Explore the Agenda
8:30 am Check-in
Coffee & Tea Served
8:55 am Chair’s Opening Remarks
Mastering Time-Sensitive Logistics & Distribution Networks to Ensure Reliable Delivery of Short Half-Life Therapies
9:00 am Designing Logistics Strategies Across Clinical Phases to Balance Cost, Reliability, & Patient Risk
- 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
Building & Staffing the Infrastructure: Facility Design, Equipment Procurement, & the Talent Gap That Threatens to Slow Everything Down
9:30 am Fireside Chat: Selecting & Scaling Manufacturing Sites to Support Global Expansion of Radiopharmaceutical Pipelines
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
10:15 am Morning Break & Networking
Light Refreshments Served
11:15 am Rethinking the Build vs Buy Model in Radiopharmaceutical Manufacturing
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
The Last Mile: Site Readiness, Radiopharmacy Integration, & Closing the Loop Between Manufacturing, Logistics, & Patient Administration
12:00 pm Beyond Products supply: the roles of technical operations to enable clinical success
- Identify the roles of supply chain and technical operations, enabling clinical development and operations (eg.: accelerate site activation, drug handlings)
- The patient journey: beyond drug delivered on time, understand the responsibilities of technical operations to deliver an undisrupted patient journey.
- Commercial transition: discuss the risk and success metrics based on previous launch challenges and upcoming novel RLT profiles.
12:30 pm Lunch & Networking Break
1:30 pm Aligning Manufacturing Output with Clinical Site Expectations to Improve Treatment Throughput
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
2:10 pm Overcoming Workforce & Talent Bottlenecks to Enable Manufacturing Scale-Up
- 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
2:40 pm Afternoon Break & Networking
Turning Regulatory Uncertainty Into a Strategic Advantage by Engaging Early, Documenting Rigorously, & Anticipating What Comes Next to Avoid Delays
3:30 pm Designing Robust GMP Strategies for Radiopharmaceutical Manufacturing Under 211 Expectations
- 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
4:00 pm Panel Discussion: Future Directions – Where Does the Chain Break? A Collective Assessment of the Industry’s Most Critical Unresolved Supply Chain Challenges & the Priorities That Must Be Addressed Collectively Before the Next Wave of Approvals Arrives
- 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?