The broad, long-range objective of the Translational Incubator Core (Core C) is to enhance and accelerate the translational aspects of the Center's goals to develop new classes of host-targeting antiviral therapeutics that are capable of treating multiple NIAID Emerging and Re-emerging Priority Pathogen viruses, when used alone or in combination with other available agents. The Translational Incubator Core will be responsible for providing strategic scientific, regulatory, preclinical and clinical guidance to all U19 research projects. The Core will assist projects in establishing Target Product Profiles and Development Plans for advancing their therapeutics towards the clinic. The Core will provide guidance in areas such as appropriate use of in vitro assays and in vivo models to demonstrate efficacy, pharmacokinetics, ADME (absorption, distribution, metabolism, and excretion), and preclinical safety. When appropriate, the Translational Incubator Core will provide advice regarding commercialization options when this is required to further advance the project. In addition, each year the Core will select and provide guidance to pilot projects to develop therapeutics or supportive technologies that address emerging or re-emerging infectious diseases and are both consonant with the translational research theme of the Center and capable of enhancing existing projects. The Translational Incubator Core will seek to achieve these objectives via the following specific aims: 1) To provide regulatory science expertise and support to all participating research projects. 2) To provide strategic advice, expertise and practical support on the translational aspects of the Center's projects, thereby accelerating progress in accomplishment of preclinical development activities. 3) To identify research projects and technologies within the greater Stanford community that could directly enhance the Center's projects and translational efforts to develop new classes of host-targeting antiviral therapies
In summary, we seek to develop new classes of host-targeting antiviral therapeutics that are capable of treating multiple NIAID Emerging and Re-emerging Priority Pathogen viruses, when used alone or in combination with other available agents.
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