Download Advancing Regulatory Science for Medical Countermeasure by Institute of Medicine, Board on Health Sciences Policy, PDF

By Institute of Medicine, Board on Health Sciences Policy, Forum on Medical and Public Health Preparedness for Catastrophic Events, Development, and Translation Forum on Drug Discovery, Anne B. Claiborne, Bruce M. Altevogt, Theresa Wizemann

Even if the U.S. has secure and potent scientific countermeasures--such as vaccines, medicines, and diagnostic tools--available to be used in the course of a catastrophe can suggest the variation among existence and dying for plenty of americans. The nutrients and Drug management (FDA) and the clinical neighborhood at huge may gain advantage from superior clinical instruments and analytic suggestions to adopt the complicated clinical review and choice making had to make crucial scientific countermeasures to be had. on the request of FDA, the Institute of drugs (IOM) held a workshop to envision the right way to increase the improvement, overview, approval, and rules of clinical countermeasures.

During public future health emergencies resembling influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and potent vaccines, remedies, and different clinical countermeasures are necessary to maintaining nationwide safeguard and the health of the general public. Advancing Regulatory technology for clinical Countermeasure Development examines present scientific countermeasures, and investigates the way forward for learn and improvement during this region. Convened on March 29-30, 2011, this workshop pointed out regulatory technological know-how instruments and techniques which are to be had or below improvement, in addition to significant gaps in at the moment on hand regulatory technological know-how instruments.

Advancing Regulatory technology for scientific Countermeasure Development is a important source for federal companies together with the foodstuff and Drug management (FDA), the dep. of future health and Human prone (HHS), the dept of safety (DoD), in addition to health and wellbeing execs, and private and non-private overall healthiness businesses.

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Genomics, proteomics, metabolomics) have generated a flood of new data, driving the need for new types of analytics such as in silico or computer modeling of biology. These new data enhance and align with existing knowledge of disease pathways and mechanisms from the literature. A typical systems biology approach is philosophically data driven 29 Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 30 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT Discovery Use understanding of disease mechanisms to identify and validate targets Toxicology Biomarkers Pharmacogenomics Understand Identify novel Elucidate biological mechanisms behind biomarkers by mechanisms of understanding role differential response drug action and to R(x) in disease pathways toxicity Patient Docetaxel Disease mechanisms Cellular mechanisms Molecular mechanisms Prostate cancer Apoptosis Angiogenesis Fas Vegf Cancer Experimental Data Computational Modeling Literature and Prior Knowledge FIGURE 3-1 In silico modeling of disease mechanisms for drug development.

It was suggested that instead, FDA already has the authority to approve products with conditions for their safe use. Under this authority, some argued that FDA could impose conditions such as, for example, that the MCM is only ever used under an EUA, only from the SNS, or only for specified needs. Ed Nuzum, chief of the Biodefense Vaccines and Other Biological Products Development Section at NIAID, suggested that having a defined provisional approval step—a clear and potentially attainable goal short of full approval—could help to incentivize small companies and their investors to develop MCM.

She cited the FDA-NIH regulatory science initiative as a potential opportunity to allow FDA to leverage scientific resources from NIH and further engage FDA scientists in professional development. • Third, she suggested, licensure review could be expedited by engaging cross-functional expert teams early on. S. government contracts and the relevant funding agency, at least at significant time points or milestones. • Public-private partnerships, such as early development partnerships between industry and DoD and NIH labs, could be effective, and cross-industry precompetitive collaboration models should be pursued.

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