4th Global Forum World Federation of Haemophilia Montreal September 2005

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4th Global ForumWorld Federation of
HaemophiliaMontreal September 2005

• Duncan Armstrong

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GCBS Initiative

• Project Concept
• Source of Material
• Manufacturing Aspects
• Regulatory Aspects
• Distribution
• Economic Considerations
• Conclusion

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Project Concept

• Global Collaboration Blood Safety (GCBS)
• Plasma Issues Working Group
• Core members
• Thierry Burnouf, Theo Evers, Charles Waller,
• Ana Padilla, Neelam Dhingra
• Recommendation
• Enhance the availability of affordable plasma
  derived products world wide
• Initial focus haemophilia to establish a working
  model
• David Page- The recovery and humanitarian
  distribution of currently discarded factor VIII
  and IX proteins
• Related Topics
• Shorten expiry time of donated products
• Humanitarian donations of products
• Pledge donations in advance

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Source of Material

• Potential Plasma Suppliers
• Canadian Blood Services
• Haéma-Québec
• Australian Red Cross Blood Service
• Quality of plasma
• Intermediates
• Cryoprecipitate, cryo-poor plasma
• Bayer, CSL, NBI
• Audit of facilities
• Quality of plasma and intermediates
• Minimum requirements
• Segregation of plasma
• More activity, more product

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Manufacturing Aspects

• Product
• National Bioproducts Institute
• Additional capacity in March 2006
• Processing, Lyophilisation, Filling
• Constraints
• Quantity quality of cryo-precipitate
• Fill volume
• Products
• Factor VIII intermediate purity, SD treated
• Factor IX prothrombin complex, SD treated
• Room temperature storage

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Regulatory Aspects

• Inbound considerations
• All materials require Medicines Control Council
  approval (MCC)
• Lengthy procedure 6-9 months
• Audit reports
• Plasma source
• Intermediate processing centres

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Regulatory Aspects

• Outbound logistics
• South Africa
• Export permit Department of Health
• Ensure local requirements are met
• Routine normal procedure 3 weeks
• MCC declared its intention to become a member of
  PICS (Pharmaceutical Industry Collaborative
  System)
• Country of destination
• Import permit
• Product registration

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Distribution

• Collaborative decision
• World Federation of Haemophilia (WFH)
• World Health Organisation (WHO)
• South African Haemophilia Foundation (SAHF)
• Canadian Blood Services (CBS)
• Haéma-Québec
• National Bioproducts Institute (NBI)
• Focus
• Developing countries
• No established market

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Economic Considerations

• Source material
• Donated material (single most expensive
  component)
• Manufacturing
• Capacity
• Technology partners
• Cost recovery (direct costs)
• Regulatory Aspects
• Legal Regulatory Affairs
• Import / export requirements
• Product registration

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Economic Considerations

• Logistics
• Experience in transporting materials from
  America, Asia and Europe
• Distribution
• Out-reach program, Global Alliance for Progress
  (GAP)
• Undertaking to DOH to support Southern Africa
  Development Community (SADC) countries initiative
• Funding
• Challenge to provide free product

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Conclusion

• Can it be done?
• Judith Poole, Ben Grobbelaar, Frank Schnabel
• German Red Cross, Natal BTS, WFH, SAHF
• 1966, 1968, 1975 (Helsinki)
• 1970 to 1992
• Yes but not alone
• Collaborative program
• Different partners
• Different environment
• More challenges
• Equal commitment
• Patient is still number one
• Can make a difference