GCSG 2025 European Knowledge Forum: Program

What’s the measurable value of working with a single partner across clinical development and manufacturing? In this session, the Tufts Center for the Study of Drug Development shares the results of a new independent study that applies expected Net Present Value (eNPV) modeling to quantify the financial and operational impact of integrating CDMO, CRO, and clinical supply services under one provider. Using Thermo Fisher’s Accelerator™ Drug Development framework as a reference model, the analysis accounts for risk-adjusted progression and real-world complexity. Following the data walkthrough, Luke Wilson, senior director of biotech commercial operations at Thermo Fisher, will share stakeholder perspectives and case examples illustrating how integrated support—particularly at the intersection of clinical operations and supply—can streamline execution, accelerate timelines, and drive stronger ROI across development programs.

Presented by: Luke Wilson, Sr. Director Commercial Operations, Thermo Fisher Scientific, Global Biotech & Ken Getz, Executive Director, Research Professor, Tufts Center of the Study of Drug Development

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.

Speaker:

Melissa Wallace, Vice President of Business Development, Clinical Supplies Management & Melany Pierard, Project Manager, Team Lead

This workshop will provide participants with a clear understanding of how to build successful, regulatory compliant import/export practices for clinical supplies. Attendees will also gain practical insights into Value Added Tax (VAT) procedures, customs compliance, and required documentation to recover VAT outlays and increase cost efficiency.

During this workshop the facilitators will focus on equipping participants with key techniques to effectively manage stakeholder relationships and drive successful project outcomes. Attendees will learn strategies for clear communication, stakeholder engagement, negotiation and conflict resolution. Through practical examples and interactive exercises, this session will empower project managers to lead confidently, navigate complex stakeholder dynamics and achieve organizational objectives efficiently.

During this workshop the focus will be on key challenges related to inventory management, focusing on reducing waste and optimizing safety stock levels in clinical supply chains. Participants will explore effective methods for accurately measuring stock wastage, identifying root causes, and establishing strategies to minimize excess inventory without compromising patient safety. Practical case studies and interactive discussions will provide actionable insights for enhancing supply chain efficiency, sustainability, and cost-effectiveness.

This workshop will delve into the transformative power of artificial intelligence (AI) in clinical trials. Participants will explore how AI can revolutionize the design, execution, and analysis of clinical trials. The session aims to provide attendees with a comprehensive understanding of AI technologies and their applications in the clinical trial landscape. In this workshop we will share insights on integrating AI into clinical workflows, overcoming challenges, and maximizing the benefits of AI-driven approaches.

This workshop will require active participation from attendees and will use a gamified approach to explore different comparator sourcing strategies used in clinical trials.

Participants will gain insights into selecting the most appropriate sourcing method based on trial complexity, geographic considerations, regulatory requirements, risk management and costs efficiency.

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.

This workshop will offer critical insights into the effective preparation and submission of CTAs. Participants will gain a clear understanding of regulatory requirements, essential documentation, common pitfalls, and best practices to ensure successful submissions. Through real-world examples and expert guidance, attendees will learn practical approaches for streamlining the CTA process, minimizing delays, and increasing the likelihood of timely regulatory approval.

This workshop will explore the unique complexities and regulatory considerations involved in managing supply chains for radiopharmaceutical products. Participants will gain insights into the specialized logistics, handling, storage requirements and compliance challenges that must be considered when working with radiopharmaceutical clinical supplies. Through real-world scenarios and expert-led discussions, attendees will develop strategies to optimize supply chain efficiency, maintain product integrity and ensure timely delivery within stringent regulatory frameworks and intensely short timelines.

This workshop will focus on the essential aspects of outsourcing and collaborating with Clinical Trial Supply (CTS) suppliers. Participants will explore the best practices for establishing strong vendor relationships, implementing effective standardization, and ensuring successful and timely outsourcing. The session aims to provide attendees with the strategies and tools necessary to enhance their vendor management and relationships while streamlining their clinical supply chain processes.

This workshop will explore the unique challenges and opportunities faced by the clinical supply chain in the Middle East and Africa regions. It will cover various aspects such as regulatory hurdles, logistical complexities and market dynamics. The session aims to equip participants with the insights and strategies needed to navigate these challenges effectively and leverage the opportunities for growth, while enrolling diverse and underserved populations in these regions.

This workshop, "Patient Diversity and Reaching All Patients," explores strategies to enhance healthcare access and communication among diverse patient populations. Participants will examine cultural competence, inclusivity in healthcare services, and barriers faced by underrepresented groups. The session will also provide practical tools to create patient-centric practices and equitable healthcare environments, emphasizing the value of understanding diverse patient needs to ensure quality care.

The workshop will highlight innovative digital approaches to enhance medication adherence, patient engagement and compliance during clinical trials. Participants will explore technological solutions and user-friendly digital tools designed to empower patients and boost compliance. Case studies and best practices will demonstrate how patient-centric digital supply chains can drive better study outcomes, approval speed and market adoption.

This workshop will address the complexities of managing organizational changes while maintaining an efficient clinical supply chain. Participants will explore effective communication strategies, risk mitigation techniques and continuity planning to maintain operational stability during mergers, acquisitions, or internal restructuring. Through interactive discussions and real-world scenarios, attendees will learn practical methods to ensure seamless transitions, safeguard supply integrity and maintain regulatory compliance throughout periods of organizational change.

Practical approaches to prevent, identify, and effectively manage temperature deviations in clinical trial logistics will be the focus of this workshiop. Attendees will learn how temperature excursions (TEs) impact product integrity, regulatory compliance and overall trial outcomes. The session emphasizes proactive planning, automating your processes, real-time monitoring, corrective actions and documentation practices to provide participants with actionable strategies and solutions to safeguard sensitive pharmaceutical products while shortening TE handling timelines.

This workshop will concentrate on the importance of incorporating sustainable practices within clinical supply chain management. Participants will explore strategies to reduce environmental impact, manage waste efficiently and optimize resource use throughout the clinical trial lifecycle. Through the latest practical examples and interactive discussions, attendees will learn to align operational efficiency with sustainability goals, meeting both regulatory requirements and ethical responsibilities.

This workshop will provide an in-depth understanding of the critical components and best practices for creating effective supply planning agreements between clinical supplies, clinical teams and vendors. Participants will explore the importance of setting expectations, collaboration, strategic planning and communication to ensure the seamless delivery of clinical supplies. The workshop will cover various aspects such as inventory management, regulatory compliance and the roles and responsibilities of each stakeholder involved.

Clinical supply planning is a challenging activity, made so by trial complexities, the low amount of information available, uncertainties and the timing. In this Session, learn what kind of technology can support : 

• Long-range (high-level) demand forecast for production planning
• Straightforward clinical supply forecasting
• Ongoing trial monitoring and adaptation of supply planning
• Simulation of complex trials 
• Risk monitoring and mitigation  

This workshop, "Patient Diversity and Reaching All Patients," explores strategies to enhance healthcare access and communication among diverse patient populations. Participants will examine cultural competence, inclusivity in healthcare services, and barriers faced by underrepresented groups. The session will also provide practical tools to create patient-centric practices and equitable healthcare environments, emphasizing the value of understanding diverse patient needs to ensure quality care.

The workshop will highlight innovative digital approaches to enhance medication adherence, patient engagement and compliance during clinical trials. Participants will explore technological solutions and user-friendly digital tools designed to empower patients and boost compliance. Case studies and best practices will demonstrate how patient-centric digital supply chains can drive better study outcomes, approval speed and market adoption.

This workshop will address the complexities of managing organizational changes while maintaining an efficient clinical supply chain. Participants will explore effective communication strategies, risk mitigation techniques and continuity planning to maintain operational stability during mergers, acquisitions, or internal restructuring. Through interactive discussions and real-world scenarios, attendees will learn practical methods to ensure seamless transitions, safeguard supply integrity and maintain regulatory compliance throughout periods of organizational change.

Practical approaches to prevent, identify, and effectively manage temperature deviations in clinical trial logistics will be the focus of this workshiop. Attendees will learn how temperature excursions (TEs) impact product integrity, regulatory compliance and overall trial outcomes. The session emphasizes proactive planning, automating your processes, real-time monitoring, corrective actions and documentation practices to provide participants with actionable strategies and solutions to safeguard sensitive pharmaceutical products while shortening TE handling timelines.

This workshop will concentrate on the importance of incorporating sustainable practices within clinical supply chain management. Participants will explore strategies to reduce environmental impact, manage waste efficiently and optimize resource use throughout the clinical trial lifecycle. Through the latest practical examples and interactive discussions, attendees will learn to align operational efficiency with sustainability goals, meeting both regulatory requirements and ethical responsibilities.

This workshop will provide an in-depth understanding of the critical components and best practices for creating effective supply planning agreements between clinical supplies, clinical teams and vendors. Participants will explore the importance of setting expectations, collaboration, strategic planning and communication to ensure the seamless delivery of clinical supplies. The workshop will cover various aspects such as inventory management, regulatory compliance and the roles and responsibilities of each stakeholder involved.

This workshop will require active participation from attendees and will use a gamified approach to explore different comparator sourcing strategies used in clinical trials.

Participants will gain insights into selecting the most appropriate sourcing method based on trial complexity, geographic considerations, regulatory requirements, risk management and costs efficiency.

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.

This workshop will offer critical insights into the effective preparation and submission of CTAs. Participants will gain a clear understanding of regulatory requirements, essential documentation, common pitfalls, and best practices to ensure successful submissions. Through real-world examples and expert guidance, attendees will learn practical approaches for streamlining the CTA process, minimizing delays, and increasing the likelihood of timely regulatory approval.

This workshop will explore the unique complexities and regulatory considerations involved in managing supply chains for radiopharmaceutical products. Participants will gain insights into the specialized logistics, handling, storage requirements and compliance challenges that must be considered when working with radiopharmaceutical clinical supplies. Through real-world scenarios and expert-led discussions, attendees will develop strategies to optimize supply chain efficiency, maintain product integrity and ensure timely delivery within stringent regulatory frameworks and intensely short timelines.

This workshop will focus on the essential aspects of outsourcing and collaborating with Clinical Trial Supply (CTS) suppliers. Participants will explore the best practices for establishing strong vendor relationships, implementing effective standardization, and ensuring successful and timely outsourcing. The session aims to provide attendees with the strategies and tools necessary to enhance their vendor management and relationships while streamlining their clinical supply chain processes.

This workshop will explore the unique challenges and opportunities faced by the clinical supply chain in the Middle East and Africa regions. It will cover various aspects such as regulatory hurdles, logistical complexities and market dynamics. The session aims to equip participants with the insights and strategies needed to navigate these challenges effectively and leverage the opportunities for growth, while enrolling diverse and underserved populations in these regions.

This workshop will provide participants with a clear understanding of how to build successful, regulatory compliant import/export practices for clinical supplies. Attendees will also gain practical insights into Value Added Tax (VAT) procedures, customs compliance, and required documentation to recover VAT outlays and increase cost efficiency.

During this workshop the facilitators will focus on equipping participants with key techniques to effectively manage stakeholder relationships and drive successful project outcomes. Attendees will learn strategies for clear communication, stakeholder engagement, negotiation and conflict resolution. Through practical examples and interactive exercises, this session will empower project managers to lead confidently, navigate complex stakeholder dynamics and achieve organizational objectives efficiently.

During this workshop the focus will be on key challenges related to inventory management, focusing on reducing waste and optimizing safety stock levels in clinical supply chains. Participants will explore effective methods for accurately measuring stock wastage, identifying root causes, and establishing strategies to minimize excess inventory without compromising patient safety. Practical case studies and interactive discussions will provide actionable insights for enhancing supply chain efficiency, sustainability, and cost-effectiveness.

This workshop will delve into the transformative power of artificial intelligence (AI) in clinical trials. Participants will explore how AI can revolutionize the design, execution, and analysis of clinical trials. The session aims to provide attendees with a comprehensive understanding of AI technologies and their applications in the clinical trial landscape. In this workshop we will share insights on integrating AI into clinical workflows, overcoming challenges, and maximizing the benefits of AI-driven approaches.