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Draft biotechnology firms to pursue the development of products that meet our national security and overall public health needs. While the capital outlay necessary to establish this advanced development and manufacturing capability will be substantial, the benefits in terms of increased research and development productivity will more than justify the cost. Implementation of the multi-use principle will substantially reduce the costs associated with individual projects since multi-use value will enhance access to private capital markets, justify independent development, and reduce the need for advanced development and manufacturing support.3 V. End-to-end Multidisciplinary Project Management U.S. Government support for the development of countermeasures against deliberately released and naturally occurring health threats is parceled out across numerous departments and agencies, and the release of requests for proposals and other targeted solicitations across this bureaucratic space is not well synchronized. While there have been efforts to coordinate U.S. Government countermeasure investments in an "Integrated National Portfolio" approach, a unified approach to budgeting and governance has not been achieved. For many private-sector partners, unfortunately, the IPHEMCE remains a confusing welter of acronyms, agencies, and funding mechanisms. This complex funding and policy environment is exceptionally difficult to navigate, particularly for the smaller firms and academic start-ups that are the main engines for innovation. Coupling the challenges of negotiating this terrain with the challenges of product development and the quirks of the "animal rule" pathway to product licensure has created an environment that is inhospitable to the translation of promising basic-science discoveries into clinically useful products. The U.S. Government will implement a new program of end-to-end multidisciplinary project management to mitigate the complexity of our current institutional arrangements, identify relevant funding opportunities, facilitate handoffs between different departments and agencies, and inform private-sector partners at every stage of product development about relevant policy and the path to product approval. Multidisciplinary project management teams will include program managers, subject matter experts from DoD, NIH, BARDA, and the Centers for Disease Control and Prevention (CDC), a liaison from FDA, and, as needed, regulatory officers from NIH and BARDA. The role of these teams will be to serve as "Sherpas" to our academic and private sector partners. Sherpas, of course, are members of a people of Tibetan descent who in modern times have achieved renown as expert guides on Himalayan mountaineering expeditions. During such expeditions, each climber is assigned a Sherpa to carry his or her gear, cook food, and set up camp. The Sherpa's role is to make the climb as easy as possible for the person being guided. All the climber has to focus on is climbing. Experienced Sherpas also recognize when a climber is not going to make it and can take appropriate action. The multidisciplinary project management teams would play an analogous role for academic and private sector partners, providing strategic recommendations where appropriate, and helping them negotiate the bureaucratic, scientific, policy, and funding terrain. It will be the responsibility of the project management teams to ensure the coordinated transition of 3 In the optimal case of an already licensed product with dual utility and a substantial human safety database, the costs of development will be limited to the costs of demonstrating efficacy in validated animal models and filing a supplemental New Drug Application (NDA).