Pre-Conference Workshop Day
Tuesday | September 24, 2024
Isotope Supply & Manufacturing
8:00 am Evaluating the Commercial & Pharmaceutical Viability of Radioisotopes to Benchmark Potential
Synopsis
This workshop will focus on assessing the commercial and pharmaceutical viability of new isotopes in radiopharmaceutical production. Participants will explore the challenges and strategies for bringing isotopes actinium-225, lutetium-177, lead-212 and copper-67 to market.
This workshop will cover:
- Assessing Market Demand and Commercial Viability: Examine the market demand for new isotopes by analyzing therapeutic potential, competitive landscape, and pricing strategies. Discuss the projected market size, patient demographics, and revenue opportunities for isotopes like copper-67, actinium-225, and lutetium-177.
- Navigating Radiopharmaceutical Development Challenges: Explore the pharmaceutical challenges in developing new isotopes and radiopharmaceuticals, including production scalability, quality control, and regulatory compliance. Discuss the technical and logistical hurdles in bringing these radiopharmaceuticals from research to clinical application, ensuring they meet GMP standards.
- Strategic Partnerships and Investment Opportunities: Identify key strategic partnerships and investment opportunities that can support the development and commercialization of new isotopes. Discuss the role of venture capital, corporate investments, and licensing agreements in overcoming financial and operational barriers.
Post-production Supply Chain Logistic Networks
12:00 pm Workshop B: Streamlining Back-End Operations in Radiopharmaceutical Supply Chains to Accelerate Transport
Synopsis
This workshop will focus on enhancing back-end operations within the radiopharmaceutical supply chain, emphasizing processes that support compliance, efficient delivery, and overall logistics. Participants will learn how to integrate backend operations with frontend logistics and ensure a seamless distribution process.
This workshop will cover:
- Handling Reimbursements and Payment Processing: Discuss challenges in billing and payment processing, especially when working with insurers, health systems, and global distribution networks. Review strategies to ensure accurate reimbursement.
- Managing Inventory and Demand Forecasting: Explore methods to optimize inventory management based on precise demand forecasting. Identify ways to maintain an on-time supply while avoiding stock shortages or wastage.
- Compliance in Multi-Product Distribution Networks: Review how to maintain compliance in multi-product supply chains. Address best practices for managing inventory across multiple facilities, regions, and distribution channels while maintaining compliance.
Isotope Supply & Manufacturing
3:30 pm Workshop C: Transforming Facilities to Meet GMP Standards: Regulatory & Operational Challenges
Synopsis
This workshop panel will deep dive into the complexities of retrofitting existing facilities to achieve GMP compliance for radiopharmaceutical production. Participants will delve into the regulatory requirements, operational challenges, and strategic considerations necessary for successful facility transformation.
This workshop will cover:
- Understanding GMP Regulatory Requirements for Retrofitting: Discuss the specific regulatory standards that facilities must meet to achieve GMP compliance, focusing on the unique challenges posed by radiopharmaceutical production. Explore how these regulations impact the design and operational workflows of retrofitted facilities.
- Addressing Operational Challenges in Retrofitting: Examine the operational difficulties associated with retrofitting existing facilities, such as integrating new technologies, managing contamination risks, and ensuring continuous production during renovations. Identify best practices for minimizing disruptions and maintaining quality control throughout the retrofitting process.
- Strategic Considerations and Case Studies: Review case studies of successful facility retrofitting projects by highlighting the strategies used to overcome regulatory and operational challenges and discussing the financial implications, including costbenefit analysis, and the role of strategic planning in ensuring long-term compliance and operational efficiency.