Archives: Agenda

• Designing flexible IRT systems to accommodate multiple dose levels and protocol adaptations
• Forecasting clinical supply needs amid uncertainty in dosing, cohorts and timelines
• Collaborating across functions to align IRT, supply and clinical execution
• Applying lessons learned from a real world CNS program with high complexity and unpredictability

MODERATOR: Luiz Barberini, Head of External Manufacturing, Latin America, Bayer

• Designing your comparator sourcing strategy: key factors to consider for your clinical trial
• Exploring strategies for reliable and cost-effective sourcing: what solutions are available?
• Addressing regulatory considerations and compliance challenges for comparator sourcing both in the US and from overseas
• Leveraging technology and data analytics to streamline comparator sourcing processes

• Strategies for reducing clinical supply waste while ensuring patient needs are met
• Digital tools that enhance real-time visibility into supply shipments and their status
• Operational innovations that enable faster timelines without increasing risk
• Practical approaches to aligning supply chain efficiency with clinical trial demand

• The basics of drug substance manufacturing and what drives uncertainty in yields, especially in early phase production
• Recommendations and tactics for how supply chain planners should coordinate early and often with counterparts in CMC and manufacturing to stay abreast of expected yields, lead times, sampling requirements
• Understanding risks

• Data-driven insights: utilizing data analytics for informed forecasting decisions
• The importance of remaining flexible to adapt to changing trial dynamics and demands
• Proactive risk management: identifying and mitigating potential obstacles to streamline forecasting processes
• Effective forecasting in order to reduce waste, cost and carbon footprint

• Preparing for the unexpected: building contingency protocols in from the start of a trial
• Planning for unforeseen events and incorporating this into your risk management strategy
• Incorporating risk assessment into project management plans in order to be better prepared for every eventuality
• How to reduce risk caused by supply chain delays

• Cutting edge technologies and incorporating these into your clinical supply chain
• Sustainability and incorporating eco-friendly initiatives in clinical supply chain management
• Collaborative platforms: improving communication and efficiency among stakeholders
• Success stories, transformative case studies and key takeaways

MODERATOR: Luiz Barberini, Head of External Manufacturing, Latin America, Bayer