Conference Day Two
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 The Hidden Metric – Why Dosimetry is a Pillar of Radiopharmaceutical Manufacturing & How Integrating it Early Ensures Patient Safety, Product Consistency & Regulatory Confidence
Synopsis
- Discover how dosimetry informs production yields and formulation volumes and how this data helps optimize radioactive content per batch and adjust for decay rates during production.
- Explore how dosimetry requirements influence formulation volume, carrier molecule concentration, and specific activity which drives critical manufacturing decisions from early development through scale-up.
- Examine the ongoing lack of standardization in dosimetry methodologies, including the use of imaging, biodistribution studies, and animal models, and how this variability affects reproducibility across programs.
- Discuss challenges in defining and applying relative biological effectiveness (RBE) for alpha particles, and its implications for accurate dose estimation, toxicity prediction, and regulatory confidence.
10:00 am Follow-up Roundtable: Discussing Why Dosimetry is a Pillar of Radiopharmaceutical Manufacturing & How Integrating it Early Ensures Patient Safety, Product Consistency & Regulatory Confidence
Synopsis
- Discussing the practical role of dosimetry in Phase 3 trials and commercial settings. When does it add real value, and when does it become an unnecessary burden?
- Exploring industry-wide challenges with standardization and how to ensure consistent and reliable dosimetry across trial sites with varying equipment and expertise.
- Evaluating strategies for improving data quality and whether sponsors should centralize dosimetry efforts, limit to trusted sites, or invest in new technologies to ensure accuracy?
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
- Being aware of supplier and CMO quality oversight in a global, decentralized environment.
- Establishing robust QMS across clinical and commercial phases.
- Leveraging quality metrics to manage risk and support decision-making.
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.
2:30 pm Roundtable Discussion: Implementing Specialized Training Programs to Address Capacity Constraints in Radiopharmaceutical Manufacturing & Facilitate Reliable Drug Production
Synopsis
- Discuss shared challenges in maintaining operational efficiency amid capacity limitations, outdated equipment, and workforce gaps.
- Strategize how to close the expertise gap in radiopharmaceutical manufacturing and clinical drug administering by leveraging academic partnerships, specialized training programs, and collaboration with industry experts.
- Understand how training programs can help organizations make better use of limited infrastructure, accelerate readiness of new facilities, support regional capacity expansion, or onboard newly acquired manufacturing teams.
- Uncover strategies for sourcing, training, and retaining qualified engineers and operators to ensure equipment uptime, troubleshoot issues, and foster cross-functional collaboration.
Bridging Central Manufacturing & Patient Delivery Through Integrated Theranostics Centers to Fast-Track Clinical & Commercial Distribution
3:00 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.
3:30 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.