Reading Room Production — page 466

Draft efforts and resources on the development of more commercially viable productselsewhere. The innovative small biotechnology firms that have been attracted to countermeasure development against bioterror and pandemic threats generally do not possess the inherent expertise or capabilities that enable larger firms to complete development and industrialization projects. The result for the U.S. Government has been an inconsistent return on its investments to date. The Administration's initiative is aimed at transforming how investments are made in the countermeasure enterprise and at enhancing performance of the enterprise through highly engaged end-to-end support and management. Greater productivity from such investments will be achieved primarily by reducing or eliminating the barriers that impede progress. By reducing these barriers, the U.S. Government can change the calculus that results in an unacceptable return on investment and thus offer private sector partners a more favorable value proposition. As a complement to Complementing this approach of attacking the barriers, incentives external to the drug development process will also be employed in more creative ways. The new U.S. Government strategy comprises five principles or "pillars" necessary to transform IPHEMCE. The first is the adoption of the multi-use principle as a high priority and governing principle for future investments. The second through fifth pillars are collectively aimed at fundamentally altering the conduct and management of public-private partnerships in the area of countermeasure development against public health threats. These pillars will be pursued in tandem and as an Enterprise-wide initiative. Implementing individualtke pillars alone or in isolation will not effect the comprehensive transformation that is required or ensure greater productivity for our efforts and investment. The principles must be enacted and implemented together as a composite initiative if their full benefit is to be realized. The goal is to markedly increase the return on the U.S. Government' investment in medical countermeasures against public health threats. Achieving this breakthrough will yield a new template for government support of private sector drug development in areas where progress has been impeded by apparent market failures. I. The Multi-Use Principle Orthodox opinion holds that the U.S. Government is the only customer for biodefense and pandemic countermeasures and that viable commercial markets for these products do not exist. This received wisdom has inhibited efforts on the part of government program managers to find and leverage the market forces that will attract private sector partners to invest in projects that address our requirements. For far too long, the U.S. Government has attempted to counter market forces that drive potential private sector partners toward lower-risk investments in other areas. As our track record in countermeasure programs demonstrates quite clearly, however, ignoring market realities makes a difficult process even more challenging. The easiest way to enlist the aid of market forces is by developing specific countermeasures that have legitimate markets. Such was the case with our pandemic influenza program that successfully engaged several pharmaceutical companies and that resulted ultimately in a safe and highly effective vaccine. [The success of our pandemic influenza program illustrates this principle in a dramatic way. In other cases, the solution has been to focus on "multi-use" products that address many threats simultaneously or that among a wider range of indications demonstrate efficacy against specified threats. Where therapeutics and diagnostics are concerned, leveraging market 'Commented [a2]: Tlnow that Thave read this many times and have not changed it. However, it ust stuck me thatthe use ofthe pandemic influenza program asa "succes" story might decrease our {redbiity since the USG pot am "F"for this and this has embarassed the POTUS. Thus, Ihave changed the wording somewhat afmuci 2010-02-11 20:10:00