therapies from Preclinical Study to Human Clinical Trial

    2025-12-02, 3:15 PM

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    Dr Alison McMorn
    PH.D – VP, CLINICAL DEVELOPMENT, AMO PHARMA LTD

    Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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    Behtash Bahador
    Senior Director, Community Engagement & Partnerships, CISCRP

    Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

    Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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    Aditya Kotta
    Head of Business Development, Novotech

    Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.

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    Martin Rodriguez
    Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

    Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

    I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

     

    Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

     

    Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

     

    Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

     

    Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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