Day Two

Coffee & Tea Served

• Comparing high-touch, premium logistics models used in early-phase trials with more standardized approaches required for late-stage and commercial distribution
• Managing the trade-off between cost optimization and guaranteed delivery when each patient dose carries significant clinical and financial value
• Implementing contingency strategies including overproduction, reallocation, and backup routing to mitigate disruption
• Transitioning logistics models from bespoke to scalable while maintaining delivery performance

This session will open with a short presentation, followed by an informal discussion where audience interaction is encouraged.

• Evaluating key criteria for site selection including infrastructure, regulatory environment, proximity to patients, and logistics access
• Assessing the role of real estate, utilities, and technical feasibility in determining site suitability
• Aligning manufacturing footprint strategy with global clinical and commercial expansion plans
• Managing trade-offs between speed of deployment, cost, and long-term scalability

Light Refreshments Served

This session will feature an expert-delivered presentation, before opening to a facilitated audience discussion

• Comparing in-house manufacturing vs CDMO reliance in the context of radiopharmaceutical complexity
• Exploring strategies for combining internal capabilities with strategic CDMO partnerships to ensure continuity of supply while maintaining flexibility
• Evaluating how facility decisions impact control, flexibility, and scalability across the supply chain
• Identifying hidden constraints beyond infrastructure, particularly workforce availability and expertise

This interactive mastermind session will begin with a short presentation to challenge current industry assumptions, followed by a facilitated audience discussion where participants will collaboratively assess where the supply chain breaks today and share practical strategies to better align manufacturing, clinical operations, and patient delivery.

• Challenging the industry’s focus on isotope production by examining where the system actually fails in practice, from limited clinical trial site readiness and patient coordination, to gaps between manufacturing output and real-world delivery capability
• Defining what it takes to truly “close the loop” between manufacturing, logistics, and patient administration, ensuring coordination across stakeholders so that therapies can reliably move from production to patient treatment
• Identifying how organizations can standardize site activation, training, and support to move beyond a limited number of specialized centers and enable broader trial access

A 20-minute case study presentation exploring real-world site coordination challenges, followed by a 20 minute facilitated roundtable discussion where attendees share experiences and strategies to improve site readiness and treatment delivery.

• Defining what clinical sites require from manufacturers, including format, delivery method, documentation, and support
• Coordinating chain of custody and ensuring product integrity from production through to administration
• Identifying bottlenecks at the clinical site level, including patient throughput and handling constraints
• Improving collaboration between CMC teams and clinical stakeholders to enable smoother delivery

• Addressing the shortage of radiopharmaceutical manufacturing talent and its impact on scaling operations
• Exploring how skills from broader pharmaceutical manufacturing can be translated into radiopharma environments
• Reducing over-reliance on highly specialized radiopharmacy expertise by broadening workforce models
• Developing strategies to attract, train, and retain talent in a rapidly growing but niche field

• Examining how teams are building processes based on PET (212) experience, while being assessed against stricter 211 standards, and what this means for facility design, validation, and audit readiness
• Exploring key challenges such as pressure cascades, isolator design, and operator protection vs product sterility; and how to design systems that satisfy both
• Strategies for building robust upfront controls to compensate for limited product testing windows

• Across the two days, which single supply chain or manufacturing bottleneck has emerged as most urgent, and what does a credible industry-level response to it look like?
• Where does the field realistically stand on isotope supply security in five years, and which production pathways, technologies, and investment models will determine whether commercial-scale alpha therapy becomes a reality?
• How must the relationship between biopharma, CDMOs, isotope providers, logistics specialists, and clinical sites evolve structurally to one that can reliably deliver therapies to patients at scale?