8:30 am Coffee & Check In

9:00 am Chair’s Opening Remarks

  • Brett Miller Senior Director - Global Supply Chain, Telix Pharmaceuticals

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

  • Ken Baker Senior Director - External Manufacturing, Fusion Pharmaceuticals

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

  • Gokhan Cakmak Vice President - Supply Chain & Logistics, Fusion Pharmaceuticals

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

  • Michelle Hickey Senior Vice President - Global Manufacturing, Telix Pharmaceuticals

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 and supply chain into commercial success

  • Bryce Kanter Senior Director - Commercial Development, Clarity Pharmaceuticals

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

  • Erwin Bachmohr Consultant, acting as Head of Procurement and Supply Chain, Aricium Pharmaceuticals

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

  • Kemp Dolliver Director - Research and Senior Analyst, Brookline Capital Markets

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

4:15 pm Chair’s Closing Remarks

  • Brett Miller Senior Director - Global Supply Chain, Telix Pharmaceuticals

4:30 pm End of Conference