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

Former Royal Air Force Combat Helicopter Pilot, Executive Coach & Mindfulness Expert.

Sarah became the first female RAF helicopter pilot to fly and lead UK Special Forces missions in Iraq, she is a qualified mindfulness coach, cognitive behavioural therapist, and human factors facilitator, and uses stories from her action-packed career of service to share lessons on leadership, resilience, overcoming adversity, and peak performance. Sarah is the no. 1 bestselling author of two books: Fly Higher: Train Your Mind to Feel as Strong as You Look and The Uni-tasking Revolution; Focus on what really matters, get stuff down, waste less time

Gain an understanding of CGT supply chains, explore the key stakeholders and considerations, and learn best practices to manage complex processes effectively.

This session will provide valuable insights into the challenges and strategies for effective management, ensuring efficient and streamlined operations, and is ideal for professionals looking to enhance their knowledge and skills in this rapidly evolving fielThis workshop, "Import/Export and VAT," provides participants with essential knowledge regarding Value Added Tax (VAT) implications and regulations in international trade.

Attendees will gain practical insights into VAT procedures, customs compliance, and accurate documentation required for successful importing and exporting activities. The session will also explore common challenges, helping businesses optimize VAT management to ensure regulatory compliance and cost efficiency.d

Gain an understanding of CGT supply chains, explore the key stakeholders and considerations, and learn best practices to manage complex processes effectively.

This session will provide valuable insights into the challenges and strategies for effective management, ensuring efficient and streamlined operations, and is ideal for professionals looking to enhance their knowledge and skills in this rapidly evolving fielThis workshop, "Import/Export and VAT," provides participants with essential knowledge regarding Value Added Tax (VAT) implications and regulations in international trade.

Attendees will gain practical insights into VAT procedures, customs compliance, and accurate documentation required for successful importing and exporting activities. The session will also explore common challenges, helping businesses optimize VAT management to ensure regulatory compliance and cost efficiency.dThis workshop, "Material Pooling, JIT Labelling, and On-Demand Manufacturing (Master Protocols and Adaptive Designs)," addresses innovative strategies for efficient clinical trial supply chain management. Participants will learn how to leverage material pooling, just-in-time (JIT) labeling, and adaptive manufacturing methods to support master protocol studies and adaptive trial designs. The session emphasizes flexibility, cost reduction, and responsiveness to trial changes, enhancing the ability to quickly adapt to evolving clinical study requirements.

This workshop, "Cost of Poor Quality and Lack of Regulatory Focus (Impact on the Clinical Trial Supply Chain)," highlights the significant risks and costs associated with inadequate quality control and regulatory oversight in clinical trials. Participants will explore real-world consequences, including delayed timelines, regulatory non-compliance, financial losses, and compromised patient safety. The session provides actionable insights and strategies to proactively identify, address, and prevent quality and compliance issues within the clinical trial supply chain.Gain an understanding of CGT supply chains, explore the key stakeholders and considerations, and learn best practices to manage complex processes effectively.

This session will provide valuable insights into the challenges and strategies for effective management, ensuring efficient and streamlined operations, and is ideal for professionals looking to enhance their knowledge and skills in this rapidly evolving fielThis workshop, "Import/Export and VAT," provides participants with essential knowledge regarding Value Added Tax (VAT) implications and regulations in international trade.

Attendees will gain practical insights into VAT procedures, customs compliance, and accurate documentation required for successful importing and exporting activities. The session will also explore common challenges, helping businesses optimize VAT management to ensure regulatory compliance and 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.

The workshop "Wastage and Safety Stocks – Measuring, Managing, and Improving" addresses 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 delves into the transformative power of artificial intelligence 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.s 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 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 cost 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.

The workshop "Supply Chains of Radiopharmaceuticals" explores 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 specific to radiopharmaceuticals. 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.

This workshop focuses 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 outsourcing. The session aims to provide attendees with the strategies and tools necessary to enhance their vendor management and streamline 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 and improvement 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, "How Sponsors Can Develop a Comprehensive Organizational Approach to Interactive Response Technology (IRT)," equips attendees with the knowledge to effectively integrate IRT systems into their clinical trial strategies. Participants will explore best practices for system selection, operational integration, and cross-functional coordination. This session will highlight critical considerations for achieving streamlined trial management, data integrity, and improved decision-making through a cohesive organizational approach to IRT.

The workshop "Improving Patient Compliance and Patient-Centric Digital Supply Chains" highlights innovative digital approaches to enhance medication adherence and patient engagement in clinical trials. Participants will explore technological solutions, such as real-time tracking, personalized patient communications, 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 health outcomes, improve data accuracy, and streamline operational efficiency.

The workshop "Navigating Internal Company Transition and Change While Ensuring Clinical Trial Supply Operations Remain Intact" addresses the complexities of managing organizational changes without disrupting clinical supply chains. 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.

The workshop "Temperature Excursion Management Solutions" focuses on practical approaches to prevent, identify, and effectively manage temperature deviations in clinical trial logistics. Attendees will learn how temperature excursions impact product integrity, regulatory compliance, and overall trial outcomes. The session emphasizes proactive planning, real-time monitoring, corrective actions, and documentation practices, providing participants with actionable strategies and solutions to safeguard sensitive pharmaceutical products.

The workshop "Sustainability in Clinical Trial Supplies" highlights 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 practical examples and interactive discussions, attendees will learn to align operational efficiency with sustainability goals, meeting both regulatory requirements and ethical responsibilities.

This workshop aims to provide an in-depth understanding of the critical components and best practices for effective supply planning agreements between clinical supplies, clinical teams, and vendors. Participants will explore the importance of collaboration, strategic planning, and communication in ensuring 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, "How Sponsors Can Develop a Comprehensive Organizational Approach to Interactive Response Technology (IRT)," equips attendees with the knowledge to effectively integrate IRT systems into their clinical trial strategies. Participants will explore best practices for system selection, operational integration, and cross-functional coordination. This session will highlight critical considerations for achieving streamlined trial management, data integrity, and improved decision-making through a cohesive organizational approach to IRT.

The workshop "Improving Patient Compliance and Patient-Centric Digital Supply Chains" highlights innovative digital approaches to enhance medication adherence and patient engagement in clinical trials. Participants will explore technological solutions, such as real-time tracking, personalized patient communications, 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 health outcomes, improve data accuracy, and streamline operational efficiency.

The workshop "Navigating Internal Company Transition and Change While Ensuring Clinical Trial Supply Operations Remain Intact" addresses the complexities of managing organizational changes without disrupting clinical supply chains. 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.

The workshop "Temperature Excursion Management Solutions" focuses on practical approaches to prevent, identify, and effectively manage temperature deviations in clinical trial logistics. Attendees will learn how temperature excursions impact product integrity, regulatory compliance, and overall trial outcomes. The session emphasizes proactive planning, real-time monitoring, corrective actions, and documentation practices, providing participants with actionable strategies and solutions to safeguard sensitive pharmaceutical products.

The workshop "Sustainability in Clinical Trial Supplies" highlights 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 practical examples and interactive discussions, attendees will learn to align operational efficiency with sustainability goals, meeting both regulatory requirements and ethical responsibilities.

This workshop aims to provide an in-depth understanding of the critical components and best practices for effective supply planning agreements between clinical supplies, clinical teams, and vendors. Participants will explore the importance of collaboration, strategic planning, and communication in ensuring 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 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.

The workshop "Supply Chains of Radiopharmaceuticals" explores 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 specific to radiopharmaceuticals. 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.

This workshop focuses 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 outsourcing. The session aims to provide attendees with the strategies and tools necessary to enhance their vendor management and streamline 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 and improvement in these regions.

This workshop, "Import/Export and VAT," provides participants with essential knowledge regarding Value Added Tax (VAT) implications and regulations in international trade. Attendees will gain practical insights into VAT procedures, customs compliance, and accurate documentation required for successful importing and exporting activities. The session will also explore common challenges, helping businesses optimize VAT management to ensure regulatory compliance and cost efficiency.

This workshop, "Material Pooling, JIT Labelling, and On-Demand Manufacturing (Master Protocols and Adaptive Designs)," addresses innovative strategies for efficient clinical trial supply chain management. Participants will learn how to leverage material pooling, just-in-time (JIT) labeling, and adaptive manufacturing methods to support master protocol studies and adaptive trial designs. The session emphasizes flexibility, cost reduction, and responsiveness to trial changes, enhancing the ability to quickly adapt to evolving clinical study requirements.

This workshop, "Cost of Poor Quality and Lack of Regulatory Focus (Impact on the Clinical Trial Supply Chain)," highlights the significant risks and costs associated with inadequate quality control and regulatory oversight in clinical trials. Participants will explore real-world consequences, including delayed timelines, regulatory non-compliance, financial losses, and compromised patient safety. The session provides actionable insights and strategies to proactively identify, address, and prevent quality and compliance issues within the clinical trial supply chain.Gain an understanding of CGT supply chains, explore the key stakeholders and considerations, and learn best practices to manage complex processes effectively.

This session will provide valuable insights into the challenges and strategies for effective management, ensuring efficient and streamlined operations, and is ideal for professionals looking to enhance their knowledge and skills in this rapidly evolving fielThis workshop, "Import/Export and VAT," provides participants with essential knowledge regarding Value Added Tax (VAT) implications and regulations in international trade.

Attendees will gain practical insights into VAT procedures, customs compliance, and accurate documentation required for successful importing and exporting activities. The session will also explore common challenges, helping businesses optimize VAT management to ensure regulatory compliance and 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.

The workshop "Wastage and Safety Stocks – Measuring, Managing, and Improving" addresses 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 delves into the transformative power of artificial intelligence 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.s inventory without compromising patient safety. Practical case studies and interactive discussions will provide actionable insights for enhancing supply chain efficiency, sustainability, and cost-effectiveness.