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 us has secure and potent scientific countermeasures--such as vaccines, medicinal drugs, and diagnostic tools--available to be used in the course of a catastrophe can suggest the variation among lifestyles and demise for lots of americans. The meals and Drug management (FDA) and the medical neighborhood at huge may benefit from enhanced medical instruments and analytic thoughts to adopt the complicated clinical overview and selection making had to make crucial scientific countermeasures on hand. on the request of FDA, the Institute of medication (IOM) held a workshop to check how you can increase the improvement, review, approval, and rules of scientific countermeasures.
During public healthiness emergencies akin to influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and potent vaccines, remedies, and different clinical countermeasures are necessary to conserving nationwide protection and the health of the general public. Advancing Regulatory technology for scientific Countermeasure Development examines present clinical countermeasures, and investigates the way forward for study and improvement during this sector. Convened on March 29-30, 2011, this workshop pointed out regulatory technology instruments and techniques which are to be had or lower than improvement, in addition to significant gaps in at present on hand regulatory technology instruments.
Advancing Regulatory technology for scientific Countermeasure Development is a priceless source for federal organisations together with the nutrition and Drug management (FDA), the dep. of wellbeing and fitness and Human prone (HHS), the dept of protection (DoD), in addition to overall healthiness execs, and private and non-private wellbeing and fitness organisations.
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Additional resources for Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary
Figure 2-1 SOURCE: Susan McCune. 2011. Presentation at IOM workshop; Advancing Regulatory Science for Medical Countermeasure Development. Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary MCM ENTERPRISE AND STAKEHOLDER PERSPECTIVES 17 Center for Biologics Evaluation and Research (CBER) Products regulated by CBER include blood, blood components and derivatives, vaccines, allergenic products, cell and gene therapies, xenotransplantation products, human tissues, and various related devices, explained Carolyn Wilson, associate director for research at CBER.
To aid benefit-risk decisions, Rose suggested, reviewers of MCMs ought to have the requisite security clearances to be allowed to read the associated confidential population threat assessments. In later discussion about safety assessment, Richard Forshee of the Office of Biostatistics and Epidemiology at CBER, mentioned current agency efforts to develop risk assessment models to support regulatory decision making. These probabilistic quantitative computer simulation models can help explore how different regulatory science options could ultimately have an impact on public health, and thereby improve decision making.
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.
Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 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