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For Official Use Only Information Paper on Developing a Systems Approach for Managing the Public Health Emergency Medical Countermeasure Enterprise A. BACKGROUND • Despite significant effort and research expenditure to develop public health emergency medical countermeasures (vaccines, drugs, diagnostics, devices) there are insufficient products in the current development pipeline to address these natural or man-made threats. • The current pathway for product development involves multiple steps which include: defining product characteristics, discovery, advanced development, manufacturing, procurement, storage, distribution, and patient administration. • What we currently lack is a 'systems" or end-to-end approach for product development B. AIM We require a unified management approach for this product pipeline, potentially under a single decision authority, that incorporates metrics for success and continually monitors the progress of products through a sustainable, long-range and properly-structured enterprise. We propose to improve the current system by focusing on four components of the countermeasure development process: 1). science and technology investments, 2). advanced development and manufacturing capability, 3). regulatory science, laws and regulations and 4). product use and improvement In addressing these components, we anticipate 1) advancing science and technology, for national and global health security, 2) improving our preparedness and ability to respond to natural and man-made disasters, 3) aligning financial and market incentives for these products 4) creating public-private partnerships (government, academia and industry) for cutting edge, scientifically-based manufacturing, which 5) creates substantial job opportunity for a highly-skilled workforce. 1. SCIENCE AND TECHNOLOGY INVESTMENTS An integrated, systems approach begins with a science and technology effort that keep the end-users in mind, and builds a target product profile based on those needs. This ultimately contributes to the best "return on investment". At a minimum, we require rapid, facile point of care and multiplexed diagnostics; new broad-spectrum antimicrobial drugs and vaccines; user-expedient vaccine delivery methods; room temperature long term stability and field-friendly equipment that improves management of life support. The NIH has been transitioning to a new paradigm to address these types of needs with three "broad spectrum" strategies (products, platforms, and technology) to achieve a more flexible and responsive medical countermeasure capability that moves beyond the traditional medical countermeasure approach of "one bug - one drug - one vaccine". The goal is for