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Why Attend?

The leading  Outsourcing in clinical trials conference in Korea is returning in 2026. 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.

2026 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

Uniphar | Clinical delivers dependable, integrated clinical supply solutions from drug sourcing and packaging through global distribution and overage management, helping reduce complexity and keep trials moving for your patients and timelines.

Company Website

To learn more, please visit our website - https://unipharclinical.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 clinical trials with people-first solutions and industry-leading tech. Operating in 100+ countries, we deliver face-to-face, virtual, and hybrid clinical meeting planning, patient payment, and travel and logistics support for top pharmaceutical and biotechnology companies. Learn more at scoutclinical.com.

Company Website

To learn more, please visit our website - https://www.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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Company Information

The aim of MyData-TRUST consists in supporting the Life Sciences Industry in leveraging their compliance related to Data Protection. We are providing a services and solutions aligned with both Health R&D and Data Protection requirements (GDPR, HIPAA, Privacy Shield).

Company Website

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

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Company Information

CMIC Group, founded as Japan’s first CRO over 30 years ago, is now the largest clinical CRO in Japan with a global presence. Our services span non-clinical studies, clinical trial management, GMP manufacturing, regulatory consulting, and sales/marketing solutions. We facilitate market entry in Japan, offer leading clinical trial expertise in APAC region, and bridge drug development between the US and Japan. With 7,000+ employees and 24 global sites, we’re your comprehensive partner in the pharmaceutical, biotech, and medical device sectors.

Company Website

To learn more, please visit our website - https://en.cmicgroup.com/

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Company Information

Catalent solves today’s clinical trial supply challenges and develops innovative solutions for the future. Catalent’s commitment to quality and service excellence is evident in its comprehensive and flexible solutions for small molecules, biologics and advanced therapy medicinal products (ATMPs). With modern global facilities, and 25+ years’ experience reliably supplying thousands of studies of all sizes and complexities around the world, services include:

  • Clinical supply management
  • Integrated formulation development, clinical manufacturing & blinding
  • Specialty handling (potent, cytotoxic, controlled)
  • Direct commercial product sourcing
  • Clinical packaging/labeling
  • Extensive clinical storage, cold chain capabilities & global distribution
  • Demand-led supply
  • Direct-to-patient solutions
  • Clinical returns, reconciliation & destruction.

Company Website

To learn more, please visit our website - https://clinical.catalent.com/

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Company Information

PHOENIX is a leading healthcare provider specializing in clinical trial services. With a robust network across Europe, PHOENIX offers comprehensive solutions for pharmaceutical companies, including comparator sourcing, packaging & labeling services, central pharmacy services, and logistics support. Their expertise ensures efficient trial management, helping clients accelerate drug development and improve patient outcomes.

Company Website

To learn more, please visit our website - www.phoenixgroup.eu

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Company Information

Emmes Group, a specialty, technology and AI enabled contract research organization (CRO), is advancing and modernizing clinical research to improve patient outcomes. Founded as Emmes more than 47 years ago, we became a trusted clinical research partner to the U.S. government. Today, Emmes Group is a global full-service CRO operating in 72 countries worldwide collaborating with government agencies, public-private partnerships, and biopharma innovators. Now wholly owned by New Mountain Capital, we are transforming the future of clinical research and bringing life-changing treatments closer to patients. Where human intelligence meets artificial intelligence. Learn more at www.theemmesgroup.com.

Company Website

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

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    Agenda

    • 2 Dec 2026
    • 3 Dec 2026
    Expand All

    Streams

    Stream one

    STREAM A: Outsourcing & Clinical Operations

    Stream two

    STREAM B: Clinical Trial Supply

    11:30 AM

    Quality by Design in Clinical Supply: Driving Efficiency, Compliance, and Patient Safety

    • Embedding QbD principles across the clinical supply lifecycle to proactively manage risks
    • Strengthening risk-based quality management for compliance and supply continuity
    • Preparing quality-driven supply strategies for advanced therapies and complex trials

    Speakers

    Alicia Kim
    Clinical Trials Team Leader, LN Robotics

    12 PM

    Reserved for Akesa

    12:30 PM

    KEYNOTE: Domestic vs Global CRO Competition: What It Means for Korean Clinical Supply

    • How the growth of domestic Korean CROs is reshaping vendor selection
    • Supply chain capability comparisons between local and global CRO, CMO, CDMO offerings
    • Where domestic CROs are closing the gap on international standards

    Speakers

    Seongyun Bang
    Chief Development Officer, Vice President, SPARK Biopharma

    1 PM

    Lunch and networking

    2:15 PM

    PANEL DISCUSSION: Strengthening Collaboration Between Clinical Trial Supply and Clinical Operations

    • Ascertaining how clinical supply can get a seat at the table with clinical operations to streamline capabilities
    • Discovering how teams can collaborate and how technology can enable this
    • Sourcing raw materials in order to produce products
    • Overcoming logistical challenges within supply chain

    Speakers

    Seongyun Bang
    Chief Development Officer, Vice President, SPARK Biopharma
    Tina Karunaratne
    Founder and President, Bridge to Compassionate Care
    Tanuj Sircar
    Associate Director, Competitive Intelligence, GlobalData

    2:45 PM

    Reserved for Phoenix Pharma

    3:15 PM

    From GDP Compliance to Global Standardisation: Building More Resilient Clinical Trial Cold Chains

    • Overview of ISO/TC315 and its relevance to pharmaceutical and clinical trial supply chains
    • Bridging the gap between current GMP/GDP expectations and future global standards
    • How standardised cold chain frameworks can reduce operational variability

    Speakers

    Kyoung Chul Hong
    CEO, MegSpace

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

    The 2026 Clinical Trial Surge: Can Clinical Supply Keep Pace?

    • Exploring the key factors driving increased clinical trial activity in 2026
    • Discover the evolving clinical trial landscape and the opportunities it presents for suppliers and service providers this year
    • See how this has shaken up the biopharma competitive landscape and how this will affect the clinical trial supply chain

    Speakers

    Tanuj Sircar
    Associate Director, Competitive Intelligence, GlobalData

    4:45 PM

    Implementing an effective IRT system in your clinical trial supply chain to streamline supply planning and management

    • Overcoming challenges around implementation and use of a new IRT system
    • How to leverage your IRT systems effectively to get the most out of your technology
    • Selecting an IRT vendor that meets your needs: essential factors and considerations in supplier selection

    Speakers

    Tina Karunaratne
    Founder and President, Bridge to Compassionate Care

    5:15 PM

    Chairperson’s closing remarks

    8 AM

    Registration and refreshments

    8:40 AM

    Chairperson’s opening remarks

    8:45 AM

    KEYNOTE: The India Advantage: Rethinking Korea’s Clinical Trial Outsourcing Strategy

    • Asia-Pacific emerging as the fastest-growing region for clinical trial outsourcing, with India positioned at the center of that shift
    • Cost-competitive infrastructure without compromising data quality or regulatory rigor
    • Rethinking the strategy: from transactional to strategic

    Speakers

    Akhilesh Sharma
    President & Chief Medical Officer Alkem Laboratories

    9:15 AM

    Reserved for Novotech

    9:45 AM

    PANEL DISCUSSION: How AI Is Transforming Clinical Operations: What’s Next?

    • Realistic AI applications in protocol drafting, demand forecasting and inventory management
    • Keeping pace with fast-moving AI development while maintaining trial integrity
    • AI, data and the changing role of the CRO/vendor

    Speakers

    Hyojin Park
    Business Development Manager, GlobalData Healthcare
    Megumi Ebara
    Associate Director, Kyowa Kirin
    Akhilesh Sharma
    President & Chief Medical Officer Alkem Laboratories

    10:15 AM

    Reserved for Partners

    10:45 AM

    Morning refreshments and networking

    11:30 AM

    Operationalizing Trials in Resource-Limited Settings: Lessons from Vaccine Development

    • Key operational lessons learned from conducting large-scale vaccine trials in (LMICs)
    • Balancing rapid trial execution with regulatory compliance and Good Clinical Practice
    • Strategies for successful patient recruitment, retention, and community engagement in resource-limited settings
    • Ensuring data quality, oversight, and risk management across geographically dispersed trial sites

    Speakers

    Sunee Chuasuwan
    Head of Clinical Operations and Trial Management, International Vaccine Institute (IVI)

    12 PM

    Reserved for Nucleus Network

    12:30 PM

    Optimising Early-Phase Clinical Development: Turning Challenges into Opportunities

    • Addressing common operational and scientific challenges in Phase 1 and Phase 2 trials
    • Managing complex protocol designs incorporating biomarkers and adaptive trial elements
    • Evaluating the necessity of placebo groups in Phase 1 studies

    Speakers

    Eun-Jihn Roh
    NEX-I/Selecxine, Chief Development Officer

    1 PM

    Lunch and networking

    2:15 PM

    Patient Centricity: What Does Patient-Focused Clinical Trial Development Actually Look Like in 2026?

    • Checking out what's working and what could be better
    • Looking at the difference between research done purely for research versus for commercialization, and what that means for patients given today's

    Speakers

    Sooyoung Kim
    Manager – Clinical Research Lead, Clinical Research Investigator Engagement, Delivery & Capabilities, lilly

    2:45 PM

    Reserved for MyData-TRUST

    3:15 PM

    CASE STUDY: AriBio’s AR1001: Korea’s First Global Blockbuster Candidate for Alzheimer’s

    • AR1001 is a first-in-class, oral, disease-modifying therapy poised to reshape Alzheimer's treatment after two decades of limited progress
    • We'll cover the scientific breakthroughs and strategic lessons behind its development
    • We'll highlight AriBio's focus on delivering the right therapy to the right patients, while meeting FDA and EMA regulatory standards

    Speakers

    Jae-Young Ha
    Chief Business Officer, Aribio

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

    Selecting and Managing the Right CRO: A Strategic Guide for Korean Biotech

    • Determining when and how to engage a CRO across the clinical development lifecycle
    • Selecting a fit-for-purpose CRO based on program needs, risks and sponsor capabilities
    • Small/mid-sized CRO versus large global CRO: choosing the right operating model
    • Establishing effective governance and risk-proportionate sponsor oversight

    Speakers

    Hyerim Kang
    Head of Clinical Development Unit, GC Biopharm

    4:45 PM

    KEYNOTE: US FDA Entry Strategy in 2026: How Korean Biotech Should Approach the US Market

    • Global market trends and US FDA regulatory perception
    • Establishing a strategy for New drug development in line with updated guidance from US FDA
    • FDA engagement strategy: pre-IND/IND and accelerated clinical programs

    Speakers

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

    5:15 PM

    Chairperson’s closing remarks

    Streams

    Stream one

    STREAM A: Outsourcing & Clinical Operations

    Stream two

    STREAM B: Clinical Trial Supply

    9 AM

    From Manufacturing to Patient: Strengthening the Pharmaceutical Supply Chain Through Efficiency and Quality

    • Unpacking the challenges and complexities inherent in the full pharmaceutical supply chain journey, from production to final patient delivery
    • Navigating regulatory demands and ensuring ongoing compliance across the chain
    • Reviewing the practical strategies used to enhance performance and quality across the entire supply chain

    Speakers

    Jungwon Jung
    Production Team Manager, HK inno-N

    9:30 AM

    Reserved for Partners

    10 AM

    Ensuring Supply Continuity for Short Half Life Radiopharmaceuticals in Global Clinical

    • Building redundancy into supply chains to mitigate risk from production, transport, or equipment failures
    • Managing complex customs, import/export, and radioactive materials regulations across trial countries
    • Ensuring quality control and radiopharmaceutical stability testing within extremely narrow time windows

    Speakers

    Katrien Aerts
    Advisor, Affibody

    10:30 AM

    Reserved for Partners

    11 AM

    Morning refreshments and networking

    11:45 AM

    Strengthening Cold Chain Resilience: Addressing Emerging Challenges in Temperature-Controlled Clinical Supply

    • Overcoming the latest challenges in global cold chain logistics for clinical trials
    • Identifying common risks and mitigation strategies for international temperature-controlled shipments
    • Leveraging real-time temperature monitoring and digital technologies to enhance shipment visibility

    Speakers

    KangPyo Lee
    Vice President, Hanul TL

    12:15 PM

    PANEL DISCUSSION: AI’s Reach in Clinical Supply: How Far Are We From the Ceiling?

    • Exploring realistic AI applications across forecasting, inventory management and distribution planning for Korean and regional trials
    • Keeping pace with fast-moving AI development while maintaining trial integrity and regulatory alignment
    • AI, data and the changing role of the CRO/vendor in Korea's clinical supply ecosystem

    Speakers

    Katrien Aerts
    Advisor, Affibody
    Tanuj Sircar
    Associate Director, Competitive Intelligence, GlobalData
    KangPyo Lee
    Vice President, Hanul TL

    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

    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    9 AM

    Optimizing CRO Partnerships for Successful Clinical Trial Delivery

    • Identifying the right point for CRO involvement to improve efficiency and execution
    • Leveraging CRO insights to optimize protocol design, country selection, and study feasibility
    • Establishing clear communication, shared accountability, and collaborative ways of working

    Speakers

    Jaesun Kang
    Director/Clinical operation office, Cha bio

    9:30 AM

    Reserved for Emmes Group

    10 AM

    CASE STUDY: Advancing Clinical Development Through Meaningful Patient Engagement

    • Embedding patient voices into research, development, and lifecycle management
    • Building a structured framework to gather, evaluate, and apply patient insights
    • Enhancing clinical outcomes through patient-driven innovation
    • Success story: Transforming the patient journey with an on-body injector for chemotherapy care

    Speakers

    Megumi Ebara
    Associate Director, Kyowa Kirin

    10:30 AM

    Reserved for QPS

    11 AM

    Morning refreshments and networking

    11:45 AM

    From In-Licence to First Patient: Trial Design Lessons for an Acquired Asset

    • Assessing the existing clinical evidence and data gaps when taking on a licensed-in asset
    • Translating the asset’s development strategy into an optimized clinical trial design
    • Aligning internal teams, external partners, and investigators to accelerate study start-up and first-patient-in

    Speakers

    Alex Shin
    Director, Clinical Development, Sovargen

    12:15 PM

    PANEL DISCUSSION: From Good to Great: High-Performing Sponsor-CRO Partnerships in 2026

    • Moving beyond transactional oversight toward a genuine strategic partnership model
    • Aligning financial incentives so both sponsor and CRO win when a trial performs well
    • Leveraging joint innovation initiatives (AI, digital tools, process redesign) as a partnership accelerant rather than a point of friction
    • Defining what "great" actually looks like from both the sponsor's and the CRO's perspective before trying to get there

    Speakers

    Hyojin Park
    Business Development Manager, GlobalData Healthcare
    Megumi Ebara
    Associate Director, Kyowa Kirin
    Alex Shin
    Director, Clinical Development, Sovargen

    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 Afternoon Tea & Chat

    Connect, chat, and exchange ideas over an informal afternoon tea experience with industry leaders and peers.

    This interactive session offers a unique opportunity to step away from the main stage, join conversations that matter, and gain practical insights from professionals tackling similar challenges across the clinical trials and clinical supply ecosystem.

    Share your experiences, ask questions, and build new relationships in a relaxed and engaging environment.

    Roundtable session lasts for 30 minutes and rotate

    TOPIC 1: Risk Management Strategies: How Small Biotech’s Can Plan Ahead and Minimise Challenges

    Hyojin Park, Business Development Manager, GlobalData Healthcare

    TOPIC 2: Driving Efficiency and Results Through Strong Sponsor, CRO Partnerships

    Tina Karunaratne, Founder and President, Bridge to Compassionate Care

    TOPIC 3: Connecting Packaging and Labelling with End-to-End Clinical Supply Chain Strategies

    Speakers

    Hyojin Park
    Business Development Manager, GlobalData Healthcare
    Tina Karunaratne
    Founder and President, Bridge to Compassionate Care

    3:30 PM

    END OF CONFERENCE

    Speakers

    Select a speaker to learn more

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    Hyojin Park
    Business Development Manager, GlobalData Healthcare

    Hyojin Park, Ph.D., is a thought leader in Korea at GlobalData, where he leads consulting and data solution work for pharmaceutical, biotech, and government clients. He previously spent four years at Clarivate on due diligence, repositioning, and competitive intelligence projects, and was an author of the Drugs to Watch series. He holds a Ph.D. in Medical Science from Yonsei University College of Medicine and has been a regular speaker on global R&D and investment trends for over 8 years.

    Session Details:

    PANEL DISCUSSION: From Good to Great: High-Performing Sponsor-CRO Partnerships in 2026

    2026-12-03, 12:15 PM

    Session Details:

    PANEL DISCUSSION: How AI Is Transforming Clinical Operations: What’s Next?

    2026-12-02, 9:45 AM

    Session Details:

    Speaker Hosted Afternoon Tea & Chat

    2026-12-03, 2:30 PM

    View In Agenda
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    Akhilesh Sharma
    President & Chief Medical Officer Alkem Laboratories

    Dr Akhilesh Sharma is an M.D. from Mumbai and Fellow of Royal Liverpool hospital society-U.K, with advanced training in Clinical Research from Berkley Extension, California State University, USA and PV from Luton Medical Centre, UK.

    A visionary pharmaceutical executive with 30+ years’ experience in development of NCEs, biologics, cell & gene therapies, and complex generics. His expertise spans AI – driven drug development, translational medicine, biomarker development, Clinical R&D, market access, regulatory strategy, executive leadership, BD & global partnership across multinational pharmaceutical companies, based out of US & India.

    He has a proven track record in building and leading high-performance global functions at Alkem, Dr. Reddy’s, Glenmark, Rhône-Poulenc Rorer (Aventis), Carter Wallace, Cell Therapeutics Inc. and as an entrepreneur with GeneXY (biomarker development organization in Philadelphia, jointly with Wistar institute, Pennsylvania University campus), RYTUS Therapeutics.

    He combines scientific depth with commercial acuity to forge academic co-development partnerships with Harvard, Johns Hopkins, U. Chicago, Texas Tech University-Medical Sciences, Memorial Sloan Kettering, Miami University, NIH, Karolinska, IIT-Bombay/ Kanpur, IISc-Bangalore; and others, at the same time unlocks successful regulatory pathways with agencies worldwide such as US FDA, EMA, MHRA, TGA, MCC, DCGI, and translate innovation into measurable business value. He has created more than $6500M+ innovation driven patented product portfolio during his entire tenure.

    He is the Founding Director of Alixer NexGen Therapeutics Ltd., Alkem’s independent wholly owned Proprietary Subsidiary; and currently serves as President & Chief Medical Officer of Alkem Laboratories Ltd. He also serves on Board of Directors of Haystacks Analytics Pvt Ltd

    In addition, he is an advisor to special projects at Harvard-Wyss, visiting faculty at Johns Hopkins University, Harvard-Wyss, (USA), Karolinska, Europe, IIT’s (premium technology institutes-India) and others. Been on panel of Drug Development, Clinical Research and Drug Safety at various national and international forums including at USFDA workshops and an invited faculty at leading international conferences & institutes.

    He has to his credit more than 71 scientific & research publications, 58 patents and holds membership of International Pharmaceutical Society, American Academy of Dermatology, American Diabetes Association, European Society of Respiratory Medicine. He has been honored with a Lifetime Achievement Award in recognition of his contributions to biotechnology innovation and the development of cutting-edge therapies for patients.

    Session Details:

    KEYNOTE: The India Advantage: Rethinking Korea’s Clinical Trial Outsourcing Strategy

    2026-12-02, 8:45 AM

    Session Details:

    PANEL DISCUSSION: How AI Is Transforming Clinical Operations: What’s Next?

    2026-12-02, 9:45 AM

    View In Agenda
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    Kyoung Chul Hong
    CEO, MegSpace

    Session Details:

    From GDP Compliance to Global Standardisation: Building More Resilient Clinical Trial Cold Chains

    2026-12-02, 3:15 PM

    View In Agenda
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    Katrien Aerts
    Advisor, Affibody

    Session Details:

    PANEL DISCUSSION: AI’s Reach in Clinical Supply: How Far Are We From the Ceiling?

    2026-12-03, 12:15 PM

    Session Details:

    Ensuring Supply Continuity for Short Half Life Radiopharmaceuticals in Global Clinical

    2026-12-03, 10:00 AM

    View In Agenda
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    Sunee Chuasuwan
    Head of Clinical Operations and Trial Management, International Vaccine Institute (IVI)

    Session Details:

    Operationalizing Trials in Resource-Limited Settings: Lessons from Vaccine Development

    2026-12-02, 11:30 AM

    View In Agenda
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    Jae-Young Ha
    Chief Business Officer, Aribio

    Session Details:

    CASE STUDY: AriBio’s AR1001: Korea’s First Global Blockbuster Candidate for Alzheimer’s

    2026-12-02, 3:15 PM

    View In Agenda
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    Seongyun Bang
    Chief Development Officer, Vice President, SPARK Biopharma

    Seong-Youn Bang is a senior professional with more than 26 years of experience across pharmaceutical companies, biotechnology firms, domestic and international CROs, and academia. Her expertise spans new drug clinical development, global project management, and related regulatory and quality functions. She currently serves as President of TRIALIGN Consulting and as a Senior Consultant at YNB Partners, advising on clinical development and operational strategy for new drugs, as well as global regulatory and quality matters.

    Her key leadership roles have included Chief Operating Officer (COO) at Spark Biopharma, Head of Cell and Gene Therapy Development at GC Cell, and COO and Head of Drug Development at major biotechnology companies. She has also served as Country Head of PAREXEL International Korea and as Executive Vice President overseeing the Clinical Business Division at DreamCIS. In these positions, she played a central executive role in new drug and clinical development and clinical trial operations. From 2014 to 2020, she further strengthened her clinical trial expertise in healthcare and academia as Deputy Director of the Clinical Trial Center at CHA Bundang Medical Center and Associate Professor at CHA University.

    Session Details:

    PANEL DISCUSSION: Strengthening Collaboration Between Clinical Trial Supply and Clinical Operations

    2026-12-02, 2:15 PM

    Session Details:

    KEYNOTE: Domestic vs Global CRO Competition: What It Means for Korean Clinical Supply

    2026-12-02, 12:30 PM

    View In Agenda
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    Hye-Yeon Jeon
    Head of Clinical Operations, Korean Cancer Study Group (KCSG)
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    KangPyo Lee
    Vice President, Hanul TL

    Session Details:

    Strengthening Cold Chain Resilience: Addressing Emerging Challenges in Temperature-Controlled Clinical Supply

    2026-12-03, 11:45 AM

    Session Details:

    PANEL DISCUSSION: AI’s Reach in Clinical Supply: How Far Are We From the Ceiling?

    2026-12-03, 12:15 PM

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    Eun-Jihn Roh
    NEX-I/Selecxine, Chief Development Officer

    Eun-Jihn Roh, R.Ph, MS, is a clinical development executive with more than 20 years of experience across global pharmaceutical companies, CROs, and biotechnology companies, including over 15 years in oncology drug development. She currently serves as Chief Development Officer at Nex-I and Selecxine, where she leads global clinical and regulatory strategy for early-stage oncology programs. Her experience spans first-in-human through pivotal studies, FDA and MFDS interactions, clinical trial design, CRO oversight, business development, and global study execution.

    Session Details:

    Optimising Early-Phase Clinical Development: Turning Challenges into Opportunities

    2026-12-02, 12:30 PM

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    Alex Shin
    Director, Clinical Development, Sovargen

    Session Details:

    From In-Licence to First Patient: Trial Design Lessons for an Acquired Asset

    2026-12-03, 11:45 AM

    Session Details:

    PANEL DISCUSSION: From Good to Great: High-Performing Sponsor-CRO Partnerships in 2026

    2026-12-03, 12:15 PM

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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)

    Session Details:

    Quality by Design in Clinical Supply: Driving Efficiency, Compliance, and Patient Safety

    2026-12-02, 11:30 AM

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    Megumi Ebara
    Associate Director, Kyowa Kirin

    Session Details:

    PANEL DISCUSSION: From Good to Great: High-Performing Sponsor-CRO Partnerships in 2026

    2026-12-03, 12:15 PM

    Session Details:

    PANEL DISCUSSION: How AI Is Transforming Clinical Operations: What’s Next?

    2026-12-02, 9:45 AM

    Session Details:

    CASE STUDY: Advancing Clinical Development Through Meaningful Patient Engagement

    2026-12-03, 10:00 AM

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    Sooyoung Kim
    Manager – Clinical Research Lead, Clinical Research Investigator Engagement, Delivery & Capabilities, lilly

    2014 건국대학교 수의학과 졸업/ DVM License

    2017-2020 Celltrion Clinical Operation/ Budget & Contract management

    2020-2025 SK Bioscience Clinical Operation/CRA, CPM, Clinical Strategy/Medical Writer

    2025 - Current Eli Lilly Investigator Engagement - Clinical Research Lead

    Sooyoung Kim is a Clinical Research Lead at Eli Lilly, responsible for leading the initiation and operational execution of clinical trials for Lilly molecules. His work focuses on country feasibility, site selection, patient enrollment, and investigator engagement. He has over 10 years of experience in the pharmaceutical industry and brings deep expertise in clinical operations, spanning roles at Celltrion, SK Bioscience and Eli Lilly. He holds a Doctor of Veterinary Medicine degree and is a licensed veterinarian.

    Session Details:

    Patient Centricity: What Does Patient-Focused Clinical Trial Development Actually Look Like in 2026?

    2026-12-02, 2:15 PM

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    Hyerim Kang
    Head of Clinical Development Unit, GC Biopharm

    Career history

    Current: Head of Clinical Development Unit

    • Biotechs: clinical project director
    • Samsung Bioepis: clinical program lead
    • UCB: head of Clinical Project Management/ Site & patientsolution Asia lead
    • Roche: vendor manager

    IQVIA: CRA & regional start-up lead

    Session Details:

    Selecting and Managing the Right CRO: A Strategic Guide for Korean Biotech

    2026-12-02, 4:15 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, Head of Global Regulatory Affairs, Hanmi Pharma and a representative of IFPMA, ICH E22 informal Expert Working Group.

    Dr. Noh is also working as a committee member of KIC2026 and training on ICH guideline2026, an external Instructor in KoNECT and a reviewer of external evaluation committee of KDDF.

    Previously, Dr. Noh successfully served as the Head of Clinical Research and Development (Biometrics, Clinical Science, and Clinical Operation), leading clinical programs 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 also 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:

    KEYNOTE: US FDA Entry Strategy in 2026: How Korean Biotech Should Approach the US Market

    2026-12-02, 4:45 PM

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    Jungwon Jung
    Production Team 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)

    Session Details:

    From Manufacturing to Patient: Strengthening the Pharmaceutical Supply Chain Through Efficiency and Quality

    2026-12-03, 9:00 AM

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    Jaesun Kang
    Director/Clinical operation office, Cha bio

    Session Details:

    Optimizing CRO Partnerships for Successful Clinical Trial Delivery

    2026-12-03, 9:00 AM

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    Tina Karunaratne
    Founder and President, Bridge to Compassionate Care

    Session Details:

    Implementing an effective IRT system in your clinical trial supply chain to streamline supply planning and management

    2026-12-02, 4:45 PM

    Session Details:

    PANEL DISCUSSION: Strengthening Collaboration Between Clinical Trial Supply and Clinical Operations

    2026-12-02, 2:15 PM

    Session Details:

    Speaker Hosted Afternoon Tea & Chat

    2026-12-03, 2:30 PM

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    Tanuj Sircar
    Associate Director, Competitive Intelligence, GlobalData

    Session Details:

    The 2026 Clinical Trial Surge: Can Clinical Supply Keep Pace?

    2026-12-02, 4:15 PM

    Session Details:

    PANEL DISCUSSION: Strengthening Collaboration Between Clinical Trial Supply and Clinical Operations

    2026-12-02, 2:15 PM

    Session Details:

    PANEL DISCUSSION: AI’s Reach in Clinical Supply: How Far Are We From the Ceiling?

    2026-12-03, 12:15 PM

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    OCT Advisory Board

    Select a member to learn more

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    Dr Alison McMorn
    Head of Clinical Strategy and Development, LifeArc

    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, Center for Information & Study on Clinical Research Participation (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
    VP Business Development, Novotech

    Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

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

    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, Keenova

    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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    Edwin van Vulpen
    Executive Director and Head of Clinical Business Development Euro-Asia
    Next

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