Reading Room Production — page 467

Draft forces by investing in multi-use products is straightforward. Diagnostic platforms and multiplex technologies can address biodefense needs while simultaneously seeking access to durable and well-defined commercial markets. Many pathways and strategies for finding dual utility exist for therapeutics and these need not be enumerated here. While it is true that some required products (e.g., vaccines, antitoxins) have inherently circumscribed uses, it does not follow that market forces cannot be leveraged to support their development. One way to leverage market forces is to reduce the risk and costs of development and manufacturing to such an extent that the existing, circumscribed market becomes a sufficient incentive in itself to drive development. A more sustainable strategy, however, is to support the development of limited-use products by investing in enabling, "multi-use" platforms and technologies that reduce the complexity, time, and cost of developing the desired product. These platforms and technologies can then be turned to other commercial applications that will provide the return on investment that private sector partners seek while also providing our chief defense against newly emerging threats. The U.S. Government has already made substantial investments in such platforms and technologies through the Transformational Medical Technologies Initiative Program supported by the Department of Defense (DoD) and numerous investments at the National Institutes of Health (NIH). To lower cost and risk in pursuing novel multi-use products and platforms, the U.S. Department of Health and Human Services (HHS) and DoD can assist the pharmaceutical industry by providing scientific expertise, critical reagents, repositories of essential specimens and products, animal facilities, pilot lot manufacturing facilities, and clinical trial networks. The goal in so doing is not only to partner with industry and decrease their investment risk while facilitating the development of specific products needed for public health and national security, but also to foster and promote the development of multi-use products, platforms and technologies in which industry would otherwise not invest because of the prohibitive costs. Once developed, these technologies could be used by industry for the development of products that would attract a considerable commercial market outside of the realm of biodefense and pandemics. In turn, once up and running, these platforms and technologies could be adapted to the development of countermeasures against unpredictable threats to public health, either deliberate or naturally occurring. The challenge is to accept that in general our guiding principle should be we shouldto directconstrain our investments to products and approaches that embrace the concept of multi-use. Over time, the cascading benefits of accepting this fundamental principleconstraint promise to be enormous. Focusing on multi-use products, platforms, and technologies that provide our private sector partners with access to legitimate commercial markets will accelerate and simplify medical countermeasure development, decrease our partners' dependency on direct government subsidies, assure ongoing manufacturing capability, and decrease aggregate cost and risk to the U.S. Government. Perhaps the greatest benefit of adopting the multi-use principle is that it represents the only true path to long-term sustainability for the iPHEMCE. Under our current one-bug, one-drug, onevaccine paradigm, the aggregate costs over time of discovery, development, procurement, stockpile maintenance, and securing ongoing access to surge manufacturing capability for each of the many countermeasures we require are prohibitive. And these costs are just for the threats we know about and can predict. By adopting the multi-use principle, and by sharing the costs of discovery and development with the private sector, which will have a vested interest in maintaining the multi-use