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 powerful 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 dying for lots of americans. The foodstuff and Drug management (FDA) and the medical neighborhood at huge may gain advantage from greater clinical instruments and analytic strategies to adopt the complicated clinical assessment and determination making had to make crucial clinical countermeasures to be had. on the request of FDA, the Institute of drugs (IOM) held a workshop to ascertain how you can increase the improvement, evaluate, approval, and legislation of scientific countermeasures.

During public overall healthiness emergencies comparable to influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and potent vaccines, remedies, and different scientific countermeasures are necessary to maintaining nationwide protection and the health of the general public. Advancing Regulatory technological know-how for clinical Countermeasure Development examines present clinical countermeasures, and investigates the way forward for study and improvement during this quarter. Convened on March 29-30, 2011, this workshop pointed out regulatory technological know-how instruments and techniques which are to be had or lower than improvement, in addition to significant gaps in presently on hand regulatory technological know-how instruments.

Advancing Regulatory technology for scientific Countermeasure Development is a worthwhile source for federal corporations together with the meals and Drug management (FDA), the dept of wellbeing and fitness and Human companies (HHS), the dep. of protection (DoD), in addition to wellbeing and fitness pros, and private and non-private healthiness businesses.

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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.

Leffel identified four key regulatory science needs relative to animal models. First, she said, the essence of the Animal Rule needs to be consistently defined to product sponsors. There are different interpretations across FDA divisions, she noted, and sometimes between reviewers within the same division, of how to apply the Animal Rule. Second, appropriate review of MCMs based on risk and benefit is needed. These are high-risk, life-threatening diseases, about which clinical knowledge is often limited.

One must consider, for example, whether there is similar pathophysiology as the human disease or similar mediators of immune protection. For product development, are there well-defined generic animal models or platforms that could be used? Most of the time, Lyons said, researchers are working with a nonvalidated surrogate that is “reasonably likely” to predict clinical efficacy. Lyons opined that it is unlikely one species model will reflect human disease adequately and suggested a compartmentalization strategy, pooling data from several species models.

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