Conference Day Two
Thursday, September 25
8:00 am Coffee & Check In
8:50 am Chair’s Opening Remarks
Harnessing Diverse Production & Supply Networks to Mitigate Geopolitical Challenges in Isotope Sourcing & Ensure Stable Access for Radiotherapy Production
9:00 am Managing Geopolitical Risk in Sourcing of Medical Isotopes & Enriched Stable Isotopes (ESIs) to Safeguard Supply Continuity & Patient Access Through International Cooperation, Supplier Diversity & Accelerating Domestic Capacity
Synopsis
- Understand international initiatives involving governments, industry groups, and international organizations on policies to promote security of supply of medical radioisotopes and enriched stable isotopes.
- What actions are being pursued by governments and industry in the US and Europe to ramp up production of medical radioisotopes and enriched stable isotopes, and how likely are these efforts to succeed in ensuring a stable and secure supply chain?
- Discuss strategies to manage a complex international environment including sanctions, tariffs, banking, and complex logistics as well as evolving international regulatory actions and how they impact radioisotope and enriched stable isotope sourcing.
Precision Under Pressure: Strengthening Quality & Compliance Across Radiopharmaceutical Manufacturing & Supply Networks
9:30 am Navigating the Transition from 21 CFR 212 to 210/211 Compliance in Radiopharmaceutical Manufacturing
Synopsis
• Key differences and gaps between 21 CFR 212 and 210/211
• Impact on CDMO/CMO facilities
• Considerations for radiopharmacies and compounding pharmacies
10:00 am Extended Roundtable: Practical Strategies for Compliance Transition
Synopsis
• What are the biggest hurdles in moving from 21 CFR 212 to 210/211 compliance, and how can they be addressed?
• How are CDMOs/CMOs adapting their facilities and operations to meet late-phase and commercial needs?
• What role should radiopharmacies and compounding pharmacies play as products transition to broader commercialization?
10:30 am Morning Break & Networking
Precision Under Pressure: Strengthening Quality & Compliance Across Radiopharmaceutical Manufacturing & Supply Networks
11:30 am Ensuring Quality & Compliance in a Complex Radiopharmaceutical Supply Chain
Synopsis
- Understand the supply chain by mapping out the key activities involved. Know the regulations that apply to each step of the supply chain.
- Have an effective supplier management program in place. Responsibilities should be clearly defined in the Quality Agreements.
- Discuss supplier audits – examples of audit observations.
- Discuss FDA inspections – the Dos and Don’ts in an FDA inspection.
12:00 pm Building Scalable Quality Oversight Across Global Radiopharmaceutical Operations
Synopsis
• CMO Oversight from start-up to ready for commercial: which quality organization
• How QMS develops across clinical and commercial phases.
• CMO oversight: centralized versus decentralized in a global environment
12:30 pm Lunch & Networking
Addressing CMC Scale-Up Challenges in Radiopharmaceuticals Through Strategic Partnerships, Robust Tech Transfer, & Process Design for Commercial Readiness
1:30 pm Panel Discussion: Designing for Demand – Process Strategies to Support Scale-Up of Radiotherapeutic Manufacturing
Synopsis
- Evaluating scale-up vs. scale-out approaches in radiopharmaceutical manufacturing.
- Efficiencies for making the transition from Phase 3 to commercial.
- Future-proofing production by aligning process design with commercial demand forecast.
- Planning processes that accommodate isotope variability, decay kinetics, and short half-lives.
Bridging Central Manufacturing & Patient Delivery Through Integrated Theranostics Centers to Fast-Track Clinical & Commercial Distribution
2:30 pm Integrating Radiopharmacies Into the Radiotherapy Manufacturing Ecosystem to Expand Reach, Reduce Strain, & Accelerate Patient Access
Synopsis
- Explore how leveraging radiopharmacies for therapeutic preparation can extend regional coverage, reduce time-to-treatment for short-lived isotopes, and ease pressure on centralized manufacturing.
- Understand regulatory and operational restrictions in compounding manufacturing and radiopharmacy roles and how resolving these can unlock compliant, scalable delivery models.
- Discuss strategic partnerships with national pharmacy networks to improve batch consistency, point-of-care readiness, and public/physician trust in decentralized delivery.
3:00 pm Improving Clinical Site Preparedness Through Establishing Integrated Referral & Scheduling Frameworks to Minimize Dose Loss of Radiopharmaceutical Therapies
Synopsis
- Partner with nuclear medicine networks to pre-qualify sites for both diagnostic and therapeutic workflows and clinical trials, and collaborate with local oncologists for patient referrals
- Implement dynamic scheduling to align batch production with patient readiness, minimizing idle doses and managing cancellation risks
- Establish standalone theranostics centers as regional hubs, partnering with local physicians for efficient patient routing and maximizing dose utilization