GCSG 2025 Asia Pacific Conference: Program

Day 1 : Tuesday, March 11

8:00 am - 8:30 am
Conference Logistics

Boot Camp Registration Open

8:30 am - 4:30 pm
Boot Camp / Seminar

BC01 - Import/Export of Clinical Supplies - An Overview

This session is designed for those who want to learn more about the fundamentals of international logistics as well as best practices when planning and executing global clinical trials.
Delivered by clinical supply professionals with real life experience, various topics related to the distribution of clinical supplies will be covered, including:

●      Commodity Codes
●      Incoterms
●      Trade compliance, with a focus on the US, Europe, China, Singapore and Australia
●      Import Tax / Value Added Tax (VAT)
●      Role of the Qualified Person (QP) in the EU
●      Supply chain strategies (in-country depot vs direct to site)

Speakers:

8:30 am - 4:30 pm
Boot Camp / Seminar

BC02 - Understanding the Essentials of the Clinical Supply Chain

This class, geared towards people new to the world of clinical trial supplies, focuses on drug development and what goes into planning for and delivering a study drug for a clinical trial. Topics include: reasons behind Good Manufacturing Practices (cGMPs), phases of new drug development and approval, randomizing and blinding clinical trial materials, quality assurance and documentation, protocol interpretation, patient compliance, labeling, standard operating procedures (SOPs), stability, Good Distribution Practices (GDPs), returned drug accountability, and changing regulations in the European Union (EU) and rest of world (ROW). Attendees will hear a massive amount of information in a fun and interactive atmosphere.

Speakers:

12:00 pm - 1:00 pm
Conference Logistics

Exhibitor Registration Open

1:00 pm - 3:00 pm
Conference Logistics

Exhibitor Set Up

3:00 pm - 5:30 pm
Conference Logistics

Registration Open

4:00 pm - 4:30 pm
Presentation

Presenters/Workshop Facilitators Orientation

If you are speaking or facilitating a workshop, please join us for a short orientation session and tour of the workshop rooms.

Speakers:

5:45 pm - 6:15 pm
Presentation

Start the Asia Pac Conference Right! - Conference Orientation

Kick off the Asia Pacific Conference on the right foot! This orientation session will provide essential information and tips to help you make the most of your conference experience.

Speakers:

6:30 pm - 8:30 pm
Networking

GCSG Meet & Greet Networking Event

GCSG is new to the Asia Pacific region! Join us for light refreshments and libations while you network with other clinical supply professionals and enjoy a jazz band.

Day 2 : Wednesday, March 12

7:30 am - 9:00 am
Conference Logistics

Registration Open - Exhibitor Displays Open

9:00 am - 9:30 am
Presentation

Welcome & Opening Remarks

Speakers:

9:30 am - 10:30 am
Presentation

Keynote - David Lim - Sponsored by Abacus Medicine

David Lim is best known for leading the 1st Singapore Everest Expedition in 1998 and many other expeditions to the greater ranges. He had delivered unforgettable presentations on leadership and bouncing back from setbacks in 34 countries since 1999. David excels in helping people believe they can be more than just ordinary.

In “Lessons from Everest”, David shares not only a story of overcoming the odds, but also how anyone can apply practical steps to seize stretch goals, and bounce back from any setback.

David is the author of Mountain to Climb: The Quest for Everest and Beyond, Against Giants: The Life and Climbs of a Disabled Mountaineer, How Leaders Lead and Lessons from Edge. He lives on the west coast of Singapore with his wife, Maureen, and their dogs and cats.

Speakers:

10:30 am - 10:45 am
Conference Logistics

Room Transfer

10:45 am - 11:45 am
Workshop

WS01.1: Cell & Gene Therapy (CGT): Logistical Challenges & Best Practices

This workshop will focus on the challenges associated with cell and gene therapy supply chains and the solutions to address them. Key topics will include patient orientation for CGT, temperature-control, site requirements, manufacturing challenges, and managing aggressive timelines.

Speakers:

10:45 am - 11:45 am
Workshop

WS04.1: Reducing Drug Waste: Using Technology to Increase Efficiency in Clinical Trial Supply

This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will review all these mechanisms which will enable you to successfully understand which is the best pathway based on the patient need. Topics covered will include compassionate use, off-label access, continued access, special license sales and right-to -try.

Speakers:

10:45 am - 11:45 am
Workshop

WS07.1: Effective Packaging & Labeling Strategies for Diverse Drug Types

As our industry continues to evolve with innovative medicines in development and patients recruited from diverse populations, traditional packaging and labelling strategies are also being challenged.  This interactive workshop will review the packaging and labelling solutions to meet the needs of this evolution.

Speakers:

10:45 am - 11:45 am
Workshop

WS10.1: Selecting the Right Vendor Partner: Key Considerations for a Successful Partnership

Outsourcing has become the norm in our industry, but challenges persist on both sides. This workshop will focus on the importance of managing clinical supplies by viewing your vendor as a key partner. We will discuss strategies for seamlessly integrating your vendor into your supply chain, using internal stakeholder input to refine metrics, and minimizing risks to enhance overall success.

Speakers:

11:45 am - 12:00 pm
Conference Logistics

Room Transfer

12:00 pm - 1:00 pm
Workshop

WS02.1: Strategies for Successful Clinical Trials in China

Awareness of regulatory requirements from various agencies is crucial for success in clinical trial supplies. This workshop will explore China's regulations on importation, labeling, and distribution, and discuss how these rules affect timelines and planning for clinical trial supplies.

Speakers:

12:00 pm - 1:00 pm
Workshop

WS05.1: The Clinical Trial Supply Chain Professional Toolkit

Learning by the shared experiences of industry veterans, this workshop will focus on innovative tools and techniques to address legacy and present day challenges within the clinical supply chain.

Speakers:

12:00 pm - 1:00 pm
Workshop

WS08.1: IRT & Forecasting: Enhancing Clinical Trial Efficiency

In recent years, there has been a growing emphasis on self-service tools to swiftly address trial execution challenges. This workshop will focus on managing clinical supply chain settings within IRT systems, including forecasting activities, and will discuss the ideal level of control needed to optimize both forecasting and overall supply chain management.

Speakers:

12:00 pm - 1:00 pm
Workshop

WS09.1: What to Know & What to Avoid to Experience the Greatest Success When Sourcing Comparators

Comparator sourcing is a complex and challenging activity required to conduct the majority of clinical trials today. During this workshop we will discuss some of the key challenges of sourcing and procuring comparators and how to set yourself up for success. This workshop will prompt discussion around some of the key challenges and how to set yourself up for success when sourcing for global clinical trials.

Speakers:

1:00 pm - 2:00 pm
Networking

Lunch - Sponsored by Medizone Germany & Exhibitor Displays Open

2:00 pm - 3:00 pm
Workshop

WS01.2:Cell & Gene Therapy (CGT): Logistical Challenges & Best Practices

This workshop will focus on the challenges associated with cell and gene therapy supply chains and the solutions to address them. Key topics will include patient orientation for CGT, temperature-control, site requirements, manufacturing challenges, and managing aggressive timelines.

Speakers:

2:00 pm - 3:00 pm
Workshop

WS03.1: Reducing Drug Waste: Using Technology to Increase Efficiency in Clinical Trial Supply

On average, 55-75% of drugs are wasted in clinical trials. Although overproduction has long been an accepted practice in clinical supply and manufacturing, it is increasingly unsustainable. This workshop will examine how technology can drive the transition to a more sustainable clinical supply chain and will discuss effective strategies and best practices for achieving this shift.

Speakers:

2:00 pm - 3:00 pm
Workshop

WS06.1: Transforming Clinical Trials through Patient-Centric Integration

This workshop will explore successful patient-centric approaches for clinical trials and their clinical supplies. The GCSG Direct-To-Patient (DTP) Team will facilitate a discussion on the complexities of the DTP process, sharing insights, experiences, and lessons learned from a wide range of stakeholders, including patients, investigators, site staff, pharmacies, depots, Health Authorities, Ethics Committees, couriers, sponsors, and vendors.

Speakers:

2:00 pm - 3:00 pm
Workshop

WS10.2: Selecting the Right Vendor Partner: Key Considerations for a Successful Partnership

Outsourcing has become the norm in our industry, but challenges persist on both sides. This workshop will focus on the importance of managing clinical supplies by viewing your vendor as a key partner. We will discuss strategies for seamlessly integrating your vendor into your supply chain, using internal stakeholder input to refine metrics, and minimizing risks to enhance overall success.

Speakers:

3:00 pm - 3:15 pm
Conference Logistics

Room Transfer

3:15 pm - 4:15 pm
Presentation

Patient Testimonial - Ev Brodsky - Sponsored by Abacus Medicine

Ev was the recipient of an unusual bone marrow transplant (single unit umbilical cord blood) after being diagnosed with MDS EB-1 (myelodysplastic syndromes excess blasts 1) a month before her 32nd birthday. She is in remission and has been recovering from the effects of the transplant.

Ev is passionate about raising awareness of the importance of bone marrow and umbilical cord blood donorships. Due to Ev’s rare medical condition and type of transplant, she participated in several medical studies. She wants her rare and life-altering medical experience to help other patients and their healthcare providers navigate their own health challenges.

Ev lives in Melbourne, Australia, with her husband, David, and their 2 dogs and 2 cats. Ev holds a Bachelor of Laws and a Master of Laws degrees from Monash University, and is a commercial and intellectual property lawyer, currently advising to companies within the medicinal cannabis industry.

Speakers:

4:15 pm - 4:30 pm
Presentation

Closing Remarks

Speakers:

4:30 pm - 6:15 pm
Networking

Vendor Reception

Explore the exhibitor area and learn more about what the leading players in the industry have to offer.
6:15 pm - 7:00 pm
Break

Personal Time

7:00 pm - 10:30 pm
Networking

GCSG Evening Event at “37 Grill & Bar” at the Hotel

Experience an unforgettable evening at 37 Grill & Bar at the Conrad Hotel. Connect with fellow attendees, unwind, and be captivated by the stunning city views.

Day 3 : Thursday, March 13

8:00 am - 9:00 am
Networking

Registration Open - Exhibitor Displays Open

9:00 am - 9:15 am
Presentation

Opening Remarks

9:15 am - 10:15 am
Presentation

Plenary - Regulatory Updates for Better Clinical Trials

In our highly regulated environment, new regulations can emerge with little advance notice. This presentation will provide a summary of recent and upcoming regulations that are expected to impact the clinical supply chain, helping you stay informed and prepared for these changes.

Speakers:

10:15 am - 10:30 am
Conference Logistics

Room Transfer

10:30 am - 11:30 am
Workshop

WS02.2: Strategies for Successful Clinical Trials in China

Awareness of regulatory requirements from various agencies is crucial for success in clinical trial supplies. This workshop will explore China's regulations on importation, labeling, and distribution, and discuss how these rules affect timelines and planning for clinical trial supplies.

Speakers:

10:30 am - 11:30 am
Workshop

WS05.2: The Clinical Trial Supply Chain Professional Toolkit

Learning by the shared experiences of industry veterans, this workshop will focus on innovative tools and techniques to address legacy and present day challenges within the clinical supply chain.

Speakers:

10:30 am - 11:30 am
Workshop

WS07.2: Effective Packaging & Labeling Strategies for Diverse Drug Types

As our industry continues to evolve with innovative medicines in development and patients recruited from diverse populations, traditional packaging and labelling strategies are also being challenged.  This interactive workshop will review the packaging and labelling solutions to meet the needs of this evolution.

Speakers:

10:30 am - 11:30 am
Workshop

WS08.2: IRT & Forecasting: Enhancing Clinical Trial Efficiency

In recent years, there has been a growing emphasis on self-service tools to swiftly address trial execution challenges. This workshop will focus on managing clinical supply chain settings within IRT systems, including forecasting activities, and will discuss the ideal level of control needed to optimize both forecasting and overall supply chain management.

Speakers:

11:30 am - 11:45 am
Conference Logistics

Room Transfer

11:45 am - 12:45 pm
Workshop

WS03.2: Reducing Drug Waste: Using Technology to Increase Efficiency in Clinical Trial Supply

On average, 55-75% of drugs are wasted in clinical trials. Although overproduction has long been an accepted practice in clinical supply and manufacturing, it is increasingly unsustainable. This workshop will examine how technology can drive the transition to a more sustainable clinical supply chain and will discuss effective strategies and best practices for achieving this shift.

Speakers:

11:45 am - 12:45 pm
Workshop

WS04.2: Strategies for Successful Clinical Trials in China

This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will review all these mechanisms which will enable you to successfully understand which is the best pathway based on the patient need. Topics covered will include compassionate use, off-label access, continued access, special license sales and right-to -try.

Speakers:

11:45 am - 12:45 pm
Workshop

WS06.2: Transforming Clinical Trials through Patient-Centric Integration

This workshop will explore successful patient-centric approaches for clinical trials and their clinical supplies. The GCSG Direct-To-Patient (DTP) Team will facilitate a discussion on the complexities of the DTP process, sharing insights, experiences, and lessons learned from a wide range of stakeholders, including patients, investigators, site staff, pharmacies, depots, Health Authorities, Ethics Committees, couriers, sponsors, and vendors.

Speakers:

11:45 am - 12:45 pm
Workshop

WS09.2: What to Know & What to Avoid to Experience the Greatest Success When Sourcing Comparators

Comparator sourcing is a complex and challenging activity required to conduct the majority of clinical trials today. During this workshop we will discuss some of the key challenges of sourcing and procuring comparators and how to set yourself up for success. This workshop will prompt discussion around some of the key challenges and how to set yourself up for success when sourcing for global clinical trials.

Speakers:

12:45 pm - 2:00 pm
Networking

Lunch - Sponsored by World Courier & Exhibitor Displays Open

2:00 pm - 3:00 pm
Presentation

Panel Discussion - Exploring APAC at the Forefront of Clinical Trials

This panel discussion will delve into the dynamic landscape of clinical trials in the Asia Pacific region. We will explore emerging trends, challenges, and opportunities that are shaping the future of clinical research. Join us as we bring together industry leaders and experts to share insights on the latest developments, regulatory changes, and innovative approaches that are positioning Asia Pacific at the cutting edge of clinical trials.

Speakers:

3:00 pm - 3:30 pm
Presentation

Closing Remarks, Survey Completion & Prize Draws

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