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platforms and technologies Science Draft projects between departments and agencies and from stage to stage of product development and testing. Conclusion The development of drugs, diagnostics, and vaccines against naturally occurring pandemics and emerging infectious diseases, as well as against deliberately propagated bioterror and other threats, is a national security imperative. But the substantial U.S. Government investments made since 2002 have not succeeded in producing the desired flow of new and next-generation countermeasures. We now recognize that it is only by attacking the direct barriers to the development of countermeasures against public health threats that we will increase our prospects of success. To say this is not to belie the value of incentives external to the drug development process. It is merely to point out that external incentives by themselves are insufficient. Going forward, the U.S. Government will change the way it defines its mission and role in supporting the development and acquisition of medical countermeasures against public health threats. We will pursue a strategy with five critical pillars for biodefense product development: I. The Multi-Use Principle - for individual products but also platforms and technologies II. Precompetitive Collaboration III. Regulatory Innovation and Advancement in Regulatory Science IV. Product Development and Manufacturing Services V. End-to-end Multidisciplinary Project Management By implementing these pillars rigorously and without delay, the U.S. Government can transform the nature of the public-private partnerships it supports in this area. Ultimately, these changes will create a new template for government partnership in the arena of private-sector drug development in all the many areas where progress has been impeded by apparent market failures, will increase the productivity of our investments in the life sciences, and will enhance U.S. competitiveness. This approach is expected to provide the following clear advantages for biotechnology companies, large pharmaceutical firms, and the U.S. Government: Advantages for biotechnology companies • Increases speed and lowers risks in the development of countermeasures; • Offloads downstream development activities where expertise is lacking and more difficult to obtain; • Allows for greater focus on discovery translation and technology innovation; and • Creates a more durable business model. Advantages for large pharmaceutical firms