Day 1 : Sunday, April 27
6:30 am - 8:00 am
Conference Logistics
Boot Camp Registration Open - Sponsored by 4G Clinical
7:00 am - 8:00 am
Conference Logistics
Breakfast for Boot Camp Registrants
If you are registered to attend one of our paid boot camps, please join us for breakfast just outside the boot camp rooms.
8:00 am - 4:30 pm
Boot Camp / Seminar
BC01 - 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:
8:00 am - 4:30 pm
Boot Camp / Seminar
BC02 - Mastering Clinical Supply Planning
Planning the clinical supply chain is a formidable task, full of challenges and complexities. With the variety of information to consider, external influences, and the inherent uncertainties of clinical trials, supply managers often find themselves under pressure to deliver a supply plan that is not only accurate but also highly efficient. This advanced one-day bootcamp is tailored for supply chain managers and planners familiar with the basics who would like to elevate their skills and knowledge. Together, we will address the main drivers of inefficiencies in clinical supply planning and navigate good practices to avoid them.
Speakers:
8:00 am - 4:30 pm
Boot Camp / Seminar
BC03 - Inspection Readiness
Join our Clinical Supply Inspection Readiness Bootcamp, an intensive, full-day workshop designed to prepare you for regulatory success. Through interactive sessions, expert-led discussions, and hands-on activities, you’ll gain practical insights into inspection strategies, risk mitigation, and vendor collaboration. Perfect for professionals looking to enhance their readiness and confidence in navigating regulatory inspections.
Speakers:
8:00 am - 12:00 pm
Boot Camp / Seminar
BC04 - Artificial Intelligence (AI) in Clinical Supplies
This artificial intelligence (AI) boot camp introduces participants to essential AI concepts tailored for the clinical trial industry, emphasizing data security and privacy. Attendees will gain hands-on experience with AI tools to enhance efficiency and learn strategies for ethical and secure AI use in clinical settings. Through interactive sessions and real-world examples, participants will leave equipped to implement AI responsibly in their work.
Speakers:
3:00 pm - 5:30 pm
Conference Logistics
Exhibitor Setup
3:00 pm - 6:00 pm
Conference Logistics
Registration/Information/Welcome Table Open
Registration Welcome sponsored by:
5:00 pm - 5:30 pm
Conference Logistics
Speaker / Facilitator Meeting / Tour of Workshop Rooms
If you are speaking or facilitating any of our sessions, please plan to meet with the Presentation Coordinators for last-minute instructions and a tour of the breakout rooms.
Speakers:
5:30 pm - 6:00 pm
Presentation
Welcome to the 2025 US Conference! - Sponsored by 4G Clinical
Whether this is your first or 21st US Conference, we encourage you to attend the Conference Orientation to learn how to get the most out of your conference experience.
Speakers:
6:00 pm - 8:00 pm
Networking
Meet & Greet - "Texas Road Trip"
Join us in Henry's Hollow to capture the essence of a Texan adventure at our "Texas Road Trip"! It will be a celebration of everything that makes the Lone Star State legendary, from its wide-open roads to its rich cultural heritage. Pack your bags, the Texas adventure starts here! Experience unique Texas culture with pistolero "Pistol Packing Paula", a trick roper, live music with the Chris Story Band, and much more!
Co-Sponsored by:
Co-Sponsored by:
8:00 pm - 10:00 pm
Networking
GCSG 'After Hours' - sponsored by Xerimis
Day 2 : Monday, April 28
7:30 am - 8:15 am
Conference Logistics
Exhibitor Displays Open
7:30 am - 8:15 am
Conference Logistics
Breakfast - Monday meals sponsored by Clinigen
7:30 am - 8:00 am
Conference Logistics
Registration/Information/Welcome Table Open - ALL DAY
8:15 am - 8:30 am
Conference Logistics
Transfer to Plenary Hall
8:30 am - 8:50 am
Presentation
Welcome & Opening Remarks
8:50 am - 10:00 am
Presentation
Keynote Address - Mike Massimino
Mike is a former NASA astronaut, a New York Times bestselling author, a Columbia University professor, an advisor at The Intrepid Sea, Air and Space Museum, and a television personality. You won't want to miss him!A spacewalker on the final two Hubble Space Telescope servicing missions, Mike and his crews traveled faster (Mach 26) and higher (350 miles) than any other astronauts in the 21st century while increasing the discovery capabilities of arguably the greatest scientific instrument ever built by a factor of 100.
Mike uses humor and his unique storytelling ability to inspire audiences to identify the passion in their work, to use teamwork and innovation to solve problems, to provide leadership in the face of adversity and crisis, and to never give up when pursuing a goal.
Sponsored by:
Speakers:
10:00 am - 10:15 am
Conference Logistics
Transfer to Breakouts
10:15 am - 11:15 am
Workshop
L01 - Ask the Experts: A Candid Discussion on the Challenges of Implementing an Expanded Access Program
This session will take the form of a panel-like discussion, featuring experts from across the industry. Participants will engage in candid conversation about the primary challenges in expanded access (EA): Ethics, Supply Planning and Regulatory. Real-life scenarios (failures and successes) will be shared , highlighting how these experts navigated the obstacles.
Speakers:
10:15 am - 11:15 am
Workshop
L02 - Accelerating Clinical Trials Through Effective Supply Chain Management
Clinical supply planning is the lifeblood of successful clinical supply chains. This workshop will provide tips and techniques to effectively plan for clinical supply success.
Speakers:
10:15 am - 11:15 am
Workshop
L03 - Precision Dispensing: Packaging, Labeling and Dispensing from Central Pharmacy and the Regulations Required
This workshop will discuss the challenges of specialty pharmacies and central pharmacies in clinical supply support. It will also discuss the role and responsibilities that central and specialty pharmacies have vs. standard clinical supply chains.
Speakers:
10:15 am - 11:15 am
Workshop
WS01 - Bridging the Gaps Between Clinical Operations and Clinical Supplies for Ancillary Management Forecasting and Supply Ordering
While ancillary supplies are often a study requirement, they are typically the items no one wants to manage. This workshop will dive into best sourcing strategies, who should be responsible for the ancillary supply chain, sourcing & distribution challenges and tactics to prevent shortages or Customs delays.
Speakers:
10:15 am - 11:15 am
Workshop
WS02 - Cell Gene Therapy Supply Chains - Nightmares and Solutions
This workshop is designed to share stories that people will remember. Cognitive research shows that our negativity bias allows us to remember bad things longer. Cell and gene horror stories will be shared from both the speakers as well as the attendees.
Speakers:
10:15 am - 11:15 am
Workshop
WS04 - Cross-Functional Supply Plans and Agreements
Cross-functional supply plans and agreements are an essential and collaborative endeavor that improve clinical supply chains and timelines. This workshop will discuss why cross-functional teams and agreements need to be put in place as early as possible and how team charters will ensure effective clinical supply chain management.
Speakers:
10:15 am - 11:15 am
Workshop
WS05 - Successful Vendor-Sponsor Interactions when Sourcing Comparators
This workshop will explore common mistakes in sourcing comparators and provide mitigation strategies for choosing the right comparator from the right manufacturer. The facilitators will also identify the best forms and ways to communicate between vendor and sponsor to achieve the highest level of success.
Speakers:
10:15 am - 11:15 am
Workshop
WS06 - The Complexities of Comparator Sourcing
Attendees may be familiar with comparator central sourcing, local sourcing and site sourcing strategies. All have benefits as well as risks. This workshop will provide insights into traditional comparator sourcing strategies as well as introduce some new tools and solutions developed in response to the evolving needs in our industry.
Speakers:
10:15 am - 11:15 am
Workshop
WS07 - GCSG Conference Informational Session
Is this your first time attending the Global Clinical Supplies Conference or do you just want more information about GCSG? This informal 1-hour discussion will provide you with an overview of the conference, tips for getting the most out of it while you're here and general information about GCSG. Bring your questions!
Speakers:
10:15 am - 11:15 am
Workshop
WS08 - Successful Material Movement in the Middle East and Africa Regions
Awareness of the regulatory requirements across different agencies in the Middle East and Africa (MEA) is critical for successful clinical supply distribution to clinical sites. We now have years worth of data shipping into MEA. This workshop will plumb that data to identify some of the lessons learned from it and also discuss the regulatory requirements for distribution in this region.
10:15 am - 11:15 am
Workshop
WS09 - Life of an International Shipment: An Interactive Overview
This workshop will provide the attendees with a step-by-step interactive overview of what goes into shipping clinical supplies from shipping request to site/depot delivery. Key areas of focus will be on understanding regulatory requirements, developing risk management strategies and optimizing logistics and supply chain efficiency for international shipments.
10:15 am - 11:15 am
Workshop
WS10 - The Impact of VAT and IOR in Clinical Supply
With global trials being the standard, it is incredibly important to understand the value of your clinical supplies, the impact of value-added tax (VAT) and the importance of identifying the importer of record (IOR) when planning and budgeting for your clinical trial supplies. This workshop will discuss how to recover VAT throughout the life of the clinical trial as well as what the importer of record does and key documentation necessary for successful importation.
10:15 am - 11:15 am
Workshop
WS14 - The Stages of a Clinical Trial: Considerations and Risks
Understanding the challenges and risks at every phase (stage) of our clinical supply chain is essential for success. This workshop will explore key requirements and considerations for the following stages of the clinical supply chain: pre-planning strategy, study start, maintenance and close-out. Successful execution of these elements will help ensure clinical supply chain success.
11:15 am - 11:30 am
Conference Logistics
Transfer to Breakouts
11:30 am - 12:30 pm
Workshop
L04 - Smart Packaging and e-Labeling of Investigational Medicinal Product (IMP)
Drug administration and compliance have always been challenging. With the advent of smart devices, they have become easier. This workshop will discuss new and evolving technologies to improve compliance and adherence in clinical studies and easily update clinical supply labels.
Speakers:
11:30 am - 12:30 pm
Workshop
L05 - Practical Approaches to Managing Clinical Trial Waste
This workshop will provide a better understanding of the drivers that are responsible for clinical supply waste. We will discuss approaches to measure performance, and highlight opportunities to reduce waste throughout a trial.
Speakers:
11:30 am - 12:30 pm
Workshop
L06 - Cell & Gene Therapy - Art of The Possible
We'll discuss the ‘Art Of The Possible’, and the cultivation of best practices for cell & gene therapy (CGT) product development and clinical supply distribution.
Speakers:
11:30 am - 12:30 pm
Workshop
WS03 - Challenges of Supply Management Using Supplies Sourced Internationally: A case study on an Oncology Trial
This workshop will use a case-study based on an actual clinical trial. The facilitators will focus on using EU comparators instead of US comparators, repackaging options that had to be employed, packaging quality checks to ensure GMPs and packaging design based on risk analysis.
11:30 am - 12:30 pm
Workshop
WS11 - The Asia-Pacific Region as a Destination for Clinical Trials
Developing and maintaining a robust clinical supply chain in AsiaPac doesn't have to be challenging. Planning up front for your distribution and import/export strategy can greatly increase your chances of success within the region. This workshop will discuss best practices for storage, distribution, import/export and reverse logistics in AsiaPac as well as packaging and new regulations for manufacturing.
11:30 am - 12:30 pm
Workshop
WS12 - The Art and Science of Forecasting
Forecasting and simulation are important tools used by clinical supply professionals. This workshop will explore the relationship between the tools and technology we use vs. the human concept of forecasting and planning. The facilitator will discuss finding the perfect balance between the two.
11:30 am - 12:30 pm
Workshop
WS13 - Multi-Generational Perspectives in the Clinical Supply Industry
The diversity of age and experience within the clinical supply industry is impressive. This workshop will identify different perceptions, thinking styles and priorities that will help create more cohesive and understanding multi-generational teams.
11:30 am - 12:30 pm
Workshop
WS15 - How Sponsors Can Develop a Comprehensive Organizational Approach to Interactive Response Technology (IRT)
IRT systems have been an integral part of the clinical supply chain for over 20 years. This workshop will identify different approaches to IRT within the framework of small, medium, or large biopharma organizations. Topics of consideration will include: who owns the IRT, in-house, SaaS or traditional vendor, outsourcing models using CROs, etc.
11:30 am - 12:30 pm
Workshop
WS16 - Finding the Hidden Capabilities in Interactive Response Technology (IRT) Systems
IRT systems have been in use for over 20 years yet there is still functionality that users may be unaware of that can improve their chances of clinical supply chain success. This workshop will do a deep dive into IRT capabilities beyond what most people are aware of as well as identify best practices and common struggles working with IRT systems.
11:30 am - 12:30 pm
Workshop
WS17 - Innovative Labeling Options to Overcome Regulatory Challenges within Project Timelines
Labeling is almost always a critical path element for our clinical supply timeline. This workshop will identify strategies to overcome regulatory challenges that create delays and time intensive label completion.
11:30 am - 12:30 pm
Workshop
WS18 - Global CT Labeling Requirements and Translation Best Practices
Labeling clinical supplies is complex and varies depending upon what countries we are conducting studies in. This workshop will discuss the critical labeling elements that should go on the labels for all different clinical trial materials, where it should go and how to ensure the right language is being used at the site.
11:30 am - 12:30 pm
Workshop
WS19 - Technological Advances in Patient and Site Centricity
Patient and site centricity are concepts with which many of us are now familiar, although as the concepts gain momentum so do the technologies utilized to facilitate them. This workshop will discuss the numerous technological advances in the space, their impact on the conduct of clinical trials and potential implications for clinical supplies.
11:30 am - 12:30 pm
Workshop
WS20 - Pediatric Clinical Trials and Their Clinical Supply Chain Challenges
Standard adult clinical supplies are challenging enough, adding a pediatric component to our trials and supply chain increases the complexity exponentially. This session will share best practices on supplying clinical trial material that is tailored to our youngest patients and support regulatory decision making.
12:30 pm - 1:30 pm
Conference Logistics
Lunch / Exhibitor Displays Open / Transfer to Breakouts- Sponsored by Clinigen
Grab lunch then stop in the exhibit hall to visit our vendors.
1:30 pm - 2:30 pm
Workshop
L07 - Pooled Supply, On Demand Manufacturing and Just in Time Labeling (JIT)
Clinical supply chain concepts are constantly evolving. Some more recent ideas that have been deployed are just in time labeling, on demand, and pooling of supplies. This workshop will identify the differences and advantages of all of them as well as the challenges that hinder industry wide adoption.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS21 - Engaging New Employees and Enhancing Networking Capabilities
New employees can feel lost and adrift when starting a new job/position. This workshop will explore some of the most current issues with employee disengagement and a lack of inclusiveness. Tips and techniques will be discussed on how to increase employee's level of engagement and connectivity as well as strategies to increase the value of their networks.
1:30 pm - 2:30 pm
Workshop
WS22 - Tips and Techniques to Build Leadership and Management Capabilities
Management and leadership are two very distinct functions. Although they share many similar responsibilities, and consist of working with people and influencing others to achieve goals, they are not the same thing. This workshop will provide tips and techniques for new managers to build their leadership capabilities. Another focus of the workshop will be to identify ways of working with difficult and/or challenging bosses or stakeholders.
1:30 pm - 2:30 pm
Workshop
WS23 - Essential Project Management Skills to Influence Stakeholders and Achieve Success
This workshop will focus on defining good project management for clinical supplies and the tools and techniques to ensure projects stay on time and on budget while collaborating with all key and diverse stakeholders.
1:30 pm - 2:30 pm
Workshop
WS24 - QP Declarations, Release Inputs and Timelines
QP declarations and certification and release requirements vary more than they should. This can affect timelines and stakeholder satisfaction. This workshop will discuss what is absolutely required as inputs to get QP certifications and declarations within expected timelines.
1:30 pm - 2:30 pm
Workshop
WS25 - Best Practices for Maintaining & Archiving the TMF
A Trial Master File (TMF) should be set up at the beginning of a trial. A well maintained TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the trial during the audit/inspection process. This workshop will focus on industry best practices for maintaining and archiving TMF artifacts of the clinical supply chain.
1:30 pm - 2:30 pm
Workshop
WS27 - Clinical Supply Partners and Vendor Relationships
Outsourcing the clinical supply chain is the industry standard. Understanding the value of clinical supply management using your vendor as a partner has become essential. This workshop will explore how to best utilize your vendor partner as a seamless part of your supply chain while utilizing internal and external stakeholder inputs to update and leverage your metrics.
1:30 pm - 2:30 pm
Workshop
WS28 - Brainstorming Session to Advance Clinical Trials with Robotic Process Automation (RPA), Advanced Analytics and Generative Artificial Intelligence (AI)
With the advent of artificial intelligence (AI) and AI tools, the industry has evolved to better understand and use those tools to improve the clinical supply chain. This workshop will focus on a few of these tools to demonstrate how they can be used to identify ways to increase clinical supply chain speed and efficiency.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS29 - Data Driven Decisions - Critical Thinking, Metrics
Metrics drive performance. For years we have been collecting data in support of those metrics. This workshop will explore ways that we can use that data to drive decision-making and support critical thinking skills for clinical supply chain professionals.
1:30 pm - 2:30 pm
Workshop
WS30 - Using Simulation and Artificial Intelligence (AI) to Create and Communicate Clinical Forecasts
Often, clinical supply project managers use general overages in their forecasts (ie 50%, 30%) to cover them in case of trial changes. These overages are a good thing, and are often applied based on someone's experience and intuition. What if you're new to clinical supplies, working with a new team or have to defend your overage? This workshop will help you understand how to utilize artificial intelligence to mine and manipulate Excel to give you the tools to defend and communicate your overage calculations with more confidence.
1:30 pm - 2:30 pm
Workshop
WS31 - Exploring Artificial Intelligence(AI)-Powered Predictive Analytics for Patient and Supply Chain Forecasting
This workshop will provide learners with information to build upon the current clinical supply chain forecasting trends using broader artificial intelligence (AI) applications and emerging integration techniques to further supply chain optimization, automation in trials, protocol design and more.
1:30 pm - 2:30 pm
Workshop
WS34 - Reducing the Clinical Supply Chain Carbon Footprint
We all have a responsibility to ensure future generations have a viable planet to live on. But, it's hard for employees or even individual departments to influence corporate policy. Let's discuss how we can identify the aspects of the clinical supply chain that contribute to an unacceptably large carbon footprint and ways we can reduce it.
1:30 pm - 2:30 pm
Workshop
WS38 - Enhancing The Understanding of Clinical Supply Chain Management for Radioligand Therapies
Attendees will explore the complexities of the radioligand clinical supply chain, including the pivotal role of imaging agents in radioligand therapy, how PET scans help determine patient eligibility and the specific roles that various imaging agents play in clinical studies. This workshop will provide insights into the drug product ordering process and manufacturing on a per-patient basis and demonstrate the criticality of logistics management and strategies for optimizing just-in-time delivery globally; touching on the essential quality control measures required for radioligands to ensure their safety and efficacy.
Speakers:
2:30 pm - 2:45 pm
Conference Logistics
Transfer to Plenary Hall
2:45 pm - 3:45 pm
Presentation
Plenary Session - Clinical Supply Challenges and Opportunities
This plenary session is designed to share stories that are "sticky". Cognitive research shows that our negativity bias allows us to remember bad things longer. Horror stories will be shared from both the speakers as well submissions from our members.
Speakers:
3:45 pm - 4:00 pm
Presentation
Closing Remarks and Raffle Drawings
4:00 pm - 4:30 pm
Conference Logistics
Exhibitor Displays Open
Stop by to visit our exhibitors!
4:30 pm - 5:00 pm
Conference Logistics
Load Buses for GCSG 'Night Out'
Don't forget to wear your name badge & don't be late to board the buses to Six Flags Over Texas!
5:30 pm - 8:30 pm
Networking
GCSG 'Night Out' Event - Six Flags Fiesta Texas
An evening at Six Flags Fiesta Texas promises a fun and exciting experience, with a mix of thrilling rides, games, and a vibrant park atmosphere. As the sun dips behind the Texas Hill Country and the park lights come on, it feels like you've entered a completely different world!
Co-Sponsored by:
Co-Sponsored by:
9:00 pm - 11:00 pm
Networking
GCSG 'After Hours'
Sponsored by:
Day 3 : Tuesday, April 29
7:30 am - 8:15 am
Conference Logistics
Breakfast
7:30 am - 8:15 am
Conference Logistics
Exhibitor Displays Open
7:30 am - 4:30 pm
Conference Logistics
Registration / Information Table Open
8:15 am - 8:30 am
Conference Logistics
Transfer to Plenary Hall
8:30 am - 8:45 am
Presentation
Welcome & Opening Remarks
8:45 am - 9:45 am
Presentation
Patient Testimonial; Lindsey Wahlstrom-Edwards
Lindsey Wahlstrom-Edwards has spent the past decade helping to create space for participant voices in medical research. She has supported patient engagement and recruitment for more than 200 clinical trials in her career.In 2022, Lindsey’s daughter, Rona, was diagnosed with Aplastic Anemia, a rare form of acquired bone marrow failure. Together, the two participated in four clinical trials during a three-month period. Rona died in 2023 from complications related to treatment. Lindsey’s experience as a rare caregiver led her to question much of what she thought she knew to be true about her work, and she has since begun challenging how we think about outcomes and define success in the research industry.
Lindsey is the Co-founder and Chief Momatologist for Rona’s FUN LAB (https://www.ronasfunlab.org), an organization that advocates for factoring quality of life into the treatment equation for critically ill children. Lindsey is a trained advocate for NMDB (formerly Be the Match) and helps to coordinate blood and stem cell and bone marrow donor drives. She sits on the Parent Advisory Board for the Maria Fareri Children’s Hospital.
Lindsey also leads patient engagement and strategic partnerships for Sano Genetics, and previously worked in research at Antidote Technologies, Columbia University, and Yale University. She spent the first 10 years of her career teaching individuals around the globe how to write Entertainment-Education soap operas.
Lindsey holds an MPH from Columbia University and bachelor’s degrees (BA/BS) from Boston University. She has authored several scientific and industry publications and abstracts about how we can better engage individuals in research.
Sponsored by:
Speakers:
9:45 am - 10:00 am
Conference Logistics
Transfer to Breakouts
10:00 am - 11:00 am
Workshop
L01.2 - Ask the Experts: A Candid Discussion on the Challenges of Implementing an Expanded Access Program
This session will take the form of a panel-like discussion, featuring experts from across the industry. Participants will engage in candid conversation about the primary challenges in expanded access (EA): Ethics, Supply Planning and Regulatory. Real-life scenarios (failures and successes) will be shared , highlighting how these experts navigated the obstacles.
Speakers:
10:00 am - 11:00 am
Workshop
L02.2 - Accelerating Clinical Trials Through Effective Supply Chain Management
Clinical supply planning is the lifeblood of successful clinical supply chains. This workshop will provide tips and techniques to effectively plan for clinical supply success.
Speakers:
10:00 am - 11:00 am
Workshop
L03.2 - Precision Dispensing: Packaging, Labeling and Dispensing from Central Pharmacy and the Regulations Required
This workshop will discuss the challenges of specialty pharmacies and central pharmacies in clinical supply support. It will also discuss the role and responsibilities that central and specialty pharmacies have vs. standard clinical supply chains.
Speakers:
10:00 am - 11:00 am
Workshop
WS01.2 - Bridging the Gaps Between Clinical Operations and Clinical Supplies for Ancillary Management Forecasting and Supply Ordering
While ancillary supplies are often a study requirement, they are typically the items no one wants to manage. This workshop will dive into best sourcing strategies, who should be responsible for the ancillary supply chain, sourcing & distribution challenges and tactics to prevent shortages or Customs delays.
Speakers:
10:00 am - 11:00 am
Workshop
WS02.2 - Cell Gene Therapy Supply Chains - Nightmares and Solutions
This workshop is designed to share stories that people will remember. Cognitive research shows that our negativity bias allows us to remember bad things longer. Cell and gene horror stories will be shared from both the speakers as well as the attendees.
Speakers:
10:00 am - 11:00 am
Workshop
WS03.2 - Challenges of Supply Management Using Supplies Sourced Internationally: A case study on an Oncology Trial
This workshop will use a case-study based on an actual clinical trial. The facilitators will focus on using EU comparators instead of US comparators, repackaging options that had to be employed, packaging quality checks to ensure GMPs and packaging design based on risk analysis.
10:00 am - 11:00 am
Workshop
WS04.2 - Cross-Functional Supply Plans and Agreements
Cross-functional supply plans and agreements are an essential and collaborative endeavor that improve clinical supply chains and timelines. This workshop will discuss why cross-functional teams and agreements need to be put in place as early as possible and how team charters will ensure effective clinical supply chain management.
Speakers:
10:00 am - 11:00 am
Workshop
WS09.2 - Life of an International Shipment: An Interactive Overview
This workshop will provide the attendees with a step-by-step interactive overview of what goes into shipping clinical supplies from shipping request to site/depot delivery. Key areas of focus will be on understanding regulatory requirements, developing risk management strategies and optimizing logistics and supply chain efficiency for international shipments.
10:00 am - 11:00 am
Workshop
WS32 - Common Challenges and Mitigation in Temperature Excursion Management
Temperature excursions happen with our clinical supplies more often than we would like to admit. This session will discuss the most common challenges in ensuring the temperature integrity of our products, the biggest reasons these excursions occur and ways we can assess the risk of these excursions and mitigate them effectively.
10:00 am - 11:00 am
Workshop
WS33 - Increasing Clinical Supplies Engagement in the Clinical Trial Protocol Design Process
This workshop focuses on the importance of early engagement and information gathering between the sponsor, CRO and clinical supplies stakeholders to strengthen study designs and optimize clinical supplies execution.
10:00 am - 11:00 am
Workshop
WS35 - Supply Constraints: Tips, Techniques, Risk Assessment and Mitigation Planning
This session focuses on strategies that build understanding of risk assessment within clinical supplies. The focus will include tools, processes and techniques to develop a robust risk management plan to identify and mitigate risk for successful clinical supply outcomes.
10:00 am - 11:00 am
Workshop
WS36 - Enhancing Communication Between Clinical Operations and Clinical Supplies: Cross Functional Collaboration for Optimizing Operational Efficiencies
The relationship between Clinical Operations and Clinical Supplies is too important to have issues with communication or collaboration. This workshop will explore ways to improve efficiency by enhancing the relationship and communication between Clinical Operations, Clinical Supplies and any other cross-functional stakeholders.
10:00 am - 11:00 am
Workshop
WS37 - Packaging for Advanced Drug Delivery Devices
This workshop will explore how to pair the best packaging strategy with new delivery device drug combinations. Traditionally, these devices can be large and bulky and choosing the right packaging and labeling will have a very positive effect on clinical trial compliance.
11:00 am - 11:15 am
Conference Logistics
Transfer to Breakouts
11:15 am - 12:15 pm
Workshop
L04.2 - Smart Packaging and e-Labeling of Investigational Medicinal Product (IMP)
Drug administration and compliance have always been challenging. With the advent of smart devices, they have become easier. This workshop will discuss new and evolving technologies to improve compliance and adherence in clinical studies and easily update clinical supply labels.
Speakers:
11:15 am - 12:15 pm
Workshop
L05.2 - Practical Approaches to Managing Clinical Trial Waste
This workshop will provide a better understanding of the drivers that are responsible for clinical supply waste. We will discuss approaches to measure performance, and highlight opportunities to reduce waste throughout a trial.
Speakers:
11:15 am - 12:15 pm
Workshop
L06.2 - Cell & Gene Therapy - Art of The Possible
We'll discuss the ‘Art Of The Possible’, and the cultivation of best practices for cell & gene therapy (CGT) product development and clinical supply distribution.
Speakers:
11:15 am - 12:15 pm
Workshop
WS05.2 - Successful Vendor-Sponsor Interactions when Sourcing Comparators
This workshop will explore common mistakes in sourcing comparators and provide mitigation strategies for choosing the right comparator from the right manufacturer. The facilitators will also identify the best forms and ways to communicate between vendor and sponsor to achieve the highest level of success.
Speakers:
11:15 am - 12:15 pm
Workshop
WS06.2 - The Complexities of Comparator Sourcing
Attendees may be familiar with comparator central sourcing, local sourcing and site sourcing strategies. All have benefits as well as risks. This workshop will provide insights into traditional comparator sourcing strategies as well as introduce some new tools and solutions developed in response to the evolving needs in our industry.
Speakers:
11:15 am - 12:15 pm
Workshop
WS08.2 - Successful Material Movement in the Middle East and Africa Regions
Awareness of the regulatory requirements across different agencies in the Middle East and Africa (MEA) is critical for successful clinical supply distribution to clinical sites. We now have years worth of data shipping into MEA. This workshop will plumb that data to identify some of the lessons learned from it and also discuss the regulatory requirements for distribution in this region.
11:15 am - 12:15 pm
Workshop
WS10.2 - The Impact of VAT and IOR in Clinical Supply
With global trials being the standard, it is incredibly important to understand the value of your clinical supplies, the impact of value-added tax (VAT) and the importance of identifying the importer of record (IOR) when planning and budgeting for your clinical trial supplies. This workshop will discuss how to recover VAT throughout the life of the clinical trial as well as what the importer of record does and key documentation necessary for successful importation.
11:15 am - 12:15 pm
Workshop
WS11.2 - The Asia-Pacific Region as a Destination for Clinical Trials
Developing and maintaining a robust clinical supply chain in AsiaPac doesn't have to be challenging. Planning up front for your distribution and import/export strategy can greatly increase your chances of success within the region. This workshop will discuss best practices for storage, distribution, import/export and reverse logistics in AsiaPac as well as packaging and new regulations for manufacturing.
11:15 am - 12:15 pm
Workshop
WS12.2 - The Art and Science of Forecasting
Forecasting and simulation are important tools used by clinical supply professionals. This workshop will explore the relationship between the tools and technology we use vs. the human concept of forecasting and planning. The facilitator will discuss finding the perfect balance between the two.
11:15 am - 12:15 pm
Workshop
WS13.2 - Multi-Generational Perspectives in the Clinical Supply Industry
The diversity of age and experience within the clinical supply industry is impressive. This workshop will identify different perceptions, thinking styles and priorities that will help create more cohesive and understanding multi-generational teams.
11:15 am - 12:15 pm
Workshop
WS14.2 - The Stages of a Clinical Trial: Considerations and Risks
Understanding the challenges and risks at every phase (stage) of our clinical supply chain is essential for success. This workshop will explore key requirements and considerations for the following stages of the clinical supply chain: pre-planning strategy, study start, maintenance and close-out. Successful execution of these elements will help ensure clinical supply chain success.
11:15 am - 12:15 pm
Workshop
WS15.2 - How Sponsors Can Develop a Comprehensive Organizational Approach to Interactive Response Technology (IRT)
IRT systems have been an integral part of the clinical supply chain for over 20 years. This workshop will identify different approaches to IRT within the framework of small, medium, or large biopharma organizations. Topics of consideration will include: who owns the IRT, in-house, SaaS or traditional vendor, outsourcing models using CROs, etc.
11:15 am - 12:15 pm
Workshop
WS17.2 - Innovative Labeling Options to Overcome Regulatory Challenges within Project Timelines
Labeling is almost always a critical path element for our clinical supply timeline. This workshop will identify strategies to overcome regulatory challenges that create delays and time intensive label completion.
12:15 pm - 1:30 pm
Conference Logistics
Lunch / Exhibitor Displays Open / Transfer to Vendor Showcase
Grab lunch then stop in the exhibit hall to visit our vendors.
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Innovating in Forecasting & Planning – Deep Dive into a Freshly Released Planning Platform - Hosted by N-SIDE
Presented by: Maxime Derep, Director, Solutions Engineering at N-SIDE & Antoine Remiot, Senior Director - Global Business Development & Partnerships
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Maximizing Environmental and Cost Benefits Through End-to-End Asset Management - Hosted by DHL Supply Chain
Case Study from DHL Health Logistics EU Operations
Presented by: Richard Tencer - Head of Global Clinical Operations Development, DHL Health Logistics & Aiden Smith - Director, Global Business Development – Clinical Logistics, DHL Health Logistics
- How does end-to-end reusable thermal packaging reduce the environmental footprint across 5 key supply chain steps, from manufacturing to reuse and end of life?
- What is the impact of return logistics on both cost & environmental footprint in our asset management model?
- Workshop activity: How can these benefits be scaled & replicated across major regions, operations or other reusable assets?
Presented by: Richard Tencer - Head of Global Clinical Operations Development, DHL Health Logistics & Aiden Smith - Director, Global Business Development – Clinical Logistics, DHL Health Logistics
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Precision Logistics Showcase: A Jeopardy-Style Game on the Future of Healthcare Supply Chains - Hosted by Marken
Join us for an interactive, Jeopardy-style game where we’ll dive into the critical role of precision logistics in the advanced therapies journey. From production to patient delivery, discover how cutting-edge technology, data-driven insights, and an agile supply chain ensure every step is seamlessly coordinated. Test your knowledge and gain valuable insights into the future of healthcare logistics!
Presented by: Mark Newman, Sr. Director, Business Development & Abigail French, Sr. Director, Business Development
Presented by: Mark Newman, Sr. Director, Business Development & Abigail French, Sr. Director, Business Development
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - The Art of Optimization: Balancing Flexibility and Control in Clinical Supply - Hosted by Endpoint Clinical
Clinical trial logistics are an art—and a science. In this interactive session, we’ll build a trial live using Elosity, Endpoint Clinical’s next-generation RTSM platform. Together, we’ll navigate real-world supply chain challenges—like unexpected enrollment spikes or mid-trial adjustments—while exploring strategies to balance flexibility and control. Gain practical insights and tools to optimize clinical supplies and drive trial success.
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - The Future of Clinical Supply Chain: Leveraging AI, Automation, and Business Data Cloud for Real-Time Optimization - Hosted by SAP
Explore the transformation of clinical supply chains through AI, automation, and real-time analytics. Cutting-edge technologies are driving agility, efficiency, and compliance in an increasingly complex business and IT landscape.
Presented by: Mike Wheeler - Director, Life sciences solutions & Aparna Seksaria - Director, Life sciences solutions
Join the session and learn how to:
🔹 Harness AI and automation to optimize clinical supply management
🔹 Leverage real-time analytics for demand forecasting and inventory control
🔹 Ensure compliance, security, and traceability with digitalized supply chains
🔹 Gain insights from real-world case studies and best practices
Presented by: Mike Wheeler - Director, Life sciences solutions & Aparna Seksaria - Director, Life sciences solutions
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Trial and Error: How to Cut Costs (Without Cutting Corners) in Clinical Supply - Hosted by Clinigen
This interactive workshop explores approaches to reduce costs in clinical trial supply chains without compromising quality, data integrity or timelines. Join us to discuss actionable strategies to enhance financial efficiency and ensure the success of clinical trials.
Presented by:
Melissa Wallace, Vice President of Business Development, Clinical Supplies Management
Alex Chittim, Vice President of Strategic Accounts and Business Development, Clinical Trial Sourcing
Lisa McConnell, US Director of Project Management
Presented by:
Melissa Wallace, Vice President of Business Development, Clinical Supplies Management
Alex Chittim, Vice President of Strategic Accounts and Business Development, Clinical Trial Sourcing
Lisa McConnell, US Director of Project Management
2:30 pm - 2:45 pm
Conference Logistics
Transfer to Plenary Hall
2:45 pm - 3:45 pm
Presentation
Plenary Session - How Clinical Trial Supplies Can Help Close the Healthcare Gap
According to the World Health Organization, at least half of the world's population still lacks full coverage of essential health services. Until now, the current industry standard is to have clinical trial sites destroy any unused supplies after the completion of a trial. The destruction of medical and lab supplies is wasteful and can be burdensome and costly. Some organizations have recognized this problem and have developed innovative solutions to repurpose clinical trial supplies for global health. They work with pharmaceutical companies, research institutions, and local partners to collect, sort, and distribute the surplus supplies to low- and middle-income countries, where they can make a difference in improving health outcomes and saving lives.
Speakers:
3:45 pm - 4:00 pm
Presentation
Closing Remarks and Raffle Drawings
4:00 pm - 6:00 pm
Networking
Vendor reception / Exhibitor Displays Open
9:00 pm - 11:00 pm
Networking
GCSG 'After Hours'
Day 4 : Wednesday, April 30
7:30 am - 8:45 am
Break
Breakfast
7:30 am - 8:45 am
Conference Logistics
Exhibitor Displays Open
7:30 am - 2:30 pm
Conference Logistics
Registration / Information Table Open
9:00 am - 9:30 am
Presentation
Welcome & Opening Remarks
9:30 am - 10:30 am
Presentation
Plenary Session - Update on Assessing Patient and Site Receptivity in Direct-to-Patient Clinical Supply Solutions
GCSG sponsored a study on Assessing Patient and Site Receptivity in Direct-to-Patient Clinical Supply Solutions which was conducted by the Tufts Center for the Study of Drug Development. We are pleased to share that the initial analysis of the patient perspectives is complete, and overall, patients have very positive views of Direct-to-Patient delivery of investigational product. The study has also identified opportunities to improve the patient experience. We are looking forward to the results of the site perspectives and sharing the full results of the study with the GCSG community in early 2025.
10:30 am - 10:45 am
Conference Logistics
Transfer to Breakouts
10:45 am - 11:45 am
Workshop
L07.2 - Pooled Supply, On Demand Manufacturing and Just in Time Labeling (JIT)
Clinical supply chain concepts are constantly evolving. Some more recent ideas that have been deployed are just in time labeling, on demand, and pooling of supplies. This workshop will identify the differences and advantages of all of them as well as the challenges that hinder industry wide adoption.
Speakers:
10:45 am - 11:45 am
Workshop
WS16.2 - Finding the Hidden Capabilities in Interactive Response Technology (IRT) Systems
IRT systems have been in use for over 20 years yet there is still functionality that users may be unaware of that can improve their chances of clinical supply chain success. This workshop will do a deep dive into IRT capabilities beyond what most people are aware of as well as identify best practices and common struggles working with IRT systems.
10:45 am - 11:45 am
Workshop
WS18.2 - Global CT Labeling Requirements and Translation Best Practices
Labeling clinical supplies is complex and varies depending upon what countries we are conducting studies in. This workshop will discuss the critical labeling elements that should go on the labels for all different clinical trial materials, where it should go and how to ensure the right language is being used at the site.
10:45 am - 11:45 am
Workshop
WS19.2 - Technological Advances in Patient and Site Centricity
Patient and site centricity are concepts with which many of us are now familiar, although as the concepts gain momentum so do the technologies utilized to facilitate them. This workshop will discuss the numerous technological advances in the space, their impact on the conduct of clinical trials and potential implications for clinical supplies.
10:45 am - 11:45 am
Workshop
WS20.2 - Pediatric Clinical Trials and Their Clinical Supply Chain Challenges
Standard adult clinical supplies are challenging enough, adding a pediatric component to our trials and supply chain increases the complexity exponentially. This session will share best practices on supplying clinical trial material that is tailored to our youngest patients and support regulatory decision making.
10:45 am - 11:45 am
Workshop
WS21.2 - Engaging New Employees and Enhancing Networking Capabilities
New employees can feel lost and adrift when starting a new job/position. This workshop will explore some of the most current issues with employee disengagement and a lack of inclusiveness. Tips and techniques on how to increase employee's level of engagement and connectivity as well as strategies to increase the value of their networks will be discussed.
10:45 am - 11:45 am
Workshop
WS22.2 - Tips and Techniques to Build Leadership and Management Capabilities
Management and leadership are two very distinct functions. Although they share many similar responsibilities, and consist of working with people and influencing others to achieve goals, they are not the same thing. This workshop will provide tips and techniques for new managers to build their leadership capabilities. Another focus of the workshop will be to identify ways of working with difficult and/or challenging bosses or stakeholders.
10:45 am - 11:45 am
Workshop
WS23.2 - Essential Project Management Skills to Influence Stakeholders and Achieve Success
This workshop will focus on defining good project management for clinical supplies and the tools and techniques to ensure projects stay on time and on budget while collaborating with all key and diverse stakeholders.
10:45 am - 11:45 am
Workshop
WS24.2 - QP Declarations, Release Inputs and Timelines
QP declarations and certification and release requirements vary more than they should. This can affect timelines and stakeholder satisfaction. This workshop will discuss what is absolutely required as inputs to get QP certifications and declarations within expected timelines.
10:45 am - 11:45 am
Workshop
WS25.2 - Best Practices for Maintaining & Archiving the TMF
A Trial Master File (TMF) should be set up at the beginning of a trial. A well maintained TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the trial during the audit/inspection process. This workshop will focus on industry best practices for maintaining and archiving TMF artifacts of the clinical supply chain.
10:45 am - 11:45 am
Workshop
WS29.2 - Data Driven Decisions - Critical Thinking, Metrics
Metrics drive performance. For years we have been collecting data in support of those metrics. This workshop will explore ways that we can use that data to drive decision-making and support critical thinking skills for clinical supply chain professionals.
10:45 am - 11:45 am
Workshop
WS31.2 - Exploring Artificial Intelligence(AI)-Powered Predictive Analytics for Patient and Supply Chain Forecasting
This workshop will provide learners with information to build upon the current clinical supply chain forecasting trends using broader artificial intelligence (AI) applications and emerging integration techniques to further supply chain optimization, automation in trials, protocol design and more.
10:45 am - 11:45 am
Workshop
WS34.2 - Reducing the Clinical Supply Chain Carbon Footprint
We all have a responsibility to ensure future generations have a viable planet to live on. But, it's hard for employees or even individual departments to influence corporate policy. Let's discuss how we can identify the aspects of the clinical supply chain that contribute to an unacceptably large carbon footprint and ways we can reduce it.
11:45 am - 1:00 pm
Conference Logistics
Lunch and Puppy Party / Transfer to Breakouts
Puppy Party sponsored by:
1:00 pm - 4:00 pm
Conference Logistics
Exhibitor Displays Tear Down
1:00 pm - 2:00 pm
Workshop
WS27.2 - Clinical Supply Partners and Vendor Relationships
Outsourcing the clinical supply chain is the industry standard. Understanding the value of clinical supply management using your vendor as a partner has become essential. This workshop will explore how to best utilize your vendor partner as a seamless part of your supply chain while utilizing internal and external stakeholder inputs to update and leverage your metrics.
1:00 pm - 2:00 pm
Workshop
WS28.2 - Brainstorming Session to Advance Clinical Trials with Robotic Process Automation (RPA), Advanced Analytics and Generative Artificial Intelligence (AI)
With the advent of artificial intelligence (AI) and AI tools, the industry has evolved to better understand and use those tools to improve the clinical supply chain. This workshop will focus on a few of these tools to demonstrate how they can be used to identify ways to increase clinical supply chain speed and efficiency.
Speakers:
1:00 pm - 2:00 pm
Workshop
WS30.2 - Using Simulation and Artificial Intelligence (AI) to Create and Communicate Clinical Forecasts
Often, clinical supply project managers use general overages in their forecasts (ie 50%, 30%) to cover them in case of trial changes. These overages are a good thing, and are often applied based on someone's experience and intuition. What if you're new to clinical supplies, working with a new team or have to defend your overage? This workshop will help you understand how to utilize artificial intelligence to mine and manipulate Excel to give you the tools to defend and communicate your overage calculations with more confidence.
1:00 pm - 2:00 pm
Workshop
WS32.2 - Common Challenges and Mitigation in Temperature Excursion Management
Temperature excursions happen with our clinical supplies more often than we would like to admit. This session will discuss the most common challenges in ensuring the temperature integrity of our products, the biggest reasons these excursions occur and ways we can assess the risk of these excursions and mitigate them effectively.
1:00 pm - 2:00 pm
Workshop
WS33.2 - Increasing Clinical Supplies Engagement in the Clinical Trial Protocol Design Process
This workshop focuses on the importance of early engagement and information gathering between the sponsor, CRO and clinical supplies stakeholders to strengthen study designs and optimize clinical supplies execution.
1:00 pm - 2:00 pm
Workshop
WS35.2 - Supply Constraints: Tips, Techniques, Risk Assessment and Mitigation Planning
This session focuses on strategies that build understanding of risk assessment within clinical supplies. The focus will include tools, processes and techniques to develop a robust risk management plan to identify and mitigate risk for successful clinical supply outcomes.
1:00 pm - 2:00 pm
Workshop
WS36.2 - Enhancing Communication Between Clinical Operations and Clinical Supplies: Cross Functional Collaboration for Optimizing Operational Efficiencies
The relationship between Clinical Operations and Clinical Supplies is too important to have issues with communication or collaboration. This workshop will explore ways to improve efficiency by enhancing the relationship and communication between Clinical Operations, Clinical Supplies and any other cross-functional stakeholders.
1:00 pm - 2:00 pm
Workshop
WS37.2 - Packaging for Advanced Drug Delivery Devices
This workshop will explore how to pair the best packaging strategy with new delivery device drug combinations. Traditionally, these devices can be large and bulky and choosing the right packaging and labeling will have a very positive effect on clinical trial compliance.
1:00 pm - 2:00 pm
Workshop
WS38.2 - Enhancing The Understanding of Clinical Supply Chain Management for Radioligand Therapies
Attendees will explore the complexities of the radioligand clinical supply chain, including the pivotal role of imaging agents in radioligand therapy, how PET scans help determine patient eligibility and the specific roles that various imaging agents play in clinical studies. This workshop will provide insights into the drug product ordering process and manufacturing on a per-patient basis and demonstrate the criticality of logistics management and strategies for optimizing just-in-time delivery globally; touching on the essential quality control measures required for radioligands to ensure their safety and efficacy.
Speakers:
2:00 pm - 2:15 pm
Conference Logistics
Transfer to Plenary Hall
2:15 pm - 3:15 pm
Presentation
Plenary Session - Innovative Approaches to Clinical Trial Supply Chain using AI and Machine Learning
AI tools are now being deployed within the clinical supply chain. This plenary session will review and discuss different ways AI is being used throughout the clinical supply chain process. Focus will be on the following clinical supply chain segments: Forecasting, shipping & distribution, risk analysis and mitigation, inventory management, quality assurance and communication
Speakers:
3:15 pm - 3:45 pm
Conference Logistics
