8:50 am Chair’s Opening Remarks

9:00 am Learning from Past Experiences: Radiopharmaceutical Therapeutic Landscape, History & Future Opportunities

Synopsis

  • Set the scene for 2023, what does the supply chain and manufacturing network for radiopharmaceuticals look like at this time?
  • Detail how this landscape compares to the one that existed 20 years ago
  • Discuss how current pressures and stimulating factors will shape the field in the near future

Establishing Reliable Supply Chains for Strategic Supply of APIs & Delivery of Final Drug Product

9:30 am Distributed Manufacturing Concepts – Moving Closer to the Patient

  • Anna Kulesza Pharmaceutical Development and Regulatory Affairs Director, RegulaNova

Synopsis

  • Introduction to RegulaNova
  • Key elements and challenges of nuclear medicine applications and processes
  • Innovative regulatory approaches
  • Advancing the new regulatory concepts

10:00 am Refreshment Break & Speed Networking

11:00 am Copper Stock Levels, Current Problems & Possibilities

Synopsis

  • History Of Cu-64 and Cu-67 Production
  • Historic limitation of chelators
  • How does the copper theranostic pairing provide solutions to existing barriers and risks in TRT Commercialization?

11:30 am Exploring the Challenges Presented by Exotic Radionuclides & Their Potential to Plug Gaps in Supply

Synopsis

  • Identify specific radionuclides that pose potential alternatives to Lu or Ac
  • Explain what favorable features make them good alternatives
  • Discuss the stock levels and manufacturing challenges these compounds present  

12:00 pm Lunch Break & Networking

1:00 pm Panel Discussion: Planes, Trains & Automobiles: Working with & Around the Reliance Radiopharmaceuticals Have on Air Freight for More Reliable Delivery

Synopsis

  • Commercial vs Freight services: how do supply chain managers assess the best option for the product in question?
  • Discuss what alternative transport options available, the pros and their cons
  • Look in depth at protocols companies have in place for when a shipment is held up and how this is best handled to ensure patients and doctors needs are met when unexpected hurdles arise
  • Small charter flights vs. large commercial cost and logistical issues 

Building Resilient Supply Chains to Cope with Current Pressures & Prepare for Future Threats

2:00 pm Xofigo – How to Build a Robust & Efficient Manufacturing & Supply Network

Synopsis

  • Experiences after 10 years with commercial manufacturing and supply of Xofigo
  • “The devil is in the details’’ – a risk based approach
  • How managing manufacturing and supply holistically leads to synergies and efficiencies

2:30 pm Afternoon Break & Networking

3:00 pm Panel Discussion: Current Threats to the Supply Chain, Their Impacts & Forecasting Potential Risk Factors to Prepare For

Synopsis

  • Discuss the current impacts of the Ukraine war and computer chip shortages
  • Explore possible impacts that could be felt in the near future
  • Identify potential issues that could emerge that are less
  • Consider the impacts on the acquisition of APIs and Isotopes, as well as the delivery of products to meet ethical commitments in countries involved in events 

4:00 pm Chair’s Closing Remarks & End of Conference Day One