8:00 am Coffee & Check In
8:50 am Chair’s Opening Remarks
Strategies for Addressing Isotope Supply Bottlenecks to Ensure Scalability & Stability
9:00 am Strategies to Mitigate Isotope Supply Challenges for Actinium & Lutetium to Ensure Consistent Supply
Synopsis
- Explore scalable production techniques to enhance the availability of key isotopes
- Discuss the sourcing of purified starting materials to reduce contamination and ensure quality
- Review the impact of regulatory hurdles on the supply chain and strategies for compliance
9:30 am Advancing Generator Technologies & Cyclotron Solid Targets: A Balanced Approach for Sustainable Radiopharmaceutical Supply
Synopsis
- Ensuring Reliable Radiopharmaceutical Supply and Advancements in Generator Technologies
- Cyclotron Solid Target Technologies and Cost vs. Sustainability Comparison with Generators
- Balancing Innovation and Sustainability in Radiopharmacy
10:00 am Advancements in Contamination Control and Scalable Radioisotope Production Processes
Synopsis
- Identify the latest technological innovations that allow for scalable isotope production while reducing contamination.
- Develop a strong radiation safety program and presence in isotope production.
- Discuss case studies on successful implementations of contamination control measures in isotope production.
10:30 am Morning Refreshments & Speed Networking
Improving Isotope Production Capacity Through Technological Innovation
11:30 am Session Reserved For CRB & CAI
12:15 pm Enhancing Radiopharmaceutical Production Through Chelator Selection
Synopsis
- Discuss how selecting the right chelator enhances manufacturing efficiency and product stability
- Review considerations for scaling up production, focusing on chelator compatibility and cost-effectiveness
- Explore the regulatory implications of chelator choices and strategies for compliance in commercial production
12:45 pm Reducing Isotope Demand With an Innovative TRP Delivery Platform
Synopsis
- Common challenges of short-lived, rapidly clearing TRP. Strategies to overcome these challenges while maintaining product integrity and compliance with regulatory standards
- Evans Blue modification significantly improves pharmacokinetics of targeted peptide radiotherapeutics reducing required dose by >50%
- Lowering isotope use while maintaining efficacy and safety, improves costs, logistics and health economics, potentially expanding the market
1:15 pm Lunch & Networking
Addressing Manufacturing Capacity, Quality & Efficiency Hurdles in Radiopharmaceutical Manufacturing to Achieve Quality Drug Product
2:15 pm Managing Radioactive Waste in Radiopharmaceutical Manufacturing to Meet Regional Standards
Synopsis
- Review regional differences in radioactive waste management regulations and how they affect facility compliance
- Develop best practices for handling, storing, and disposing of radioactive waste in line with regional guidelines
- Explore strategies to integrate waste management into the manufacturing process to minimize environmental impact
2:45 pm Production of High-Volume Radiopharmaceutical Batches
Synopsis
- To share experience of challenges with international DP manufacturing
- To analyze the top 3 reasons for inability to supply
- To emphasize the need for automation and digitalization
3:15 pm Radiopharmaceutical’s Production Meets Automation, Digitalization, and AI – Boosting Operational Excellence & Compliance
Synopsis
- Promising automation concepts, which go beyond (semi-)automated synthesis and dispensing
- The benefits of digitalization for production efficiency and compliance (show case)
- How AI can help to keep the focus of human resources on things that matter
3:45 pm Afternoon Refreshments & Poster Session
Understanding Regional & Logistical Complexities in Radiopharmaceutical Manufacturing Across Production Landscape
4:15 pm Roundtable Discussion: Overcoming Global cGMP Regulatory Hurdles for Efficient Market Access
4:15 pm Integrating Supply Chain Planning and Tracking Strategies to Ensure Consistent Patient Delivery
Synopsis
- Investigate how to optimize the supply chain to meet clinical demand and maintain a just-in-time inventory to minimize wastage
- Review supply chain forecasting and coordination with clinical sites to improve the availability of radiopharmaceuticals
- Explore tracking technologies to ensure accurate dosage delivery and maintain high patient safety standards
4:45 pm Mastermind Session: Overcoming Global cGMP Regulatory Hurdles for Efficient Market Access
Synopsis
- Explore the regulatory differences affecting manufacturing and supply chain across regions, particularly in Europe and the U.S
- Discuss strategies to harmonize compliance practices for providing clinical supply
- Identify partnerships with regulatory experts to better navigate international approval processes for faster market entry