Pre-Conference Workshop Day
8:00 am Check-In & Coffee
9:00 am – 12:00 pm | Workshop A
Optimizing Isotope Selection for Improved Patient Outcomes, Manufacturing Efficiency & Commercial Benefit: A Scandium-Based Strategy
Synopsis
Selecting the ideal isotope for targeted radiotherapy or imaging requires deep understanding not only of physical properties like radiation type, half-life, and decay chains but also how isotope generation methods impact downstream quality control, and safety. Discover how strategic isotope selection that leverages theragnostic pairing can significantly improve the commercial viability of radiopharmaceuticals.
This workshop will gather experts to:
- Evaluate the integration of ⁴⁴Sc with its therapeutic pair ⁴⁷Sc to enable scalable scandium-based theranostic platforms.
- Explore how cyclotron-based production enables higher isotope yields and batch sizes, and how longer-lived isotopes like scandium support wider distribution and commercialization improving patient access and market potential.
- Outline considerations for commercial translation, centralized manufacturing, for ⁴⁴Sc/⁴⁷Sc applications
- Discuss how pharma and biotech teams can better integrate production method considerations into sourcing strategy to ensure reliable, compliant, and cost-effective manufacturing.
12:00 pm Lunch Break & Networking
1:00 pm – 4:00 pm | Workshop B
Addressing Unique Challenges in Radioactive Material Compliance to Harmonize Global cGMP Standards & Enhance Regulatory Confidence for Drug Approval
Synopsis
Navigating differing U.S. and European regulations is increasingly challenging. This workshop explores how regional GMP requirements affect manufacturing and supply chains, offering strategies to align compliance globally. Learn how early collaboration with regulators can speed up clinical supply approvals and international market entry.
Join this workshop to:
- Uncover 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, with a focus on how cGMP requirements for radiopharmaceuticals differ due to concerns around radiological safety, dose consistency, and product stability.
- Identify partnerships with regulatory experts to better navigate international approval processes.