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these science and technology investments to be able to translate products more effectively into the advanced development process. A. Broad Spectrum Products: Existing anti-infective products possess narrow activity across the wide range of potential pathogens, a) Vaccines. Using Influenza as an example, vaccines are exquisitely targeted such that a new influenza vaccine is required annually. Cross-protective vaccine concepts offer the potential for a universal influenza vaccine, eliminating annual vaccines and essentially providing pre-existing pandemic protection, b) Drugs. Given the virtually limitless number of natural and potential organisms that could constitute public health threats, it is essential to pursue the broad spectrum approach towards therapeutics. Truly broad spectrum products offer the potential not only to address the vast, existing and emerging infectious disease spectrum, but to produce effective countermeasures for 'unpredictable' diseases, c) Diagnostics. Highly multiplexed methods that take advantage of the specificity in nucleic acid, antibody and other protein signatures are well recognized as the approaches needed to develop rapid, sensitive and specific diagnostic tools, but challenges lie in miniaturization, cost, computational analysis of multiplexed information and signal to noise issues. B. Broad Spectrum Platforms: The concept of new platforms pertains most readily to vaccines and other biologics. Standardized recombinant DNA technologies must be developed for immediate application in the context of emerging infectious diseases. Standardized methods offer the potential to significantly reduce the complexity, time, and cost required to bring medical countermeasures to general use. In addition, multiplexed platform diagnostics systems offer the capability to test for a wide array of pathogens that are already recognized, while at the same time, offering a simple and straightforward path for diagnosis as novel pathogens evolve or emerge. C. Broad Spectrum Technology: Technological enhancements offer greater capabilities in storage, dispersal, and utilization of countermeasures. NIH has focused on temperature stabilization and alternative delivery for vaccines as ancillary technologies with potential applicability to existing as well as future vaccines. This focus reflects the end-user needs for products that are less reliant on cold chain, and can be self administered with a single dose. For example, temperature stabilization allows for room temperature stockpiling which reduces storage and shipment costs as well as extending the shelf life of the vaccine. The potential to improve the vaccination effectiveness in the 3rd world where cold chain capability can be limited is enormous. 2. ADVANCED DEVELOPMENT AND MANUFACTURING CAPABILITY Successful efforts at the bench prove their worth in the advanced development stages of candidate product development. Platform technologies must succeed against the increasing levels of regulatory scrutiny during the scale up and testing process, and ultimately must produce a specific vaccine, drug or diagnostic, and not just a general demonstration of technology feasibility. Currently, challenges to advanced development include lack of product and manufacturing expertise among innovative sponsors which are often small biotech companies, strong reliance on animal models for efficacy data in lieu of trials in humans, insufficient methods to address safety and discard those products likely to cause unacceptable toxicity in human trials, or to ensure product reliability and stability, and lack of flexible capacity to surge or dampen manufacturing capacity based on population and market needs. Early alignment of the biotechnology / innovator