8:00 am Coffee & Check In

9:00 am Chair’s Opening Remarks

  • Brett Miller Senior Director - Global Supply Chain, Telix Pharmaceuticals

Strategies for Addressing Isotope Supply Bottlenecks to Ensure Scalability & Stability

9:15 am Strategies to Mitigate Isotope Supply Challenges for Actinium & Lutetium to Ensure Consistent Supply

  • Brett Miller Senior Director - Global Supply Chain, Telix Pharmaceuticals

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

9:45 am Advancements in Generator Technologies for Sustainable Radiopharmaceutical Supply

  • Angel Colina Director - Cyclotron Engineering and Operations, Columbia University Irving Medical Center

Synopsis

  • Discuss the latest advancements in generator technologies that facilitate the on-site production of radioisotopes, enhancing accessibility and efficiency
  • Explore how these innovative generator systems can streamline the supply chain, reducing the need for frequent and complex logistics associated with isotope transport
  • Examine how novel generators contribute to more sustainable practices in radiopharmaceutical production, potentially lowering costs and reducing environmental impact

10:15 am Morning Refreshments & Speed Networking

Improving Isotope Production Capacity Through Technological Innovation

11:15 am Session Reserved For CRB

12:00 pm Enhancing Radiopharmaceutical Production Through Chelator Selection

  • Daniel Thorek Associate Professor, Washington University School of Medicine in St. Louis

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

12:30 pm Optimizing Production Processes for High-Yield Radiopharmaceuticals

  • Chris Pak President & Chief Executing Officer, Molecular Targeting Technologies

Synopsis

  • Discuss technologies such as automation and real-time monitoring systems that help maximize production efficiency and yield
  • Review the latest advancements in separation technologies critical for purifying radiopharmaceuticals
  • Identify common challenges faced when scaling up production processes to meet commercial demand. Discuss strategies to overcome these challenges while maintaining product integrity and compliance with regulatory standards

1:00 pm Lunch & Networking

Addressing Manufacturing Capacity, Quality & Efficiency Hurdles in Radiopharmaceutical Manufacturing to Achieve Quality Drug Product

2:00 pm Managing Radioactive Waste in Radiopharmaceutical Manufacturing to Meet Regional Standards

  • Aruna Korde Scientist, International Atomic Energy Agency

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

2:30 pm Overcoming Manufacturing Bottlenecks & Maintaining Quality in Radiopharmaceutical Production

Synopsis

  • Examine the shortage of manufacturing facilities and specialized equipment like hot cells
  • Identify quality control challenges in multi-product facilities and strategies for maintaining GMP compliance
  • Explore effective approaches to streamline production timelines while ensuring adherence to health and radiation safety regulations

3:00 pm Afternoon Refreshments & Poster Session

Understanding Regional & Logistical Complexities in Radiopharmaceutical Manufacturing Across Production Landscape

4:00 pm Roundtable Discussion: Overcoming Global cGMP Regulatory Hurdles for Efficient Market Access

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

5:00 pm Chair’s Closing Remarks

  • Brett Miller Senior Director - Global Supply Chain, Telix Pharmaceuticals

5:15 pm End of Conference Day One