Module C: CMO Selection & Relationship Management

14:15 – 14:45
Identifying the criteria to help you find a CMO that meets your specific needs
• Exploring which criteria should be used when sourcing an external manufacturer, including:
    o Cost
    o Quality
    o Capacity
    o Technical and scientific expertise
• Understanding the capabilities of the CMO for sourcing raw materials including excipients at best quality and value
• Ensuring the legal accountability of the CMO at all stages of sourcing and production
• Establishing guidelines for the formation of an appropriate partnership model which suits the manufacturing requirement and company type/capability
Roberto Margarita, Ph.D., Business Development Director, Bristol-Myers Squibb

14:50 – 15:25
Ensuring quality output from your CMO: Implementing assurance measures
• Understanding how different country regulatory frameworks supports quality assurance - how might this change in coming years?
• How to effectively lower the total cost of ownership for the client, while maintaining quality from the CMO
• Performing due diligence and creating confidence through quality system audits: Both internal and external
• Checking for contamination at all critical stages within a complex supply chain
• Avoiding substitution of products without prior consent or knowledge of the client
Eric Hilton, Director, FDAS
Paul Sidhu, VP Marketing and Strategy, DSM

15:30 – 16:00
Exploring the increasing role of CMOs and the changing relationship
• How are CMOs adapting to client pressure to take on larger roles and more responsibility
• What are the implications for both CMOs and the client?
• A 5-year outlook on the future of manufacture outsourcing
• Assessing the role CMOs will play in biopharma manufacturing
• Mergers and acquisitions - are they the future?
Jo Pisani, Partner, Pharma Outsourcing, PriceWaterhouseCoopers
 

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