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

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 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.

10:45 am Morning Refreshments & Speed Networking

Improving Isotope Production Capacity Through Technological Innovation

11:45 am Session Reserved For CRB & CAI

12:15 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

12:45 pm Reducing isotope demand with an innovative TRP delivery platform

  • Chris Pak President, Molecular Targeting Technologies

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

  • 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

2:45 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

3:15 pm Afternoon Refreshments & Poster Session

Understanding Regional & Logistical Complexities in Radiopharmaceutical Manufacturing Across Production Landscape

3:45 pm Integrating Supply Chain Planning and Tracking Strategies to Ensure Consistent Patient Delivery

  • Jarrod Longcor Chief Business Officer and SVP Operations, Cellectar Biosciences Inc.

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.

4:15 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