Conference Day One
8:30 am Coffee & Check In
9:20 am Chair’s Opening Remarks
From Scarcity to Stability: Securing Supply Chain Pipelines for the Future of Radiotherapies
9:30 am Panel Discussion: Addressing Barriers in Supply Chains to Ensure Reliable Isotope Access & Consistent Patient Delivery
Synopsis
- Identify sourcing and logistics bottlenecks including cold chain constraints, regulatory delays, and cross-border customs challenges that impact isotope availability and the timely delivery of radiopharmaceuticals.
- Compare centralized and local production models for short- and long-lived isotopes to minimize supply chain risks, costs, and lead times while ensuring the delivery of therapies to clinical sites on time.
- Assess the impact of sourcing disruptions, like lost shipments or transport delays, on radio decay, and manufacturing timelines, and explore strategies to maintain dose integrity and minimize patient treatment disruptions.
- Integrate supply chain planning and tracking strategies to optimize clinical demand fulfilment.
10:30 am Morning Break & Networking
Enhancing Radiotherapy Production Capacity Through Technological Innovation, Infrastructure Optimization & Logistical Advancements
11:30 am Harnessing Automation & Digitization in Targeted Radiotherapy Manufacturing to Ensure Consistent Quality
Synopsis
- Consider high-impact areas for automation to improve batch consistency, reduce human error, and enhance operator safety.
- Discuss integration challenges in retrofitting automation into facilities while maintaining GMP compliance.
- Evaluate the return on investment, the benefits and the challenges of automation, including improved scalability and consistency versus difficulties like maintenance requirements.
- Assess the use of AI platforms in automation of manufacturing processes.
12:00 pm Roundtable Discussion: Addressing Facility Downtime & Regulatory Delays by Designing Robust Infrastructure Strategy to Accelerate Safe, Scalable Radiopharmaceutical Manufacturing
Synopsis
- Compare the cost, speed, and scalability trade-offs between building new facilities and repurposing existing infrastructure for radiopharmaceutical production.
- Explore how isotope-specific properties (e.g. half-life, emission type, regulatory perception) impact facility design, contamination protocols, and downtime risk.
- Understand how evolving regulatory expectations and environmental monitoring requirements influence long-term compliance, capacity, and facility utilization.
12:30 pm Lunch & Networking
Strategic Formulation Approaches for Maximizing Isotope-Specific Performance & Supply Efficiency
1:30 pm Translating Supply Chain Lessons from Long-Lived to Short-Lived Radiotherapeutics: Overcoming Gaps in Handling, Quality & Distribution
Synopsis
- Explore how established distribution models for isotopes such as Lutetium-177 differ from those required for short half-life radiotherapies (Lead-212 and Astatine-211), and what adaptations are needed.
- Discuss what elements of long-lived isotope supply (licensing, training, automation, and packaging) can be reused, and where entirely new systems are needed for short-lived compounds.
- Examine approaches to minimize dose loss due to delays, weather, or site readiness when working with short half-life products, including localized production vs hub-and-spoke delivery.
2:00 pm Maximizing Radiopharmaceutical Production Speed with Best-in-Class Precursor Selection
Synopsis
- Discuss how to boost reliability and yield through consistent, GMP-grade materials that minimize batch failures and waste.
- Streamline downstream processing by reducing purification complexity with cleaner, high-purity reactions.
- Reduce synthesis time by using precursors engineered for fast, efficient radiolabeling under mild conditions.
2:30 pm Afternoon Break & Poster Session
Accelerating Clinical Submissions by Clarifying Regulatory Expectations & Filing Scope Across Radiopharmaceutical Development
3:30 pm Panel Discussion: Discussing Perspectives on Regulatory Expectations to Improve Submission Clarity & Accelerate Development Timelines
Synopsis
- Explore key differences in manufacturing practices for pharmaceutical vs industrial isotope use, including how processes, quality standards, and documentation are adapted for GMP compliance.
- Review common regulatory questions and challenges faced when submitting Drug Manufacturing Files (DMFs), and how these vary across agencies like the FDA and EMA.
- Discuss how to balance confidentiality with regulatory transparency, and how pharma and isotope suppliers can better align to meet submission requirements without disclosing sensitive IP.
4:30 pm Navigating Filing Scope for Targeted Radiotherapies & Engaging Authorities Under Evolving Guidance Standards to Fast-Track Submissions
Synopsis
- Clarify how to define the appropriate Module 3 scope when filing radiopharmaceuticals with multiple radionuclides, production routes, or variable target materials.
- Explore how to establish target purity profiles and target product profiles, and how these impact quality specifications, comparability, and filing complexity.
- Discuss best practices for early engagement with regulators (FDA, EMA, etc.) to align on isotope source qualification, dossier structure, and evolving quality standards.