Reading Room Production — page 475

Draft • Increases speed and lowers risks in the development of countermeasures against public health threats; • Enhances innovation by providing access to newer technologies sooner; • Provides an incubator and test bed for new platforms and technologies for future use in the development of commercially desirable products; and • Enables more productive engagement with the FDA Advantages for the U.S. Government • Increases speed and lowers costs and risks in the development of medical countermeasures; • Ensures sustained domestic U.S. production capability; • Enhances USG surge capacity available for emerging and reemerging diseases; • Provides for a critical mass of technical expertise that is available for a more rapid response when needed; • Enables more overall drug development effort due to lower investment cost; • Raises the potential to partner with NGOs and others to address global health problems; and • Establishes a model for drugs, diagnostics, and vaccines for any and all diseases, including in cases where commercial viability is doubtful. The strategy outlined is a significant departure from the U.S. Government's previous approach. It is not without some risk. But to eschew the uncertain risk associated with establishing a new business model and continue with the certain risk of unacceptable return that our current model continues to demonstrate would be untenable. Even if we were better able to produce effective countermeasures with our current model, over time our one-bug, one-drug, one-vaccine approach will inevitably lead to a lack of sustainability for the Enterprise as a whole, as the costs of discovery, development, procurement, stockpile maintenance, and securing ongoing access to surge manufacturing capability are aggregated for each of the many countermeasures we require. A critical factor for successful implementation of our new strategy is a holistic approach to knocking down barriers impeding progress. There currently exists pockets of effort attempting to address these barriers and adopt some of the pillars of the strategy outlined here, but an ad hoc and incomplete approach will not create the conditions for a breakthrough in establishing a successful, sustainable approach. Incremental improvements will not achieve our goals. Only by leaping forward, employing the outlined strategy pillars comprehensively and broadly, will we achieve the output for which many in the IPHEMCE have worked tirelessly. Now is the time to establish an approach yielding dramatically improved return on investment. Our return will not be measured in dollars but in the protection of the safety and security of the American people. In pursuing this fundamental charge of the Federal government, it is abundantly clear that failure is not an option.