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
  • Ticketed
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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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

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:

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

2024-12-04, 12:15 PM

Session Details:

STREAM B: Clinical Trial Supply

2024-12-04, 8:59 AM

Session Details:

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

2024-12-04, 9:00 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:

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 Manager, CMG Pharmaceutical Shau-Feng Chang, CEO, BELX BioPharmaceuticals
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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.

Session Details:

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

2024-12-03, 2:15 PM

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Miyang Kim
Director, Clinical Site Lead, Merck
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Clare tan
Director of Clinical Operations and Project Management, Tikva Allocell

Session Details:

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

2024-12-04, 12:15 PM

Session Details:

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

2024-12-04, 11:45 AM

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
KangPyo Lee
Vice President, Hanul TL

Session Details:

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

2024-12-03, 4:45 PM

Session Details:

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

2024-12-03, 11:30 AM

View In Agenda
Next speaker
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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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Suntae Kim
Director, Clinical Development, Connext
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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

View In Agenda
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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
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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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SeungWoo Shin
AI drug discovery Team Leader, Daewoong Pharmaceutical
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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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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.

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OCT Advisory Board

Select a member to learn more

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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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Plan Your Visit

Venue

JW Marriott Hotel Seoul 176, Sinbanpo-ro, Seocho-gu Seoul, South Korea 06546

176, Sinbanpo-ro, Seocho-gu Seoul, South Korea 06546

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Sponsors

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Featured Sponsor

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Why partner?

 

Contact us to become a partner

Partnership Opportunities

We work with you to design a bespoke package to meet your business needs, where you could:

  • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
  • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
    Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
  • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

Event reach

  • 250+ attendees each year
  • 80% attendees C-suite level

 

Take a look at our current sponsors

Media Centre

Media Partners

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Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Nicholas McCudden

Head of OCT Events

+61 280 978 126

SPEAKER ENQUIRIES

Ranhee Yoo

Conference Producer

+44 207947 2793

MARKETING ENQUIRIES

Haida Amirzadah

Marketing Manager

DELEGATE ENQUIRIES

Sunny Saikia

VIP Delegate Manager

Sponsorship Enquiries

To enquire about sponsorship opportunities for the conference, please contact:

Nicholas McCudden

Head of OCT Events


+61 280 978 126

Speaker Enquiries

To enquire about speaking opportunities for the conference, please contact:

Ranhee Yoo

Conference Producer


+44 207947 2793