9th Annual Outsourcing in Clinical Trials East Asia 2024

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

3 - 4

December

2024
  • JW Marriott Hotel Seoul, South Korea
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Why attend?

Agenda

  • 3 Dec 2024
  • 4 Dec 2024
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8 AM

Registration and refreshments

8:40 AM

Chairperson’s opening remarks

8:45 AM

The Biotech’s Gambit: Key considerations to identify right CRO/vendor partners

• What is vital for a biotech in CRO/vendor selection?
• As a biotech, who is a good partner? A small/medium-sized CRO or large global CRO?
• How can a biotech engage a CRO to prioritize its study?

Speakers

Woohyung Wayne Lee
Director, Clinical Planning, GI INNOVATION

9:15 AM

Beyond Excel: Innovative Solutions for Clinical Supply Forecasting & Planning

• Identify critical areas often overlooked in clinical supply chains that lead to inefficiencies
• Explore the benefits and limitations of each type of tool: from excel-based to specialized forecasting tools dedicated to the clinical supply chain
• Gain practical insights from case studies that explore complex trial designs, waste management, monitoring processes, and adaptability to changes

Speakers

Antoine Remiot
Antoine Remiot, Senior Director - Global Business Development & Partnerships, Clinical Supply Optimization, N-SIDE
Laurent Verdickt
Laurent Verdickt, Senior Solutions Engineer, 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

Post-pandemic: Strategies to advance your journey in vaccine development

  • Trend of vaccine trials landscape
  • Leveraging Southeast Asia in vaccine development
  • Case study on expediting clinical development in a multi-regional vaccine study

Speakers

Chris Chong
Senior Director Clinical Services, Novotech

10:45 AM

Morning refreshments and networking

STREAM A: Outsourcing & Clinical Operations

11:30 AM

Why Patient Access Matters – From Korea Perspective

• Where Korea stands from Global view
• Country Allocation, and Site Selections
• New ways of recruitments

Speakers

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

12 PM

Australia, your springboard for early phase clinical development

• Clinical Trial Ecosystem in Australia
• Regulatory Requirements in Australia vs USA
• Case studies : FIH Studies Robotic Pill and Vaccine Programs

Speakers

Jeffery Wong
Senior Director of Business Development, Nucleus Network

12:30 PM

Using AI (Artificial Intelligence) in Drug Discovery and Development

• Implement machine learning models to predict biological activity and optimize lead compounds
• Integrate AI with genomic data to develop personalized medicine approaches
• Utilize AI for real-time monitoring and adaptive trial designs

Speakers

SeungWoo Shin
AI drug discovery Team Leader, Daewoong Pharmaceutical

1 PM

Lunch and networking

2:15 PM

Four essential factors for success in your Oncology trials

• Why biomarker-driven study is needed
• Development strategy using single-arm trial for rare disease
• What is important for a successful phase 1 clinical trial?
• How to improve the data quality of complex structures

Speakers

Sung Young Lee
Senior Vice President, Head of Clinical Strategy and Operation, ImmuneOncia Therapeutics

2:45 PM

Guiding Principles for Effective Global RTSM Solution Deployment

• Strategic Planning for New Technology Adoption: Key factors to consider for effective integration in evolving business regions
• Enabling Efficient and Reliable Clinical Trials: Best practices to ensure trials are fast, compliant, and well-supported
• Leveraging Global Experience for Success: Real-world insights to navigate complexities and enhance outcomes locally and internationally.
• Preparing for Future Market Demands: Forward-thinking strategies for seamless integration and adaptability

Speakers

Jon Lee
Business Development Engineer, 4G Clinical

3:15 PM

FIRESITE CHAT: Overcoming challenges in CRO and site management to enhance success in your trials

• Successful cases of collaboration with CROs that led to a positive impact on clinical trials
• The key element when beginning a partnership with a CRO
• The approach to handling and resolving issues when they arise

Speakers

Sangwoo Lee
General Manager Clinical Development, Oblato (former)

3:45 PM

Afternoon refreshments and networking

4:15 PM

The advantages and hurdles of Risk-Based Monitoring frameworks in clinical trials

• Exploring how risk-based monitoring improves resource allocation by minimizing on-site monitoring visits
• How can clinical teams step back and self-analyse what risk could occur rather than rush straight in?
• Choosing the correct RBM strategy to apply to your trial to reduce the time to approval for INDs

Speakers

Seongyun Bang
Chief Development Officer, Vice President, SPARK Biopharma

4:45 PM

PANEL DISCUSSION: Deep dive into the industry landscape with a focus on current challenges

• The impact of the medical strike on your trials
• Regulatory and compliance; Whats new?
• Data integrity and management challenges
• Financial and operational efficiency; How to reduce costs and timelines

Speakers

Moon H. Kim
Chief Technical Officer, InnoCure Therapeutics Inc
Maggie Lim
Clinical Quality Assurance Director (Asia Pacific), GSK
Seongyun Bang
Chief Development Officer, Vice President, SPARK Biopharma

5:15 PM

Chairperson’s closing remarks

8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

STREAM A: Outsourcing & Clinical Operations

Speakers

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

9 AM

THINK TANK: Clinical Vendor Quality Management – A Sponsor’s Perspective

• Establish quality benchmarks and standards to ensure vendors meet the specific needs of clinical trial protocols
• Conduct regular audits, reviews, and KPI assessments to track vendor performance
• Validate vendor adherence to regulations to minimize risks and preserve the integrity of data

Speakers

Joy Quinal
Head Clinical Quality Operations, Asia Pacific, CSL
Renee Loredo
Senior Clinical Quality Assurance Manager, Global R&D Quality, CSL Ltd

9:30 AM

Exploring the UAE’s Clinical Research Landscape in Rare Disease

• UAE: A Rising Research Hub: The UAE has rapidly positioned itself as a key player in clinical research for rare diseases, fuelled by a commitment to healthcare innovation and a patient-first philosophy.
• Regulatory Framework: A robust regulatory framework in the UAE actively supports and streamlines clinical research, enabling groundbreaking studies in the rare disease domain.
• Talent Development: Investments in talent development are central to the UAE's research strategy, focusing on upskilling local researchers and clinicians in rare disease methodologies.
• Patient-Centric Approaches: The UAE prioritizes patient-centric approach, engaging patient community and advocacy groups

Speakers

Rohan Simon
Associate Director - Business Development, IROS by M42

10 AM

Navigating early clinical development

  • Developing a robust preclinical research plan to inform early clinical strategies
  • Sponsor/CRO Project timelines
  • Avoiding incidents by considering guidance, Pre-clinical data, and tested design options

10:30 AM

FIRESITE CHAT: Vendor Selection Strategies: Building knowledge for optimal decision-making

• Clearly define requirements to outline specific needs and expectations
• Evaluate Cost vs. Value: Look beyond price

11 AM

Morning refreshments and networking

11:45 AM

Achieving successful trial outsourcing from the perspective of small biotech companies

• As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
• Addressing clinical development planning and strategic decision making with limited resources
• Overcoming hurdles and sharing best practice to successfully outsource trial

Speakers

Suntae Kim
Director, Clinical Development, Connext

12:15 PM

PANEL DISCUSSION: Setting up global clinical Trials, with a focus on Asia Pacific

• Opportunities and challenges of conducting clinical trials in Asia: Benefits and factors to consider when selecting Asian nations as trial locations
• How different notified bodies and their regulations present challenges to our clinical execution strategies
• Grasping the distinct regulatory frameworks and prerequisites for clinical trials

Speakers

Moon H. Kim
Chief Technical Officer, InnoCure Therapeutics Inc
Suntae Kim
Director, Clinical Development, Connext

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?

Dayeon Ko, Director of Clinical development, Enzychem Lifesciences

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

Select a speaker to learn more

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Moon H. Kim
Chief Technical Officer, InnoCure Therapeutics Inc
Moon H. Kim, PhD.
PhD: Medicinal Chemistry at SNU
MSKCC, SUNY Buffalo, Affymax, Exelixis in US
OncoVenture, IPK, ARIBIO, BiSiChem, VeraVerse in Korea
InnoCure Therapeutics, CTO

Session Details:

PANEL DISCUSSION: Deep dive into the industry landscape with a focus on current challenges

2024-12-03, 4:45 PM

Session Details:

PANEL DISCUSSION: Setting up global clinical Trials, with a focus on Asia Pacific

2024-12-04, 12:15 PM

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:

STREAM A: Outsourcing & Clinical Operations

2024-12-04, 8:59 AM

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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:

PANEL DISCUSSION: Deep dive into the industry landscape with a focus on current challenges

2024-12-03, 4:45 PM

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

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:

Why Patient Access Matters – From Korea Perspective

2024-12-03, 11:30 AM

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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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Woohyung Wayne Lee
Director, Clinical Planning, GI INNOVATION

Session Details:

The Biotech’s Gambit: Key considerations to identify right CRO/vendor partners

2024-12-03, 8:45 AM

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KangPyo Lee
Vice President, Hanul TL
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Dayeon Ko
Director of Clinical development, Enzychem Lifesciences
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Suntae Kim
Director, Clinical Development, Connext

Director, Clinical Development, Connext Co. Ltd.

 

Previously worked as CDO, MedGene Therapeutics Inc.;

Project Manager & Senior Director, KCRN Research;

Principal Scientist, G+FLAS Lifesciences;

Postdoc & Research Fellow, NCI, NIH;

Ph.D. in Biochemistry & Molecular Biology, Environmental Toxicology, Michigan State University;

BS & MS, Seoul National University

Session Details:

PANEL DISCUSSION: Setting up global clinical Trials, with a focus on Asia Pacific

2024-12-04, 12:15 PM

Session Details:

Achieving successful trial outsourcing from the perspective of small biotech companies

2024-12-04, 11:45 AM

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Hanuk Kim
Quality expert
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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.

Session Details:

The advantages and hurdles of Risk-Based Monitoring frameworks in clinical trials

2024-12-03, 4:15 PM

Session Details:

PANEL DISCUSSION: Deep dive into the industry landscape with a focus on current challenges

2024-12-03, 4:45 PM

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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)

Session Details:

Four essential factors for success in your Oncology trials

2024-12-03, 2:15 PM

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SeungWoo Shin
AI drug discovery Team Leader, Daewoong Pharmaceutical

Education

1999.03 ~ 2005. 08 Ph.D., Department of Computer Engineering, Kyungpook National University
1997. 03 ~ 1999. 02 M.S., Department of Computer Engineering, Kyungpook National University

Professional Experiences

2021. 12 ~

2018. 12 ~ 2021. 12

2009. 03 ~ 2018.12

Daewoong Pharmaceutical / AI New Drug Discovery team leader

Syntekabio / AI New Drug Discovery team leader

SOONCHUNHYANG UNIVERSITY HOSPITAL / Academic Research Professor

2007.4 ~ 2009.2

2005.10~ 2007.03

Korea Institute for Advanced Study (KIAS) / Senior Researcher

Korea National Institute of Health, Genomics Research Center, Bioscience information team / Senior Researcher

Publications (Selected or Past 5 years)

○ A new algorithm for detecting Low-complexity regions in protein sequences, bioinformatics, pp 160-170, vol. 21, 2005

○ Asthma-Predictive Genetic Markers in Gene Expression Profiling of Peripheral Blood

Mononuclear Cells, ALLERGY ASTHMA & IMMUNOLOGY RESEARCH, pp 265-272, vol. 3, 2011

○ Differential gene expression profile in PBMCs from subjects with AERD and ATA: a gene

marker for AERD, Molecular Genetics and Genomics, pp 361-371, vol 287, 2012

○   A Highly Sensitive and Specific Genetic Marker to Diagnose Aspirin-Exacerbated Respiratory Disease Using a Genome-Wide Association Study, DNA AND CELL BIOLOGY, p1604-1609, vol 31, 2012

○ Genome-wide association study of aspirin-exacerbated respiratory disease in a Korean

population, Hum Genet, March 2013, Volume 132, Issue 3, pp 313–321

○ Elevation of Eosinophil-Derived Neurotoxin in Plasma of the Subjects with Aspirin-Exacerbated Respiratory Disease: A Possible Peripheral Blood Protein Biomarker, PLOS ONE, vol 8, 2013.

○ Exonic Variants Associated with Development of Aspirin Exacerbated, Respiratory Diseases,

PLOS ONE 9(11), 2014.

○ Genome wide identification and expression profile in epithelial cells exposed to TiO₂ particles, Environ Toxicol, 2015 Mar;30(3):293-300

○ Association between TAAR6 polymorphisms and airway responsiveness to inhaled

corticosteroids in asthmatic patients, Pharmacogenetic Genomics, 2015 Jul;25(7):334-42

○ Development of a genetic marker set to diagnose aspirin-exacerbated respiratory disease     in a genome-wide association study, Pharmacogenomics J. 2015 Aug;15(4):316-21

○ Clinical Characteristics of Exacerbation-Prone Adult Asthmatics Identified by Cluster

Analysis, Allergy Asthma Immunol Res, 2017 Nov;9(6):483-490

○ lung function trajectory types in never-smoking adults with asthma: clinical features and

inflammatory patterns, Allergy Asthma Immunol Res. 2018 Nov;10(6):614-627

 

Session Details:

Using AI (Artificial Intelligence) in Drug Discovery and Development

2024-12-03, 12:30 PM

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Seunghyun Hong
Head of QA, GCPharma
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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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Jeffery Wong
Senior Director of Business Development, Nucleus Network

Jeffery Wong is the Senior Director of Business Development at Nucleus Network, one of the world’s largest Phase I Clinical Trial Service provider with operations spreading across both Australia and the USA.

A strong business development professional, Jeffery graduated from RMIT University, holds a Masters in Business and Biotechnology with a major in Pharmaceutical Sciences. During his 18 years with Nucleus Network, Jeffery has seen the growth of Nucleus Network from a 24 bed not for profit organisation to its current capacity of over 200 phase I beds spread across the globe.

Jeffery has a passion in supporting industry members to achieve their clinical development goals and leverages on his extensive knowledge in business development, project operation, clinical study design and regulatory affairs.

Session Details:

Australia, your springboard for early phase clinical development

2024-12-03, 12:00 PM

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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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Karen Montgomery-Douglas
Regional Business Development Manager,Akesa

Karen Montgomery-Douglas | Commercial Development Manager | BSc (Biomedical), Grad. Dip. Medical Laboratory Science

Karen brings over 20 years’ experience in sales and business development in the clinical trials and laboratory sectors. With a strong background in managing global and Asia-Pacific sales strategies, Karen drives growth and fosters client relationships across the pharmaceutical and biotechnology industries. She has demonstrated leadership in developing robust business processes to support commercial objectives.

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Con Konstantopoulos
Co-CEO, Akesa

Con Konstantopoulos | Founder and Co-CEO | BSc (Pharmacology, Physiology)

Con leverages over 25 years of expertise in international pharmaceutical supply chains. His strategic approach and innovative thinking have positioned Akesa as a leader in delivering bespoke solutions for clinical trials, enhancing outcomes and forging global partnerships.

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Antoine Remiot
Antoine Remiot, Senior Director - Global Business Development & Partnerships, Clinical Supply Optimization, N-SIDE

Antoine Remiot is N-SIDE's Director of BD and Partnerships. Over the past years, Antoine has been sharing his enthusiasm for lean clinical supply chain management, waste reduction, and sustainability with various pharma partners he supported in their change management journey toward digitalization.
Antoine is passionate about leveraging data and AI to improve clinical supply efficiency. He gained expertise in forecasting, planning, IRT configuration, and end-to-end clinical supply chain optimization through his work on hundreds of trials on multiple indications.

Session Details:

Beyond Excel: Innovative Solutions for Clinical Supply Forecasting & Planning

2024-12-03, 9:15 AM

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Laurent Verdickt
Laurent Verdickt, Senior Solutions Engineer, N-SIDE
Laurent Verdickt is a Senior Solutions Engineer at N-SIDE, where he helps tackle everyday challenges in the clinical supply chain for biopharma companies. After spending years as a Medical Advisor at MSD and Viatris, he found his passion in the world of clinical supply at N-SIDE. He's especially interested in how digital tools can make the supply chain more efficient and, in the long run, improve patients' lives. Laurent loves finding practical solutions that have a real impact on healthcare.

Session Details:

Beyond Excel: Innovative Solutions for Clinical Supply Forecasting & Planning

2024-12-03, 9:15 AM

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Chris Chong
Senior Director Clinical Services, Novotech

Chris joined Novotech as Clinical Team Leader in 2013, to manage Hong Kong office from inception. He led expansion of Hong Kong team, positioning the company as one of active players in clinical research industry. He also had exposed to China and Taiwan for around a year. Since 2022, he has been heading the clinical operations team across Southeast Asia and Hong Kong and additionally oversees Clinical Lead function at department level for 2 years.

Chris has over 16 years industry experience in multiple settings including CRO, pharmaceutical and academic. In his career, he led various initiatives to improve efficiency and delivery, including the most recent one on implementing changes for trial subject recruitment. He is now driving the capability expansion and site relationship in Southeast Asia countries.

Chris holds a Master of Social Sciences from the University of Hong Kong

Session Details:

Post-pandemic: Strategies to advance your journey in vaccine development

2024-12-03, 10:15 AM

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Renee Loredo
Senior Clinical Quality Assurance Manager, Global R&D Quality, CSL Ltd

Renee’s long professional journey in the pharmaceutical/biotechnology industry enabled her to work or support across multiple GxP areas. She has experiences in production quality control, clinical operations, operational quality management, pharmacovigilance, and clinical research quality assurance -  where majority of her exposure is and where she finds her drive.

Currently at CSL Ltd, Renee provides quality and qualification oversight of third parties involved in their clinical trials globally, manages audit program for specific clinical studies, performs audits, and supports regulatory authority inspections. She was previously with GSK, Quintiles, Eli Lilly, Pfizer, and Ciba-Geigy.

Renee obtained her Bachelor of Science in Pharmacy degree from the University of the Philippines Manila and resides in Melbourne, Australia.

Session Details:

THINK TANK: Clinical Vendor Quality Management – A Sponsor’s Perspective

2024-12-04, 9:00 AM

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Joy Quinal
Head Clinical Quality Operations, Asia Pacific, CSL

Joy has over 20 years of experience in the pharmaceutical industry, working across a diverse range of cross-functional environments in Clinical Research & Development and Clinical Quality Management. Her expertise spans Good Clinical Practice (GCP), Good Vigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP), and Clinical Good Manufacturing Practice (cGMP).
Currently, Joy serves as the Head of Clinical Quality Assurance Operations for Asia Pacific and the Global Compliance Area Lead for Clinical Vendor Quality Management at CSL Limited, based in Australia.

Session Details:

THINK TANK: Clinical Vendor Quality Management – A Sponsor’s Perspective

2024-12-04, 9:00 AM

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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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SoonYoung Lee
Director of Clinical Development and Operations, ImmunAbs
2021-Present; Director of Clinical Development and Operations at ImmunAbs Inc.
2018-2021 Global Clinical Project Manager at TiumBio
2017-2018 Project Lead at IQVIA
2011-2017 Global Clinical Project Manager, Clinical Operations Team Leader at Celltrion Inc.
2008-2011 CRO Clinical Research Associate
2006-2008 Clinical Research Nurse at Oncology, Seoul National University Hospital
2003-2006 Nurse at SICU, Asan Medical Center
2003 Graduated Ewha Womans University, Department of Nursing Science
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Jon Lee
Business Development Engineer, 4G Clinical

Session Details:

Guiding Principles for Effective Global RTSM Solution Deployment

2024-12-03, 2:45 PM

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Vasee Moorthy
Senior Advisor, R&D, World Health Organization

Dr. Vasee Moorthy is Senior Advisor, Research for Health Department, WHO Science Division, Geneva, Switzerland. Since 2008, he has held progressively senior roles at WHO in malaria vaccine policy development, Ebola vaccine phase 1-2 trials, global norms in sharing research data and results during public health emergencies, WHO R&D Blueprint for action to prevent epidemics, global consensus on clinical trials policy norms, WHO COVID-19 Research & Innovation Roadmap and the WHO Solidarity Trial of therapeutics supporting clinical trials networks in over 40 Member States in all WHO regions, and most recently, the adoption of resolution (WHA75.8) on clinical trials. Prior to joining WHO, Dr. Moorthy worked as a medical researcher at the University of Oxford, UK (2005-2008); with an NGO, PATH, in USA (2003-2005); running a clinical trials programme at MRC Laboratories in The Gambia (1999-2003), and as a government medical officer in Kwazulu/Natal, South Africa (1996-1997). He received a B.A. and M.A. from the University of Cambridge in Natural Sciences, a B.M.B.Ch medical degree and a Ph.D in malaria immunology and clinical trials both from the University of Oxford.

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OCT Advisory Board

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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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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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THOMAS M TREMBLAY
Vice President Of Clinical Development, Trefoil Therapeutics, Inc

Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy 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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Bao
Vendor Engagement and Business Operations Leader | Strategic Advisor | Clinical Data Management Expert

With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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