9th Annual Clinical Trial Supply East Asia 2024

The leading clinical trial supply conference in East Asia helping you enhance your end-to-end clinical strategy

3 - 4

December

2024
  • JW Marriott Hotel Seoul, South Korea
  • Ticketed
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
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2023 Sponsors Include:

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Company Information

Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.

Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.

The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.

For more information or to speak to an expert team member visit www.Novotech-CRO.com

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

At Akesa, we embrace the spirit of exploration and innovation that fuels discovery. We understand that pioneering new treatments and therapies requires a unique combination of creativity, persistence, and courage.  

As the leader in APAC for clinical trial procurement, we proudly collaborate with global pharmaceutical, biotech, and CRO organisations. We employ our expertise to craft and execute supply solutions in sourcing comparators, concomitant and standard or care products for use in clinical trials.

Company Website

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

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Company Website

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

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Company Information

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit 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 an integrated synergetic approach to assess novel drug compounds for safety and effectiveness which often span esoteric, regulated and safety outcomes in all phases of the drug development life-cycle.

The companies of Eurofins BioPharma Services provide a seamless solutions-based approach in support of phase I to IV clinical trials with a unique analytical testing portfolio for Central Laboratory Services, Bioanalytical Services and complex Biomarker Assay Development and Testing Services for drug and vaccine development.

Company Website

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

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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 Website

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

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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    Why attend?

    The leading  Clinical trials supply conference in East Asia is returning in 2024. 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.

    Senior level speakers from leading organisations with keynotes including GSK, Lilly Korea, and GCPharma along with exciting small medium local start-up biotech’s.

    Not only will the audience be discussing clinical partnership and supply challenges, but we also have the Outsourcing Clinical Trials East Asia 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

    • 3 Dec 2024
    • 4 Dec 2024
    Expand All

    8 AM

    Registration and refreshments

    8:40 AM

    Chairperson’s opening remarks

    8:45 AM

    Choosing CRO and vendor partners as a small/midsize biotech sponsor: priorities and key considerations

    • How vital is knowledge of therapeutic area in CRO selection?
    • As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
    • Ensuring your CRO and vendor partners prioritize your study

    Speakers

    Woohyung Wayne Lee
    Director, Clinical Planning, GI INNOVATION

    9:15 AM

    Reserved for N-SIDE

    9:45 AM

    ICH E6R3 – What we need to know and do to optimize trial management

    ·       Familiarize with the major revisions and updates in ICH E6R3 guidelines compared to previous versions

    ·       Adopt standardized documentation practices to ensure consistency and compliance with ICH E6R3

    ·       Training and Capacity Building

    Speakers

    Maggie Lim
    Clinical Quality Assurance Director (Asia Pacific), GSK

    10:15 AM

    Reserved for Novotech

    10:45 AM

    Morning refreshments and networking

    STREAM B: Clinical Trial Supply

    11:30 AM

    Evaluating the most recent cold chain challenges and strategies to streamline your supply chain

    ·       Addressing major challenges in international cold chain shipping, pitfalls to avoid

    ·       Utilizing advanced technology for complete remote temperature monitoring

    ·       What are the most recent developments and advancements in cold chain technology?

    Speakers

    KangPyo Lee
    Vice President, Hanul TL

    12 PM

    Reserved for Akesa

    12:30 PM

    Selecting the optimal CMO Partner(Contract Manufacturing Organization)

    ·       Analyzing quality and financial considerations in your CMO selection

    ·       communication channels and effective collaboration between your team and the CMO partner

    Speakers

    Jandee Kim
    Director Clinical Development, ADDPHARMA

    1 PM

    Lunch and networking

    2:15 PM

    Providing insights into recent updates on IATA Temperature Control Regulations and best practices for managing global logistics of temperature-controlled airfreight

    • Overview of the most recent changes to the IATA Temperature Control Regulations and their implications for clinical trial logistics
    • Insights into ongoing efforts to harmonize regulations across different regions and the impact on global supply chains
    • Discussing the integration of sustainable practices in temperature-controlled logistics

    Speakers

    Baek-Jae KIM
    Country Manager Korea, IATA

    2:45 PM

    Reserved for the Event Partner

    3:15 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

    Hanuk Kim
    Quality expert

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

    Ensuring clinical quality assurance in supply chain management: An integrated approach

    ·       Regularly auditing suppliers and manufacturing partners to ensure compliance with regulatory standards

    ·       Conducting regular training and workshops to align all parties on quality assurance standards and practices

    ·       Developing and maintaining detailed risk management plans

    Speakers

    Seunghyun Hong
    Head of QA, GCPharma

    4:45 PM

    PANEL DISCUSSION: Discussing the necessity of orchestrating global supply chains to overcome potential delays

    ·       How can we foster trust and effectively manage risk when shaping strategic partnerships?

    ·       What factors should we consider in deciding which supply chain processes to outsource?

    ·       How a global orchestration model can enhance clinical supply operations?

    Speakers

    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData
    KangPyo Lee
    Vice President, Hanul TL
    Hanuk Kim
    Quality expert

    5:15 PM

    Chairperson’s closing remarks

    8:15 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    STREAM B: Clinical Trial Supply

    Speakers

    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData

    9 AM

    State of the biopharma industry: the outlook for drugs, trials, and manufacturing

    ·       What’s coming in the pharma pipeline?

    ·       Drug manufacturing for clinical trials

    ·       Emerging trends: gene therapy, mRNA, and AI

    ·       Opportunities for contract development and manufacturing organisations (CDMOs)

    Speakers

    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData

    9:30 AM

    Reserved for the Event Partner

    10 AM

    Start-up pharma & biotech’s; Establishing a relationship, engaging with your supply chain and selecting the right partners for you

    ·       Identify key supply chain stages, from raw material sourcing to final product distribution

    ·       Conduct due diligence to assess supplier capabilities, reliability, and compliance with regulatory standards

    ·       Evaluate potential partners based on their expertise

    Speakers

    Dayeon Ko
    Director of Clinical development, Enzychem Lifesciences

    10:30 AM

    Sharing strategies for effectively managing temperature during the transfer of IP (Investigational Products)

    • Overcoming common events of temperature fluctuation during distribution
    • Exploring efficient strategies for risk management
    • Partnering with specialized logistics providers experienced in handling temperature-controlled shipments

    Speakers

    Hye Jung Yang
    Clinical Research Manager/Team Lead, MedPacto

    11 AM

    Morning refreshments and networking

    11:45 AM

    Considering new digital logistics tools to keep your supply chain running effortlessly

    • Utilizing AI technology to identify order processes and assure error-free delivery
    • Unpacking new concepts; supply by design, cross-functional alignment, self-qualification and relationship risk mapping
    • Using digital technology on site to keep locations open to prevent product deliveries from being delayed

    Speakers

    Clare tan
    Director of Clinical Operations and Project Management, Tikva Allocell

    12:15 PM

    PANEL DISCUSSION: Mitigating unnecessary delays in clinical supply logistics: Challenges and Solutions

    • Strategies to minimize delays in clinical supply Logistics
    • Implementing effective communication through Huddles
    • Practical Solutions for Streamlining Supply Chain Processes

    Speakers

    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData
    Hye Jung Yang
    Clinical Research Manager/Team Lead, MedPacto
    Clare tan
    Director of Clinical Operations and Project Management, Tikva Allocell

    1 PM

    Lunch and networking

    2:15 PM

    Prize Draw

    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: What key aspects of inspection readiness should we be considering right now?

    Moon H. Kim, CTO, InnoCure Therapeutics Inc

    ROUNDTABLE 2: Getting the best out of your sponsor – CRO partnership

    Speakers

    Moon H. Kim
    Chief Technical Officer, InnoCure Therapeutics Inc

    3:30 PM

    Chairperson’s closing remarks

    END OF CONFERENCE

    Speakers

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    Moon H. Kim
    Chief Technical Officer, InnoCure Therapeutics Inc

    Session Details:

    Speaker Hosted Roundtables

    2024-12-04, 2:30 PM

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    Fiona Barry
    Editor-in-Chief and Director of PharmSource, GlobalData

    Experienced healthcare editor with a demonstrated history of B2B journalism covering drug development, manufacturing, and the pharma industry. Skilled in editing, news writing, KOL interviews and financial journalism. Special focus on pharmaceutical manufacturing, clinical trials, rare disease and women's healthcare. Bilingual Glasgow/London-based English and French-speaking media professional with a Master of Arts (M.A.) in English from the University of Bristol.

    Session Details:

    PANEL DISCUSSION: Discussing the necessity of orchestrating global supply chains to overcome potential delays

    2024-12-03, 4:45 PM

    Session Details:

    STREAM B: Clinical Trial Supply

    2024-12-04, 8:55 AM

    Session Details:

    State of the biopharma industry: the outlook for drugs, trials, and manufacturing

    2024-12-04, 9:00 AM

    Session Details:

    PANEL DISCUSSION: Mitigating unnecessary delays in clinical supply logistics: Challenges and Solutions

    2024-12-04, 12:15 PM

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    Maggie Lim
    Clinical Quality Assurance Director (Asia Pacific), GSK

    Maggie LIM has been in the clinical research industry for the last 26 years; she graduated from Singapore National University Pharmacy and took up Clinical Pharmacy postgraduate in Canberra Australia while working as a pharmacist in Singapore General Hospital.
    She took an interest in Clinical Research and joined Eli Lilly as a CRA and study manager, specializing in early phase clinical pharmacology studies.
    When the opportunity came to join GSK as a regional Asia-Pacific GCP trainer came in 2007, she covered training for R&D medical and clinical teams for 5 years before joining Global Clinical Quality Assurance in 2012,  and has since been managing a team of auditors delivering the QA strategized audits for the region.

    Session Details:

    ICH E6R3 – What we need to know and do to optimize trial management

    2024-12-03, 9:45 AM

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    Youngwook Kim
    Associate Director, Investigator Engagement – Korea, Clinical Research Investigator Engagement, Delivery & Capabilities, Lilly Korea Ltd
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    Jiyeoun Jeong
    Clinical Research Team Leader, CMG Pharmaceutical(former)
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    Jaewoo Park
    Executive Director, Thpharm
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    Baek-Jae KIM
    Country Manager Korea , IATA

    BJ (Baek-Jae) Kim, Ph.D., is the IATA Country Manager Korea, based in Seoul, Republic of Korea. BJ leads a team of 3 (Mr. HT Lee, Ms. Anna Park, and Ms. Hyein Jeon) in the Korea field office work.

    Prior to joining IATA in Aug 2019, BJ has about 25 years of aviation experience, including 6 years in United Airlines, 4 years in Air France, and 16 years in Qatar Airways as Airport Services Manager in ICN airport, the Republic of Korea.

    BJ holds a Ph.D. and Master of Aviation Business Administration from the Korea Aerospace University (KAU) and a Bachelor's degree in Economics from Hankuk University of Foreign Studies (HUFS) in the Republic of Korea.

    BJ is a citizen of the Republic of Korea. He is a Christian and married with 2 children. BJ enjoys hiking, mountain climbing, and other sports in his spare time.

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    Miyang Kim
    Director, Clinical Site Lead, Merck
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    Woohyung Wayne Lee
    Director, Clinical Planning, GI INNOVATION

    Session Details:

    Choosing CRO and vendor partners as a small/midsize biotech sponsor: priorities and key considerations

    2024-12-03, 8:45 AM

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    KangPyo Lee
    Vice President, Hanul TL

    Session Details:

    Evaluating the most recent cold chain challenges and strategies to streamline your supply chain

    2024-12-03, 11:30 AM

    Session Details:

    PANEL DISCUSSION: Discussing the necessity of orchestrating global supply chains to overcome potential delays

    2024-12-03, 4:45 PM

    View In Agenda
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    Dayeon Ko
    Director of Clinical development, Enzychem Lifesciences

    Session Details:

    Start-up pharma & biotech’s; Establishing a relationship, engaging with your supply chain and selecting the right partners for you

    2024-12-04, 10:00 AM

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    Hanuk Kim
    Quality expert

    Session Details:

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

    2024-12-03, 3:15 PM

    Session Details:

    PANEL DISCUSSION: Discussing the necessity of orchestrating global supply chains to overcome potential delays

    2024-12-03, 4:45 PM

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    Suntae Kim
    Director, Clinical Development, Connext
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    Seongyun Bang
    Chief Development Officer, Vice President, SPARK Biopharma

    She has been an expert in drug development, clinical trials, projects, and quality control since 2001 and has worked in domestic pharmaceutical companies and global CRO, as well as university. He graduated from Seoul National University with B.S and Doctor degree and obtained Ph.D. from the CHA university.

    And she served as a branch manager(country head), global task manager and quality manager in a Global CRO, PAREXEL International and as a professor at the University of CHA univeristy for five years from 2014, she has served as the head of the New Drug Development Division at Bioteches since 2020. she is currently leading clinical development as the head of development and vice president of Spark Biopharma.

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    Jonghwan Bae
    Director, Veraverse
    • EDUCATIONS 

    2016.09 - PhD in Regulatory affairs, Department of Pharmaceutical Industry Management,

    Chungbuk National University

    2003.02 - M.S. in Biochemistry and Cell biology, Department of Biochemistry,

    Konyang University

    2001.02 - B.S. in Chemistry, Department of Chemistry,

    Konyang University

     

    • EXPERIENCES 
    1. Korea Research Institute of Bioscience and Biotechnology (KRIBB)
    2. Neopharm. Co., Ltd.
    3. Bischem. Co., Ltd.
    4. Biopharm solutions. Co.Ltd.
    5. Veraverse Co.Ltd. - Currently employed

     

    • PUBLICATIONS
    1. Lee KB, Bae JH, Kim JS, Yoo YC, Kim BS, SKwak ST, KimYS, ”Anticoagulant Activity of Sulfoalkyl Derivatives of Curdlan”, Arch Rharm Res. 2001,24:109-13.
    2. Bae JH, Yoo YC, Kwak ST, Seo EY, Moon EH, Lee MJ, Lee KB, “Antiviral and anticoagluant activity of sulfoalkyl derivatives of curdlan “, Korean J.Lab Anin. Sci. 2001,02. 119-124.
    3. Bae JH, Kim GS, Yoo YC, Lee HY, Lee KB, ”The investigation of Synovial Fluid and Serum for Biochemical Markers of Joint diseases in the horse (Review)”, J Vet Clin. 2001,02:304-310.
    4. Bae JH, Yoo YC, Hong GH, Moon EH, Song GS, Lee KB, “Biochemical analysis of synovial fluid and serum to diagnose early joint diseases in equine”, Korean J.Lab Anin. Sci. 2004.05:37-43.
    5. Yeop YJ, Bae JH “Effect of an extraction solvent on the antioxidant of pine tree”, J. Soc. Cosmet. Scientists Korea. 2005.02.
    6. Jung M, Lee S, Park HY, Youm JK, Jeong S, Bae JH, Kwon MJ, Park BD, Lee SH, Choi EH, “Anti-ageing effects of a new synthetic sphingolipid (K6EAA-L12) on aged murine skin”, Exp Dermatol. 2011, 20(4):314-9.
    7. Sul GD, Park HJ, Bae JH, Hong KD, Park BD, Chun J, Jeong SK, Lee SH, Ahn SK, Kim HJ, “Preventive effects of multi-lamellar emulsion on low potency topical steroid induced local adverse effect.”, Ann Dermatol. 2013,25(1):5-11.
    8. Rho JK, Choi YJ, Kim SY, Kim TW, Choi EK, Yoon SJ, Park BM, Park E, Bae JH, Choi CM, Lee JC, “MET and AXL inhibitor NPS-1034 exerts efficacy against lung cancer cells resistant to EGFR kinase inhibitors due to MET or AXL activation”, Cancer Res. 2013, 10.
    9. Hong JY, Bae JH, Lee KE, Kim M, Kim MH, Kang HJ, Park EH, Yoo KS, Jeong SK, Kim KW, Kim KE, Sohn MH, “Antibody to FcεRIα Suppresses Immunoglobulin E Binding to High-Affinity Receptor I in Allergic Inflammation”, Yonsei Med J. 2016,57(6):1412-9.

     

    • PATENTS
    1. Lee KB, Bae JH “Method for extracting high purified hyaluronic acid for arthritis therapy from cocks comb”, 2003.05.
    2. Park BD, Yeom JG, Jeong SK, Bae JH, Kwon MJ, Kwak HS, Sin DM, Choi YH, “New anti-skin aging and wrinkle-treating agents and cosmetic compositions containing the same” , 2007.03.30.
    3. Park BD, Kwak HS, Jeong SK, Bae JH, “Human antimicrobial peptides promoter, method for preparing thereof and composition comprising the same as active ingredient”, 2008.04.01.
    4. Choi HS, Bae JH, Park HJ, Jeong SK, “Compostion comprising mycolic acid derivatives for anti-inflammatory activity”, 2009.10.12.
    5. Park BD, Yeon SJ, Kim UD, Bae JH, Kim MH, Kang HJ, Park EH, “Conjugate comprising soluble fragment of FcεRI and composition for treating allergy diseases mediated by IgE comprising the conjugate”, 2012.05.23.
    6. Park BD, Yeon SJ, Bae JH, Park EH, Kim UD, Kim MH, Kang HJ, Ryu GS, “FcεRI specific human antibody and composition for treatment or diagnosis of allergy disease comprising thereof”, 2012.05.30.
    7. Jeong SK, Kim BW, PARK BM, Jeon JE, Bae JH, “Heterocyclic compounds”, 2013.11.18.
    8. Park BD, Kim Y, Yang MG, Jeong SK, Bae JH, “Wound dressing comprising pseudo-dermal lipid”, 2014. 01. 07.
    9. Jeong SK, Bae JH, Park BM, “Composition for preventing hair loss or promoting hair growth”, 2015. 01.19.
    10. Jeong SK, Bae JH, Kim DH, “Composition for improving condition of scalp”, 2015.07.20.
    11. Jeong SK, Bae JH, Kim DH, “Composition for improving condition of damaged hair”, 2015.07.20.
    12. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as ALK4/5 inhibitors”, 2018.10.
    13. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as RIPK1 inhibitors”, 2019.09.
    14. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as STING agonist” , 2020.01.
    • ORAL PRESENTATION
    1. Diagnosis method for degenerative joint disease of equine, The Korean society of veterinary science, 2001. 03.
    2. Effects of anti-microbial peptides stimulating molecules on epidermal permeability barrier function, The Korean Society for skin barrier research, 2007. 06.
    3. Effects of physiologic lipid mixture on epidermal anti-microbial peptides in experimental atopic dermatitis model, Asian Dermatological Congress, 2008.10.
    4. Overseas company visit program (France and Germany) – IR, 2024,09

     

    • IND SUBMISSION 
    1. FDA IND approval for Phase 2 (Alzheimer’s disease)
    2. FDA IND approval for Phase 2 (Diabetic Macular Edema)
    3. FDA IND approval for Phase 2 (Alzheimer’s disease
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    Sung Young Lee
    Senior Vice President, Head of Clinical Strategy and Operation, ImmuneOncia Therapeutics

    -   MS (PhD course completion), RN, APN of Oncology

    -   Experience in clinical trials for 22 years;

    • developed whole clinical regulatory package for new anti-cancer immunotherapy in ImmunoneOncia Therapeutics Inc. (current)
    • developed whole clinical regulatory package and gained the approval for biosimilars from EMA, FDA and PMDA in CELLTRION Inc.
    • developed the systemized data capturing module and clinical study conducting program in National Cancer Center Korea

    -   Published 30 articles and 53 congress presentations (including The Lancet, Lancet Oncology, Lancet Hematology, etc)

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    Seunghyun Hong
    Head of QA, GCPharma

    Session Details:

    Ensuring clinical quality assurance in supply chain management: An integrated approach

    2024-12-03, 4:15 PM

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    SeungWoo Shin
    AI drug discovery Team Leader, Daewoong Pharmaceutical
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    HyeJung Yang
    Clinical Project Manager, MedPacto

    Hyejung Yang is the Clinical Research Manager and Clinical Research Team Lead at MedPacto Inc,. She has almost 12 years of experience in Clinical Research Project management by local pharmaceutical companies.

     

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    Elvira Suniega-Tolentino
    Senior Clinical Trial Portfolio Manager (Asia), Nestle

    Elvira Suniega-Tolentino is the Senior Clinical Trial Portfolio Manager for Singapore at the Nestlé Clinical Research Unit, responsible for end-to-end clinical project management and operational activities of Nestlé corporate clinical trials serving all Nestle Business Units.

    Prior to joining Nestlé, Elvira was the Area Clinical Operations Manager for Abbott Nutrition R&D, Asia Pacific Center in Singapore for 11 years. Over the years, she has sharpened her expertise in the industry, bringing in thoughtful and strong competency into Nestlé’s clinical projects.

    The combination of her expertise, leadership and passion for innovation strongly supports the continuous improvement and excellence of Nestlé’s clinical research activities to further unlock the power of food and enhance the quality of life for every consumer, today and for generations to come.

    Social Links:

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    Kyungdong Bae
    KyungDong Bae, Chief Manufacturing Officer, ArtBlood, Korea
    2023~Current: Chief Manufacturing Officer, ArtBlood, Korea
    2000~Current: Expert Committee Member, Advanced Therapies (Bio5), United States Pharmacopeia (USP)
    2018~2003:  Executive Director, Head of Manufacturing Operations, Helixmith, Korea
    1998~2018: Director, Head of Vaccine Process and Analytical Development, Janssen Vaccines, Korea
    1992~1988: Scientist, Process Development Department, Hanhyo Institute, Korea
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    Advisory Board

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    Chris Wallace
    Head of Distribution EMEA, Argenx

    Chris has over 35 years’ varied supply chain experience, having worked for several blue chip companies in a number of industries including 3rd party logistics services, automotive, medical device, nuclear fuels and biotech/pharmaceuticals.

    Originally from the UK but now based in Switzerland, he has been involved in life science - biotech/pharmaceuticals & medical device - for over 20 years of his career and has latterly been SVP Global Supply Chain at Clover Biopharmaceutical before last year moving to Argenx as Head of Distribution EMEA.

    He has developed, implemented and managed global healthcare supply chain strategies and operations on 6 continents. This has included different set-ups in multiple countries, including many in the Emerging Markets as well as the developed world.

    Chris has a degree in economics from Manchester University, an MBA from Aston University and a postgraduate diploma from London University. In his spare time, he plays golf badly and loves to sample great Italian food and red wines!

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    Luiz Barberini
    Head of External Manufacturing Latin America, Bayer
    • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
      Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
    • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
    • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
    • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
    • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
    • Solid team management skills, as well as Customer Service relationship and management
    • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

    CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

    Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

    Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

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    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals

    Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

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    Francesco Santo
    Associate Director, Clinical Supply Lead, Exelixis

    A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

    • Strategic Supply Chain Management
    • Regulatory Compliance
    • Cross-Functional Collaboration
    • Risk Management
    • Innovative Problem-Solving

    Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

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    Arnaud Dourlens
    Head of Clinical Trial Supply, Sanofi

    Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group. During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio. Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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    Paul Larochelle
    Director Global Clinical Supply Chain Planning, Takeda

    Paul Larochelle has over 17 years of experience in a variety of positions within Clinical Supplies, including roles in clinical planning, production scheduling and planning, secondary packaging operations management, and business expert for a clinical inventory management system. Paul currently leads a team of Clinical Planning Leads at Takeda and is a member of the Global Clinical Supply Chain (GCSC) Leadership Team. He also oversees Takeda’s GCSC Post-PharmD Fellowship Program in partnership with the Massachusetts College of Pharmacy and Health Sciences (MCPHS). Paul’s prior organizations include Genzyme/Sanofi and Biogen, supporting therapies across all indications and stages of development.

    In addition to his primary responsibilities, Paul served as a coordinator of Pharmacy Industry Fellowships for the Genzyme/Sanofi MCPHS Fellowship Program (2009-2014) and precepted over 50 pharmacy students interested in a career in industry for several schools. He is currently the Chair of the Dean’s Advisory Board for MCPHS Boston School of Pharmacy and a member of the Pharmacy Advisory Board for Western New England University. He is also a member of the Clinical Trial Supply Conference Series Advisory Board.

    Paul completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with Genzyme/MCPHS, a Doctorate in Pharmacy from MCPHS, an MBA from Worcester Polytechnic Institute, and a degree in Biology from Providence College. Paul has also served previously as President of the Board of Directors for the Massachusetts Pharmacists Association (MPhA), and as President of the MCPHS Alumni Association.

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