Looking Ahead: Strategies for Building a Platform

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Looking Ahead Strategies for Building a Platform

• Pandemic Influenza Vaccines Building a Platform
  for Global Collaboration
• David Nabarro
• January 30th 2007

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Pandemic Influenza Vaccines
Not an easy prospect for Manufacturers

• Pandemic Vaccines have
• Potentially a high public health value and huge
  social and economic benefits,
• low commercial value for developers and
  manufacturers
• There is not agreement on the optimal product
• The market is uncertain
• There are risks for manufacturers in scaling up
  production
• Regulatory, Intellectual Property challenges lie
  ahead
• There are deep concerns about equity of access
  there will be public pressure for equity of
  predictable and prompt access to vaccines
• Pandemic vaccines do not have the potential to
  result in sustained multi-billion dollar markets

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Pandemic Influenza Vaccines
The Public Health Imperative

• Need for faster research and development to
  develop better vaccine production technologies
• Need to shorten lead times and manufacturing
  cycles of existing vaccines
• Need to factor in the inevitable redundancy in
  the product short shelf life, reduction in
  potency due to antigenic drift
• Need for global coverage
• And so on.
• To respond manufacturers and researchers will
  need adequate incentives
• Finance for strategic R and D finance to reduce
  manufacturers risks
• Are there Investors convinced that the cost is
  worthwhile?

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Pandemic Influenza Vaccines
Why a global platform might help

• Potential Stakeholders
• R and D groups
• Manufacturers
• Regulators
• Governments
• International Bodies
• Potential value of a global platform
• A meeting place where open (and critical)
  dialogue is possible
• An opportunity for structured exchanges to tackle
  difficult issues (strategies to find solutions,
  together)
• A grouping of committed partners determined to
  move forward in synergy an INITIATIVE

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Pandemic Influenza Vaccines
Platform for Talk or Initiative for Action which
way to go?

• An Initiative for Action means having
• Common Vision and Goal
• Agreed Strategy (product, development,
  manufacture, distribution, administration,
  control)
• An Implementation Process
• Attention to Access and Distribution Issues
• Backing to make it happen

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Pandemic Influenza Vaccines
Strategy for a New Initiative
WHO Global Action Plan to Increase Access to
Pandemic Vaccines

• Components
• Increase use of seasonal influenza vaccine
• Increase production capacity for pandemic
  vaccines, independent of seasonal vaccine use
• Research and develop new technologies and new
  vaccines
• ? comprehensive analyses of existing problems
  global overview of generic solutions strategic
  basis for a new initiative

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Pandemic Influenza Vaccines
Establishing an Initiative Challenges to be
addressed

• Challenge 1 Ensuring there is worldwide
  political support for international attention to
  pandemic vaccines (funding follows a political
  wind)
• Challenge 2 Selection of technology Speed and
  cost of production, streamlined regulatory
  review. safety and intellectual property issues,
  administration route
• Challenge 3 Establishing the demand Need for
  developing as well as developed countries to
  agree on potential demand in a context of
  uncertainty willingness to stockpile, to
  vaccinate before a pandemic, to guarantee
  supply to poor countries
• Challenge 4 Clarifying the supply potential
  specifically the potential for steady state
  manufacture, for surge in the event of pandmeic
  determining the risks that industry will face
• Challenge 5 Preparing an initiative Options for
  different partners to work together on (a) Demand
  analysis, (b) R and D, (c) Intellectual Property
  Protection, (d) Production, (e)
  Regulation and PMS, (e) Distribution issues, (f)
  Advance Purchase
• Challenge 6 Structure and programme for the
  Initiative