8:00 am Coffee & Check In
9:00 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
Scaling Radiopharmaceutical Production Through Improved Training, Tech Transfer, Safety & Regulatory Compliance to Meet More Demand
9:30 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
10:00 am Morning Refreshments & Networking
Improving Logistical Efficiency, Safety & Navigating Quality Compliance Challenges in Radiopharmaceutical Facilities
11:00 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
11:30 am Developing CMC Strategies for Radiopharmaceuticals from Academia to Commercial
Synopsis
- Investigator INDs to Commercial INDs: Considerations for comparibility and bridging
- Developing a qTPP
- Enabling Type C Meetings for Phase 3
12:00 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
1:00 pm Lunch & Networking
Understanding the Diverse Development, Market Potential & Risk Management in Radiopharmaceutical Commercialization
2:00 pm Maximizing the Commercial Potential of Radiopharmaceuticals With Best-In-Class Supply Chains and Products
Synopsis
- Discuss the challenges with radiopharmaceutical supply chains that must be addressed to achieve commercial success
- Review the diagnostic and therapeutic isotope landscape: which isotopes have the greatest commercial potential
- What ultimately matters to physicians and patients: availability, efficacy and safety
2:30 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
3:00 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