8:30 am Coffee & Check In
9:00 am Chair’s Opening Remarks
Scaling Radiopharmaceutical Production Through Improved Training, Tech Transfer, Safety & Regulatory Compliance to Meet More Demand
9:15 am Enhancing Radiopharmaceutical Production Through Effective Tech Transfer
Synopsis
- Discuss the critical steps involved in transferring technology from R&D to production scale, emphasizing pre-process validation to ensure consistency and quality
- Explore real-world examples where tech transfer has been pivotal in scaling up production of radiopharmaceuticals. Analyse challenges and solutions encountered during these transitions
- Review key strategies for a smooth tech transfer in radiopharmaceutical production, including collaboration with CDMOs, rigorous process validation, and maintaining regulatory compliance
9:45 am Addressing Shortfalls in Radiopharmaceutical Production Capacity & Equipment to Improve Production Efficiency
Synopsis
- Discuss the shortage of specialized equipment, such as hot cells, and identify strategies to enhance production capacity through vendor partnerships
- Investigate approaches to balance existing manufacturing facilities’ capacity with increasing clinical and commercial demands
- Explore partnerships and internal production strategies to alleviate equipment supply chain issues
10:15 am Enhancing Radiopharmaceutical Safety & Quality Through Radiolabeling
Synopsis
- Explore the latest techniques in radiolabeling that enhance the specificity and stability of radiopharmaceuticals
- Discuss how radiolabeling contributes to stringent quality control measures, ensuring that radiopharmaceuticals meet safety standards
- Review the impact of precise radiolabeling on improving the safety profiles of radiopharmaceuticals and complying with regulatory frameworks
10:45 am Morning Refreshments & Networking
Improving Logistical Efficiency, Safety & Navigating Quality Compliance Challenges in Radiopharmaceutical Facilities
11:45 am Navigating Regulatory & Logistical Complexities During Import/Export to Ensure Safe & Effective Delivery
Synopsis
- Discuss the challenges of transporting radiopharmaceuticals, including adhering to import/export regulations for hazardous materials
- Examine how to coordinate with customs authorities to streamline the clearance process for radiopharmaceuticals
- Develop best practices to maintain the integrity of radiopharmaceuticals during transport to clinical sites and ensure efficacy
12:15 pm Aligning Compliance Standards in Multi-Product Facilities to Ensure Regulatory Approval
Synopsis
- Review challenges in maintaining regulatory compliance when manufacturing multiple radiopharmaceutical products in a single facility
- Develop best practices for achieving GMP compliance in multi-product facilities that handle complex production processes
- Discuss ways to integrate health and radiation safety protocols for smoother regulatory approvals
12:45 pm Roundtable Discussion: Build vs Buy: Navigating Facility Development Choices in Radiopharmaceutical Production
Synopsis
- Evaluate cost implications and operational efficiencies between constructing new facilities and acquiring existing ones
- Examine regulatory and compliance factors for building new facilities versus retrofitting existing ones
- Review case studies of strategic decisions and their outcomes in facility development
1:45 pm Lunch & Networking
Understanding the Diverse Development, Market Potential & Risk Management in Radiopharmaceutical Commercialization
2:45 pm Translating a Reliable Manufacturing & Supply Chain Into Commercial Success
Synopsis
- Review the characteristics of radiopharmaceuticals that matter most for physicians and patients
- Discuss the commercial risks and opportunities of the different therapeutic isotopes (Cu67, Ac-225, Pb-212, etc.)
- Explore the critical links between production and supply and the successful commercialization of radiopharmaceuticals
3:15 pm Developing Comprehensive Risk Assessment Models for Radiopharmaceutical Development
Synopsis
- Identify key regulatory, manufacturing, and distribution risks affecting the commercialization of radiopharmaceuticals
- Develop robust risk assessment frameworks that consider supply chain complexities, product quality, and regulatory compliance
- Review strategies to minimize clinical and market risks, including contingency planning and investment diversification
3:45 pm Evaluating the Market Potential of New Radiopharmaceutical Therapies
Synopsis
- Assess the commercial viability of isotopes like copper-67, and lead-212
- Explore investment trends and venture capital funding in CDMOs to diversify product offerings
- Identify strategic partnerships and licensing opportunities to secure sustainable supply chains for new therapies